Explanatory Guide For Application of Quality System Standards (IS/IS0 9001,9002 AND 9003)

SP 63: 1997
EXPLANATORY GUIDE FOR APPLICATION OF QUALITY SYSTEM STANDARDS (IS/IS0 9001,9002 AND 9003)
LICENSED TO ESSAR STEEL LIMITED, HAZIRA FOR INTERNAL USE AT THIS LOCATION ONLY, SUPPLIED BY BOOK SUPPLY BUREAU.
ICS
03.120.10
BIS 1997
BUREAU
MANAK
OF
INDIAN
STANDARDS
MARG
BHAVAN, 9 BAHADUR SHAH ZAFAR NEW DELHI 110002
December
1997
Price Group
14
Quality Management Sectional Committee, MSD 2
FOREWORD This Special Publication was adopted by the Bureau of Indian Standards on the recommendation of the Quality Management Sectional Committee (MSD 2), and approval of the Management and Systems Division Council.
IS0 has brought out the publication, IS0 !XOO-2,as a guide for implementation of quality systems based on IS0 9001, IS0 9002 and IS0 9003. While adopting this publication under dual numbering system as IS/IS0 9000-2, a need was felt for supplementing the same to help Indian industry in the implementation of quality system as per IS/IS0 !XlCKl series of standards. In addition, Indian industry differs very widely in size, technology and resources available to it. Because of this wide disparity within the industry, it has also been feIt that additional guidance is required for rapid introduction of quality system by all sectors of industry, irrespective of their size, product category (for example, hardware, software, processed material or service) and the technology adopted by them. It may be mentioned that the clauses of the respective standards are not being reproduced as these standards have already been adopted and published by BIS. in this guide,
It should be clearly understood that this Supplementary Guide is in the form of explanatory guide and not a standard. The Supplementary Guide is specifically meant for the type of industries existing in our country and as such, it may have a short-life and be withdrawn as soon as our industries acquire the requisite expertise in the implementation of the quality system standards. Quality Management and Quality Assurance Technical Committee, TC 176 of IS0 has also brought the following handbook, specially to provide guidance for small business: IS0 9000 For small businesses what to do - Advice from ISO/rC 176. The concerned sectional committee has reviewed the provisions of this publication and has decided that this is also acceptable for use as reference along with this guide. The Committee responsible for the formulation of this document is given at Annex J.
SP 63 : 1997
EXPLANATORY GUIDE FOR APPLICATION OF QUALITY SYSTEM STANDARDS (IS/IS0 9001,9002 AND 9003)
1 SCOPE
1.1 The Guide provides elaboration of quality system elements and supplements the provisions of ISASO 9000-2. It also takes into account the provisions of ISASO 9004-l in addition to those of IS/IS0 9001, ISASO 9002 and IS/IS0 9003, already covered in ISASO 9000-2. While the examples given in this Guide are meant to clarify the concepts regarding the correct use of quality system standards and help any organization in implementing the same, they should not be considered by the auditors as essential elements to be fulfilled by the organization. IS No.
Title Part 4 : Guide to dependability programme management Quality systems - Model for quality assurance in design/ development, production, installation and servicing Quality systems - Model for assurance in quality production, installation and servicing Quality systems - Model for quality assurance in final inspection and test management and Quality quality system elements Part 1 : Guidelines and Quality management quality system elements Part 2 : Guidelines for services management and Quality quality system elements Part 3 : Guidelines for processed materials management and Quality quality system elements Part 4 : Guidelines for quality improvement management Quality Guidelines for quality plans Guidelines for auditing quality systems - Part 1 : Auditing Guidelines for auditing quality systems - Part 2 : Qualification criteria for quality systems auditors Guidelines for auditing quality systems - Part 3 : Management of audit programmes Quality assurance requirements for measuring equipment Metrological Part 1 : system for conlirmation measuring equipment for developing Guidelines quality manuals
ISASO 9001
IS/IS0 9002
ISASO 9003
1.2 In case of conflicting interpretation of IS/IS0 9001, ISASO 9002 or ISASO 9003 on the one hand and ISASO 9000-2 on the other, the interpretation of the text in ISASO 9001, ISASO 9002 or ISASO 9003 takes precedence. This guide is equally applicable to both manufacturing and service sectors of industry. 2 REFERENCES 2.1 The following Indian Standards on Quality System which are identical to the corresponding IS0 Standards, are necessary adjuncts to this guide: IS No. ISASO 8402 ISASO 9ooo-1 Title and Quality management quality assurance -Vocabulary and Quality management quality assurance standards Part 1 : Guidelines for selection and use management and Quality quality assurance standards Part 2 : Generic guidelines for the application of IS0 9001, IS0 9002 and IS0 9003 Quality management and quality assurance standards Part 3 : Guidelines for the application of IS0 9001 to the development, supply and maintenance of software and management Quality quality assurance standards 1
ISASO 9004-l
ISASO 9004-2
ISASO 9004-3
ISASO 9004-4
ISASO 1ooo5 ISASO 10011-1 IsAso 10011-2
ISASO 9ooo-2
ISASO 10011-3
ISASO 9000-3
ISASO 10012-l
ISASO 9ooo-4
ISASO 10013
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1997
3 DEFINITIONS 3.1 For the purpose of this Guide, the definitions given in IS/IS0 8402 shall apply. 4 QUALITY SYSTEM REQUIREMENTS 4.1 Management Responsibility 4.1.1 Qualiry Policy
Such an exercise, in addition to providing the basis for implementation of quality policy, would give the Head of the unit/department a sense of ownership of the policy being implemented. The quality policy should not be generic in nature. It should be clearly spelt out with specific reference to the activities of the organization. It should be brief, precise and comprehensive to cover all the activities. It may include a preamble highlighting the need for the policy. While the organization should not be contended with the existing quality levels, they should not also pitch the same at a very high level which would shy the personnel away from accepting it. The policy should, therefore, be ambitious enough for the quality level to raise from the current level and at the same time, should be achievable over a period of time. The policy statement may also include the quality system standards being aimed at, namely, IS/IS0 9001, IS/IS0 9002 or IS/IS0 9003. The quality policy should be given the widest publicity within the organization. It may be displayed prominently at various places and copies of the same may be made available to each and every employee of the organization. Efforts should be made .to educate the employees about the objectives of the organization and the need for adhering to the quality policy to achieve the stated objectives. These could be in the form of training programmes, refresher courses, as part of celebrations, and induction training at the time of recruitment. The top management should stand by the policy even at the critical moments when its implementation may involve temporary increase in cost, rejections or scrap. On such occasions, accepting deviations from the policy would have serious repercussions on the employees who subsequently, may not take the quality policy seriously. The demonstration of the commitment by the management would ultimately result in reducing rejections and wastage and increasing productivity and quality. A few typical quality policy statements are given in Annex A; these may help in identifying various elements to be included in the policy. 4.1.2 Organization It is imperative for quality management function to be under the direct control of the Chief Executive for successful implementation of quality systems by any organization. Quality assurance function continues to be a part and responsibility of all individual units/departments. However, a core group for quality management which cuts across all other functional groups to monitor implementation of quality system, should report to the Chief Executive directly. Each functional 2
Each organization should have a quality policy. The quality policy should be supporting the aspects contained in the corporate policy. The aspects of corporate policy may include the intention of the organization to become a market leader by increasing its market share of the product or service being dealt with, to maximize the profits, to improve the productivity, to excel in quality, to provide maximum satisfaction to the customer on a continuing basis. Satisfaction of the customer should be one of the primary objectives, keeping in view the expectations and needs of other stakeholders, of an organization because its very existence depends upon the customer satisfaction and their support in availing the services or products of that organization. While defining the quality policy, the organization should project its vision, mission and key strategies for the future and the policy should aim at achieving the same. It is also essential that the commitment of the management is visibly spelt out. Issuance of a sort of directives by the Chief Executive may not yield the desired results unless supported by the second and other levels of the management which are very important for the successful implementation of the quality policy. It is, therefore, necessary that the quality policy is evolved with the consensus and participation of all concerned and should take into account the background and culture of the organization, the trends in technology and markets and the long-term goals set by the management. The quality policy should be adequately supported by data and the rationale behind specifying various components of the policy should be explained. The quality policy issued under the signature of the demonstrate the Chief Executive would organizations commitment to quality and this, in turn, would pave the way for effective implementation of the quality system. Quality policy may also be established at several levels. The corporate quality policy applicable to the entire organization may be elaborated at the unit/department level, clearly bringing out what the corporate quality policy means to the units/ departments activities and what policies they should adopt to meet the corporate quality policy.
SP 63 : 1997 group shall have the responsibility for quality in its area of operation with adequate infrastructure. In addition to displaying the commitment to the quality systems approach by signing the quality policy and having direct control of the quality system function, the Chief Executive should motivate all the personnel and physically demonstrate the commitment visibly and on a, continuing basis by supporting the cause of quality systems, suitably providing additional resources to implement the quality policy. A typical organizational chart giving the position of quality assurance is given below: the quality systems. Management representative should provide leadership and inputs to evolve, establish, implement and integrate Quality System in the organization. Management representative also takes appropriate measures for ensuring adequate resources for effective implementation of the system. A management representative may himself be the quality assurance manager. If management representative oversees more functions including quality assurance, he should be able to maintain the independence of quality assurance functions and uphold the quality policy envisaged by the organization without any conflict of interest with other functions.
CHIEF ENECUTIVE
Head Design DeV.
Head Production
Head Purchase
f
I
I
Head Finance
Head Marketing
Head Quality
Head Service
I Others
r-i-r
m---iT
T-I-T
n---lTlrrtTl
41.3 Management Review Management review should be suitably structured; otherwise, there is a chance of an activity not receiving the due attention it deserves from the top management. Therefore, review of quality assurance function should form part of structured review by the top management. This could be done as a part of overall review on an annual basis by the Chief Executive and may suitably be reported. More frequent reviews could be undertaken by the management representative and the findings of these reviews and the actions taken may form part of the annual management review. The management review may include the review of the organizational structure, adequacy of staff and other resources to ensure effective implementation of the quality system. A check list of actions to be taken for providing information for annual review by the management may be developed. The check list may include the following: a) b) Setting up of yearly quality objectives along with quantitative targets to be achieved. Assessment of the staff requirements and their training needs and the details of training imparted.
4.1.2.1 Responsibility and authority No additional guidance is necessary. 4.1.2.2 Resources SpeciEying a set of quality system requirements alone will not achieve quality. Even strict instructions to implement them may not yield results, if the activity is not implementable due to resource constraints. It is, therefore, necessary to identify the resource constraints which may be in the form of lack of adequate manpower, lack of training, lack of testing and inspection facilities, inadequate time for testing and inspection, inadequate facilities for design, manufacturing, maintenance, etc. The suppliers organization requires qualified and trained personnel along with verification software and hardware in the form of checksheets, tools, instruments, etc. For example, if final inspection and testing involves a time period of two days and if a job after production is scheduled for despatch on the same day, it may result in inadequate testing and inspection. Similar anomalies may exist with regard to other resources. 4.1.2.3 Management representative The management representative refers to a person or position from within the organization which has overall responsibility to monitor the functioning of 3
Cl The internal audits on quality systems carried out and their findings. d) Complaints received from the customers relating to the quality of end products or services and the actions taken.
SP 63 : 1997
e) f)
Feedback or complaints received subcontractors and vendors.
from
Internal feedback received from all the departments as well as persons responsible for implementation of quality systems. g) Analysis of nonconformities, trends and improvements effected. There should be a documented procedure for organizing management review of the quality systems. The periodicity of the management review may be specified in the quality manual itself. A record of all reviews and implementation of decisions taken should be maintained. It may also be necessary to draw out list of functionaries to be invited for such reviews. The management review should be performed and directions given to the functionary areas concerned.
form of company standards. It should, therefore, be ensured that the various elements of the quality system do not address themselves to a purpose which will counter the above objective. 4.2.1 General (Quality Mqmal) To facilitate implementation of the quality system on a continuing basis, it should be documented. The documented quality system comprises several tiers of documents, the apex of which is the quality manual. The quality manual makes brief description of all the elements of the quality system applicable to an organization and gives specific details relating to the product or service whose quality is being controlled. In case any of the elements of the quality system standard is not applicable, the same should be brought out rather than omitting them in the quality manual. Broadly, it provides who is to do what type of information essential for implementation of quality system. It is supported by several other documents like quality plans, procedures, work instructions, specifications for various materials, etc. Each subsequent document is progressively more detailed and addresses a specific aspect or an activity. The customer may like to get an assurance that the supplier is capable of meeting his requirements on a continuing basis. In such cases, the suppliers quality manual would provide the necessary confidence to the customers in accepting the product or service. The quality manual may also be used by the supplier to project his commitment to quality for better customers acceptance. Copies of quality manual may also be supplied to customers or assessment authorities on demand. Quality manual should be maintained up-to-date by a suitable document control system. For this purpose, it is necessary to maintain a list of persons holding the controlled copies of quality manual and establish a system for incorporating all amendments/revisions. Some of the reasons for preparing a quality manual may include the following:
Check list
Have you enunciated policy? Does the companys quality policy? your companys objectives quality
align with the
Is management commitment to quality visible? Is every one in the organization aware of the quality policy? Are all activities identified? affecting product quality
Are responsibilities and authority for personnel involved in various activities defined? Are personnel clearly identified for the various activities required for ensuring product quality? Are all verification activities identified? Do you have a management representative who is responsible for implementation of the quality system? Has management representative authority to be effective in his role? sufficient
Is there a documented procedure for carrying out regular management reviews of the quality system? Do you maintain proper records of management review?
4.2 Quality System
a) To win customers confidence
b)
Even though quality system is described as an element in IS/IS0 9001, it comprises other elements and includes the organizational structure, responsibilities, procedures, processes and resources for implementing quality management. The ultimate objective of the quality system is to ensure that the products or services conform to specified requirements. These may be specified under statutory requirements or by the standards organization or by the organization itself in the 4
To project companys image with specific contractual requirements d) To streamline existing quality system e) To define the responsibility and authority of persons dealing with quality related functions. This may either be with the quality assurance department or with other departments who may have been delegated the task of implementation of different elements of the quality system
Cl To meet
SP63: 1997
product line, organizational structure, etc To provide a basis for quality audit g) To educate all concerned within the h) organization about the various quality elements and their impact on their working.This would facilitate changing the attitude of the personnel to accept quality audit as an aid for quality improvement To have a channel for communication with j) the management about the quality needs and achievements of the organization. The quality manual should be prepared with utmost care and with the involvement of all concerned. Quality manual may not be a confidential document. The quality procedures, work instructions, specifications of products or materials may contain confidential information which the organization may not like to divulge. Quality manual should make reference to other documents which act as an adjunct to it. It need not list out the actual documents that are used for maintaining the quality by an organization but it should give reference to the type of documents which one may look for in that direction. For example, quality manual may give reference to specifications which aid purchase function and may not list out all the specifications drawn out by the organization. However, this list should be separately available to the quality assurance department as well as to others concerned so that they will be able to implement the quality system with proper understanding.
NOTE - Reference may also be made to WSO 10013.
f) To facilitate introduction of changes in the
activities giving check points whether quality related aspects are measured and improvements made based on the feedback The need for the procedures would depend on the organization, the type of product or service it offers and the need for effectively controlling the quality at various stages.
Work instructions
Work instructions, on the other hand, are specific instructions for performing a job, the absence of which will affect the quality. They should be sufficiently detailed to prescribe clearly the manner in which the work will be performed and the required quality demonstrated. An example is the inspection sheet. It provides all important dimensions, tolerances, classification of dimensions, gauges and aids, the required finish, etc. In the case of sampling, the inspection sheet gives the sample size, the acceptance number, gauges, fixtures and instruments to be used, use of inspection stamp and forms to be completed. Figure 1 given below will indicate the link between the quality manual which is the apex document specifying ,the quality system and the supporting documents required for smooth implementation of quality systems. It is to be specifically mentioned here that while the quality manual provides useful guidance for the preparation of down the line documents, these documents, in turn, supplement the quality manual and get referred to in the same. The quality system is not complete unless all the documents are available and put into actual practice. The various functional areas indicated in the diagram are not exhaustive. IS 9001 lists out 20 elements and the documentation is called for in all of them and may be for several sub-elements, Figure 1 explains the inter-relationship between various documents of the quality assurance management system:
42.2 QualitySystemProcedures
Procedures
Another level of documentation required to support the quality system relates to procedures. These procedures are primarily to describe the
Describes the quality system in accordance with the stated quality policy and objectives and the applicable standard Describes the activities of individual functional units needed to implement the quality system Consists of detailed work documents
Consists of HUnxords generated due to various quality related activities
FIG.
1 TYPICAL QUALITY SYSTEM DOCUMENT
HIERARCHY
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Check l& 4.3 Contract Review
Have you identified the relevant element of the standard that pertains to your organization? Have you identified detailed procedures? the activities that require
Have the procedures been written by the operating departments concerned? Have the proper interfaces departments identified? Are all Manual? procedures between different Quality
Contract review is essential to match the suppliers production capabilities with the purchasers requirements. A contract review carried out at the tendering stage would help in making important decisions regarding the cost of the product or service for the purpose of quotation, and in specifying the requirements more precisely to avoid any ambiguity and dispute. Even in case of verbal orders, it should be ensured that the requirements are agreed before acceptance and execution of such orders. When the purchaser is a general customer, contract review assumes different connotation (see 7 of IS/IS0 9004-l) and should identify stated as well as implied needs of the customer and the ways and means of achieving them. For example, while ordering food in a restaurant, the waiter confirms back the items ordered to ensure that there is no ambiguity about the order. This also constitutes a contract and contract review activity. It is a general practice for the supplier organization to have its own company standards for both purchased items as well .as for the manufactured items. Referring to the company standards in the contracts would take care of the requirements to be fulfilled in a comprehensive manner, since the process of formulation of company standards involves consultations with all concerned including the customers and optimum utilization of available inputs at the suppliers command. Contract review organized during the execution of a contract helps in timely completion of the project and in avoiding any disputes. For the contract review to be effective, a suitable procedure is required to be established and documented. The responsibility for carrying out the contract review should be assigned to a designated person. The functions to be involved in the review process needs to be objectively identified. For example, for a routine contract review, functions, such as, marketing, design, production, sales, servicing and quality assurance may be involved. In the case of a contract review relating to large projects like major construction projects, turn-key erection of a sub-station, etc, all the functional areas may have to be involved right from the tendering stage. Whenever a change in contract is introduced, the complete review procedure should be followed so that everyone is aware of the change and it is understood. Necessary change notice should be released to all departments and old specifications should be withdrawn. It is also essential that the proceedings of all the contract reviews are recorded properly giving the 6
available in the
Are there proper systems for release and control of the procedures and manual? Is there a procedure for updating these documents? Have you identified the needs for quality plans for various activities of your organization? Where necessary, have you made a procedure for obtaining the customers approval for the quality plans? How do you ensure system? the effectiveness of your
Such documentation may exist separately for various activities of an organization like marketing, design, materials, production, finance, personnel, etc. 42.3 Quality Planning Each organization needs to have detailed planning to implement Quality Systems, meet product quality requirement and monitor the quality improvement activities. These are done through detailed quality plans for each of these activities. These plans draw out various actions that are required to be undertaken at different levels and the system of monitoring the same. The Scheme of Testing and Inspection (STI) which is given to a manufacturer as a part of a licence granted to him under the third party product certification scheme of BIS should be considered as an example for quality plan. This document envisages various quality related activities that the licensee is expected to follow for controlling the quality of the inputs like raw materials, in-process control and the tests that are to be carried out on the finished products to ensure conformity of the product to the relevant standards. Such quality plans may also exist for other operations including personnel management, training, etc. A typical format of quality plans along with explanation of various columns, is given in Annex B.
NOTE - Reference may also be made to IS/IS0 10005.
SP63: 1997
details of the contract review, persons present at the review meeting, findings of the contract review and the actions proposed to be taken as a result of the contract review. The designated person responsible for carrying out the contract review should also maintain a record of contract reviews and monitor the actions arising out of such reviews. Any changes made to the contract should be properly documented and recorded.
Check L&
procedure for organizing a contract review? b) Is there a designated person for carrying out the contract review and for arbitrations, if any? 9 What are the functions to be involved in the contract reviews? d) What should be the form of contract review and what resources are required to be provided for carrying ,out the contract reviews? What are the methods available for resolving disputes? Are the proceedings of the contract reviews documented? Is there a record of all the contract reviews and the actions taken arising out of them? h) Is there a mechanism for adequately identifying the customer needs? j) Is there a formal company standardization activity in the organization? 4.4 Design Control 4.4.1 General
a) Is there a documented
Design control is exercised right through the entire process of design. The major steps in the design process are: a) Design and development planning, b) Organizational and technical interfaces, C) Design input, 4 Design output, e) Design review, 9 Design verification, g) Design validation, and h) Design changes.
4.4.2 Design and Development Planning
e> f,
Design and development planning starts with the identification of all activities in the design process, assigning duties and responsibilities and scheduling them to ensure that the stated and implied needs are met in an economical manner and at the same time, adhering to the time targets. In the case of non-contractual situations, design and development planning should also incorporate details regarding correct identification of cOnstimer needs and expectations. Design and development planningshould be documented and should include various elements, such as, Design, Design calculations, Preparation of drawings, Review of design reports, Verification methods, Safety and regulatory requirements, etc. Design and development planning should also take into account the resources required. Further, design and development planning should be viewed as a dynamic activity and should get modified based on continuous inflow of design inputs or changes taking place in the technology front. It should also address to the training requirements to ensure development of effective designs and their execution.
4.4.3 Organizational and Technical Interfaces
g>
Design is the important process of translating the concepts reflecting the customers needs into concrete products or services. During the initial stages, normally, a proto-type model is developed for evaluating the design. It is necessary to convert the proto-type model into a production model taking into consideration available materials, machinery and other infrastructural facilities so that the ultimate product is economical and at the same time, meets the quality parameters envisaged during the design stage before the final design output is generated and issued for implementation. Value engineering techniques may be applied at this stage to effect cost reduction. Basic quality and reliability is required to be built into the product at the design stage itself as during further stages of production, only the conformance to the design is checked. Design control is the process where the efficacy of design as a function is put to test and enhanced.
7
The Design Department should have active and regular interaction with other concerned departments such as Research and Development, Marketing, Purchasing, Engineering, etc, to take inputs for controlling the various facets affecting the design process. 4.4.4 Design Input Design input forms the basis for evolving the design. It is, therefore, necessary that the design input is exhaustive, and takes into consideration the needs of the purchaser, regulatory requirements and the available resources. Design input should be properly documented in the form of design description document. In the contractual situations, the design input may be provided by the
SP 63 : 1997 purchaser. Contract review carried out prior to the tender stage would go a long way in correctly identifying the design input requirements. In the case of non-contractual situations, the supplier should have a mechanism for identifying the consumer requirements and suitably converting the same into technical terms as design inputs. This should take into account safety, health and other regulatory stipulations as well as any implied needs of the consumers. It may also be worthwhile for organizations to develop their own proformae for the design description document based on their previous experience and the products or services dealt with by them, Every organization should identify the basic standards, criteria for designs, standard components and materials available, etc, and provide them as inputs to the designers to ensure uniformity and economy in designs. 4.45 Design Output Design output forms the basis for executing contracts or manufacturing products or providing services. The design output is always documented and takes several forms as given in 4.4.4 of IS/HO 9000-2. Every organization should evolve a style and format appropriate to the products or services dealt with by them for issuing design output documents. They should be properly identified so as to avoid any wrong use in the execution of the project. The design output documents are used by various functional groups within the organizations to convert design into concrete products or services. It is, therefore, necessary that the design output is given in an explicit manner giving all the details precisely and unambiguously. It should also reflect the totality of design input requirements without losing any of them. The design output, while specifying the parameters, may also give the tolerance limits to ensure verification of ultimate product or service. The design output shall conform to all regulatory or legislative requirements irrespective of their mention in the contract or in the design description document. The design output may be brought out in several documents to enable different functional groups to make use of them in executing the contract or carrying out production operation or providing the services. For example, the design output for procurement of materials may be in the form of purchase specifications to be used by the purchase department or in the form of procedures for the respective departments. 4.4.6 Design Review Design review comprises systematic and critical examination of design output to determine that it 8 meets the design input requirements. The design review may be carried out in a phased manner with a preliminary review at the start of the designing process or at the pre-tender stage, if required followed by intermediate reviews at the completion of the significant stages as it progresses. While doing so, the element of the design review namely producibility, serviceability, inspectibility, ease of procurement, etc, should be taken into account. The final design review may be undertaken after the design activity is completed. The design review activity may be done by a team designated for the purpose. The personnel engaged in design reviews should not have direct responsibility for the design but should be knowledgeable about the same. It is necessary to maintain the record of design reviews and actions taken on the recommendations arising out of such reviews. At the design review stage, it would also be possible for the organization to verify implementation of its policies relating to use of standard materials and components, adherence to correct conventions for drawings and other documentation and application of efficiency techniques like Value Engineering (VE), etc. The design reviews may be made use of to generate information relating to the percentage of standard components used in the new designs and utilize the same to set internal targets for reviewing future designs. Such an approach helps in achieving economy due to rationalization of varieties and enhances productivity. 4.4.7 Design Verification Design verification is an important aspect of design control measures. Design verification is undertaken to verify that the design input requirements have been adequately taken care of in the design output. The design verification activity is required to be carried out in a planned manner and as per the documented procedures. It is, therefore, necessary for the organization to establish design verification procedures and plans and document the same. The method for design verification varies for different organizations and for different designs depending on the complexity of the product or service or design itself. The various methods for design verification include:
a)
Alternative calculations;
b) Comparison with proven designs, etc; Cl Qualification tests; and
d)
Reviewing of design stage documents: 1) Alternative calculations -This is a method to verify the correctness of the original calculations and whether the methods used for design adequately take care of the design input
SP 63 : 1997 requirements. To achieve this, sometimes, a full independent recalculation of the design is carried out and compared with the original calculation or a shortened calculation routine is followed to determine approximate correctness of the original calculations. The organization should have a procedure for carrying out alternativecalculations, if required, and the procedure should be documented. A record of alternative calculations carried out to verily the design should also be maintained. that the product meets the requirements users/customers. 4.4.9 Design Changes Mid-course changes in design are undertaken due to several reasons. Quite often, design changes are proposed after the design output reaches the users within the organization or outside. Internal users of design output include purchase departments who use the design output in their procurement operation, manufacturing departments, quality control departments, etc. The external users of design output are the customers who may get the design output in the form of finished product or service or in the document form as part of a tender or purchase order. Any proposal for a change in design should be considered carefully for its implications in altering the design input and/or output and how they would affect other parameters not contemplated through the design change. It is, therefore, like interchangeability of corresponding parts essential that design changes are performed in accordance with the documented procedure involving persons concerned who are responsible for the original designs. The authority for approving the design changes should be established and should, as far as possible, be the same person who approved the original design. If these procedures are not followed and design changes are carried out in an uncontrolled manner, they could produce undesired results affecting several design output parameters and may ultimately result in not meeting the design input requirements. After the design changes have been approved, if necessary, a review may be undertaken to verify that the design output meets the design input (see 4.4.3 of IS/IS0 !3000-2). The procedure for introducing changes to the design output document should be the same as the procedure established for document control to prevent use of obsolete designs even after the design changes have been effected.
Check :,list -
of all the
2)
Comparison of the design with proven design - When the organization has
long experience in dealing with the items covered by the design or when it has got an access to the products or services of similar nature, comparison of the designs may be undertaken with a similar proven designs. Any unexplained variation should be examined to verify whether they are required to be retained or any modifications are to be made to the original design. All the design verification measures undertaken should be recorded to provide evidence about the correctness of the design to meet the design description document or the design input. Qualification test - Generally, proto-type models are developed at the end of a design process. Proto-type models are subjected to qualification tests to determine the efficacy of the design in meeting the design input (4.4.3 of IS/IS0 !XlOO-2). The results obtained on such tests are recorded and used for design review and improvement, as necessary.
of design stage documents
3)
4) Reviewing
-These documents need to be thoroughly reviewed in order to ensure that all aspects of the design requirements are covered.
Are there formats development planning?
for
design
and
4.4.8 Design Validation After final product is developed, it should be subjected to validation tests to ensure that it meets not only the design specification but also meets the customers requirements. Where necessary, validation tests may have to be carried out on sub assemblies/semi-finished products to ensure that we are on the right track. If a product has multiple uses then multiple tests may be needed to ensure
9
Are there documented procedures for dealing with new proposals for designs? Does the design and development plans assign responsibilities for each activity? Are there proper controls and identification systems for the design and development plans? Are there adequate resources for carrying out design activities?
SP 63 : 1997 Are there formats for documenting design inputs for each project/product/service? Who are responsible for verifying the authenticity of design input requirements? Are there formats for design description documentation? Is there a record documents? of design description
-
Are design documented?
validation
procedures
Are results of the tests carried out included in design records? Are design change procedures documented including proformae for proposing design changes within a time frame? Are the personnel responsible for effecting design changes identified? What are the procedures for verification of the design changes before they are finally accepted? What are the procedures for incorporating design changes in the designs which have been already issued?
and Data Control
Is there a procedure for resolving incomplete/ am,biguous/complicated requirements? Are the national standards used as the basis for design input? Are there standardized inputs to the designers to facilitate uniformity in design output? Are there procedures documentation? for design output
4.5 Document 4.5.1 General
No additional guidance required.
Do design output documents contain verification and acceptance criteria? Do you have a mechanism to ensure conformity with safety, legislative and regulatory requirements in the design output, even in cases where design input has not taken them into account? Are there guidelines for use of standard components in the design output? Does design output comprehensively provide for all the subsequent operations, namely, procurement, receiving inspections and testing, manufacturing, in-process control, finished products, testing, packing, labelling and marking, installation, maintenance, after-sales services, etc? Does design verification form part of the design activities and is it fully established and documented? What are the various activities prescribed for verifying different design activities? Have personnel for design verification activities been identified and are they independent of the persons who have carried out the original designs? Are alternative calculations to be employed for design verification being identified and documented? Are proven parison? designs available for com-
4.52
Document and Data Approval and Issue
control requirement is relevant to all types of documents in design, planning, manufacturing, testing and delivery/installation. These documents may be in the form of manuals, procedures, drawings, work instructions, specifications, technical delivery conditions, testing schedules, test results, etc. The procedure may include methods for preparation of the documents including issuing of amendments/ revisions with the consensus of the users of the documents and data, methodology for implementation and authority for approving the documents and data. By evolving consensus, it is possible to pool the knowledge and experience of the organization and documenting the same helps in their wide spread use. The procedure for identification, issue and control of documents is equally important to enable the task performers to have knowledge of the documents as well as ready access at the place of work. The requirement lays emphasis on the latest issues of appropriate documents to be available at the locations where they are applicable. There are three methods for preparation of documents relating to quality systems within an organization. They are : (a) Committee method, (b) Consultation method, and (c) Combination of (a) and (b). Whatever may be the method employed, the responsibility for preparation and maintenance of documents should rest with an identified department or individual. In the committee method, a core group of experts drawn from various functional areas involved in the use of the documents sit together and prepare the documents 10
The document
Are records maintained for all design verification activities carried out?
SP 63 : 1997 based on consensus. In the consultation method, the designated department or individual consults other interests within the organization and prepares the document which is then circulated to the interests concerned for their views/comments and finalized based on the consensus. The committee method though ideal, takes considerable time. The consultation method, on the other hand, involves less time but does not give the feeling of participation. Therefore, many organizations give preference to a combination of these two methods where the initial document is prepared by the designated department/individual in consultation with other interests concerned and finalized through in depth discussions at a committee meeting. All documents and data should be authenticated by a designated person indicating the date on which the document would come into force. The same authority should have the power to make changes (amendments/ revisions) as well as withdrawal of the documents. The documents should be identified not only by their title but also by a distinct number given to each document. These numbers may follow a significant code or may merely be a serial number depending on the type and size of the organization. It is also necessary to indicate the issue number and the date of issue as well as the amendment/revision status. The document should also contain the name of the issuing department and signature of the designated authority approving the document. When the amendments become sufficiently large, the documents should be re-issued as revised versions incorporating all the amendments. The document and data control mechanisms should ensure that the current issues are available at relevant places of work. The system should have a provision for recall or destruction of obsolete documents so that they are not referred to inadvertently during the manufacturing or other operations. One of the methods used to control is to issue the new versions only after the old versions have been received back by the issuing department. The recall system enables complete removal of obsolete documents from the place of work. It is possible that user departments resort toduplication of documents required, using the original copy supplied to them. This practice may result in copies of obsolete documents remaining in circulation even though the original document has been revised and replaced. To avoid such a situation required number of copies of the documents should be supplied by the issuing department and duplication of the documents at the user end discouraged. It is important that the Quality Assurance Department or any designated department 11 should have a master list of all the documents including proformae so that it is possible to identify the current revision of the documents to prevent use of any obsolete versions. The issuing department should, in addition to maintaining a list of all the documents issued by them along with their revision status, maintain the history of develop- . ment of each document right from the beginning. This would help in understanding the reasons behind specifying or modifying the documents at different stages of processing. It is also possible to classily the documents into two categories, namely, controlled copies and uncontrolled/ information copies. The distribution list of controlled copies of the document should be maintained by the issuing department. This facilitates revision/servicing of the limited number of copies which are issued as The responsibility and controlled copies. mechanism for making available the revised documents at the place of work needs to be clearly identified in the system. The effectiveness of the system should be verified by means of periodic internal quality audits. 4.5.3 Document and Data Changes It is to be recognized that the documentation and data requirements within the organization may need to undergo review and changes. These changes may be necessary for various reasons, such as, a) b) c) d) e) Changes in technology, Changes in design, Feedback arising out of implementation, Changes in degree of control based on the performance reviews, and Changes in customer/purchaser requirements.
All changes to the documents and data should be made in writing with proper identification and processed with the approval of the authorized personnel in a manner which will ensure prompt action at the specified working point. Records of revisions/ amendments should be maintained in a chronological order. Written notes on documents are not acceptable unless they are issued by the designated person working to an established procedure. Procedures have, therefore, to be laid down for review/revision of documents and effected with proper approval. One of the common ways may be to have an approval authority, the same as the one who originally formulated the document. Alternatively, there may bc a group or committee representing concerned sections of the organization to review such documents. There should be a provision for periodic review of all documents even when there are no comments on them from the user departments.
SP63: 1997
Check list h) Supply of Test facilities and providing technical expertise in areas where needed.
a) Is there a written procedure for the issue of

new documents (drawings, procedures, instructions, quality plans, quality manual, etc)?
4.6.2 Evaluation of Sub-Contractors Ultimate customer @urchaser) - The persons or organization who will be buying goods or services from outside agencies or suppliers. The ultimate customer will directly use the material without carrying out any further operations on it. SuppZier - The organization which will supply material to the final customer. This organization may manufacture the product completely by themselves or may partly manufacture and partly buy from sub-contractors and assemble the final product before delivery to the customer. Sub-contractor - The organization which will supply raw material, parts, components or sub-assemblies to the supplier. These organizations are mainly specialized dealing with specific material, parts, components, etc, and are able to produce these for the supplier as per suppliers specifications or as per national or lnternational Standards. Sub-contractors should be selected on the basis of their ability to meet the following requirements:
b) Is there
identification
a written procedure of documents?
for
C> Are the distribution
lists for controlled copies of the documents available?
Are documents essential to the accomplishment of a work available at the place of work? the history of development maintained?
4 Are master copies of documents along with
f)
Is there a master list of documents indicating the latest status?
4.6 Purchasing 4.6.1 General Purchased material, components and assemblies form an important part of an organizations product and directly affect the quality of its end product. The purchasing activity should be properly planned, controlled and executed in a systematic manner. At the outset, the sub-contractor should be made aware of the suppliers quality requirements in detail, to build a clear understanding of each others needs. Close working relationship should be established with each sub-contractor and regular feed back should be given to the sub-contractor on the quality of their supplies. Regular feed back will ensure a continuous improvement in supply quality and at the same time, also avoid any disputes regarding quality at a later stage. Sub-contractors should be given training in areas like SQC, productivity, etc. All the above shall also apply to the purchase of services like calibration, transportation, etc. The procurement quality programme include the following elements: should
a) Quality requirements.
b) C)
Technical requirements (facilities like machinery, tooling, skilled manpower, etc). Commercial /Financial requirements. Delivery schedules. the
d) e) Requisite
capability to deliver quantities ordered by the supplier. Requisite requirements
capability to translate into products or services. the
There are a number of ways in assessing suitability of a sub-contractor:
a)
b)
a>Selection
Cl
d)
e)
9
g)
of qualified sub-contractors. Regular monitoring of sub-contractors quality and their training. Requirements for specifications, drawings and purchase orders. Agreement on verification methods and Quality Assurance. Provision for settlements of quality disputes. Receiving inspection plans, controls and quality records. Procedure for addition and deletion of vendors based on their performance and assessment. 12
If a sub-contractors quality system has been approved by other bodies like Defence organization, Export Agencies, BIS, etc, then this can be used as a starting point for evaluating a sub-contractor for ability to meet supplier requirement. demonstrated capability and performance in supplying the same or similar kind of product. For this, it is essential that a detailed record of past supplies and their quality status should be maintained by which it will be possible to evaluate the quality capability of a sub-contractor. These records should contain details of (a) Quantity supplied (b) Quantity rejected, (c) Adherence to delivery schedules, and (d) Share of business vis-a-vis other sub-contractors for similar parts.
b) Previously
SP 63 : 1997 c) Sub-contractors capability may be evaluated by means of a visit to their plant to assess the technical capabilities, quality system in operation, commercial procedures in operation and capabilities of personnel working in the plants. In case none of the above methods can be used, products being manufactured by sub-contractor may be subjected to detailed testing for evaluation purposes. all documents referred to in the purchase order should be clearly mentioned. Where technical requirements., drawings, inspection procedures, etc, are referred to, it is essential that the documents are identified by their document number to remove any cause for confusion. Detailed quality requirements should be stated on the purchase order and any intermediate inspection requirements should be shown as hold points on the purchase order/inspection instruction sheet. Hold point is that point in the manufacturing process beyond which the sub-contractor may not proceed further without the explicit permission/clearance of the supplier (for example, Testing of welds on pressure vessel before cleaning for further operations). Copies of test certificates to be submitted by sub-contractor should also be stated on the purchase order. The supplier should thoroughly review the purchase order before release for correctness and accuracy and the authority of the person carrying out this task should be clearly established. Any amendment to the purchase order at a later date should also be preferably reviewed and authorized by the person who had released the original purchase order. A system to ensure the prompt and clear communication of such modification/changes to sub-contractors should be established and implemented. For example, a sheet metal component being manufactured by a deep drawing process. This requires use of extra deep drawing (EDD) quality CR sheet. This is usually specified as CR-EDD sheet of x thickness. Now, when placing the order, if we forget or omit to put the letter E and mention the specification as CR-DD sheet, this supply will fail during production and the material will go as a waste. If the order is reviewed by a person who knows the specifications well, then he will be able to detect the mistake and correct the same. Therefore, it is necessary that specifications are correct and it is reviewed before release of purchase order. Most of the companies have their own method of verifying the purchase order before release. 46.4 Venjication of Purchased Product The system of verification of the product being supplied by the sub-contractor should be clearly stated on the purchase order. The verification system should be agreed to between the supplier and sub-contractor before finalizing the purcha-e order. Any of the following methods may be used for verification of the purchased product: a) The supplier relies on the sub-contractors quality assurance system.
d)
Whatever may be the basis on which selection of the sub-contractors is done, the same should be documented properly and backed up by proper records. The supplier should maintain a list of approved sub-contractors and the list should be backed up by sufficient data on each sub-contractor to justify his selection. If a sub-contractor cannot be found who meets all the required criteria and some minor deficiencies are observed, then these should be brought to the notice of the sub-contractor and all efforts should be made to have the deficiencies removed. This is all the more true in the case of system deficiencies like lack of procedures, non availability of records, etc. Sub-contractors should have appropriate method of ensuring the quality of the material being procured from outside. Periodic assessment of sub-contractors performance should be carried out to ensure that they are maintaining quality standards and requirements as laid down. Large organization should have a formal system of sub-contractor quality assurance and assessment as a part of purchasing/Quality Assurance department. A separate team should be formed to audit and monitor the performance of the sub-contractor periodically. The activities should be recorded properly and should form a part of the data used for maintaining approved sub-contractor list. Suitable provision should be provided in the system for addition and deletion of vendors based on their performance. 46.3 Purchasing Data The suppliers purchasing data should define the complete technical requirements to ensure the quality of the procured product or services. This data must be properly communicated to the sub-contractor and most importantly he should understand the requirements completely. All test methods and technical requirements should be made in reference to appropriate national or International Standards. The status of 13
SP 63 : 1997
b) The sub-contractor
submits inspection test data and statistical process control records. by the
4 Are records of assessments and selection
100 percent inspection/testing supplier at receipt stage. at receipt stage.
0 8 h) j)
d) Sampling inspection/testing by the supplier
e>Inspection
at sub-contractors end before inspection at despatch or stage sub-contractors end. Any third-party certification agencies like BIS, etc. operated by
The supplier must clearly indicate on the purchase order to the sub-contractor if the ultimate customer will be carrying out any verification activity at sub-contractors premises. The sub-contractor should provide all facilities and records to aid verification. The level of verification activity should be commensurate with the kind of product being verified. The standard makes it clear that the supplier cannot take shelter behind any verification carried out by the main purchaser at sub- contractors end. The final responsibility of delivering a quality product to the purchaser lies with the supplier and not the sub-contractor. The agreement on verification procedures should include provision for exchange of inspection and test data with the aim of furthering quality improvements. Reaching an agreement on verification procedures will minimize difficulties in interpreting the requirements as well as inspection, test and sampling methods. Suitable systems and procedures should be established for settling of all disputes regarding quality with sub-contractors. These procedures may include routine and non routine matters. A good communication channel and regular interaction between the supplier and the sub-contractor should be established on all matters relating to quality.
Check list
k)
m>
n)
PI
9)
criteria of all the sub-contractors being maintained? Is there an approved list of sub-contractors based on the assessment made? Are periodic assessment of sub-contractors carried out? Has the level of quality verification activity been fured? Has it been determined where the verification activity is to be carried out? That is, at sub-contractors end or at the suppliers end? Is it ensured that product specification is complete? Is it also ensured that all drawings, specifications, etc, are clearly identified? Does the purchase order clearly state the quality standards to be used? Does the purchase order contain complete details of the inspection requirements and tests to be carried out by the sub-contractor? Is there a system for review of the purchase order and is it established who will review the purchase orders before release? Product
4.7 Control of Customer-Supplied
Customer-Supplied material is usually called Free Issue material and the purchaser has full responsibility for ensuring that the supplied material fully conforms to the requirements. Examples of these are: a) Supply of cut pieces by garment manufacturers to tailors for stitching into complete dresses. b) Supply of yarn by textile manufacturers to processing mills for conversion into cloth. Cl Supply of raw material like sheet, bar stocks, etc, for conversion into required parts/ components. d) Supply of certain critical part for incorporating into a control system. e) Supply of special bins, racks, etc, to subcontractor for storage and transportation of material from sub-contractor to supplier. From the above examples, it is seen that the quality of the end product will depend on the quality of the material supplied by the customer. The supplier has the responsibility to ensure material received is free from damage occurring during transit, and is adequately identified. Suitable provision must be made for storage and handling of this material while in his possession, keeping in mind that this material is the property of the purchaser. 14
a) Is there an established criteria for selection b)
of sub-contractors? Does the criteria include the subcontractors ability to meet quality requirements? What is the method used to evaluate sub-contractors ability to meet the quality requirements?
C) 4
Does the evaluation procedure of sub-contractors allow for assessment based on component criticality?
Supplier should develop procedures to ensure that material is inspected on receipt for damage and correct quantity as well as the correct identity of material. Any non-conformance should be immediately notified to the purchaser. Suitable steps should be taken to prevent deterioration during storage; for example, paint tin when stored for considerable period of time should be shaken to prevent the paint from hardening or solidifying. Care should be taken to prevent unauthorized usage or disposal. If the purchaser supplied product is a service like transport for delivery, the supplier should make sure of the suitability of that service and the maintenance of its effectiveness. Documentary evidence, where appropriate, should be maintained that this is being done. The purchaser should give all information concerning the correct usage and maintenance of the product supplied and should also ensure that the correct material has been supplied. Suitable procedures should be laid down which will detail the controls necessary and also establish a recording system to demonstrate that material was received in a satisfactory condition, identified and was maintained in a satisfactory condition. Procedure should be established for action to be taken in the event of defects being detected in such material. No rectification action should be taken. The purchaser should be immediately informed of all such defects for resolution.
NOTE --All the above steps are also applicable in the case of material supplied by the supplier to sub-contractor.
unique identification of a particular product or service or groups thereof. While categorization helps to correctly identify the product or service to facilitate handling and use, unique identification helps in tracing back to the records for the purpose of identifying the materials used in the manufacture, process/operations involved, test results, etc. The first type of identification may be through colour coding; for example, identification of class of steel tubes, such as, light, medium, heavy and by means of colour bands of yellow, blue or red respectively. Similarly, some organizations use green or red labels to identify conformity or otherwise of the product to the stated requirements. Unique identification helps in tracing back the history of the product or service and may be given in the form of a serial number, batch number, date of manufacture, etc. The principal reasons for maintaining product identification and traceability are enumerated below: Provide identification to avoid mix-up of products. b) Assure that only materials and components meeting the specified quality requirements are used in the final product. 9 Assist in failure analysis and enable corrective actions to be initiated. d) Provide for recall of products from the field in the event of non-conformity/complaints. Enable adopti.on of First In First Out (FIFO) principle for issue of items where shelf-life matters.
a>
e>
Check list
a>Has a procedure
been established for proper identification of Free Issue material at goods receipt and through out the process till the final product is made?
b) Has a procedure
been established to determine the level of checking required when the material is received? and maintenance of material?
C> Has proper provision been made for storage
(9
Are the steps to be taken identified, in the event of non-conformity being detected? adequate steps been taken to ensure that non-conforming material is not used without customers instructions? and Traceability
e>Have
4.8 Product Identification
Identification can basically be of two types. They are categorization of products or services and
Depending upon the nature of the product and its application, the product identification and traceability requirements have to be provided for in a documented quality system. Identification requirements are to be stipulated where appropriate by the supplier. For example, in a pressure vessel or boiler manufacturing operation, it may be essential to identify each piece of plate or forging used for manufacture to the full requirement of the material specification. Further, the identity may have to be maintained in the form of transfix labels or identification tags during all stages of production. Similarly, for a drug industry, the importance of this requirement of product identity and traceability is very critical. Whenever a batch is to be formulated, a lot number should be assigned and a document created to correlate all associated data including input materials, process variables, etc. This lot number is to be carried through into the packaging so that each strip, bottle, cartons carry the lot number. 1.5
SP 63 : 1997 On the other hand, in the work, the raw materials may be verified only at maintaining the identity inprocess and final stages case of a light fabrication like plates and sections, the receiving stage and of heat numbers during may not be necessary. Preventive maintenance of equipment/ machines at regular intervals
In order to have control over all the factors which affect the process, the following aspects must be kept in mind: a) b) c) d) Work instructions/operating
also 4.2),
Whatever may be the mechanism of identification, it is important that all the relevant records should clearly contain the identification and marking details for traceability.
Check list
procedure (see
Close monitoring, Process approvals, and Acceptance standards for workmanship.
a) Are adequate procedures

identification of the product? traceability of important method of identification?
employed
for
Work instructions (see also 4.2)
b) Are there instructions for describing the

items and the
C> Are there procedures for rechecking and

reidentification in case the markings get obliterated during handling? 4.9 Process Control 4.9.1 General A process is a series of planned and systematic actions needed to be undertaken to achieve or attain a target (goal). Any process contains many sources of variability. The differences among the product turned out by the process may be large or small, but they are always present. For example, the diameter of a machined shaft would be susceptible to variation due to machine, tool, material, operator, maintenance and environment. It is essential that these3riations are kept within limits and therefore, control over the process is necessary. Lack of control can cause the product to go out of specification limits into rejections and scrap. Control on the process is essential to meet the contract, drawing and specification requirements and these have to be identified during the contract review stage itself. A proper manufacturing programmewill have to be established to ensure all items are produced under controlled conditions. A few important requirements of this programme are: Fix the limits and standards. Assessment of process capability. Measure process. the actual performance of the
Depending on the kind of process, it should be determined whether work instructions are required or not. These instructions may be in the form of written documents, visuals, drawings, computer menu operations, models, oral instructions, etc. These instructions will help to guide the operator about what is to be done and the level of workmanship required. The instructions should be simple, and easily understandable by the clear, operator who reads it. Satisfactory work instructions need to cover the following: a) What is the activity to be carried out?
b) C) d) 9
The correct sequence of activities Correct identification of material to be used Tools and equipment completion of the activity needed for
e) Test equipment needed

Requirements for operational checks, calibration and set-up of the equipment
g) Precise methods of inspection h) Reference standards including regulatory

requirements with to be followed and complied like etc,
j) k) m)
Environmental conditions temperature, humidity, cleanliness, necessary for carrying out the activity
Criteria for acceptance of the product resulting from the activity carried out Sampling techniques criteria and related decision
Work instructions should be issued for such specific functions and jobs which have a direct bearing on quality of product/service. Work instructions should also be covered by document control procedures (see 4.5) and a complete record of all work instructions prepared should be maintained. One factor which is to be kept in mind is that all important specified requirements should be translated into clearly understandable work 16
Compare the results with the above limits and standards. If results are out of limits, take necessary corrective action to bring them within limits.
SP 63 :1997 instructions work. without generating excessive paper Acceptance standards The standards required for all the processes should be clearly defined. Wherever possible these should form a part of the work instructions so that the operator is clear about the standards that need to be achieved. Wherever it is not possible to clearly state the standards in writing then physical samples or photographs may be made use of. For example, for a quick check on the shop floor, an approved sample of the finished piece may be kept with the operator, who can then compare the pieces he is producing with the sample piece before removing it from the machine. The acceptance criteria should be available at the point where the process is carried out and the same criteria should be available to the inspection staff in order to ensure that all follow the same acceptance standards. 4.9.2 Special Processes These are processes, the results of which cannot be fully verified by subsequent inspection and testing of the product and where, for example, processing deficiencies may become apparent only after the product is in use. Accordingly, continuous monitoring and/or compliance with documented procedures is required to ensure that the specified requirements are met. The frequency of checking the control parameters should be such that the processes would meet the specified requirements. Special processes are mainly of two categories: a) Production and installation process: i) Welding ii) Casting iii) Forging and forming iv) Plastic and wood fabrication v) Chemical mixing vi) Heat treatment vii) Painting and protective coatings viii) Brazing, soldering and impregnation b) Inspection and testprocesses: 0 Radiography ii) Ultrasonic testing iii) Pressure testing iv) Surface flaw detection v) Temperature and humidity cycling
Close monitoring Close monitoring of the process is essential in order to have effective control over it. For close monitoring, the following need to be done: a) b) c) Carefully select the characteristic monitored. to be
Define the limits clearly for characteristics which are to be monitored. Take prompt corrective action when any of the characteristics go out of limits.
In most cases monitoring of the production and installation process will need to be done either by process monitoring or product characteristic monitoring or a combination of both. The quality system procedures should clearly mention which of the above has been selected for each process and should also mention the corrective action to be taken in case of nonconformity. Monitoring process characteristics have certain advantages. Changes in the process leading to nonconformity of requirements, can be detected earlier and errors can be controlled to the minimum. This will result in better economics due to fewer rejections. The relation between process control and the final product quality requirements is a very important one and needs to be established at the beginning itself and the same should be communicated to all personnel in production and inspection. Proper records of the implementation of the above controls and requirements should be maintained. Process approvals Once the process specifications have been specified either by the purchaser or the supplier, procedures should be established to demonstrate that the process and equipment are capable of achieving and maintaining the specified tolerances. Process capability studies are one of the methods for achieving this objective . If the contract specifies that some of the processes to be used need the approval of the purchaser, steps should be taken to identify all such processes and get prior approval before commencing these processes. Another important aspect of the process approval is the qualifications of the operator. There are many processes the results of which are dependent on the skill and training of the operator. All such processes must be identified and it should be ensured that the operators working on these processes have the necessary level of qualification, skill and training (see 4.18). 17
Example : Consider the case of a forged crankshaft. The forging is carried out at high temperatures and pressures to ensure proper distribution of material and correct grain flow . If the temperature and pressure are not as specified, then the grain flow will be affected; but, this will not be detected by regular inspection and testing. Grain flow can only be detected by destructive testing. Hence, strict
SP 63 : 1997 process controls and monitoring are very essential to ensure the quality of the forging. Further after machining of the crankshaft it is subjected to induction hardening on the journal areas. After induction hardening, it is tempered to remove internal stresses of hardening. Inspection of these pieces will only tell us that the hardness achieved is within limits. They would not confirm whether other important aspects/parameters as given below, were under satisfactory control:
P) Are
n)
procedures established for taking prompt corrective actions for all nonconformities? Are there procedures for maintaining all processes and inspection records? processes separately identified?
0 Are the special
S) Are qualification procedures established for

special processes which need them?
a) b)
Cl
Current at the electrodes. Temperature achieved. Time for which the crankshaft was subjected to high temperature. Quality of quenching water. Calibration of the various instruments used in the process.
t)
Are there suitable procedures for regular maintenance and calibration of all equipment used in process control and monitoring?
U) Are the operating persons suitably qualified

and trained as necessary?
d) Quenching water bath temperature.
e)
f)
-9
Are the records of the process control and calibration available readily for verification?
The only way to verify that the requirements were met at all stages is through the use of process control documents and charts. This will provide evidence that process control norms were met and give confidence that the final product quality can meet the required specifications.
Check list
4.10 Inspection and Testing 4.10.1 General Inspection and testing activity should be planned and detailed procedures should be drawn up for carrying out the activity so as to give the customer the confidence that the item or product being manufactured will meet the specifications. The extent of planning will depend on the type of item or product being produced. The following points should be kept in mind when preparing inspection procedures: a) b) c) d) e) f) The documents should identified and controlled. be uniquely the
a>Is
there a procedure for identifying, approving and controlling manufacturing/ installation process which has a bearing on product quality?
b) Are the controlled conditions specified for Cl

these processes? Are there procedures to ident@ which of the processes require work instructions? work instructions for their completeness?
The product or contract to which procedures apply should be identified.
d) Is there a procedure to check and verily the
The various stages at which the procedures will apply. The personnel procedures. The characteristics who will use these
e) 9
Has the acceptance specified?
criterion been clearly
Have you ensured whether all work instructions are covered under document control procedures? updating the work instructions?
to be inspected.
g) Is there a mechanism for reviewing and
h) k)
Have all the process characteristics that need to be monitored been clearly identified? How are stipulated? the workmanship criteria
Procedure of inspection to be carried out (sampling or 100 percent). If sampling inspections is to be done then the sampling plan to be used should be stated in the procedure. Criteria for acceptance. The kind of information to be recorded and systems for maintaining records.
g) h)
ml Have
you ensured that the equipment/ machine available is compatible and suitable for the process selected? and responsibility established for the acceptance of a product? 18
n) Is the authority
Although it is expected that inspection and testing will be carried out by inspection personnel, verification activities may be carried out by the operator themselves provided they have been trained for it and are authorized to do so. However, when operators have been authorized to inspect the
SP 63 : 1997 items, it is necessary to ensure that the operators have all the resources available for carrying out the verification activity. In planning for inspection, a balance will have to be struck between various activities like supply source inspection (at sub-contractors end, wherever relevant), receiving inspection, in-process inspection, final inspection, etc. The level of activities will depend on the kind of quality the customer is expecting and the resources available with the organizations. 410.2 Receiving Inspection and Testing There are many ways of ensuring the quality of products received from sub-contractors. These have been described in 4.6. In general, it is better if we carry out as much of the verification activities as possible close to the source of production so as to reduce the possibility of nonconforming products being procured. Receiving inspection activities should not duplicate the inspection activities being carried out at the source of production but should be complementary to it. Records are an important part of inspection activities. These records should also include all material test certificates and inspection reports which need to be given by the sub-contractors. The quality system should ensure that the material is not released for production and quarantined till all necessary certificates have been received and all the inspections have been carried out. If it becomes necessary to release the material for production due to urgent requirements then steps should be taken to positively identify the same so that the finished product can be traced and recalled, if necessary, at a later date/stage. 410.3
In-process Inspection and Testing
the specified requirements. For this, it is necessary to ensure that all receiving inspection, process. control checks and in-process inspections have been carried out and records are available to prove that the results of these checks are satisfactory. When the product is a complex one, involving a number of operations, the activities are many and therefore, these activities have to be planned properly to ensure that inspection activities run concurrently with the production process. This will help to complete the final inspection process quickly and all necessary data will be available for verification at the final inspection stage. When various components or sub-assemblies are being assembled into a larger product then it is imperative that each of these components or sub-assemblies are treated as a final product since they may not be accessible for inspection separately after assembly. The stages where components start getting assembled into sub-assemblies or final assemblies, can be treated as hold points to ensure that these items are checked properly before clearing for assembly. These hold points are independent of customers hold points. The quality system should ensure that a product does not get despatched until all activities specified in the quality plan are completed. Further the system must be able to collect all the results of activities affecting quality so that they can be reviewed immediately after production of final product is complete. Whenever a deficiency in the product is noticed, the Quality Assurance Department should have the freedom and authority to discuss the same with the purchaser and resolve it to the satisfaction of all. But on no account should any deficient material be despatched without the explicit permission of the purchaser. 4.10.5 Inspection and Test Record
These records are essential to demonstrate to the purchaser that not only has the product quality been achieved but has been maintained at various stages of production.
Similar to receiving inspection, detailed plans and procedures should be prepared for in-process inspection also. The level of inspection should be sufficient to ensure that the product meets specified requirements. Records of these should be maintained as evidence that inspection and testing has been carried out. The inspection activities should be supplementary to the process control activities that may be in place. If any hold points have been specified by the customer then suitable provision should be made in the system to ensure that the production does not proceed beyond this point and customer is notified accordingly. 410.4 Final Inspection and Testing Final inspection is the activity which is carried out to determine a products overall compliance with 19
The type of records will vary from product to product and operation to operation. However, the record should contain all the essential data required for ensuring product quality. Some guidelines are given below on the kind of information to be recorded on inspection reports: a) b) c) d) Component, sub-assembly or product inspected. Characteristics inspected. Reference inspection procedure sheets. Reference standard (Company Standard, National Standard, International Standard, etc). Results of the inspection or testing.
e)
SP 63 : 1997
t)
g) h)
0
k)
Decision (Whether accepted or rejected). Name and designation of the persons who carried out the inspection. Authority for final acceptance (If other than inspector). Date on which inspection was carried out. Any other information used during inspection/evaluation.
which will carry out all the activities of planning, calibration, and maintenance of records for all instruments and gauges in the factory. Neglect of these activities can lead to loss of confidence in product or service by the customer. The maintaining of records will also help to assess any variations in equipment performance and take decision on maintenance, repair and replacement. 4.11.2 Control Emcedure
Check list
a) Are
all planned?
inspection
and
test activities
b) Are all necessary resources available for

carrying activity? out the inspection and test
In order to ensure compliance with the requirements of the standard, a number of steps are required to be followed. Some of these essential requirements have been dealt with as given below:
a>It is very
C) Are all inspection and test activities carried

out as per established procedures?
d) Are there suitable measures to prevent

nonconforming production? material being released for
e>Are
there procedures to ensure recall of material released without inspection and later found defective? of all inspection results
f) Are records
maintained?
i-9 Does inspection
procedure provide for identification of equipment to be used for checking the characteristics? chaser wherever hold points are specified?
essential to identify the type of measuring equipment that is needed based on the following: 9 What is thekind of measurement to be carried out? ii) What is the accuracy required? iii) What is the degree of precision required of the equipment? iv) What are the conditions under which the measurements will be made? v) Who will carry out the inspections? of the vi) Any special requirements purchaser or contract?
h) Are there procedures to inform the purj> Does the final inspection procedure provide
for a review of all preceding inspection and test activities?
Addressing these questions at the planning stage will ensure that the right equipment is selected for each measuring activity. It is also necessary to clearly define the responsibility for the control, calibration and maintenance of the equipment to ensure the accuracy of the equipment at all stages and times of use.
Are there suitable measures to prevent despatch of finished product till all documentation and authorization are complete? authority clearly specified?
b) Having identified
ml Is the final acceptance
4.11 Control of Inspection, Measuring and Test Equipment 4.11.1 General All measurement activity undertaken by us will be effective only when the results are known to be sufficiently accurate and valid for the purpose it is intended for. When we plan for a measurement facility we have also to plan for the selection of suitable equipment, proper instructions for its use, the availability of skilled persons to carry out the measuring activity, and calibration of the equipment from time to time. The general practice in industry is to have a separate metrology laboratory or Standards Room
20
the equipment, it is necessary to maintain a list of all equipment containing all the details about the equipment. The register should also contain details about the calibration of these equipment and the measurement standard against which these equipment have been calibrated. The calibration of these measurement standards should be traceable to national or international measurement standards and appropriate certificates certifying the same should be available on record. Where an equipment is not used frequently, it would be better to calibrate the equipment prior to use to remove any doubts or error. In such cases, this should be indicated on the equipment through suitable means; for example, suitable stickers. The register used for maintaining the details of the equipment should also
SP 63 :1997 record the location of each equipment so that it is possible to recall the same when recalibration has to be carried out at designated intervals. Documented procedures must be prepared for the calibration of all measurement standards. and equipment. During the preparation of procedures, manufacturers written instructions may be used as a part of the procedure. The extent and details of procedure will depend on the type of equipment, but in general the procedure should cover the following areas: manual and should ideally be available in the Standards Room for easy reference.
d)
c)
During the planning stage for selection of measuring equipment, an important factor that must be kept in mind is the accuracy and precision of measurement required as per the design of the item to be measured. This can easily be identified at the design review stage itself. proper identification of the state of calibration of all measuring equipment is very essential in order to prevent the use of uncalibrated equipment. This can usually be done by a tag, label or sticker. The essential features of this identification system is that it indicates when the equipment was last calibrated, what was the accuracy of the instrument and when the next calibration is due. It will also indicate if there are any specific restrictions on the use of-this equipment.
e>The
9
ii)
iii) iv)
v) vi)
vii) viii) ix)
The type or class of equipment which the procedure covers. Identification of all accessories and standards to be used for performing the calibration. Detailed instructions for carrying out the calibration. The type of calibration data to be recorded and methods of tabulating the same. The environmental conditions in which the calibration is to be carried out. The time period required to stabilize the equipment in the above environment. Actions to be taken if the equipment calibration is not satisfactory. Frequency of calibration. Issue number and date of issue of procedure.
fl
The frequency of calibration will depend on the type of equipment and the amount of use it is subjected to. The following guidelines applicable to a typical automobile component manufacturer may, however, be useful: Frequency Type of Equipment 2 months Micrometer, verniers and length measuring devices Plain ring and plug gauges 3 months 4 months Screw gauges 12 months Slip gauges 2l3 months Pressure gauges 6 months Qualifying gauges The frequency of calibration for electrical and electronic instruments such as multimeters, frequency meters, voltmeters and milli-amperemeters is usually one year. However, individual firms should fix their recalibration intervals. The procedures for all the gauges, equipment, etc, can be kept as a procedure 21
Detailed records will have to be maintained as these are the only objective evidence that the measuring equipments are in a known state of calibration. These records also give us a history of the calibration of a device. The extent of information to be recorded will vary from instrument to instrument; but, as a general guideline, recording the following information will be useful: and identification of i> Description equipment. ii) Date of introduction/issue for use. was iii) Date on which calibration performed. iv) Results of the calibration. v) Planned calibration interval. vi) Permissible limits of error. vii) Reference to calibration procedures. to establish viii) Source of calibration traceability. conditions during W Environmental calibration. of any maintenance, xl Details modification, adjustments, etc, carried out on the equipment. xi) Limitation in use. inspection results of product(s) should be assessed if any equipment is found to be out of calibration. When such a situation occurs the following actions should be taken: i) Examine the records of the last calibration and if possible revalidate the same.
s>The validity of previous
SP 63 : 1997 ii) Confirm that the inaccuracy has occurred only after the latest calibration. iii) Where possible recheck the product features measured with the out of calibration equipment. If any product is found to be out of specified limits then immediate actions should be taken to isolate 311 such nonconforming products. iv) Assess the possible effects of the nonconformance on the final quality of the product. v) Reappraise the frequency of calibration for this particular equipment. In order to help in back tracking the product measured by out of calibration equipment, the quality system should have 3 suitable procedure to identify the measuring and test equipment used for inspecting critic31 parameters of 3 product batch and where these parameters will have 3 major bearing on the final quality of the product. However, in doing this, consideration should be given to the way in which this can be accomplished easily and economically.
k)
Once the measuring equipment and test facilities have been calibrated steps should be taken to prevent any tampering with them. This is also applicable to any computer software which may form part of the equipment. The level of protection will vary and should generally be determined by practice 3s required. All jigs, fixtures and software that are used for verifying product acceptability should also be protected against tampering and should be checked prior to release to production. They must also be periodically rechecked to verify their calibration status.
The purchaser or customer must have access to 311measurement and calibration data to verify that the equipment is functionally adequate for fhe job it is being used for.
Check list
Have the characteristics to be measured been clearly identified? Have the selection and availability of test equipment been planned properly? Are 311 equipment covered under calibration procedures? Are 311equipment identified properly and their details recorded? Do the system procedures ensure that new equipment is calibrated before release for first use?
h) All measurements
are to some extent affected by the environmental conditions under which they are carried out. Environmental conditions like temperature, humidity, dust, etc, will affect the calibration and the measurement carried out. However, these problems can be overcome to 3 certain extent by selecting the equipment which is having considerably higher level of accuracy than the tolerance of the characteristic to be measured. Further, most of the equipment manufacturers provide charts indicating the error compensation to be provided in the measurements when these are made in conditions other than standard conditions specified. These error compensation figures can be used to adjust the measured values. quality of the products and hence, should be handled, transported and stored so as not to cause any damage to them or cause them to loose their calibration. The performance of the equipment may be impaired by careless use, exposure to extremes of humidity, temperature, vibration, dust, etc. These factors should be kept in mind when developing procedures for control and maintenance of measuring equipment.
22
f) Are 311calibration standards that are being

used traceable to internationally nationally recognized standards?
or
g> Are there detailed calibration procedures

available for 311 measuring use? recalibration of equipment? equipment in for
h) Are there suitable recall procedures
j> Is the frequency of recalibration fixed? k) Is the status of calibration suitably identified
on the equipment?
j> All measuring equipment are critical to the
ml
Are records of 311 calibration done maintained and available for verification? equipment usage be traced to the product batch checked? conditions 3s appropriate for the
n>Can the
PI Are necessary environment31

being maintained equipment?
4) Are suitable handling and storage facilities

provided for 311equipment?
f) Are suitable
steps taken tampering of all equipment?
to prevent
SP 63 : 1997 4.12 Inspection and Test Status Measures should be established to provide for the identification of an item to ensure segregation between inspected and uninspected materials. Where an item has undergone inspection, the means of identification should be such that distinction is made between the materials inspected and conforming; inspected and rejected; inspected and found nonconforming; and requiring repairs/rectification. The omission of any particular inspection or test from the planned inspection stages may result in an uninspected material or material of unacceptable quality proceeding to the next stage. Therefore, it is essential that requisite control procedures are established to identify the inspection status of materials during all stages of production. Special emphasis is to be laid here to explicitly identify materials which are under hold awaiting decision or have been rejected and ought to be scrapped. The identification on the materials for this purpose could be in the form of details on the traveller sheet moving with the job or by way of colour coding or tagging/labelling or etching or by using segregated areas of storage. The identification of the material should begin right at the incoming stage where the materials are received. The correlation of the test certificates with the material and successful completion of verilication activities enables the material release for further processing which should be accompanied with suitable markings to indicate the acceptance status. In case of raw materials, one of the methods could be colour coding with different combination indicating grades of accepted material. Another method could be of allotting Stores Receipt Voucher numbers or any other form of code numbers. The essential part is to maintain identity of ?he material having been accepted as well as ability to correlate the same to the test certificates. For identification during in-process stage, the commonly used method is to indicate the inspection status of the material on the route card/process card/traveller sheet with initials and date by the authorized person on the stage which has been inspected and cleared. Wherever details on the process card/route card/traveller sheet are being used as a means of identifying the inspection status of a material, it is essential that either the card accompanies the product during the entire stage of manufacturing or some other positive identification is provided on the product to correlate the same with the process/route card. For the identification at the final stage, one way could be to colour code the items using green colour for accepted material, red colour for
23
material rejected and yellow colour for material under hold. Another commonly used method of identifying the inspection status of a finished product is by putting authorized inspection stamp on a specific location of the material signifying final acceptance of the product.
Check List
Has the supplier established and maintained a system for identifying the inspection status of material during all stages of manufacture? b) Is the system able to distinguish between inspected and uninspected material by some suitable form of identification? C> Who is responsible for ensuring that identification of the status of the material takes place? 4 When and where will the identification take place? What method of tracing status records will be used? 0 Have you ensured that any transfer of identification of status or change of status is verified by the nominated quality control representative? g) Are the systems employed for indication of inspection status effective? h) Is the system capable of readily identifying the materials rejected or nonconforming and under hold?
a)
e>
4.13 Control of Nonconforming 4.13.1 General
Product
IS/IS0 8402 provides clear distinction between a nonconformity and a defect. Nonconformity is the failure to comply with the specified requirements; whereas, the defect is defined as the failure to meet the intended usage requirements. The intended usage requirements may be included in the specified requirements. In the context of this standard, the extent of conformance to the specified requirements is dealt with here. Nonconforming product or service may occur anywhere during production process. It is, therefore, essential for a suppliers organization to develop and establish a procedure which would preclude dispatch of such nonconforming products to the purchasers or consumers. In addition, the control procedure should also ensure prevention of inadvertent processing of nonconforming product. 4.13.2 Review and Disposition of Nonconforming Products
The control procedure
should cover documentation,
of nonconforming product aspects, such as, identification, segregation, review, disposition
SP63:
1997 These are explained as given compliance to the specified requirements. The following examples would illustrate the process of rework: 16 mm hole was drilled in a steel plate against specified requirement of 20 mm. The item can be reworked to enlarge the hole to 20 mm when it would conform to the specification. On analysis of a pesticidal formulation, the technical content was found to be less than the specified value. The batch can be reformulated to bring the technical content to the specified value. iii) Repair - Sometimes, the nonconforming batch or lot can be repaired or reprocessed so as to meet the specified requirements. The following examples would illustrate the repair process: A few of the steeldrums from a lot have been found to be leaking during air pressure test. They could be repaired by welding and subjected to test before acceptance. An electric storage water heater was found to be failing in performance requirements. It could be repaired by replacing the defective parts and accepted after subsequent testing. The repair procedure needs to be approved by the purchaser. iv) Re-grade - This procedure calls for redesignating the product to another quality classification to which it complies. The following examples would illustrate the regrading operations: A chemical was formulated and tested for the requirements of analytical grade and found to be having in excess of the specification. The chemical couldberegraded as technical grade, if it conforms to the requirements of technical grade and released as such. A batch of carbon film resistor of a particular value with +l percent accuracy was made. During testing, it was observed that 10 percent of the resistors were having resistance value in excess of 1 percent variation permitted and were within +2 percent of the nominal value. Those resistors which meet all other requirements can be regraded under accuracy class +2 percent and released. 24
and notification. below:
a) Identi@ation
The moment a nonconforming product or service is noticed, the same should be clearly identified by means of a suitable code or mark. The method of identification should be such that it becomes apparent to the observer that the product does not conform to the specified requirements. Further, the method should be so ensured that the code or mark applied to such products cannot be removed or obliterated inadvertently. It should be ensured that the nonconforming product is identified as above and stored separately, at all times, till the same is finally disposed off.
b) Documentation -
The supplier should develop and institute a procedure for recording of occurrence of nonconforming products through nonconformance report. This report should have provision for recording details of identification of the product, the stage at which the nonconformance was noticed, the number or volume of the production involved and full description of the nonconformity. It may also incorporate particulars of review made and the method of disposal.
C)
Segregation - The supplier should have a procedure to physically segregate nonconforming product. This can be established through a quarantine store wherein nonconforming products are stored, pending review and disposition. It is vital to designate a person to ensure strict control over such quarantined stores. components, products or services should be subjected to a review by a designated authority. The nonconformance report referred to in (b) above could form an excellent starting point for the review. The review of nonconforming product may lead to the following decisions/actions: 0 Accept as ti-condition -The designated person may decide in favour of release of nonconforming product as such, in view of minor nature of nonconformity not affecting the performance of the product. This procedure, of course, would call for the approval of the purchaser prior to delivery. ii) Rework - It may, sometimes, be possible to rectify the nonconformity by rework thereby ensuring complete
d) Review - All the nonconforming material,
SP 63 : 1997 The product cannot be classified unde; any of the above categories and therefore, has to be discarded as nonusable. Depending on the products or services dealt with by the supplier, clear procedures for rework, repair or regrading of nonconforming products or services should be laid down.
v) Scrap -
e)
Is there a procedure of recording the details of nonconforming conditions and the concessions offered or repairs undertaken?
4.14 Corrective and Preventive Action 4.14.1 General The supplier should have documented procedures for establishing and eliminating the causes of actual or potential nonconformities in products, processes, or the quality system. Causes of detected (or potential) nonconformities should be promptly identified so that corrective action may be taken and recurrence (or occurrence) prevented. These causes may include, failures, malfunctions or nonconformities in incoming materials, processes, tools, equipments, noncompliance with systems and procedures, inadequate resources, etc. The conditions resulting from these causes may be revealed by analysis of inspection test and records, nonconformity records, audit observations, management review results, inadequate process capability, etc. The degree of corrective and preventive action taken should be dependent upon and directly related to the risk, size and nature of the problems and their direct effects on product quality. 4.14.2 Corrective Action The most important aspect of quality systems lies in taking effective and prompt corrective action. The quality system envisages appropriate actions at all stages of quality-related activities so as to prevent occurrence of nonconformity. The first aspect of corrective action is identification of nonconformance, segregating the nonconforming product or service and prevention of inadvertent use in further work. In case, the nonconformance warrants repair or rectification, the same should be accomplished promptly. The aspects relating to control of nonconforming product have been covered, in detail, under 4.13. The second aspect of corrective action calls for review of the entire gamut of quality-related activities which caused the nonconformity and taking appropriate steps to eliminate the root-causes of nonconformity thereby ensuring prevention of the same in further production. Corrective action covers continued analysis of data at all stages of suppliers activities and an effective quality system would enable identification of adverse trends sufficiently in advance for prompt action and to apply the mid-course correction, as necessary. The concept of prevention is better than cure can be achieved through application of many statistical techniques like process capability
e>Disposition
- The decision taken based on the review of nonconforming product or service should be quickly implemented to minimize further rejection and hence, cost of production. If the product is to be reworked or repaired, the supplier should have a procedure which details out the operations to be carried out and the re-inspections to be performed to assess its conformity prior to release for further production or supply.
Notification - The effectiveness of the control of nonconforming product depends on a series of actions initiated/taken as per the documented procedure. In particular, the function responsible for the occurrence of nonconformity should be immediately advised so that appropriate remedial action is taken to prevent repetition of such nonconformities. This would apparently call for involvement of different departments and quality-related functions. All the departments concerned should be notified about the occurrence of nonconformity, the investigations carried out, the findings thereof and the disposition decisions taken. The review, disposition and notification activities would also equally apply to nonconforming product or service identified at sub-contractors premises. These details should be precisely covered in the contracts entered into. Check list a) Is there a procedure for recording and distribution of information on nonconforming product? Is there a designated person to carry out the review of nonconforming products and to make the disposition decisions? Does a detailed concession procedure exist for adherence? Does the procedure incorporate re-inspection of reworked or repaired product prior to release for further processing or supply?
b)
c) d)
SP 63 : 1997 studies, control chart techniques, etc (see 4.20 for further details). The suppliers organization should install an efficient and cost-effective corrective action procedure. For the purpose, it should develop a good inspection reporting and analysis technique. This should be made available to quality assurance function which can review the same and determine which aspects of production process call for corrective action and at what cost. It may be noted here that chance occurrence of nonconformities may not demand further investigation or corrective action. While applying a corrective action policy, it may be necessary to consider the entire activities of the suppliers organization. This is because of the fact that the root-cause of a quality problem is not always apparent to the observer and may have to be studied in depth. This would mean that the supplier should be armed with a lot of valid and relevant data or information so that a more accurate analysis can be performed regarding the corrective actions to be undertaken. This would call for an effective documented system of quality. Often the causes of nonconformance occur due to incorrect working methods and noncompliance to proceduresbork instructions. The production personnel may be following a modified procedure different from the approved process instruction which may be difficult to achieve. In such cases, it would be necessary to determine whether the operation causing the difficulty can be modified to a simple procedure or calls for intensive training of the personnel concerned so as to educate them as to the correct method of operation. As such, corrective actions may ultimately lead to either changing the methods, designs, drawings, etc, which are in some way unsatisfactory, or enforcing compliance with the existing work instructions through comprehensive and diligent training. In short, the objective is to identify and eliminate the potential causes of nonconforming product. Yet another aspect which is to be noted is taking effective corrective action at the right time. This would demand for development and establishment of quality records relating to the results of investigations carried out on nonconforming product, actions to be initiated and complied with, etc. 4.14.3 Preventive Action Regular analysis of quality data should be carried out to determine potential areas of non-conformities. These can be process data, concessions and waivers, customer complaints, field reports, warranty data, inspection data, etc. 26 Based on the analysis steps should be taken to prevent non-conformity from occurring. Actions taken should be recorded and monitored to ensure effectiveness of the actions taken. Changes carried out should be incorporated into the procedures. Management should review the actions taken from time to time. Check fist
a) Is prompt action provided to correct causes

of non-conformities?
b)
Are there procedures to analyse trends to prevent occurrence of non-conformities? to verify that corrective/preventive action has been implemented and it is effective? Are corrective/preventive recorded? actions taken
Cl Have you a procedure
d)
e) Are reports
on corrective/preventive actions submitted to management regular review?
for
4.15 Handling, Storage, Packaging, Preservation and Delivery 4.151 General

It is nec&saty to ensure that product quality is not affected by improper handling, inappropriate storage, inadequate packaging, improper preservation and incorrect delivery procedures. The handling of materials require proper planning, control and documented procedures for all incoming materials, in-process materials and finished goods. This applies right up to the time of being put into use. The customers requirements, where necessary, regarding handling, packaging, storage, preservation and delivery should be incorporated into the work instructions and quality plans.
4.15.2 Handling Handling methods have to be carefully planned to suit the items being handled, including prevention of damage and deterioration of quality. Where necessary, protective coatings should be applied on the surface to protect the product; for example, plastpeel coating on bearing surfaces and oil or grease coating on highly finished surfaces. While handling it should be ensured that identification of the item is not obliterated. Timely maintenance of the handling equipment is very essential to ensure their proper functioning. 4.153 Storage Storage is not only for the final product but also for in-process items and for items received from sub-contractors. Stores personnel should be made
SP63:1997 aware of the kind of storage required for the different kinds of items and these must be followed strictly. Access to stores should be limited to authorized personnel only and suitable procedures should be adopted for receipt, storage and issue of material from stores. To prevent deterioration during storage, appropriate steps like protective coatings, fumigation, etc, as necessary should be taken. Some of the factors like ventilation, proper lighting, proper air circulation, contamination by other products, etc, should be taken into consideration when deciding about the storage area. Further when deciding about the storage, accessibility to the stored item to material handling equipment should also be kept in mind. Dangerous and inflammable goods should be stored separately well away from other general items. The expiry dates of all items having restricted shelf-life like loctite adhesives, etc, should be monitored carefully. These items should be issued on FJRST IN FIRST OUT (FIFO) basis. Detailed record of these items should be maintained to allow for suitable action to be taken in case the shelf-life expires. Periodic inspection of all stored goods should be undertaken to ensure that product quality has not deteriorated during storage. In case such deterioration is noticed, immediate action should be taken to isolate these items in a separate place pending action and disposal. 4.154 Packaging All products must be packaged in such a way that its quality will not deteriorate during shipment and storage prior to its use by the customer. The type of packaging will, to a large extent, depend on the kind of product, and the time period for which it has to be stored in the packed condition. For example, food products. The kind of transportation that will be used for transporting the product should be considered before deciding on the type of packaging to be provided. For example, if a product has to be sent to another country by ship, then factors like moisture proofing, rough handling and resistance to salt water, etc, should be kept in mind when deciding on the type of packaging. Many a time, there is a tendency to use recycled packaging material or old and used packaging material. In such cases, care should be taken to ensure that the old markings are completely removed and the new markings are legible to prevent any misuse or mishandling. An important element is the care that has to be given to the marking and identification of the packages. Any special instructions for handling 27 and storage should be marked on the package depending on the contents. The ink and paint used for marking should be such that it does not cause damage to the product or get obliterated during transportation. 4.15.5 Preservation Supplier should have suitable procedures to ensure the product is preserved in a proper manner. These may include maintaining of proper temperature, humidity, etc, as well as storing it in a manner which will prevent any deterioration of the product during storage. If any additional treatment like fumigation, chemical treatment, etc, are needed, then these should be carried out in a safe and controlled manner. In industries like food processing where preservation is a very crucial factor, suitable preservatives will need to be added to the product to ensure the food product will be in good condition till the customer gets to use it. 4.156 Delivery It is necessary to ensure that the quality ofa product does not deteriorate between the time it has been despatched and the time it is received by the customer; for example, in the case of export items where it may take many months to reach its destination. It may also be necessary to consider the environmental conditions that will be encountered during transit and on arrival at customers destination. In addition to the above, any specific instructions of a customer regarding packaging and delivery will also have to be adhered to. Check list
a) Does the customers purchase order specify
b) 4
d) e) 0 8
any packaging, handling, storage and delivery requirements? Are all procedures documented for handling right from receipt of raw material to final despatch of finished goods? Is there a provision for appropriate container to preserve the quality of the environmental and product from mechanical damage? Are there provisions for suitable means of movement of goods, that is, fork lifts, pallet trucks, conveyer systems, vehicles, etc? Is there a provision for suitable means of cleaning and preservation of goods during storage? Is there a provision for controlled receipt and issue of material from storage areas? Where necessary, is there a provision for maintaining the necessary environmental conditions?
SP63:
1997 Are the S:J;ZS periodically checked to ensure theii quality during storage? Are there suitable procedures to store and issue material having restricted shelf-life? Is there a suitable means of identification for all goods that are stored? Are suitable instructions provided for packaging and delivery of goods appropriate to the kind of item and their destination?
h) 0 k)
ml
b)
c)
Record of acceptance of review findings by both parties for implementation. Any requirement modified from those in the tender/purchase order and the details of their acceptance by both parties. Details of design verifications undertaken. output worked out based on calculations and analysis and their verification in the production line. Details of design changes agreed upon and issued to production for appropriate implementation.
Design Control
a)
b) Design
4.16 Control of Quality Records Quality records primarily consist of a proof about the applicability and implementation of various quality system elements by the organization. These records may also include production records which may not be normally recorded as quality related records. The proformae for maintenance of quality records should be designed taking care of the requirements for using various data for investigation, analysis and improvement purposes. If computers are used for analysis, the quality records should, right from the beginning be made compatible to computerization. The period to which a quality record should be maintained depends upon the expected life time of the product or service and the minimum retention time specified by legislation or in the contract, etc. The retention period should be specified as part of quality system documentation to avoid any disputes in that regard. Some examples of the types of quality records applicable to an organization with regard to various quality system elements are given below. This list is not exhaustive and may vary depending upon the products, the size of the organization and contractual requirements. The list also may change depending on the quality system employed. The above list is based on IS/IS0 9001:
Management Responsibility
Document Control
a)
b)
Details of documents available with the organization including proformae and the date of their issue with clear identification number. The changes/modifications to documents issued and the dates of their implementation. The details of purchase orders giving reference to purchase specifications, drawings, etc. The details of sub-contractor assessment and selection, list of approved suppliers. Records of purchase specification, ordering quantities, purchase procedures, etc. Incoming inspection carried out to verify purchased products, conformity of quantities accepted and rejected.
Purchasing
a)
b) c) d)
Purchaser Supplied Product
a)
Record of assessment of resources and personnel required for maintaining quality system. Records of management review, its findings and action taken.
List of products for a particular order which are supplied by the purchaser. b) Verification of purchaser supplied product for suitability for use. c) Nonconformity material report.
Product Identification and Traceability
a)
b)
Qz4alilySystem
a) Records of distribution of quality manual

and related documents ments.
including amend-
System of identification provided for products and the arrangement for traceability of various components, raw-materials, process, period of production, etc, to enable investigation of the causes of nonconformity if observed on the finished product. Process Control Record of observations and the decisions taken for process control.
Inspection and Testing
b)
Record of amendments issued to quality systems documents and the effective dates of their implementation.
Contract Review
a)
a)
Minutes of all contract reviews undertaken on various contracts being executed.

28
Inspection and test reports. This may relate to the receiving, in-process and final stages of inspection and testing.
SP 63 : 1997
b)
Identification of the finished products before clearance by the inspection indicating traceability of the same starting from the raw-material.
b)
Record of the changes in procedures introduced based on findings of the internal quality audits and the dates of their implementation.
Inspection, Measuring and Test Equipment
Training
a) b) c)
List of inspection, measuring and test equipment calibration records. Record of major maintenance undertaken. Disposal of nonconforming equipment.
a) b) c)
Details of personnel affecting quality.
engaged in functions
Record of training needs of the personnel. Record of training organized.
Inspection and Test Status
Servicing products authority a) b) Details of servicing undertaken the contract. as part of

Details of the release of conforming including identity of the inspection responsible for such release.
Control of Nonconfoming Product
a>Record
b) Cl Record
of identification, evaluation, segregation and disposition of nonconforming products and notification issued to various functions concerned. Record of concessions/waivers obtained. of reworked products nature of repair/rework. and the
Record of major nonconformities noticed during the servicing operation and the corrective actions taken including changes in procedures or materials.
Statistical Techniques
Details of statistical techniques identified, established and maintained in different functional areas.
Check Ltit
d) Record of rejects and scrap.

Corrective/Preventive Action
a) Is a mechanism established and documented

for collection indexing, accessing, filing, storage, maintenance and disposition of quality records?
a) b)
Details of corrective actions expected for each type of nonconformity. Record of investigation of nonconforming products and analysis, record of corrective actions taken and the results obtained. Record of changes in procedures issued as a result of corrective action.
b)
c)
Handling, Storage, Packaging and DeliveT
Has the supplier identified all quality records which should be maintained to demonstrate conformance to specified requirement? C> Does the established system ensure that all quality records are collated, indexed and filed correctly? Are responsibilities established for generating and maintaining quality record? Are records maintained storage? ensuring secured
4 Total
quantity of goods produced as recorded at various stages of handling, storage, packaging and delivery. Record of packaging materials used and markings on the labels affixed to the packages.
Records
(9 e) 9 !a h) j) k) ml 1
29
b)
@al@
Are the records easily retreivable? Are suitable persons authorized access to the records? to have
a)
b)
List of quality records maintained to demonstrate attainment of the required quality and implementation of the quality system. Record of the type of storage and locations where the records are stored.
Are suitable steps taken to ensure that data tampering/misuse does not take place? Is the mechanism for accessing records established? Are records maintained legibly? Are records stored r&d maintained under suitable environmental conditions to avoid damage/deterioration? Is the system for storage of records on electronic media documented. Does it quality
Internal Quality Audits
a)
Record of internal quality audits carried out, their findings and corrective actions taken.
SP63:lW
P)
q)
r)
s)
ensure access control, back-up control and virus control? Are quaiity record on magnetic tapes/floppies appropriately identified and stored under suitable environmental conditions? Are retention periods for quality records determined and documented? Is the mechanism of disposal of quality records established? When contractually agreed, are quality records made available to customer or his representative for evaluation?
Scheduling of Audit Activities
If a programme is available as described in Annex D, firm schedules for the forthcoming two or three months may be prepared by the department responsible for audits. The sequence of activities to be performed during the audit or the scope need not be specified on the schedule. The schedule may contain the following information and distributed to the departments/functions concerned: Audited activity (from annual schedule) Date of commencement duration of audit and likely
4.17 Internal Quality Audit The efficacy of the Quality Management System depends on internal quality audits. Quality Assurance Department or any other designated department should have the responsibility to plan and execute the internal quality audits. The department should also monitor the corrective actions taken based on nonconformities noticed during the audits and prepare a summary of audit results for review by the management.
Audit team leader and members

These schedules may be modified to suit circumstances, as long as all planned audits are performed within the stipulated quarter.
Qualities of the Auditors
The audit can be viewed as a process which itself must be adequately documented and controlled against established criteria. This is accomplished by establishing a procedure for internal quality audits. The audit process consists of determining as to whether a system exists, whether the system is implemented and to make a judgment on its effectiveness. By questioning, witnessing the activities, and collecting objective evidence, the auditor can assess the adequacy of the system and its compliance.
Development of Audit Plan The approach
of an audit depends to a great extent on the personnel carrying out the audits. The auditors role is not merely to report facts, but to be able to obtain information from a variety of sources and interpret the data to make a judgment as to the effectiveness of the quality system. As such, a good auditor may require the following attributes: a) b) c) d) e) g) h) j) k) m) Professional competence Integrity Objectivity Persistence Flexibility Adaptability Curiosity Common sense Consistency Leadership
The satisfactory and practical administration
f) Tact
to internal quality audits must be systematic. Internal Quality Audit should be conducted according to a pre-planned schedule so that each applicable requirement of the standard is addressed and all areas of the organization are covered within a stipulated period. The audit planning commences with the development of an audit programme, covering all the departments/functions affecting quality. The period of auditing should be determined in advance. A typical illustration is contained in Annex C. The frequency of audit will depend on several factors including the criticality of the functions being audited. There must be a provision to adjust the frequency of audits based on the results obtained. In the early stages of implementation of quality systems, it will generally be necessary to carry out the audits more frequently to ensure that the implementation of quality system has been effective.
The auditor is required to interact with individuals at all operational and managerial levels. Therefore his personal skills assume importance.
Selection of Audit Team The selection
of audit team comprising a lead auditor and members is important for effective auditing. If the organization does not have qualified personnel it may use external sources to perform the audits. The techniques of auditing can be acquired by training and practice and the organization can, in due course, develop suitable personnel for carrying out audits.
SP 63 : 1997 Cm-tying out theAudit Each audit begins with a brief opening meeting between the audit team, and the head of the department of the area to be audited. During this meeting, the auditor discusses the approach, the scope of audit and any administrative arrangements. In carrying out audit, the auditor should be accompanied by a representative of the area concerned. To facilitate effective conduct of audit, the auditor may prepare checklists for guidance and follow the au&t trail as it opens up, to collect objective evidence of any non-compliance or deficiency in the system. The results of this examination should be recorded on the checklist pages or on supplemental notes. On completion of the audit, a closing meeting is held by the auditor(s) with the management of the area/department concerned. At this meeting, the findings (non-conformities) or observations are discussed. The possible corrective actions to be taken, and time required for corrective actions are also discussed. Copy of the Non-conformity report or audit findings along with conclusions, are provided to the management/auditee at the closing meeting. The audit findings shall be presented as a statement giving details such as nonconformities observed, where they were observed, and why they were nonconformities. Cross reference to the clause of the standard or manual or document, shall be given invariably. This will assist the management/department concerned in taking corrective action. The audit report is prepared after the closing meeting by the audit team leader and forwarded to the designated person in charge of audits. The audit report normally contains the following information: Audit title, number and other identifying information. b) Background information, such as, audit purpose, scope, dates, audit team members, and procedures used. A brief description of the activities audited. C> Summary of any findings or observations and how they affect the products or deliverables and overall conclusions of the effectiveness of the quality programme as implemented by the audited department(s). d) Listing of those who participated in the audit. This is normally presented as an attachment. or e) Specific findings (non-conformities) observations as attachments. requested for corrective actions as applicable. A response to audit findings and the corrective action taken is to be submitted by the Auditee Department normally within 30 days of audit closing meeting. In many organizations, the nonconformity audit report and corrective action response are all combined in single format and copies are distributed to all affected. A typical format is given in Annex E. Follow-up The audit team leader or the designated department for Audits should follow up the corrective actions taken by the auditee through: a) b) c) d) Obtaining a written response to the audit report. Evaluating the adequacy of the response. Verifying that corrective action has been accomplished as scheduled. Determining that the action was effective in preventing recurrence.
Follow up action may be accomplished through written communication, review of revised documents, re-audit after the reported implementation date. The audit team leader or designated person of audits, should periodically review the status of outstanding corrective actions and take steps to resolve outstanding audit issues. Summary results of the reports of quality audits should be circulated to the senior management of the organization on regular basis (may be quarterly or annually) to appraise them of the effectiveness of the quality system. This will form a significant input into the management review of the quality system. The summary can highlight the requirements which cause frequent noncompliances; areas, activities or processes which are frequently not complying, and the corrective actions recommended and taken in these areas. Records The following audit records are to be maintained by the Audit Team Leader and designated department of Audit Programmes: a) b) d) Audit notification memo and Audit Plan Blank audit checklists used Audit response, including completed audit finding response forms working records Auditor may also be qualification
a>
c) Audit report and forwarding memo
The following maintained: a)
The auditee department shall be provided with the report by management representative and shall be 31
Auditor/Lead records.
SP63: 1997 b) Completed audit check lists and auditors working papers. c) Related miscellaneous correspondence. d) Annual audit programmes and any revisions. e) Quarterly audit schedules. f) Auditing procedures used. The duration of keeping these records is to be decided, as also the storage and retrieval methods.
Check ltit
keep pace with change. Thus training should be approached in a systematic manner. In any organization, training needs are always there. Moreover, certain skills are acquired only by training, for example, welding, ultrasonic testing, operation of computers and other electronics/data processing machines. Training needs will arise when new equipment or process are introduced or when personnel are required to take up additional roles or responsibilities. In the initial stages of installing quality system, training encompasses all the personnel in the organization. Quality policy of the organization, objectives to be achieved and individuals role in the operation of the quality management systems are best disseminated through a training programme. This requirement is contained in 4.1.1 of the respective models of quality systems; but it applies to all levels in the organization. Similarly training needs arise when significant alterations are sought to be introduced in Quality Systems, diversification in production, changes in the organization or even changes to the Quality System Standards. As far as the development of skills with respect to Quality System is concerned, it may be required to train various personnel in conducting internal quality audits.
Identipation of Needs for Training The standard requires that procedures shall be
a) Has the organization

b)
C)
d)
e) f) 8 9 0
k)
an)
assigned the responsibility to a designated person for carrying out internal quality audits? Has a programme for audits been established covering all departments and activities of the company? How is this programme developed and documented? Have you taken into account the criticality of activities in determining the frequency of audits? Are detailed procedures available for the conduct of audit? Are checklists prepared for use in audits? Have you established criteria for auditors qualification? Are formats available for Audit Schedule and Audit Plans? Do the audit reports identify the activity, the area, the date and the findings of the audit? What is the method used for taking up the reports of audits and noncompliances, with the department concerned? What is the provision made for the management of the area audited to detail corrective action to be taken, the timescale for action and who is responsible? How are corrective actions followed up? How are audit results made available for use in management review? What are the various records used for internal quality audits?
established and maintained for identifying the training needs. It is therefore necessary to review all the activities of an organization which affect quality and identify those personnel who require training, by ensuring that the personnel carrying out these activities have the appropriate qualifications, skills and/or experience to carry out the task. Having identified the needs for training, it is equally important to establish and document the level of competence required, and the means by which attainment of the level of competence can be demonstrated. In respect of special skills such as for welding, ultrasonic testing, radiography and other non-destructive testing, the need for achieving levels of competence prescribed in national or international standards should be examined.
TrainingMethodologies The range of skills and knowledge which is required
professions and %~%%+:gies, directly affect the quality function +I& hfl,eforc appropriate training programmes *isp =.%tial in order to create or update individual tim*wrge and skills. Since there is no single ~~*~srrrr:rne of training which will satisfy the vast f q*ei~m of industry, each individual organization XV*;. m!, develop and implement an ongoing r+tiG? ftrr 1he training of its personnel which will
32
P&G *?, in trade practices,
may vary xcording to the circumstances and the individuals role in the organization; the training programmes may normally range from in-house/on the job training to quite advanced courses in external institutions.
SP 63 : 1997
Training Records
Once the training is given, it will be necessary to employ trained people at the right position so that the competence and skills of the personnel are used to ensure product quality. For this purpose, training records of all personnel are to be maintained in each department and made available to those responsible for selecting the personnel with proper skills for that particular activity. The training records must provide all pertinent information and will be useful for identifying the training need. A typical training record is given in Annex F.
Evaluation of Training Results It is equally important to ensure that the training given and the level of skills attained is documented. This will not only help as an objective evidence but
can also be used to ascertain further needs of training. It also requires that the results of training towards required skill level is monitored. Thus the review of activities for identifying training needs must be an on going process in an organization and should be documented in the procedures established for training.
RefresherIRe-Training
In certain areas, like boiler operations or welding, there is need for revalidation of qualifications at regular intervals and these may require retraining or demonstration of continued competence. For this purpose, the establishing and updating of the records will become crucial for relevant demonstrating compliance. A typical training cycle is shown in Fig. 2.
1. Identifying training needs
ACT / ADJUST
6. Evaluating the impact of training and acting, on conclusions I
2. Analysing
the
CHECK
/ STUDY
PLAN
I
3. Designing and planning training
DO 4. Carrying training out
FIG. 2 TRAINING CYCLE DIAGRAM 33
SP 63 : 1997 4.19 Servicing
Servicing is an important contributory factor for the satisfaction of consumer. In durable products, often satisfactory performance during the entire life cycle, depends on the maintenance and servicing. This may be required to be carried out either at a regular periodicity or based on the condition of the product measured while it is still in service or whenever there is a breakdown. When provided for in the contract, it becom.es the responsibility of the supplier to provide the services either by himself or through an agency appointed by him. Servicing is also quite similar to manufacturing activities except that the environment under which servicing is performed may be different from that of manufacturing. Since more often there would be one to one interface with customers during servicing phases, there is a need for greater attention to quality of servicing to ensure customers satisfaction. The aspects to be addressed in providing satisfactory service include the following: a) Formulation and Periodic Validation of
Service and Service DeliverySpecifications-
Such quality control operations shall be based on measurement of service and service delivery characteristics to verify conformance to quality control specifications which define the procedure for evaluating and controlling the service and service delivery characteristics. c) CorrectiveActions to be Taken - Corrective actions in services comprise of two stages; the first, an immediate positive action to satisfy the needs of the customer and second, an evaluation of the root cause of non-conformity and action taken to prevent its recurrence. The first stage is essential since customers reaction to a non-conformity may be immediate, delayed or retrospective in nature and lead to his dissatisfaction. Efforts should also be made to identify potential non-conformities before the customers are affected and corrective actions taken to prevent them. d) Training and Motivation of Personnel for
Development of Behavioural and Communication Skills in Addition to a Technical Competence in ProvidingE@cient Service -Personnel engaged in service
A service is based on customers needs and the capabilities of the supplier. Service specification should clearly define the characteristics that affect service performance and the method of their evaluation. These characteristics may be observable and subject to evaluation by the customers or sometimes not observable by the customers. Service specification defines the services and provides clear description of the service characteristics. It also specifies the standard of acceptability. Service delivery specification on the other hand defines the means and methods used to deliver the service and contains, in addition to the services delivery characteristics and acceptance criteria, delivery procedure and resource requirements. These specifications should take into account the regulatory requirements as well. Service delivery specifications shall be validated to ensure that they meet the needs of the customer. These are also reviewed based on actual field experience, customers feedback, potential improvements in the provision of the service and their control. b) Measurement and Control of Service and
Service Delivery Characteristics- Services
activities, quite often, are in direct contact with the customers. Their behaviour, communication skills and performance directly impacts quality of service. It is, therefore, essential that the suppliers should give emphasis to the adequacy and quality of personnel engaged in service function. The aspects that need to be addressed include motivation of personnel, training and development and communication skills. e) Special Purpose Tools or Equipment for
Handling and Servicing of Products-For
efficiently performing certain services operation, special tools and equipment may be necessary. Quality system for servicing should also address to these requirements. f) Measuring and Test Equipment Required for
Verifying Proper Installation and Service
-Controls similar to those exercised for measuring and test equipment used in the manufacture are required to be exercised in respectof equipment aswellas procedures used for measurement of service performance. g) Provisionof Service Spares and Consumables ofAcceptable QuaZity - Quality of servicing also depends on the material resources required for providing the service. This include spare parts and consumables. Supplier should identify the material
should be subjected to quality control to ensure that the services consistently satisfy the service specification and the customers. 34
SP 63 : 1997
resources required. He should also ensure their availability with due consideration for appropriate quality and adequate quantity.
h) Provisionof Suitable Instructionsin theform
of a ProductlServicesManual Dealing with Assembly and Installation, Commissioning Operation,Maintenance,List of SparesParts, Services Provided by the Supplier, Addresses of Suppriersand S&e Stations,etc - It is a
quality system. Quality records would be helpful in identifying the quality trends and effecting quality improvement. For this purpose, quality records should be validated and made easily retrievable. PI Feedback
to be Provided for Product Improvement, etc - Results of analysis of
Even when servicing is not provided for in the contract, it is advisable for suppliers of durable products to address the above aspects to ensure customers delight. The data generated during provision and evaluation of services will also be 0 Suppliers Assessment of Service Quality helpful in product improvement.
Through Inspection, Verification, Measurement and Testing as Appltiable -
good idea to provide along with the durable products, a manual giving instructions for dealing with assembly and installation, commissioning, operation, maintenance, list of spare parts, services provided by the suppliers, addresses of suppliers and service stations, etc. This manual may also contain details of suppliers obligation in terms of warranty, service delivery, etc.
service performance should be fed to marketing and design processes. Such a feedback system would help in effecting system correction to prevent the occurrence of non-conformities and also contribute to service quality improvement.
The requirement on this element of quality system places the responsibility on the supplier to determine the appropriateness and extent of application of statistical techniques in the organization. This would naturally depend upon k) Customers Assessment of Service Quality the type and nature of the product or service offered Through Invited Response and Analysti of and the technology adopted for manufacture. Customer Complaints Customers assessment of service quality may be When judiciously employed, statistical techniques subjective. Quite often, a dissatisfied provide an effective means of objectively estimating customer may not prefer a complaint. the product quality or control of processes in the Therefore, reliance on customers most economical way. These are widely used for complaint as a measure of customers both product sampling and process control satisfaction can result in misleading functions. conclusions. Customers reaction, both positive and negative, should be While a number of statistical techniques are obtained in a prescribed form. Comparison available as tqols for achieving the quality of of customers assessment with suppliers products or services, there exists seven important own perception and assessment should simple tools of Statistical Quality Control (SQC) be used to effect service quality which can help in sorting out most of the quality problems of our industry. In addition, these tools improvement. are simple in nature and can be easily understood Service Performance Analysis and and adopted by persons at the level of Improvement - Analysis of data collected operators/workers. They are as given below: through suppliers assessment, customers a) Checksheet/checklist, assessment and quality audit should be used to effect service quality improvement. b) Pareto diagram, 9 Histogram, n> QualityRecords to be Maintained- Quality records in servicing are similar to those d) Cause and effect diagram, maintained in manufacturing function. e) Stratification, They provide information on the degree of 9 Scatter diagram, and achievement of quality objectives, levels of customers satisfaction and the results of g) Graph and control chart.
35
This may be accomplished through measurement and ,verification of key processes, self-inspection by service delivery personnel and also independent assessment by the supplier on sampling basis. Service quality assessment may involve inspection, verification, measurement and testing as applicable.
Guidance for establishing quality system for servicing function could also be obtained from IS/IS0 9004-z 4.20 Statistical Techniques
SP 63 : 1997 It has been observed that the causes of irregularity in industrial production follow a certain law or principle and exhibit the phenomenon of vital few and trivial many. Often a single dominant cause is of far greater importance than all the remaining put together. The purpose, therefore, is to identify the dominant causes (known as vital few) from the remaining (known as trivial many) which mainly account for quality deficiencies. Pareto diagram is used for this purpose. Once a Pareto diagram is constructed, the next step is to enumerate systematically all possible causes/factors. The Cause-and-Effect (CE) diagram gives a visual picture of all causes or factors which affect quality (nonconformance). The diagram permits viewing the factors in perspective and in relation to each other with resulting improvement in communication and planning. This is very simple, easy and effective tool of understanding the factors that affect the response of interest. The CE diagram is also known as fish-bone-diagram or Ishikawa diagram. The use of Pareto and CE diagram is not limited only to the manufacturing areas (like high rejections, rework, low productivity, high wastages), but is also widely used in other fields, such as, productivity, profitability, public relations, education and training, research and development, new project development, standardization, safety control, purchase, sale and service efficiency. Numerical data arise in modern industrial operations at a number of stages. The first and foremost requirement of any statistical study is to ensure that only such data as is really useful and necessary is collected. Once this is done, it becomes necessary to condense and present the data in a manner which would aid in drawing correct inferences or conclusions. Here, Histogram provides a very useful graphical method from which the basic distribution of the data could be assessed and other parameters could be determined. Study of the condensed data would reveal its pattern which may well be explained by other discrete or continuous models, available in the form of Probability distributions. Techniques, such as, scatter diagram, regression and correlation are very useful in studying the relationship between two variables and also for the purpose of prediction. In many statistical studies, a small portion of the population is drawn for estimating the lot quality. The reliability of the conclusions drawn on the basis of sample, depends upon its representativeness and method of selection. Statistical techniques provide useful guidance in the selection of random samples under diverse situations on a scientific basis. 36 In problems where small sample data are to be used to evaluate claims regarding quality aspects or to understand if the observed data have arisen due to random sampling fluctuation in an assumed set up, statistical tests of significance are extremely useful. Yet another useful statistical technique is Analysis of variance, which aids in the analysis of the experimental data involving quantitative measurements and is particularly helpful when several independent sources of variations are present in the data. Using the analysis of variance technique, it is possible to estimate how much of the total variation in a set of data can be attributed to one or more assignable causes of variation, the remainder which is not attributable to any assignable causes of variation being classified as due to chance causes which produces the residual or error variation. In the problems of decision making regarding product/ process designs, process specifications, quality improvement, dominant factors affecting quality, cost reduction, one is confronted with several alternatives and has to choose that alternative which satisfies the requirements at minimum costs. Towards this objective, the design of experiments come very handy. While prescribing a test method, it is important to assess the precision of the test method in quantitative terms so as to serve as a guide to the users of the test method for judging the acceptability of the test results. It is also necessary to ensure the reproducibility and reproducibility factors of a test method. The technique precision of test methods provides useful guidance in sorting out issues of this nature. It has always been the endeavour of any industry to produce products of uniform quality by ensuring use of similar raw materials, identical machines, and proper training of the operators. Inspite of these efforts, the causes of irregularity often creep in inadvertently. The Control chart techniques form useful tools based on which the supervisor/ operator can assess the trend of quality variation and take appropriate action to remedy the situation thereby bringing the process under statistical control. Methods are available which are useful in the determination of the inherent variability in the process referred to as process capability. The process capability studies are useful for:
a)
b)
Purchasing agent who has a means of comparing the actual performance of equipment with manufacturers claims; Design engineer who has more rationai basis for the specification of tolerances when he is acquainted with the capability of the available equipment;
SP63:1997 Planning engineer in assigning the jobs to the various machines/processes after due consideration to the tolerances and capabilities; and d) Production and inspection personnel in employing this as a basis for process control. One of the important aspects of any system of quality control is the assurance about the quality of the product when it changes hands. This may happen within a factory or between manufacturers or from producer to the ultimate consumer. Due to the fundamental increase in the quantum of production, it is extremely uneconomical to inspect each and every item of the product. Thus sampling inspection techniques have been developed on a scientific basis which provide useful guidance in the assessment of lot quality based on selection of random sample from the lot. Thus, statistical techniques find wide application in many functional areas and may typically be applied to the following areas. For each area the relevant Indian Standard on the subject is indicated in parenthesis and the complete list of Indian Standards on statistical techniques is given in Annex G: a) Product, Service and Process Design i) Pareto diagram and cause and effect diagram (IS 12801) ii) Scatter diagram, correlation and regression analysis (IS 7300) iii) Probability distributions [IS 9300 (Parts 1 and 2)] iv) Process capability (IS 10645) v) Analysis of variance (IS 7600) vi) Design of experiments [IS 10427 (Parts 1 and 2)] vii) Analysis of means (IS 12347) viii) Testsofsignificance[IS6u)o(Parts1to4)] ix) Precision of test methods [IS 5420 (Parts 1 and 2)] b) Process Control and Nonconformity
Avoidance
Cl
diagram, correlation and regression analysis (IS 7300) vi) Analysis of variance (IS 7600) vii) Design of experiments [IS 10427 (Parts 1 and 2)] viii) Precision of test methods [IS 5420 (Part 1 and 2)] d) Risk Determination i) Sample size determination (IS 5002) ii) Probability distributions [IS 9300 (Parts 1 and 2)] iii) Sampling inspection [IS 1548, IS 2500 (Parts 1 and 2) and IS 49051 e) Establishment of Product and Process Limits 0 Process capability (IS 10645) distributions [IS 9300 ii) Probability (Parts 1 and 2)] iii) Precision of test methods [IS 5420 (Parts 1 and 2)] iv) Design of experiments [IS 10427 (Parts 1 and 2)]
f) Forecasting
V) Scatter
i) Special control charts [IS 397 (Part 3)] ii) Scatter diagram, correlation and regression analysis (IS 7300) iii) Design of experiments [IS 10427 (Parts i and 2)] g)
Verification
i) Sampling inspection [IS 1548, IS 2500 (Parts 1 and 2) and IS 49051 ii) Tests of significance [IS 6200 (Parts 1 to iii) Analysis of means (IS 12347) h) Measurement
Characteristics or Assessment of Quality
91
i) Sampling inspection [IS 1548, IS 2500 (Parts 1 and 2) and IS 49051 ii) Precision of test methods [IS 5420 (Parts 1 and 2)] iii) Analysis of variance (IS 7600)
NOTE-Application of various statistical techniques in the functional areas referred to above is reproduced in the fonu of a matrix (see Annex H).
i) Pareto diagram and cause and effect diagram (IS 12801) ii) Control chart techniques [IS 397 (Parts 1 to 4)] iii) Process capability (IS 10645) c) Problem AnalysislFinding Root Causes i) Summarization of data and analysis [IS 7200 (Parts 1 and 2)] ii) Pareto diagram and cause and effect diagram (IS 12801) iii) Probability distributions [IS 9300 (Parts 1 and 2)] iv) Tests of significance [IS 6200 (Parts 1 to
Check list
a) b) 4 d) e)
37
Has responsibility been assigned for selecting appropriate SQC techniques for each application? Have specific detailed procedures been documented for each application? Are the techniques being applied selected from published standards? If not, is it possible to demonstrate the statistical validity of selected method(s)? Are the personnel concerned adequately trained in the SQC techniques selected?
4)l
SP63:1997
ANNEX A (Clause 4.1.1)

EXAMPLES OF QUALITY POLICY A-l QUALITY POLICY AND OBJECTIWS BIS OF gets top priority in the organization. Every one shall work towards achieving zero error level to meet customer requirements. By conducting programmes, displaying and on the job training, personnel at all levels shall be trained to ensure proper understanding, implementation and maintenance of the quality policy. The Company has established its name for quality reputation and by implementing quality system, the Company shall acquire the foremost position in quality for its product range. A-4 QUALITYPOLKYAND COMPANY
-
The Bureau of Indian Standards (BIS), the National Standards Body of India, resolves to be the leader in all matters concerning Standardization, Certification and Quality. In order to attain this, the Bureau would strive: to provide efficient timely service. to satisfy the customers needs for quality of goods and services. to work and act in such a way that each task, performed as individuals or as corporate entity, leads to excellence and enhances the credibility and image of the Organization.
OBJECTIVES OF C
BIS would achieve these objectives by working in close cooperation with all concerned organizations and by adopting appropriate management systems, motivating and ensuring active participation of all its employees. A-2 QUALITY POLICY OF A COMPANY To build and sustain an organization which is customer oriented, innovative and where quality is the hallmark of every operation. In order to attain this the company would strive: to create a reputation for supply of competitive and reliable iron, steel ,and related products and services of international standards. to continuously develop, adapt and improve technologies to attain higher productivity, better cost effectiveness, quality performance and greater customer satisfaction. to play a leading role in developing products and markets. new
C is a Quality Company Quality is the Basic Business for C. Quality means providing our External and Internal customers with innovative products and services that fully satisfy their requirements. Quality improvement employee. is the job of every C
A-4.1 Objectives To instill Quality as the basic business principle at C and to ensure that Quality Improvement becomes the job of every employee. To ensure that employees, individually and collectively, provide our external and internal customers with innovative products and services that fully satisfy their existing and latent requirements. To establish, as a way of life, management and work processes that enable all employees to continuously pursue quality improvement in meeting customer requirements.
to develop highly motivated and skilled human resources imbibed with a strong sense of values. to create a work environment and condition which support attainment of excellence.
A-5 QUALITY POLICY OF D COMPANY D is committed to achieve the highest quality standards of its products and services for maximum customer satisfaction by following systematic quality assurance system: To adopt latest equipment and technology in our field comparable with any world class worsted manufacturer. To achieve highest level of quality and services for utmost customer satisfaction. To play a major role in exports of our products by maintaining our competitive
A-3 QUALITY POLICY OF B COMPANY B commits itself to provide satisfaction of highest order to all its clients, whether small or big, domestic or overseas.
B shall market only such products which fulfil the

customer requirements as agreed upon. The objective of supplying consistently quality products conforming to customer requirements 38
SP 63 : 1997 position in International market, while maintaining our leadership in the domestic business. To develop a cheerful working environment with well trained and motivated workers and staff. To be a Pride to Our Nation. Every F employee will become involved in qualityandccst improvement programmes, and strive for excellence in everything that is done. independent Suppliers, sales representatives and distributors will become part of this quality policy. F will maintain mutually beneficial relationships with all of its business associates. A-8 QUALITY POLICY AND OBJECTIVES OF G COMPANY Our Credo We believe the first responsibility is to the customers who use our products and services. In meeting their needs everything we do must be of high quality, we must constantly strive to reduce our costs in order to maintain reasonable prices. Customers orders must be serviced promptly and accurately. Our suppliers and dealers must have an opportunity to make a fair profit. We are responsible to our employees, the men and women who work with us throughout the country. Everyone must be considered as an individual. We must respect their dignity and recognize their merit. They must have a sense of belonging to the organization. Performance and innovativeness must be encouraged and appreciated. Compensation must be fair and adequate in relation to performance, and working conditions clean, orderly and safe. Employees must feel free to make suggestions and complaints. There must be equal opportunity for employment, development and advancement for those qualified. We must provide competent management and their actions must be just and ethical. Experiment with New Ideas Research must be carried on, innovative programmes developed and mistakes paid for. New equipment must be purchased, new facilities provided and new products launched. Reserves must be created to provide for adverse times. When we operate according to these principles, the stockholders should realize a fair return. A-9 QUALITY POLICY AND OBJECTIVES OF H COMPANY We are committed to quality and excellence in all endeavours. We have se; our goals to achieve total customer satisfaction, and to deliver error-free, competitive products and customer solution on-time, with service second-to-none. A-10 QUALITY POLICY AND OBJECTIVES OF J COMPANY We will deliver to our customer, external and internal, products and services conforming at all times to clearly established requirements. 39
A-6 QUALITY POLICY OF E COMPANY Our policy is to ensure: Quality service Improved customer satisfaction Profitable deployment of resources Contributing priorities towards national and social
Our objective in this regard will be to devise and implement systems and procedures that will ensure satisfactory customer service. The strategies include: making the products/services and competitive adopting user friendly systems improving the cost effectiveness of our services by adopting improved technology laying greater emphasis in motivating the staff members toward quality assurance (being basically a service oriented industry) imparting necessary training to the personnel engaged in the proces s o f quality assurance providing them the necessary resources for achieving the quality standards contributing towards achieving national and social priorities in accordance with the guidelines of Government and Reserve Bank of India. A-7 QUALITYPOLICYAND COMPANY OBJECTIVES OFF qualitative
Quality is the guiding principle of F company. Our goal is to find a better way - to do it right the first time - to give quality priority status and primary dedication in every decision we make and every activity we undertake. This quality policy will be implemented at every F location and will be guided by the following :
Fs number one priority is to make every one
of its services and products the quality leader in its market segment, as perceived by the customer. Every manager in F will develop and initiate programmes that address this quality policy.
SP63: 1997 We commit ourselves, as a corporate and as individuals, to do it right the first time, every time. To achieve this, we will create an environment that en~urag~ our employs and supplies to prevent defects. A-11 QUALITY POLICY AND OBJECTIVES OF
K COMPANY
outstanding quality, prompt delivery and the lowest mst for each product. Every employ= of K till strive for professional excellence in his/her activity in the company and promote team work by personal example. The message of Quality, Delivery, Cost will be distinctly visible at all levels, in the management, officers and employees Total customer satisfaction shall be the goal. The very name Kshould become synonymous with quality in the national and international markets.
Quality, Delivery, philosophy.
Cost shall be the guiding
Every employee of the K will constantly work for eliminating all waste in the manufacturing and areas to achieve non-manufacturing
40
SP 63 : 1997
ANNEXB
( CZame 4.2.3 )
QUALITY PLAN FORMAT
Contract No. : Contractor Name : Contract Name :
1.0 Material
This section to include : Vendor approval Verification of suppliers certificate Testing to be done on receipt of material, etc
Q.P. No. Sl No. Component and Operation Characteristics Revision No. Classification Type of Check Quantum of Check Ref Dot Quality Plan for Acceptante Format of Record 9 Agency Remarks
10
11
41
SP 63 : 1997 2.0 In-process Inspection This section to include : All the tests and inspection carried out during processing Checks during assembly Functional testing including hydraulic and/or performance
Q.P. No. SI No. Component and Operation Characteristics Revision No. Class& cation I&of Check Quantum of Check Ref Dot
testing, etc
Quality Plan for Acceptante Format of Record 9 Agency Remarks
10
11
42
SP 63 : 1997 3.0 Final Inspection
This section to include : Verification of completeness and acceptance of all previous tests, inspection and quality audits performed and satisfactory documentation of the same Checks for appearance and cleanliness Checks for identification, painting preservation and packing, etc
Q.P. No. Sl No. Component and Operation 1 2 Characteristics Revision No. Classification ljpe of Check Quantum of Check Ref DOc Quality Plan for Acceptante Format of Record 9 Agency Remarks
10
11
43
SP 63:1997
ANNEX C ( Ch.43e 4.17 )

QUALITY
Dept Design Purchase Manufacture Q. Control Marketing Training ... Jan Feb Mar Apr
AUDIT PROGRAMME
May June July Aug Sep act Nov Dee
ANNEX
(Clause 4.17)
TYPICAL INTERNAL AUDIT SCHEDULE Period: Dept. to be Audited Circulated to: Auditee Responsible Audit Scope/ Activity Dates of Audit Coverage Auditors Name
SdlManagement Rep
44
SP 63 : 1997
ANNEX E ( CZuf4.se 4.17 )

NONCONFORMITY AUDIT REPORT AND CORRECTIVE ACTIONS
Name of Company Audit Ref No. Document used for Evaluation Details of Non-conformity Signature of Auditor Representative Action of Auditee Deptt Department/Location
Ref No. Date
Comments/Recommendation/Agree Auditor(s) Audit finding acknowledged by Corrective Action Proposed completion-.-date Corrective action verified Comments Verified by NCR Closed Date Signature
Name/ritle
Response required by (Date)
Condition corrected bY Yes/No
Date
Date
45
SP 63 : 1997
ANNEX F ( CZullse4.18 )
TRAINING RECORD
Name of Company Name: Qualification: Previous Experience: In-House Training

Date of Joining:
From Outside Courses Attended Title To be Trained in Subject: Subject:
To
Details
From
To
Details
Dept Head
46
SP 63 : 1997
ANNEX
LIST OF INDMN IS No. STANDARDS
G
TECIINIQUES
( CZmse 4.20 )
ON STATISTICAL
Title
IS No. 7300 : 1995 7600 : 1975 7920 (Part 1) : 1994
TitZe Methods for regression and correlation Analysis of variance Statistical vocabulary and symbols Probability and general statistical terms (based on IS0 3534- 1) quality control Statistical (based on IS0 3534-2) Design of experiments Criteria for the rejection of outlying observations Statistical models for industrial applications Discrete models Continuous models Designs for industrial experimentation Standard designs Orthogonal arrays Method for estimation of process capability Analysis of means - A graphical procedure Use of probability papers Pareto diagram and cause and effect diagram Statistical tolerance interval Methods for determination Statistical interpretation of Test results - Estimation of mean, Standard deviation, regression coefficient confidence interval Statistical Handbook on Quality Control
397
Method for statistical quality control during production Control charts for variables (Part 1) : 1972 Control charts for attributes (Part 2) : 198.5 and count of defects Special control charts (Part 3) : 1980 Master control systems (Part 4) : 1987 Manual on basic principles of 1548 : 1981 lot sampling inspection Sampling 2500 procedures Attribute sampling plans (Part 1) : 1992/ IS0 2859-l : 1989 indexed by acceptable quality level (AQL) for lot-by-lot inspection Inspection by variables for (Part 2) : 196.5 percent defective Sampling plans indexed by (Part 3) : 1995/ IS0 2859-2 : 1985 Limiting Quality Level (LQL) for isolated lot inspection Methods for random sampling 4905 : 1968 Guide on precision of test 5420 methods Principles and applications (Part 1) : 1969 Inter-laboratory testing (Part 2) : 1973 Statistical tests of Significance 6200 t, Normal and F-tests (Part 1) : 1995 X2 test (Part 2) : 1977 Tests for normality (Part 3) : 1984 Nonparametric tests (Part 4) : 1953 Presentation of statistical data 7200 Tabulation and (Part 1) : 1989 summarization Diagrammatic representation (Part 2) : 1975 of data Management information (Part 3) : 1982 systems quality control
(Part 2) : 1994 (Part 3) : 1996 8900 : 1978 9300 (Part 1) : 1979 (Part 2) : 1989 10427 (Part 1) : 1982 (Part 2) : 1986 10645 : 1983 12347 : 1988 12348 : 1988 12801: 1989 13131: 1991 14277 : 1996
SP 28 : 1994
47
SP 63 : 1997
ANNEX H (Clause 4.20 )

MATRIX SHOWING APPLICATION OF VARIOUS STATISTICAL FUNCTIONAL AREAS
Problem alysisl Finding Root Causes Risk Determination Finding Root
CaUseS
TECHNIQUES
IN CERTAIN
Statistical Techniques 1 1.
-\--\
Functional Areas
Product Service and Process Design
2 Control Chart techniques [IS 397 (Parts 1 to 4)] Sampling Inspection [IS 1548, IS 2500 (Parts 1 & 2) and IS 49051 Sampling Size Determination [IS 50021 Precision of Test Methods [IS 5420 (Parts 1 & 2)J Tests of Significance . [IS 6200 (Parts 1 to 4)] Summarization of Data [IS 7200 (Parts 1 & 2)] Scatter Diagram Correlation and Regression Analysis [IS 73001 Analysis of Variance [IS 76001
P *
Process ControV Nonconform&y Avoidante
Eatablishment of Product/ Process Limits 7
Fore-
Verification
Measurement of Assesment of Quality Characteristics 10
2.
3.
4.
-It 4
l
I
I
l
l*I
I I
* *
5.
--I-* --i----F
* *
6.
7.
8.
9.
Probability Distributions [IS 9300 (Parts 1 & 2)] Design of Experiments [IS 104271 Process Capability [IS 106451 Analysis of Means [IS 123471 Pareto Diagram & Cause & Effect Diagram [IS 12SOl]
10.
-I--r
t
11.
A--
12.
13.
* I
48
SP 63 : 1997
ANNEX
(Foreword)
COMMITTEE COMPOSITION Quality Management Sectional Committee, MSD 2
Chairman
Lieut Gen H. Lal, PVSM (Retd) DR SHARWAN KUMAR(Alternate to Lieut Gen H. Lal, PVSM (Retd)
Members
Federation of Indian Chambers of Commerce and Industry (FICCI), New Delhi

Representing
SHRIKR. ANANDAKUMARANNAIR SHRIC. RANGANATHAN(A~&TTI~&Z) SHRI M. S. ARUN KUMAR SHRIP.R.TAGORE(Alternate) SHRISKAGARWAL SHRISURESHKUMAR(Alternate) SHRISUDHIRANDREWS SHRIR.A.GU~TA(Alternate) LI~~TGENS.S.AFTE, PVSM(RETD)
SHRI P.K.BANERJEE
Lucas-TVS Limited, Chennai Klrloskar Electric Company Ltd, Bangalore Powergrid Corporation of India Ltd, New Delhi Institute of Hotel Management, Catering & Nutrition, New Delhi In personal capacity (E-506, Som ViharApan?nent& R K Puram, New Delhi 110022) National Thermal Power Corporation Ltd, New Delhi HMT Limited, Bangalore Flakt India Limited, Calcutta Indian Statistical Institute, Calcutta Directorate General of Technical Development, New Delhi Research Designs & Standards Organization, Lucknow
SHR~ANILGLJPTA( Alternate) SHRI H.R. BA~AVARAJU SHRIA.SRIDHARAREDDY(Alternate) SHRI R.N. BHA-ITACHARYA SHRISABYASACHILAHA( Alternate) PROFS.C.CHAKRABORTY DRD.R.CHAWLA CHIEFMECHANICALENGINEER(@) DY CHIEF MECHANICALENGINEER (P)(Alfemafe ) SHRlK.GANAPATHY SHRIK.K.M~IHU (Alternate) SHRIS.Y.GHARE SHRIR.I.TANNA( Alternate) SHRIS. K. GUFTA DRP.DASGU~TA SHRlC.P.GUPTA INDU~IALADVISER(ELEC) SHRIA.BANDHOPADHYA(Alternate) SHRIG.S.JAMAUAGNI (Alternate ) SHIXS.D.JANAKIRAMAN SHRIP.D.JOSHl SHRIN.V.WAGLE(A~~~~~~~) SHRIJ.KKHANNA SHRIRAIENDERPRA~AD( Alternate) SHRIS.LAKSHMIKANTHAN SHRIM.L.GUPTA( Alternate) DRKL.MADHOK SHRIH.WADHWA( Alternate) SHRI V.M. MANEL SHRI M.k KULKARNI( Alternate) PROFS.P.MUKHERJEE DRU.MUKHOPADHYAY( Altemare) DRSARITANAGPAL SHRIANILSACHDEV( Alternate) SHRIS.N.NANDI COLJ.KNANGPAZ LTCOLR.L.PUNI( Alternate) PROF A.N.NANKANA SHRIA.V.NARAYANAN SHRIM.JAGANNATHAN( Alemate) SHRIC.S.V.NARENDRA SHRIPRANNATW SHRIR. P.SINGH(Alternate)
Quality Circle Forum of India, Secunderabad Siemens Limited, Mumbai Mahanagar Telephone Nigam Ltd, New Delhi Directorate General of Health Services, New Delhi Indian Telephone Industries Ltd, Bangalore Development Commissioner of Small Scale Industries, New Delhi Hindustan Aeronautics Limited, Bangalore Larsen & Toubro Limited, Mumbai Directorate General of Supplies and Disposals, New Delhi Export Inspection Council of India, New Delhi VOICE, New Delhi Bajaj Auto Limited, Pune University of Calcutta, Calcutta Confederation of Indian Industry, New Delhi Department of Industrial Development, Ministty of Industry, New Delhi Directorate of Standardization, Ministry of Defence, New Delhi In personal capacity (B-109, Malviya Nagar, New D&i 110017) National Institution for Quality and Reliability, Chennai Escorts Limited, Faridabad Steel Authority of India Limited, New Delhi ( Continued on page 50 )
49
SP 63 : 1997
( Continued fiompage 49 ) Representing
Members SHRIB. S. PRABHAKAR SHRI S. K KAPooR ( Alternate ) SHFU P. SADANANDAN SHRID. R. SEN SHRIAm SINGH SHRI M. P. SINGH SHRID. I. SRW,WAVA (Ahnate ) SHRICHANDRA SHEKHAR DR V. K. KHANDFLWAL( Alremute ) SHRIV. B. SRINIVASAN SHRI K. BASIJRAO (Akmate ) SHRISANJEEV SOOD DR K S. MEHDIRA~TA ( Akemae ) SHRI S. C. TALWAR SHRI3. R. PRASHER(Alternate)
Bharat Heavy Electricals Limited, New Delhi National Centre for Software Technology, Mumbai DCM Limited, New Delhi ASSOCHAM, New Delhi Directorate General of Ordnance Factory, Calcutta Standardization, Testing and Quality Control Directorate, New Delhi Bharat Electronics Limited, Bangalore
Hospital Setvices Consultancy Corporation (India) Limited, New Delhi Engineers India Limited, New Delhi
B~UG GURDAS VERMA SHRIkKTALwAR Director (MSD),
Directorate General of Quality Assurance, New Delhi Director General, BIS (&-officio Member)
Member Secretary
SHRlk K TALWAR DIR!XCIUR (MSD), BIS
Subcommittee
Convener
for Preparation
of Supplementaxy Guides on Quality Management, MSD 2 : 2

Bureau of Indian Standards, New Delhi Export Inspection Council of India, New Delhi Bharat Heavy Electricals Ltd, New Delhi Ammunition Factory, Khadki Flakt India Limited, Calcutta National Thermal Power Corporation Ltd, New Delhi Escorts Limited, Faridabad Indian Statistical Institute, New Delhi RITES, New Delhi Bureau of Indian Standards, New Delhi Bureau of Indian Standards, New Delhi Bureau of Indian Standards, New Delhi
SHRIK RAGHAVENDRAN Members SHRIT. S. NARULA SHRIB. S. PRABHAKAR SHRID. I. SRIVAS~AVA
SHRISABYASACHI LAHA SHRIANILGU~A

SHRIC. S. V. NARENDRA
PROFS. C. CUAKRAVAFUY
SHRIRAW MILIND SHRIK M. BHATIA SHIUA. K TALWAR SHRISANJAYG~SWAMI
50
Bureau of Indian Standards BIS is a statutory institution established under the Bureau of Indian Stahdards Act, 1986 to promote harmonious development of the activities of standardization, marking and quality certification of goods and attending to connected matters in the country. Copyright No part of these publications may be reproduced in any form BIS has the copyright of all its publications. without the prior permission in writing of BIS. This does not preclude the free use, in the course of implementing the standard, of necessary details, such as symbols and sizes, type or grade designations. Enquiries relating to copyright be addressed to the Director (Publication), BIS. Review of Indian Standards Amendments are issued to standards as the need arises on the basis of comments. Standards are also reviewed periodically; a standard along with amendments is reaffirmed when such review indicates that no changes are needed; if the review indicates that changes are needed, it is taken up for revision. Users of Indian Standards should ascertain that they are in possession of the latest amendments or edition by referring to the latest issue of BIS Handbook and Standards Monthly Additions. This Indian Standard has been developed from Dot: No. MSD 2 (122). Issued Since Publication Text Affected
Amendments Amend No. Date of Issue
BUREAU Headquarters:
OF INDIAN
STANDARDS Telegrams: Manaksanstha (Common to all offices) T&phone 323 76 17,323 38 41 337 84 99,337 85 61 337 86 26,337 9120 60 38 43 1 60 20 25 235 02 16,235 04 42 1 235 15 19,235 23 15 832 92 95,832 78 58 { 832 78 91,832 78 92
Manak Bhavan, 9 Bahadur Shah Zafar Marg, New Delhi 110002 T&phones: 323 01 31,323 33 75,323 94 02 Regional Offices: Central Eastern Northern Southern Western Branches
: Manak Bhavan, 9 Bahadur Shah &far Marg
NEW DELHI 110002

: l/14 C.I.T. Scheme VII M, V.I.P. Road, Maniktola
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Explanatory Guide For Application of Quality System Standards (IS/IS0 9001,9002 AND 9003)

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Explanatory Guide For Application of Quality System Standards (IS/IS0 9001,9002 AND 9003)

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SP 63: 1997

BHAVAN, 9 BAHADUR SHAH ZAFAR NEW DELHI 110002

Quality Management Sectional Committee, MSD 2

ISASO 1ooo5 ISASO 10011-1 IsAso 10011-2

Head Design DeV.

Feedback or complaints received subcontractors and vendors.

align with the

a) To win customers confidence

f) To facilitate introduction of changes in the

Consists of HUnxords generated due to various quality related activities

1 TYPICAL QUALITY SYSTEM DOCUMENT

b) Comparison with proven designs, etc; Cl Qualification tests; and

Are there formats development planning?

Are design documented?

4.5 Document 4.5.1 General

No additional guidance required.

Document and Data Approval and Issue

a) Is there a written procedure for the issue of

a written procedure of documents?

C> Are the distribution

lists for controlled copies of the documents available?

4 Are master copies of documents along with

Is there a master list of documents indicating the latest status?

capability to deliver quantities ordered by the supplier. Requisite requirements

capability to translate into products or services. the

There are a number of ways in assessing suitability of a sub-contractor:

4 Are records of assessments and selection

100 percent inspection/testing supplier at receipt stage. at receipt stage.

d) Sampling inspection/testing by the supplier

4.7 Control of Customer-Supplied

a) Is there an established criteria for selection b)

C> Has proper provision been made for storage

4.8 Product Identification

Close monitoring, Process approvals, and Acceptance standards for workmanship.

a) Are adequate procedures

Work instructions (see also 4.2)

b) Are there instructions for describing the

C> Are there procedures for rechecking and

e) Test equipment needed

g) Precise methods of inspection h) Reference standards including regulatory

0 Are the special

S) Are qualification procedures established for

U) Are the operating persons suitably qualified

d) Quenching water bath temperature.

b) Are the controlled conditions specified for Cl

The product or contract to which procedures apply should be identified.

d) Is there a procedure to check and verily the

Has the acceptance specified?

criterion been clearly

g) Is there a mechanism for reviewing and

b) Are all necessary resources available for

C) Are all inspection and test activities carried

d) Are there suitable measures to prevent

i-9 Does inspection

ml Is the final acceptance

vii) viii) ix)

s>The validity of previous

f) Are 311calibration standards that are being

g> Are there detailed calibration procedures

h) Are there suitable recall procedures

j> All measuring equipment are critical to the

PI Are necessary environment31