Company QAM

Quality Assurance Manual (QAM-1) Table of Contents Revision 4 Procedure Number QAM-001
Type: QUALITY ASSURANCE Title: QUALITY ASSURANCE MANUAL
Revision Number: 4 Effective Date: 2/15/2010
REVISION SUMMARY Revision 0 1 2 3 4 Date 4/22/02 4/24/03 1/2/07 4/1/08 2/15/10 Description of Change Original Issue Various minor editorial changes Reformatted. No substantive changes. Complete Reissue Section 17 revised Affected Pages All Various All All Section 17
Approved By:
A. J. Armbrust - Signature on file
Date:
2/15/2010
This is a controlled copy if viewed on a corporate network site. Other sources are not controlled and require verification prior to use.
Page TC-i
Quality Assurance Manual (QAM-1) Table of Contents Revision 4
Table of Contents
Table of Contents ............................................................................................................ ii List of Effective Pages .....................................................................................................iv Quality Assurance Introduction ....................................................................................... 1 Terms and Definitions ..................................................................................................... 4 SECTION 1 - ORGANIZATION ....................................................................................... 1 QA FORM 1-1: STOP WORK ORDER FORM ............................................................ 6 SECTION 2 - QUALITY ASSURANCE PROGRAM AND TRAINING.............................. 1 QA FORM 2-1: NEW HIRE INDOCTRINATION RECORD .......................................... 7 QA FORM 2-2: TRAINING MEETING RECORD ......................................................... 8 QA FORM 2-3: TRAINING ASSIGNMENT (READING) .............................................. 9 QA FORM 2-4: ON-THE-JOB TRAINING RECORD ................................................. 10 SECTION 3 - DESIGN CONTROL .................................................................................. 1 QA FORM 3-1: DESIGN CHANGE AUTHORIZATION................................................ 4 SECTION 4 - PROCUREMENT DOCUMENT CONTROL .............................................. 1 SECTION 5 - INSTRUCTIONS, PROCEDURES AND DRAWINGS ............................... 1 SECTION 6 - DOCUMENT CONTROL ........................................................................... 1 QA FORM 6-1: DOCUMENT TRANSMITTAL ............................................................. 6 SECTION 7 - CONTROL OF PURCHASED ITEMS AND SERVICES ............................ 1 QA FORM 7-1: SUPPLIER EVALUATION AND QUALIFICATION RECORD ........... 11 QA FORM 7-2: SUPPLIER EVALUATION QUESTIONNAIRE .................................. 12 QA FORM 7-3: SUPPLIER RE-EVALUATION .......................................................... 15 QA FORM 7-4: SOURCE INSPECTION REPORT .................................................... 16 QA FORM 7-5: PURCHASE REQUISITION .............................................................. 17 QA FORM 7-6: PURCHASE ORDER (TYPICAL) ...................................................... 18 QA FORM 7-7: GENERAL TERMS AND CONDITIONS ........................................... 19 QA FORM 7-8: SAMPLE CONSULTING AGREEMENT ........................................... 22 SECTION 8 - IDENTIFICATION AND CONTROL OF ITEMS ......................................... 1 QA FORM 8-1: CHAIN OF CUSTODY RECORD (TYPICAL) ..................................... 6 SECTION 9 - CONTROL OF PROCESSES ................................................................... 1 QA FORM 9-1: PROCESS REVIEW PLANNING CHECKLIST ................................... 4 SECTION 10 - INSPECTION .......................................................................................... 1 SECTION 11 - TEST CONTROL .................................................................................... 1 SECTION 12 - CONTROL OF MEASURING AND TEST EQUIPMENT ......................... 1 QA FORM 12-1: CALIBRATION HISTORY RECORD................................................. 4 SECTION 13 - HANDLING, STORAGE AND SHIPPING................................................ 1 QA FORM 13-1: MAINTENANCE RECORD ............................................................... 3 SECTION 14 - INSPECTION, TEST AND OPERATING STATUS.................................. 1 SECTION 15 - CONTROL OF NON-CONFORMING ITEMS .......................................... 1 QA FORM 15-1: NON-CONFORMANCE REPORT .................................................... 4 QA FORM 15-2: NON-CONFORMANCE REPORT LOG ............................................ 5
Page TC-ii
Quality Assurance Manual (QAM-1) Table of Contents Revision 4 SECTION 16 - CORRECTIVE ACTION .......................................................................... 1 QA FORM 16-1: CORRECTIVE ACTION REQUEST.................................................. 4 QA FORM 16-2: PREVENTIVE ACTION REQUEST .................................................. 5 SECTION 17 - QUALITY ASSURANCE RECORDS ....................................................... 1 TABLE 17-1 - RECORD RETENTION MATRIX .......................................................... 5 Section 18 - AUDITS ....................................................................................................... 1 QA FORM 18-1: AUDIT FINDING FORM .................................................................... 5 QA FORM 18-2: AUDIT OBSERVATION FORM ......................................................... 6
Page TC-iii
Quality Assurance Manual (QAM-1) Table of Contents Revision 4
List of Effective Pages

Section TC-I through TC-iii Intro-1 through Intro-8 1-1 through 1-2 2-1 through 2-2 3-1 through 3-2 4-1 through 4-2 5-1 through 5-2 6-1 through 6-2 7-1 through 7-2 8-1 through 8-2 9-1 through 9-2 10-1 through 10-2 11-1 through 11-2 12-1 through 12-2 13-1 through 13-2 14-1 through 14-2 15-1 through 15-2 16-1 through 16-2 17-1 through 17-5 18-1 through 18-2 Revision 4 3 3 3 3 2 3 3 3 3 3 3 3 3 3 3 3 3 4 3
Page TC-iv
Quality Assurance Manual (QAM-1) Introduction Revision 3
Quality Assurance Introduction

The American Society for Quality defines quality assurance as the planned and systematic activities implemented in a quality system so that quality requirements for a product or service will be fulfilled. Every product and service that we provide has quality requirements. Sometimes those requirements are specified by the customer, by federal or state regulations, or by industry standards. Sometimes we impose those requirements on ourselves to reduce the risk of failure associated with a product or service. Philotechnics uses a graded approach to quality assurance, meaning that the application of quality requirements must be done in a manner consistent with the relative importance of the item or activity. The degree of control for a process should be proportional to the degree of risk associated with the process, risk being the likelihood of a problem associated with the process and the impact of such a problem. Those processes which involve less risk have less formal and less pervasive quality controls which meet the minimum requirements of this manual. Processes which involve greater risk have more formal and more pervasive controls. This allows us to remain competitive and to provide to the customer those specific services which the customer wants, without charging the customer for quality controls which the customer does not need and for which the customer does not want to pay. This graded approach requires the project or product manager to exercise judgment in the degree of control needed and requires a well trained work force. The managers application of these procedures is subject to review and evaluation during routine quality audits. The format of this manual is based on a quality standard called Quality Assurance Requirements for Nuclear Facility Applications (NQA-1), which was issued by the American Society of Mechanical Engineers (ASME) and approved by the American National Standards Institute (ANSI). The sections of this manual refer to the corresponding section of NQA-1 and to 10 CFR Part 830.120, a federal regulation dealing with facilities operated for the Department of Energy, and ISO 9001, an international quality program standard. Other federal and state organizations have issued their own requirements for quality programs, such as the Environmental Protection Agency. It is not practical or reasonable to comply with all aspects of all governing regulations in all quality applications, and no attempt has been made to do so in this manual. Most regulatory agencies recognize this and require a project-specific Quality Assurance Project Plan (QAPP) or require compliance with the customers specific quality procedures. The decision chart in this section provides guidance on when to use this manual.
Intro-1
Quality Assurance Manual (QAM-1) Introduction Revision 3 This revision to the corporate quality assurance manual combines the former quality assurance manual and quality procedures manual into one document. QPM-001, Quality Procedures, is cancelled.
Intro-2
Quality Assurance Manual (QAM-1) Introduction Revision 3 When to Use This Manual Decision Chart:
Does the contract or project: DECISION NO YES
1.
Involve design or fabrication OR require NQA-1 compliance?
Limited to packing for DOT approved containers, such as source encapsulation? Write a local, limited compliance procedure that covers issues such as materials, sketches and fabrication. This manual and associated quality procedures must be complied w ith in their entirety for that process or project. Comply w ith applicable sections of this manual. Comply w ith sections 2, 5, 6, 9, 11, 12, 14
2.
Involve management of NRC licensed facilities?
3.
Involve material processing - shipping, sorting, shredding, etc.?
Comply w ith applicable sections of this manual. Comply w ith sections 2, 5-7, 9, 11-18.
4.
Call for use of customer QA procedures?
Do not use this manual. Use customer procedures.
5.
Call for use of QAPP?
Develop a QAPP specifically for the project or contract using the contents of this manual as a basis. The QAPP can be a supplement to this manual or a substitute, depending on customer requirements. The remaining processes done by Philotechnics are small or closely regulated. The requirements of this manual and the procedures manual need to be follow ed only for guidance w ith the follow ing exceptions: 1. Perform QA training per section 2 for full time employees. 2. Control M&TE per section 12. 3. Comply fully w ith the manual for radioactive w aste shipments. 4. Comply w ith section 7 purchasing requirements for M&TE and w aste shipment, processing, packaging and disposal.
Intro-3
Terms and Definitions

The following definitions are provided to ensure a uniform understanding of select terms as they are used in this manual: 1. Acceptance Criteria Specified limits placed on characteristics of an item, process, or service defined in codes, standards, or other required documents. Assessment The act of reviewing, inspecting, testing, checking, conducting surveillances, auditing, or otherwise determining and documenting whether items, processes, or services meet specified requirements. Senior management, project staff, or an independent organization, performs assessments. Audit - A planned and documented activity performed to determine by investigation, examination, or evaluation of objective evidence the adequacy of and compliance with established procedures, instructions, drawings, and other applicable documents, as well as the effectiveness of implementation. An audit should not be confused with surveillance or inspection activities performed for the sole purpose of process control or product acceptance. Business Unit Managers Business Unit Managers as defined in the attached procedures shall indicate: Operations Manager, Project Manager, and Facility Manager. Certificate of Compliance (CoC) A document signed or otherwise authenticated by an authorized individual certifying the degree to which items or services meet specified requirements. Certification The act of determining, verifying, and attesting in writing to the qualifications of personnel, processes, procedures, or items in accordance with specified requirements. Characteristic Any property or attribute of an item, process, or service that is distinct, describable, and measurable. Condition Adverse to Quality An all-inclusive term used in reference to any of the following: failures, malfunctions, deficiencies, defective items, and nonconformances. A significant condition adverse to quality is one that, if uncorrected, could have a serious effect on safety or operability. Corrective Action Measures taken to rectify conditions adverse to quality and, where necessary, to preclude repetition. Intro-4
2.
3.
4.
5.
6.
7.
8.
9.
10.
Design Change Any revision or alteration of the technical requirements defined by approved and issued design output documents and approved and issued changes thereto. Design Input Those criteria, parameters, bases, or other design requirements upon which detailed final design is based. Design Output Drawings, specifications, and other documents used to define technical requirements of structures, systems, components, and computer programs. Design Process Technical and management processes that commence with identification of design input and that lead to and include the issuance of design output documents. Deviation A departure from specified requirements. Document Any written or pictorial information describing, defining, specifying, reporting, or certifying activities, requirements, procedures, or results. Guideline A suggested practice that is not mandatory in programs intended to comply with a standard. The word should denotes a guideline; the word shall denotes a requirement. Inspection Examination or measurement to verify whether an item or activity conforms to specified requirements. Inspector A person who performs inspection activities to verify conformance to specific requirements. Item An all-inclusive term used in place of any of the following: appurtenance, assembly, component, equipment, material, module, part, structure, subassembly, subsystem, system, or unit. Interim Storage: The period of time that documents can be held by the generator prior to turn over to DCC. Measuring and Test Equipment (M&TE) Devices or systems used to calibrate, measure, gauge, test, or inspect in order to control or acquire data to verify conformance to specified requirements.
11.
12.
13.
14. 15.
16.
17.
18.
19.
20.
21.
Intro-5
Quality Assurance Manual (QAM-1) Introduction Revision 3 22. Non-conformance A deficiency in characteristic, documentation, or procedure that renders the quality of an item or activity unacceptable or indeterminate. Objective Evidence Any documented statement of fact, other information, or record, either quantitative or qualitative, pertaining to the quality of an item or activity, based on observations, measurements, or tests that can be verified. 24. Procedure A document that specifies or describes how an activity is to be performed. 25. Procurement Document Purchase requisitions, purchase orders, drawings, contracts, specifications, or instructions used to define requirements for purchase. 26. Qualification, Personnel The characteristic or abilities gained through education, training, or experience, as measured against established requirements such as standards or tests, which qualify an individual to perform a required function. 27. Qualification, Personnel The characteristic or abilities gained through education, training, or experience, as measured against established requirements such as standards or tests, which qualify an individual to perform a required function. 28. Quality Assurance (QA) All those planned and systematic actions necessary to provide adequate confidence that a structure, system, or component will perform satisfactorily in service. In project management, quality assurance is those steps undertaken to verify that the quality planning for the project is being properly applied and that the project is employing all the quality processes needed to meet requirements. 29. Quality Assurance Project Plan (QAPP) a project-specific plan which supplants and/or augments procedures in this manual and specifies quality requirements for a particular task, project or contract. 30. Quality Control As used in project management, quality control means monitoring specific results to determine whether they comply with relevant quality standards and identifying ways to eliminate causes of unsatisfactory performance. 31. Quality Planning As used in project management, quality planning involves identifying which quality standards are relevant to the project or process and determining how to satisfy them. This is of particular important when developing a Quality Assurnace Project Plan (QAPP) for performing work under DOE, EPA or other federal or state regulations.
23.
Intro-6
Quality Assurance Manual (QAM-1) Introduction Revision 3 32. Quality Record A completed document that furnishes evidence of the quality of items and/or activities affecting quality. 33. Preventive Action An activity directed toward eliminating the cause of potential non-conformances. 34. Receiving Taking delivery of an item at a designated location. 35. Repair The process of restoring a nonconforming characteristic to a condition such that the capability of an item to function reliably and safely is unimpaired, although that item still does not conform to the original requirement. Rework The process by which an item is made to conform to original requirements by completion or correction. Risk An expression of possible loss that considers both the probability of an event causing harm or loss and the consequences of that event. Scrap Items that cannot be repaired, reworked, or serve no useful purpose. Service The performance of activities such as design, fabrication, inspection, nondestructive examination, repair, or installation. Shall Refer to guideline for the definition. Should See definition of the term guideline. Special Process A process, the results of which are highly dependent on the control of the process or the skill of the operators, or both, and in which the specified quality cannot be readily determined by inspection or test of the product. Supplier Any individual or organization that furnishes items or services in accordance with a procurement document. An all-inclusive term used in place of any of the following: vendor, seller, contractor, subcontractor, fabricator, consultant, and their sub tier levels. Surveillance The act of monitoring or observing to verify whether an item or activity conforms to specified requirements. Testing An element of verification for the determination of the capability of an item to meet specified requirements by subjecting the item to a set of physical, chemical, environmental, or operating conditions.
36.
37.
38. 39.
40. 41. 42.
43.
44.
45.
Intro-7
46.
Traceability The ability to trace the history, application, or location of an item and like items or activities by means of recorded identification. Use-as-is A disposition permitted for a nonconforming item when it can be established that the item is satisfactory for its intended use. Verification The act of reviewing, inspecting, testing, checking, auditing, or otherwise determining and documenting whether items, processes, services, or documents conform to specified requirements.
47.
48.
Intro-8
Quality Assurance Manual (QAM-1) Section 1. ORGANIZATION Revision 3
SECTION 1 - ORGANIZATION
A. REFERENCES NQA-1 Section 1 ISO 9001-2000 Clause 5.5.1 10 CFR 830.120 Criterion 1 B. APPLICABILITY. Per the decision chart at the front of this manual. C. PURPOSE AND POLICY 1. The President, management and staff of Philotechnics, Ltd. are committed to providing services and products that conform to the requirements, both specified and implied, of its customers. This commitment shall be met by ensuring that all levels of the organization understand and adhere to quality policies and procedures, work instructions, regulations, standards, specifications, and contractual agreements. 2. The organizational structure, functional responsibilities, levels of authority, and lines of communication for activities affecting quality shall be documented. Persons or organizations responsible for assuring that an appropriate quality assurance program has been established and verifying that activities affecting quality have been correctly performed, shall have sufficient authority access to work areas and organizational freedom to identify quality problems and their resolutions. Such persons or organizations shall have direct access to responsible management at a level where appropriate action can be effected. Such persons or organizations shall report to a management level such that required authority and organizational freedom are provided, including sufficient independence from cost and schedule considerations. 3. The organizational structure and the responsibility assignments shall be such that: a. Quality is achieved and maintained by those who have been assigned responsibility for performing work. b. Persons or organizations not directly responsible for performing the work verify quality achievement. c. The individual(s) or organization(s) responsible for establishing and executing this Quality Assurance Program may delegate any or all of the work to others, but shall retain responsibility. d. Responsibility for the control of further processing, delivery, installation, or operation on nonconforming items shall be designated in writing.
Page 1-1
Quality Assurance Manual (QAM-1) Section 1. ORGANIZATION Revision 3 e. Where more than one organization is involved in the execution of quality related activities, the responsibility and authority of each organization shall be clearly established and documented. f. The external interfaces between organizations and the internal interfaces between organizational units, and changes thereto, shall be documented. Interface responsibilities shall be defined and documented. D. RESPONSIBILITIES 1. The President of Philotechnics, Ltd. shall be responsible for ensuring the persons performing quality functions such as inspection, test, examination, and audits have the authority and organizational freedom to perform the following: a. b. c. d. e. f. Identify quality problems Initiate and recommend solutions for quality problems Verify implementation of solutions to problems Control further processing or delivery of a nonconforming or deficient item(s) until proper disposition has occurred Provide support and coordination to project management and quality assurance personnel Resolve, with the QAM, conflicts pertaining to quality assurance requirements and other departments to ensure resolutions are such that they meet the requirements and intent of the Quality Assurance Program Participate in the Annual Assessment of the Quality Assurance Program Foster continuous improvement methods within the quality program
g. h.
2. The President may assign authority to administer the Quality Assurance Program to a Quality Assurance Manager (QAM) who reports to the president or a designated Vice President. The duties and responsibilities of persons directly involved with quality achievement are defined below and the main duties and responsibilities of the QAM are as follows: a. Organize, develop, and administer the policies, procedures, and work instructions required to meet customer and company quality objectives. b. Assist in the development and administration of the employee indoctrination and training programs. c. Review and/or approve new and revised policies, procedures, work instructions or project specific Quality Assurance Program Plans. d. Revise the Quality Assurance Program when required by corporate quality objective, customer specification, or regulatory changes. e. Perform internal and external Quality Assurance Program audits.
Page 1-2
Quality Assurance Manual (QAM-1) Section 1. ORGANIZATION Revision 3 f. Train and qualify Auditors, Lead Auditors, Quality Assurance Representatives, and inspection and test personnel. g. Act as primary interface with customer representatives concerning quality related issues. h. Oversee document control and quality assurance record maintenance measures. (1) Participate in management assessments of the Quality Assurance Program (2) Review non-conformance and corrective action reports, audit findings, and customer complaints for trends. Report results to management. (3) Provide support to project management, procurement and production departments for all Business Unit Managers. i. Monitor quality related activities throughout all levels of the organization. 3. Certain projects may have an individual assigned primary responsibility for quality at the project. In this manual, that individual is referred to as the Quality Assurance Representative (QAR). If assigned, the main duties and responsibilities of the Quality Assurance Representative (QAR) who reports to the QAM are as follows: a. Implement the Quality Assurance Program requirements as they pertain to the nature of each business unit operation. b. Develop, approve, and ensure implementation of facility or project specific procedures or work instructions. c. Perform or assign trained and qualified personnel to monitor and verify inspection and test activities. d. Assemble and approve documentation packages required by contract; e. Monitor special process parameters such as those related to painting, welding, and contamination detection. f. Identify, resolve, and/or communicate quality related problems to the Quality Assurance Manager and Business Unit Managers. 4. The main duties and responsibilities of the Project, Business Unit or Facility Manager as related to quality are as follows: a. Assure that work executed under his/her cognizance is performed in accordance with applicable standards, specifications, procedures, work instructions, and the requirements established in the Quality Assurance Manual. b. Assure that customer purchase order or contract document requirements are properly reviewed, documented, and effectively communicated to all departments responsible for completing the scope of work. c. Interface with the QAM or the Business Unit QAR on matters concerning the achievement of quality.
Page 1-3
Quality Assurance Manual (QAM-1) Section 1. ORGANIZATION Revision 3 d. Provide Quality Assurance Program assessment input.
Quality Organization Chart
President
Vice President
Quality Assurance Manager
Project Manager
Quality Assurance Representative
5. Each Philotechnics, Ltd. employee shall be responsible for stopping his/her own work when continuation will produce or conceal results that are not in accordance with the requirements of the Quality Assurance Program and/or the quality requirements of the specific activity. He/she shall be responsible for reporting such conditions to the QAM, the QAR, or the direct supervisor. 6. The QAM, QAR, and project managers shall be responsible for determining and communicating quality assurance requirements to vendors, subcontractors, and consultants. Purchase orders, contracts, statements of work, task records, drawings, or similar documents shall be used to document these requirements. E. STOP WORK
Page 1-4
Quality Assurance Manual (QAM-1) Section 1. ORGANIZATION Revision 3 1. Each individual within the organization has the authority and responsibility to stop his or her work when continuation of the work will produce or conceal results that are not in accordance with prescribed requirements or will create safety hazards. This individual is responsible for stopping work and immediately contacting the immediate supervisor. The immediate supervisor shall contact the Quality Assurance Manager (QAM), the Quality Assurance Representative (QAR), or the supervisor, business unit or project manager for quality related issues and the appropriate site safety representative for safety related matters to confirm that work should be stopped. 2. If the immediate supervisor disagrees with the individual concerning the need to stop work, or if site or project management disagrees with the site safety or quality representative concerning the need to stop work, work shall be stopped until the matter is resolved and the resolution is documented. 3. If a Stop Work Order (SWO) is deemed necessary for quality purposes, the QAM, QAR, or business unit or project manager shall take the following measures: a. Stop work. b. Obtain a SWO form, Form QF 1.2-1 and complete section 1. c. Complete part 2 of the form by describing the unacceptable condition(s) and the cause(s). d. Investigate the cause(s) of the condition and recommend corrective action measures in section 3 of the form. e. Forward the SWO Form to the appropriate Vice President for review and approval to implement corrective action measures. f. Implement corrective action measures and verify that the unacceptable condition is now in accordance with original requirements. Document the verification results in part 4 of the form. g. Obtain approval from the appropriate Vice President to lift and close the SWO and forward to document control (defined in section 6).
F. QUALITY RECORDS The following documents shall be processed and maintained as quality records in accordance with Section 17, Quality Assurance Records: Stop Work Order Form (Form QF 1-1); and Supporting documents to the Stop Work Order Form.
Page 1-5
Quality Assurance Manual (QAM-1) Section 1. ORGANIZATION Revision 3 QA FORM 1-1: STOP WORK ORDER FORM
Part 1 Originator Section Date: Affected Item or Activity and Unacceptable Condition:
Originator Signature: Part 2 Corrective Action Proposed Corrective Action
Action Proposed By:
Date:
Proposed Action Approved By: Vice President or Project Manager Quality Manager (for quality related work
stoppages)
Signature
Date
Safety Manager (for safety related work

stoppages)
Action Verified Complete: Quality Manager, Safety Manager or Project Manager Vice President Review
Signature
Date
Upon review by the appropriate Vice President, this Stop Work Order is lifted. Send the original copy of the Stop Work Order to Corporate Document Control.
Page 1-6
Quality Assurance Manual (QAM-1) Section 2 QUALITY ASSURANCE PROGRAM AND TRAINING Revision 3
SECTION 2 - QUALITY ASSURANCE PROGRAM AND TRAINING

A. REFERENCES NQA-1 Section 2 ISO 9001-2000 Clause 5.6 10 CFR 830.120 Criterion 1, 2, 9 B. APPLICABILITY. Per the decision chart at the front of this manual. 1. Unless required by the customer, formal documents pertaining to training, procedures, physical requirements, etc. need be written only when necessary to augment standard work instructions, job descriptions, job hazard analyses and other documentation which might exist. 2. Training need not be conducted on procedures which are considered standard industry practices unless required by a customer or unless deemed necessary based on job site supervision or prior problems. Training on project-unique procedures is required. C. PURPOSE AND POLICY 1. Philotechnics, Ltd. shall maintain a formal Quality Assurance Program to ensure that our services and products conform to specified requirements and customer expectations. 2. This Quality Assurance Manual, when imposed by the decision chart, represents minimum corporate requirements. A Quality Assurance Project Plan (QAPP) must be developed for higher risk work or when required by the contract associated with a project. Generally, federal work requires the development of a project-specific QAPP or the adoption of that agencys quality umbrella. 3. Regardless of the documentation associated with a project, an essential part of quality assurance is that employees must be trained to do their jobs. No amount of paperwork can compensate for a lack of training. D. BASIC REQUIREMENTS 1. The documented Quality Assurance Program shall identify the activities and items to which it applies. The program shall include consideration of technical aspects of activities affecting quality and provide controls to an extent consistent with their importance. The program shall also provide the following:
Page 2-1
Quality Assurance Manual (QAM-1) Section 2 QUALITY ASSURANCE PROGRAM AND TRAINING Revision 3 a. Planning and accomplishment of activities affecting quality under suitably controlled conditions b. Special controls, processes, test equipment, tools, and skills required to attain required quality and for the verification of quality c. Sufficient indoctrination and training of personnel performing activities affecting quality 2. Management implementing the Quality Assurance Program, or portions thereof, shall regularly assess the adequacy of that part of the program for which they are responsible and shall assure its effective implementation. 3. Activities that require qualified inspection and test personnel shall be identified and the minimum requirements for such personnel shall be defined in procedures or work instructions. 4. Personnel shall be indoctrinated to the technical objectives and requirements of applicable codes, standards, and program elements specific to their job functions. 5. Formal, documented training of personnel shall be required to perform inspection and test activities. 6. Performance of inspection and test personnel shall be reevaluated at periodic intervals not to exceed three years. The qualification of personnel shall be certified in writing. 7. Special physical characteristics required in the performance of each activity including physical and vision examinations shall be defined in procedures or work instructions. 8. Personnel qualification records shall be established and maintained in accordance with established procedures or work instructions. E. RESPONSIBILITIES 1. The President of Philotechnics, Ltd. shall be responsible for the formation of the companys quality policies and objectives required to provide control over activities affecting quality to an extent consistent with their importance. The President shall be responsible for providing adequate resources such as sufficient skilled personnel, appropriate equipment, and suitable environmental conditions to support each Manager performing quality related activities. He or she shall also be responsible for creating an environment for continuous improvement by: a. b. c. d. e. f. Encouraging and sustaining a supportive style of management Promoting values, attitudes, and behavior that foster improvement Setting clear quality improvement goals Encouraging effective communication and teamwork Recognizing successes Providing the training and education necessary to promote improvement
Page 2-2
2. The President and appropriate members of the management staff shall assess the adequacy and effectiveness of the Quality Assurance Program on an annual basis. This task may be delegated to a Vice President specifically assigned quality assurance responsibilities. At a minimum, this assessment shall address the following topics or actions: a. A review of the companys quality policy and quality objectives b. A review of all existing Quality Assurance Procedures and work instructions c. A review of all non-conformances, customer complaints, audit reports, and subsequent corrective or preventive actions d. The need to provide additional employee training e. A review of service improvement issues f. Assessment decisions, recommendations, and identified areas requiring corrective or preventive actions shall be documented in a report. This report shall indicate the following information: (1) (2) (3) (4) (5) Date of the Assessment Assessment meeting attendees All topics discussed Individuals assigned to provide resolution of any identified corrective or preventive actions; Target dates for the completion and/or implementation of corrective or preventive actions
3. Each Philotechnics, Ltd. employee shall be responsible for the quality of their work and performing their assigned tasks in accordance with program policies, procedures, and work instructions. 4. The Quality Assurance Manager (QAM) and cognizant managers shall be responsible for the development, implementation, and subsequent revisions to the program. The documentation required to support and implement the program shall be as follows. (1) This Quality Assurance Manual establishes the basic and supplemental quality requirements for the company. The manual provides the Quality Policy, the general philosophy with regards to quality, and a broad description of what shall be done to achieve quality, and if needed a more descriptive outline of what is to be done and also when, where, who, and how the work process or activity is to be accomplished. Work Instructions or Business Unit specific programs and procedures shall provide detailed requirements of how a particular task or complex activity
(2)
Page 2-3
Quality Assurance Manual (QAM-1) Section 2 QUALITY ASSURANCE PROGRAM AND TRAINING Revision 3 is to be accomplished. Such instructions or procedures shall be traceable back to and be in line with the requirements set forth in this manual. Quality Assurance Program Plans (QAPPs) shall define additional quality requirements necessitated by the project scope of work, the client or regulatory expectations. Documentation such as forms, check lists, inspection/test reports, audit reports, etc., that provide evidence of conformance to specified requirements shall support the effectiveness of the program.
(3)
(4)
5. Quality Program Manuals, Procedures, Work Instructions, specific programs and procedures, and QAPPs shall be issued and controlled in accordance with Section 6, Document Control. 6. The QAM and cognizant managers shall be responsible for identifying inspection and test activities requiring qualified and certified personnel. The indoctrination, training and subsequent qualification of personnel performing such activities shall be accomplished in accordance with this section. 7. Quality Assurance Program audit personnel shall be trained, qualified, and certified in accordance with this section. The Philotechnics, Ltd. Lead Auditor shall be responsible for administering the training, qualification, and certification process. F. INDOCTRINATION AND TRAINING 1. Indoctrination and training shall be provided to personnel engaged in the performance or management of the following activities: a. b. c. d. e. f. g. h. i. j. Design Procurement Contract Management Fabrication Material/Item Processing Testing Inspection Operating Calibration Handling, Storage, and Shipping
2. Indoctrination of newly hired personnel shall be provided before the commencement of the assigned tasks. This indoctrination shall be documented on a New Hire Indoctrination Record, Form QF 2-1, or a form with similar data and
Page 2-4
Quality Assurance Manual (QAM-1) Section 2 QUALITY ASSURANCE PROGRAM AND TRAINING Revision 3 shall be forwarded to Human Resources (HR) for retention as a corporate record, and at a minimum shall cover the following topics: a. The companys position on quality b. General criteria, including applicable quality assurance codes/standards and procedures c. Job responsibilities and authority 3. The extent of additional training required shall be commensurate with the scope, complexity, and nature of the activity and the education, experience, previous training, and proficiency of the individual. 4. Prior to the start of an assigned task, the individual shall be trained to fully understand new procedures or revised procedures/ work instructions that have been affected by a major change associated with the assigned task and if necessary demonstrate proficiency before proceeding. Training may also include understanding of the following: a. The Quality Assurance Program including quality terms and definitions b. Customer specific requirements c. Commonly used acronyms 5. One or more of the following methods shall be employed to provide and document the required training: a. Training Meetings. Use Training Meeting Record, Form QF 2-2 or equivalent. to document training conducted at meetings. Complete the form as follows: (1) Instructor(s)/Date: Self-explanatory. (2) Document Name(s): Instructor shall list what training documents are being covered. (3) Document Number: Instructor lists the unique number assigned to the document. (4) Revision Number: Instructor lists, if any, the revision of the document. (5) Attendees: Instructor shall have all attendees print their name legibly and then signature as indicated. b. Assigned Reading. Use Training Assignment (Reading), Form QF 2-3, to document the reading of new or revised selected manual sections, procedures, work instructions, or externally provided training, which relates to the employees job function. c. On-the-Job Training. Use On-the-Job Training Record, Form QF 2-4 to document completion of this training.
Page 2-5
6. All training documents are retained in the business unit. A copy of the training form may be provided to Human Resources to update the individuals personnel record and to allow corporate tracking of selected training.. 7. Individual managers must determine whether periodic evaluations of employee training needs and current training methods should be performed and documented to determine training effectiveness and the need to provide refresher or additional training. G. QUALITY RECORDS The following documents shall be processed and maintained as Quality Records in accordance with Section 17, Quality Assurance Records: New Hire Indoctrination Records Training Meeting Records Training Assignments On-the-Job Training Records Evidence of completed external training Training program evaluations
Page 2-6
Quality Assurance Manual (QAM-1) Section 2 QUALITY ASSURANCE PROGRAM AND TRAINING Revision 3 QA FORM 2-1: NEW HIRE INDOCTRINATION RECORD Employee Name: Employee No. Work Location: Hire Date:
Overview of the following checked topics was provided to the above named individual. The companys position on quality Quality Assurance Codes/Standards/Procedures Quality Assurance Program Elements Job Responsibilities and Authority OTHER
Comments:
Indoctrination Provided By: Review:
Date: Date:
Page 2-7
Quality Assurance Manual (QAM-1) Section 2 QUALITY ASSURANCE PROGRAM AND TRAINING Revision 3 QA FORM 2-2: TRAINING MEETING RECORD INSTRUCTOR(S): DOCUMENT NAME DOCUMENT NUMBER DATE: REVISION NUMBER
ATTENDEES: PRINTED NAME 1. 2. 3. 4. 5. 6. 7. 8. 9. 10. 1. 2. 3. 4. 5. 6. 7. 8. 9. 10
EMPLOYEE # 1. 2. 3. 4. 5. 6. 7. 8. 9. 10.
SIGNATURE
Page 2-8
Quality Assurance Manual (QAM-1) Section 2 QUALITY ASSURANCE PROGRAM AND TRAINING Revision 3 QA FORM 2-3: TRAINING ASSIGNMENT (READING) To: From: Employee No. Date:
Please read, understand, and comply with the indicated documents. Document Title & Number Rev. No.
By my signature, below I have read, understand, and will comply with all above listed new and/or revised procedures. Signature: Date:
Page 2-9
Quality Assurance Manual (QAM-1) Section 2 QUALITY ASSURANCE PROGRAM AND TRAINING Revision 3 QA FORM 2-4: ON-THE-JOB TRAINING RECORD Employee Name: Work Location: The above named employee has performed the following job functions or tasks. It is my opinion that the employee understands what is expected, has read all associated new or revised procedures and work instructions, and can perform these tasks in a satisfactory manner. TASK/FUNCTION ON-THE-JOB TRAINING HOURS Employee No.
Supervisor: Project or Facility Manager: Other:
Date: Date: Date:
Page 2-10
Quality Assurance Manual (QAM-1) Section 3. DESIGN CONTROL Revision 3
SECTION 3 - DESIGN CONTROL

A. REFERENCES (a) (b) (c) NQA-1 Section 3 ISO 9001-2000 Clause 7.3.1 10 CFR 830.120 Criterion 6
B. APPLICABILITY. Per the decision chart at the front of this manual. C. PURPOSE AND POLICY 1. It is the policy of Philotechnics, Ltd. to ensure that the essential quality aspects of a product or system, such as a safety, performance, and dependability are established during the design and development phase. This section defines the requirements and responsibilities for documenting and implementing design control activities. The requirements in this section do not apply when design control activities are specified by a business unit design control work instruction or project specific procedure. 2. This section is applicable when Philotechnics, Ltd. is solely responsible for a product or system design. It does not apply to existing and proven designs, nor does it apply to designs created by subcontractors retained by Philotechnics, Ltd. When design work is subcontracted, the project or business unit acting as the buyer of this service has the responsibility to review and approve the subcontractors design control measures. This review and approval process shall be documented. Design activities performed by Philotechnics approved subcontractors shall be controlled in accordance with Philotechnics procedures, project specifications or approved subcontractor procedures. 3. This section specifically does not apply to the design and development of radiological controls survey patterns unless required by contract or if radiation levels exceed the criteria for a very high radiation area based on current NRC definitions. The design and development of ordinary radiation surveys is governed by a variety of industry standard methodologies including NUREG 1757, Consolidated Decommissioning Guidelines and the Multi-Agency Radiation Survey and Site Investigation Manual (MARSSIM) requirements. D. BASIC REQUIREMENTS. 1. Designs of products or systems shall be defined, controlled, and verified. 2. Procedures shall be established and maintained to control design activities. 3. Design interfaces shall be identified and controlled to ensure a coordinated effort among participating design organizations.
Page 3-1
Quality Assurance Manual (QAM-1) Section 3. DESIGN CONTROL Revision 3 4. Design inputs such as design bases, performance requirements, regulatory requirements, codes, and standards shall be identified and documented and their selection shall be reviewed and approved. 5. Design output documentation shall be reviewed and approved. Design analysis shall be conducted before final design release. 6. Design verification shall be performed to demonstrate that design outputs meet design-input requirements. The extent of verification shall be based on the complexity of the design, importance to safety, degree of standardization, the state of the art, and the similarity with previously proven designs. 7. Changes to final designs shall be subject to the design controls applied to the original design. 8. Design activities performed by Philotechnics approved subcontractors shall be controlled in accordance with internal or approved subcontractor procedures. E. DESIGN RESPONSIBILITIES 1. Design Planning. The Project Engineer or other individual responsible for design work, shall establish a design plan that will address all design activities, including required design reviews and design verification requirements. The plan shall also include, but need not be limited to, the identification of the individual(s) or departments responsible for the completion of the activity and the planned completion date of each activity. The Project Engineer shall ensure that this plan is documented, approved by the Project Manager, appropriately distributed, and updated as the project advances. 2. Design Inputs. The Project Engineer shall be responsible for reviewing and approving design inputs such as sketches, drawings, design bases, performance requirements, regulatory requirements, codes, and standards. Changes from approved design inputs shall be documented, approved, and controlled. 3. Design Outputs. The Project Engineer shall develop primary and secondary design outputs. Design output documents shall define how the product is to be manufactured or assembled. The Project Engineer shall also indicate the sequence of operations and inspection/test requirements. Primary design output documents may be, but are not limited to drawings, specifications and procedures and work instructions. 4. Secondary design output documents that support the design include but are not limited to calculations, analyses; and test results. 5. When required, the Project Engineer shall be responsible for providing project specific procedures or work instructions for project designs requiring additional or unique workmanship standards, acceptance criteria, and inspection methods. 6. Prior to issue, the Project Engineer shall present all design output documents to the appropriate manager and the client for review and approval.
Page 3-2
Quality Assurance Manual (QAM-1) Section 3. DESIGN CONTROL Revision 3 7. Design Review. The Project Engineer or manager shall ensure that design reviews are conducted at predetermined stages of the design process. A minimum of one design review shall be performed on any given project. The first review should be held shortly after the beginning of the project and involve appropriate members of the project. Intermediate design reviews should be conducted as deemed necessary to evaluate the evolving design process and assess how well the process is meeting design-input requirements and schedules. Design reviews should consider, but need not be limited to, the following topics: Safety Ergonomics Training Intended use Environmental compatibility Reliability Serviceability Manufacturability Capability to inspect and test Operating/maintenance instructions
8. Design Verification. Design verification shall be performed to demonstrate that design output meets design input requirements. The extent of design verification employed is based on the complexity of the design, importance to safety, and the degree of standardization. The project manager shall select a competent individual who did not participate in the design process to perform and document the verification process. If the Project Engineer is the designing engineer or is instrumental in the development of any design portion of the project requiring verification, then an independent designee shall perform verification. Design verification may be performed by employing any one or all of the following methods: performing alternate calculations; or performing qualification tests; or comparing the new design with similar proven designs. 9. Design Changes. When design changes are deemed necessary, the individual requesting the change shall describe the change, provide justification, or describe the benefits of the change on a Design Change Authorization, Form QF 3-1. Design changes shall be subject to applicable design controls defined in this procedure. F. QUALITY RECORDS The following documents shall be processed and maintained as Quality Records in accordance with Section 17, Quality Assurance Records. Design Plans Design Inputs Design Outputs Design Review Meeting Notes Design Verification Results Design Change Requests
Page 3-3
Quality Assurance Manual (QAM-1) Section 3. DESIGN CONTROL Revision 3 QA FORM 3-1: DESIGN CHANGE AUTHORIZATION
Design Change Requested By: Product or Part Number and Description: Date:
Description of Change:
Justification:
Affected Documents: Document Number or Other Designation
Revision Level / Date
Impact on Other Products or Activities:
Reviewed / Approved By: Distribution:
Date:
Page 3-4
Quality Assurance Manual (QAM-1) Section 4. PROCUREMENT DOCUMENT CONTROL Revision 3
SECTION 4 - PROCUREMENT DOCUMENT CONTROL

A. REFERENCES NQA-1 Section 4 ISO 9001-2000 Clause 7.4.1 10 CFR 830.120 Criterion 7 B. APPLICABILITY. Per the decision chart at the front of this manual.This section applies to documents associated with the procurement of quality-related items and services only, and then only when specified by the customer or when the cognizant manager determines the need to reduce risk associated with procurement. C. PURPOSE AND POLICY Philotechnics, Ltd. shall control procurement documents relating to quality-related items and services in accordance with established procedures or work instructions. D. BASIC REQUIREMENTS 1. Applicable design bases and other requirements necessary to assure adequate quality shall be included or referenced in documents for procurement of items and services. To the extent necessary, procurement documents shall require Suppliers to have a quality assurance program consistent with the applicable requirements of this manual. 2. As deemed necessary, Philotechnics, Ltd. shall incorporate the following provisions in quality related procurement documents prior to issuance. a. A statement of the scope of work for service related procurements b. Technical requirements shall be specified by reference to drawings, specifications, codes, standards, regulations, procedures, or work instructions. c. Require tests, inspections, and associated acceptance criteria d. Applicable Philotechnics, Ltd. quality assurance program requirements e. A statement allowing Philotechnics right of access to the suppliers facility f. Required documentation to be submitted by the supplier g. The method of reporting, dispositioning, and approving non-conformances h. The identification of appropriate spare and or replacement parts or assemblies i. The type of procurement (sole source, CPFF, T&M, FFP, etc.) 3. Procurement documents and associated changes shall be reviewed and approved prior to issuance. Procurement document changes shall be subject to the same degree of control as used for the preparation of the original documents.
Page 4-1
Quality Assurance Manual (QAM-1) Section 4. PROCUREMENT DOCUMENT CONTROL Revision 3
E. INSTRUCTIONS 1. It shall be the responsibility of the requisitioner and purchase order approval authority to ensure that all quality related procurement documents are reviewed and approved prior to issuance to the extent dictated by the risk associated with the purchase. Items to be considered in this review include: a. For services, a statement of the scope of work to be performed by the supplier b. Technical requirements such as adherence to specific drawings, specifications, codes, standards, regulations, and procedures c. Identification of test, inspection, and acceptance requirements for monitoring and evaluating supplier performance d. Requirements to ensure Philotechnics, Ltd. quality assurance expectations will be met and incorporated into the item or service e. A statement that allows Philotechnics, Ltd. personnel the right of access to the suppliers facilities and records for the purpose of inspection or audit f. A list of supplier documents to be submitted to Philotechnics, Ltd. for information, review, or approval. A time frame for submittal shall be established g. When Philotechnics, Ltd. requires the supplier to maintain specific Quality Assurance records; the retention times shall be indicated h. Philotechnics, Ltd. requirements for reporting and approving non-conformance report dispositions i. The identification of spare or replacement parts or assemblies and the method of ordering these parts or assemblies j. Mandatory flow-down clauses and terms and conditions imposed by Philotechnicss customers. 2. The above provisions, if applicable to the procurement, shall be documented on a Purchase Requisition Form or a Purchase Order Form and processed by the Purchasing Department in accordance with established administrative purchasing procedures. 3. The adequacy of quality review will be assessed during routine audits. F. QUALITY RECORDS Purchase order requisitions (if utilized); and a copy of the completed purchase order and/or changes shall be processed and maintained as Quality Records in accordance with Section 17, Quality Assurance Records.
Page 4-2
Quality Assurance Manual (QAM-1) Section 5. INSTRUCTIONS, PROCEDURES AND DRAWINGS Revision 3
SECTION 5 - INSTRUCTIONS, PROCEDURES AND DRAWINGS

A. REFERENCES NQA-1 Section 5 ISO 9001-2000 Clause 4.2, 4.2.1 10 CFR 830.120 Criterion 5 B. APPLICABILITY. All projects at all times. The President may exempt specific contracts from compliance with this procedure, using the flowchart at the beginning of this manual as a guide. Note: NQA-1 Section 5 states that The need for, and level of detail in, written procedures and instructions shall be determined based on the complexity of the task, the significance of the item or activity, work environment, and worker proficiency and capability (education, training, experience). Application of this section therefore requires a graded approach and common sense. C. PURPOSE AND POLICY It is the policy of Philotechnics, Ltd. to perform quality-related work in accordance with requirements specified in instructions, procedures, and drawings. The purpose of this section is to define the responsibilities and minimum requirements for the preparation and control of quality related instructions, procedures, and drawings. D. BASIC REQUIREMENTS 1. The underlying criteria, regardless of project size, are that: a. Personnel need to be instructed on work requirements, b. Whether instructions need to be documented shall be based on criteria described above. Whether documentation is needed and adequate will be assessed during audits based on project performance and historical information for similar projects. c. Distribution of instructions needs to be controlled. d. Training on instructions needs to be documented. 2. Activities affecting quality shall be prescribed by and performed in accordance with documented instruction, procedures, or drawings of a type appropriate to the circumstances. These documents shall include or refer to appropriate quantitative or qualitative acceptance criteria for determining that prescribed activities have been satisfactorily accomplished. 3. Formal procedures and work instructions, project/facility specific procedures and Quality Assurance Program Plans (QAPPs) shall be uniquely identified, reviewed
Page 5-1
Quality Assurance Manual (QAM-1) Section 5. INSTRUCTIONS, PROCEDURES AND DRAWINGS Revision 3 and approved prior to issuance, and have distribution controlled per Section 6 of this manual. Client provided instructions, programs, and procedures may be employed in lieu of existing instructions and procedures when specified by contract requirements. Instructions, procedures, drawings, QAPPs, and project/facility specific procedures shall identify the required documentation required to support completion and acceptance of the specified task. As applicable, these documents shall also include a sequence of operations; precautions and safety requirements; required tools, instruments, etc.; and inspection or verification schedules. Industry standards such as A.S.T.M., A.W.S., etc., may be employed in lieu of or to supplement existing instructions and procedures. Vendor supplied instructions, procedures, and drawings shall be reviewed and approved by Philotechnics, Ltd. when work is subcontracted.
4. 5.
6. 7.
E. CONTENTS AND APPROVAL FOR INSTRUCTIONS AND PROCEDURES 1. All forms of instructions, procedures, and other quality related documents shall be organized in a manner that will allow the user to understand and be able to accomplish the specified task or activity in a satisfactory manner without further clarification. The degree of formality required in these instructions will depend on the complexity, scope and duration of the project. Formal procedures such as those used for Philotechnics licensed applications shall, at a minimum, contain the attributes shown in Table 5-1. 2. Based on the nature of the prescribed activity the Author and the unit manager shall decide whether or not to include the following information in the instruction or procedure: a. Precautions A description of safety problems that may arise while the activity is being performed; b. Prerequisites Steps that should be taken before beginning the activity; c. References A list of reference material used during the development of the procedure or during the performance of the activity; d. Definitions - The definition of key words and/or acronyms used throughout the procedure; and e. Annual Review Status A review of the procedure on an annual basis. 3. Prior to issuance, all quality related documents shall be reviewed for correctness. The Quality Assurance Manager must review customer-mandated Quality Assurance Project Plans. Other instructions, such as project manager orders pertinent to a short term project, do not require review prior to approval but will be
Page 5-2
Quality Assurance Manual (QAM-1) Section 5. INSTRUCTIONS, PROCEDURES AND DRAWINGS Revision 3 assessed during routine audits. Approval authority is determined by the business unit or senior manager associated with the work. 4. Minor changes to instructions, procedures etc., such as, inconsequential editorial corrections, reformatting, word replacement to enhance clarity, and redundant requirements will only require review and approval by the appropriate manager and approver. Minor changes to a document do not require formal training. 5. All major changes to instructions, procedures etc. other than those classified and defined as minor changes shall be reviewed and approved by the same authorities who issued the original document. These individuals shall have access to pertinent background data or information upon which to base their review and approval. Major changes to a document might require formal training, and training shall be conducted in accordance with Section 2 of this manual. 6. All new and revised quality related documents shall be processed, issued, and controlled in accordance with the requirements of Section 6, Document Control. F. CONTENTS AND APPROVALS FOR DRAWINGS 1. This section pertains to formal drawings presented as final records or to control production processes. It does not generally apply to working sketches, routine survey maps, ad hoc surveys for contaminants, or similar working documents. Individual managers can require compliance with parts or all of this section as an additional control on a case-by-case basis. 2. In lieu of in-house drawing preparation, managers may elect to have drawings prepared by other individuals or engineering firms. These subcontracted sources must be qualified and approved by Philotechnics in accordance with Section 7 and procurement documents must comply with Section 4. 3. When the customer provides the drawings as part of a purchase order or contract, the responsibility for drawing control maintenance shall rest with the customer. 4. Drawings produced in-house or by subcontracted sources shall be processed, controlled, and maintained in accordance with this section. At a minimum, drawings shall: a. Be titled and numbered; b. Indicate the most current revision level; c. Provide generally accepted engineering symbols or include a legend if the symbols used in the drawing are uncommon or not standardized; d. List materials of construction; e. Indicate all dimensions and their tolerances; f. Provide enlargements or separate sections of details for clarification; and g. Include a note section to define or reference specific processes, procedures, test instructions, painting and marking/identification requirements, and special customer requirements.
Page 5-3
5. Formal drawings shall be: a. Checked by an individual other than the Originator of the drawing; b. Reviewed and approved by the Project Manager and, for production processes, by the Quality Assurance Manager. These reviews and approvals shall be indicated on the drawing by signature and date. c. Controlled in distribution using procedures described in section 6 or equivalent; d. Collected and destroyed when obsolete. A copy of obsolete drawings shall be marked as obsolete and maintained as a quality record per Section 17. 6. Revisions to drawings shall be subject to the same degree of drawing requirements, reviews, and approvals as were performed on the original drawing. A description of the change shall be noted/dated in the drawing revision block section and the new revision level shall be indicated in the title block of the drawing. 7. Drawings furnished by Philotechnics retained subcontractors shall be reviewed and approved by the manager prior to the commencement of work. G. QUALITY RECORDS The following documents shall be processed and maintained as quality records in accordance with Section 17, Quality Assurance Records: Instructions, procedures, forms, and subsequent revisions; Drawings and subsequent revisions; Subcontractor generated instructions, procedures, drawings, and subsequent revisions; and
Page 5-4
TABLE 5-1: PROCEDURE CHARACTERISTICS Attribute

Revision History
Formal Procedures
A cover page providing a revision summary with review and approval signatures. All instruction, procedure, and exhibit/attachment pages shall be titled, uniquely identified, numbered by page, and shall indicate revision levels starting at revision zero.
Less Formal Procedures

A date of issue and signature or initials of the originator. A less formal procedure sent by e-mail would have date and time and identify the sender.
Applicability
A purpose or overview section providing the document purpose and when required applicability (when and when not to use the document). An instruction section that defines the individual(s) responsible for implementing the step-by-step sequence of events to be taken. This section shall also include or reference appropriate quantitative or qualitative acceptance criteria for determining that the task or activity has been satisfactory accomplished. Specify the step-by-step sequence of events to be taken Identify the individuals(s) responsible for implementing the action to be taken
A statement of applicability (who does this apply to), unless it applies to all project personnel. Might be NA.
Responsibilities
Action
Might only require a note to use a standard procedure, or indicating specific situations to deviate from a standard Refer to a standard form, specify use of a handdrawn map, and state what retention is required.
Documentation/ Record Requirements
An exhibit or attachment section which defines the documentation to be completed in support of procedure implementation, and a quality record section that establishes required documentation to be maintained as quality assurance records
Page 5-5
Quality Assurance Manual (QAM-1) Section 6. DOCUMENT CONTROL Revision 3
SECTION 6 - DOCUMENT CONTROL

A. REFERENCES NQA-1 Section 6 ISO 9001-2000 Clause 4.2.3 10 CFR 830.120 Criterion 4 B. APPLICABILITY. Per the decision chart at the front of this manual. When this manual applies, all projects will exercise sufficient control over documents so that: 1. 2. 3. 4. current instructions are available for use and reference as needed by employees a method exists to control changes obsolete documents are removed from service and not used. personnel are informed of document changes which might affect them.
C. PURPOSE AND POLICY It is the policy of Philotechnics, Ltd. to control all quality-related documents and data. This section defines the requirements and responsibilities for the preparation, issuance, and change of controlled documents. Controlled documents are instructions, procedures and drawings that specify quality requirements or prescribe activities affecting quality. They are controlled to be certain that only current, approved procedures are used for quality-related functions. D. BASIC REQUIREMENT 1. The preparation, issuance, and change of documents that specify quality requirements or prescribed activities affecting quality shall be controlled to assure that correct documents are being employed. This includes formal drawings as described in Section 5. Such documents, including changes thereto, shall be reviewed for adequacy and approved for release by authorized personnel. 2. Document and data control procedures and systems shall be established and implemented. The procedures shall provide the following: a. Identification of documents and data to be controlled and their distribution; b. Responsibility of individuals assigned for the preparation, review, approval, and issuance of documents and data; and c. Method(s) of document and data review for adequacy, completeness, and correctness.
Page 6-1
E. INSTRUCTIONS FOR CORPORATE DOCUMENTS 1. Controlled documents can be disseminated in one of two ways: through distribution of a controlled number of paper copies to specific individuals or through placement of a read-only document on a distributed drive for widespread referral and use. This procedure covers both methods. 2. An administrative assistant or another technically qualified individual shall be designated as Document Control (DC) for the company and will be responsible for the control of corporate documents. This function shall ensure that only the most current corporate documents are issued to the location where the prescribed activity is performed. DC shall be responsible for the following controls: a. Assign document identification numbers and maintain a master list of all corporate level controlled documents. This list shall include, but need not be limited to the following: (1) (2) (3) (4) (5) (6) Document title; Document identification number; Effective date of controlled document; Current revision number; Copyholder name; and Date of controlled distribution. Documents issued to personnel and outside parties who are not affected by the document, but request copies for information purposes only, are released as UNCONTROLLED. Documents issued as UNCONTROLLED do not receive updates and need not be tracked.
b. Word process a new or revised document and mark the document as draft until approved. c. Issue a document identification number to the Originator for a new document. d. Review and incorporate all changes made to a document that is transmitted from the Originator. The revised document(s) shall show revision marks in the margin. e. Review new and revised documents to ensure that all required signature approvals have been obtained. f. Maintain and control the original document and all revisions. g. Identify and maintain vendor or subcontractor furnished corporate documents. Documents for business units or projects are kept by that unit or project. h. Ensure that the distribution of corporate level controlled documents and revisions are made by utilizing a Document Transmittal (DT), Form 6-1. An e-
Page 6-2
Quality Assurance Manual (QAM-1) Section 6. DOCUMENT CONTROL Revision 3 mail is used in lieu of a Document Transmittal Sheet if the document is electronically distributed. 3. Establishing a New Document a. Originator shall prepare the document as a draft in accordance with applicable requirements stated in Section 5. Originator shall forward the draft document to DC and request distribution to the reviewer(s). b. DC shall mark the new document as a draft until approved; properly format the document; assign a unique document identification number; and review the document for grammatical errors. DC shall distribute the new document to the reviewer(s), in accordance with Section 5. c. Reviewer(s) shall submit comments to Originator using either a Comment Sheet or indicating the desired changes on the draft document. d. Originator shall resolve all document review comments and forward the changes to DC for incorporation into the new document. e. DC shall obtain all review and signature approvals in accordance with Section 5. DC shall distribute the document to a controlled distribution utilizing the DT or e-mail. 4. Revision of a document a. Employees at all levels may request a change to an existing document. The employee requesting the change shall discuss the change with their supervisor (Originator). If the supervisor deems the change is appropriate, the supervisor shall follow the steps below. b. Originator shall forward the desired changes either on a draft document or by memorandum to DC. c. DC shall mark a revised document as a draft until approved; properly format the document; and review the document for grammatical errors. DC shall distribute the draft document to the reviewer(s) in accordance with Section 5. d. Reviewer(s) shall submit comments to Originator using either Comment Sheet or indicating the desired changes on the draft document. e. Originator shall review and resolve all comments/changes made by the Reviewer(s) and forward changes to DC for incorporation into draft document. f. DC shall incorporate all Originator accepted changes into revised document. DC shall obtain all review and signature approvals in accordance with Section 5, Instructions, Procedures, and Drawings. DC shall distribute revised document to controlled distribution utilizing the DT or notify affected persons by e-mail if the document is electronic. 5. Corporate Controlled Distribution
Page 6-3
a. The copyholder upon receipt of a controlled document (new or revised) shall complete the receipt acknowledgement portion of the DT and return the DT on or before the date specified. In the event that a DT cannot be completed and mailed to DC in the time frame allotted, an e-mail indicating receipt of the document to DC shall be accepted. b. Some corporate controlled documents are not distributed, but are rather maintained in a protected file format on a corporate electronic network. This improves control, reduces paperwork and makes the document more readily accessible for use. For a document change to an item maintained in electronic form on a network file system, DC shall update the electronically stored template and provide general notification of the document change by e-mail. Summary of Corporate Document Control
Function
New Document Approval New Document Issue
Paper Distribution
Document Control (DC) obtains an approval signature on a (paper) cover sheet and files the approved document. (DC) sends out hard copy with Document Transmittal and receives Document Transmittal back indicating that the controlled copy has been received.
Electronic Distribution
Document Control (DC) obtains an approval signature on a (paper) cover sheet and files the cover sheet to represent the approved document. DC places a read-only version of the electronic file onto a corporate distributed drive for general access and use. DC sends an e-mail as a substitute for the Document Transmittal form, notifying potential users of the new document. The business unit determines whether paper copies of procedures or forms are needed for business operations, such as for use as posted operating instructions. If paper copies are needed, the business unit develops a method to track location of these uncontrolled paper copies, to change them if the parent document changes. Document Control (DC) obtains an approval signature on a (paper) cover sheet and files the cover sheet to represent the approved document. DC places a read-only revised version of the electronic file onto a corporate distributed drive for general access and use. DC sends an e-mail as a substitute for the Document Transmittal form, notifying potential users of the change to the document. The business unit determines whether paper copies of procedures or forms have been made. If paper copies have been made, the business unit changes or replaces them. A copy of the document is made and sent to the requestor.
Uncontrolled Document Creation (inside the company)
Document Change Approval Document Change Issue
The business unit determines whether additional copies of procedures or forms are needed for business operations, such as for use as posted operating instructions. If additional copies are needed, the business unit develops a method to track location of these uncontrolled copies and to change them if the parent document changes. Document Control (DC) obtains an approval signature on a (paper) cover sheet and files the approved document. (DC) sends out hard copy with Document Transmittal and receives Document Transmittal back indicating that the controlled copy has been changed and old pages destroyed.
Uncontrolled Document Creation (inside the company) Uncontrolled Document Creation (outside the company) Compliance Verification
The business unit determines whether additional copies of procedures or forms have been made. If additional copies have been made, the business unit develops a method to track location of these uncontrolled copies and to change or replace them. A copy of the document is made and sent to the requestor.
Internal audits check for controlled and uncontrolled copies that are not current.
Internal audits check for uncontrolled copies that are not current.
Page 6-4
Quality Assurance Manual (QAM-1) Section 6. DOCUMENT CONTROL Revision 3 F. INSTRUCTIONS FOR UNIT DOCUMENTS 1. Managers may either use the corporate system for document control or establish their own system. The control system shall apply to those documents that specify quality requirements or prescribe activities affecting quality. These documents include, but need not be limited to the following: a. b. c. d. Work Instructions Procedures Drawings Project or unit specific Quality Assurance Program Plans (QAPPs)
2. A local system, at a minimum, shall address the following requirements: a. The business units method of designating controlled documents covers all documents which must be controlled. b. The business unit can identify current revisions for each controlled document and has a history of changes. c. The business unit has a method of limiting and/or tracking distribution of controlled documents. d. Documents in use have been properly reviewed and approved in accordance with Section 5. Document changes have undergone a similar formal review and approval process by the same personnel who reviewed the original document, unless business unit procedures specifically designate another method of formal review. e. Personnel have been trained to new and revised procedures. This verification may include a review of training records and/or questioning of site personnel. 3. The business unit document control system shall comply with the intent of all other requirements in this procedure. The business unit does not need to issue a procedure for local control of documents; the need for such a procedure is governed by the graded approach described in section 5. If a business unit cannot comply with these requirements due to a contractual requirement, the corporate officer responsible for the corporate quality program may waive the requirement in writing and specify alternative requirements. G. QUALITY RECORDS Obsolete Documents shall be processed and maintained as quality records in accordance with Section 17, Quality Assurance Records.
Page 6-5
Quality Assurance Manual (QAM-1) Section 6. DOCUMENT CONTROL Revision 3 QA FORM 6-1: DOCUMENT TRANSMITTAL ISSUE DATE: PROJECT TITLE: DOCUMENT TITLE: TRAINING REQUIRED: NAME YES JOB TITLE NO DOCUMENT NO.
ISSUED FOR: INFO COMMENT APPROVAL APPROVED ACTION FOR REVIEW AND COMMENT FOR YOUR CONTROLLED USE
MEMO NO.:
REVISION NO: DT DUE DATE:
First Class Mail UPS Second Day Air Priority Mail

CONTROLLED DOCUMENT:
UPS Next Day Fed-X Next Day Hand Delivered

YES NO
REVISION LIST:
Signature requested upon receipt of a controlled document. Please return this Document Transmittal to: Document Control I have received the document identified above and prior revisions of these have been(MARK THE APPROPRIATE BOX):
Destroyed Voided N/A
DOCUMENT TRANSMITTAL ORIGINATED BY:
SIGNATURE
PRINTED NAME: DATE RECEIVED
Page 6-6
Quality Assurance Manual (QAM-1) Section 7. CONTROL OF PURCHASED ITEMS AND SERVICES Revision 3
SECTION 7 - CONTROL OF PURCHASED ITEMS AND SERVICES

A. REFERENCES NQA-1 Section 7 ISO 9001-2000 Clause 7.4.1, 7.4.2 10 CFR 830.120 Criterion 7 B. APPLICABILITY. Per the flowchart at the front of this manual; when imposed by a specific customer, or when imposed by a project manager to minimize risk associated with a particular project or task. When a project has special requirements that may affect compliance with this procedure, the Project Manager and the Contracts Administrator shall jointly establish site-specific procedures, which shall be approved by the Controller. C. PURPOSE AND POLICY. It is the policy of Philotechnics, Ltd. to control the procurement of quality related items and services to ensure conformance with procurement document requirements. This section defines the requirements and responsibilities for the control of vendors who provide quality-related items and services and develops a uniform method for purchasing items and services that will provide for controlled and effective purchasing activities by the various business units. Purchasing - the acquisition of goods and services to support business operations - shall be performed in a manner that complies with corporate standards and quality programs, minimizes risk and maximizes overall value to the company. D. BASIC REQUIREMENT 1. The procurement of items and services shall be controlled to assure conformance with specified requirements. Such control shall provide for the following as appropriate: source evaluation and selection, evaluation of objective evidence of quality furnished by the supplier, source inspection, audit, and examination of items or services upon delivery or completion. 2. Procurement activities shall be planned and documented in accordance with established procedures to assure a systematic approach to the procurement process. 3. The selection of suppliers shall be based on evaluation of their capability to provide the item or service. 4. As deemed necessary, bid evaluations shall be performed to determine the extent of conformance to the procurement documents. 5. As deemed necessary, a supplier performance evaluation shall be performed and documented. 6. Supplier generated documents shall be controlled, handled, and approved in accordance with established methods. 7. Procurement document changes shall be controlled, implemented, and documented. This is a controlled copy if viewed on a corporate network site. Page 7-1
Other sources are not controlled and require verification prior to use.
Quality Assurance Manual (QAM-1) Section 7. CONTROL OF PURCHASED ITEMS AND SERVICES Revision 3 8. Procedures shall identify the method or methods employed for the acceptance of an item or service. 9. Provisions for the control of supplier generated non-conformances shall be established and documented within procedures or procurement documents. 10. Documentation generated to verify requirements of procurement documents shall be evaluated to determine the supplier's quality program effectiveness. E. SUPPLIER/VENDOR CONTROL 1. The purchase of quality related materials, items, and services shall be from only reputable suppliers. The following quality guidelines should be used when selecting a supplier: a. If a service is being provided and licensing or certification is required to perform the service, select suppliers who have approved licensing or certification. Examples include laboratory analysis (various certifications exist), hazardous material transport (DOT and state licensing may be required), etc. In most cases, laboratories and transport companies do not need to be on the Approved Suppliers List. b. Specialty containers for storage and transport of radioactive, hazardous or mixed waste and items manufactured specifically for Philotechnics require purchase from a supplier on the Approved Suppliers List. General purpose containers such as common drums, supersacks and other industry standard containers should be purchased from a reputable supplier who need not be on the Approved Suppliers List. c. Items which carry an approval from UL, CSA or other nationally recognized certification can be purchased from any reputable supplier. d. Products and services may be purchased from companies which have been approved by an external quality certifying agency, such as ISO 9000. 2. The Approved Suppliers List (ASL) provides a known source of suppliers whose practices and products have been evaluated and approved. This list is a controlled document and shall be maintained, revised, and distributed by Document Control (DC). Distribution and revisions of the ASL shall be made as a minimum to the Quality Assurance Manager (QAM) and purchasing departments. 3. Suppliers shall be added or deleted from the ASL as determined by the QAM. This determination shall be based on the suppliers ability to meet quality assurance and purchase order requirements. 4. To add a vendor to ASL, the person requesting the addition fills out the Supplier Evaluation and Qualification Record, Form QF 7-1 in accordance with the following guidelines. a. Commodity: Provide an accurate description of items and services being provided. b. Methods of Evaluation: It is the requisitioners responsibility to indicate how many items, if any, must be checked.
Page 7-2
Quality Assurance Manual (QAM-1) Section 7. CONTROL OF PURCHASED ITEMS AND SERVICES Revision 3 c. Supplier Quality Document Review: If you select this method, the requisitioner shall attach document(s). d. Supplier Evaluation Questionnaire, Form QF 7-2: If checked, the requisitioner shall request Document Control to begin the process. e. Historical Experience: If checked, it is the responsibility of the requisitioner to provide an explanation of historical experience and document this experience. f. Quality Program Audit: If checked, the requisitioner shall determine if a quality assurance program audit is required for this supplier. g. Reviewing results of QA Program Audits performed by other organizations: If checked, the requisitioner shall attach document(s). h. Quality Program Registration: If checked, the requisitioner shall obtain the appropriate certification(s) document(s) and forward to Document Control. ISO 9001 certification is evidence of an acceptable quality program. Other registrations which can be considered include industry-specific certifications such as laboratory certifications, state or federal licenses which require examination and periodic audits, and product certifications such as UL or CSA. i. Customer Specified Source: If checked, the requisitioner shall explain why we need to use this customer (i.e., per customer requirements). 5. The requisitioner upon completion shall forward the Supplier Evaluation and Qualification Record and supporting documentation to the QAM. 6. The QAM upon review, but prior to approval, may elect to add additional evaluation methods as deemed necessary. 7. The QAM shall re-evaluate the supplier every (5)-five years and document results on the Supplier Re-Evaluation form, Form 7-3. 8. Upon approval by the QAM, the Supplier will be placed on the ASL and a purchase order may be issued in accordance with established administrative procedures. Subsequent purchase orders may then be issued without the need to perform additional evaluations. Note: Any additional information, records, or evidence that is deemed necessary for the approval of a supplier shall be retained with the Supplier Evaluation and Qualification Record. 9. Based on the importance, complexity, and quantity of the item or services to be procured, the requisitioner, together with the purchasing department, and the QAM shall consider the need to conduct a bid evaluation and/or supplier performance evaluation. The bid evaluation, if deemed necessary, shall be performed to determine the extent of conformance to procurement documents by evaluating the following subjects: a. b. c. d. e. f. g. Technical considerations Quality assurance requirements Suppliers personnel Suppliers production capability Suppliers past performance Alternates Exceptions Page 7-3
10. The supplier performance evaluation, if deemed necessary, shall be documented and forwarded to DC to become part of the supplier history file. It shall consider the following measures: a. Establishing an understanding between Philotechnics, Ltd. and the supplier to the provisions and specifications of the procurement documents b. Requiring the supplier to identify planning techniques and processes to be utilized in fulfilling procurement document requirements c. Reviewing supplier documents that are generated or processed during activities fulfilling procurement requirements d. Identifying and processing necessary change information e. Establishing method of document information exchange between purchaser and supplier f. Establishing the extent of source surveillance and/or inspection activities 11. Supplier Generated Documents. The requisitioner and QAM or QAR shall identify the supplier-generated documents required and their submittal time frames within appropriate Philotechnics, Ltd. procurement documents. These suppliergenerated documents shall be reviewed for acceptance and processed as quality assurance records in accordance with established procedures. 12. Procurement Document Changes. The purchasing department shall establish measures with the supplier to control changes to the procurement. These measures shall be agreed upon and documented within appropriate Philotechnics, Ltd. procurement documents. 13. Methods of Acceptance. Regardless of supplier, the project manager shall be responsible for ensuring that the following methods of acceptance for items and services are complied with. a. When a Certificate of Conformance is used the certificate shall: (1) (2) (3) (4) Identify the purchased material or equipment by purchase order number Identify the specific procurement requirements met by the purchased material or equipment Identify any procurement requirements that have not been met, together with an explanation as to why and when these requirements will be met Be signed or otherwise authenticated by a person responsible for quality assurance
b. Source Verification. When source verification is used, it shall be performed at intervals consistent with the importance and complexity of the item or service. Source inspections shall be performed and documented in accordance with established procedures. This is a controlled copy if viewed on a corporate network site. Page 7-4
Other sources are not controlled and require verification prior to use.
Quality Assurance Manual (QAM-1) Section 7. CONTROL OF PURCHASED ITEMS AND SERVICES Revision 3 c. Receiving Inspection. When receiving inspection is used, the inspection shall be documented and performed in accordance with established procedures or work instructions. Receiving inspection shall be coordinated with the review of supplier-supplied documentation. d. Post-Installation Testing. When post-installation testing is used, test and acceptance documentation requirements shall be mutually established with the supplier. e. Acceptance of Services. The QAM or QAR shall ensure that acceptance of services shall be made by any one or all of the following methods. (1) (2) (3) Technical verification of data produced Surveillance and/or audit of the activity Review of objective evidence for conformance to the procurement document requirements such as certifications, stress reports, etc.
14. The Quality Assurance Manager (QAM) or the Quality Assurance Representative (QAR) shall be responsible for conducting and documenting source inspection activities. All source inspections shall be documented on a Source Inspection Report, Form QF 7-4. Normally, this report will include, but need not be limited to, the following attributes: a. Inspection Report Number a unique number identifying the source inspection b. Vendor the name of the vendor that manufactured or is supplying the item c. References a listing of the references that were consulted in conducting the inspection d. Details of Inspection a detailed listing of the items or activities that were inspected and the results of the inspection e. Remarks requirements for additional vendor submittals or corrective action shall be listed if applicable f. Accepted and Released (Yes/No) the Inspectors judgment of whether the items should be released for shipment g. Re-inspection Required if the item is not acceptable, determine whether or not another inspection is required prior to accepting the item 15. Control of Supplier Non-conformances. The QAM shall be responsible for reviewing and approving the supplier disposition of non-conformances. As deemed necessary, verification of disposition implementation shall be performed and documented. 16. Commercial Grade Items. When commercial grade items are specified in design and procurement documents, alternate commercial grade items may be substituted providing the Philotechnics Project Engineer approves them. Commercial grade items shall be identified in procurement documents by the manufacturers published product description (catalog number, etc.), and accepted by employing any of the methods defined in this section. Items which have a general public use such as common types of tools, containers, protective clothing
Page 7-5
Quality Assurance Manual (QAM-1) Section 7. CONTROL OF PURCHASED ITEMS AND SERVICES Revision 3 and fasteners can be considered commercial grade unless customer specifications indicate otherwise. Vendors of commercial grade items are exempt from supplier qualification unless they also sell non-commercial, quality related materials which are being purchased by Philotechnics. Such vendors include hardware companies and most distributors. If a distributor sells a quality-related product, the product manufacturer must be considered for addition to the Approved Supplier List rather than the distributor. F. PURCHASING 1. The Business Unit Vice President, with guidance from the President and Treasurer, is responsible for establishing individual limits of purchase authority. Personnel are responsible for knowing their individual limits for purchasing. If a purchase requisition is used, that individual is responsible for obtaining the appropriate approval and signature from a manager whose authority covers the requested purchase. 2. Purchase Requisitions. a. Credit or purchasing cards have been distributed to key personnel for more responsive procurement of items to support field projects. The purchaser must determine prior to purchasing an item whether it is quality related, as described in this section. Quality related items may be purchased with a credit or purchasing card if the vendor is on the Approved Suppliers List. Purchase requisitions are not required for these purchases. b. A purchase requisition is required if a purchase exceeds an individuals credit/purchasing card limit or, for employees without credit/purchasing cards, if the item cost exceeds $1000. Use Form QF 7-1 or an electronic equivalent. For purchases of items known to be $1000 or less, the individual supervisor or project manager shall determine whether a purchase requisition is appropriate or whether the material should be directly purchased and reimbursed. The project managers may purchase items which, when combined, exceed $1000 with individual credit/purchasing card as long as the total purchases do not exceed their level of authority. c. Purchases and rentals of equipment exceeding $1,000 from suppliers with national accounts (Home Depot, Fedex, Grainger, Unied Rentals, etc.) may be procured without a purchase requisition if the total value does not exceed the authorization limit of the individual making the purchase. d. If the purchase is determined to be a quality-related item or service, the requisitioner shall refer to the requirements contained in Sections 4, 7 and 10 of this manual. Contact the corporate Quality Manager for guidance if it is unclear whether an item is quality related. e. The requisition shall be issued to personnel who perform purchasing for the business unit. This person is called the Buyer.
Page 7-6
Quality Assurance Manual (QAM-1) Section 7. CONTROL OF PURCHASED ITEMS AND SERVICES Revision 3 3. Vendor Selection a. Three requests for quotations will normally be done by the Buyer to determine the best value (usually the lowest price). Buyers should use common sense and experience when seeking quotes. Often the price of a commonly obtained commodity is known. Sometimes the cost savings obtained by getting multiple quotes is offset by the extra administrative time and effort. In these cases, dispense with multiple quotes. b. Buyers are not expected to be experts on the material they are purchasing and can only decide on the basis of price, delivery and other quantifiable factors. This is commonly but not always lowest price. If the requisitioner has a reason for purchasing from a specific vendor, it should be stated on the purchase requisition. 4. Purchase Orders. The Buyer shall contact the accounting department if necessary for required data such as organization, project and account numbers and perform the following: a. Generate the Purchase Order, using Form QF 7-2 or a software-generated equivalent and, if applicable, obtain an approval signature from a person who has authority to sign for the purchase. b. The Purchase Order price might be different from the expected cost listed on the Purchase Requisition form. The Buyer shall contact the requisitioner and resolve the difference if the actual price is $200 higher or 10% higher than the Purchase Requisition price, whichever is less. c. Send a copy of the Purchase Order, along with General Terms and Conditions (QF 7-3) or special terms and conditions for this order, to the Vendor to obtain a Vendor acknowledgment. d. File a copy of the Purchase Order and acknowledgement. e. For purchasing services, such as consulting services, a Purchase Order form shall be used and either the Philotechnics General Terms and Conditions (Form QF 7-3) or sample Consulting Agreement (Form QF 7-4) shall be incorporated into the Order. For maintenance or construction services at a Company owned location, General Terms And Conditions For Construction And Maintenance Services Company Owned Property is used (Form QF 7-5). For purchasing temporary labor for a project, engaging Health Physics Technicians from Kelly Technical Services or similar agency, use Terms and Condition for Supplying Temporary Technical Personnel (Form QF 7-6). f. Blanket Purchase Orders shall be used when specific goods and services are needed over a given period, with a maximum limit on quantity and/or price. g. The Buyer, as required, shall issue a change order should any of the terms of the purchase order need to be changed. The change order must be issued prior to any actual changes to the terms of the purchase order.
Page 7-7
Quality Assurance Manual (QAM-1) Section 7. CONTROL OF PURCHASED ITEMS AND SERVICES Revision 3 5. Subcontract Purchases. Subcontracting is the purchase of services or goods in order to support a contract for which Philotechnics is the provider. a. Subcontracting is a special type of purchase that carries more risk than the straightforward purchase of goods or services. Subcontracting must comply with this procedure and with the requirements in corporate administrative procedures for contract management. b. Typically, the Contracts Administrator will be designated as the Buyer. c. Subcontracts must contain, at a minimum, terms and conditions that comply with Philotechnics standard terms and conditions contained in Form QF 7-3. d. Risk Management determines the requirements for bonding of a subcontractor. e. When Philotechnics is purchasing services to enable it to perform a contract for a customer, a subcontract should be used if any of the following situations occur: (1) (2) Work is performed on the customers property There are flowdown requirements in the contract with the customer where non-performance by the subcontractor can result in significant liability to Philotechnics, Ltd Bonds are required Liquidated damages are present
(3) (4)
f. Commercial subcontracts are used when the work requested by Philotechnics customer is not funded through a government issued contract or through a government agency. Government subcontracts are used when a Philotechnics customer is a government agency or a contractor working for the government. The Buyer should consult with General Counsel as necessary to determine which subcontract form is appropriate. g. The Buyer shall integrate the appropriate Terms and Conditions into the subcontract. The Project Manager shall complete all necessary documentation such as the Scope of Work and the designated purchasing personnel shall integrate this documentation into the subcontract. h. For purchases where there are site specific procedures, then those procedures should be followed. i. All Changes shall be approved in advance by the Buyer. Only the Buyer has authority to agree to any change to the terms of the subcontract. The Buyer shall consult with General Counsel to determine the appropriate manner to issue the change. j. Project managers may initiate discussions for subcontract changes but have no authority to authorize a change. The Buyer will consult with appropriate Business Unit Manager and General Counsel before authorizing a subcontract change. 6. It shall be the responsibility of each Business Unit Manager to ensure that all appropriate personnel have been trained to the requirements of all administrative
Page 7-8
Quality Assurance Manual (QAM-1) Section 7. CONTROL OF PURCHASED ITEMS AND SERVICES Revision 3 procedures. The training shall be performed and documented in accordance with the requirements of Section 2. 7. Supplemental Guidance for Terms and Conditions. Terms and Conditions Guidance. Note that terms and conditions often require negotiation and these forms are templates only. Contact risk management if questions arise about contractual requirements. a. Terms and Conditions are referenced on the face of the Purchase Order. The particular format of the terms and conditions or form document will depend upon the type of service or goods required. b. GENERAL TERMS AND CONDITIONS (Form QF 7-3). Used for purchase of miscellaneous goods and services. These terms will be used on majority of Purchase Orders. c. CONSULTING AGREEMENT (Form QF 7-4). Used for Consultants, i.e., individuals other than employees providing professional services for a temporary period of time. d. GENERAL TERMS AND CONDITIONS FOR CONSTRUCTION AND MAINTENANCE SERVICES COMPANY OWNED PROPERTY (Fixed Price) (Form QF 7-5). Use for services (maintenance and construction) performed on Company owned property. Terms can be modified for: Insurance limits, bonding requirements, compensation (fixed price, fixed unit rates or retention percentage) and schedule. Modifications may be made depending upon the scope of services required. e. Temporary Employee Terms and Conditions. (Form QF 7-6) This type of agreement, the temp agency supplies one or more of its employees to perform work at the direction of a Philotechnics manager. The temp agency retains the obligation to provide workers compensation insurance for the temporary employee. f. Subcontract Agreements. Used when engaging vendor to perform Services for a Philotechnics Client. When Philotechnics is under contractual obligations to a Client to perform services, it is important to ensure that all Client requirements are flowed down to the vendor. g. GENERAL SUBCONTRACT TERMS AND CONDITIONS ON-SITE WORK (Form QF 7-7). This form should be used for subcontracts under $50K or for subcontracts not requiring handling hazardous materials. Typically used for Commercial Subcontracts. h. SUBCONTRACT TERMS AND CONDITIONS SITE WORK, CONSTRUCTION AND REMEDIATION ACTIVITIES (Form QF 7-8). This form should be used for all work requiring remediation of radiological materials. Additionally, use of this form may be appropriate if a project has higher levels of risk. Typically used for Commercial Subcontracts. This form can be used, with modifications, when Philotechnics uses a vendor for transportation of hazardous material such as material for Bulk Survey for Release i. Project specific Purchasing Terms and Conditions.
Page 7-9
Quality Assurance Manual (QAM-1) Section 7. CONTROL OF PURCHASED ITEMS AND SERVICES Revision 3 (1) ALL PES treatment, storage, and disposal and transportation agreements. Agreements are typically negotiated with vendors on a case by case basis. Terms vary. ALL Large scale Government subcontracts and purchase orders. Site Specific requirements apply.
(2)
G. RECORDS 1. The following documents are quality records and shall be maintained as specified in Section 17. a. b. c. d. e. f. g. h. i. Supplier Evaluation and Qualification Records Supplier Evaluation Questionnaires Supplier Re-Evaluation Bid and performance evaluations (including any additional information, records, or evidence supporting these evaluations) Certificates of Conformance Supplier generated documents (Quality Assurance Program Manuals and applicable procedures) Supplier audit and source inspection reports Quality Assurance Program registration certificates Supplier non-conformance reports
2. The following documents are not quality records and shall be maintained as required by company administrative procedures. a. b. c. d. e. f. g. Authorization for Expenditures Limits of Authority Status Sheet Purchase Requisitions Purchase Orders Change Order Consulting Agreement Subcontract Agreement
Page 7-10
Quality Assurance Manual (QAM-1) Section 7. CONTROL OF PURCHASED ITEMS AND SERVICES Revision 3 QA FORM 7-1: SUPPLIER EVALUATION AND QUALIFICATION RECORD SECTION 1 Requisitioner fills out Requisitioner: Supplier Name: Address: Telephone No: Commodity (Material, Services, etc.): Date:
Methods of Evaluation: 1. Supplier Quality Document Review 2. Supplier Evaluation Questionnaire 3. Historical Experience 4. Site Audit 5. Reviewing results of QA Program Audits performed by other organizations 6. Quality Program or Other Registration/Certification 7. Customer Specified Source Justification:
SECTION 2 Quality Manager fills out Evaluated and Approved By: 5-Year Re-Evaluation Date: Date:
Page 7-11
Quality Assurance Manual (QAM-1) Section 7. CONTROL OF PURCHASED ITEMS AND SERVICES Revision 3 QA FORM 7-2: SUPPLIER EVALUATION QUESTIONNAIRE General Information: Company Name: Address: City: Telephone No: Number of Employees: Item or Service Supplied to Philotechnics, Ltd.: Part 1 - All Suppliers: 1. Quality System
Does your company have a formal Quality Assurance Program? Is your company ISO/QS certified? Does your company hold any ASME code certificates? Does your company hold any certifications from government agencies for the item or service you will provide to us? If yes, please specify. Yes No
Year Est.:
State: Fax No.:
Zip Code:
2. Organization:
Does your company perform regular and routine quality activities?
3. Purchase Order Review:

Does you company involve itself in customer quality requirements?
4. Corrective Action:
Does your company have a corrective action plan to track non-conformances and resolve problems?
5. Training:
Does your company have a formal training program?
6. Statistical Techniques:
Does your company have procedures for selecting sampling methods, sample sizes, inspection methods, or other acceptable control plan procedures for accepted products or services or for internal process improvement?
7. Document Control:
Does your company have a procedure or system to maintain quality documentation? This is a controlled copy if viewed on a corporate network site. Other sources are not controlled and require verification prior to use.
Page 7-12
Part 2 - Manufacturing/Materials Suppliers: (other suppliers go to Part 3) If you provide a manufactured item, or materials for fabrication, please answer the following additional questions. Otherwise, please go to the next page. Y 8. Design Control:
Do you create/maintain a design plan? Do you have a system for documenting design control? Do you review and verify drawings against the design-input requirement?
N/A
9. Purchasing and Purchaser Supplied Products:

Do you have a system for verifying that product or raw material used in the manufacture of goods for Philotechnics, Ltd. meets the quality requirements?
10. Customer Supplied Products:

Do you have a system for ensuring that supplied materials or products comply with drawings and/or purchase orders?
11. Product Identity and Traceability:

Do you have a system for identifying product throughout the manufacturing cycle and can your product be traceable to Philotechnics purchase order?
12. Receiving Inspection and Testing:

Do you have procedures to ensure incoming product is inspected and verified?
13. Final Inspection:

Do you have a system to verify required inspections (including final inspection) are completed and documented prior to release of product?
14. Inspection, Measuring, and Test Equipment:

Do you have a procedure to control, calibrate, and maintain inspection for measuring and testing equipment?
15. Inspection and Test Status:

Do you route, tag, label, or use suitable means to identify product throughout the manufacturing cycle that indicate conformance to requirements and ensure only conforming product is released for shipment?
16. Control of Non-Conforming Product:

Do you have a system that provides for the identification and documentation of non-conforming items?
17. Handling, Storage, Packaging, and Delivery:

Do you provide storage areas to prevent damage or deterioration of product pending delivery? This is a controlled copy if viewed on a corporate network site. Other sources are not controlled and require verification prior to use.
Page 7-13
Is your product properly identified and packaged to allow for proper delivery?
18. Quality/Inspection Records:

Does your company maintain inspection and test records to demonstrate conformance to requirements of your quality system?
Part 3 All Suppliers: Name of individual completing this form: Title: Date: Please mail or fax this completed questionnaire to: Philotechnics, Ltd. Attention: Document Control 2328 Bluff Road Harriman, TN 37748 Facsimile: (865) 483-1530 Thank you for your cooperation in this matter. For Philotechnics internal use: Reviewed and Approved By: Quality Assurance Manager Date:
Page 7-14
Quality Assurance Manual (QAM-1) Section 7. CONTROL OF PURCHASED ITEMS AND SERVICES Revision 3 QA FORM 7-3: SUPPLIER RE-EVALUATION
Re-Evaluation Date: Supplier Name: Philotechnics Business Unit: Commodity:
1. 2.
Does the Supplier still maintain a Quality Program? Does this Supplier provide Philotechnics with the requested documentation (e.g., CoC etc.)? Has the Supplier established an understanding to the provisions and specifications of the procurement documents? Has the Supplier identified planning techniques and processes to be utilized in fulfilling procurement document requirements? Has the Supplier identified and processed necessary change information? Is a surveillance and/or audits required for this Supplier? Has any non-conformances been generated by the Supplier? If so, has the disposition of the non-conformance been reviewed and approved by Philotechnics? Has the procured item or service been provided in the required time frame? Comments:
Yes Yes
No No
N/A N/A
3.
Yes
No
N/A
4.
Yes
No
N/A
5.
Yes
No
N/A
6. 7.
Yes Yes
No No
N/A N/A
8.
Yes
No
N/A
9.
Based on the information above, the Supplier has performed in accordance with QP 7.1, Control of Purchased Items and Services and should remain on our Approved Suppliers List (ASL). The next re-evaluation date scheduled for this Supplier is .
Based on the information above, the Supplier has not performed in accordance with the requirements of QP 7.1, Control of Purchased Items and Services and should be removed from the ASL.
Evaluated By:
Quality Manager Date
Page 7-15
Quality Assurance Manual (QAM-1) Section 7. CONTROL OF PURCHASED ITEMS AND SERVICES Revision 3 QA FORM 7-4: SOURCE INSPECTION REPORT Inspection Report Number: Vendor:
Items Inspected:
References:
Details of Inspection:
Remarks:
Item Inspected and Released? Yes Inspected By: No
Reinspection Required? Yes Inspected Date: No
Page 7-16
Quality Assurance Manual (QAM-1) Section 7. CONTROL OF PURCHASED ITEMS AND SERVICES Revision 3 QA FORM 7-5: PURCHASE REQUISITION QTY DESCRIPTION OF ITEM UNIT (Use extra lines or the back of the sheet if necessary PRICE to adequately describe the items)
ITEM #
PART #
EXTENDED PRICE
Blanket Order (Y/N)
Tax included above? (Y/N)
Required documentation (Certificate of Compliance, etc.) in place. Supplemental Information:
PROJECT NAME: ORGANIZATION: Approved Vendor Required?:

VENDOR NAME: VENDOR ADDRESS:
PROJECT #: Acct Code (optional): Yes No Project Manager or QAR Signature:
PHONE NUMBER:
Name of Requisitioner
Date
Authorization
Date
Page 7-17
Quality Assurance Manual (QAM-1) Section 7. CONTROL OF PURCHASED ITEMS AND SERVICES Revision 3 QA FORM 7-6: PURCHASE ORDER (TYPICAL)
Purchase Order Number:
BILL TO: Philotechnics, Ltd. 2328 Bluff Road Harriman, TN 37748 (865) 483-1551 (865) 483-1530 (fax) Notice: The P.O. Number must appear on all invoices, bills of lading and acknowledgments relating to this purchase order. General Terms and Conditions are attached and expressly made a part thereof, unless otherwise stated in writing below. VENDOR: CONTACT NAME: SHIP TO ADDRESS:
PHONE:
FAX:
PHONE:
FAX:
P. O. DATE
BUYER
DATE EXPECTED
SHIP VIA
F. O. B.
TERMS
ORGANIZATION #
PROJECT #
ACCOUNT NUMBER
ITEM #
QTY.
UNIT
DESCRIPTION
UNIT PRICE
TOTAL
OTHER REQUIREMENTS:
SUBTOTAL SHIPPING & HANDLING SALES TAX RATE SALES TAX TOTAL DUE
Signature of Quality Assurance Personnel Vendor Signature: Authorized Signature
Quality Related: Date: Date:
Yes
No
Page 7-18
QA FORM 7-7: GENERAL TERMS AND CONDITIONS

1. ACCEPTANCE (a) THIS ORDER IS BUYER'S OFFER TO SELLER AND DOES NOT CONSTITUTE AN ACCEPTANCE BY BUY OF ANY OFFER TO SELL, QUOTATION OR PROPOSAL. THE TERMS OF ANY SUCH OFFER TO SELL, QUOTATION OR PROPOSAL REFERRED TO HEREIN ARE MADE A PART OF THIS ORDER ONLY TO THE EXTENT OF SPECIFYING THE NATURE AND DESCRIPTION OF THE GOODS AND SERVICES ORDERED, AND THEN ONLY TO THE EXTENT THAT SUCH TERMS ARE CONSISTENT WITH THE OTHER TERMS OF THIS ORDER. THIS ORDER IS EXPRESSLY LIMITED TO AND MADE CONDITIONAL UPON ACCEPTANCE BY SELLER OF THE EXACT TERMS CONTAINED HEREIN AND ON THE FACE OF THIS ORDER AND ANY SUPPLEMENTS, SPECIFICATIONS OR OTHER DOCUMENTS EXPRESSLY INCORPORATED HEREIN BY REFERENCE. (b) SELLER SHOULD ACCEPT THIS ORDER BY SIGNING THE ACKNOWLEDGMENT COPY AND RETURNING IT TO BUYER. HOWEVER, SELLER'S SHIPPING THE GOODS OR COMMENCEMENT OF PERFORMANCE OF THE WORK CALLED FOR BY THIS ORDER SHALL BE DEEMED TO BE SUCH ACCEPTANCE UPON THE TERMS CONTAINED HEREIN EVEN IN THE ABSENCE OF A WRITTEN ACKNOWLEDGMENT, AN ACKNOWLEDGMENT OF THIS ORDER CONTAINING ANY ADDITIONAL OR DIFFERENT TERMS FROM THOSE CONTAINED HEREIN CONSTITUTES AN ACCEPTANCE BY SELLER UPON THE TERMS CONTAINED IN THIS ORDER EVEN IF SELLER'S ACCEPTANCE IS EXPRESSLY MADE CONDITIONAL ON BUYER'S ASSENT TO THE ADDITIONAL OR DIFFERENT TERMS. ANY SUCH ADDITIONAL OR DIFFERENT TERMS, WHETHER OR NOT SUCH TERMS MATERIALLY ALTER THIS ORDER, SHALL BE DEEMED OBJECTED TO BY BUYER WITHOUT NEED OR FURTHER NOTICE OF OBJECTION AND SHALL BE OF NO EFFECT NOR IN ANY CIRCUMSTANCE BINDING UPON BUYER UNLESS ACCEPTED BY BUYER IN WRITING. 2. TAXES. The prices stated herein include all taxes applicable to this order except sales, USP or similar taxes. Specific instructions in this order concerning the invoicing of sales, use or similar taxes must be followed. 3. PAYMENT. Payment date and cash discount period shall be calculated from the date of Buyer's receipt of an acceptable invoice or Buyer's acceptance of the goods and supporting documentation at destination, whichever last occurs. Drafts will not be honored. 4. SET OFF. Buyer shall be entitled at all times to set off any amount owing from Seller to Buyer or to any of Buyer's affiliated companies in connection with any transaction or occurrence against any amount due or owing to Seller in connection with this order. 5. ASSIGNMENT. Assignment of this order, or any interest herein or any payment due or to become due hereunder, without the written consent of Buyer, shall be void. The assignee of this order or any interest herein or payment due or to become due hereunder pursuant to an assignment to which such consent has been given shall be subject to all provisions hereof, to all claims and defenses of Buyer, and to the provisions of all revisions of modifications hereto whether made before or after such assignment. 6. TITLE AND RISK OF LOSS. Title to the goods purchased hereunder shall pass to Buyer when loaded on board carrier for transportation to the Site. If purchased F.O.B. destination, risk of loss shall pass to Buyer upon delivery to the Site. If purchased F.O.B. shipping point, risk of loss shall pass to Buyer upon loading on board carrier at the shipping point. 7. TRANSPORTATION AND INSURANCE. (a) Insurance or Declared Valuation. Seller shall not insure or declare value on shipments made F.O.B. shipping point. Charges resulting from failure to comply with this provision shall be for Seller's account. (b) Released Valuation. When transportation charges are governed by the released value of the shipment, Seller shall on shipments made F.O.B shipping point release such shipment at the lowest valuation provided. Additional transportation charges resulting from failure to comply with this provision shall be for Seller's Account. (c) Shipping Documents, Packing and Markings. All goods shall be identified and packaged adequately to ensure arrival at destination in an undamaged condition. All shipping documents and shipping containers or structures shall be plainly marked with the complete "ship to" address, purchase order number, equipment part or piece number (mark number), purchase order item number and quantity, description of goods, partial/complete shipment, and, where applicable, drawing number, project name and unit number, and any special markings required by this order. All goods, including components and subassemblies, not shipped in a shipping container, shall be plainly tagged using metal tags securely attached by wire, with the above information in a manner approved by Buyer prior to shipment. (d) Routing. All excess transportation charges resulting from failure to follow any routing instructions given by Buyer shall be for Seller's account. 8. CHANGES AND SUSPENSION. Buyer acting only through its procurement group may by notice to Seller at any time before complete delivery is made under this order, make changes within the general scope of this order in any one or more of the following (a) drawings, designs or specifications, (b) quantity, (c) delivery, and (d)by issuing a change order to this Order,(e)method of shipment or routing, or Buyer for any reason may direct Seller to suspend in whole or in part, delivery of goods or performance of services here under for such period of time as my be determined by Buyer to be necessary or desirable. If any such change or suspension causes a material increase or decrease in the cost of, or the time required for, the performance of any part of the work under this order, an equitable adjustment shall be made in the order price or delivery schedule, or both, provided Seller shall have notified Buyer in writing of any claim for such adjustment within thirty days from the date of such notice from Buyer or from the date
Page 7-19
of any act of Buyer which Seller considers constitutes such a change. No such adjustment or any other modification of the terms of this order will be allowed unless authorized by Buyer by means of a purchase order revision. Seller shall proceed with the work as changed without interruption and without awaiting settlement of any such claim. 9. INDEMNITY AND INSURANCE. Seller shall take all necessary precautions to prevent the occurrence of any injury to persons or property during the performance of the work under this order and shall defend and indemnity Buyer and Buyer's successor in interest to the goods against all claims, loss or expense (including attorney's fees) arising out of or resulting in any way from any act or omission of Seller, its agents, employees or subcontractors during the performance of the work. Seller shall maintain such Public Liability, Property Damage and Employee's Liability and Compensation insurance as will adequately protect Buyer and Buyer's successor in interest to the goods against such loss or expense and from any claims under any applicable Workmen's Compensation and Occupational Disease Acts. 10. TERMINATION. (a) Buyer may terminate this order without liability except in goods previously delivered and accepted if Seller ceases to conduct its operations in the normal course of business (including inability to meet its obligations as they mature or if any proceeding is brought against or instituted by Seller under bankruptcy or insolvency laws, or if a receiver for Seller is appointed or applied for or an assignment for benefit of creditors is made by Seller. (b) Buyer may at any time terminate this order in whole or in part for its convenience upon written notice to Seller on which event Seller shall be entitled to reasonable termination charges consisting of a percentage of the order price reflecting the percentage of the work performed prior to termination plus actual direct costs resulting from termination. 11. NOTICE OF DELAYS. Whenever any actual or potential cause delays or threatens to delay the performance of the work. Seller shall immediately notify the Buyer in writing. Such notice shall include all relevant information concerning such cause of delay and its background. Seller shall keep Buyer advised during the period such actual or potential cause exists of its effect on the schedule of work and shipments or deliveries and of the measures being taken to remove it. 12. DELAYS. (a) All shipping or delivery dates in this order are firm, and time is of the essence. Buyer's rights and remedies contained herein are not exclusive but are in addition to any other rights and remedies provided by law or this order. (b) If Seller for any reason whatsoever fails to ship or deliver goods or perform services within the lines specified herein, Buyer may without liability, except for goods previously delivered and accepted, terminate this order or any part thereof, If at any time reasonable grounds for insecurity arise with respect to performance of this order by Seller in accordance with the terms, and Seller does not provide adequate assurance of due performance within ten (10) days after receipt of a demand from Buyer for such assurance. Buyer may without liability, except for goods previously delivered and accepted, terminate this order or any part thereof. (c) Seller shall be liable to Buyer (1) for damages for non-delivery (including the excess cost of cover over the order price) in the event that Buyer terminates this order or any part thereof or (2) for damages for late shipment or delivery unless Buyer agrees in writing that Seller is excused from making timely shipment or delivery as a result of causes beyond the reasonable control and without the fault or negligence of Seller, including but not restricted to acts of God or of the public enemy, acts of the Government, fires, floods, epidemics, quarantine restrictions, strikes, freight embargoes, unusual severe weather, and delay of subcontractor of Seller resulting from such causes unless Buyer shall determine that the goods or services to be furnished under the subcontract are procurable in the open market, and if within seven days after the commencement of any such cause Seller provides Buyer with a written explanation of the relevant facts and circumstances and Seller's reasonable estimate of the effect upon performance of this order. In the event of any such excused delay, the shipping or delivery dates shall be extended by a period equal to the time actually lost by the delay unless Buyer has terminated this order. (d) If this order is terminated in whole or in part by Buyer under any provision of this order, Buyer may require Seller immediately to transfer title and deliver to Buyer any undelivered completed goods and any or all partially completed goods, materials, parts, tools, dies, jigs, fixtures, plans, drawings, information, data and contract rights (collectively called "manufacturing materials") as Seller has produced or acquired for the performance of such part of this order as has been terminated, and Seller shall, upon direction of Buyer, protect and preserve completed goods and manufacturing materials in the possession of Seller in which Buyer has an interest. Buyer shall pay to Seller the order price for completed goods and an amount agreed upon by Seller and Buyer for manufacturing materials delivered to and accepted by Buyer. 13. WARRANTY. Seller warrants to Buyer and to Buyer's successor in interest to the goods that all goods and services furnished under this order will conform in all respects with the terms of this order, including any drawings, specifications, and standards incorporated herein; that they are free from latent and patent defects in materials, workmanship, and title and free from such defects in design unless designed by Buyer; that they are suitable and adequate for, and will perform in accordance with the purposes for which they were fabricated, manufactured or constructed and the purposes for which they were designed unless designed by Buyer, and for such other purposes as are specified in this order; and that they will give efficient and satisfactory service under such conditions as may be described herein. Such goods will also be subject to all statutory warranties and all express or implied warranties created by acts or statements of Seller or usage of trade. Any attempted exclusion of such warranties or limitation of remedy for breach thereof by Seller shall be of no effect. 14. INSPECTION TESTING AND EXPEDITING. All goods and services furnished under this order may be inspected, tested and expedited at all times and places, including the premises of Seller and its suppliers (regardless of use) either before, during or after manufacture, by representatives designated by the Buyer. The exercise, or failure to exercise, of this right to inspect, test, and expedite or any approval given thereunder shall not believe Seller of its obligation to furnish all goods and services in strict conformance with all of the terms of this order. If inspection, testing and expediting are made on the premises of Seller or its
Page 7-20
suppliers. Seller shall furnish without additional charges all reasonable facilities and assistance for the safety and convenience of Buyers representatives in the performance of their duties. The right of final inspection and acceptance or rejection of the goods at Buyer's plant or at such other place of receipt as may be specified in this order is reserved to Buyer if prior to final acceptance by Buyer any of the goods are found to be defective in design, materials or workmanship, or otherwise not in conformance with the terms of this order, Buyer shall have the right to reject the same or require that such goods be repaired or replaced promptly with satisfactory goods at Seller's risk and expense (including transportation and insurance charges to and from Buyers plant or such other place of receipt as may be specified in this order) and pursue such other remedies as may be provided by law or this order. 15. FAIR LABOR STANDARDS ACT. In accepting this order, Seller shall be deemed to represent that the goods to be furnished hereunder where or will be produced in compliance with the requirement of the Fair Labor Standards Act of 1938, as amended, and Seller shall insert a certificate on all invoices submitted in connection with this order stating the goods covered by the invoice were produced in compliance with all the requirements of the Fair Labor Standards Act of 1938 as amended. 16. INFRINGEMENT INDEMNITIES. (a) Seller shall at its expense indemnity and defend Buyer and Buyer's successor in interest to the goods (collectively called "Buyer") against any claim, suit or proceeding (collectively called "suit") brought against Buyer which is based upon a claim, whether rightful or otherwise that the goods or services, or any part thereof, furnished under this order, or Buyer's use (including resale) thereof constitutes an infringement of any patent, trademark, copy-right in the United States, if Seller is given reasonable notice of such suit and, Seller shall pay all damages and costs awarded against and reasonable expenses incurred by Buyer in connection with such suit. In case the goods or services or use, thereof is in such suit held to constitute infringement and the use thereof is enjoined, Seller shall at its expense and at its option either procure for Buyer the right to continue the use of such goods or services; or in a manner acceptable to Buyer make replacement or modification to avoid infringement. (b) The foregoing indemnity shall not apply, and Buyer shall indemnity and defend Seller's given notice and in the same manner and extent as provided in Paragraph (a) above where such goods or services are allegedly infringing as a result of Seller's compliance with specific written instructions by Buyer directing use by Seller of a feature not customarily used by Seller. 17. INFORMATION. (a) Except with Buyer's prior written consent, Seller shall not at any time use or reproduce (other than in the performance of this order), or publish or communicate to third parties any technical or economic information furnished by Buyer in connection with this order or any such information derived therefrom. Upon completion or termination of this order, Seller shall promptly return to Buyer all materials and any copies thereof, except for one record copy, incorporating any such information. (b) Except with Buyer's prior written agreement, information which Seller shall have disclosed or only hereafter disclose to Buyer in connection with the placement or performance of this order shall be deemed nonconfidential and nonproprietary. Accordingly, such information shall be acquired free from any restrictions (other than restrictions which may result from a claim for patent infringement) and Buyer shall have the right to ignore or obliterate any notices or legends to the contrary. 18. COMPLIANCE WITH LAWS. Seller agrees to comply with the applicable provisions of any federal, state or local law or ordinance and all orders, rules and regulations issued thereunder any provisions, representations or agreements, including the Equal Opportunity clause (Executive Order 11246 as amended by Executive Order 11375) set forth in 41 CFR Chapter 60, required there by to be included in the contract resulting from acceptance of this order are incorporated herein by reference. 19. LIEN WAIVERS AND AFFIDAVITS. When required by Buyer, Seller shall provide, in a form satisfactory to Buyer, lien or claim waivers and affidavit from Seller and its subcontractors and suppliers.
Page 7-21
Quality Assurance Manual (QAM-1) Section 7. CONTROL OF PURCHASED ITEMS AND SERVICES Revision 3 QA FORM 7-8: SAMPLE CONSULTING AGREEMENT THIS AGREEMENT made Corporation and at , WITNESSETH: IN CONSIDERATION of the obligations stated herein and the exchange for other good and valuable consideration, receipt of which is hereby acknowledged, and both parties intending to be mutually bound, the parties agree as follows: 1. The term of the Agreement will be from the date of execution until terminated pursuant to the terms hereof. While this Agreement is in effect, the Contractor will perform certain work and services under the terms and conditions hereinafter set forth. The work and services herein provided for will be furnished from time-to-time upon oral or written request by Philotechnics, Ltd., which will be confirmed by a purchase order to be executed by both parties setting forth the scope, time, and fees to be paid for the provision of such services. As a part of the work and services to be performed, the Contractor will furnish intermediate reports to , of Philotechnics, from time-to-time when requested, in such form and number as may be required by Philotechnics, and will make such final reports as may be required by Philotechnics concerning the work and services performed under this Agreement. In the performance of the work and services hereunder, the Contractor will act solely as an independent contractor, and nothing contained or implied will at any time be so construed as to create the relationship of employer and employee, partnership, principal and agent, or joint adventurer as between Philotechnics and Contractor. It is understood that Philotechnics has no obligation under local, state, or federal laws regarding the Contractor or any employee, agents, or subcontractors employed by the Contractor and that the total commitment and liability of Philotechnics in regard to any arrangement or work performed hereunder is to pay the fees and expenses pursuant to the provisions hereof. While this Agreement is in effect, Philotechnics will compensate the Contractor in accordance with the rates set forth in the purchase order for time spent by the Page 7-22 , by and between Philotechnics, Ltd., a Delaware
, hereinafter called the Contractor with corporate office located
2.
3.
4.
5.
Quality Assurance Manual (QAM-1) Section 7. CONTROL OF PURCHASED ITEMS AND SERVICES Revision 3 Contractor in rendering such services, excluding travel time (unless expressly approved by Philotechnics). No fees or compensation will be paid or payable until execution by both parties of a purchase order. Compensation for fees and expense payments will be made at least once a month upon the Contractors submittal to Philotechnics of signed timesheets supporting the time spent in rendering services described in this Agreement, and a signed expense report, accompanied by a Contractor invoice with receipts detailing expenses. The timesheets and expense reports must be signed by . Contractor should use Philotechnics Travel and Expense forms for reporting of expenses. Payment terms will be net 10 days, unless otherwise specified in the purchase order. 6. The information developed by or communicated to the Contractor or any employee, agents, or subcontractors employed by the Contractor in the performance of services whether described in this Agreement, in any purchase order executed pursuant hereto or otherwise, is of a highly confidential nature. Unless the prior written approval of Philotechnics has been received, Contractor agrees to make no oral or written disclosure of such information either during or after the term of this Agreement to any persons (including, but not limited to, any corporate parent, subsidiary, or affiliate of Contractor or any employees, agents, or subcontractors of Contractor who have no need to know such information) other than persons, including employees of Philotechnics and its subsidiaries, who may be designated by Philotechnics to work with the Contractor. This restriction does not apply to information that is in the public domain. Contractor will further require all employees, agents, and subcontractors who have access to such information to sign a statement in a form acceptable to Philotechnics binding them to the restrictions of this clause in consideration of their continued employment. Executed copies of all such statements will be provided to Philotechnics upon request. Contractor will indemnify and hold Philotechnics harmless from any and all liabilities, claims, demands, actions, costs, damages, and any expenses relating thereto (including, but not limited to, reasonable attorneys fees) arising from any non-authorized disclosure of information protected by paragraph six (6) above by Contractor or any of its directors, officers, employees, agents, subcontractors, or permitted assigns. The Contractor agrees that, upon expiration or termination of this Agreement for any reason whatsoever, all drawings, designs, specifications, notebooks, tracings, photographs, negatives, reports, findings, recommendations, data, and memoranda of every description, arising out of and relating to the services described under this Agreement, are (and will continue to be after the expiration of this Agreement) the property of Philotechnics or its assigns and Philotechnics shall Page 7-23
7.
8.
Quality Assurance Manual (QAM-1) Section 7. CONTROL OF PURCHASED ITEMS AND SERVICES Revision 3 have the exclusive rights to copyright or publish such material. To the extent such material can be considered a work for hire under the copyright laws it shall be so considered. To the extent it cannot be so considered Contractor agrees to assign its entire right, title, and interest, throughout the world in all copyrights obtainable of such material and shall follow Philotechnics reasonable direction in the implementation and administration of such rights. It is understood and the Contractor agrees that the modification, use, reproduction, and disclosure of these materials in any manner by Philotechnics or its assigns shall not result in any additional claim for compensation by the Contractor. 9. The Contractor will make prompt and complete disclosure to Philotechnics of all inventions and discoveries made or conceived, alone or with others, while this Agreement is in effect, or within three (3) years thereafter, which arise out of or relate to the services rendered under this Agreement. The Contractor will keep necessary records, including notes, sketches, drawings, models, and data supporting all such inventions and discoveries made, alone or with others, during the course of performing the services described in this Agreement, and will furnish to Philotechnics upon request, all such records.
10. The Contractor hereby assigns to Philotechnics all inventions and discoveries made by Contractor, which arise out of and pertain to the services described in this Agreement, together with patents as may be obtained on these inventions and discoveries. Upon request of Philotechnics, Contractor will execute all necessary papers and cooperate in the fullest degree with Philotechnics in securing, maintaining, and enforcing any such patents which arise out of service performed under this Agreement, provided any obligations undertaken hereunder will be at no expense to the Contractor. 11. Notwithstanding the expiration or termination of this Agreement for any reason whatsoever, the respective rights and obligations set forth in paragraphs 6, 7, 8, 9, and 10 above will continue in full force and effect until they have been completely exercised or discharged. 12. If at any time during work covered under the purchase order the Contractor proposes to perform services for others that may conceivably either directly or indirectly conflict with the interests of Philotechnics, the Contractor will notify Philotechnics in writing in at least two weeks in advance. If, in the opinion of Philotechnics, such proposed services constitute a conflict of interest, and such services are performed by the Contractor, Philotechnics, at its election, may terminate this Agreement without any further obligation. By entering into this Agreement with Philotechnics, it is understood that the Contractor presently has no conflicting interests, agreements, or obligations with any other party.
Page 7-24
13. Philotechnics has the right to designate a specific employee(s) of the Contractor to perform work and services for each job or project undertaken during the term of this Agreement. 14. The Contractor hereby releases Philotechnics from any and all liability for damage to property or loss thereof, personal injury, or death during the term of this Agreement (and any extensions thereof) or thereafter, sustained by the Contractor, and any employee, agent, or subcontractor employed by the Contractor as a result of performing the services under this Agreement or arising out of the performance of such services, and the Contractor will indemnify and save Philotechnics harmless from any and all claims arising from or by reason of such property damage or loss, personal injury or death, except where such damage, loss, injury, or death is caused by or results from the negligence of Philotechnics, its agents, or employees. 15. All taxes applicable to any amounts paid by Philotechnics to the Contractor under this Agreement will be the Contractors liability and Philotechnics shall not withhold nor pay any amounts for federal, state, or municipal income tax, social security, unemployment, or workers compensation. In accordance with current law, Philotechnics shall annually file with the Internal Revenue Service a form 1099-misc., U.S. information return for recipients of miscellaneous income, reflecting the gross annual payments by Philotechnics to the Contractor, net of any reimbursed expenses incurred by the Contractor on behalf of Philotechnics, pursuant to this Agreement. 16. In the event that services to be performed under this Agreement involve work covered under contracts which Philotechnics may have as a government prime contractor or subcontractor, the obligations set forth in such contracts shall be binding upon Contractor. If the services to be performed by Contractor include the receiving, handling, or development of any government classified material, Contractor will submit a confidential report to Philotechnics immediately whenever for any cause it has reason to believe that there is an active danger of espionage or sabotage affecting any work under such government contracts. 17. Both, Philotechnics and the Contractor have the right to terminate this Agreement or any work being performed under any purchase order executed pursuant thereto at any time by a written notice. In such event, notwithstanding any other provisions herein, all work and services being performed under this Agreement or any purchase order being terminated will automatically terminate and Philotechnics will
Page 7-25
Quality Assurance Manual (QAM-1) Section 7. CONTROL OF PURCHASED ITEMS AND SERVICES Revision 3 have no liability or obligation for any performance by Contractor after the Contractor received or should have received such notice. 18. The Contractor may not assign this Agreement or any purchase order executed pursuant thereof, nor may the Contractor delegate or subcontract the performance and obligations imposed hereunder without the consent of Philotechnics. 19. The Contractor has no authority whatever, express or implied, by virtue of this Agreement to commit Philotechnics in any way to perform in any manner or to pay money for services or material. 20. This Agreement and any purchase order executed pursuant thereto are to be governed by the laws of the State of Tennessee, except its rules regarding choice of laws. 21. The whole and entire Agreement of the parties is set forth in this Agreement and the purchase order executed pursuant thereto (which are hereby incorporated herein and make a part hereof as executed) and the parties are not bound by any agreements, understandings, or conditions otherwise than as expressly set forth herein or in any purchase order incorporated herein. 22. The terms of this Agreement and of any of the purchase orders executed pursuant hereto and incorporated herein are to be read and interpreted, if possible, so that there is no conflict between them. To the extent there is such conflict, the terms of the applicable purchase order will prevail. Neither this Agreement nor any purchase order incorporated herein may be changed or modified in any manner except by a writing mutually signed by the parties or their respective successors and permitted assigns. 23. This Agreement and purchase orders incorporated herein will inure to the benefit of the parties and their respective successors and permitted assigns. AGREED: PHILOTECHNICS, LTD. By: Name: Date:
CONTRACTOR: By: Name: Date:
Page 7-26
Quality Assurance Manual (QAM-1) Section 7. CONTROL OF PURCHASED ITEMS AND SERVICES Revision 3 Required Information: 1. Consultants Federal Taxpayer Identification Number Social Security Number: Or Employer Identification Number: 2. Indicate Your Current Status (check one): Corporation Partnership Individual Proprietorship
Page 7-27
Quality Assurance Manual (QAM-1) Section 8. IDENTIFICATION AND CONTROL OF ITEMS Revision 3
SECTION 8 - IDENTIFICATION AND CONTROL OF ITEMS

A. REFERENCES NQA-1 Section 8 ISO 9001-2000 Clause 7.5.3 10 CFR 830.120 Criterion 5 B. APPLICABILITY. Per the decision chart at the front of this manual. This section is applicable only when imposed by specific customer requirements such as if the customer requires traceability of the item or material to applicable codes, standards, or specifications. or when required by federal or state regulations, including license requirements. C. PURPOSE AND POLICY. It is the policy of Philotechnics, Ltd. to identify and provide traceability methods when required and when the item, sample, or material is in the sole control of Philotechnics, Ltd. operations or processes. This section: 1. defines responsibilities, requirements, or controls to ensure that only correct and accepted items are used or installed 2. establishes traceability procedures for materials 3. establishes the method to be used to maintain chain-of-custody for items such as samples, specimens, or test materials, used in experimentation or testing or when the validity of the corresponding data or results depends on maintaining accurate identification and traceability D. BASIC REQUIREMENTS 1. Controls shall be established to assure that only correct and accepted items are used or installed. Identification shall be maintained on the items or in documents traceable to the items, or in a manner that assures that identification is established and maintained. 2. Procedures or work instructions shall be established to control the identification of materials and items from the point of receipt and through various stages of the process or production. 3. Philotechnics, Ltd. or independent laboratory chain of custody procedures shall be employed to identify and trace samples or specimens. 4. Physical identification shall be employed to the maximum extent possible, otherwise physical separation or procedural controls shall be employed. 5. The manner in which identification is placed on the material, item, or container shall be clear and legible.
Page 8-1
Quality Assurance Manual (QAM-1) Section 8. IDENTIFICATION AND CONTROL OF ITEMS Revision 3 6. When required by the customer or Philotechnics, Ltd., unique serialization or other traceability methods shall be implemented in accordance with established procedures or customer specific instructions. 7. Items having limited shelf or operating life shall be identified and controlled. 8. Procedures or work instructions shall address provisions for the control of item identification consistent with the planned duration and condition of storage. 9. Documentation generated as a result of implementing this manual section shall be maintained as quality assurance records. E. IDENTIFICATION AND CONTROL OF ITEMS 1. The Project Manager shall be responsible for ensuring the following: a. Appropriate work process documents such as work instructions, process sheets, drawings, inspection checklists, etc., define what materials or components of a product require identification and/or traceability measures b. Procurement documents specify which materials or product components are to be identified with heat, lot, serial and part numbers, etc., allowing traceability to the manufacturing source. Procurement documents shall also specify that the material or product component documentation such as Certified Mill Test Reports or Test Data Reports accompany the shipment c. Material or product component identification is verified during the receiving inspection process and that the associated documentation is reviewed for accuracy and completeness d. Physical identification is used to the maximum extent possible. Where physical identification on the item is either impracticable or insufficient, physical separation, procedural control, or other appropriate means shall be employed; e. Identification markings, when used, are applied using material and methods that provide a clear and legible identification and do not detrimentally affect the function or service life of the item f. Markings are transferred to each part of an identified item when the item is subdivided g. Items having limited shelf or operating life are identified as such and controlled to preclude their use after shelf or operating life is expired 2. The QAR shall also perform routine surveillance of materials and items in storage to ensure that identification markings have not been obliterated due to handling, aging, or deterioration from environmental exposure. Adequacy of marking shall be checked during routine audits. F. CHAIN OF CUSTODY
Page 8-2
Quality Assurance Manual (QAM-1) Section 8. IDENTIFICATION AND CONTROL OF ITEMS Revision 3 1. Precautions a. The survey/sampling technician collecting samples is responsible for maintaining surveillance of the sample until custody of the sample is transferred to another individual. Samples will be in the possession of the technician, under direct surveillance, or secured in a locked vehicle, building, or container until they are transferred. b. All samples must be labeled with an identification number and accompanied by a Chain-of-Custody Record (COCR), Form QF 8.2-1 at all times. The survey/sampling technician shall be responsible for ensuring that all samples are labeled with an identification number and accompanied by a completed COCR. If the laboratory requires the use its chain-of-custody forms, the local form is not required. Also, Form QF 8.2-1 should be regarded as typical and modifications to the form should be made as needed to accommodate project, sample type and specific control requirements. c. Samples collected and processed by Philotechnics at a project site do not require a chain-of-custody. 2. Materials Required a. Chain-of-Custody seals b. Chain-of-Custody Record 3. Logging the Collected Samples a. Sample custody is assigned to a specific individual until samples or groups of samples are analyzed, transferred, or properly disposed. A sample shall be considered to be under the custody of an individual if the sample is in the possession of that individual; the sample is in view of the individual after being in his or her possession; and the individual places the sample in a secured location. b. Clearly identify each sample collected with a unique sample identification number, date, time, sample provided by and analysis type on the sample container. Place a tamper resistant Chain Of Custody seal on the container or on the exterior of the package such that if the container is opened the seal will break. c. Record the following in the appropriate locations on the Chain-of- Custody Record or equivalent chain of custody form provided by the receiving laboratory: (1) Client Information: This refers to Philotechnics client or where the sample is physically taken from.
Page 8-3
Quality Assurance Manual (QAM-1) Section 8. IDENTIFICATION AND CONTROL OF ITEMS Revision 3 (2) (3) (4) (5) (6) (7) Company Signature: If required, a representative of the client whom authorizes the removal of the samples from their site for analysis. Comments: This section is reserved for comments on any special conditions involving the samples. Sampler Signature: The sampler must legibly sign this area. Project Name: The project name if different from the clients name is printed in this area. If it is not different then print the clients name. Send Report To: The person and address to whom the results should be sent. Project No.: The assigned project number is printed in this area.
d. For each sample collected, record the following information on the COCR. (1) (2) (3) (4) (5) (6) Sample number Date and time of sample collection Type of sample (Grab or Composite) Identify the sample matrix Indicate yes or no if the samples were preserved or not preserved in the field The number of containers per sample
e. Under the Analysis Required section record the following: (1) (2) (3) On the diagonal lines across the top, record the analytical tests (one per line) required for all samples For each sample place an x in the box below the appropriate test(s) that should be performed on that sample Under the Comments on Samples section, indicate any further instructions for each samples analysis
f. After the last sample is entered, a diagonal line from upper left to lower right must be drawn in the empty cells of the COCR. For example, after the last sample, in the sample information section, a diagonal line will be drawn from the Sample No. box to No. of Containers box. 4. Transferring Custody a. Relinquishing Custody of a Sample. (1) When relinquishing custody to another person or laboratory the current individual responsible for the samples (initially this is the sampler identified on the COCR) signs and dates on the Relinquished By line at the bottom
Page 8-4
Quality Assurance Manual (QAM-1) Section 8. IDENTIFICATION AND CONTROL OF ITEMS Revision 3 of the COCR (if the transfer occurs during the same day the responsible individual signs and notes the time); A copy of the signed COCR should be maintained for tracking purposes; If the samples are shipped via a common carrier to a designated off-site laboratory for analysis, ensure samples are packaged correctly and accompanied by a COCR; Record method of shipment, courier names, and pertinent information for tracking purposes; and If required, request a signed copy of the COCR and a brief description of the final disposition of the sample from the laboratory custodian after the samples are received and analyzed. This documentation is not normally needed.
(2) (3)
(4) (5)
b. Accepting Custody of a Sample. (1) When accepting custody of samples, the accepting individual must sign and date the Received By line on the COCR (if the acceptance occurs during the same day the accepting individual signs and notes the time); Inspect sample containers to ensure tampering has not occurred and custody has been maintained; and Note any deviations or problems on the COCR.
(2) (3)
G. QUALITY RECORDS. The following material identification documents shall be processed and maintained as Quality Records in accordance with Section 17 1. Material Identification Documents a. b. c. d. e. Vendor furnished identification and traceability documentation Travelers Drawings Inspection checklists Inspection reports
2. Chain of custody Documents a. All completed sampling documentation b. Chain-of-Custody Record
Page 8-5
Philotechnics, Ltd P. O. Box 4489 Oak Ridge, TN 37831-4489 888-RADWAST
Page 1 of ______
CHAIN OF CUSTODY RECORD

Contact: _______________________ Telephone:______________________ Fax: Needed By:______________________ Matrix * Grab Yes No # of Containers Sample Location Preserved in Field Analysis Reqd Comments on Samples Sampler Signature ____________________ _______________________ Send Report to: _________________ Project #: ________ Project Name _____________________________
Client Name: Address: City/State/Zip: Rush Normal
______________________ ______________________ ______________________
Turn Around:
Priority
Company (Signature) _________________ Time Comp
Date/Time Date/Time Date/Time Date/Time Date/Time Date/Time Containers Labeled: Yes No Seals Intact Upon Receipt: Yes No
Quality Assurance Manual (QAM-1) Section 8. IDENTIFICATION AND CONTROL OF ITEMS Revision 3
Sample
Date
Relinquished by (Signature)
Lab Use Only
Received by (Signature)
Broken Containers:
Yes
No
QA FORM 8-1: CHAIN OF CUSTODY RECORD (TYPICAL)
Page 8-6
Comments
Suspected Contamination:
Yes
No
* 1 Soil, 2 Water, 3 Sludge, 4 Urine, 5 Air, 6 Dust, 7 Building Material, 8 - Other
Quality Assurance Manual (QAM-1) Section 9. CONTROL OF PROCESSES Revision 3
SECTION 9 - CONTROL OF PROCESSES

A. REFERENCES NQA-1 Section 9 ISO 9001-2000 Clause 7.5.3 10 CFR 830.120 Criterion 5 B. APPLICABILITY. Per the decision chart at the front of this manual and for those projects, business units or tasks where either a customer or regulatory requirement exists, or where the business unit manager has determined a need for additional control to minimize risk associated with a process. C. PURPOSE AND POLICY It is the policy of Philotechnics, Ltd. to perform project tasks, processes, manufacturing or assembly operations, and test activities under controlled conditions defined in established procedures, work instructions, or Quality Assurance Program Plans (QAPPs). Specific process control requirements, instructions, acceptance criteria, and responsibilities are contained in business unit procedures, work instructions, and drawings. D. BASIC REQUIREMENTS 1. Processes affecting quality of items or services shall be controlled. Special processes that control or verify quality, such as those used in welding, heattreating, and nondestructive examination shall be performed by qualified personnel using qualified procedures in accordance with specified requirements. 2. Procedures, work instructions, drawings, checklists, travelers, or other appropriate means shall control project tasks, processes, and special processes. 3. Special processes shall be performed in accordance with appropriate instructions, which include or reference procedure, personnel, and equipment qualification requirements. 4. Qualification of personnel, procedures, and equipment shall comply with specified requirements. 5. Conditions necessary for accomplishment of the process shall be included in procedures. These conditions shall include proper equipment, controlled process parameters, and calibration requirements. 6. The requirements of applicable codes and standards, including acceptance criteria for the process, shall be specified or referenced in the procedures or instructions. 7. Records shall be maintained as appropriate for currently qualified personnel, processes, and equipment of each special process. Page 9-1
Quality Assurance Manual (QAM-1) Section 9. CONTROL OF PROCESSES Revision 3 8. For special processes not covered by existing codes and standards or where quality requirements specified for an item exceed those of existing codes or standards, the necessary requirements for qualifications of personnel, procedures, or equipment shall be specified or referenced in the procedures or instructions. 9. Activities performed by subcontractors shall be in accordance with their applicable process control documents approved by Philotechnics, Ltd. 10. Employees shall be trained to ensure a complete understanding of their tasks and the benefits of proper job performance. 11. Tools, equipment, and materials shall be specified in drawings, work instructions, or procedures. Equipment shall be maintained at preplanned intervals to ensure continuous process capability. 12. Inspection, measuring, and test equipment used to monitor work processes shall be calibrated in accordance with established procedures. 13. Process control documentation shall be maintained and processed as quality assurance records. E. CONTROL OF PROCESSES 1. Each business or project manager is responsible for ensuring that the general requirements specified in this section and specific process control work documents are complied with. The Quality Assurance Manager (QAM) and each Business Unit Quality Assurance Representative (QAR) will assist with: a. The development of new or revision of existing process control documents including but not limited to sequence of operations; precautions/safety requirements; required tools, instruments, etc.; process monitoring schedules; and inspection and test acceptance criteria. b. Determining the extent of process monitoring required to ensure the process is in compliance with specified requirements. Process monitoring activities shall be planned, scheduled, and documented. c. Ensuring that all process controls are included in periodic audits. 2. All proposed and awarded quality related work shall be reviewed. The purpose of this review is to identify and plan the necessary measures required to achieve the highest level of quality and reliability. A Process Review Planning Checklist, Form QF 9-1 shall be employed to document this review and identify process control needs. Appropriate personnel shall be assigned to resolve identified process control needs prior to the commencement of work. 3. All quality related repetitive processes such as welding, painting, coating, heat treating, laundry decontamination etc., shall be accomplished and controlled by instructions, procedures, drawings, checklists, travelers, or industry recognized standards. These documents shall assure that process parameters are
Page 9-2
Quality Assurance Manual (QAM-1) Section 9. CONTROL OF PROCESSES Revision 3 maintained and that specified environmental conditions are adhered to. The documents that specify process controls shall be made available to appropriate personnel in accordance with Section 6. All appropriate work shall be performed and monitored by trained and qualified personnel. For special processes not covered by existing codes and standards or where quality requirements specified for an item exceed those of existing codes or standards, the necessary requirements for qualifications of personnel, procedures, or equipment shall be specified or referenced in the procedures or instructions. As deemed necessary, auxiliary materials and utilities used in the process shall be monitored, controlled, and documented. Materials, chemicals, gases, etc., used in the process shall be supplied with Material Safety and Data Sheets (MSDS) and/or certificates of conformance. Processes performed by subcontracted personnel shall be defined in procedures and/or work instructions or contract specified agreements. These documents shall be reviewed and approved prior to commencement of work. Departures from approved process control measures shall be documented and tracked in accordance with Section 15, Control of Nonconforming Items.
4. 5.
6.
7.
8.
F. QUALITY RECORDS The following documents shall be processed and maintained in accordance with Section 17: Certificates of Compliance; Process planning documentation; and Subcontractor process control procedures.
Page 9-3
Quality Assurance Manual (QAM-1) Section 9. CONTROL OF PROCESSES Revision 3 QA FORM 9-1: PROCESS REVIEW PLANNING CHECKLIST
Project No.: Task: Product: Customer:
YES 1 Are existing procedures/work instructions available and adequate for the task?
NO
N/A
Are there any special or non-routine environmental conditions that must be controlled?
Are acceptance/rejection criteria different from the criteria specified in existing work documents? Are additional safety precautions required?
Is present process equipment adequate to perform or support the task work?
Does process equipment require routine calibration and, if so, is it properly calibrated?
Are process control materials and supporting utilities available?
Does the process or task require additional personnel?
Is there a need to provide additional or refresher training to personnel performing the process or task?
10
Is a mock-up or other demonstration required for new evolutions or technologies?
11
Are pre-job and pre-shift briefings required prior to commencing work?
12
13
14
Page 9-4
Quality Assurance Manual (QAM-1) Section 10. INSPECTION Revision 3
SECTION 10 - INSPECTION
A. REFERENCES NQA-1 Section 10 ISO 9001-2000 Clause 7.1 10 CFR 830.120 Criterion 8 B. APPLICABILITY. Per the decision chart at the front of this manual or when imposed by a customer. Managers should implement these procedures as needed for other tasks when needed to adequately control process quality. C. PURPOSE AND POLICY It is the policy of Philotechnics, Ltd. to apply adequate inspection and test activities to each scope of work, task, or product. These quality verification activities include, but are not limited to: Receipt inspection In-process monitoring Final inspection Internal and external audits Reviews of vendor/subcontractor documentation Project data validation D. BASIC REQUIREMENTS 1. Inspections required to verify conformance of an item or activity to specified requirements shall be planned and executed. Characteristics to be inspected and inspection methods to be employed shall be specified. Inspection results shall be documented. Persons other than those who performed or directly supervised the work being inspected shall perform inspection for acceptance. 2. Inspection activities shall be documented and controlled by procedures, work instructions, drawings, travelers, or other appropriate means. 3. Inspection personnel shall not report directly to the immediate supervisors who are responsible for performing the work being inspected. 4. Personnel performing inspections for the purpose of acceptance shall be qualified to perform the assigned inspection task. 5. When required or deemed necessary, inspection hold points shall be established and indicated in appropriate process documents. 6. Planning for inspection activities shall be accomplished, documented, and provide for recording objective evidence of inspection results.
Page 10-1
Quality Assurance Manual (QAM-1) Section 10. INSPECTION Revision 3 7. In-process inspection of items shall be performed where necessary to verify quality or indirect control monitoring methods shall be employed. Both in-process inspection and monitoring shall be provided when control is inadequate without both. 8. Final inspection shall include a records review of the results and resolution of nonconformances identified by prior inspections. 9. Acceptance of the item, task, or tests shall be documented and approved by qualified and authorized personnel. 10. Inspection documentation shall be maintained as quality assurance records. E. INSPECTION REQUIREMENTS 1. Inspection personnel shall not report directly to immediate supervisors who are responsible for performing the work being inspected unless the small size of the business unit or project makes this impractical. 2. Inspection, test, and non-destructive test personnel shall be trained and qualified in accordance with Section 2. 3. Inspection activities shall be planned to ensure all customer requirements or expectations have been addressed. Existing procedures or work instructions shall be reviewed to ensure these requirements have been established or to determine the need for additional inspection procedures or work instructions. 4. Requirements for receipt, in-process,final and other inspections will be documented. Compliance with performance and adequacy of inspections will be assessed during routine audits. 5. Services provided to Philotechnics, Ltd. are to be reviewed and accepted by inspection, surveillance, or review. The method of acceptance shall be preplanned and the results shall be documented. F. RECEIPT INSPECTION. 1. As applicable, receipt inspection activities shall consist of: a. A review of material inspection and test certificates, vendor compliance certificates, or other documentation delivered with the product; b. Verification of product size, quantity, color, etc. to purchase order requirements; c. A review of chain-of-custody documentation; d. Visual inspection to detect any damage or other visible quality problems; and e. Taking measurements or performing acceptance tests. 2. Acceptance of items shall be documented. The extent of receiving inspection documentation shall be based on the critical characteristics of the item. Methods of indicating item acceptance may be as follows:
Page 10-2
Quality Assurance Manual (QAM-1) Section 10. INSPECTION Revision 3
a. Completion of a Receiving Inspection Report; and/or b. Signing and dating the receiving copy of the purchase order. 3. All accepted items shall be marked, tagged, or placed in areas designated for the storage of acceptable items. Unacceptable items shall be marked, tagged, or placed in designated hold areas to preclude their use. Unacceptable items shall be processed in accordance with Section 15. G. IN-PROCESS INSPECTION. 1. In-process inspection and testing shall be performed to verify that an operation, task, or process was performed satisfactorily allowing or not allowing the work to continue. In-process inspection requirements shall be defined in one or more of the following work or process control documents: a. b. c. d. e. f. Quality Assurance Procedures Business Unit Work Instructions, process sheets or shop travelers Business Unit specific Quality Assurance Program Plans (QAPPs) Business Unit project specific procedures Specifications and drawings Customer furnished instructions/procedures which shall, at a minimum, define the following: (1) (2) (3) (4) (5) (6) What is to be inspected or tested How it will be inspected or tested When the inspection or test is to take place Who is responsible for conducting the inspection or test What forms of verification documentation is required Acceptance or rejection criteria
2. The individual performing the activity shall document all in-process inspection and test results. Documentation may be in the form of signed and dated: a. b. c. d. e. Shop travelers, process sheets, or drawings Inspection and test checklists Field logbooks or survey forms Maps and control charts Documentation associated with the applicable governing work document
Page 10-3
Quality Assurance Manual (QAM-1) Section 10. INSPECTION Revision 3 3. When a sample is used to verify acceptability of a group of similar items, procedures or work instructions shall define sample inspection requirements based on recognized standard practices. 4. Unacceptable or questionable in-process inspection and test results shall be documented in accordance with Section 15. H. FINAL INSPECTION 1. Final inspection shall be performed to verify the quality and completeness of the product, process, or task. Methods of final inspection may be, but are not limited to, the following: a. A physical inspection of the finished product and a review of all associated receipt and in-process inspection documentation b. A review of all data, test results, and related documentation associated with the completed process c. A review of any non-conformances, and corrective action measures to ensure closure d. Resolution of any client concerns e. Application of tags, stickers, etc. to indicate acceptance (if applicable). 2. Final inspection of the product or verification of process completeness shall be documented on the appropriate inspection forms, certificates of compliance, tasks checklists, or document review sheets. These forms shall indicate the project or job number, description of the task, process, or product, quantity, signature and date of the individual performing the final review or inspection. 3. Nonconforming conditions identified during the final inspection or verification shall be processed in accordance with Section 15. As deemed necessary, nonconforming conditions shall be reported to the client. I. QUALITY RECORDS. The following documents shall be processed and maintained as Quality Records in accordance with Section 17: Receipt inspection reports Process sheets or shop travelers Maps and control charts Field logbooks In-process inspection, test reports, or checklists Document review sheets Certificates of Compliance
Page 10-4
Quality Assurance Manual (QAM-1) Section 11. TEST CONTROL Revision 3
SECTION 11 - TEST CONTROL

A. REFERENCES NQA-1 Section 10 ISO 9001-2000 Clause 7.3.5 10 CFR 830.120 Criterion 5 B. APPLICABILITY. Per the decision chart at the front of this manual, or when imposed by a customer. C. PURPOSE AND POLICY The purpose of this Quality Assurance Procedure (QP) is to define the general requirements and responsibilities associated with the testing of quality related products, items, or equipment It is the policy of Philotechnics, Ltd. to ensure the integrity or function of quality related items, components, or systems are tested during the fabrication process or prior to shipment.. Specific test control requirements and/or precautions will be performed in accordance with project, business unit test procedures, work instructions, and this QP.
D. BASIC REQUIREMENTS 1. Tests required to verify conformance of an item or computer program to specified requirements and to demonstrate satisfactory performance for service shall be planned and executed. Characteristics to be tested and test methods to be employed shall be specified. Test results shall be documented and their conformance with acceptance criteria shall be evaluated. 2. Tests to acquire data for tasks such as site positioning or design input shall be planned, executed, documented, and evaluated. 3. Test procedures shall be established to include or reference test objectives and provisions for assuring that: a. b. c. d. Prerequisites for the test have been met Adequate instrumentation is available and used Necessary monitoring is performed Suitable environmental conditions are maintained
4. Prerequisites shall, as applicable, include: a. Calibrated instrumentation
Page 11-1
Quality Assurance Manual (QAM-1) Section 11. TEST CONTROL Revision 3 b. c. d. e. f. g. Appropriate equipment Trained personnel Condition of test equipment Item, component, or system to be tested Suitable environmental condition Provisions for data acquisition
5. In lieu of specially prepared written test procedures, industry recognized test standards may be employed. 6. Test results shall be documented, evaluated, and maintained as quality assurance records. E. PROCEDURES 1. The appropriate Project Manager or the Project Engineer shall be responsible for ensuring that qualification tests, production tests, and operational tests are planned and coordinated with the Business Unit Manager. These individuals shall also ensure that the general requirements contained in this QP are addressed or referenced in the development of new or existing test procedures. 2. The Quality Assurance Manager (QAM) or Quality Assurance Representative (QAR) shall be responsible for verifying compliance with these requirements through scheduled audits and routine monitoring activities. 3. All new and existing test procedures must contain or reference test objectives and provisions for assuring that prerequisites have been met. Test procedures shall also include, but need not be limited to: a. b. c. d. e. f. g. The required calibrated instrumentation The monitoring frequency Environmental conditions to be maintained Appropriate equipment Test personnel qualification requirements Provisions for recording data Acceptance criteria
4. In lieu of specially prepared written test procedures, appropriate sections of related documents, such as ASTM methods, supplier manuals, equipment maintenance instructions, or approved drawings or travelers with acceptance criteria, can be used. Such documents shall include adequate instructions to assure the required quality of work. 5. The responsible Project/Engineer Manager shall evaluate test results. 6. Test records shall, as a minimum, identify the following criteria:
Page 11-2
Quality Assurance Manual (QAM-1) Section 11. TEST CONTROL Revision 3 a. b. c. d. e. The item, product, or equipment tested The date(s) of test(s) The name(s) of the individual(s) conducting the test Observations made during the test period Test results and acceptability
7. Test deviations and or unacceptable results shall be documented and tracked in accordance with Section 15. 8. Subcontracted organizations involved in the performance of tests shall be qualified and approved in accordance with Section 7. F. QUALITY RECORDS. Test records and subcontractor test procedures; and test reports shall be processed and maintained in accordance with Section 17.
Page 11-3
Quality Assurance Manual (QAM-1) Section 12. CONTROL OF MEASURING AND TEST EQUIPMENT Revision 3
SECTION 12 - CONTROL OF MEASURING AND TEST EQUIPMENT

A. REFERENCES NQA-1 Section 12 ISO 9001-2000 Clause 7.6 10 CFR 830.120 Criterion 8 B. APPLICABILITY. All processes at all times, except that M&TE used in situations where the accuracy of measurements is not important, or where the measurement is not related to the verification of quality, are exempt from the requirements of this QP. C. PURPOSE AND POLICY It is the policy of Philotechnics, Ltd. to maintain a system for the strict control of Measuring and Test Equipment (M&TE). The degree or level of system controls shall be maintained to provide confidence in decisions or actions based on measurement data. The purpose of this Quality Assurance Procedure (QP) is to define the basic requirements and responsibilities for the control of Measuring and Test Equipment (M&TE). This QP applies to all M&TE owned or leased by Philotechnics, Ltd. and used to gather data in support of quality related project and production activities. D. BASIC REQUIREMENTS 1. Tools, gauges, instruments, and other inspection, measuring, and test equipment used for activities affecting quality shall be controlled and at specified periods calibrated or adjusted to maintain accuracy within necessary limits. 2. Procedures shall be established to define the method, calibration interval, calibration standards, required accuracy, intended use, and other conditions affecting M&TE control. 3. The selection of M&TE shall be controlled to assure the items are of the proper type, range, accuracy, and tolerance to accomplish conformance with specified requirements. 4. M&TE shall be calibrated, adjusted, and maintained at specified intervals or prior to use. 5. If possible, M&TE shall be calibrated against certified equipment having a known relationship to nationally recognized standards. 6. When M&TE is found to be out of calibration, an evaluation shall be made to judge the validity of previous inspection or test results. 7. Out-of-calibration M&TE shall be tagged or segregated and not used until they have been recalibrated. 8. A calibration history file shall be maintained for each item of M&TE. 9. Labels shall be affixed to M&TE for identification of their calibration and operational status. 10. M&TE shall be properly handled and stored to maintain accuracy.
Page 12-1
Quality Assurance Manual (QAM-1) Section 12. CONTROL OF MEASURING AND TEST EQUIPMENT Revision 3 11. M&TE calibration records and associated documentation shall be maintained as quality assurance records. E. CONTROL OF MEASURING AND TEST EQUIPMENT 1. M&TE and calibration standards shall be acquired from only those suppliers appearing on the Philotechnics, Ltd. Approved Suppliers List (ASL). M&TE and calibration standards shall be of the proper type, range and accuracy. Procurement documents shall specify the required certificates of accuracy, initial calibration status record, and if applicable, maintenance and calibration procedures. 2. A master M&TE inventory list, when applicable, shall be prepared and maintained by each project or business unit including but not limited to: a. b. c. d. e. f. g. Equipment name/description Quantity Operating range Owned or leased status The Philotechnics, Ltd. equipment/inventory number Supplier name Date purchased
3. M&TE calibration shall be performed and documented in accordance with the requirements and schedules specified in established Philotechnics, Ltd. work instructions, procedures, or written instructions provided by the manufacturer. If possible, calibration standards shall be traceable to nationally recognized standards. If not, the history of the standards used shall be documented to establish their acceptability. 4. Periodic maintenance shall be performed and documented in accordance with the manufacturers recommendations. 5. Only trained and qualified personnel shall be allowed to perform calibration and maintenance activities. 6. A calibration sticker indicating the date of calibration, the date of the next calibration, and the initials of the person performing the calibration shall be affixed to the M&TE. When M&TE configuration does not allow for placement of the calibration sticker, the sticker may be placed on the items storage container. 7. The Facility or Project Manager determines when an instrument is being used for measurements where accuracy is not important and calibration is not required. These conditions are rare and are typically limited to: (1) manufacturer installed instrumentation which is not needed for a specific installation, or (2) the presence or absence of a parameter rather than the amount. In these cases, the ability of the instrument to detect and for a meter to deflect must be observed. Installed instrumentation which is not used for quantitative measurement, and which is exempt for calibration requirements must be specifically marked as such. 8. A Calibration History Record, similar to Form QF 12-1, shall be completed to indicate calibration status attributes. This record is not required when approved
Page 12-2
Quality Assurance Manual (QAM-1) Section 12. CONTROL OF MEASURING AND TEST EQUIPMENT Revision 3 calibration laboratories perform calibration but the laboratory must provide equivalent certifications. 9. M&TE shall be properly handled and stored to maintain accuracy. 10. When M&TE cannot be calibrated or adjusted in-house, it shall be sent to a Philotechnics, Ltd. approved calibration laboratory. Procurement documents must specify required laboratory furnished calibration documentation (certificate of accuracy, as found as left data, and primary standard accuracy) information traceable to the National Institute of Standards and Technology (N.I.S.T.). 11. When M&TE is found to be out of calibration or not functioning as expected an Out of Service tag or a similar status indicator shall be affixed to the item. An evaluation shall be made to assess the validity of the data obtained since the last calibration and the acceptability of items previously inspected or tested. This evaluation shall be documented and if required, processed as a non-conformance. 12. If M&TE is consistently found to be out of calibration, it shall be repaired or replaced. A calibration shall be performed when equipment accuracy is suspect. F. QUALITY RECORDS. All calibration documentation; and Calibration History Records shall be processed and maintained as Quality Records in accordance with Section 17. .
Page 12-3
Quality Assurance Manual (QAM-1) Section 12. CONTROL OF MEASURING AND TEST EQUIPMENT Revision 3 QA FORM 12-1: CALIBRATION HISTORY RECORD
Item Name: Serial Number: ID Number:
Manufacturer:
Model Number:
Test or Calibration Frequency
Calibration Procedure No:
Calibration Standards / Cert. No.:
Item Location / Assigned to:
Calibration Date
Calibrated By
Calibration Due Date
Calibration Date
Calibrated By
Calibration Due Date
Remarks
Page 12-4
Quality Assurance Manual (QAM-1) Section 13. HANDLING, STORAGE AND SHIPPING Revision 3
SECTION 13 - HANDLING, STORAGE AND SHIPPING

A. REFERENCES NQA-1 Section 13 ISO 9001-2000 Clause 7.5.3 10 CFR 830.120 (not addressed) B. APPLICABILITY. Per the decision chart at the front of this manual or when imposed by the customer. In addition, all processes involving the movement of radioactive material shall comply with this section. C. PURPOSE AND POLICY It is the policy of Philotechnics, Ltd. to ensure that all items and products are adequately handled, stored, and shipped to maintain their intended integrity, identification, or physical characteristics. D. BASIC REQUIREMENTS 1. Handling, storage, cleaning, packaging, shipping, and preservation of items shall be controlled to prevent damage or loss and to minimize deterioration. 2. Procedures or work instructions shall be established to define how products and items are to be handled, stored, packaged, preserved, and shipped. 3. Procedures and work instructions shall consider customer, regulatory, and Philotechnics Ltd., established environmental protection and safety requirements. 4. Product or item integrity and identification shall be maintained during storage. The controls applied shall be consistent with the planned duration and conditions of storage. 5. Products or items shall be handled, stored, packaged, and transported by trained and qualified individuals in accordance with established procedures or work instructions. 6. When special handling or lifting equipment is required, personnel operating the equipment shall be trained and qualified. Equipment shall be periodically inspected to ensure safe operation.
Page 13-1
Quality Assurance Manual (QAM-1) Section 13. HANDLING, STORAGE AND SHIPPING Revision 3 7. All documentation related to handling, storage, packaging, preservation, and shipping shall be maintained as quality assurance records.
Page 13-2
Quality Assurance Manual (QAM-1) Section 13. HANDLING, STORAGE AND SHIPPING Revision 3 QA FORM 13-1: MAINTENANCE RECORD
Equipment Name: Location
Model Number:
Serial Number:
Maintenance/Inspection/Test Interval
Performed By:
Date:
Maintenance/Inspection/Test Criteria 1. 2. 3. 4. 5. 6. 7. 8. 9. 10. 11. 12. 13. 14.
Pass/Fail
Remarks/Recommendations:
Page 13-3
Quality Assurance Manual (QAM-1) Section 14. INSPECTION, TEST AND OPERATING STATUS Revision 3
SECTION 14 - INSPECTION, TEST AND OPERATING STATUS

A. REFERENCES NQA-1 Section 14 ISO 9001-2000 Clause 7.5.3 10 CFR 830.120 Criterion 5 B. APPLICABILITY. Per the decision chart at the front of this manual. Generally, this section applies to all such projects. However, implementation of these requirements must take a graded approach based on requirements determined by the project manager and his or her superiors. For example, the complexity of some projects may require formal turnover/turnback procedures as agreed upon with the customer; in other cases no documentation might be required. C. PURPOSE AND POLICY It is the policy of Philotechnics, Ltd. to employ sufficient provisions enabling positive inspection and test status of items at any stage of the items progress through the process. This procedure applies to quality and safety related activities performed inhouse or during field operations. D. BASIC REQUIREMENTS 1. The status of inspection and test activities shall be identified either on the items or in documents traceable to the items where it is necessary to assure that required inspections and tests are performed and to assure that items that have not passed the required inspections and tests are not inadvertently installed, used, or operated. 2. Procedures, project/product specific work instructions, or quality plans shall be established to define required inspections or testing activities. 3. The inspection and test status of items or tasks shall be identified by use of markings, stamps, tags, labels, and/or physical location to indicate their acceptability. 4. Unacceptable inspection, test, or verification results shall be processed in accordance with established non-conformance control procedures. 5. Status indicators shall provide for the operational status of quality and safety related systems or components.
Page 14-1
Quality Assurance Manual (QAM-1) Section 14. INSPECTION, TEST AND OPERATING STATUS Revision 3
6. Task or item related documentation such as process sheets, monitoring logs, calibration records, inspection sheets, and test reports shall indicate the status of in-process work or final completion of the task or item. 7. Completed documentation indicating inspection and test status shall be maintained as quality assurance records. E. PROCEDURES 1. The Project Manager shall ensure that status indicators such as tags, labels, security seals, stamps, etc., are controlled and made available to all personnel engaged in quality and safety related activities. Examples of status indicators are shown as Exhibit 1. 2. The Project Manager shall monitor the use of inspection and test status indicators and ensure implementation of the following requirements: a. All items, materials, and components shall be marked or tagged to indicate their acceptance or rejection at the point of receipt inspection. In lieu of marking or tagging items that have been accepted, the items may be placed in clearly marked areas designated for storage of acceptable items b. Hold areas shall be used to place items, etc., which have not been inspected or found to be nonconforming. Hold and/or reject tags shall be affixed to nonconforming items or placed on the item or its container c. In-process and final inspection results shall be documented on production process sheets, checklists, or forms associated with the procedure dictated activity d. In-process items awaiting inspection or test shall be tagged or marked to indicate their status e. Completed items awaiting shipment shall be tagged, marked, or placed in staging areas designated for completed and inspected items; and f. Test status indicators shall be placed on or near the test equipment to indicate the following: (1) (2) (3) Special test precautions Duration of test Notification requirements.
g. In addition, test plans or instructions shall define additional test status indicator requirements. The test plan or instruction shall be available at the test location. 3. Only personnel designated by the Project Manager shall remove status indicators.
Page 14-2
Quality Assurance Manual (QAM-1) Section 14. INSPECTION, TEST AND OPERATING STATUS Revision 3 F. QUALITY RECORDS. Documentation generated as a result of procedure implementation.shall be processed and maintained as Quality Records in accordance with Section 17. G. SAMPLE STATUS INDICATORS
HOLD
INSPECTED
DATE
INITIALS
_________________ _ _________________
SCRAP
INSPECTED BY:
______________ ____
Page 14-3
Quality Assurance Manual (QAM-1) Section 15. CONTROL OF NON-CONFORMANCE Revision 3
SECTION 15 - CONTROL OF NON-CONFORMANCE

A. REFERENCES NQA-1Section 15 ISO 9001-2000 Clause 8.3 10 CFR 830.120 Criterion 3 B. APPLICABILITY. Per the decision chart at the front of this manual. C. PURPOSE AND POLICY It is the policy of Philotechnics, Ltd. to identify, document, and control all nonconformities, regardless of how insignificant they seem to be or how easily they can be corrected. This section defines the responsibilities and requirements for documenting, controlling, and dispositioning quality related non-conformances identified during the performance of field activities or created by suppliers. D. BASIC REQUIREMENTS 1. Items that do not conform to specific requirements shall be controlled to prevent inadvertent installation or use. Controls shall provide for identification, documentation, evaluation, segregation (when practical), disposition of nonconforming items, and for notification to affected organizations. 2. Nonconforming items and activities shall be controlled in accordance with written procedures. 3. Nonconforming items and activities shall be segregated or identified. 4. Nonconforming conditions shall be evaluated, dispositioned, and approved by authorized personnel. 5. The responsibility and authority for the evaluation and disposition process shall be defined. 6. The disposition, such as, use-as-is, reject, repair, or rework of the nonconformance, shall be identified and documented. 7. Technical justification for the acceptability of repair or use-as-is dispositions shall be documented. 8. As applicable, as-built records shall reflect accepted deviations to original design requirements. 9. Repaired or reworked items shall be reinspected with applicable procedures and original acceptance criteria unless the disposition provides alternate acceptance criteria. E. CONTROL OF NON-CONFORMANCE 1. A non-conformance is defined as a deficiency in characteristic, documentation or procedure that renders the quality of an item or activity (including service)
Page 15-1
Quality Assurance Manual (QAM-1) Section 15. CONTROL OF NON-CONFORMANCE Revision 3 unacceptable or indeterminate. A Non-conformance Report shall be written when the following occurs: a. A purchased quality related item does not meet purchase order specified requirements discovered during receipt inspection or when in use b. A Philotechnics manufactured, assembled or processed item fails to meet design or customer requirements. c. A quality-related failure in service occurs. 2. When a non-conformance is identified, action involves isolating and correcting the specific problem. Properly used, non-conformance reports identify a problem and identify the specific steps taken to contain the problem. In most cases, a detailed evaluation of the root causes for a non-conformance is not necessary and wastes time. Non-conformance reports are intended to be easily and quickly written and resolved. Weaknesses in the quality program can be identified by periodic review and trend analysis of non-conformances. If a detailed analysis of underlying problems is necessary, a corrective action report is written. 3. The basic requirements for the control of non-conformance are as follows and explained in more detail within this procedure. a. b. c. d. e. f. Identify and/or segregate the nonconforming item Document the nonconforming condition Evaluate the nonconforming condition Provide a disposition, and when required, justification Notify affected personnel and/or affected organizations Verify implementation of the required disposition
4. Each employee shall be responsible for ensuring that a nonconforming item is brought to the attention of the immediate supervisor, or the Quality Assurance Manager (QAM), Quality Assurance Representative (QAR) or the Business Unit Manager (business unit or project manager). 5. DC shall be responsible for maintaining a Non-conformance Report Log, such as Form QF 15.1-1 to track NCR status. An equivalent electronic spreadsheet may be used in place of a paper file. F. USING THE NON-CONFORMANCE REPORT (NCR) 1. The originator fills out the form, obtaining a serial number from document control. The form is then delivered to the business unit or project manager. Forward a copy of the NCR to DC. 2. Information shall be completed by the appropriate business unit or project manager or an authorized individual competent to provide a disposition, a justification and the ability to determine if a design change is required. 3. Disposition and Justification This section applies primarily to material nonconformances. Justification for applying the disposition should also be indicated. Normally, non-conformance dispositions will be:
Page 15-2
Quality Assurance Manual (QAM-1) Section 15. CONTROL OF NON-CONFORMANCE Revision 3
a. Use-As-Is A disposition permitted for a nonconforming item when it can be established that the item is satisfactory for its intended use. b. Repair The process of restoring a nonconforming characteristic to a condition such that the capability of an item to function reliably and safely is unimpaired, although that item still does not conform to the original requirement. c. Rework The process by which an item is made to conform to original requirements by completion or correction. d. Reject A decision that a nonconforming item or activity cannot be accepted as is, reworked, or repaired. Rejected items are either scrapped or returned to the supplier or subcontractor. 4. When required, as-built drawings, records, or other related documentation that are affected by the non-conformance, shall include the non-conformance number and a brief description of the dispositioned non-conformance. 5. Design Change Required A decision to make a design change. If a change is required, the design change authorization number shall be indicated in accordance with QP 3.1, Design Control and processed accordingly. 6. Distribution - The name(s) of the individuals responsible for implementing the stated disposition and the name(s) of the individuals or department which maybe affected by the non-conformance. 7. The completed NCR is forwarded to the QA Manager who makes the following determinations: a. Corrective Action Required A determination made to judge the significance or the possible trends of the nonconforming condition. If corrective action is required a Corrective Action Request (CAR) number is obtained from DC and the CAR is processed accordingly. b. Closeout An indication that the stated disposition was completely carried out and verified. This action allows closure of the NCR and subsequent removal of the hold tag (if applicable). 8. The original NCR shall be forwarded to DC upon closure. G. QUALITY RECORDS. Non-conformance Reports and associated documentation; and the Non-conformance Report Log, shall be processed and maintained as quality records in accordance with Section 17
Page 15-3
Quality Assurance Manual (QAM-1) Section 15. CONTROL OF NON-CONFORMANCE Revision 3 QA FORM 15-1: NON-CONFORMANCE REPORT Originator Section
NCR #: PO #: Project #: Vendor Name:
For material non-conformances:
Hold Tag #
Hold Area
Non-conformance (including specification not met):
Item Nomenclature
Signature of Originator
Date:
Disposition and Justification: (use as is, scrap, rework, etc. and explanation)
Dispositioned By:
Date:
Closeout:
Disposition Approved: Corrective Action Required: Design Change Required: Quality Manager: Yes Yes No No
Yes
No
Date:
Distribution: Send original to Document Control. Send copies to business unit manager and other affected managers.
Page 15-4
Quality Assurance Manual (QAM-1) Section 15. CONTROL OF NON-CONFORMANCE Revision 3 QA FORM 15-2: NON-CONFORMANCE REPORT LOG NCR NUMBER DESCRIPTION ISSUE DATE CLOSURE DATE
Page 15-5
Quality Assurance Manual (QAM-1) Section 16. CORRECTIVE ACTION Revision 3
SECTION 16 - CORRECTIVE ACTION

A. REFERENCES NQA-1 Section 16 ISO 9001-2000 Clause 8.5.2, 8.5.3 10 CFR 830.120 Criterion 3 B. APPLICABILITY. Per the decision chart at the front of this manual. C. PURPOSE AND POLICY Philotechnics, Ltd. shall ensure prompt detection and correction of conditions adverse to quality. Corrective and preventive action will extend to the performance of suppliers and subcontractors, and will be responsive to feedback and complaints from customers. This section defines the requirements and responsibilities for documenting, reporting, and verifying corrective actions using a Corrective Action Request (CAR). It also addresses the responsibilities and requirements for identifying and processing preventive action measures. The distinction between corrective and preventive action is that corrective action addresses a condition adverse to quality and preventive action addresses the elimination of situations that may lead to a condition adverse to quality.
D. BASIC REQUIREMENTS 1. The identification, cause, and corrective action for significant conditions adverse to quality shall be documented and reported to appropriate levels of management. Follow-up action shall be taken to verify implementation of these corrective actions. 2. Procedures shall be established and maintained for implementing corrective and preventive actions. 3. Corrective action procedures shall address, but need not be limited to the following: a. Effective handling of customer complaints and non-conformance reports; b. Determining the cause of the non-conformance related to the product, process, and/or the Quality Assurance Program; and c. Application of controls to ensure that corrective action is taken and that it is effective.
Page 16-1
Quality Assurance Manual (QAM-1) Section 16. CORRECTIVE ACTION Revision 3 4. Preventive action procedures shall address, but need not be limited to the following: a. Review of appropriate sources of information such as process and work instructions, audit results, quality related records, service reports, etc. to detect, analyze, and eliminate potential causes of non-conformances b. Initiation of preventive action and application of controls to ensure that the action is effective. E. CORRECTIVE/PREVENTIVE ACTION 1. Each Philotechnics employee is responsible for reporting conditions adverse to quality to the immediate supervisor, or to the Quality Assurance Manager (QAM), the Quality Assurance Representative (QAR) or the appropriate Business Manager. 2. The QAM, QAR or the business unit or project manager shall be responsible for evaluating the reported conditions to determine if a Non-conformance Report (NCR) applies and should be written to document and track the condition. If an NCR is judged to be inadequate to correct underlying problems associated with quality, the corrective action process shall be employed. Some examples of conditions adverse to quality that fall under the corrective action reporting process are as follows: a. An NCR might be appropriate if a machine cannot be operated due to a loose or leaking hose. A CAR might be required when the condition impacts reliability, availability, maintainability of equipment or the facility such as number of problems with the machine indicating an underlying lack of maintenance. b. An NCR might be appropriate if a safety hazard is observed. A CAR is required when the condition impacts safety and health of the public or environment. c. An NCR might be appropriate for minor non-conformances with internal requirements. A CAR might be necessary when the condition affects compliance with regulatory requirements. d. An NCR is appropriate for specific failures to adhere to procedures. A CAR is required when a condition results in repeated failure to implement a portion of or all of a procedure. e. A CAR is required when prior corrective action has not been effective. 3. The QAM may determine the need for corrective action during periodic reviews of recurring audit findings or non-conformance reports. 4. When corrective action is deemed necessary, a Corrective Action Request (CAR), Form QF 16-1, shall be generated by the QAM, QAR or business unit or project
Page 16-2
Quality Assurance Manual (QAM-1) Section 16. CORRECTIVE ACTION Revision 3 manager. Exhibit 2 provides an illustration of the flow of activities associated with the corrective action process. 5. DC shall be responsible for maintaining a Corrective Action Request Log to document and track CARs. F. PREVENTIVE ACTION 1. Preventive action is defined as an activity directed toward eliminating the cause of POTENTIAL conditions adverse to quality. Each Philotechnics employee is encouraged to identify any activity, process, procedure, etc., which could be improved. 2. The QAM, QAR or business unit or project manager shall, periodically, review quality performance documentation such as, work processes, audit results, quality records, and customer complaints to detect, analyze, and eliminate potential problems that could lead to adverse conditions. In addition, they shall annually review existing quality procedures, work instructions, or plans to determine if clarification or improvement of the document is required. 3. When a potential preventive action is identified, a Preventive Action Request (PAR), Form QF 16-2 shall be used to document and track preventive action resolutions. 4. NOTE: In cases where a preventive action is required to be implemented immediately, it can be presented to any member of the management staff for review, acceptance, and subsequent implementation. 5. DC shall be responsible for maintaining a Preventive Action Request Log for documenting and tracking proposed and completed preventive action requests. G. QUALITY RECORDS The following documents shall be processed and maintained as quality records in accordance with Section 17: Corrective Action Requests Preventive Active Requests Corrective and Preventive Action Request Logs
Page 16-3
Quality Assurance Manual (QAM-1) Section 16. CORRECTIVE ACTION Revision 3 QA FORM 16-1: CORRECTIVE ACTION REQUEST REFERENCE DOCUMENT(S): DATE:
CAR NO.: ORIGINATOR:

CAR Assigned To:
Response Due Date:
DESCRIPTION: The significant condition(s) adverse to quality is brought to your attention.
Complete cause and corrective action section and return the form to the undersigned.
Originator Signature
Date
CAUSE AND CORRECTIVE ACTION: Indicate the root cause; the impact on related activities; a
schedule as to when the corrective action will be taken to correct the cause; action(s) to preclude recurrence; and corrective action implementation dates.
Signature: CONCURRENCE: Originator:
Date:
Date:
CORRECTIVE ACTION COMPLETED AND VERIFIED: Quality Assurance Manager: DISTRIBUTION: Date:
Page 16-4
Quality Assurance Manual (QAM-1) Section 16. CORRECTIVE ACTION Revision 3 QA FORM 16-2: PREVENTIVE ACTION REQUEST PAR No.: Requested by: Date:
Reason: Opportunity for process or procedure improvement Client feedback and/or customer complaints Other Requestor: explain the reason (marked above) for the proposed preventive action: Recurring non-conformance of the same nature Internal audit findings or observations
Requestor: describe the proposed preventive action:
Management Comments:
Responsibility: Verified By:
Completion Date: Date:
Page 16-5
Quality Assurance Manual (QAM-1) Section 17. QUALITY ASSURANCE RECORDS Revision 4
SECTION 17 - QUALITY ASSURANCE RECORDS

A. REFERENCES NQA-1 Section 17 and corresponding guidance ISO 9001-200 Clause 4.2.4 10 CFR 830.120 Criterion 4 B. APPLICABILITY. All projects at all times. C. PURPOSE AND POLICY It is the policy of Philotechnics, Ltd. to establish and maintain a record control system. Records are considered a principal form of objective evidence that indicate the adequacy and effectiveness of the Quality Assurance Program. The purpose of this section is to define the requirements and responsibilities for the collection, maintenance, storage, and subsequent disposal of quality related records. This QP applies to all records required by the client and records that indicate implementation of Philotechnics, Ltds Quality Assurance Program. D. BASIC REQUIREMENTS 1. Records that furnish documentary evidence of quality shall be specified, prepared, and maintained. Records shall be legible, identifiable, and retrievable. Records shall be protected against damage, deterioration, or loss. Requirements and responsibilities for record transmittal, distribution, retention, maintenance, and disposition shall be established and documented. 2. Quality related documents that are to become quality assurance records shall be identified in procedures, work instructions, Quality Assurance Program Plans (QAPPs) or project/facility specific procedures. 3. Record control procedures shall be established and implemented. Procedures shall define the following requirements for records: Validation Indexing Retention Identification Distribution Classification Receipt Storage Preservation Safekeeping
4. Access to record files and storage areas shall be controlled. 5. Quality related supplier and subcontractor furnished documentation or data shall be controlled and maintained as quality assurance records. 6. Philotechnics Ltd. shall make quality assurance records available to the customer or his or her representative for review or evaluation.
Page 17-1
Quality Assurance Manual (QAM-1) Section 17. QUALITY ASSURANCE RECORDS Revision 4
E. QUALITY ASSURANCE RECORDS 1. The Record Matrix in Table 17-1 provides a list of quality related documents that shall be processed as quality records. Specific projects might require longer record retention times; if so, the longer time will be used. Each individual who generates, receives, or is otherwise responsible for the control of documents shall ensure that the following measures are taken during interim storage of documents: a. Documents shall be identified and traceable to a project number, activity, or operation. b. A suitable storage method (file cabinets, job folders, etc.) shall be provided. Documents shall not be stored in desk drawers or other obscure locations that are not generally known to others. c. Documents shall be returned to their regular storage area when not being used. d. When a document is complete and is no longer required to support the project or activity the aforementioned individual shall transfer documents for storage in a controlled manner. The degree of control needed for document handling depends on the risk of mishandling. 2. Each document control custodian shall maintain a record locator log or equivalent system to indicate the location of stored quality assurance records, unless locations are obvious. 3. Special processed records such as radiographs, photographs, microfilm, and magnetic media shall be stored and protected to prevent damage from excessive light, stacking, and electromagnetic fields. 4. Record storage areas shall be restricted to authorized personnel and remain locked whenever records are not being accessed. Record storage areas should be equipped with a fire protection system and temperature/humidity controls. The fire protection criterion is not met for storage in Harriman and non-project records are exempt from this requirement. 5. At the end of the specified record retention time, each business unit or facility manager may dispose of the records. F. CONVERSION OF PAPER RECORDS TO ELECTRONIC RECORDS 1. Quality records may be converted from paper format to electronic media through processes referred to as digitizing or scanning. This section covers the requirements which must be met for conversion of quality records initially created in paper form. It does not establish an electronic records management system (ERMS) as that term is commonly used.
Page 17-2
Quality Assurance Manual (QAM-1) Section 17. QUALITY ASSURANCE RECORDS Revision 4 2. There are advantages and disadvantages to records conversion. The advantages include reduced size of records and better protection of records from environmental degradation. The primary disadvantage is an inability to add records to a digitized set without possibly needing to compile a new record. Another disadvantage is the time it takes to digitize the record and verify that the resulting record is a faithful, complete and legible reproduction of the original. Consequently, one should verify that a record set is complete before digitizing and consider the cost and benefits. A copy of all non-conformance reports for the retained period will typically be a thin folder, and digitizing might not be worthwhile. A large record set from a major, long term complex project might be a prime candidate for digitizing. Even then, digitizing might not be appropriate until any audits associated with the project are complete and the project contract is formally closed. 3. As described in this procedure, digitizing provides little improvement in the ability to share records (not true in a full ERMS). Record access might be improved if the digitized record is more accessible to a possible user than a paper record placed into a remote long term storage facility. 4. Conversion. a. Digitized records must be as easily retrievable as the paper copy would be. If paper copies of instrument calibration records are sorted by instrument, then electronic data should be similarly organized and individual files must be clearly labeled. In other words, do not take three years of calibration history, filed separately by instrument in two full file cabinet drawers, and scan the records into a single huge amorphous file which requires the user to sift through data to find history for a specific instrument. Scan the records for each instrument into a separate file or, if each instrument only has a few pages of data, into reasonably sized combined files of related information (e.g., instrumentation of a certain type). b. Use scanner settings that will provide adequate resolution. A black-and-white text document will require less resolution than a photograph or survey map. While lower resolution means smaller files, err on the side of higher resolution documents. c. Scan the document into a format which is likely to endure for the life of the document. PDF (document) and JPG (photo) formats are industry standards and preferred. TIF and PNG file formats have less history of use. If the document is merely a printout of an existing electronic file, it is permissible to use the original electronic file if the format is a durable one and any signatures on the record copy also appear on the original electronic file. d. Use names on scanned files which fully describe the contents of the file to someone who was not involved either in the original work or the scanning process. Modern scanners assign a file name based on date or scan sequence number, both of which are useless for record identification. Although file names
Page 17-3
Quality Assurance Manual (QAM-1) Section 17. QUALITY ASSURANCE RECORDS Revision 4 can be as long as 256 characters in most systems, many people who learned file management with older systems still use extremely short 8.3 names. Use a name which will identify a file if it is inadvertently moved from its parent folder. For example, Final Survey Results Zone 2 would need the project number. e. The scanned data must be validated. Someone must review the electronic file to verify that all desired records were copied, that each record was scanned completely (no double-fed pages) and that each page is legible. The file validation must be documented. The common way to do this is to prepare a simple sheet indicating the records scanned, the resulting file names, a statement that all scanned files in the batch have been validated and a signature. The validation sheet is commonly scanned and filed with the records batch. 5. Labeling and Storage. a. Documents which are digitized and retained as official records will be maintained on non-rewriteable optical recording media (CD-R, DVD-R, or BlueRay). Insofar as possible, select media which will allow all documents in a set to be retained on 1 disk. If there are too many documents to use only 1 disk, then each disk must be numbered 1 of 3, 2 of 3, etc. Two copies will be kept: an official and backup copy. Media must have an official and a backup copy, must be marked as such, and copies will be stored in physically separate locations (ideally, different buildings). b. Disk labeling must be done with permanent ink or laser etching (such as using lightScribe technology) and must include the following: (1) Date compiled (2) The name of the person who compiled the data. (3) Contents. Generally, the label(s) on the files and folders could be listed on the disk or a compilation name could be used (e.g. PES shipments 2006). (4) Disk 1 of XX (if necessary). (5) Date for disposal or review. 6. Retention. a. If the document is converted to a digital format, then the digital format becomes the official record. b. Paper copies of digitized quality records may be retained or destroyed depending on the users preference. However, if paper copies are retained: (1) The cover page of original documents must be marked with the date they are digitized and are no longer official records (2) The records must be stored separately from quality records.
Page 17-4
Quality Assurance Manual (QAM-1) Section 17. QUALITY ASSURANCE RECORDS Revision 4 TABLE 17-1 - RECORD RETENTION MATRIX RECORD
Audits (Internal & External) Drawings Chain of Custody Forms Corrective Action/Preventive Action Reports Design Change Authorizations Document Transmittal Dosimetry Records Environmental Discharge Document ES&H Plans and Procedures Inspection and Test Records Instrument and Measuring Equipment Calibration Data Non-conformance/Occurrence Reports Personnel Qualification Procedures and Plans (Licensed activities) Project Files QA Management Reviews QAPPs (Project Specific) Quality Assurance Manual and obsolete revisions Quality Assurance Procedures and obsolete revisions Purchase Orders and Requisitions Radioactive Material Inventory Radiological Surveys Shipment Records (DOT) Shipment Records (NRC) Source Inspection Reports Stop Work Orders Surveillances Supplier Evaluation and Qualification Records Training Records
RETENTION
3 years 3 years 1 year 3 years 3 years 1 year Termination of License Termination of License For project-specific HASP, maintain with project files. Otherwise, 3 years 3 years 3 years 3 years or Termination of license Current qualification and past 3 years Termination of License 3 years or Contract Specific time 3 years Maintain with project files for project records duration 3 years. See Note 1. 3 years 3 years or termination of contract 5 years beyond termination of license Termination of License. Also see Note 2. Non-radioactive hazardous materials: 3 years Radioactive and/or mixed waste: for term of license NRC - Termination of License 3 years 3 years For project-specific surveillances, maintain with project files. Otherwise, 3 years 3 years after Vendor evaluation is performed or removed from ASL Project-specific training records are retained with the project. Otherwise, 3 years after employee termination. Also see Note 3.
Notes: 1. Reduced from 5 years. Rationale: few other records are retained beyond 3 years and compliance beyond 3 years cannot be demonstrated. Retention beyond 3 years is therefore not useful. 2. ANSI/HPS N13.49-2001 recommends retention of surveys that may be necessary for dose reconstruction for the life of the facility or longer, if practicable. 3. ANSI/HPS N13.36-2001 recommends radiological training records be maintained for 75 years or as directed by appropriate regulatory authority.
Page 17-5
Quality Assurance Manual (QAM-1) Section 18. AUDITS Revision 3
Section 18 - AUDITS
A. REFERENCES NQA-1 Section 18 ISO 9001-2000 Clause 8.2.2 10 CFR 830.120 Criterion 10 B. APPLICABILITY. All projects at all times. C. PURPOSE AND POLICY It is the policy of Philotechnics, Ltd. to perform controlled, planned, and documented audits and assessments to: Ensure that quality, safety, customer, and regulatory requirements are met; and Identify opportunities for continuous improvement. The purpose of this Quality Assurance Procedure (QP) is to define the requirements and responsibilities for performing internal and supplier Quality Assurance Program Audits. This QP provides a means of identifying and correcting violations, weaknesses, and potential problems associated with the quality program. This QP applies to all Philotechnics Business Units engaged in quality related work and, when applicable, to suppliers or subcontractors supporting or otherwise associated with the performance of quality related activities. D. BASIC REQUIREMENTS 1. Planned and scheduled audits shall be performed to verify compliance with all aspects of the Quality Assurance Program and to determine its effectiveness. 2. Documented procedures shall be established for the performance of Quality Assurance Program Audits. Audits shall be as follows: a. Planned and scheduled according to the status and importance of the activity b. Performed with the aid of audit checklists and appropriate forms to record audit results c. Carried out by trained and qualified personnel who are independent of the activity being audited. 3. Audit results shall be documented and communicated to appropriate individuals and affected organizations.
Page 18-1
Quality Assurance Manual (QAM-1) Section 18. AUDITS Revision 3 4. Follow-up audits or other verification activities shall be performed to ensure the effectiveness of corrective action measures. 5. Philotechnics, Ltd. management shall assess their management processes and procedures on an annual basis. The assessment shall be documented and address, but need not be limited to the following: a. b. c. d. Organizational structure Implementation of the Quality Assurance Program Customer feedback; Results of internal and external audits and independent assessments.
6. Problems that hinder the organization from achieving its objectives shall be identified and corrected. 7. Project management shall perform independent assessments of project activities at least once during the life of the project when the project is expected to be longer than 6 weeks. Independent assessments shall be planned, conducted, and documented. The assessment shall consider or address the following: a. b. c. d. e. Project cost and schedule requirements Effectiveness of the project Quality Assurance Program Plan (QAPP) Health and Safety Program adherence; Environmental objectives Non-conformances and their impact on the project.
8. Identified concerns shall be examined to determine the root causes and appropriate corrective action shall be established. 9. All documentation resulting from the performance of audits and assessments shall be maintained as quality assurance records. E. CONDUCT OF AUDITS 1. The Lead Auditor shall be responsible for implementing the audit process. Should additional audit personnel be required, they shall be qualified, have sufficient knowledge of the activity being audited, and be independent of the activity being audited. 2. Scheduling 3. Each element of the Quality Assurance Program shall be audited at least once each calendar year. An audit schedule shall be prepared, reviewed periodically, and revised as necessary to ensure that coverage is maintained current. The schedule maybe adjusted to accommodate significant changes to the program or the importance of the audited activity. 4. Audit planning and preparation shall be performed, documented, and consider the following applicable audit attributes:
Page 18-2
Quality Assurance Manual (QAM-1) Section 18. AUDITS Revision 3 a. b. c. d. e. f. Audit scope and dates Audit number or other unique identifier Activities to be audited Organization/personnel to be notified Applicable quality documents Checklist preparation.
5. The audited organization shall be provided with an audit announcement letter confirming the audit scope and audit date(s). 6. A pre-audit meeting with appropriate members of the audited organization should be held to review the audit scope and determine the individuals or departments to be interviewed. 7. The audit should be performed with the aid of a pre-planned checklist or other appropriate means. The audit questions extracted from procedures, Work Instructions, or Quality Assurance Program Plans (QAPPs) should be used as audit criteria. 8. Identified departures from specified quality assurance program requirements shall be documented on an Audit Finding Form (AFF) Form QF 18.1-1. Observations that can be defined as potential departures, weaknesses, or could otherwise enhance the program shall be documented on an Audit Observation Form (AOF) Form QF 18.1-2. 9. At an audit conclusion, the preliminary results of the audit, including areas of compliance, identified departures (findings), and recommendations (observations), should be discussed during the post-audit meeting. Any misunderstandings or clarifications should also be addressed. Copies of preliminary findings and/or observations should be provided to the audited organization. 10. Within (15)-fifteen days from the actual audit date, the audited organization shall be provided with a formal audit report, which should include, but need not be limited to the following: a. A list of audited Quality Assurance Program elements b. The names of the personnel interviewed c. A summary of the audit results including a statement describing the overall effectiveness of the Quality Assurance Program d. A formal copy of each finding and/or observation form e. Required documentation (objective evidence of corrective action) to be provided to the Lead Auditor. 11. The audit shall remain open until all responses that are tracked by Document Control (DC) are reviewed, verified, found acceptable, and documented on the appropriate form. Unacceptable responses shall be discussed with the audited organization and rectified.
Page 18-3
Quality Assurance Manual (QAM-1) Section 18. AUDITS Revision 3 12. Response due dates may be extended if the audited organization requests an extension in writing and includes the date a response can be provided. Responses to findings are submitted to the Lead Auditor for closure. Responses to observations should be submitted to the Business Unit Manager for evaluation. The Lead Auditor does not review observation responses. The request shall be reviewed to determine the impact of the required extension with respect to the importance and/or complexity of the associated finding or observation. If the extension is approved, an additional (15)-fifteen days will be granted and the new response date will be indicated on the finding or observation form. 13. When all finding responses have been accepted, an audit closure letter shall be provided to the audited organization closing the audit activity. 14. Supplier and subcontractor quality program audits shall be scheduled and performed with applicable requirements of this procedure. F. QUALITY RECORDS. Audit documents (schedules, plans, reports, checklists, finding and observation forms and corrective action verification documentation).shall be processed and maintained as quality records in accordance with Section 17.
Page 18-4
Quality Assurance Manual (QAM-1) Section 18. AUDITS Revision 3 QA FORM 18-1: AUDIT FINDING FORM
Audit No,: REQUIREMENT: Organization or Supplier: Finding No.: Auditor/Date:
FINDING:
CORRECTIVE ACTION RESPONSE DUE ON OR BEFORE: CORRECTIVE ACTION RESPONSE (completed by individual responsible for corrective action)
Signature (Individual responsible for corrective action) Evaluation/Verification:
Date:
Closure Date:
Closed By:
Page 18-5
Quality Assurance Manual (QAM-1) Section 18. AUDITS Revision 3 QA FORM 18-2: AUDIT OBSERVATION FORM
Audit No,: OBSERVATION: Organization or Supplier: Observation No.: Auditor/Date:
RECOMMENDATION:
RESPONSE DUE ON OR BEFORE: RESPONSE (completed by individual responsible for evaluation)
Signature (Individual responsible for corrective action) Evaluation/Verification:
Date:
Closure Date:
Closed By:
Page 18-6

Company QAM

Încărcat de

Informații document

Drepturi de autor

Formate disponibile

Partajați acest document

Partajați sau inserați document

Opțiuni de partajare

Vi se pare util acest document?

Este necorespunzător acest conținut?

Drepturi de autor:

Formate disponibile

Company QAM

Încărcat de

Drepturi de autor:

Formate disponibile

Quality Assurance Manual (QAM-1) Table of Contents Revision 4 Procedure Number QAM-001

Type: QUALITY ASSURANCE Title: QUALITY ASSURANCE MANUAL

Revision Number: 4 Effective Date: 2/15/2010

A. J. Armbrust - Signature on file

Quality Assurance Manual (QAM-1) Table of Contents Revision 4

Quality Assurance Manual (QAM-1) Table of Contents Revision 4

List of Effective Pages

Quality Assurance Manual (QAM-1) Introduction Revision 3

Quality Assurance Introduction

Do not use this manual. Use customer procedures.

Quality Assurance Manual (QAM-1) Introduction Revision 3

Terms and Definitions

Quality Assurance Manual (QAM-1) Introduction Revision 3

40. 41. 42.

Quality Assurance Manual (QAM-1) Introduction Revision 3

Quality Assurance Manual (QAM-1) Section 1. ORGANIZATION Revision 3

Quality Organization Chart

Quality Assurance Manager

Quality Assurance Representative

Originator Signature: Part 2 Corrective Action Proposed Corrective Action

Action Proposed By:

Safety Manager (for safety related work

SECTION 2 - QUALITY ASSURANCE PROGRAM AND TRAINING

Indoctrination Provided By: Review:

ATTENDEES: PRINTED NAME 1. 2. 3. 4. 5. 6. 7. 8. 9. 10. 1. 2. 3. 4. 5. 6. 7. 8. 9. 10

Supervisor: Project or Facility Manager: Other:

Date: Date: Date:

Quality Assurance Manual (QAM-1) Section 3. DESIGN CONTROL Revision 3

SECTION 3 - DESIGN CONTROL

Affected Documents: Document Number or Other Designation

Revision Level / Date

Impact on Other Products or Activities:

Reviewed / Approved By: Distribution:

Quality Assurance Manual (QAM-1) Section 4. PROCUREMENT DOCUMENT CONTROL Revision 3

SECTION 4 - PROCUREMENT DOCUMENT CONTROL

Quality Assurance Manual (QAM-1) Section 4. PROCUREMENT DOCUMENT CONTROL Revision 3

SECTION 5 - INSTRUCTIONS, PROCEDURES AND DRAWINGS

TABLE 5-1: PROCEDURE CHARACTERISTICS Attribute

Less Formal Procedures

Documentation/ Record Requirements

Quality Assurance Manual (QAM-1) Section 6. DOCUMENT CONTROL Revision 3

SECTION 6 - DOCUMENT CONTROL

Quality Assurance Manual (QAM-1) Section 6. DOCUMENT CONTROL Revision 3

Quality Assurance Manual (QAM-1) Section 6. DOCUMENT CONTROL Revision 3

Uncontrolled Document Creation (inside the company)

Document Change Approval Document Change Issue

REVISION NO: DT DUE DATE:

First Class Mail UPS Second Day Air Priority Mail

UPS Next Day Fed-X Next Day Hand Delivered

DOCUMENT TRANSMITTAL ORIGINATED BY:

PRINTED NAME: DATE RECEIVED

SECTION 7 - CONTROL OF PURCHASED ITEMS AND SERVICES

State: Fax No.:

3. Purchase Order Review:

9. Purchasing and Purchaser Supplied Products:

10. Customer Supplied Products:

11. Product Identity and Traceability:

12. Receiving Inspection and Testing:

13. Final Inspection:

14. Inspection, Measuring, and Test Equipment:

15. Inspection and Test Status:

16. Control of Non-Conforming Product:

17. Handling, Storage, Packaging, and Delivery:

18. Quality/Inspection Records:

__