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IDENTIFICATION AND TRACEABILITY (7.5.3)2 h4 h# L. ]& h) J. r
Identifying Product (7.5.3.1)' b2 T8 B0 z3 s6 `# K
The standard requires the organization to identify the product by suitable means
8 S; I, Y% P9 |) x( O8 E, z# lthroughout product realization where appropriate.% S% }6 Q: _5 _: N! K& @
What Does this Mean?
: n- p5 m! u1 Z# N- v; PThe requirements for product identification are intended to enable products and services
2 R* c# }! E& H9 d' k* Zwith one set of characteristics to be distinguishable from products or services with
6 {% L$ ]. d/ ^. z2 tanother set of characteristics.0 T8 [% |! K) t2 m' @
The option of applying this requirement ‘where appropriate’ implies that there are1 u$ j$ C. h! }. |
situations where product identity is unnecessary. There are of course situations where: \# j q8 C3 o* B7 [' @7 G2 N
attaching an identity to a product would be impractical such as for liquids or items too* X: h/ t1 t6 q) {
small but the product nevertheless has an identity that is conveyed through the pack-7 ~' ?. @; q: |/ _' E7 @
aging and associated information. In the food industry, the biscuits on the conveyor' E. D- x' X0 ?- R; s+ x
might not carry an identity but the box into which they are packed does as does the
) B- L5 J! |. x$ g$ y0 Kinstruction that ordered the biscuits to be produced. Thus identifying a product by( S$ T5 Q, L3 p( O
suitable means might require the product to be labelled, or might require the container to6 }7 l" @) \, w" G9 q/ U
be labelled. Services are somewhat different. Many are not identified other than by the
) m7 @0 k: J6 D9 V' fnature of what the organization does by generic categories such as investment, mort-
) f. ]/ t$ j) D% R5 agage, financial planning services of banks. Where there are differences for instance in) \: ~: q; M+ _$ ?& O/ c
interest rates, the ‘products’ are given different names such as Instant Access Account," [3 D5 k# a$ [: f, @
90 Day account and so on.
7 U/ o% \# B) `0 n3 kWhy is this Necessary?- q+ b6 p2 p# u9 }. M. O
This requirement responds to the Process Approach Principle.8 c3 L& ~, [' C e
Product identity is vital in many situations to prevent inadvertent mixing, to enable/ t0 a4 G8 ]) a5 _
re-ordering, to match products with documents that describe them and to do that basic of- x" Z7 l0 w) y# ?. t/ z
all human activities – to communicate.Without codes, numbers, labels, names and other( i2 {( F1 @6 K
forms of identification we cannot adequately describe the product or service to anyone5 V5 w5 a4 d; D. L% {" a
else or be certain we are looking at the right product. The product must be identified in/ f3 [' U5 }) k0 g% @
one way or another otherwise it cannot be matched to its specification.. N- k" I) K8 T+ n( `7 r
How is this Demonstrated?
3 C4 K7 G9 U& }* x8 H8 _' l9 YSeparate product identity is necessary where it is not inherently obvious. If products are" V6 a" q7 b/ C [# V
so dissimilar that inadvertent mixing would be unlikely to occur, a means of physically# k' x/ Y7 d0 R0 F" ]
identifying the products is probably unnecessary. ‘Inherently obvious’ in this context
! [$ {7 f3 r' g% A. }: l; m) |6 t7 Hmeans that the physical differences are large enough to be visible to the untrained eye.
0 ~ [# {3 [) zFunctional differences, therefore, no matter how significant as well as slight differences
9 w) X( g; _: U4 u0 A; }; sin physical characteristics such as colour, size, weight and appearance would constitute/ T0 q* H, ^/ o: c+ z5 i
an appropriate situation for documented identification procedures.
. Y8 B9 X/ y4 v) R0 n4 S1 qIdentifying product should start at the design stage when the product is conceived. The
. D: F5 @/ r" {' H0 wdesign should be given a unique identity, a name or a number and that should be used on all; r- b& P- T5 Z5 E3 ]7 x5 f4 ^, }6 Y" q
related information.When the product emerges into production, the product should carry2 l* ]4 K5 y% \) \
the same number or name but in addition it should carry a serial number or other iden-
: d3 B" r6 z$ Wtification to enable product features to be recorded against specific products. If verification
$ p0 e6 ~5 | B$ ?) fis on a go or no go basis, product does not need to be serialized. If measurements are8 a! m# Y8 k; B' b5 M
recorded some means has to be found of identifying the measurements with the product {. }+ _0 ?- u. {" M
measured. Serial numbers, batch numbers and date codes are suitablemeans for achieving0 V# q( t0 Q; [; `9 L
this. This identity should be carried on all records related to the product.0 O4 g3 g' r+ o/ ?( `. r3 i- W
Apart from the name or number given to a product you need to identify the version
4 p. L& F8 `. P# X6 nand the modification state so that you can relate the issues of the drawing and specifi-
( j& d1 y( I2 @. l6 \cations to the product they represent. Products should either carry a label or markings" p2 M; f! N) x+ R2 V
with this type of information in an accessible position or bear a unique code number that v, |+ b! W% f3 J$ t1 \
is traceable to such information.% }6 z8 Y+ J8 _) }9 a
You may not possess any documents that describe purchased product. The only
- J' G; j; F( f! x: e8 Gidentity may be marked on the product itself or its container. Where there are no
8 T* P1 `9 Z2 h lmarkings, information from the supplier’s invoice or other such documents should be
( T% X' Z( t; }' Ltransferred to a label and attached to the product or the container. Information needs to
, ^/ z1 l& B5 m- Kbe traceable to the products it represents.9 [' L4 D. Z5 R5 T S) Y: ]
The method of identification depends on the type, size, quantity or fragility of the K+ x/ @/ J j2 w# Z+ C$ I+ t
product. You can mark the product directly (provided the surface is not visible to the end
O6 V- J' g0 s. G' w' Z& yuser unless of course identity is part of the brand name) tie a label to it or the container in
. L# a1 x0 t0 `- l537 Chapter j 27 Production and Service Provisionwhich it is placed. You can also use records remote from the product providing they bear
! ?- h1 H3 S+ v9 Sa unique identity that is traceable to the product.
7 \' }. q# W0 B; P; u) WMarking products has its limitations because it may damage the product, be removed8 P X S6 ^* [# r5 o; @
or deteriorate during subsequent processing. If applied directly to the product, the
" a9 F. C2 ~. v% k+ b) [# ~location and nature of identification should be specified in the product drawings or
" J, o2 l+ Y, ^referenced process specifications. If applied to labels which are permanently secured to
/ R% n" D' J6 }; fthe product, the identification needs to be visible when the product is installed so as to
7 S0 a- g: v. K$ vfacilitate checks without its removal. If the identity is built into the forging or casting, it1 U- S5 H0 d" R: Q5 A
is important that it is legible after machining operations. One situation which can be
9 k- K" D: {9 d4 G$ D" U) o1 o: Pparticularly irritating to customers is placing identification data on the back of equip-
/ ^3 h: [ R; l" x- B! zment and then expecting the customer to state this identity when dealing with a service
$ r& P' {9 m4 fcall thus causing delay while the customer dives under the desk to locate the serial M; [$ ?9 j7 E6 S
number and drops the telephone in the panic!
' ]; e( E+ L" p; _ `4 y6 ^Verification Status (7.5.3)
/ I1 r% P1 D8 m* g- @& A$ o* iThe standard requires the organization to identify the status of the product with respect
0 ~9 f& \" L+ t; B$ P9 V- Mto measurement and monitoring requirements throughout product realization.
% F% u. E7 a6 V) R! p0 J! wWhat Does this Mean?
% K7 F' @& l) _: }Product status with respect to monitoring and measurement means an indication as to) K) J: q( j* [
whether the product conforms or does not conform to specified requirements. Thus X$ x l1 g* z9 R- n/ X t8 Y
identifying product status enables conforming product to be distinguishable from: y! W; t7 b$ s! C
nonconforming product.
6 B U- i4 R% [& W1 x, }Why is this Necessary?# l+ [# E- E) b/ o0 p
This requirement responds to the Factual Approach Principle.
& H: d+ y0 j+ p8 YMeasurement does not change a product but does change our knowledge of it.
2 e. r4 w/ r; |Therefore it is necessary to identify which products conform and which do not so that5 i6 O c( C2 f) w
inadvertent mixing, processing or delivery is prevented.
4 K4 ^& I* ]2 T2 EHow is this Demonstrated?
/ R5 G' L6 f: CThe most common method of denoting product status is to attach labels either to the
6 L" C1 T) w; I5 h- g, |$ o+ ?product or to containers holding the product. Green labels for acceptable good and Red
6 X) C% Q/ C' V6 h1 xlabels for reject goods. Labels should remain affixed until the product is either packed or
# r" `6 ^, z& J) M/ z4 ?% Yinstalled. Labels should be attached in a way that prevents their detachment during" |9 b, D& F- g, S/ r1 X" {
handling. If labels need to be removed during further processing, the details should be
$ ]; n' Q& A% t3 ^8 \6 L9 Rtransferred to inspection records so that at a later date the status of the components in an9 @$ @3 r& e. t" b! C! G7 r1 j
assembly can be checked through the records. At dispatch, product status should be+ G+ T8 u- R" I9 l8 G. Y8 f# z
visible. Any product without status identification should be quarantined until re-verified2 n" _# }$ \* ]5 c$ e
and found conforming. Once a product has passed through the product realization
* D) X$ C- u7 s/ |+ Hprocess and is in use, it requires no product status identity unless it is returned to the
: N* R$ L8 }3 k7 j* `2 M, A) ~production process for repair or other action." B2 v k/ b9 k; m
It should be possible when walking through a machine shop for example, to identify" ^& A/ C$ {& @7 h3 w
which products are awaiting verification, which have been verified and found
2 X) ?7 x. Y9 ]538 PART j 6 Complying with ISO 9001 Section 7 Requirementsconforming and which have been rejected. If by chance, some product was to become& L: e. w4 ? t: C* G3 f
separated from its parent batch, it should still be possible to return the product to the
% m6 r% X5 }( plocation from whence it came. A machine shop is where this type of identification is
8 s. N. \, U [! s: J9 `( \essential – it is where mix-ups can occur. In other places, where mix-ups are unlikely,
% ?8 o5 G8 a0 c. i4 ~1 S, nverification status identification does not need to be so explicit.$ O9 Z: G" A% Y1 ]
Identifying product status is not just a matter of tying a label on a product. The status0 z; y1 h* m) h5 s( e
should be denoted by an authorized signature, stamp, mark or other identity which is
! D7 T) ^7 N( P' I0 Z2 D7 `applied by the person making the accept or reject decision and which is secure from C0 ]+ V7 g6 n
misuse. Signatures are acceptable as a means of denoting verification status on paper# b/ `1 F- q, W' F
records but are not suitable for computerized records. Secure passwords and ‘write only’( [6 i2 z x, Y6 N, m0 |
protection has to be provided to specific individuals. Signatures in a workshop envi-# Z% b6 e5 k( D. I; D$ U _
ronment are susceptible to deterioration and illegibility that is why numbered inspection
$ K7 x3 a p6 E: _stamps with unique markings evolved. The ink used has to survive the environment and8 z: z, |9 C- u% N) \6 r- q, R
if the labels are to be attached to the product for life, it is more usual to apply an imprint9 m) M" Y. l+ L$ O
stamp on soft metal or bar code.6 A9 m* ~; ~ ^
Small and fragile products should be held in containers and the container sealed and) D( T; s2 h* J, O( h
marked with the product status. Large products should either carry a label or have: ^1 g3 U8 i( x- S v0 P1 T
a related inspection record.
- ?/ I% y) W7 a( ]: J3 eIn some situations the location of a product can constitute adequate identification of
. ~/ F# w; ?; x5 d+ ~0 T! {4 [6 Eproduct status. However, these locations need to be designated as Awaiting Inspection,1 j1 S* e0 }% W& q, o7 n
Accepted Product or Reject Product or other such labels as appropriate to avoid3 V1 T* y% S3 S8 Z$ s. D
the inadvertent placement of items in the wrong location. The location of product in the! @+ Z! A& h, H- ~5 t6 i- R) |
normal production flow is not a suitable designation unless an automated transfer route
7 Q& d2 g/ S4 Eis provided.& l m3 F. y$ e; M x; e. O: M* D
When a service is out of service, tell your customers. Services that rely on products2 _' X) h* C3 o! q# ?, c* U; ^
should carry a label or a notice when accessed. A bank cash machine is one example
2 k2 k: l5 C$ ~9 p0 q' rwhere a notice is displayed when the machine is out of service. In some cases customers
8 A2 e/ Q: y' C1 ?) Z9 pmay need to be informed by letter or telephone.
: e3 e U& W2 J v' e. a2 sWith software the verification status can be denoted in the software as a comment or
" c: p [$ L1 I$ M9 {* S' r. q! bon records testifying its conformance with requirements.- K4 T9 s, g) s& n' V* `
With documentation you can either denote verification status by an approval signa-0 M+ t$ P: z# X5 F# C1 O
ture on the document or by a reference number, date and issue status that is traceable to( @9 e8 R9 R7 u
records containing the approval signatures.
" e8 E N: f. b4 b- PIf you use stamps, you will need a register to allocate stamps to particular individuals
7 `7 ?/ C* o3 \4 cand to indicate which stamps have been withdrawn.When a person hands in his stamp it
* c0 x0 ~8 N* N9 l. x$ X5 I- @. zis good practice to avoid using the same number for 12 months or so to prevent mistaken! V, ^. n# }3 l: |1 ^: g3 C
identity in any subsequent investigations.
0 f6 C) A1 J5 \6 gTraceability
' Q. R$ C4 w6 z; c) \! |Where traceability is a requirement the standard requires the organization to control the/ X) ~, c. b9 c, f; j' B7 }5 ~; B
unique identification of the product and maintain records.$ P' ], ~& _& C
What Does this Mean?- c' }% V; b! \: }3 a& A: U
Traceability is a process characteristic. It provides the ability to trace something through* k2 G x5 j8 c
a process to a point along its course either forwards or backwards through the process
7 o) B' w2 K. E/ \539 Chapter j 27 Production and Service Provisionand determine as necessary, its origin, its history and the conditions to which it was
: ~ W0 m4 r3 z$ c: z7 Msubjected. Traceability may be a requirement of the customer, legislation or statutes or
. G( A( m6 A" _ F' j# s! psimply a requirement of the organization in order to conduct investigations when events1 |1 b, b0 S1 e& t4 n Z
do not proceed as planned.& f9 x5 N9 x$ G
Why is this Necessary?! {) i* W) L6 u$ H e7 p1 c6 D! S
This requirement responds to the Factual Approach Principle.0 E) }- \8 q/ o
One needs traceability to find the root cause of problems. If records cannot be found& [' S+ x3 U! u2 y
which detail what happened to a product then nothing can be done to prevent its9 Z0 i& [, C! N7 P) u" k- b6 D
recurrence. Although the standard only requires traceability when required by contract9 u; z/ |& x$ X6 n5 q; l
or law, it is key to enabling corrective action.
+ ~& o. Y1 I; t( b OIn situations of safety or national security it is necessary to be able to locate all
0 L7 U3 _8 v- G* a. G* c+ F* uproducts of a batch in which a defective product has been found so as to eliminate them% O1 c0 J) l" m
before there is a disaster. It is also very important in the aerospace, automobile, medical |! t# O3 W' y; b9 g7 H
devices and food and drugs industries – in fact, any industry where human life may be at
& G! R- r- N( ]6 srisk due to a defective product being in circulation., T# {% l7 ^4 ?2 e( z+ g
Traceability is also important to control processes. You may need to know which0 t" y- j, |' d/ e
products have been through which processes and on what date if a problem is found. |1 H* l6 P' N1 V+ o) W; k
sometime later. The same is true of test and measuring equipment. If on being calibrated( Z0 U g5 X! h2 i4 Z' S- w( s7 c
a piece of test equipment is found to be out of calibration then it is important to track
+ V' t* P, n: U3 v) b7 n0 t! }3 x4 ?down all the equipment which has been validated using that piece of measuring
% ?2 A1 i3 F* {: L3 L7 G/ T) y3 C5 Sequipment. This in fact is a requirement of ISO 9001 Clause 7.6 but no requirement for9 ]" r: @# B9 S2 l9 o
traceability is specified.- u% a: V% L0 e& E
How is this Demonstrated?
8 t& V6 y; ]/ }6 qProviding traceability can be an onerous task. Some applications require products to
( P, j# ]8 T. F2 \; T6 L, I" @! m' tbe traced back to the original ingot from which they were produced. Traceability is ~6 u( ?5 c' v7 [# s' O$ E+ f
achieved by coding items and their records such that you can trace an item back to
# I2 F8 z, m* ^0 T9 xthe records at any time in its life. The chain can be easily lost if an item goes
4 j& g' h4 q6 V* a! f) S4 C6 uoutside your control. For example, if you provide an item on loan to a development
5 v6 `$ Q0 G' n- ^2 horganization for investigation and it is returned sometime later, without a certified! E) x3 k( \ c( z7 |
record of what was done to it, you have no confidence that the item is in fact the8 M2 L- h% D, X2 J6 P5 q
same one, unless it has some distinguishing features. The inspection history may
C3 b. f/ R: g9 M, Halso be invalidated because the operations conducted on the item were not certified.* x! Q: D S+ [4 J' N1 G. v$ N( ]
Traceability is only helpful when the chain remains unbroken. It can also be costly
( L- O- F6 `5 D1 S" v1 Xto maintain. The system of traceability that you maintain should be carefully K& P7 C/ n2 P. A% y, K$ O
thought out so that it is economic. There is little point in maintaining an elaborate
6 D. F+ N* M8 r7 c/ ~6 P: p! Jtraceability system for the once in a lifetime event when you need it, unless your
) J0 y$ r% O0 H& k' L% dvery survival or society’s survival depends on it. However, if there is a field failure,$ z5 b- P9 k; [( l
in order to prevent recurrence you will need to trace the component back through2 }7 E" ~2 O* J: Y3 K! s
the supply chain to establish which operation on which component was not per-( D' [/ `7 v6 E6 f) k# t
formed correctly simply to rule out any suggestion that other products might be1 r2 a/ d8 Z8 ^1 }& ]( t; P- a9 Z( Y
affected. i: K4 o" r8 [8 D
The conventions you use to identify product and batches need to be specified in the- M* q/ ^! N6 ] x3 D s' k8 a
product specifications and the stage at which product is marked specified in the relevant! y6 T0 r" [( L" s
procedures or plans. Often such markings are automatically applied during processing,# \" T3 E& b; @+ }& y/ D& T+ M& y
540 PART j 6 Complying with ISO 9001 Section 7 Requirementsas is the case with printed circuits, mouldings, ceramics, castings, products etc. Process
! m0 _/ a+ g# P9 ~6 gsetting up procedures should specify how the marking equipment or tools are to be5 [; w% q! n4 c2 ?2 C
set up.
& @- n+ N' N3 a: rIf you do release a batch of product prior to verification being performed and one out7 {# S4 ?' x! B3 |8 f1 x3 \
of the batch is subsequently found to be nonconforming, you will need to retrieve all
2 S/ `6 I* N( m3 Mothers from the same batch. This may not be as simple as it seems. In order to retrieve
, {7 N4 Q0 u7 Ra component which has subsequently been assembled into a printed circuit board, which. n. W7 u2 t+ X$ Q+ Z
has itself been fitted into a unit along with several other assemblies, not only would you6 ]0 M: u/ D" ?! E2 i1 T' t5 s
need a good traceability system but also one that is constantly in operation.+ I" _% [5 \9 w4 Z( n$ Q
It would be considered prudent to prohibit the premature release of product if you did( H" c! n$ ], a6 H1 Z1 h
not have an adequate traceability system in place. If nonconformity will be detected by1 n7 a; @) _4 N# f0 |1 g
the end product tests, allowing production to commence without the receipt tests being
3 D7 w0 G- t4 U) K; i! G1 [available may be a risk worth taking. However, if you lose the means of determining
# u- }+ t9 S# u. m( \8 V# h. zconformity by premature release, don’t release the product until you have verified it as4 D2 r- F! q) E7 e: A
acceptable.( M; G9 C2 t- }
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发表于 7-16 11:18:26
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封喉老师勿拍砖啊。
