Automotive Quality Systems Handbook Episode 11 pptx

l Definition of the inspection aids and test equipment to be used (see above). l Definition of the environment for the measurements to be made (see Part 2 Chapter 11). l Provision for the results of the inspections and test to be recorded  these need to be presented in a form that correlates with the specified requirements. Having carried out these inspections and tests it should be possible for you to declare that the product has been inspected and tested and objective evidence produced that will demonstrate that it meets the specified requirements. Any concessions given against requirements should also be identified. If you cant make such a declaration, you havent done enough verification. Whether or not your customer requires a certificate from you testifying that you have met the requirements, you should be in a position to produce one. The requirement for a certificate of conformance should not alter your processes, your quality controls, or your procedures. One advantage of ISO 9000 is that it will enable you to build a quality system that will give you the kind of evidence you need to assure your customers that your product meets their requirements without having to do anything special. Ensuring all inspections and test have been carried out (4.10.4.1) The standard requires the quality plan or documented procedures for final inspection and testing to require that all the specified inspections and tests, including those speci- fied either on receipt of product or in-process, have been carried out and that the data meets specified requirements . There are two aspects to final inspection. One is checking what has gone before and the other is accepting the product. Final inspection and test checks should detect whether: l All previous inspections and checks have been performed. l The product bears the correct identification, part numbers, serial numbers, modifi- cation status, etc. l The as-built configuration is the same as the issue status of all the parts, sub-assem- blies, assemblies, etc. specified by the design standard. l All recorded nonconformities have been resolved and remedial action taken and verified. Inspection and testing 387 auto210.qxd 10/04/00 21:36 Page 387 l All concession applications have been approved. l All inspection and test results have been collected. l Any result outside the stated limits is subject to an approved concession, an approved specification change, or a retest which shows conformance with the requirements. l All documentation to be delivered with the product has been produced and con- forms to the prescribed standards. Where the standard requires data to meet specified requirements this could be inter- preted in two ways. If the specified requirements included data requirements, clearly you will have to satisfy them. But if the specified requirements do not define what you have to record, whatever you record you will meet the specified requirements. Alternatively, the standard could be interpreted, and this is more likely, as implying that the results you achieve are within the limits defined by the specified requirements. The next clause requires you to complete the evidence. You may have some difficulty with this as the specified requirements may not define the same parameters as you are measuring and some analysis may be necessary to correlate the results. This analysis is all part of inspection even though it may be performed by another group of people. Ensuring no incomplete product is dispatched (4.10.4.1) The standard requires that no product be dispatched until all the activities specified in the quality plan or documented procedures have been satisfactorily completed and the associated data and documentation are available and authorized . This requirement can impose unnecessary constraints if you take it literally. Many activ- ities in quality plans and procedures are performed to give early warning of nonconformities. This is in order to avoid the losses that can be incurred if failure occurs in later tests and inspections. The earlier you confirm conformance the less costly any rework will be. ¢¢ The later the inspection the more costly the rework. Therefore you should not hold shipment if later activities will verify the same parame- ters whether or not earlier activities have been performed. It is uneconomic for you to omit the earlier activities, but if you do, and the later activities confirm that the end prod- uct meets the requirements, and that this can be demonstrated, it is also uneconomic to 388 Inspection and testing auto210.qxd 10/04/00 21:36 Page 388 go back and perform those activities that have not been completed. Your quality plan could cover installation and maintenance activities which are carried out after dispatch and so it would be unreasonable to insist that these activities were completed before dis- patch or to insist on separate quality plans just to sanitize a point. A less ambiguous way of saying the same thing is to require no product to be dispatched until objective evi- dence has been produced to demonstrate that it meets the specified or contracted requirements and authorization for its release has been given. You need four things before you can release product whether it be to a storage area, to the customer, to the site for installation, or anywhere else: l Sight of the product l Sight of the requirement with which the product is to conform l Sight of the objective evidence which purports to demonstrate that the particular product meets the requirement l Sight of an authorized signatory or the stamp of an approved stamp holder who has checked that the particular product, the evidence, and the requirement are in com- plete accord Layout inspection and functional testing (4.10.4.2) The standard requires a layout inspection and a functional verification to applicable cus- tomer engineering material and performance standards to be performed for all products at a frequency specified in the control plan . When a product undergoes design verification and validation, the tests are conducted on a small sample of product that is representative of the production standard. The vari- ation in materials, environment, and characteristics that is possible over long production runs cannot be fully predicted and, therefore, periodic tests are necessary to verify that the product in current production is of the same standard as the product that gained pro- duction approval. In some industries these checks are called verification of qualification (VOQ). In the automobile industry they are called layout inspection and functional verification. A layout inspection is the complete measurement of all part dimensions shown on the design record and a functional verification is testing to ensure that the part conforms to all customer engineering material performance standards and hence fully satisfies the approved design requirements. Inspection and testing 389 auto210.qxd 10/04/00 21:36 Page 389 The frequency of such checks and the sample size will be specified by the customer and could be annually or more or less often, depending on quantities produced and other considerations. The tests and inspections carried out need to be to the same specifications and proce- dures as those used for the original production part approval and as amended by subsequent approved engineering changes. The results of the tests should be recorded in the same format as the original tests, unless otherwise required by the customer. Inspection and test records (4.10.5) The standard requires that the supplier establishes and maintains records which provide evidence that the product has been inspected and/or tested . Types of inspection and test records Your inspection and test records or verification records should be of two forms: one which indicates what inspections and tests have been carried out and the other which indicates the results of such inspections and test. They may be merged into one record but when parameters need to be recorded it is often cleaner to separate the progress record from the technical record. Your procedures, quality plan, or product specifications should also indicate what measurements have to be recorded. Content of inspection and test records (4.10.5) The standard requires that the inspection and test records show clearly whether the product has passed or failed the inspections and/or tests according to defined accept- ance criteria. Dont assume that because a parameter is shown in a specification that an inspector or tester will record the result. A result can be a figure, a pass/fail, or just a tick. Be specif- ic in what you want recorded as you may get a surprise when gathering the data for analysis. If you use computers, you wont have the same problems but beware, too much data is probably worse than too little! In choosing the method of recording meas- urements, you also need to consider whether you will have sufficient data to minimize recovery action in the event of the measuring device subsequently being found to be out of calibration. As a general rule, only gather that data you need to determine whether the product meets the requirements or whether the process is capable of producing a product that meets the requirements. You need to be selective so that you can spot the 390 Inspection and testing auto210.qxd 10/04/00 21:36 Page 390 out-of-tolerance condition. All inspection and test records should define the acceptance criteria, the limits between which the product is acceptable and beyond which the prod- uct is unacceptable and therefore nonconforming. Action required on failed product (4.10.5) The standard requires the procedures for control of nonconforming product to apply to any product which fails to pass any inspection and/or test . The standard emphasizes that a nonconforming product is one which has failed a planned inspection and/or test. Up to that stage the product is neither conforming nor nonconforming  it is merely in-process. Hence the requirements of section 4.13 only apply after product or service has been inspected or tested and are clearly not intended to be applied at any other stage. Identifying the inspection authority (4.10.5) The standard requires that records identify the inspection authority responsible for the release of conforming product . The inspection authority is the organization that decides whether the product is con- forming or nonconforming. It may be an individual or an organization. Within an organization you may wish to identify the individual responsible so that you can go back to him/her and ask questions. This is more likely in the case of a reject decision as opposed to an acceptance decision. As products emerge from the organization there is less need to identify individuals and more of a need to identify which organization made the decision but it can be either. It is also important to protect your staff from prying users or customers or those with a grudge against the person who released the defective product. The use of numbered inspection stamps avoids putting the name of an individual on a product. The inspection authority for a document is the person who approved it. There may be other personnel in the chain such as the issuing authority or the publishing authority, but the person who verified the content is normally the approval authority. With documents that carry signatures you have less protection from prying users and so here is a good reason for excluding the name of the author or approver from the finished document if it is to be used externally. Separate document development records can be used to trace authors and approvers to specific documents. Inspection and testing 391 auto210.qxd 10/04/00 21:36 Page 391 Some organizations maintain a list of authorized signatures as a means of being able to trace signatures to names of people who carry certain authority. If you have a large number of people signing documents and records and there is a possibility that the wrong person may sign a document, the list is a good tool for checking that there has been no abuse of authority. Otherwise, the name of the individual and his or her posi- tion below or alongside the signature should be adequate. The quality system is a tool for achieving quality not for detecting criminals. If people want to commit fraud they will and the only system that comes close to preventing such incidents is a real-time com- puterized quality system  but even that is not immune to the determined hackers. Laboratory requirements (4.10.6) Use of suppliers laboratories (4.10.6) The standard requires that where inspection, testing, and calibration services are con- ducted by a suppliers laboratory facility, the laboratory shall comply with ISO/IEC 17025 including use of a laboratory scope . ISO/IEC 17025 replaces ISO/IEC Guide 25 and defines the internationally-accepted cri- teria for the technical evaluation of laboratories in the future. There are two sources of confusion with this requirement. First is the issue of accredita- tion and second is the difference between ISO/TS 16949 and ISO/IEC 17025. Accreditation and certification Laboratory accreditation is defined by ISO as formal recognition that a laboratory is competent to carry out specific tests or specific types of tests. The key words in this def- inition are competent and specific tests. Each accreditation recognizes a laboratorys technical capability (or competence) to do specific tests, measurements, or calibrations. In that sense, it should be recognized as a standalone form of very specialized technical certification, as distinct from a purely quality system certification as provided by ISO 9000. An accredited organization is authorized to issue certificates of conformity to national or international standards. ISO 9000 certification does not authorize an organ- ization to issue such certificates. Accreditation is awarded for a specific scope of service or range of products, as is certification, except that for laboratory accreditation they are accredited for very specific tests or measurements  usually within specified ranges of measurement  with associated information on uncertainty of measurement and for par- ticular product and test specifications. An ISO 9000 certificate for a laboratory does not accurately specify the performance characteristics of the product that the organization is capable of supplying. 392 Inspection and testing auto210.qxd 10/04/00 21:36 Page 392 ISO/TS 16949 vs ISO/IEC 17025 ISO/TS 16949 states that accreditation of supplier facilities to ISO/IEC 17025 or nation- al equivalent is neither required nor does it satisfy all requirements in ISO/TS 16949 . It can also be said that ISO/TS 16949 does not satisfy all the requirements of ISO/IEC 17025. Hence, ISO/IEC 17025 is the equivalent of ISO/TS 16949 for the cali- bration sector. The intent is that wherever the calibration is performed, the same standards apply. Calibrating equipment in-house should not absolve you from complying with the same requirements that you would need to impose on an external test house. As ISO/IEC 17025 does not cover some of the system elements, your laboratory should therefore be subject to audit against the relevant requirements of ISO/TS 16949. Use of independent laboratories (4.10.6) The standard requires that where inspection, testing, and calibration services are con- ducted by a commercial/independent laboratory facility, the laboratory shall be accredited to ISO/IEC 17025 or national equivalent . Currently laboratories seek accreditation to ISO/IEC Guide 25 but this is being replaced by ISO/IEC 17025 in 2000. ISO/IEC Guide 25 states in its introduction that: Laboratories meeting the requirements of this Guide comply, for calibration and testing activities, with the relevant requirements of the ISO 9000 series of standards, including those of the model described in ISO 9002, when they are acting as suppliers producing calibration and test results. However, lab- oratories meeting the minimum requirements of ISO 9002 would not meet the requirements or the intent of Guide 25 and will therefore not meet the requirements of ISO/IEC 17025. Inspection and testing 393 auto210.qxd 10/04/00 21:36 Page 393 Task list 1 Establish a receipt inspection area for processing incoming goods. 2 Prepare procedures for inspecting and testing incoming goods. 3 Classify goods so as to apply inspection and test according to the need. 4 Define the criteria for acceptance of goods into the organization. 5 Appoint an authority for releasing incoming product to storage areas or for use. 6 Establish means of dealing with nonconforming product. 7 Provide measuring facilities and equipment for use in the receipt inspection area and measures for their control. 8 Provide a quarantine area to place nonconforming product pending disposition. 9 Establish a means of tracing product back to its inspection on receipt. 10 Produce procedures for in-process and final inspection and test. 11 Provide for inspection and test plans to be produced for verifying product through the various stages of production. 12 Provide a means for progressing the inspections and tests and for identifying those responsible for carrying them out. 13 Provide inspection stations in-process to which product is passed for inspection. 14 Provide inspection aids, tools, and measuring equipment appropriate for the task. 15 Provide environmental controls for inspection and test areas where measurement accuracy requires them. 16 Provide facilities for inspectors to obtain current versions of all relevant product specifications, drawings, and process specifications. 17 Provide a means of recording inspection and test results so that any omissions can be checked at subsequent inspections. 18 Provide secure areas for storing inspection and test records. 19 Provide areas for held product pending results of final inspection. 20 Provide for products to re-enter the inspection flow following rework, repair, or mod- ification. 21 Assess your internal laboratories against ISO/IEC 17025 and act on the differences. 22 Check that your external laboratories are accredited to ISO/IEC Guide 25 as a min- imum. 23 Perform layout inspection and functional testing at a frequency defined by the cus- tomer. 394 Inspection and testing auto210.qxd 10/04/00 21:36 Page 394 Inspection and testing questionnaire 1 How do you establish the inspections and tests required to verify that the specified requirements for product are met? 2 In which procedures are the inspection and test activities documented? 3 In which documents are the inspecting and testing requirements defined? 4 In which document do you specify the inspection and test records to be established? 5 How do you ensure that product is not used until verified as conforming with spec- ified requirements? 6 How do you ensure that product is not processed until verified as conforming with specified requirements? 7 How do you ensure that product is not dispatched until verified as conforming with specified requirements? 8 How is the amount and nature of receipt inspection determined? 9 When you need to release incoming product for urgent processing, how do you enable immediate recall and replacement in the event of nonconformities being revealed? 10 How do you ensure that incoming product released for urgent production purposes is identified and recorded? 11 How do you ensure that product is inspected, tested, and identified as required by the quality plan or documented procedures? 12 How do you ensure product is held until the required inspections and tests or nec- essary reports have been received and verified? 13 In which documents do you define the inspections and tests required to complete the evidence of conformance with specified requirements? 14 How do you ensure that no product is dispatched until all the inspections and tests specified have been satisfactorily completed? 15 Which documents record the evidence that product has been inspected and tested and passed or failed defined acceptance criteria? 16 How do you ensure that records identify the inspection authority responsible for the release of product? Inspection and testing 395 auto210.qxd 10/04/00 21:36 Page 395 Dos and donts J Do attach labels to products on receipt to indicate their inspection status. L Dont mix inspected product with uninspected product. L Dont permit the release of incoming product until it has either passed inspection or a sample has been taken for inspection. J Do ensure current purchasing data is available at the place of receipt inspection. L Dont place product back in the receipt inspection area once it has been released. J Do keep a register of the articles placed in quarantine. L Dont permit articles to be removed from quarantine without authorization, a record of why they have been removed, and who has removed them. L Dont permit product to skip planned inspections and tests without the prior author- ization of the planners. J Do re-plan inspection and test in the event of rework, repair, or modification action. L Dont accept product back into the inspection flow without verification that previous inspection stages have not been invalidated. L Dont delegate inspection and test operations to others without confirming that they meet the criteria for trained inspectors and testers. L Dont permit designers to tinker with deliverable product. J Do re-validate processes that have been stopped for remedial action before running product. L Dont use gages or other tools for inspection and test purposes unless verified as accurate. L Dont release nonconforming product until remedial action has been authorized and carried out. L Dont permit inspectors to rework product unless they produced it. J Do train operators to inspect and test their own work. J Do monitor inspection errors, classify them, and act on those which are under your control. J Do protect product after inspection operations. J Do keep a check on the criteria your inspectors are using to accept product. L Dont assume that a laboratory that is registered to ISO 9002  whether internal or external  can meet the requirements of ISO/IEC 17025. L Dont apply AQLs to attribute data  set the standard as zero defects. 396 Inspection and testing auto210.qxd 10/04/00 21:36 Page 396 [...]... MEASUREMENT SYSTEM (4 .11. 2) MEASUREMENT SYSTEM ANALYSIS PLAN (4.2.3) DOCUMENT CONTROL (4.5) CALIBRATION PROCEDURES (4 .11. 2) PROTOTYPE PROGRAM (4.4.8.3) STATISTICAL TECHNIQUES (4.20) MEASUREMENT SYSTEM ANALYSIS (4 .11. 1.2) REFINE MEASUREMENT SYSTEM (4 .11. 2) MEASUREMENT SYSTEM ANALYSIS (4 .11. 4) PROCESS CONTROL (4.9) CALIBRATION/ VERIFICATION (4 .11. 2) CALIBRATION/ VERIFICATION RECORDS (4 .11. 2) QUALITY RECORDS... precise - Figure 11. 3 Dispersion of measurements relative to the true value Precise but not accurate auto 211. qxd 10/04/00 21:37 Page 412 412 Inspection, measuring, and test equipment Identifying devices that can affect product quality (4 .11. 2b) The standard requires the supplier to identify all inspection, measuring, and test equipment including measurement devices that can affect product quality Devices... however, does not cover all the aspects of element 4 .11 of ISO 9001 The requirements in element 4 .11 are linked with other elements of the standard even when there is no cross reference This relationship is illustrated in Figure 11. 1 Although the concept of a measurement system is not specifically addressed in ISO 9001, the requirements in element 4 .11 serve to establish and maintain a measurement system,...auto 211. qxd 10/04/00 21:37 Page 397 Chapter 11 Inspection, measuring, and test equipment Scope of requirements The integrity of products depends upon the quality of the devices used to create and measure their characteristics This part of the standard specifies requirements for ensuring the quality of such devices If the devices you use to create... samples used for proving the method should also be retained so as to provide a means of repeating the measurements should it prove necessary auto 211. qxd 10/04/00 21:37 Page 408 408 Inspection, measuring, and test equipment Measurement systems analysis (4 .11. 1.2) Conducting statistical studies The standard requires appropriate statistical studies to be conducted to analyze the variation present in the... In the bibliography to ISO/TS 16949 there is only one customer reference manual mentioned: the QS-9000 Measurement Systems Analysis Manual This provides excellent guidelines for selecting procedures to assess the quality of a measurement system It includes an introduction to measurement systems, explains the factors that cause variation in a measurement system, has guidance for preparing for a measurement... results With mechanical devices this is not normally necessary because wear should be detected well in advance of there being a problem by periodic calibration auto 211. qxd 10/04/00 21:37 Page 411 Inspection, measuring, and test equipment 411 With electronic devices subject to drift with time or handling, a record of the device used will enable you to identify suspect results in the event of the device... CALIBRATION/ VERIFICATION (4 .11. 2) CALIBRATION/ VERIFICATION RECORDS (4 .11. 2) QUALITY RECORDS (4.16) INSPECTION AND TESTING (4.10) PRODUCT APPROVAL (4.2.4 .11) Figure 11. 1 Clause relationships with the inspection, measuring, and test equipment element auto 211. qxd 10/04/00 21:37 Page 399 Inspection, measuring, and test equipment 399 The standard refers you to ISO 10012 for guidance in meeting these requirements... to meet this requirement you will either need a register or listing of all devices that can affect product quality or label each device so that those that affect product quality are distinguishable from those that do not This is not the same as a calibration label, as some devices that affect quality may not require calibration The means you use should enable anyone to determine whether or not the... The relationship between the various standards is illustrated in Figure 11. 4 MEASUREMENT TRACEABLE TO NATIONAL STANDARDS NATIONAL STANDARDS C A PRIMARY STANDARD (CALIBRATION LAB) L I B R SECONDARY STANDARD (CALIBRATION LAB) A T I O WORKING STANDARD (PRODUCTION) N PRODUCT CHARACTERISTICS Figure 11. 4 Traceability of standards auto 211. qxd 10/04/00 21:37 Page 414 414 Inspection, measuring, and test equipment . CONTROL (4.5) CALIBRATION PROCEDURES (4 .11. 2) CALIBRATION/ VERIFICATION (4 .11. 2) CALIBRATION/ VERIFICATION RECORDS (4 .11. 2) QUALITY RECORDS (4.16) ESTABLISH MEASUREMENT SYSTEM (4 .11. 2) STATISTICAL TECHNIQUES (4.20) auto 211. qxd. (4.2.3) PROTOTYPE PROGRAM (4.4.8.3) MEASUREMENT SYSTEM ANALYSIS (4 .11. 1.2) REFINE MEASUREMENT SYSTEM (4 .11. 2) PROCESS CONTROL (4.9) INSPECTION AND TESTING (4.10) MEASUREMENT SYSTEM ANALYSIS (4 .11. 4) PRODUCT APPROVAL (4.2.4 .11) CONTROL PLAN (4.2.4.10) DOCUMENT. element 4 .11 of ISO 9001. The requirements in element 4 .11 are linked with other elements of the standard even when there is no cross reference. This relationship is illustrated in Figure 11. 1. Although