Automotive Quality Systems Handbook Episode 12 pptx

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 nonco

be combined with nonconforming services if they remain accessible to the user If ices are found nonconforming they are usually stopped and measures put in place toprevent their use until corrected.

serv-The requirements in element 4.12 are linked with other elements of the standard evenwhen 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 withregard to inspection and tests performed

Inspection and test status is either “reject” or “accept” There are no gray areas If notfully conforming the product should be rejected and identified as such If conforming theproduct should be accepted and identified as such If a nonconforming product is laterdeemed acceptable, the identification should be changed but this can lead to problems

If the rejection was for cosmetic reasons, there is no problem but if the rejection was anout-of-tolerance condition the product should either be reworked, repaired, or regradedbecause the original decision may not be acceptable to all customers If you do not dothese things, the internal concessions should be carried through to the final inspectionlabel, so that if a customer requires products to a particular specification you can checkwhether the out-of-tolerance condition will be acceptable.

You are only required to indicate whether product conforms to the inspections and testsperformed 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 theseinspections and tests may not be sufficiently comprehensive to verify conformance to allthe customer’s requirements However, the only indication you can give is the product’sconformance or nonconformance with some verification requirement It follows there-fore that you should not go around putting reject labels on products, or acceptancelabels for that matter, if you have not performed a specific inspection to determine con-formance There are only three conditions: “uninspected”, “inspected and foundconforming”, and “inspected and found nonconforming” If you have a policy of onlyapplying 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

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)

from misuse Signatures are acceptable as a means of denoting verification status onpaper records but are not suitable for computerized records Secure passwords and

“write-only” protection has to be provided to specific individuals Signatures in a shop environment are susceptible to deterioration and illegibility, which is whynumbered inspection stamps with unique markings have evolved The ink used has tosurvive the environment and if the labels are to be attached to the product for life, it ismore usual to apply an imprint stamp on soft metal or a bar code

work-The method of identification depends upon the type, size, quantity, or fragility of theproduct You can mark the product directly (provided the item is not an “appearanceitem”) or tie a label to it or the container in which it is placed You can also use recordsremote from the product providing they bear a unique identity that is traceable to theproduct

Marking products has its limitations as it may damage the product, be removed, or riorate during subsequent processing If applied directly to the product, the location andnature of identification should be specified in the product drawings or referencedprocess specifications If applied to labels which themselves are permanently secured tothe product, the identification needs to be visible when the product is installed so as tofacilitate checks without its removal

dete-Small and fragile products should be held in containers and the container sealed andmarked with the inspection status Large products should either carry a label or have arelated inspection record

In some situations the location of a product can constitute adequate identification ofinspection status However, these locations need to be designated as “AwaitingInspection”, “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 ofproduct 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 productsshould carry a label or a notice when accessed A bank cash machine is one examplewhere a notice is displayed when the machine is out of service In some cases customersmay need to be informed by letter or telephone

With software the verification status can be denoted in the software as a comment or onrecords 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 torecords containing the approval signatures

Maintaining inspection and test status

The standard requires the supplier to maintain the identification of inspection and teststatus of the product, as defined in the quality plan and/or documented proceduresthroughout production, installation, and servicing to ensure that only product that haspassed 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 theyhave been affixed or recorded until your responsibility for the product ceases Labelsshould be attached in a way that prevents their detachment during handling If labelsneed to be removed during further processing, the details should be transferred toinspection records so that at a later date the status of the components in an assemblycan be checked through the records At dispatch, the inspection status of product should

be visible Any product without inspection status identification should be quarantineduntil re-inspected and found conforming

It should be possible when walking through a machine shop, for example, to identifywhich products are awaiting inspection, which have been inspected and found con-forming, and which have been rejected If, by chance, some product were to becomeseparated from its parent batch, it should still be possible to return the product to thelocation from whence it came A machine shop is where this type of identification isessential – 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 inspectionsand 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 Identifyingproduct correctly will help preclude any unidentified or nonconforming product frombeing delivered, used, or installed However, the only way to make certain is to removethem 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 themethods 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 havebeen withdrawn When a person hands in a stamp it is good practice to avoid using thesame number for 12 months or so to prevent mistaken identity in any subsequent inves-tigations

4 Label these areas to prevent inadvertent misplacement of product.

5 Maintain registers of inspection stamp holders.

Inspection and test status questionnaire

1How do you identify product in a way that indicates its conformance or mance with regard to inspections and tests performed?

nonconfor-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.

speci-es, and services and when addressing quality system elements the term deficiencies isused 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 toavoid 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’sresponsibility ceases, as is the case with nonconformity reports received from customers.Reports of nonconformities are also addressed under Corrective Action in clause 4.14but 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 uct is unfit for use because of omissions in the specified requirements ISO 8402 statesthat the nonfulfillment of intended usage requirement is a defect ISO 9000 does notaddress the subject of defects because it assumes that a product which meets the speci-

prod-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 plicates the issue even more ISO 9000 requires that you meet specified requirements, itdoes 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:

com-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 avoidany 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 evenwhen 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 hasfailed the sampling inspection Only the samples checked are definitely nonconforming

– the others in the batch are only suspected as being nonconforming You should fore look further than the product that has been found to be nonconforming and seekout other products which may possess the same characteristics as those found to benonconforming These other products may have already been released to customers.This latter situation can arise if you discover the measuring or processing equipment to

there-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 clause4.11.2(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 ous signs of damage This may arise when product is dropped or not handled in thestipulated clean conditions or in accordance with electrostatic safe-handling procedures.Suspect product should be treated in the same manner as nonconforming product andquarantined until dispositioned However, until a nonconformity can be proven, the doc-umentation of the nonconformity merely reveals the reason for the product being suspect

obvi-Classifying nonconformities

Although the standard does not recognize any classification of nonconformities, thepractical application of nonconformity controls requires controls to be balanced with theseverity of the nonconformity It is not necessary to seek concessions from a customeragainst requirements that have not been specified, or seek design authority approval forworkmanship imperfections The definition of the term defect in ISO8402, and the factthat there are many requirements other than those specified in a contract or needed tosatisfy market needs, demands that it is sensible to classify nonconformities into threecategories:

l Critical Nonconformity: a departure from the specified requirements which rendersthe product or service unfit for use

l Major Nonconformity: a departure from the specified requirements included in thecontract or market specification

l Minor Nonconformity: a departure from the supplier’s requirements not included inthe contract or market specification

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

SHIPPED? Yes INFORM CUSTOMER(4.13.1.3)

Note that these are not the same as the nonconformity classifications used in assessingquality 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 toensure that product that does not conform to specified requirements is prevented frominadvertent use or installation

A nonconformity exists only when product has been inspected against an acceptancestandard and found not to comply Prior to this the product is either serviceable orunserviceable Unserviceable products are not necessarily nonconforming – they maysimply lack lubrication or calibration A piece of test equipment, the calibration date ofwhich has expired, is not nonconforming – it is merely unserviceable When checkedagainst 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 conformity by repair, completion of processing, or rework A more practical way ofpreventing the inadvertent use or installation of nonconforming or unserviceable prod-ucts is to identify the product as nonconforming or unserviceable and place in an areawhere access to it is controlled These two aspects are covered further below

non-Identifying nonconforming product (4.13.1.1 and 4.13.1.2)

The standard requires the supplier to provide for the identification of nonconformingproduct and that this identification be visual

The most common method is to apply labels to the product that are distinguishable fromother labels It is preferable to use red labels for nonconforming and unserviceable itemsand green labels for conforming and serviceable items In this way you can determineproduct 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 ofmixing or confusion, this means alone should not be used

On the labels themselves you should identify the product by name and reference ber, specification and issue status if necessary and either a statement of thenonconformity or a reference to the service or nonconformity report containing full

num-details of its condition Finally the person or organization testifying the nonconformityshould be identified either by name or inspection stamp.

Unlike products, nonconforming services are usually rendered unavailable for use bynotices such as “Out of Order” or by announcements such as “Normal service will beresumed as soon as possible” Products are often capable of operation with nonconfor-mities whereas services tend to be withdrawn once the nonconformity has beendetected, however trivial the fault

Documenting nonconforming product (4.13.1.1)

The standard requires the supplier to provide for the documentation of nonconformingproduct

There are several ways in which you can document the presence of a nonconformity.You can record the condition:

l On a label attached to the item

l On a form unique to the item, such as a nonconformity report

l Of functional failures on a failure report and physical errors on a defect report

l In a log book for the item, such as an inspection history record or snag sheet

l In a 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 itneeds to be communicated In some cases a patrol inspector or quality engineer candeal 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 Ratherthan gather around the nonconforming item, it may be more practical to document theremedial action on a form In some cases the details may need to be conveyed to thecustomer off-site and in such cases a log book or label would be inappropriate It isimportant when documenting the nonconformity that you record as many details as youcan because they may be valuable to any subsequent investigation in order to preventits recurrence In addition to the product name, reference number, serial number, andspecification issue, you may need to record the operating conditions, temperature,humidity, time of day, identification of inspection and test equipment used, and anyother details that may help diagnose the cause

Evaluation of nonconforming product (4.13.1.1)

The standard requires the supplier to provide for the evaluation of nonconformingproduct

Evaluating nonconforming product is a process of determining the effects of the conformity, classifying it as to its severity, and providing information of use to those whowill decide what to do about it Establishing the cause of the nonconformity so as toavoid making further nonconforming product is dealt with under Corrective action;however, with new products the remedial action may well take the form of a redesignwhich will not only eliminate the nonconformity but prevent it from recurring with thatparticular product Of course, it may not prevent it from recurring with other designs;that is the purpose of preventive action (see Part 2 Chapter 14)

non-Segregation of nonconforming product (4.13.1.1 and 4.13.1.2)The standard requires the supplier to provide for the segregation (when practical) ofnonconforming product and that quarantine areas have visual identification

Segregating a nonconforming product (or separating good from bad) places it in an areawith restricted access Such areas are called quarantine areas Products should remain

in quarantine until disposal instructions have been issued The area should be clearlymarked and a register maintained of all items that enter and exit the area Without a reg-ister you won’t be able to account for the items in the area, check whether any aremissing, or track their movements The quarantine store may be contained within anoth-

er area, providing there is adequate separation that prevents mixing of conforming andnonconforming articles Where items are too large to be moved into a quarantine area,measures should be taken to signal to others that the item is not available for use andthis can be achieved by cordons or floor markings With services the simplest method is

to render the service unavailable or inaccessible

Disposition of nonconforming product (4.13.1.1)

The standard requires the supplier to provide for the disposition of nonconforming uct and for notification to the functions concerned

prod-Disposition means to dispose of or decide what to do with the nonconforming item:whether to use it, repair it, scrap it, etc The options available are discussed later By pro-viding for the disposition of product you need to determine the action to take and notify

those who are to carry it out You cannot merely accumulate nonconforming items in aquarantine area Apart from anything else they occupy valuable space and could pres-ent a hazard as they deteriorate To implement this requirement you will need a form orother such document in which to record the decision and to assign the responsibility forthe remedial action.

Nonconformity reduction plan

The standard requires suppliers to quantify, analyze, and reduce all nonconformingproduct by establishing a corrective action plan and tracking progress

Element 4.13 of ISO 9001 deals with specific nonconformities and element 4.14 dealswith the action to eliminate their cause and prevent their recurrence This additionalISO/TS 16949 requirement does seem to duplicate what is covered in clause 4.14.2.However, it does add a significant aspect – a reduction plan One could be complyingwith elements 4.13 and 4.14 of ISO 9001 but have no reduction plan, since element4.14 does not impose any time constraints on corrective action or require the incidence

of nonconformity to be reduced It is quite possible to take corrective action ously and still not reduce the number of nonconformities The requirement may be inthe 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 qual-ity tools (see Part 2 Chapter 14), preferably the Pareto analysis You can then devise aplan to reduce the 20% of causes that account for 80% of the nonconformities.However, take care not to degrade other processes by your actions (see Theory of con-straints in Part 2 Chapter 2) The plan should detail the action to be taken to eliminatethe cause and the date by which a specified reduction is to be achieved You should alsomonitor the reduction The appropriate data collection measures therefore need to be inplace to gather the data at a rate commensurate with the production schedule Monthlyanalysis may be too infrequent; analysis by shift may be more appropriate

continu-Defining disposition responsibility (4.13.2)

The standard requires the supplier to define the responsibility for review and authorityfor the disposition of nonconforming product

The decision on product acceptance is a relatively simple one because there is a fication against which to judge conformance When product is found to benonconforming there are three decisions you need to make based on the following ques-tions:

speci-l Can the product be made to conform?

l If the product cannot be made to conform, is it fit for use?

l If the product is not fit for use, can it be made fit for use?

The authority for making these decisions will vary depending on the answer to the firstquestion If, regardless of the severity of the nonconformity, the product can be made toconform simply by rework or completing operations, these decisions can be taken byoperators or inspectors, providing rework is economical Decisions on scrap, rework,and completion would be made by the fund-providing authority rather than the designauthority If the product cannot be made to conform by using existing specifications,decisions requiring a change or a waiver of a specification should be made by theauthority 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 cedures or the quality plan you should identify the various bodies that need to beconsulted for each type of specification Departures from customer requirements willrequire customer approval; departures from design requirements will require designapproval; departures from process requirements will require process engineeringapproval, etc The key lies in identifying who devised or selected the requirement in thefirst place All specifications are but a substitute for knowledge of fitness for use – anydeparture from such specification must be referred back to the specification authors for

pro-a judgement

Review of nonconforming product (4.13.2, 4.13.3, and 4.15.3.2)The standard requires the supplier to review nonconforming product in accordance withdocumented procedures and advises that it may be:

a) Reworked to meet the specified requirements, or

b) Accepted with or without repair by concession, or

c) Regraded for alternative applications, or

d) Rejected or scrapped

There is also a supplementary requirement in clause 4.15.3.2 that requires obsoleteproduct to be controlled in a similar manner to nonconforming product This requires

that you identify obsolete product and pass it through your nonconforming productprocess for appropriate disposition.

Several terms here may need explanation as they are unusual outside manufacturingindustry

Rework means the continuation of processing that will make an item conform to fication Rework requires only normal operations to complete the item and does notrequire any additional instructions Rework when applied to documents means correct-ing errors without changing the original requirement

speci-If you choose to accept a nonconforming item as is without rework, repair, etc., you are

in effect granting a concession or waiving the requirement only for that particular item

If the requirements cannot be achieved at all, this is not a situation for a concession but

a case for a change in requirement If you know in advance of producing the product orservice that it will not conform with the requirements, you can then request a deviationfrom the requirements This is often referred to as a production permit Concessionsapply after the product has been produced, production permits apply before it has beenproduced and both are requests that should be made to the acceptance authority for theproduct

In some cases products and services are offered in several models, types, or other ignations but are basically of the same design Those which meet the higher specificationare graded as such and those which fail may meet a lower specification and can beregraded The grading should be reflected in the product identity so that there is no con-fusion

des-The inclusion of the term rejected is not a disposition because all nonconforming itemsare initially rejected Items may be rejected and then returned to their supplier for actionbut all other rejections should be subject to one of the other dispositions

Scrapping an item should not be taken lightly – it could be an item of high value.Scrapping may be an economical decision with low cost items, whereas the scrapping

of high value items may require prior authorization as salvage action may provide a sibility of yielding spares for alternative applications

pos-The list in the standard omits two other possibilities, those of modification and tion A product that is nonconforming may be so due to errors in the specification andcan be eliminated by a modification to the design The product may meet the specifiedrequirement but be unfit for use, in which case this is a major modification

comple-Alternatively, the product may meet the supplier’s specifications but not meet the tomer or market specified requirements; this calls for a minor modification Some

cus-modifications may be necessary only for certain batches due to variations in material orcomponent tolerances Modifications may be necessary to overcome component obso-lescence or changes in bought-in parts that were not covered by the procurementspecification.

Completion of product is different to rework as “rework” implies that something was ried out incorrectly whereas “returning product for completion” implies that somethingwas not done at all This minor distinction can be a useful classification in subsequentanalyses

car-To meet this requirement your documented procedures should specify the authoritieswho make the disposition, where it is to be recorded, and what information should beprovided in order that it can be implemented and verified as having been implemented

In order to implement these requirements your nonconformity control proceduresshould include the following actions:

l Specify how product should be scrapped or recycled, the forms to be used, theauthorizations to be obtained

l Specify the various repair procedures, how they should be produced, selected, andimplemented

l Specify how modifications should be defined, identified, and implemented

l Specify how production permits (deviations) and concessions (waivers) should berequested, evaluated, and approved or rejected

l Specify how product should be returned to its supplier, the forms to be completed,and any identification requirements in order that you can detect product on itsreturn

l Specify how regrading product is to be carried out, the product markings, priorauthorization, and acceptance criteria

When making the disposition your remedial action needs to address:

l Action on the nonconforming item to remove the nonconformity

l A search for other similar items which may be nonconforming (i.e suspect product)

l Action to recall product containing suspect nonconforming product

If you need to recall product that is suspected as being defective you will need to devise

a recall plan, specify responsibilities and time-scales, and put the plan into effect.Product recall is a remedial action not a corrective action, as it does not prevent a recur-rence of the initial problem

An auditor would expect to find staff consulting the rework instructions when carryingout rework However, information in documents can be memorized or become habitthrough familiarity with the process Rework instructions are often unique to the non-conformity and therefore personnel cannot rely on prior knowledge This is addressed

as a supplementary requirement in clause 4.14.3

When deciding on repair or rework action, you may need to consider whether the resultwill be visible to the customer on the exterior of the product Rework or repairs that maynot be visible when a part is fitted into the final assembly might be visible when thesesame parts are sold as service spares To prevent on-the-spot decisions being at varianceeach time, you could:

a) Identify in the drawings, plans, etc those products which are supplied for serviceapplications: i.e for servicing, maintenance, and repair

b) Provide the means for making rework invisible where there are cost savings overscrapping the item

c) Stipulate on the drawings etc the approved rework techniques

Use of nonconforming product (4.13.2 and 4.13.1.3)

The standard requires that where required by the contract, the proposed use or repair

of product which does not conform to specified requirements shall be reported for cession to the customer or customer’s representative The supplementary requirementrequires customers to be informed promptly in the event that nonconforming product isshipped

con-The original ISO 9001 requirements and the additional ISO/TS 16949 requirementdefine two situations: one where you know in advance that the product is nonconform-ing and you want permission for its shipment, the other where at the time of shipmentyou did not know it was nonconforming and only found out subsequently

The only cases where you need to request concession from your customer are when youhave deviated from one of the customer requirements and cannot make the productconform Even when you repair a product, providing it meets all of the customer

requirements, there is generally no need to seek a concession from your customer While

it is generally believed that nonconformities indicate an out-of-control situation, ing you detect and rectify them before release of the product, you have quality undercontrol, and have no need to report nonconformities to your customer

provid-In informing your customer when nonconforming product has been shipped you ously need to do this immediately you are certain that there is a nonconformity If youare investigating a suspect nonconformity it only becomes a matter for reporting to yourcustomer when the nonconformity remains suspect after you have concluded yourinvestigations Alerting your customer every time you think there is a problem willdestroy confidence in your organization Customers appreciate zeal but not paranoidpersonnel!

obvi-Deviating from approved processes (4.13.4)

The standard requires prior written customer authorization whenever the product orprocess is different from that currently approved

This may seem a very onerous requirement since it stops you changing almost anythingwithout customer approval In the context of nonconforming product, it applies to anyaction you take to eliminate the nonconformity other than scrapping and regrading theitem, if permitted Any rework and repair procedure has to be approved in the productapproval submission Obviously to improve performance continuously you must changesomething, but not the product’s physical and functional characteristics, the key processparameters, or the dimensions and tolerances of the tools and gages used The require-ment also applies to your subcontractors Therefore you will need a product approvalsubmission from each of your subcontractors and will need to put in place procedures

to regulate deviations from the approved standard An example where this may be quitecommon is where specified materials become unobtainable and alternatives need to beselected, or where there is a slight change in the material specification ISO/TS 16949allows for such a situation but you must seek prior authorization It means that beforeyou deviate from approved specifications for production items you must obtain author-ization to apply the procedure You will need a procedure for conveying the information

to the customer, obtaining approval, and keeping records of the expiration date or tity authorized Concessions or waivers are issued only on specific quantities or for aspecific duration, therefore cannot be open-ended

quan-You also need a system of identifying the concessed product up to shipment in orderthat the shipping staff can apply the same identity to the shipping containers One way

of doing this is to tag the parts with a special label that is neither red nor green (signifyingreject or pass) in order that the identity of concessed product will not be overlooked

Recording the actual condition of

by the original nonconformity report If the product has to be repaired or modified, theactual condition can be specified by the repair, salvage, or modification scheme, which

is usually a separate document and can either be detailed on the nonconformity report

or cross referenced to it A lot of time can be saved if this information is readily ble when problems arise later

accessi-Re-inspection of repaired and reworked product (4.13.2)

The standard requires the supplier to re-inspect repaired and reworked product in dance with the quality plan and/or documented procedures

accor-Any product that has had work done to it should be re-inspected prior to it beingreleased to ensure the work has been carried out as planned and has not affected fea-tures that were previously found conforming There may be cases where the amount ofre-inspection is limited and this should be stated as part of the remedial action plan.However, after rework or repair the re-inspection should verify that the product meetsthe original requirement, otherwise it is not the same product and must be identified dif-ferently

The inspection and test records should indicate the original rejection, the disposition,and the results of the re-inspection in order that there is traceability of the decisions thatwere made

Task list

1 Decide what constitutes a nonconformity.

2 Decide what products and processes will be governed by the nonconformity control procedures.

3 Develop a means of classifying nonconformities.

4 Decide who the acceptance authority is to be for each product, project, or contract for each class of nonconformity.

5 Provide forms or logs for recording details of nonconformities.

6 Provide reject labels for identifying nonconforming articles.

7 Provide serviceable and unserviceable labels for identifying operational equipment.

8 Provide a register of nonconformity 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 dispositions.

15 Provide for product to re-enter the process for rework, repair, or modification action.

16 Provide procedures for product recall.

17 Provide a means of controlling the return of reject articles to suppliers.

18 Provide a means for scrapping unusable articles under controlled conditions.

19 Provide forms for requesting deviations and waivers from your customer when appropriate.

20 Provide a means for tracking remedial actions on nonconforming articles.