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Manual for Third Party Verification (TPV) and 3-A Symbol Authorization
Table of Contents
TABLE OF CONTENTS ..............................................................................................................2 DISCLAIMER................................................................................................................................5 INTRODUCTION..........................................................................................................................6 B1 B2 B3 B4 B5 How to Use this Manual ....................................................................................................6 3-A Sanitary Standards, Inc..............................................................................................6 3-A Sanitary Standards .....................................................................................................7 3-A Symbol .........................................................................................................................7 3-Symbol Authorization List.............................................................................................8
B6 Policies of the TPV Program.............................................................................................8 B6.1 Integration of Existing Authorization Holders to the TPV Program ..............................8 B6.2 Random Audits Following TPV Integration .................................................................11 B6.3 New 3-A Symbol Authorizations..................................................................................12 B6.4 3-A Symbol Authorization Renewals ...........................................................................12 B6.5 3-A Symbol Authorization Amendments......................................................................13 B6.6 Reports of Alleged Nonconformance (RAN) ...............................................................13 B6.7 Used and Remanufactured Equipment..........................................................................17 B6.8 Ownership of Certified Conformance Evaluator (CCE) Certificates ...........................17 B6.9 Code of Ethics ...............................................................................................................18 TPV EQUIPMENT AND MACHINERY CERTIFICATION ................................................19 C1 Notice to Applicants.........................................................................................................19
C2 Verification Report Format ............................................................................................19 C2.1 Report Language ...........................................................................................................19 C2.2 Cover Page ....................................................................................................................20 C2.3 Verification Checklist Pages .........................................................................................22 C3 TPV Certification Procedures ........................................................................................23
C4 TPV Report Submission Procedures..............................................................................26 C4.1 CCE Report ...................................................................................................................26 C4.2 TPV Reports of Conformance.......................................................................................26 3-A Sanitary Standards, Inc. Manual Issuance Date: Jan. 2003 2 Revision Date: June 2007
C4.3 C5 C6
TPV Reports of Nonconformance................................................................................ 26 TPV Report Review and CCE Monitoring Procedures ...............................................30 3-A Interpretations Committee (IC) ..............................................................................30
C7 Dispute Review and Determination Procedures ...........................................................31 C7.1 Applicant Rights and Procedures ..................................................................................31 C7.2 TPV Dispute Resolution ...............................................................................................31 C8 C9 C10 TPV Certificate of Conformance....................................................................................34 TPV Certificate of Nonconformance..............................................................................34 3-A Symbol Authorization Forms and Documents.......................................................35
CERTIFICATION.......................................................................................................................36 D1 Basic Qualifications for Education and Experience .....................................................36 (See Appendix 3, Exhibits 2 and 3) Required Knowledge, Skills, and Abilities ....................................................................36 CCE Candidate Application Package Requirements ...................................................37 Submission of Applications .............................................................................................38 Application Evaluation....................................................................................................38
D2 D3 D4 D5
D6 CCE Certification ............................................................................................................38 D6.1 Initial CCE Certification ...............................................................................................38 D6.2 Annual Maintenance .....................................................................................................38 D6.3 Renewal of CCE Certification ......................................................................................39 D6.4 Denial or Withdrawal of CCE Certification..................................................................39 D6.5 Appeal of Denial or Withdrawal of CCE Certification.................................................39 D7 D8 Maintenance of CCE Competence .................................................................................40 CCE Certification Documentation and Listing.............................................................40
ADMINISTRATION ...................................................................................................................41 E1 File Retention ...................................................................................................................41 E1.1 CCE Certification Files .................................................................................................41 E2 3-A Symbol Authorization Files .....................................................................................42 Issuance Date: Jan. 2003 3 Revision Date: June 2007
E3 E4
E5 Fees ....................................................................................................................................44 E5.1 3-A Symbol Authorization............................................................................................44 E5.2 Certification of CCEs....................................................................................................44 E6 TPV Operations Manual Maintenance..........................................................................44
APPENDIX 1: Glossary of Terms .............................................................................................45 APPENDIX 2: 3-A Symbol Application Materials ..................................................................49 APPENDIX 3: TPV Forms ........................................................................................................70 APPENDIX 4: Engineering Design and Technical Construction File ...................................85 APPENDIX 5: 3-A Sanitary Standards, Inc.............................................................................90
DISCLAIMER
A1 The authorized appearance of the 3-A Symbol on equipment indicates verification by a third party that the equipment conforms to the applicable 3-A Sanitary Standards. Appearance of the 3-A Symbol does not represent an endorsement of the equipment by 3-A Sanitary Standards, Inc. as to quality, sanitation, or safety. 3-A Sanitary Standards, Inc. disclaims all warranties, expressed or implied, with respect to such equipment, including warranties of marketability and fitness for use. 3-A Sanitary Standards, Inc. also disclaims any and all liability for injury to persons or property, or other damages of any nature, including special, indirect, consequential, compensatory, and punitive damages, directly or indirectly resulting from the performance operation, or the failure to operate, of any equipment. Certified Conformance Evaluator (CCE) status is achieved by satisfying a combination of defined education, experience, and/or examination requirements. Certification is not an assurance of competence or ability. 3-A Sanitary Standards, Inc. disclaims liability for any injury to persons or to property, or other damages of any nature whatsoever, including special, indirect, consequential, compensatory, and punitive damages, directly or indirectly resulting from negligent conduct or other acts or omissions of any individual certified as a CCE. By issuing the 3-A Symbol, and by providing for certification of individuals as CCEs, 3-A Sanitary Standards, Inc. is not undertaking to render professional or other services for or, on behalf of, any person or entity. 3-A Sanitary Standards, Inc. does not undertake to perform any duty owed by any person or entity to someone else. 3-A Sanitary Standards are developed through a consensus standards development process that brings together individuals representing varied viewpoints and interests to achieve consensus. While 3-A Sanitary Standards, Inc. administers the process and establishes rules to promote fairness in the development of consensus, it does not independently test, evaluate, or verify the accuracy of any information or the soundness of any judgments contained in the standards.
INTRODUCTION
B1
B1.1
B1.2
B1.3
B1.4
B2
B2.1
B3
B3.1
B3.2
B4
B4.1
3-A Symbol
The use (display) of the 3-A Symbol is beneficial to all 3-A stakeholder groups. The TPV prior to 3-A Symbol authorization documents the manufacturers commitment to conformance to the 3-A Standards. Use of the 3-A Symbol advises regulators and processors that a credible, objective, third party has verified that certified products conform to standards and applicable regulatory requirements. The cost for the third party verification is based on the contract established between a CCE and the applicant for the TPV evaluation. 3-A SSI oversees TPV and 3-A Symbol authorization. The Board of Directors of 3-A SSI may revise at any time the policies and procedures in this manual. Equipment and machinery evaluated using the 3-A TPV program and determined to conform to the applicable 3-A Standards will be authorized to use the 3-A Symbol on equipment. The companies so authorized will sign a declaration (Appendix 2, Exhibit 2) agreeing that the 3-A Symbol will be placed only on equipment fully complying with the relevant 3-A Standard(s) and that the company will abide by all other applicable requirements (see Appendix 2). The 3-A Symbol must be displayed in accordance with the provisions found in Appendix 2, Exhibit 6. Rubber and plastic materials meeting 3-A Standards 18-xx or 3-A 20-xx must restrict symbol use to print materials or on a website.
B4.2
B4.3
B5
B5.1
B6
B6.1
B6.1.1
B6.1.1.1
B6.1.1.2
B6.1.2
Full integration will be achieved within four (4) years. Future TPV certifications will be required in accordance with the certification policy established in the Certification Policy Section C. The sequence of rotation may change due to an amendment if a RAN is substantiated. Sequence of TPV Integration Standard Number 0105132224253032Group 1 - Tanks and Processors Storage Tanks Automotive Tankers Farm Bulk Tanks Silos Batch Pasteurizers Batch Processors Farm Storage Tanks Uninsulated Tanks Group 2 - Fillers Fluid Fillers Viscous Product Fillers Dry Products Filler Group 3 Valves and Fittings Plug Valves Plastic Plug Valves Compression Valves Diaphragm Valves Boot Seal Valve Leak Detect Valve Tank Outlet Valve Vacuum Breakers and Check Valves Sample Valves Rupture Disks Steam Injectors Hose Assemblies Fittings Pressure Reducing Valves Sight Glasses Ball Valves Spray Devices 2006 2006
B6.1.3
172327-
2005
5152535455565758596061626364656878-
043536444773-
Group 4 Pumps and Mixers Homogenizers Continuous Blenders Colloid Mills Diaphragm Pumps CIP Pumps Shear Mixers Group 5 Heat Exchangers/ Ice Cream Freezers Plate Heat Exchangers Tubular Heat Exchangers Ice Cream Freezers Scraped Surface Heat Exchangers Group 6 Conveyors and Feeders Pneumatic Conveyors Mechanical Conveyors Belt Feeders Auger Feeders Group 7 - Instruments Pumps Rubber Plastics Flow Meters Refractometers Dry Product Level Sensors Sensors Group 8 - Other Filters Evaporators Sifters Air Eliminators Tubing Bulk Bins Cottage Cheese Vats Bag Collectors In-Line Strainers Membrane Modules
2003
2006
11121931-
2006
39417581-
2004
02182028465074-
2003
10162629333438404245-
B6.2
B6.2.1
B6.2.1.1
B6.2.1.1.1
B6.2.1.2
The materials submitted will be compared by 3-A SSI to the supporting materials on file with the most recent TPV certificate. If conformance discrepancies are observed with the newly submitted information, a new TPV certificate will be required.
B6.3
B6.3.1
B6.4
B6.4.1 B6.4.2
B6.4.3 B6.4.4
B6.4.5
B6.4.6
If the symbol holders renewal authorization notification is not received within at least ten (10) days of the anniversary date, it is the symbol holders responsibility to determine the status of the materials. A grace period of fifteen (15) days will be automatically granted. Beyond fifteen (15) days, written justification for additional time is required but in no case shall it be more than an additional fifteen (15) days. If the additional fifteen (15) days is granted, a late fee of $100 will be assessed. After thirty days (30) of no response, the 3-A Symbol authorization shall be rescinded. For all authorizations, 3-A SSI shall respond within ten (10). If the authorization is denied, thirty (30) days are granted to resolve any nonconformance issues. If nonconformance issues are unresolved, 3-A Symbol authorization will be rescinded. (See Section C7.2 for TPV dispute resolution.) The application notice and materials may be transmitted electronically or in hard copy.
B6.4.7
B6.4.8
B6.5
B6.5.1
B6.5.2
B6.5.3
B6.6
B6.6.1
B6.6.1.1
1. Name of equipment or machinery; 2. Model 3. Serial Number (if available); 4. Physical location [address, phone and fax numbers]; 5. Applicable 3-A Standard(s); 6. All criteria for which conformance is not met and the reasons, including quantitative measurements, if appropriate; and 7. Any other appropriate documentation. Within ten (10) days of receipt, 3-A SSI shall notify the alleged nonconforming party(s) of the allegation, the standard criteria in question, and procedures to be followed to obtain resolution to the allegation(s). The manufacturer and user are to respond within ten (10) days to 3-A SSIs inquiry. Following the response from the manufacturer and the user, the 3-A SSI will evaluate, with advice from the 3-A Interpretations Committee (IC, see Section C6) as appropriate, the validity of the allegation within ten (10) days. All interested parties are encouraged to maintain files. If the allegation is not substantiated, the alleged parties involved in the complaint will be notified within ten (10) days the reasons for rejection of the RAN. If the allegation is substantiated, 3-A SSI will conduct an investigation sufficient to determine the party responsible for the condition(s) that initiated the RAN. The responsible party may be the original fabricator, a distributor, or the end user of the equipment. The responsible party will be notified and allowed to respond. 3-A SSI will conduct informal discussions with the responsible party and the individual submitting the RAN to resolve the nonconformance and develop a plan for corrective actions. If a resolution is agreed upon, the responsible party will be informed that a TPV evaluation and certificate will be required in order to close the RAN investigation. If the informal discussions are unsuccessful at resolving the RAN, the RAN will be presented to the 3-A IC to determine the validity of the RAN. (See Section C6.) If the IC determines the RAN is unsubstantiated, 3-A SSI will notify all of the interested parties in writing that the RAN has been resolved and the reason for the decision. If the IC determines the RAN is substantiated, the responsible party shall develop a plan of corrective action. If the manufacturer is the responsible party, they shall notify all purchasers of record of the in-service equipment sold since the last documented TPV report of nonconformance that manufacturer corrections need to be made.
B6.6.2
B6.6.3
B6.6.4
B6.6.5
B6.6.6
B6.6.7
B6.6.7.1
B6.6.7.2 B6.6.8
If the user is the responsible party, they shall complete all corrective actions as soon as possible to bring the equipment into conformance. If the responsible party is the manufacturer and chooses not to make corrections, 3-A SSI will immediately revoke the authorization, notify all interested parties, and when appropriate, publish a notice of the revocation. If the responsible party is the user and chooses not to make corrections, 3-A SSI will notify all interested parties that the Symbol on that piece of equipment is no longer sanctioned. Resolution of the RAN must be completed within ninety (90) days of its receipt by 3A SSI or the 3-A Symbol authorization will be rescinded. Revocation of 3-A Symbol authorization use or a nonrenewal of an application will require a TPV certification to be submitted with any future authorization application for the equipment.
B6.6.9
B6.6.10
B6.6.10.1 Resolution shall include a documented mutually agreed upon plan for corrective action, scheduling of the corrective actions, and scheduling of the appropriate TPV evaluation. To accommodate completion of all necessary actions, the actual performance of some activities may exceed the 90 days provided they have been scheduled within an agreed upon timeframe. B6.6.11 Throughout the evaluation and processing of the RAN, 3-A SSIs responsibilities and actions include: 1. Thorough review of all applications, nonconformance reports and appeals with advice from the 3-A IC when needed. 2. Communication of decisions to all materially affected parties and organizations. 3. If nonconformance is substantiated, a TPV evaluation is required to resolve the nonconformance issue(s). When resolved, a new authorization anniversary date is established and a TPV certificate is required to be submitted with the first anniversary renewal application. The initial (maximum) authorization fee will be assessed. 4. If a nonconformance is substantiated and the applicant chooses not to resolve the issue(s), actions shall be taken to revoke the 3-A Symbol Authorization. 5. Publish, when appropriate, nonrenewed authorizations on the 3-A SSI website and in Food Protection Trends (FPT). 6. If revocation of 3-A Symbol use is for nonconforming design or serial manufacture quality control reason, publish as in item 5. 7. If a substantiated RAN is due to in-plant (user) modification, only the appropriate control authorities will be notified. 8. Communicate issues of public health significance to regulatory agencies and encourage them to report nonconformance issues. 9. When a 3-A Symbol authorization is revoked, the applicant will be required to return the 3-A Symbol Authorization certificate, and a letter confirming that the use of the 3-A Symbol has been discontinued, including removal of the Symbol from existing nonconforming equipment. 10. Engage legal counsel when necessary. Issuance Date: Jan. 2003 15 Revision Date: June 2007
Processor Responsible
Notice to Purchaser Of Record of Nonconformance Makes Corrections Letter To Interested Parties Resolving And Ending The RAN Process
B6.7
B6.7.1
B6.7.2
B6.7.3
B6.7.3.1
B6.7.4
B6.7.5
B6.7.6
B6.8
B6.8.1
B6.9
B6.9.1
Code of Ethics
To ensure that every user of a 3-A Symbol can have confidence in the integrity of the 3-A Symbol authorization, CCEs shall respect and adhere to the principles of ethical conduct set forth in this section (Form Appendix 3, Exhibit 3). The following general principles apply to every CCE. Where a situation is not specifically covered by these principles, a CCE shall apply the intent of the principles in determining whether their conduct is proper. 1. CCEs shall not hold financial interests that conflict with the conscientious performance of duties. 2. CCEs shall not engage in financial transactions using audit-derived information or allow the improper use of such information to further any private interests. 3. CCEs shall not solicit or accept any gift or other items of monetary value beyond reasonable compensation for their duties from any person or entity seeking audit activities from, doing business with, or whose interests may be substantially affected by the performance or nonperformance of their duties. 4. CCEs shall perform only the TPV activities within the scope of their knowledge. 5. CCEs shall maintain strict confidentiality of proprietary information learned through their TPV activities. 6. CCEs shall act impartially and they shall not give preferential treatment to any organization(s) or individual(s). 7. CCEs shall adhere to all laws and regulations that provide for equal opportunity for all regardless of race, color, religion, gender, national origin, age, or disability. 8. CCEs shall endeavor to avoid any actions creating the appearance that they are violating the ethical tenets set forth in this section. Whether particular circumstances create an appearance that these tenets have been violated shall be determined from the perspective of a reasonable person with knowledge of the relevant facts.
B6.9.2
Violators of any of the Code of Ethics tenets shall be subject to removal from the TPV program.
Notice To Applicants
3-A SSI shall notify authorized 3-A Symbol holders prior to their authorization renewal dates with appropriate notification materials. Notification letters will be sent at least ninety (90) days prior to renewal date when TPV certification is required, and at least forty-five (45) days prior to renewal date when no TPV certification is necessary. The notification packet will contain materials and information necessary to obtain the renewal. New applicants for 3-A Symbol authorization will be provided with similar packets of necessary information. The packet will include: Sample notification letter (See Appendix 2, Exhibit 1); Website where 3-A Standards and listing of CCEs can be found.
C1.1.1
C2
C2.1
C2.1.1
Report Language
TPV reports shall be prepared using standard English and typed.
C2.2
Cover Page
Each cover page and support page(s) shall refer to one evaluation. If a TPV assignment is for multiple equipment or machinery type(s), a separate TPV report shall be prepared for each equipment and machinery type.
C2.2.1
The CCE shall complete all of the information blocks on the Verification Report cover page (Appendix 3, Exhibit 1). If information is not available, such as the applicant has not assigned a serial number to the equipment, use the phrase Not Applicable. Applicant: Record the applicants complete name and mailing address. Verification Location: Record the location address where the verification was performed. If the verification is performed at the same location as the applicants address, use the phrase Same as Applicant. Date: Record the date(s) that the verification was performed. CCE: The CCE shall record his/her name. Equipment or Machinery Type: Record a generic description of the equipment verified such as, Compression Valve or Fluid Milk Filler. Model Number: Record the model number(s) of the equipment verified. Serial Number: Record the serial number(s), if applicable, of the equipment verified. 3-A Standard: Record the number and effective date of the covering 3-A Standard used for the verification. Applicant/Verification Contact: Record the name and telephone number of the applicant contact who can respond to inquiries pertaining to the verification or who should be provided a copy of the completed report. A fax number or e-mail address may also be included. 3-A Authorization Number: Record the authorization number from the applicants current authorization certificate. Type of Verification: Place an X in the appropriate box. Declaration of Findings: Upon completion of the verification, indicate whether the equipment verified was in conformance or nonconformance by placing an X in the appropriate box.
C2.2.2 C2.2.3
C2.2.10
C2.2.11
C2.2.12 C2.2.13
C2.2.13.1 To mark the In Conformance box, there shall be no marks on the checklist (Appendix 3, Exhibit 1) in the No column. If any No items are checked, the Nonconformance box shall be marked. C2.2.13.2 When the Nonconformance box is marked, additional statements specifically describing which criteria from the base 3-A Sanitary Standards were not in conformance must be included in the Observations and Findings column or on an attached page. C2.2.14 Observations and Findings: Refer to the guidance below in the Verification Checklist pages section for the proper format to document nonconformance issues in the body of the report. The following are examples only of statements of nonconformance using the 3-A Sanitary Standards For Compression-Type Valves for Milk and Milk Products, Number 53-01 as the base standard. C2.2 D2.1 D4.1 D7.7 D7.8 C2.2.15 C2.2.16 Certification of the rubber gasket material could not be documented. Valve body not readily disassembled; held in place by 6 bolts. No radius at the juncture of the valve stem to the gasket plate. Power actuator bolted flush with the valve body with no clearance. Power actuator cannot be removed from the valve stem.
CCE Signature: The CCE must sign the report for it to be official. When the typed report is received by 3-A SSI, the following information shall be added to the form.
C2.2.16.1 Date Received: Record the date received by 3-A SSI. C2.2.16.2 Received By: Record the name of the individual who received the TPV Report. C2.2.16.3 Verification Number: 3-A SSI shall assign a unique verification number to facilitate tracking and filing of verification reports.
C2.3
C2.3.1
C2.3.2
C2.3.3
Certification of the rubber gasket material could not be documented. Valve body not readily disassembled. No radius at the juncture of the valve stem to the gasket plate. Power actuator bolted flush with the valve body with no clearance. The power actuator cannot be removed from the valve stem.
44 65 102 103
C3
C3.1
C3.2
The CCE shall use his/her knowledge and experience to conduct a detailed physical evaluation of the equipment, drawings, and documentation. The CCE shall conduct the verification at a pace to assure all components are carefully evaluated against the standards criteria. If the equipment offered for evaluation can be configured using multiple optional components or accessories, all of the optional features must be presented for evaluation. The CCE shall be diligent in asking sufficient questions to determine such items as identification of all materials of construction, options, or addon features offered with the equipment, methods of fabrication, etc. Throughout the evaluation the CCE shall exercise critical observation/critical analysis (as in careful judgment and scholarly recommendations) at all times. The verification is to be conducted on the basis of a detailed physical evaluation of the equipment and a review of all engineering drawings and documentation associated with the equipment to be verified. This may include general assembly drawings and drawings of individual equipment components and subassemblies. The CCE shall request and review all certifications for components fabricated from rubber or rubber-like materials, plastic materials, adhesives, or metal alloys not identified by the applicable 3-A Standards. When the verification is to evaluate a series of equipment, which is of an identical design except for scaling up or down in size, only one set of drawings representative of the basic design need be evaluated. The CCE is to verify that the applicant has a written quality control procedure with documentation to assure conformance to 3-A Standards. The CCE shall perform an on-site evaluation at the applicants manufacturing/fabrication or assembly location where the complete, assembled item identified for 3-A Symbol authorization is available. When deemed necessary by the CCE, an additional on-site evaluation shall be performed at the installation location of the applicants choosing to evaluate a fully
C3.3
C3.3.1
C3.4
C3.5
C3.5.1
installation for items being evaluated for conformance to the following Evaporators Silo Tanks Pneumatic conveyors Bag Collectors
To assure uniformity of verification presentation and to assist 3-A SSI evaluate the TPV report, all checklist items in which an X has been placed in the No column must have a detailed explanatory note describing the nonconforming observation. (See Appendix 3, Exhibit 1) for sample TPV report forms. Additionally, the following checklist items also require an explanatory comment when the line item is applicable. Mark the columns as appropriate. As necessary, additional pages are to be added in order to clearly describe the observations. A. Scope Metals Line 5: Cast CF-16F, CF-8 or CF-8m. If used, record the component and the cast grade. Line 6: Other recognized 3-A Alloy. If used, record the component and the alloy. Line 7: Alloy equivalent to above. If a nonlisted alloy is used, record the alloy used, the component(s) fabricated from the alloy, and the certification of equivalency documentation. Line 10: Gold or Silver Solder. If used, record the type of solder, and that the certification of conformance (silver solder only) is available. Nonmetals Line 13: Rubber 3-A 18- compliant. If rubber or rubber-like materials are used, record the materials used, and that the certification documentation is available. Line 15: Plastic 3-A 20- compliant. If plastics are used, record the plastics used and that the certification documentation is available. Line 16: Adhesives meets 21 CFR 175. If adhesives are used, record the adhesive(s) used, and that the documentation of 21 CFR 175 conformance is available. Fabrication Line 39: Adhesives meets 21 CFR 175. If an adhesive is used, add the statement See Line 16. Issuance Date: Jan. 2003 24 Revision Date: June 2007
C3.6.2.2 C3.6.2.3
C3.6.2.4
C3.6.3 C3.6.3.1
C3.6.3.2
C3.6.3.3
C3.6.4 C3.6.4.1
C3.6.4.2
Line 84: Agitators (meets criteria). Record the type of agitator(s) provided, e.g., top mounted, side mounted, bottom mounted, etc. Line 85: Type. Record the type(s) of support(s) provided, e.g., legs, slab mounted, wall mounted, hanging mount, etc. See line 88. Lines 89-92: Appurtenances meet referenced 3-A Standards. Record each nonconforming appurtenance on a separate line. Identify the specific appurtenance and the corresponding covering 3-A Sanitary Standard. If there are any nonconforming observations, they are to be clearly documented that the appurtenances do not conform to 3-A Sanitary Standards. Line 100: Engineering Design and Technical Construction File (EDTCF) (See Appendix 4). This information, which may be assembled from multiple sources, is to be used by the CCE as a primary source of verification details. Since each EDTCF is unique to the equipment type manufactured, the amount and types of information present will vary widely. The CCE shall review the EDTCF carefully, and utilizing his/her expertise, determines if the file is complete. In order to mark this item with an X in the Yes column at least the following sections, as listed in the 3-A Sanitary Standards Form and Style Manual Document, shall be present in the EDTCF: Other documentation: a. an overall drawing of the subject equipment; b. full detailed drawings, accompanied by any calculations, notes, test results, etc. required to check the conformity of the equipment to the 3-A Standards or 3-A Practices; e. if essential, any technical report or certificate obtained from a competent testing body or laboratory (The following examples are not intended to be an all-inclusive list, plastic certification, rubber certification, adhesive certification, air filter certification, etc.); i. a copy of the instructions for the product (Instruction Manuals/Instruction Books); j. for serial manufacturing, the internal measures that will be implemented to ensure that the equipment will continue to be manufactured in conformity to the provisions of the 3-A Sanitary Standards; m. bills of material; o. sales order engineering files documenting modifications to design; and q. change records. See page 75, Lines 102 to 131 List Other Criteria
C3.6.4.3
C3.6.4.4
C3.6.4.5
C3.6.4.5.1
C3.6.4.6
C4
C4.1
C4.2
C4.2.1
C4.3
C4.3.1
C4.3.1.1
C4.3.1.2
Renewal Applications (See Appendix 2, Exhibit 4) The CCE shall complete a verification report documenting the nonconformance issues. If the applicant chooses to correct the nonconforming element(s), they may contract with the CCE (it is recommended that the same CCE conduct the follow-up verification) to conduct a follow-up verification to verify that the corrections have been completed. The follow-up verification shall be conducted within a reasonable timeframe in order to accomplish the corrections and comply with the timeframe of the authorization renewal anniversary date. The follow-up report shall include specific provisions on how correction of any nonconforming units in use will be accomplished. Resolution of the nonconforming issues shall be within ninety (90) days or the 3-A Symbol authorization will be rescinded. Upon completion of the
follow-up verification, the CCE will issue a final Conformance report within thirty (30) days. Both the initial Verification Report of nonconformance and the final Verification Report of conformance are to be provided to the applicant and sent by the CCE to 3-A SSI. It is recommended that the CCE maintain a file copy for his/her records. C4.3.1.3 For RAN follow-up reports, the CCE conducting the follow-up shall provide the: Applicant the signed, original, follow-up report; 3-A SSI a copy of the follow-up report; CCE retains a copy of the follow-up report.
TPV Report is Held Up. When ready, Applicant Arranges for Follow-up TPV Applicant Sends Compliant TPV and Application Package to 3-A SSI for Review and Authorization
The TPV Evaluation Is Made When TPV Shows Non-Conformance Applicant Chooses Not to Make Corrections Applicant Chooses to Make Corrections in Reasonable Timeframe When TPV Shows Conformance Applicant Sends Application Package to 3-A Symbol for Review and Authorization
Applicant Sends Compliant TPV and Application Package to 3-A SSI for Review and Authorization
C5
C5.1
C5.2
C5.3
C5.3.1
C6
C6.1
C6.2
C6.3
C6.4
C6.5
When appropriate, the IC may also recommend that conflicting issues be resolved by amendment or revision of 3-A Sanitary Standards. The IC may also recommend how such issues should be handled until the standards change.
C7 C7.1
C7.2
C7.2.1
C7.2.2
C7.2.3
C7.2.3.1
C7.2.3.2
C7.2.3.2.1 When the dispute confirms that a nonconforming design or quality control condition exists, the applicant shall be required to notify all owners of in-service equipment of the nonconformance and arrange for the nonconformance issue to be corrected. The notification shall include all units of equipment sold since the date of the last TPV certificate documenting conformance C7.3 The applicant, when determined to be in nonconformance, may choose not to make corrections. In such case, 3-A SSI will revoke the symbol authorization, publish the revocation in the appropriate publications, and notify all interested parties. The applicant shall be required to notify all purchasers of record of the nonconformance issue, remove the 3-A Symbol from all undistributed equipment, and return the 3-A Symbol Authorization Certificate to 3-A SSI.
C7.3.1
TPV Report is Unchanged Responsible Party Chooses Not to Correct Nonconformance Issue(s) Responsible Party Notifies All In-service Users 3-A SSI Revokes Authorization and Publishes Notificatication
C8
C8.1
C8.2
C9
C9.1
C9.2
C9.3
C9.4
C9.4.1
C10
C10.1
CCE CERTIFICATION
D1 Basic Qualifications For Education and Experience (See Appendix 3, Exhibits 2 and 3)
3-A SSI shall retain the right to waive or alter CCE qualifications as may be necessary. All CCE candidates shall comply with the following basic qualifications for education and experience: A minimum of a Bachelor of Science degree in engineering, physical or biological science curriculum plus three (3) years experience in relevant food or pharmaceutical processing. One (1) year of the three (3) years of general experience shall be directly related to 3-A covered equipment design or sanitary processes, or Completion of at least a secondary education plus five (5) years experience in relevant food or pharmaceutical processing. Three (3) years of the five (5) years of general experience shall be directly related to 3-A covered equipment design or sanitary processing. Examples of appropriate practical workplace experience may include: dairy industry, food industry, pharmaceutical industry, or similar sanitary (hygienic) process industry; equipment and process design, review, installation, and Food Safety/HACCP development. This list of examples is not all-inclusive. D1.1 D1.2
D1.2.1
D1.2.2
D1.3
D2
D2.1
3. The ability to read and to understand engineering drawings and documentation customarily used in machine shops engaged in manufacturing equipment and instrumentation for the food processing industries. 4. Knowledge of machine shop quality control testing techniques and sample plans, quality documentation, sanitary weld inspection and quality assurance and the ability to use the necessary inspection instruments. 5. Basic knowledge and understanding of materials science and the regulations used in fabricating food or pharmaceutical processing equipment. 6. Knowledge of 3-A Sanitary Standards and possession of up-to-date copies of all standards. 7. The ability to exercise good judgment, analytical skills, and thoroughness, free from bias, to arrive at acceptable and reasonable evaluation conclusions. 8. The ability to operate independently without supervision or guidance, particularly during the performance of the evaluation. 9. The ability to organize evaluation steps, and the time available and human resources to conduct and complete a TPV evaluation. 10. The ability to clearly communicate orally with management, staff, and fellow CCEs utilizing terminology familiar to the parties involved to obtain information relevant to the evaluation. 11. The ability to communicate effectively in writing that is legible, clear in meaning, factually correct and concise. Spelling and grammar are important and necessary components of acceptable written communication abilities. 12. The ability to communicate orally and in writing in English.
D3
D3.1
D4
Submission Of Applications
The CCE candidate shall submit all appropriate documentation of conformance with application package (see section D3) to: 3-A Sanitary Standards, Inc. 6888 Elm Street, Suite 2D McLean, Virginia 22101-3829 USA
D5
Application Evaluation
In evaluating CCE candidates, 3-A SSI may make use of: Examinations; Candidates submitted application package; Review of educational background and professional affiliations; and Interviews with candidates (Used at the discretion of 3-A SSI) (Interviews may be in person or by telephone) Program orientation.
D6
D6.1
D6.1.1
CCE Certification
Initial CCE Certification
A CCE candidate will be granted certification by an affirmative vote of 3-A SSI upon completion of the evaluation of the items listed under the Application Evaluation section of these procedures. (See Section D5.) Annual Maintenance 3-A SSI will charge a nominal annual CCE accreditation maintenance fee to help 3-A SSI offset direct program expenses. Notice of the annual maintenance fee will be sent to the CCEs on or around the anniversary date of initial accreditation.
D6.2 D6.2.1
D6.3
Renewal of CCE Certification D6.3.1 Renewal of all CCE certifications is required every three (3) years. The candidate must complete the necessary validations, attend joint meetings of the 3-A Committees, and is not under investigation for code of ethics violations or dereliction of duty. The 3-A SSI shall annually review records for 3-A Committees Meeting(s) attendance, completion of three (3) required validations within the first two years after receiving accreditation and compliance with the code of ethics.
D6.4
D6.4.1
D6.5
D6.5.1
4. The appellant may request a hearing before the 3-A IC to present evidence, to confront witnesses who are present at the hearing, and the right to counsel (not required to be an attorney). 5. The date of the hearing shall not be less than one (1) month nor more than three (3) months from the request. 6. The appellant may request pre-hearing discovery when requested in writing and listing the disclosure items. 7. The location of the appeal hearing is at the discretion of 3-A SSI, but must be in the contiguous United States. 8. The appellant shall be provided with written notification of the ICs ruling including any sanctions within four (4) weeks of the appeals hearing.
D7
D7.1 D7.1.1
D8
D8.1
D8.2
D8.3
ADMINISTRATION
E1
E1.1
E1.1.1
File Retention
CCE Certification Files
Successful candidates files are to be retained for the length of the certification period. The file shall contain the initial application materials, yearly records required for continuing the certification and re-application materials. If the candidate is unsuccessful in the certification process, files are retained for one (1) year. For candidates who apply but never complete the process, the incomplete files are retained for six (6) months. After six (6) months, the candidate must begin the entire process again with a new application and application fee. The examination file shall be retained for as long as the CCE is certified or until it is replaced by a subsequent exam. If a candidate was initially approved but has not renewed at five (5) years or has not met the minimum requirements, the certification has technically expired. A three- (3) month period is allowed for reinstatement without penalty. Beyond that, the procedures and fees for new certification shall apply. When a certified person is deceased or withdraws the certification voluntarily, files may be immediately disposed, except for the letter of withdrawal. The documentation for all of the above may be stored as hard copy or electronically. It is, however, highly encouraged to store records electronically for easy retrieval and editing. To facilitate this, all application materials, forms, etc. should be available for electronic distribution and completion. If signatures are required on original applications and on ethics statements, hard copies are required. It should be clearly established that the relationship between 3-A SSI and with those who take examinations (written or oral) is contractual. The terms of that contract are the 3-A SSI right, at their sole discretion, to cancel test scores in the event of suspected cheating or loss of exam confidentiality.
E1.1.2
E1.1.3
E1.1.4
E1.1.5
E1.1.6
E1.1.7
E1.1.8
E2
E2.1
E3
E3.1 E3.2
E3.3
E3.4
E4
E4.1
Service Mark
Certification programs often use some form of trademark registration. There are several types of Marks that can be registered under the Trademark Act of 1946, 15 U.S.C. t seq. The one appropriate for 3A is 102 Service Marks. These service marks are used to identify services (activities) that are performed by a person for the benefit of others. The term service mark includes any word, name, symbol, or device that is used by a person to identify and distinguish their unique services from those offered by others, and to indicate the source of those services. Titles, character names and other distinctive features may be registered as service marks. (15 U.S.C. 1127.)
E4.2
3-A SSI will use a registered service mark and shall make it available to all categories of those people who are certified to conduct TPV on equipment included in the scope of any and all 3-A Standards. This mark may be used by a CCE as a display on business cards, paperwork, and promotional materials with the approval of 3-A SSI.
E4.2.1
E5
E5.1
Fees
3-A Symbol Authorization
New Authorization: $995 Authorization Renewal (Annual): $495 Authorization Amendment: $350 Fees listed are subject to change by 3-A SSI.
E5.2
Certification of CCEs
Application Renewal Examination (written, oral and/or practical) Reinstatement Fees to be determined by 3-A SSI.
E6
E6.1
E6.2
APPENDIX 1
GLOSSARY OF TERMS
The following terms and definitions are commonly used in reference to the evaluation and certification industries. Not all of the terms are used in this document. They are presented here to provide a common understanding of terms that may be used in association with the work conducted under the 3-A SSI, Third Party Verification (TPV) and 3-A Symbol Authorization Program. Organization acronyms may be found in Standards Management.1 F1 3-A Steering Committee: Implements the policies and procedures for developing 3A Standards and 3-A Practices. The committee reviews requests for new standards activity as their relevance to the industry, and for conformance to federal and state regulations. 3-A Symbol Council: Is a founding member of 3-A SSI and has granted it the right to authorize the use of the 3-A Symbol under the Third Party Verification program. Administrative Officer (AO): The person(s) that is responsible for accomplishing the functions of 3-A Symbol authorization, renewals, nonconformance, record keeping and any other described in the TPV Manual. American Dairy Products Institute (ADPI): A trade association representing dairy processor stakeholders and is a Founding Member of 3-A SSI. Certification Body (3-A SSI): An impartial body possessing the necessary competence and other qualifications to sponsor and operate a certification program. A certification body is an organization under whose authority a certification program is developed, promulgated, operated, and financed, and with whose name the certification program is identified. (ANSI) Certification System: The organizational and procedural process or the institutional mechanism for accomplishing product certification. (EIPSC) Certification: The act of issuing a warranty, certificate, or mark or other appropriate evidence that attests that a product or service conforms to specific standards or specifications. (ILAC)
F2 F3
F4 F5
F6 F7
Source for most is Standards Management a handbook for profits; edited by Robert B. Toth. ANSI, 1430 Broadway, New York, NY 10018.
Quality assurance programs are used to assure that the product(s) continue to comply with the specified requirements. Satisfactory tests, inspections, and quality assurance are the basis for certification. Evidence of certification may be by labeling of the product. (ASTM E699) F8 Certified Conformance Evaluator (CCE): Person(s) meeting the requirements in Section D to perform third party verification (TPV) for conformance of equipment and machinery to 3-A Sanitary Standards criteria. The CCE must have a current recognition (certification) document. Conformance: The state of having satisfied the requirements of some specific standard(s) and/or specification(s). (IEEE) Note: Conformance is used with respect to voluntary standards and specifications, whereas compliance is used with respect to mandatory standards and regulations. (OSCI) F10 Consensus Procedures: The rules and regulations of a recognized or duly appointed authority that pertain to the development of standards: 1) requiring that all known interested and affected parties be given due notice of the initiation and development of a standard; 2) providing interested and affected parties the opportunity to participate in the development of each standard; 3) providing for the considerations of all significant objections to the standard; and 4) reaching substantial agreement in support of the standard with no unresolved objections, as judged by a panel of standards professionals. (OSCI) Consensus: General agreement, characterized by the absence of sustained opposition to substantial issues by any important part of the concerned interests and by a process that involves seeking to take into account the views of all parties concerned and to reconcile any conflicting arguments. (ISO) Note: Consensus need not imply unanimity. (ISO) F12 Engineering Design, Technical Construction File (EDTCF): This file consists of the recorded information necessary to demonstrate that a machine and equipment to be in conformance to applicable 3-A Sanitary Standards. The information is collected from multiple sources and is the primary source for verification details. An example of an EDTCF is found on pages 82 through 85 of this manual. Examples are also found in 3-A Sanitary Standards. Food and Drug Administration (FDA): The U.S. federal agency responsible for protecting the nations food and drug supply. Food Protection Trends (FPT): Association for Food Protection. The primary journal of the International
F9
F11
F13 F14
F15
Harmonization: The process whereby two or more nations (or standards bodies) agree on the content and application of a standard. Harmonization is accomplished by modification of a national standard (or agreement on a common document by two or more standards bodies) so that it is consistent with the harmonized standard or by countries agreeing to accept products and services that are in conformance to the harmonized standard even if they do not conform to the requirements of their national standard. Furthermore, a standard may be said to be harmonized if its text is technically equivalent to another standard (e.g., a national standard which is technically equivalent to an international standard.) (EIPSC) Inspection: The process of measuring, examining, testing, gauging or otherwise comparing the unit with the applicable requirements. (ASQC) International Association for Food Protection (IAFP): A professional society whose interest is protecting public health and food protection. IAFP is one of five Founding Members of 3-A SSI and represents the regulatory stakeholders. International Association of Food Industry Suppliers (IAFIS): A trade association whose members are capital equipment and ingredient suppliers. IAFIS is a Founding Member of 3-A SSI and represents the capital equipment stakeholders. International Dairy Food Association (IDFA): A trade association representing dairy processor stakeholders and is a Founding Member of 3-A SSI. International Standard: A standard that is adopted by an international standardizing/standards organization and made available to the public. (ISO) Mark of Conformity: The sign or symbol owned or controlled by the certification body that is used exclusively by the third party certification program to identify products or services as being certified and is registered as a certification mark with the U.S. Patent Office under the Trade Mark Act of 1946. (ANSI) Qualified Product: A product that has been inspected, evaluated, tested, or otherwise determined to be in conformance to applicable or specified provisions of reference standards, codes, or other requirements and approved for listing in a qualified products list (QPL). (EIPSC) Qualified Products List (QPL): A list of products which have met the qualification requirements stated in the applicable specification, including appropriate product identification and test or qualification reference with the name and plant address of the manufacturer or distributor, as applicable. QPL is the accepted abbreviation for the term Qualified Products List. (DOD) Note: This definition as used here applies to the 3-A Symbol Holders List. Quality Assurance: A planned system of activities whose purpose is to provide assurance that the overall quality control program is in fact being effectively implemented (see quality control). This system involves a continuing evaluation of the adequacy and effectiveness of the overall quality control program with a view to having corrective action initiated where necessary. For a specific material, product, Issuance Date: Jan. 2003 47 Revision Date: June 2007
F16 F17
F18
F22
F23
F24
service, etc., this involves verification, audits, and evaluations of the quality factors that affect the specification, production, inspection, and use of the material product, service, system, or environment. (ASTM E699) F25 Quality Control: A planned system of activities whose purpose is to provide a level of quality that meets the needs of users; also, the use of such a system. The objective of quality control is to provide an overall system integrating the quality factors of several steps, including: the proper specification for what is wanted; production to meet the full intent of the specification; inspection to determine whether the resulting material, product, service, etc., is in accord with the specification; and review of usage to determine necessary revisions of the specification. (ASTM E699) Recognition Arrangement: A written agreement or document between the 3-A SSI and the CCE to accept data for the determination of product conformance to 3-A Sanitary Standards. Report of Alleged Nonconformance (RAN): This is a provision for reporting perceived nonconformance items. (See Section B6.5.) Self-certification: A form of certification by a producer, on its own authority and not under the procedures of a third party certification program, that a product or service is in conformance to the designated standards or specifications. (ANSI) Standard: A prescribed set of rules, conditions, or requirements concerned with the definition of terms; classification of components; delineation of procedures; specification of dimensions, materials, performance, design, or operations; measurement of quality and quantity in describing materials, products, systems, services, or practices; or descriptions of fit and measurement of size. (OMB) Third Party Verification (TPV): A form of certification in which the producers claim of conformity is verified (reviewed and verified) as part of the certification program, by a technically and otherwise competent body or person other than one controlled by the producer or the buyer. (Adapted from ANSI). United States Department of Agriculture (USDA): The federal department responsible for inspecting and regulating the nations food supply. Interpretations Committee (IC): The committee is the arbitrator on disputed actions in 3-A Symbol authorizations and RANs. The committee will also resolve questions on variant application of 3-A criteria. Verification: The process of determining whether an implementation is in conformance to some specific standard(s) and/or specification(s). (IEEE) Voluntary Standard: A standard that is usually developed by a consensus process for voluntary use and with which there is no obligation to comply. However, a voluntary standard may become quasi-mandatory or mandatory as a result of its use, reference, or adoption by a regulatory authority. (EIPSC) Issuance Date: Jan. 2003 48 Revision Date: June 2007
F26
F27 F28
F29
F30
F31 F32
F33 F34
APPENDIX 2
3-A SYMBOL APPLICATION FORMS AND RELATED DOCUMENTS
(Sample Renewal Letter Showing TPV Report Submission Requirement) (Date) Sir_Name ContactFirstName ContactLastName Company_Name Address_1 Adress_2 City, StateOrProvince Zip_Code Country Dear Sir_Name ContactLastName: The 3-A Symbol Authorization No. Authorization_, issued to your company for use on equipment covered by Standard No. Standard_Number, expires on the anniversary date of issue shown on the renewal application form. Enclosed you will find a renewal form to renew this authorization for another year.
*** Third Party Verification Report Required to Renew This Authorization ***
This renewal notice is reaching you earlier than usual because a Third Party Verification (TPV) Report is required for the renewal of this authorization. Please read the attached summary for essential details on the TPV Program and how you can expedite the process to complete your renewal on schedule. We urge you to share this information with others at your company who may be involved in obtaining a TPV Report. 3-A SSI must receive your completed renewal form, including the TPV Report, and your renewal fee, within ten (10) days of the anniversary date shown on your 3-A Symbol authorization.
The 3-A Symbol begins a new era of integrity and recognition with the new Third Party Verification (TPV) Program. Participation in the 3-A Symbol program will enhance your product recognition within the dairy, food, and pharmaceutical industries.
In brief, it is your responsibility to engage a qualified independent inspection professional, a Certified Conformance Evaluator (CCE), to obtain a TPV Report. A roster of CCEs is available at the 3-A SSI web site. The TPV Report must be submitted with your application for renewal of your symbol authorization. A renewal will not be granted without the required TPV Report.
The TPV Report constitutes independent verification that your equipment conforms to the sanitary design and fabrication requirements of the specific 3-A Standard shown on your authorization for use of the 3-A Symbol. The fees and expenses for performance of the TPV services are independent of the 3-A Symbol authorization fees and are to be negotiated directly with the CCE.
Renewal Checklist
Please review the contact information shown on your renewal application for accuracy and completeness; please include current email addresses and other updates as needed. If there are no changes in the scope of equipment covered by your authorization, please submit your renewal form showing the same model designations as before. Your renewal will cover only model designations currently listed on your certificate. If you wish to make changes in the scope of equipment covered by your authorization, such as adding additional model designations, you may mark such changes on the renewal form or attach a revised list. (If you wish to amend your authorization at any other time during the year, you must submit an amendment form and payment to 3-A SSI. A copy of the symbol amendment form is available at the 3-A SSI web site under The 3-A Symbol at http://www.3-a.org/forms/3-a_symbol_amendment_form.pdf.) Be sure to verify the following for your renewal submission to 3-A SSI: 1. Please make sure you sign and date the renewal application 2. Please include the renewal fee of $495 with your renewal form. 3. Attach a copy of the TPV Report, if required. If you have questions on the general administration of the program and what steps you must take to obtain a TPV Report, please contact a CCE, see the TPV Manual at the 3-A SSI web site, or call 3-A SSI. Thanks for your support and participation in this very important investment in the future of the 3-A Symbol program.
Sincerely,
Appendix 2 Exhibit 2
We, the undersigned, do hereby certify and attest that these statements and any other information provided with this form are true, complete, and accurate. We acknowledge that any failure to provide true, complete, and accurate information will result in the immediate forfeiture of all 3-A Symbol authorizations and fees. New Applicant: The design, materials, and fabrication used for the equipment referenced above have been reviewed and meet all of the appropriate criteria of the standards. Renewal Applicant: The design, materials, and fabrication used for the equipment referenced above have not been changed or modified since the prior authorization dated, (Insert Date). The design, materials, or fabrication of the equipment referenced above have been changed or modified* since the prior authorization as described below. Attached is a copy of the current TPV certificate and report covering the changes. Changes or Modifications (add additional pages as necessary):
Date: President/CEO Name (print): Signature: AO office use only File Number:
Appendix 2 Exhibit 3 This is a sample of a Certificate of Quality Control that is to be submitted as part of the 3-A Symbol authorization or renewal package. It is to be prepared on the applicants letterhead stationery and be signed by the President/CEO and the Director of Manufacturing.
APPLICATION FOR RENEWAL OF AN AUTHORIZATION TO APPLY THE 3-A SANITARY STANDARDS SYMBOL TO EQUIPMENT
The application shall apply to only one type of equipment to which 3-A Sanitary Standards pertain. Company Name: ______________________________________________________________ Address: _____________________________________________________________________ _____________________________________________________________________________
(City) (Phone) (State) (Fax) (Zip) (E-mail) (Country)
_____________________ _____________________ __________________________________ Hereby applies to the 3-A Sanitary Standards, Inc. for renewal of Authorization No. _____, initially issued ____________ to apply the 3-A Symbol to the following:
(Insert Date)
TYPE OF EQUIPMENT ___________________________________________________ MODEL DESIGNATIONS _________________________________________________ ________________________________________________________________________ ________________________________________________________________________ DECLARATION OF THE APPLICANT It is hereby declared and affirmed that the models of equipment herein listed comply in all respects with the currently effective 3-A Sanitary Standards for: _________________________________________________________________________
(3-A Standard Title)
________________
(3-A Standard Number) 3-A SSI office use only File Number:
___________
(Effective Date)
Please complete and return the renewal form with attached payment information sheet.
3-A Sanitary Standards, Inc. 6888 Elm Street, Suite 2D McLean, VA 22101-3829
Credit Card Type and Card Information
Card Number
Exp. Date
*To help assure a secure transaction, we REQUIRE that a valid Card Identification Number be provided with each credit card transaction. This number is recorded as an additional security precaution. For Visa, MasterCard and Discover: The Card Identification Number is the 3-digit, nonembossed number printed on the signature panel on the back of the card immediately following the card account number. For Amex: The Card Identification Number is the 4-digit, non-embossed number printed above your account number on the face of your card. If you cant see your Card Identification Number on your card, please do one of the following options. 1. Call your Credit Card Company to obtain a new card. 2. Utilize another payment method. PRINT Cardholder Name as it appears on Card: SIGNATURE of Cardholder: I, authorize payment to 3-A Sanitary Standards, Inc. , hereby
Payment may be made by check for the amount in U.S. dollars to: 3-A Sanitary Standards, Inc.
APPLICATION FOR AMENDMENT OF AN AUTHORIZATION TO APPLY THE 3-A SANITARY STANDARDS SYMBOL TO EQUIPMENT
The application shall apply to only one type of equipment to which 3-A Sanitary Standards pertain. Company Name: ______________________________________________________________ Address: _____________________________________________________________________ _____________________________________________________________________________
(City) (Phone) (State) (Fax) (Zip) (E-mail) (Country)
_____________________ _____________________ __________________________________ Hereby applies to the 3-A Sanitary Standards, Inc. for amendment of Authorization No. ________, initially issued _____________ to apply the 3-A Symbol to the following:
(Insert date)
TYPE OF EQUIPMENT: _______________________________________________________ MODEL DESIGNATIONS: _____________________________________________________ _____________________________________________________________________________ _____________________________________________________________________________ DECLARATION OF THE APPLICANT It is hereby declared and affirmed that the models of equipment herein listed comply in all respects with the currently effective 3-A Sanitary Standards for: _____________________________________________________________________________
(3-A Standard Title) ____________________, (3-A Standard Number) __________________________ (Effective Date)
It also is hereby declared that the signer of this application has read and will abide by the rules of the TPV program as set forth in the TPV program manual.
It is also affirmed that the applicant will maintain, for the duration of the authorization for which application hereby is made, an organized system of inspection, quality control of units of equipment, machinery and an Engineering Design and Technical Construction File (EDTCF).
The applicant understands that the issuance of an authorization for the use of the 3-A Symbol is based upon the TPV certification, issued by a Certified Conformance Evaluator (CCE), that the equipment listed in the application fully complies with the 3-A Sanitary Standards named. It is further understood that when an authorization has been issued the legal responsibility for conformance is solely that of the holder, and 3-A SSI and the CCE will not warrant that the holder will at all times conform to the provisions of the said 3-A Sanitary Standards. This understanding in no way affects the responsibility of 3-A SSI to take appropriate action in cases in which evidence of nonconformance to the said 3-A Sanitary Standards has been established.
Date: ____________________
Please complete and return the amendment form with attached payment information sheet.
3-A Sanitary Standards, Inc. 6888 Elm Street, Suite 2D McLean, VA 22101-3829
Credit Card Type and Card Information
Card Number
Exp. Date
*To help assure a secure transaction, we REQUIRE that a valid Card Identification Number be provided with each credit card transaction. This number is recorded as an additional security precaution. For Visa, MasterCard and Discover: The Card Identification Number is the 3-digit, nonembossed number printed on the signature panel on the back of the card immediately following the card account number. For Amex: The Card Identification Number is the 4-digit, non-embossed number printed above your account number on the face of your card. If you cant see your Card Identification Number on your card, please do one of the following options. 3. Call your Credit Card Company to obtain a new card. 4. Utilize another payment method. PRINT Cardholder Name as it appears on Card: SIGNATURE of Cardholder: I, authorize payment to 3-A Sanitary Standards, Inc. , hereby
Payment may be made by check for the amount in U.S. dollars to: 3-A Sanitary Standards, Inc.
APPLICATION FOR AUTHORIZATION TO APPLY THE 3-A SANITARY STANDARDS SYMBOL TO EQUIPMENT
The application shall apply to only one type of equipment to which 3-A Sanitary Standards pertain. Company Name: ______________________________________________________________ Address: _____________________________________________________________________ _____________________________________________________________________________
(City) (Phone) (State) (Fax) (Zip) (E-mail) (Country)
_____________________ _____________________ __________________________________ Hereby applies to the 3-A Sanitary Standards, Inc. for authorization to apply the 3-A Symbol to the following: TYPE OF EQUIPMENT: ________________________________________________________ MODEL DESIGNATIONS: ______________________________________________________ ______________________________________________________________________________ ______________________________________________________________________________ DECLARATION OF THE APPLICANT It is hereby declared and affirmed that the models of equipment herein listed comply in all respects with the currently effective 3-A Sanitary Standards for: _____________________________________________________________________________
(3-A Standard Title) ____________________, (3-A Standard Number) ______________________ (Effective Date)
Appendix 2 Exhibit 6 Page 2 of 7 It also is hereby declared that the signer of this application has read and will abide by the rules of the TPV program, as set forth in the TPV program manual.
It is also affirmed that the applicant will maintain, for the duration of the authorization for which application hereby is made, an organized system of inspection and quality control of units of equipment and maintenance of an Engineering Design and Technical Construction File (EDTCF).
The applicant understands that the issuance of an authorization for the use of the 3-A Symbol is based upon the TPV certification, issued by a Certified Conformance Evaluator (CCE), that the equipment listed in the application fully conforms to the 3-A Sanitary Standards named. It is further understood that when an authorization has been issued, the legal responsibility for conformance is solely that of the holder. 3-A SSI will not warrant that the holder will at all times comply with the provisions of the said 3-A Sanitary Standards. This understanding in no way affects the responsibility of 3-A SSI to take appropriate action in cases in which evidence of nonconformance to the said 3-A Sanitary Standards has been established.
Date: ____________________
3-A SANITARY STANDARDS, INC. PROVISIONS FOR THE USE AND DISPLAY OF THE 3-A SYMBOL
The 3-A Symbol, where possible, shall be made of stainless steel, and shall be affixed upon the equipment in juxtaposition to the nameplate or shall be part of the nameplate. The hyphenated serial number of the 3-A Sanitary Standard with which the equipment conforms shall appear and be affixed to the equipment or machinery, the 3-A Symbol, or the name-plate in a clear, concise, permanent manner. Where the nature or size of the equipment is such as to make the above impracticable, the 3-A Symbol and hyphenated serial number shall be stamped, etched, or embossed on the equipment; or affixed in any other permanent manner. Applications shall be filed on forms supplied, in duplicate, by 3-A SSI, a duplicate to be kept by the applicant. Applications shall be submitted to 3-A Sanitary Standards, Inc., 6888 Elm Street, Suite 2D, McLean, VA 22101. Every application shall be accompanied by: 1. A statement as to whether the applicant is or is not the manufacturer of the models of equipment or machinery listed in the application. If the applicant is a non-manufacturer, the name(s) and address(s) of the manufacturer(s) shall be supplied to 3-A SSI. A reprint of the 3-A Sanitary Standards named in the applications shall be: (a) initialed at each paragraph applicable to the equipment or machinery by an employee thoroughly acquainted and knowledgeable with its design and construction indicating conformance to the 3-A Sanitary Standards, (b) signed by a corporate officer of the applicant confirming conformance (If a paragraph is not applicable, it shall be so noted by NA), (c) and a copy of the TPV Report and Certification issued by a Certified Conformance Evaluator (CCE). A specimen of the nameplate to be used or a drawing showing the nameplate with exact dimensions and full text (not including data for specific models).
2.
3.
Appendix 2 Exhibit 6 Page 4 of 7 4. A specimen of the 3-A Symbol and the 3-A Sanitary Standard hyphenated serial number to be employed, or a drawing showing its height; and, if not made of stainless steel, a sample and description of the material to be used, and the manner of its attachment. (See page 64.) Descriptive literature and photographs or drawings depicting specific features. Detailed drawings of specified parts or areas are to be furnished upon request of 3-A SSI. If required, a completed TPV shall be included. An account or description of the construction or fabrication inspection and quality control system in effect, or to be provided, and the Certificate of Quality Control signed by the President/CEO and the Director of Manufacturing. The appropriate application fee made payable to 3-A SSI.
5.
6.
7.
Each Authorization shall remain in effect for one (1) year and may be extended by renewal for periods of one (1) year, as provided in the TPV Manual, beginning with the day following expiration of the original authorization or any renewal upon the filing of an application for renewal, and the payment of the renewal fee. Upon revisions of 3-A Sanitary Standards, authorizations or renewals of authorizations predicated upon the 3-A Sanitary Standards in effect prior to the revision shall not be valid for equipment manufactured after the effective date of the revised 3-A Sanitary Standards. Holders of authorizations for equipment manufactured after the effective date of the revised 3-A Sanitary Standards shall submit the documentation required. When a holder of an authorization wishes to modify the design, fabrication, or materials of construction of covered equipment or machinery; or, add one or more models of equipment or machinery conforming to the 3-A Sanitary Standards upon which authorization or a renewal of 3-A Authorization in effect was predicated, the authorization or renewal of authorization may be amended upon the filing of an application (or applications by the non-manufacturer and manufacturer(s), supported by pertinent data required. Amended authorizations or renewals of authorizations shall expire on the date on which the authorizations or renewals of authorizations would have expired. Each holder of an authorization shall be notified, as specified in Section B6.2, B6.3, and B6.4 before an authorization, renewal of authorization, or amended authorization expires, and shall be furnished a form for applications for renewal of the authorization, or shall be notified that the authorization cannot be renewed, as the case may be.
Appendix 2 Exhibit 6 Page 5 of 7 The application forms for renewal of an authorization, to be furnished by 3-A SSI, shall conform, with appropriate modification, to the provisions of the TPV Manual. The fee prescribed by the Board of Directors of 3-A SSI, is to accompany each application for renewal or for amendment of an authorization. Authorizations and renewals of authorizations may be relinquished by the holders. If such relinquishment is announced by all of the manufacturers of equipment or machinery for a nonmanufacturer, the authorization or renewal of authorization of the nonmanufacturer automatically expires. Any authorizations and renewals of authorizations, for which application for renewal is not made, become invalid on the day following the date of expiration. If all of the manufacturers for a nonmanufacturer fail to renew their authorizations, the authorization or renewal of authorization of the nonmanufacturer automatically expires. The right of the holder of an authorization or renewal of authorization to use the 3-A Symbol on the equipment and machinery covered by the authorization shall cease upon the cancellation or termination of the said authorization or renewal of authorization by the Board of Directors with cause. Information regarding relinquished, canceled, or revoked authorizations or renewals of authorizations are published in Food Protection Trends (FPT) and on the 3-A Sanitary Standards Inc. website.
Standard Number _______ 3-A SANITARY STANDARDS, INC. 3-A SYMBOL SPECIFICATIONS
These specifications shall apply to all methods of 3-A Symbol display (a) The 3-A Symbol shall be:
Capital Gothic A outline with serifs, on which is superimposed the antique numeral 3. (See cut previous page.) Ratio of width, w to h = 1.08:1 Ratio of width at top, t to h = .26:1 Ratio of distance from top to top of cross bar, b to h = .49:1 Ratio of width of cross bar, c to h = .175:1 Ratio of width of side bars, d to h = .21:1 Ratio of height of figure 3, y to h = .45:1 Ratio of width of figure 3, x to h = .333:1 (maximum) Radius of serif, r to h = .0625:1 On reproductions with h=1/2 or less, the serifs may be omitted. The registered designation shall be proportionally displayed as part of the 3-A Symbol.
AO office use only File Number:
3-A SANITARY STANDARDS, INC. NOTICE TO APPLICANTS FOR 3-A SYMBOL AUTHORIZATION
The 3-A SSI has established procedures to authorize manufacturers of equipment and machinery that meet the requirements of published 3-A Sanitary Standards applicable to specific items of equipment to mark and/or affix the 3-A Symbol to that piece of equipment. An organization holding authorization to apply the 3-A Symbol may state this capability in its advertising literature. The 3-A SSI or its employees do not approve, certify, rate, or endorse the design, construction, or use of the equipment and there shall be no statements or implications, which might so indicate. An organization holding a 3-A Symbol Certificate of Authorization may state in advertising literature that items for which they have been issued 3-A Symbol authorization meet the requirements of the 3-A Sanitary Standards. Unauthorized use of the 3-A Symbol, or statements to that effect and statements about 3-A Sanitary Standards conformance is not allowed. Please complete and return the application form with attached payment information sheet.
New Authorization Fee: See current on-line version at http://www.3-a.org/symbol/forms.htm for calculation of fee (payable by credit card or check). Please send payment information below or a check with completed application to:
3-A Sanitary Standards, Inc. 6888 Elm Street, Suite 2D McLean, VA 22101-3829
Credit Card Type and Card Information
Card Number
Exp. Date
*To help assure a secure transaction, we REQUIRE that a valid Card Identification Number be provided with each credit card transaction. This number is recorded as an additional security precaution. For Visa, MasterCard and Discover: The Card Identification Number is the 3-digit, nonembossed number printed on the signature panel on the back of the card immediately following the card account number. For Amex: The Card Identification Number is the 4-digit, non-embossed number printed above your account number on the face of your card. If you cant see your Card Identification Number on your card, please do one of the following options. 5. Call your Credit Card Company to obtain a new card. 6. Utilize another payment method. PRINT Cardholder Name as it appears on Card: SIGNATURE of Cardholder: I, authorize payment to 3-A Sanitary Standards, Inc. , hereby
Payment may be made by check for the amount in U.S. dollars to: 3-A Sanitary Standards, Inc.
Appendix 2 Exhibit 8
R
___________________________________
Name
Give the appropriate standard, serial number and reference paragraph in the 3-A Sanitary Standards, which relate to the item in question (All paragraphs in the 3-A Sanitary Standards are clearly identified). Use additional pages as necessary.
____________________________________________________________________________
Person making this report Title
____________________________________________________________________________
Street City State Zip Telephone Number
Signature ________________________________________________________
APPENDIX 3
TPV FORMS AND RELATED DOCUMENTS
THIRD PARTY VERIFICATION REPORT AND CERTIFICATION FOR 3-A SYMBOL AUTHORIZATION
Applicant: Date: CCE: Equipment Type: Verification Location: Model Number: Serial Number: 3-A Standard: Applicant/Verification Contact (name and phone number): 3-A Authorization Number:
Nonconformance (Note: If any No items are checked, the Nonconformance box shall be marked.) When the Nonconformance box is marked, additional statements specifically describing which criteria from the base 3-A Sanitary Standards were not in conformance must be included in the Observations and Findings column or on an attached page.) Conformance I, the undersigned CCE, do hereby certify that the equipment covered by this report has been thoroughly evaluated and complies with all the appropriate criteria of the covering 3-A Sanitary Standards. Observations and Findings:
CCE Signature: To be completed by 3-A Symbol Administrative Officer: Date Received: Received By: AO office use only File Number:
Verification Number:
Yes 1 2 Scope Equipment included in the scope 3-A Standard No. displayed within Symbol Definitions Apply to equipment Materials Metals AISI 303 or better Cast CF-16F, CF-8 or CF-8m
(If used, record the component and cast grade.)
No
NA
4 5 6 7
8 9 10
Nonmetals Rubber type Rubber applications according to 3-A Standards 13 Rubber 3-A 18- compliant 11 12
(If rubber or rubber-like materials are used, record the materials used, and that certification documentation is available.)
Yes Nonmetals (Continued) 14 Plastic applications according to 3-A Standard 15 Plastic 3-A 20- compliant
(If plastics are used, record the plastics used and that the certification documentation is available.)
No
NA
16
17 18 19 20 21
22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38
Rubber/Plastic durable Coatings durable Ceramic materials (use limits) - durable, nonporous Carbon (use limitations) Glass (use limitations) - heat resistant, clear Other Sterilizability materials Nonproduct Surfaces Corrosion resistant Relatively nonabsorbent Relatively durable Cleanable Acceptable coating Other Fabrication Surface texture
(No. 4/32in. or 0.8m Ra)
No pits, folds or crevices Permanent Joints Continuous Weld/Bond Welds Ra 32in. or 0.8m Ra Solder limited to specified areas/Acceptable Press or shrink fits Metal-to-metal Other Limited to specified areas Joint crevice free Issuance Date: Jan. 2003 74 Revision Date: June 2007
No
NA
40
Meets 3-A criteria Coatings 41 Sound and defect free 42 Minimum thickness
Cleaning and Inspectability
43 44 45 46 47
Mechanically cleaned All product contact surfaces accessible and inspectable Removable parts accessible CIP where allowed Representative surfaces inspectable
Draining
48 49
50 51
Nonexposed/CIP cleaned
(use limits)
Springs 52 Round stock 53 3/32 in. (2.4 mm) openings 54 No flat ends Sterilization meets criteria (list) 55 56 57 58 Gaskets meets criteria (list) 59 60 61 62
Yes 63 64 65 66 67 68 69 70 71 72 73 74 75 Mechanical Seals, packless & sanitary 76 77 78 Openings & Covers Size/shape Location Meets other criteria Shielding 82 Adequate 83 Allows no liquid to self-return to product zone 84 Agitators (meets criteria) 79 80 81
(Record the type of agitator(s) provided, e.g., top mounted, side mounted, bottom mounted, etc.)
No
NA
Radii Internal angles > 135 135 Meets minimums (list) O-Ring grooves Other (list) Perforations Woven wire (use limits) Hole size/shape Free of burrs Shafts & Bearings
NA
86 87 88 89
Meets fabrication criteria Adequate clearance Slab mounting provisions Appurtenances meet referenced 3-A Standards (list)
(Appurtenances meet referenced 3A Standards. Record each nonconforming appurtenance on a separate line. Identify the specific appurtenance and the corresponding covering 3-A Sanitary Standard. If there are any nonconforming observations, they are to be clearly documented that the appurtenances do not conform to 3-A Sanitary Standards.)
90 91 92 Nonproduct Contact Surfaces 93 Relatively smooth 94 Relatively free of pockets/cleanable 95 Exposed threads minimized Meets other applicable criteria (list) 96 97 Guards/Safety devices
(meets criteria)
Information plates Documentation 99 Manual(s) Engineering Design and Technical 100 101
Construction File (EDTCF) Certificate of quality control verified
98
Yes Other (list criteria section and criteria required) 102 103 104 105 106 107 108 109 110 111 112 113 114 115 116 117 118 119 120 121 122 123 124 125 126 127 128 129 130 131
No
NA
General Information:
Name (Last, First, Middle): ________________________________________________ Address: ________________________________________________ ________________________________________________ ________________________________________________ City State Zip Code Other Names Used (e.g., maiden name, nickname, etc.): __________________________________________ Home Telephone: ___________________ Work Telephone: ____________________ Fax Number: ___________________ Yes E-mail: No ____________________
___________________________________
I, the undersigned, do hereby attest that all statements and information provided or attached in this application are true, accurate and complete.
List all language(s), which you speak or read. Indicate whether you read, speak, or both and the level of fluency.
Appendix 3
Exhibit 2
Page 3 of 4
Education:
Did you graduate from high school or receive a GED high school equivalency certificate? GED Yes No Diploma Attached Yes No Identify the name and location (city and state) of the high school you attended or where you received your GED certificate.
Name and location (city, state, zip code) of any college or university attended:
Name City State Zip From To Semester Hr. Quarters Type of Degree Month and Year of Degree
1. 2. 3.
Semester Hr.
Quarters
Semester Hr.
Quarters
1. 2. 3.
List any other courses or training received related to the position. Identify the name and location (city, state, and zip) of the training, month and year attended, classroom hours, subjects, and if the training completed, include a diploma, degree granted or certification.
Work Experience:
List most recent employment first. 1. Name and Address of Employer: Dates Employed (month, day, year): From: Exact Job Title: To:
Description of work: Describe your specific duties, responsibilities, and accomplishments as they relate to the specific knowledge, skill and ability requirements. Add additional pages as necessary.
Dates Employed (month, day, year): From: Exact Job Title: To:
Description of work: Describe your specific duties, responsibilities, and accomplishments as they relate to the specific knowledge, skill and ability requirements. Add additional pages as necessary.
If you need more experience blocks, add additional pages with the requested information. 3-A Sanitary Standards, Inc. Manual Issuance Date: Jan. 2003 82 Revision Date: June 2007
8. I shall endeavor to avoid any actions creating the appearance that I am violating the ethical tenets set forth in this certificate. Whether particular circumstances create an appearance that these tenets have been violated shall be determined from the perspective of a reasonable person with knowledge of the relevant facts. 9. I certify that I will abide by the above Code of Ethics as a Certified Conformance Evaluator and that all of the statements and information provided or attached to my application are true, accurate and complete.
Signature:
AO office use only File Number:
Date:
Appendix 3 Exhibit 4
JANE DOE
Is Hereby Declared and Affirmed by 3-A Sanitary Standards, Inc. as a CERTIFIED CONFORMANCE EVALUATOR Authorized to Conduct Third Party Verifications for 3-A SYMBOL AUTHORIZATIONS
Granted this date: ______________ Expiration date: _______________ (Insert Date)
APPENDIX 4
ENGINEERING DESIGN AND TECHNICAL CONSTRUCTION FILE EXAMPLE
SANITARY STANDARDS COMMITTEES GUIDANCE FOR THE ESTABLISHMENT OF AN ENGINEERING DESIGN AND TECHNICAL CONSTRUCTION FILE
The Engineering Design and Technical Construction File (EDTCF) is information, which may be assembled from multiple sources, and will be used by the Certified Conformance Evaluator (CCE) as a primary source of verification details during a Third Party Evaluation (TPV). Since each EDTCF is unique to the equipment types manufactured, the amount and types of information present will vary widely. The following example of an EDTCF, as listed in the 3-A Sanitary Standards Form and Style Manual, Appendix Y, (May 2002), is to be maintained by the fabricator as evidence of complying with 3-A Sanitary Standards. The file may contain more or less information as applicable to the equipment or system. 1 1.1 Purpose To establish and document the material, fabrication, and installation (where appropriate) requirements for the engineering design and technical construction files for all products, assemblies, and sub-assemblies supplied by the manufacturer thereof to be in conformance to the sanitary criteria found in 3-A Sanitary Standards. It is recommended that the engineering and construction file be submitted with applications for 3-A Symbol use authorization.
Scope This EDTCF applies to equipment specified by: 3-A Sanitary Standards for {full title}, Number {document number} List all other applicable 3-A Sanitary Standards Other referenced documents. List by full title and document number. Responsibilities This EDTCF is maintained by: The Engineering Manager (or other company official) {name and title of responsible official} is responsible for maintaining, publishing, and distributing this EDTCF. Implementation: All divisions, specifically development engineering, standards engineering, sales engineering, and product departments are responsible for implementing this EDTCF. Applicability The 3-A Sanitary Standards and are voluntarily applied as suitable sanitary criteria for dairy and food processing equipment. 3-A Sanitary Standards are referenced in the Grade A Pasteurized Milk Ordinance: Equipment manufactured in conformity with 3-A Sanitary Standards complies with the sanitary design and construction standards of this Ordinance. They are also required in plants accepted for USDA grading. References List any additional regulations that apply to the equipment or system covered by this EDTCF. Date of conformity or 3-A Symbol authorization and certificate number, if authorized.
3.2
4 4.1
5 5.1
5.2
6 6.1
Design and Technical Construction File The Engineering Design and Technical Construction File may consist of the following: a. an overall drawing of the subject equipment; b. full detailed drawings, accompanied by any calculations, notes, test results, etc. required to check the conformity of the equipment with the 3-A Standards or 3-A Practices; c. a list of: (1) the essential requirements of the standards or practices; (2) other technical specifications, which were used when the equipment was designed; d. a description of methods adopted; e. if essential, any technical report or certificate obtained from a competent testing body or laboratory; f. any technical report giving the results of tests carried out internally by engineering or others; g. documentation and test reports on any research or tests on components, assemblies and/or the complete product to determine and demonstrate that by its design and construction the product is capable of being installed, put into service, and operated in a sanitary manner (optional); h. a determination of the foreseeable lifetime of the product (optional); i. a copy of the instructions for the product (instruction manuals/instruction books); j. for serial manufacturing, the internal measures that will be implemented to insure that the equipment will continue to be manufactured in conformity with the provisions of the 3-A Sanitary Standards; k. engineering reports; l. laboratory reports; m. bills of material; n. wiring diagrams, if applicable; o. sales order engineering files; p. hazard evaluation committee reports, if executed; q. change records; r. customer specifications; s. any notified body technical reports and certification tests; t. copy of the 3-A Symbol authorization, if applicable.
6.2
The file does not have to include detailed plans or any other specific information regarding the sub-assemblies, tooling, or fixtures used for the manufacture of the product unless knowledge of them is essential for verification of conformity with the basic sanitary requirements found in 3-A documents. The documentation referred to in 6.1 above need not permanently exist in a material manner in the EDTCF, but it must be possible to assemble them and make them available with a period of time commensurate with its importance (one week is considered reasonable time). As a minimum, each product EDTCF must physically contain an index of the applicable document of 6.1 above. The EDTCF may be in hard copy or software form. Confidentiality The EDTCF is the property of the manufacturer and is shown at their discretion, except that all or part of this file will be available to the 3-A Symbol Administrative Officer or a regulatory agency for cause and upon request. File Location The EDTCF shall be maintained at {location}. File Retention The EDTCF (including all documentation referred to in 6.1) shall be retained and kept available for twelve (12) years following the date of completion of the TPV inspection and placing the product in use or from the last unit produced in the case of series manufacture.
6.3
6.4 7 7.1
8 8.1 9 9.1
APPENDIX 5
RESERVED FOR 3-A SSI