Iso9000 Quality Systems Hand

8/2/2019 Iso9000 Quality Systems Hand

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2 ISO 9000 Quality Systems Handbook

Control of nonconforming product (8.3)

Preventing unintended use (8.3)

19942000 Differences

Previously the standard

required the supplier to:

(a) establish and maintain

documented

procedures to ensure

that product that doesnot conform to

specified requirements

is prevented from

inadvertent use or

installation;

(b) provide for

identification,

documentation,

evaluation,

segregation,

disposition of

nonconforming

product and for

notification to the

functions concerned.

The requirement remains

unchanged.

The standard requires the organization to

ensure that product which does not conform

to product requirements is identified and

controlled to prevent unintended use or

delivery and goes on to require the controls

and related responsibilities for dealing with

nonconforming product to be defined in a

documented procedure.

What does this mean?

Nonconforming product is product that does

not conform to agreed product requirements

when subject to either planned or unplanned

verification. Product requirements are not

limited to customer requirements (see also

Chapter 7) therefore a nonconforming

product is one that fails to meet the:

Specified customersrequirements Intended usagerequirements Stated or impliedneeds Organizations ownrequirements Customerexpectations

A product is judged either conforming or non-

conforming at a verification stage. A product

could

also be judged nonconforming if it becomes damaged or fails at anyother stage but is normally considered unserviceable. Unserviceable

products however 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 then it is


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nonconforming, but it could be found to be within the specifiedcalibrationlimit

s.

A product may be suspected of being nonconforming as 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. We should therefore look

further than

the product that has been found to be nonconforming and seekout other

products that 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. Another example of suspect product is when

product is

mishandled but shows no obvious signs of damage. This may

arise when

product is dropped or not handled in stipulated clean

conditions or inaccordance with electrostatic safe handling procedures. Suspect

product

should be treated in the same manner as nonconforming

product and

quarantined until dispositioned. However, until nonconformity can be

proven,

the documentation of the nonconformity merely reveals the reason

for the

product beingsuspect.

This requirement relates to the controls exercised over the

product itself

whereas clause 8.5.2. on corrective action addresses the measures

needed to

prevent recurrence of the nonconformity. The scope of procedures for


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Identifying nonconforming product

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 forconforming and serviceable items. In this way you can determine

product status at a distance and reduce the chance of confusion. You

can use segregation as a means of identifying nonconforming product

but if there is the possibility of mixing or confusion then this means

alone should not be used.

On the labels themselves you should identify the product by name

and reference number, specification and issue status if necessary

and either a statement of the nonconformity or a reference to the

service or nonconformity report containing full details of its condition.Finally the person or organization testifying the nonconformity should

be identified either by name or inspection stamp.

Unlike products, nonconforming services are usually rendered

unavailable for use by notices such as Out of Order or by

announcements such as Normal service will be resumed as soon as

possible Products are often capable of operation with

nonconformities whereas services tend to be withdrawn once the

nonconformity has been detected however trivial the fault.

Controlling nonconforming product

To control nonconforming product you

need to: (a) know when it became

nonconforming(b) know who decided it wasnonconforming

(c) know of its

condition(d) know where it is

located

(e) know that it is not being

used

On detection of a nonconformity, details of the product and the

nonconformity should be recorded so as to address a), b) and c)

above.

Segregating a nonconforming product (or separating good frombad) places it in an area with restricted access and addresses d) and

c) above. Such areas are called quarantine areas or quarantine stores.

Products should remain in quarantine until disposal instructions have

been issued. The store should be clearly marked and a register

maintained of all items that enter and exit the store. Without a

register you wont be able to account for the items in store, check

whether any are missing, or track their movements. The quarantine


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store may be contained within another store providing there is

adequate separation that prevents mixing of conforming and

nonconforming articles. Where items are too large to be moved into a

quarantine store or area, measures should be taken to signal to

others that the item is not available for use and cordons or floor

markings can achieve this. With services the simplest method is torender the service unavailable or inaccessible.


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Documented procedures

Documented procedures should specify the authorities who make the

disposition, where it is to be recorded and what information should be

provided in order that it can be implemented and verified as havingbeen implemented.

In order to implement these requirements your nonconformity

control procedures should include the following actions:

Specify how product should be scrapped, or recycled, the forms tobe used, the authorizations to be obtained Specify the various repair procedures, how they should beproduced, selected and implemented

Specify how modifications should be defined, identified andimplemented Specify how production permits (deviations) and concessions(waivers)

should be requested, evaluated and approved or rejected Specify how product should be returned to its supplier, theforms to be

completed and any identification requirements in order that you can

detectproduct on its return Specify how regrading product is to be carried out, the productmarkings,

prior authorization and acceptance criteria

When making the disposition your remedial action needs toaddress:

action on the nonconforming item to remove thenonconformity and a search for other similar items which may be nonconforming (i.e.

suspect

product) and action to recall product containing suspect nonconformingproduct

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 because it does not prevent a recurrence of

the initial problem.

Defining responsibility

The decision on product acceptance is a relatively simple one


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The authority for making these decisions will vary depending on the

answer to the first question. If, regardless of the severity of the

nonconformity, the product can be made to conform 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 design authority. 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

the authority responsible for drawing up or selecting the

specification.

It may be sensible to engage investigators to review the

options to be considered and propose remedial actions for theauthorities to consider. In your procedures you should identify the

various bodies that need to be consulted for each type of

specification. Departures from customer requirements will require

customer approval; departures from design requirements will require

design approval; departures from process requirements will require

process engineering approval etc. The key lies in identifying who

devised or selected the requirement in the first place. All

specifications are merely a substitute for knowledge of fitness for use

any departure from such specification must be referred back to the

specification authors for a judgement.

Correction of nonconforming product (8.3a)



required the supplier to:

(a) review nonconforming

product in accordance

with documented

procedures and

advises that it may be

reworked, accepted,

re-graded, rejected or

scrapped;

(b) define the

responsibility forreview and authority

for the disposition of

nonconforming

product.

The intent of the

requirement remains

unchanged.


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The standard

requires the

organization when

appropriate to

deal with

nonconforming product by taking

action to eliminate

the detected

nonconformity.

Wh

atdoesthismean

?Action to remove the

detected

nonconformity is a

remedial action and

can include the

completion of

operations, rework,

repair or

modification. Some-

times a product may

be inadvertently

submitted for

verification before all

operations have

been completed.

Rework means the continuation of processing

that will make an item conform to

specification. Rework requires only normal

operations to complete the item and does not

require any additional instructions. Rework

when applied to documents means correctingerrors without changing the original

requirement. Repair is an action that restores

an item to an acceptable condition but unlike

rework, it may involve changing the product

so that it differs from


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the specification but fulfils the intended use requirement.

Modification may involve changing the requirement as would be the

case if the product requirement was found to be incorrect when

assembling or operating product.In some cases it may not be cost effective to attempt to eliminate

the nonconformity and therefore such action would be

inappropriate and the product should be disposed of.

Why is this necessary?

This requirement responds to the Process ApproachPrinciple.

Remedial action is warranted when there are cost benefits from

attempting

to eliminate the

nonconformity.

How is this implemented?

To implement this requirement you will need a form or other such

document in which to record the decision and to assign theresponsibility for the remedial action. When deciding on repair or

rework action, you may need to consider whether the result will be

visible to the customer on the exterior of the product. Rework or

repairs that may not be visible when a part is fitted into the final

assembly might be visible when these same parts are sold as service

spares. To prevent on-the-spot decisions being at variance each time,

you could:

(a) Identify in the drawings, plans etc. those products that are

supplied for service applications: i.e. for servicing, maintenance

and repair

(b) Provide the means for making rework invisible where there

are cost savings over scrapping the item

(c) Stipulate on the drawings etc. the approved rework

techniques

Authorizing use of nonconforming product (8.3b)

The standard requires the organization when appropriate to deal with

nonconforming product by authorizing its use, release or acceptance

under concession by a relevant authority and where applicable by

the customer.


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If you choose to accept a nonconforming item as it is without rework,

repair etc., then you are in effect granting a concession or waiving the

requirement onlyfor that particular item. If the requirements cannot

be achieved at all then this


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required that where

required by the contract:

(a) the proposed use or

repair of product

which does not

conform to specified

requirements be

reported for

concession to the

customer or

customersrepresentative;

(b) the supplierrecords

the description of

nonconformity that has

been accepted, and of

repairs, to denote the

actual condition.

Though less prescriptive,

the intent of therequirement remains

unchanged.

is not a situation for a concession but a case

for a change in requirement. If you know in

advance of producing the product or service

that it will not conform with therequirements, you can then request a

deviation from the requirements. This is often

referred to as a production permit.

Concessions apply after the product has been

produced. Production permits apply before it

has been produced. Both are requests that

should be made to the acceptance authority

for the product.

The relevant authority is the authority thatspeci- fied the requirement that has not

been met. This authority could therefore be

the customer, the reg- ulator or the designer.


This requirement responds to the Process

ApproachPrinciple

.

Product that does not conform to

requirement may

be fit for use. All specifications are but a

substitute

for knowledge of fitness for use. Any departure

from

such specification should be referred backto the

specification authors for a

judgment.


In order to determine whether a nonconforming product could be

used, an analysis of the conditions needs to be made by qualifiedpersonnel. There are two ways of doing this. Either you refer all

such nonconformities to the relevant authority or the authority

appoints representatives who are capable of making these decisions

within prescribed limits. A traditional method is to classify

nonconformities, assign authority for accepting concessions for each

level and define the limits of their authority. These levels could


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be as follows:

Critical Nonconformity (a departure from the requirements whichrenders the product or service unfit for use) Major Nonconformity (a departure from the requirements includedin the contract or market specification) Minor Nonconformity (a departure from the requirements notincluded in the contract or market specification)


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The only cases where you need to request concessions from your

customer are when you have deviated from one of the customer

requirements and cannot make the product conform. 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, provided that 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 certain

that there is a nonconformity. If you are investigating a suspect

nonconformity it only becomes a matter for reporting to yourcustomer when the nonconformity remains suspect after you have

concluded your investigations. Alerting your customer every time you

think there is a problem will destroy confidence in your organization.

Customers appreciate zeal but not paranoia!

Action to preclude use or application (8.3c)

The standard requires the organization when

appropriate to deal with nonconforming

product by taking action to preclude its

original intended use or application.


Precluding intended use or application meanseither scrapping the product so no one

can use it or



required the

nonconformity to be

regraded, rejected or

scrapped.

The intent of the

requirement remains

unchanged.

regrading it so that it may be used in other applications. In some

cases products and services are offered in several models, types or

other designations but are basically of the same design. Those which

meet the higher specification are graded as such and those which fail

may meet a lower specification and can be regraded. The grading

should be reflected in the product identity so that there is noconfusion.


This requirement responds to the Process ApproachPrinciple.


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If a nonconforming product cannot be made conforming or

accepted as is,

some other action is needed to prevent inadvertent use and this

leaves the two

options

stated.


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Regrading can be accomplished by assigning a new identity to the

product. Scrapping an item should not be taken lightly it could be

an item of high value. Scrapping may be an economical decision withlow cost items, whereas the scrapping of high value items may

require prior authorization as salvage action may provide a

possibility of yielding spares for alternative applications.

Records of nonconformity (8.3)

The standard requires records of the natureof non-

19942000 DifferencesPreviously the standard

required the description of

the accepted

nonconformity and the

repairs undertaken to be

recorded to denote the

actual condition.

The intent of the

requirement remains

unchanged.

conformities and any subsequent actions

taken, including concessions to be maintained.


The records of nonconformities are the

documented details of the product (its

identity), the specific deviations from

requirements (what it is and what it shouldhave been), the condition under which the

nonconformity was detected (the

environmental or operating conditions what

was happening at the

time the nonconformity was detected), the time and date of detection,

the name of the person detecting it and the actions taken with

reference to any instructions, revised requirements and decisions.


This requirement responds to the Factual ApproachPrinciple.

Records of nonconformities are needed for presentation to the

authorities

responsible for deciding on the action to be taken and for subsequent

analysis.

Without such records, decisions may be made on opinion resulting

in the

means for identifying opportunities for improvement being

absent.


There are several ways in which you can document the


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presence of a nonconformity. You can record the condition: on a label attached to theitem on a form unique to the item such as a nonconformityreport

of functional failures on a failure report and physical errors on adefectreport


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in a logbook for the item such as an inspection history recordor snag sheet in a logbook for the workshop or

area

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 around the

nonconforming item, it may be more practical to document the

remedial action on a form. In some cases the details may need to beconveyed to the customer off site and in such cases a logbook or

label would be inappropriate. It is important when documenting the

nonconformity that you record as many details as you can because

they may be valuable to any subsequent investigation in order to

help diagnose the cause and prevent its recurrence.

Re-verification of corrected product (8.3)

The standard requires nonconforming

product to be subject to re-verification after

correction to demonstrate conformity to the

requirements.


Any rework, repair, modification or other

action taken to correct the nonconformity willchange the product and therefore it needs to

be subject to re- verification. This may

involve verification against different

requirements to the original requirements.



required the supplier to re-

inspect repaired or

reworked product in

accordance with the

quality plan and/or

documented procedures.

The intent of therequirement remains

unchanged.


This requirement responds to the Factual ApproachPrinciple.

If a nonconforming product is accepted as is without correction,

no re-

verification is necessary, but if the product is changed the previous

verification

is no longer

valid.


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Any product that has had work done to it should be re-verified prior to

it being released to ensure the work has been carried out as planned

and has not affected features that were previously found conforming.There may be cases where the amount of re-verification is limited and

this should be stated as part


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of the remedial action plan. However, after rework or repair the re-

verification should verify that the product meets the original

requirement, otherwise it is not the same product and must be

identified differently. The verification records should indicate the original rejection, the

disposition and the results of the re-verification in order that there is

traceability of the decisions that were made.

Consequences of nonconformity (8.3)



required the procedures

for corrective action to

include the effective

handling of reports of

product nonconformities.

This new requirement

implies that a process is

needed to manage the

consequences of

detecting nonconforming

product such as informing

customers, product recall

etc.

The standard requires the organization to take

action appropriate to the effects or potential

effects of the nonconformity whennonconforming product is detected after

delivery or use has started.


A nonconformity may be detected by a

subsequent user of the product either within

the organization or by the customer. Also a

nonconformity might be detected prior to

release and implicate products already in use

such as when subsequent analysis reveals

inaccurate measurements or when verifica-

tion methods or acceptance criteria change.

Such product may not have failed in service

because it has

not been used in a manner needed to cause failure but if part of the

same batch or lot contains a common cause nonconformity all productis suspected. Action taken as a result of latent nonconformity may

involve product recall, product alerts or the issue of instructions for

correction.


This requirement responds to the Customer FocusPrinciple.

The requirement acknowledges that problems may bedetected after

shipment or use that need action to prevent undesirable

effects.



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Nonconformities detected by internal or external users indicate that

the controls in place are not effective and should give cause for

concern. Details should be recorded and an investigation

conducted to establish why the planned verification did not detect

the problem. Action should then be taken to improve the verification

methods by changing procedures, acceptance criteria, equipment orretraining personnel.

When a nonconformity is

detected by verification

personnel in a product where

products of the same type are

in use, an analysis is needed to

establish whether thenonconformity would previously

have escaped detection. If not,

there is no cause for alarm but

if something has now changed

to bring the nonconformity to

light, an evaluation of the

consequences needs to be

conducted. It may only be a

matter of time before the user

detects the same

nonconformity.

The procedures should cover:

The method ofreceiving andidentifyingreturned product The method of logging reportsof nonconformities from

customers and other

users The process ofresponding to

customer requests

for assistance

The process of dispatchingservice personnel to thecustomer s premises A form on which to recorddetails of the nonconformity,

the date, customer

the report in order that the

customer knows

you care A process forinvestigating the

nature of the

nonconformity

A process for replacing, orrepairing nonconforming productand restoring

customer equipment into

service A process for assessing allproducts in service that are

nonconforming,

determining and implementing

recall action if necessary

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