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IDENTIFICATION AND TRACEABILITY (7.5.3)' o1 \/ \; Z0 C' t
Identifying Product (7.5.3.1)2 g" M& S; ~$ U% h' Y3 z
The standard requires the organization to identify the product by suitable means
1 o2 Q' q6 B" E1 Lthroughout product realization where appropriate.
: ^! g' a& Z1 ^- YWhat Does this Mean?
% U4 x& `" K. Y% L$ U6 v; JThe requirements for product identification are intended to enable products and services
' z3 m5 b8 J0 k0 ]+ Vwith one set of characteristics to be distinguishable from products or services with
3 X, s0 o' l; k3 b6 Hanother set of characteristics.
% [% `% T# f3 ]The option of applying this requirement ‘where appropriate’ implies that there are* A$ O/ p) U0 a. X
situations where product identity is unnecessary. There are of course situations where
- y8 E" U# K% g* K' F( Zattaching an identity to a product would be impractical such as for liquids or items too
2 o9 l. c/ b& k' f* Dsmall but the product nevertheless has an identity that is conveyed through the pack-
: @3 G' k9 d* X+ h. D' p3 Haging and associated information. In the food industry, the biscuits on the conveyor" `7 a) u- L9 R$ K B8 H
might not carry an identity but the box into which they are packed does as does the
% K! l! i; r! k7 U1 Vinstruction that ordered the biscuits to be produced. Thus identifying a product by
2 Y! a# Z7 p6 Usuitable means might require the product to be labelled, or might require the container to3 t. P: `8 J4 n8 e6 d$ u9 X! X5 F7 \: Y
be labelled. Services are somewhat different. Many are not identified other than by the4 L8 w. x+ Y! S* @$ I
nature of what the organization does by generic categories such as investment, mort-% D, z& a5 }, `7 F% _
gage, financial planning services of banks. Where there are differences for instance in
" i* t, [' \3 _interest rates, the ‘products’ are given different names such as Instant Access Account," S, D) {- `4 w! D
90 Day account and so on.
8 y" B$ ~5 s9 U9 ~9 ~Why is this Necessary?% B0 ]5 t4 `+ X7 k
This requirement responds to the Process Approach Principle.1 J& a* p+ V4 o* C9 d( U. a! a1 }
Product identity is vital in many situations to prevent inadvertent mixing, to enable
( f6 l: G7 @4 Lre-ordering, to match products with documents that describe them and to do that basic of0 A/ h# I5 i, ?* k) G- O$ e1 c2 D. x
all human activities – to communicate.Without codes, numbers, labels, names and other# ~4 h' T+ R: \# k% v
forms of identification we cannot adequately describe the product or service to anyone
/ y# g9 e) E2 a2 b3 d9 aelse or be certain we are looking at the right product. The product must be identified in
" {' }3 G4 E |$ j4 k* Z, |one way or another otherwise it cannot be matched to its specification.
' R3 Z, q: w& r7 [How is this Demonstrated?
2 w; |5 i0 j2 [$ ~Separate product identity is necessary where it is not inherently obvious. If products are
& [! m0 b! n1 K) rso dissimilar that inadvertent mixing would be unlikely to occur, a means of physically: D* P4 W; e/ e
identifying the products is probably unnecessary. ‘Inherently obvious’ in this context" D: x& h9 G2 \2 Y
means that the physical differences are large enough to be visible to the untrained eye.
2 `8 U" D5 @% x9 V& G- lFunctional differences, therefore, no matter how significant as well as slight differences
6 s, h" d/ y5 u6 R k/ Vin physical characteristics such as colour, size, weight and appearance would constitute; \7 `8 Y" g% J( u3 C
an appropriate situation for documented identification procedures.6 U/ }6 B# T- w" Q
Identifying product should start at the design stage when the product is conceived. The
' G% J5 e" n t/ b, K9 q( Adesign should be given a unique identity, a name or a number and that should be used on all- v# Q: H2 ]) t
related information.When the product emerges into production, the product should carry
9 _9 w5 g, ^4 Q/ `4 S+ Rthe same number or name but in addition it should carry a serial number or other iden-
g* Y) S4 P' D) ~2 B! ^! |5 f ztification to enable product features to be recorded against specific products. If verification
: y( Q; r [( t% W0 Y& w; F# f' qis on a go or no go basis, product does not need to be serialized. If measurements are f& J9 U8 }8 m, F; O8 l
recorded some means has to be found of identifying the measurements with the product8 S7 C, ?. L% W6 [4 l9 c
measured. Serial numbers, batch numbers and date codes are suitablemeans for achieving C; Z4 f0 X* m$ s) A$ Q
this. This identity should be carried on all records related to the product.6 g& O- B) B- J* E
Apart from the name or number given to a product you need to identify the version
) {. j1 W/ n# L8 f; |8 t& @+ dand the modification state so that you can relate the issues of the drawing and specifi-5 r2 ?3 e$ I6 o. Z8 ^# d" Q
cations to the product they represent. Products should either carry a label or markings
& |# C! D, v9 Q' h: y8 v2 Swith this type of information in an accessible position or bear a unique code number that8 {% ^4 O9 G9 ]1 N
is traceable to such information.
! K2 q7 f) y- ~You may not possess any documents that describe purchased product. The only
2 _ ^; L& N* U3 z( v9 Yidentity may be marked on the product itself or its container. Where there are no* U- S& Z1 o* b& L4 K5 B c; t4 }
markings, information from the supplier’s invoice or other such documents should be i' V5 x7 @& F. u& B, y" T
transferred to a label and attached to the product or the container. Information needs to0 z" G3 @8 G' J' ~( o5 z
be traceable to the products it represents.
7 y Z1 \3 J$ {* xThe method of identification depends on the type, size, quantity or fragility of the+ h6 m2 X5 S6 [4 H
product. You can mark the product directly (provided the surface is not visible to the end
& c8 ]6 F( Q# K/ l7 O" x3 kuser unless of course identity is part of the brand name) tie a label to it or the container in/ O \: t' G; ]
537 Chapter j 27 Production and Service Provisionwhich it is placed. You can also use records remote from the product providing they bear8 V5 P& c% V5 _7 z5 F8 _9 v9 J$ i
a unique identity that is traceable to the product., ^' k2 h6 i. ]) z9 g* r. u- t& r
Marking products has its limitations because it may damage the product, be removed
( C+ E; o$ _ \+ A, }or deteriorate during subsequent processing. If applied directly to the product, the8 Z* M( F5 F6 ]7 a
location and nature of identification should be specified in the product drawings or7 A$ y1 T0 u; d' A# `4 }
referenced process specifications. If applied to labels which are permanently secured to' R3 l! V& a: J
the product, the identification needs to be visible when the product is installed so as to
3 H9 f$ D# E* ^facilitate checks without its removal. If the identity is built into the forging or casting, it3 @( e2 e @6 P6 W" f" t
is important that it is legible after machining operations. One situation which can be
* q6 s( p" u' o/ b% {. dparticularly irritating to customers is placing identification data on the back of equip-+ x* H4 f3 K: I- V1 @6 X
ment and then expecting the customer to state this identity when dealing with a service
" e# e+ K; @5 rcall thus causing delay while the customer dives under the desk to locate the serial5 ^# ?# S9 f0 ` u+ q$ L2 Y
number and drops the telephone in the panic!( H3 }/ a1 n- u* S9 Z' E7 X3 |, f
Verification Status (7.5.3)
& C' @4 r. |8 W0 H" S( _6 a8 N3 J1 ~The standard requires the organization to identify the status of the product with respect
, O* j( s; I0 x g4 n7 \- V+ w' ]7 |to measurement and monitoring requirements throughout product realization.
# x% K7 D. Z: E6 D$ R+ B& aWhat Does this Mean?
0 [/ r! w* f/ _& R! @ S. ^" MProduct status with respect to monitoring and measurement means an indication as to" J) p. _) r( T, H8 l
whether the product conforms or does not conform to specified requirements. Thus
% w& s8 {1 y' ?0 Z: }+ H/ P1 Eidentifying product status enables conforming product to be distinguishable from
6 G x" Q- N+ knonconforming product.; ]. q0 o; m9 x" z
Why is this Necessary?
( j3 X: k- I. g- W% r6 OThis requirement responds to the Factual Approach Principle.
8 h: N" Q" S( A2 zMeasurement does not change a product but does change our knowledge of it.7 Y. o/ a$ I6 o; W
Therefore it is necessary to identify which products conform and which do not so that* R. ?7 ~* T }7 J* W
inadvertent mixing, processing or delivery is prevented.
3 b8 h5 w+ }& ~How is this Demonstrated?
; ]! Q- O# X% u1 mThe most common method of denoting product status is to attach labels either to the% J X( g# n D; q; M( c9 n
product or to containers holding the product. Green labels for acceptable good and Red0 X' [& n% C, s% \* B+ x. `4 p
labels for reject goods. Labels should remain affixed until the product is either packed or
8 O9 H1 x& G0 k- }" x# Yinstalled. Labels should be attached in a way that prevents their detachment during- e( D4 d5 g* `) S
handling. If labels need to be removed during further processing, the details should be
1 E S# W+ O( ^ ]4 A1 }% W. S2 otransferred to inspection records so that at a later date the status of the components in an3 u' E* q* S' c+ r H
assembly can be checked through the records. At dispatch, product status should be
1 v& k. z) n% {" L3 d! Uvisible. Any product without status identification should be quarantined until re-verified
9 @- K( \6 ]- }9 f+ A1 K5 ~and found conforming. Once a product has passed through the product realization
9 y0 F7 G/ N7 X9 bprocess and is in use, it requires no product status identity unless it is returned to the
! B6 g, n- o. e0 Wproduction process for repair or other action.
& E+ T" L _4 s7 h4 q9 F% X' S, X5 zIt should be possible when walking through a machine shop for example, to identify! {( t) {* {6 s! V- z
which products are awaiting verification, which have been verified and found6 `: j7 B4 @, J0 ]# w! m+ g
538 PART j 6 Complying with ISO 9001 Section 7 Requirementsconforming and which have been rejected. If by chance, some product was to become; ]% b2 n& o! p) _8 M0 _9 s" V
separated from its parent batch, it should still be possible to return the product to the
( H' Z _6 Y" H# |. O: Elocation from whence it came. A machine shop is where this type of identification is
9 e& G, \6 v8 A' U0 k- }essential – it is where mix-ups can occur. In other places, where mix-ups are unlikely,* f: E* }+ B) D. B; I- ^- o* D
verification status identification does not need to be so explicit.) D3 {% \* ?* f0 w- Z) Q
Identifying product status is not just a matter of tying a label on a product. The status: g. N- Z q0 o# U
should be denoted by an authorized signature, stamp, mark or other identity which is2 \* j% q4 G2 F9 Y
applied by the person making the accept or reject decision and which is secure from
1 R0 A) K7 [( q6 \, i3 S4 h1 }misuse. Signatures are acceptable as a means of denoting verification status on paper
/ A( w. J* [: x9 D/ n3 r% w4 z2 frecords but are not suitable for computerized records. Secure passwords and ‘write only’
0 j4 e; c) F: T6 r( f' Vprotection has to be provided to specific individuals. Signatures in a workshop envi-
! t. a& x$ V1 t% z0 wronment are susceptible to deterioration and illegibility that is why numbered inspection' z- }: I' N c( q0 `8 v- _
stamps with unique markings evolved. The ink used has to survive the environment and
* k* a+ n, |: jif the labels are to be attached to the product for life, it is more usual to apply an imprint5 E* U/ z8 b) O- h6 g7 }+ t3 C
stamp on soft metal or bar code.% e6 U& A" J- j7 [( d0 J. a; H
Small and fragile products should be held in containers and the container sealed and
- l, @! F9 Q7 P5 B( amarked with the product status. Large products should either carry a label or have
" t8 K8 U8 l" n5 ka related inspection record.
& D2 e4 c' c J, e2 u8 _In some situations the location of a product can constitute adequate identification of( I5 x5 s* ^3 a) I% s
product status. However, these locations need to be designated as Awaiting Inspection,
5 G- O. a% s1 U' k7 L$ DAccepted Product or Reject Product or other such labels as appropriate to avoid8 ~: o4 A" b4 F- D9 I9 @
the inadvertent placement of items in the wrong location. The location of product in the
, R! ~- o+ f. p- W- V" ^6 inormal production flow is not a suitable designation unless an automated transfer route
2 ~* `: L$ h) ]4 zis provided.% `& C" K4 a9 C# p, I
When a service is out of service, tell your customers. Services that rely on products
2 P- b% r1 n" h" y, {8 Ashould carry a label or a notice when accessed. A bank cash machine is one example% V. N$ ^% |2 a: L& v/ x% M' G
where a notice is displayed when the machine is out of service. In some cases customers
4 m, c/ H( ?. m7 L6 D' n1 qmay need to be informed by letter or telephone.
1 W1 L% X* I6 D; f ~- ~% hWith software the verification status can be denoted in the software as a comment or
9 S7 [- B k: S( S' w, e3 X0 don records testifying its conformance with requirements./ Y5 n A7 }6 T0 [9 {
With documentation you can either denote verification status by an approval signa-
+ q8 R* m' j7 S$ Z1 ~! `2 Z5 oture on the document or by a reference number, date and issue status that is traceable to
9 M, _2 X5 ^7 J, @5 J urecords containing the approval signatures.
' A" s: B8 S& a7 S- C5 n4 |, r1 uIf you use stamps, you will need a register to allocate stamps to particular individuals
: T9 B! h1 M# a- F/ yand to indicate which stamps have been withdrawn.When a person hands in his stamp it
% Y5 W( W& R% t/ M3 y7 I3 Q2 s) ~is good practice to avoid using the same number for 12 months or so to prevent mistaken
* U6 ~" e9 S1 V N$ didentity in any subsequent investigations.
+ \) [8 ~; {! g1 l7 y& B8 U) }Traceability9 p0 ~" D3 b7 Y( {
Where traceability is a requirement the standard requires the organization to control the
/ Z) c2 h. ~* p9 j, munique identification of the product and maintain records.
6 u8 `) v6 v* @7 l+ ]+ P0 XWhat Does this Mean? I: p B/ s- V) `1 V' l. e
Traceability is a process characteristic. It provides the ability to trace something through) Q3 k! ~/ L6 U( h$ b
a process to a point along its course either forwards or backwards through the process- x6 p4 B9 q+ U {3 x
539 Chapter j 27 Production and Service Provisionand determine as necessary, its origin, its history and the conditions to which it was* f/ \( Y% K/ i
subjected. Traceability may be a requirement of the customer, legislation or statutes or
4 c& |/ l2 t# z1 F0 F7 Esimply a requirement of the organization in order to conduct investigations when events( V% `5 R. L7 k& X' u5 t
do not proceed as planned.
, Y. O ?# U& E- ]' q) J$ l/ C \1 XWhy is this Necessary?5 a* g2 s8 y2 I* g
This requirement responds to the Factual Approach Principle.' ?$ J3 Y9 o+ D6 \8 @
One needs traceability to find the root cause of problems. If records cannot be found# F. t& t% C, A* a9 J
which detail what happened to a product then nothing can be done to prevent its2 H, L# \9 R& u% F$ d- h" }$ K
recurrence. Although the standard only requires traceability when required by contract X8 @4 f; Q6 n9 [/ L- E
or law, it is key to enabling corrective action.3 l. R- o3 f1 T! C: }! v
In situations of safety or national security it is necessary to be able to locate all* a8 r/ w. f1 X8 F4 h1 d: z
products of a batch in which a defective product has been found so as to eliminate them: B) L; `+ M9 i! ]' i; ]4 o: X
before there is a disaster. It is also very important in the aerospace, automobile, medical
& W s1 E# b) b% l" udevices and food and drugs industries – in fact, any industry where human life may be at
& s5 T& G- J# f) E/ N) Krisk due to a defective product being in circulation.! a: J" e9 K) H. C
Traceability is also important to control processes. You may need to know which
$ s. r9 D5 `5 Bproducts have been through which processes and on what date if a problem is found
3 o+ N7 ]4 \# Asometime later. The same is true of test and measuring equipment. If on being calibrated0 n! |" b5 U3 l+ V3 F! s
a piece of test equipment is found to be out of calibration then it is important to track
( y n+ R! E) ~' y6 Fdown all the equipment which has been validated using that piece of measuring
; E- D5 X f) C8 nequipment. This in fact is a requirement of ISO 9001 Clause 7.6 but no requirement for/ `$ o6 j# J, B1 [- `; T
traceability is specified.5 @9 @4 N: Z. m {
How is this Demonstrated?4 Z* }- R3 W, i7 L, v+ U+ {
Providing traceability can be an onerous task. Some applications require products to
1 R( ~3 S5 ]/ e, B5 [& i8 U7 qbe traced back to the original ingot from which they were produced. Traceability is8 t h7 z- d X4 K2 y& y
achieved by coding items and their records such that you can trace an item back to( ]1 e! k0 f* N: {9 E8 w. T
the records at any time in its life. The chain can be easily lost if an item goes7 g& S, C$ ]( c! y D4 [
outside your control. For example, if you provide an item on loan to a development
8 z3 x) n! c2 t6 sorganization for investigation and it is returned sometime later, without a certified
, M! R1 L5 ]# v) {/ \# Jrecord of what was done to it, you have no confidence that the item is in fact the
/ f& K" ^- {# D) c: Isame one, unless it has some distinguishing features. The inspection history may+ e. R0 O: m' P. ~0 l% A) Z
also be invalidated because the operations conducted on the item were not certified.
, f u3 \: b4 A- {- U" dTraceability is only helpful when the chain remains unbroken. It can also be costly
6 \# V V! V; D0 R) f# ~to maintain. The system of traceability that you maintain should be carefully
, P, v4 c6 k! Nthought out so that it is economic. There is little point in maintaining an elaborate: L: K$ P ~0 {# F; ^
traceability system for the once in a lifetime event when you need it, unless your X5 i: E! U0 l4 B
very survival or society’s survival depends on it. However, if there is a field failure,
0 s {# `& B1 T% e, }- l) {+ Win order to prevent recurrence you will need to trace the component back through
* y! e& { G3 |. w; Zthe supply chain to establish which operation on which component was not per-
# B% f/ @# U7 Q$ rformed correctly simply to rule out any suggestion that other products might be
" z5 V" n! V! k. B" ~1 Q9 k. S9 Raffected.
8 C2 E4 N. v5 m8 x- B1 QThe conventions you use to identify product and batches need to be specified in the
- z+ y: G# c; `. K! aproduct specifications and the stage at which product is marked specified in the relevant3 x! p8 y; {, F9 G8 \
procedures or plans. Often such markings are automatically applied during processing,
! @4 }1 I7 e, ~7 f$ k/ R: ~540 PART j 6 Complying with ISO 9001 Section 7 Requirementsas is the case with printed circuits, mouldings, ceramics, castings, products etc. Process
$ f: G* W% ^0 N% s' Rsetting up procedures should specify how the marking equipment or tools are to be* H7 D" u1 U0 _, K
set up., R3 C0 B" l* Q8 i" X
If you do release a batch of product prior to verification being performed and one out
* A1 W" }! X7 {5 g+ _ x. p& y. Wof the batch is subsequently found to be nonconforming, you will need to retrieve all
7 u' U- J" Q; A5 e; qothers from the same batch. This may not be as simple as it seems. In order to retrieve
4 h( s0 n* _, I+ g) S4 R7 \5 W/ ea component which has subsequently been assembled into a printed circuit board, which/ e% s" {: V3 {' z. g
has itself been fitted into a unit along with several other assemblies, not only would you$ I" |; x4 g* D# w4 g5 N
need a good traceability system but also one that is constantly in operation., G$ Q4 X, L5 B" s! `# i
It would be considered prudent to prohibit the premature release of product if you did- R+ ?7 t- `, o
not have an adequate traceability system in place. If nonconformity will be detected by
' N8 R0 B, ?3 v$ z# E: B1 m$ hthe end product tests, allowing production to commence without the receipt tests being$ O( ~; T: \7 R
available may be a risk worth taking. However, if you lose the means of determining v: R8 ]' y" X! p+ y7 z6 u3 I' S
conformity by premature release, don’t release the product until you have verified it as7 I' f! H& ^. L+ k: C% T% ]4 K# J
acceptable.
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发表于 7-16 11:18:26
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