Automotive Quality Systems Handbook Episode 12 pptx

Chapter 12 Inspection and test status Scope of requirements The requirements for inspection and test status are identification requirements that enable conforming product to be distinguishable from nonconforming product. Another term would be verification status because means other than inspection and test may be used to determine whether an item conforms with a requirement. The requirements mainly apply to manufactured product but can equally apply to software and to deliv- erable documentation. They also apply to services which involve a product such as maintenance, transport, computing, etc. but it is difficult to apply the requirements to services such as teaching, consultancy, accounting, etc. Conforming services can only be combined with nonconforming services if they remain accessible to the user. If serv- ices are found nonconforming they are usually stopped and measures put in place to prevent their use until corrected. The requirements in element 4.12 are linked with other elements of the standard even when there is no cross reference. This relationship is illustrated in Figure 12.1. Identifying inspection and test status The standard requires the supplier to identify the inspection and test status of product by suitable means, which indicate the conformance or nonconformance of product with regard to inspection and tests performed . Inspection and test status is either reject or accept. There are no gray areas. If not fully conforming the product should be rejected and identified as such. If conforming the product should be accepted and identified as such. If a nonconforming product is later deemed acceptable, the identification should be changed but this can lead to problems. auto212.qxd 10/04/00 21:38 Page 427 If the rejection was for cosmetic reasons, there is no problem but if the rejection was an out-of-tolerance condition the product should either be reworked, repaired, or regraded because the original decision may not be acceptable to all customers. If you do not do these things, the internal concessions should be carried through to the final inspection label, so that if a customer requires products to a particular specification you can check whether the out-of-tolerance condition will be acceptable. You are only required to indicate whether product conforms to the inspections and tests performed. This is not the same as indicating whether the product conforms to the cus- tomer requirements. It may well pass the prescribed inspections and tests but these inspections and tests may not be sufficiently comprehensive to verify conformance to all the customers requirements. However, the only indication you can give is the products conformance or nonconformance with some verification requirement. It follows there- fore that you should not go around putting reject labels on products, or acceptance labels for that matter, if you have not performed a specific inspection to determine con- formance. There are only three conditions: uninspected, inspected and found conforming, and inspected and found nonconforming. If you have a policy of only applying labels after inspection, anything without a label is therefore deemed unin- spected, unless it has been installed and the label removed. Identifying inspection and test status is not just a matter of tying a label on a product. The status should be denoted by an authorized signature, stamp, mark, or other identi- ty which is applied by the person making the accept/reject decision and which is secure 428 Inspection and test status Figure 12.1 Clause relationships with the inspection and test status element UNINSPECTED PRODUCT CONTROL OF NONCONFORMING PRODUCT (4.13) CONFORMING PRODUCT IDENTITY (4.12) CONTROL OF CONFORMING PRODUCT (4.15) NONCONFORMING PRODUCT IDENTITY (4.12) INSPECTION AND TESTING (4.10) auto212.qxd 10/07/00 16:49 Page 428 from misuse. Signatures are acceptable as a means of denoting verification status on paper records but are not suitable for computerized records. Secure passwords and write-only protection has to be provided to specific individuals. Signatures in a work- shop environment are susceptible to deterioration and illegibility, which is why numbered inspection stamps with unique markings have evolved. The ink used has to survive the environment and if the labels are to be attached to the product for life, it is more usual to apply an imprint stamp on soft metal or a bar code. The method of identification depends upon the type, size, quantity, or fragility of the product. You can mark the product directly (provided the item is not an appearance item) or tie a label to it or the container in which it is placed. You can also use records remote from the product providing they bear a unique identity that is traceable to the product. Marking products has its limitations as it may damage the product, be removed, or dete- riorate during subsequent processing. If applied directly to the product, the location and nature of identification should be specified in the product drawings or referenced process specifications. If applied to labels which themselves are permanently secured to the product, the identification needs to be visible when the product is installed so as to facilitate checks without its removal. Small and fragile products should be held in containers and the container sealed and marked with the inspection status. Large products should either carry a label or have a related inspection record. In some situations the location of a product can constitute adequate identification of inspection status. However, these locations need to be designated as Awaiting Inspection, Accepted Product, or Reject Product or other such labels as appropri- ate to avoid the inadvertent placement of items in the wrong location. The location of product in the normal production flow is not a suitable designation unless an automat- ed transfer route is provided. When a service is out of service, tell your customers. Services which rely on products should carry a label or a notice when accessed. A bank cash machine is one example where a notice is displayed when the machine is out of service. In some cases customers may need to be informed by letter or telephone. With software the verification status can be denoted in the software as a comment or on records testifying its conformance with requirements. With documentation you can denote verification status either by an approval signature on the document or by a reference number, date, and issue status which is traceable to records containing the approval signatures. Inspection and test status 429 auto212.qxd 10/04/00 21:38 Page 429 Maintaining inspection and test status The standard requires the supplier to maintain the identification of inspection and test status of the product, as defined in the quality plan and/or documented procedures throughout production, installation, and servicing to ensure that only product that has passed the required inspections and tests (or released under an authorized concession) is dispatched, used, or installed . Maintaining inspection and test status means retaining the status markings once they have been affixed or recorded until your responsibility for the product ceases. Labels should be attached in a way that prevents their detachment during handling. If labels need to be removed during further processing, the details should be transferred to inspection records so that at a later date the status of the components in an assembly can be checked through the records. At dispatch, the inspection status of product should be visible. Any product without inspection status identification should be quarantined until re-inspected and found conforming. It should be possible when walking through a machine shop, for example, to identify which products are awaiting inspection, which have been inspected and found con- forming, and which have been rejected. If, by chance, some product were to become separated from its parent batch, it should still be possible to return the product to the location from whence it came. A machine shop is where this type of identification is essential  it is where mix-ups can occur. In other places, where mix-ups are unlikely, inspection and test identification does not need to be so explicit. Not all product intended for delivery may in fact have passed the required inspections and tests as the customer may have waived some of the requirements for that particu- lar delivery. Hence the reference to release under an authorized concession. Identifying product correctly will help preclude any unidentified or nonconforming product from being delivered, used, or installed. However, the only way to make certain is to remove them from areas where they may be inadvertently dispatched, used, or installed. Inspection and test status procedures The standard doesnt require a procedure covering inspection and test status; however, as clause 4.2 requires a documented quality system, you will need to document the methods employed to denote inspection and test status. If you use stamps you will need a register to allocate stamps to particular individuals and to indicate which stamps have been withdrawn. When a person hands in a stamp it is good practice to avoid using the same number for 12 months or so to prevent mistaken identity in any subsequent inves- tigations. 430 Inspection and test status auto212.qxd 10/04/00 21:38 Page 430 Task list 1 Document the methods you employ to denote inspection and test status for hard- ware, software, documents, and services. 2 Specify the status identification methods to be used in product drawings and speci- fications. 3 Provide separate designated areas for holding product awaiting inspection, passed inspection, and failed inspection. 4 Label these areas to prevent inadvertent misplacement of product. 5 Maintain registers of inspection stamp holders. Inspection and test status questionnaire 1 How do you identify product in a way that indicates its conformance or nonconfor- mance with regard to inspections and tests performed? 2 How do you ensure the identification of inspection and test status is maintained throughout production and installation? Dos and donts L Dont re-assign inspection stamps to another individual until a reasonable period of time has elapsed. J Do secure stamps from unauthorized use. L Dont leave stamps unattended. L Dont lend your stamp to another person. L Dont stamp anything unless you have personally inspected the item. L Dont stamp any document unless there is a proper location to place the stamp because it could mean anything  a stamp has to indicate that the specified require- ments have been met. Inspection and test status 431 auto212.qxd 10/04/00 21:38 Page 431 auto212.qxd 10/04/00 21:38 Page 432 Chapter 13 Control of nonconforming product Scope of requirements The definition of nonconformity in ISO 8402 states that it is the nonfulfillment of speci- fied requirements; therefore a nonconforming product is one that does not conform to the specified requirements. Specified requirements are either requirements prescribed by the customer and agreed by the supplier in a contract for products or services, or are requirements prescribed by the supplier which are perceived as satisfying a market need. This limits the term nonconformity to situations where you have failed to meet customer requirements. However, ISO 8402:1987 suggests that nonconformity also applies to the absence of one or more quality system elements, but clearly the requirements of clause 4.13 cannot be applied to nonconformity with quality system requirements . Both ISO 9001 and ISO 9004 only address nonconformity in the context of products, process- es, and services and when addressing quality system elements the term deficiencies is used. Some auditors use the term nonconformity to describe a departure from the require- ments of ISO 9001 but it would be preferable if they chose the term noncompliance to avoid any confusion. The requirements of clause 4.13 therefore only apply to products, processes, and services and not to activities, quality system elements, or procedures. The standard does not make it clear whether these requirements apply to nonconformi- ties detected while the supplier is responsible for the product or after the suppliers responsibility ceases, as is the case with nonconformity reports received from customers. Reports of nonconformities are also addressed under Corrective Action in clause 4.14 but it is assumed that in this case the standard is concerned with external reports of non- conformities. There will also be cases where you fully satisfy the specified requirements but the prod- uct is unfit for use because of omissions in the specified requirements. ISO 8402 states that the nonfulfillment of intended usage requirement is a defect. ISO 9000 does not address the subject of defects because it assumes that a product which meets the speci- auto213.qxd 10/04/00 21:38 Page 433 fied requirements must meet intended usage requirements. However, a product may fail to meet the specified requirements and still be fit for use. The definition of quality com- plicates the issue even more. ISO 9000 requires that you meet specified requirements, it does not require that you produce products which satisfy stated or implied needs, or sat- isfy intended usage requirements or meet customer expectation. In practice, however, you should produce products and services which: l Satisfy the specified requirements l Satisfy intended usage requirements l Satisfy stated or implied needs l Satisfy your own requirements l Satisfy customer expectations All these may be in harmony but there may be occasions when there is conflict. To avoid any confusion you should classify all failures to meet these four requirements as non- conformities and then assign classification so as to treat each according to its merits. The requirements in element 4.13 are linked with other elements of the standard even when there is no cross reference. This relationship is illustrated in Figure 13.1. The standard indicates that these requirements are to apply to product that is suspected of being nonconforming  which might be the case with a batch of product that has failed the sampling inspection. Only the samples checked are definitely nonconforming  the others in the batch are only suspected as being nonconforming. You should there- fore look further than the product that has been found to be nonconforming and seek out other products which may possess the same characteristics as those found to be nonconforming. These other products may have already been released to customers. This latter situation can arise if you discover the measuring or processing equipment to be inaccurate or malfunctioning. Any product that has passed through that process since it was last confirmed as serviceable is now suspect. This aspect is also covered in clause 4.11.2(f). Seeking suspect product should also be a factor to be considered when deter- mining corrective action (see Part 2 Chapter 14). Another example of suspect product is when product is mishandled but shows no obvi- ous signs of damage. This may arise when product is dropped or not handled in the stipulated clean conditions or in accordance with electrostatic safe-handling procedures. Suspect product should be treated in the same manner as nonconforming product and quarantined until dispositioned. However, until a nonconformity can be proven, the doc- umentation of the nonconformity merely reveals the reason for the product being suspect. 434 Control of nonconforming product auto213.qxd 10/04/00 21:38 Page 434 Classifying nonconformities Although the standard does not recognize any classification of nonconformities, the practical application of nonconformity controls requires controls to be balanced with the severity of the nonconformity. It is not necessary to seek concessions from a customer against requirements that have not been specified, or seek design authority approval for workmanship imperfections. The definition of the term defect in ISO 8402, and the fact that there are many requirements other than those specified in a contract or needed to satisfy market needs, demands that it is sensible to classify nonconformities into three categories: l Critical Nonconformity: a departure from the specified requirements which renders the product or service unfit for use l Major Nonconformity: a departure from the specified requirements included in the contract or market specification l Minor Nonconformity: a departure from the suppliers requirements not included in the contract or market specification Control of nonconforming product 435 Figure 13.1 Clause relationships with the control of nonconforming product element INSPECTION AND TESTING (4.10) REMEDIAL ACTION (4.9) APPLY FOR WAIVER (4.13.2 & 4.13.4) PRODUCT CONFORMS? INSPECTION AND TEST STATUS (4.12) SEGREGATE PRODUCT (4.13.1.1) DOCUMENT NONCONFORMITY (4.13.1.1) STORAGE (4.15.3) CORRECTIVE ACTION (4.14.2.1) EVALUATE NONCONFORMITY (4.13.1.1) REVIEW NONCONFORMITY (4.13.1.2) DISPOSITION PRODUCT (4.13.1.2) USE-AS-IS? RECORD DISPOSITION (4.13.1.1) QUALITY RECORDS (4.16) No INSPECTION AND TEST STATUS (4.12) Yes CONFORMING MATERIAL (4.15) No Yes NONCONFORMITY REDUCTION (4.13.1.3) PRODUCT SHIPPED? INFORM CUSTOMER (4.13.1.3) Yes auto213.qxd 10/07/00 16:49 Page 435 Note that these are not the same as the nonconformity classifications used in assessing quality systems; see Part 1 Chapter 5. Ensuring that nonconforming product is not used (4.13.1.1) The standard requires the supplier to establish and maintain documented procedures to ensure that product that does not conform to specified requirements is prevented from inadvertent use or installation . A nonconformity exists only when product has been inspected against an acceptance standard and found not to comply. Prior to this the product is either serviceable or unserviceable. Unserviceable products are not necessarily nonconforming  they may simply lack lubrication or calibration. A piece of test equipment, the calibration date of which has expired, is not nonconforming  it is merely unserviceable. When checked against a standard it may be found to be out of calibration and it is then nonconform- ing, but it could be found to be within the specified calibration limits . The only sure way of preventing inadvertent use of nonconforming product is to destroy it, but that may be a little drastic in some cases. It may be possible to eliminate the non- conformity by repair, completion of processing, or rework. A more practical way of preventing the inadvertent use or installation of nonconforming or unserviceable prod- ucts is to identify the product as nonconforming or unserviceable and place in an area where access to it is controlled. These two aspects are covered further below. Identifying nonconforming product (4.13.1.1 and 4.13.1.2) The standard requires the supplier to provide for the identification of nonconforming product and that this identification be visual . The most common method is to apply labels to the product that are distinguishable from other labels. It is preferable to use red labels for nonconforming and unserviceable items and green labels for conforming and serviceable items. In this way you can determine product status at a distance and reduce the chance of confusion. You can use segrega- tion as a means of identifying nonconforming product but if there is the possibility of mixing or confusion, this means alone should not be used. On the labels themselves you should identify the product by name and reference num- ber, specification and issue status if necessary and either a statement of the nonconformity or a reference to the service or nonconformity report containing full 436 Control of nonconforming product auto213.qxd 10/04/00 21:38 Page 436 [...]... be made by the authority responsible for drawing up or selecting the specification It may be sensible to engage investigators or quality engineers to review the options to be considered and propose remedial actions for the authorities to consider In your procedures or the quality plan you should identify the various bodies that need to be consulted for each type of specification Departures from customer... nonconformities The requirement may be in the wrong place (i.e in 4.13 rather than 4.14) but it is a useful addition nonetheless The nonconformity data should be collected and quantified using one of the seven quality tools (see Part 2 Chapter 14), preferably the Pareto analysis You can then devise a plan to reduce the 20% of causes that account for 80% of the nonconformities However, take care not to degrade... log book for the workshop or area, such as a process log The detail you record depends upon the severity of the nonconformity and to whom it needs to be communicated In some cases a patrol inspector or quality engineer can deal with minor snags on a daily basis, as can an itinerant designer Where the problem is severe and remedial action complicated, a panel of experts may need to meet Rather than gather... a concession from your customer While it is generally believed that nonconformities indicate an out-of-control situation, providing you detect and rectify them before release of the product, you have quality under control, and have no need to report nonconformities to your customer In informing your customer when nonconforming product has been shipped you obviously need to do this immediately you are... readily accessible when problems arise later Re-inspection of repaired and reworked product (4.13.2) The standard requires the supplier to re-inspect repaired and reworked product in accordance with the quality plan and/or documented procedures Any product that has had work done to it should be re-inspected prior to it being released to ensure the work has been carried out as planned and has not affected... reports 9 Decide on who is to evaluate nonconformities 10 Prepare procedures for the processing of nonconforming articles 11 Provide quarantine areas in which to place articles pending disposition action 12 Prepare procedures for controlling these quarantine areas 13 Set up a review board to disposition nonconformities and allocate responsibilities 14 Set up a file for storing records of nonconformity... agreement to any repair instructions prior to being implemented J Do file nonconformity data where operators and inspectors can review it L Don’t limit the nonconformity review board to members of the quality department J Do subject reported subcontractor nonconformities to equal treatment J Do achieve unanimous agreement on the disposition of all nonconformities J Do keep the records of the nature... action because it should prevent the supply of nonconforming product to the customer However, an error becomes a nonconformity when detected at any acceptance stage in the process, as indicated in clause 4 .12 of the standard Therefore an action taken to eliminate a potential nonconformity prior to an acceptance stage is a preventive action This rules out any inspection stages as being preventive action measures... relationship is illustrated in Figure 14.1 auto214.qxd 10/07/00 16:51 Page 451 Corrective and preventive action 451 FAILURE MODE & EFFECT ANALYSIS (4.2.4.5) RETURNED PRODUCTS PURCHASING (4.6) INTERNAL QUALITY AUDIT (4.17) TRAINING (4.18) PROCESS CONTROL (4.9) DESIGN CONTROL (4.4) PURCHASING (4.6) TRAINING (4.18) INTERNAL AUDITS (4.17) ACTUAL/SUSPECT NONCONFORMITIES (4.13.1.2) DIAGNOSIS (4.14.2.1 & 4.14.2.3)... ANALYSIS (4.14.3) EVALUATION (4.14.2.1) EVALUATION (4.14.3) CORRECTIVE ACTION PLAN (4.14.2.1) PREVENTIVE ACTION PLAN (4.14.3) IMPLEMENTATION (4.14.2.1) MISTAKE PROOFING (4.14.1.3) IMPLEMENTATION (4.14.3) QUALITY SYSTEM (4.2) DOCUMENT CONTROL (4.5) CORRECTIVE/ PREVENTIVE ACTION VERIFICATION (4.14) DESIGN CONTROL (4.4) PROCESS CONTROL (4.9) PLANT/FACILITY.EQUIPMENT PLANNING (4.2.5) TOOLING MANAGEMENT (4.2.6) . corrected. The requirements in element 4 .12 are linked with other elements of the standard even when there is no cross reference. This relationship is illustrated in Figure 12. 1. Identifying inspection and. test status Figure 12. 1 Clause relationships with the inspection and test status element UNINSPECTED PRODUCT CONTROL OF NONCONFORMING PRODUCT (4.13) CONFORMING PRODUCT IDENTITY (4 .12) CONTROL OF CONFORMING PRODUCT. IDENTITY (4 .12) CONTROL OF CONFORMING PRODUCT (4.15) NONCONFORMING PRODUCT IDENTITY (4 .12) INSPECTION AND TESTING (4.10) auto 212. qxd 10/07/00 16:49 Page 428 from misuse. Signatures are acceptable as a means