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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 sub- ject to either planned or unplanned
verification. Product requirements are not
limited to customer requirements (see also
Chapter 7) therefore a non- conforming
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 require- ments 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)
19942000 Differences
Previously the standard
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
appro- priate 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 com- pleted.
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 instruc- tions. 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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What does this mean?
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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19942000 Differences
Previously the standard
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.
Why is this necessary?
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.
How is this implemented?
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 non- conformities 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
appro- priate to deal with nonconforming
product by taking action to preclude its
original intended use or application.
What does this mean?
Precluding intended use or application meanseither scrapping the product so no one
can use it or
19942000 Differences
Previously the standard
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.
Why is this necessary?
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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How is this implemented?
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.
What does this mean?
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.
Why is this necessary?
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.
How is this implemented?
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.
What does this mean?
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.
19942000 Differences
Previously the standard
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.
Why is this necessary?
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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How is this implemented?
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)
19942000 Differences
Previously the standard
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.
What does this mean?
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.
Why is this necessary?
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.
How is this implemented?
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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
Zero defects, 28, 657