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IDENTIFICATION AND TRACEABILITY (7.5.3)4 M& @' |. U" T7 ^
Identifying Product (7.5.3.1)
' T0 ? u( S0 aThe standard requires the organization to identify the product by suitable means O4 O2 g) y0 Z' I5 ~- f
throughout product realization where appropriate.9 G/ w6 @: x- y+ `
What Does this Mean?1 A! b2 H8 {8 D, ?7 t+ w& u- `9 b
The requirements for product identification are intended to enable products and services
8 Q# P( ^( k' U: {% x! swith one set of characteristics to be distinguishable from products or services with
5 k9 |6 C. y; Q8 x: j: X, uanother set of characteristics.0 \* e) r/ w4 c. r
The option of applying this requirement ‘where appropriate’ implies that there are
3 b0 F5 k# O: ~! B! n3 u4 Bsituations where product identity is unnecessary. There are of course situations where. Y2 Z7 t- t0 W5 ]9 m# o2 k3 a
attaching an identity to a product would be impractical such as for liquids or items too3 D- c: ~2 q3 S3 N- w
small but the product nevertheless has an identity that is conveyed through the pack-
2 r5 h% H$ O" b- U% _7 ^. H+ `aging and associated information. In the food industry, the biscuits on the conveyor
G3 k0 ] E6 H" Jmight not carry an identity but the box into which they are packed does as does the5 \0 O3 t6 S" h, Q" p) y* E; w8 s$ g
instruction that ordered the biscuits to be produced. Thus identifying a product by
C2 [6 c% M; ]) Psuitable means might require the product to be labelled, or might require the container to
- `" z' `; F4 h! J" k. b6 vbe labelled. Services are somewhat different. Many are not identified other than by the/ n) R9 [3 f) P
nature of what the organization does by generic categories such as investment, mort-
% J& }6 H" r0 ~1 g/ p% Ogage, financial planning services of banks. Where there are differences for instance in: f' E, y! {- V# `+ R2 J9 u: l3 ^
interest rates, the ‘products’ are given different names such as Instant Access Account,4 [3 n0 ^2 W# h2 l/ U
90 Day account and so on.
# C+ ]5 B* p1 E g8 VWhy is this Necessary?) z) \9 a. u: L0 F
This requirement responds to the Process Approach Principle.
- m" f) U5 O9 e& ~' X6 VProduct identity is vital in many situations to prevent inadvertent mixing, to enable
9 `% u8 W3 d; K; K! Yre-ordering, to match products with documents that describe them and to do that basic of
" I. O8 X. G# L/ u) I2 M Jall human activities – to communicate.Without codes, numbers, labels, names and other
) n1 L4 f- u$ o; D/ t+ e1 `7 gforms of identification we cannot adequately describe the product or service to anyone% J7 ?1 _5 K5 d6 K5 x
else or be certain we are looking at the right product. The product must be identified in M; g8 B3 l- q+ S3 u3 b
one way or another otherwise it cannot be matched to its specification.
0 j5 ?. v& M: h8 M) }* h' g0 VHow is this Demonstrated?1 i( Q! p6 y: }* U% O1 y* x
Separate product identity is necessary where it is not inherently obvious. If products are
5 N* r Y; ^5 [8 h" J& }+ ]so dissimilar that inadvertent mixing would be unlikely to occur, a means of physically
& o2 R- ~* I! V( Nidentifying the products is probably unnecessary. ‘Inherently obvious’ in this context- g( z$ I. s* `0 E: f% k2 a/ c
means that the physical differences are large enough to be visible to the untrained eye.
5 _0 O5 I' m6 I1 `1 x" J7 p; [8 M6 WFunctional differences, therefore, no matter how significant as well as slight differences) \. B X2 m; U; p6 b) ~- J
in physical characteristics such as colour, size, weight and appearance would constitute
8 k* r; @3 f: C0 X# ?) u; kan appropriate situation for documented identification procedures.4 \: c6 M9 s0 b9 H( b
Identifying product should start at the design stage when the product is conceived. The- a; p4 V4 K* S* [ i6 I
design should be given a unique identity, a name or a number and that should be used on all* }) c- w1 O1 d1 ^# R; X
related information.When the product emerges into production, the product should carry
d4 i. | }9 E" L' S/ r/ }the same number or name but in addition it should carry a serial number or other iden-
) B" e- [5 v5 btification to enable product features to be recorded against specific products. If verification& H: L' k4 E; J, G' ~7 ~
is on a go or no go basis, product does not need to be serialized. If measurements are: G3 j8 _! v7 x5 R
recorded some means has to be found of identifying the measurements with the product2 H" |/ F8 M" T( o. `; H' s1 l
measured. Serial numbers, batch numbers and date codes are suitablemeans for achieving3 e6 b" H$ N& l9 o8 ?- w7 u2 I
this. This identity should be carried on all records related to the product.0 Z6 z4 v9 [. V8 i: `# V
Apart from the name or number given to a product you need to identify the version
- \5 q" A9 }9 m" ^) Band the modification state so that you can relate the issues of the drawing and specifi-3 x6 d d* P. |( Z
cations to the product they represent. Products should either carry a label or markings- ?, R+ i' C8 ]% G. k
with this type of information in an accessible position or bear a unique code number that! X% g: c" }' h# v
is traceable to such information.- |6 l O+ ?! V, R2 \! @3 C @6 i
You may not possess any documents that describe purchased product. The only) s0 T& s6 U) K+ g) l" M) ]. w6 W
identity may be marked on the product itself or its container. Where there are no {9 O5 Y" z: P8 ?0 A1 m4 |
markings, information from the supplier’s invoice or other such documents should be
: ?+ r: a" }$ N: J9 E7 \transferred to a label and attached to the product or the container. Information needs to- P8 C2 l/ A3 r/ K4 }
be traceable to the products it represents.( h! Q2 x* B9 E5 [
The method of identification depends on the type, size, quantity or fragility of the
. `# `- y" G y; x+ R4 t: D+ Wproduct. You can mark the product directly (provided the surface is not visible to the end
. ~ p9 b& I4 g1 cuser unless of course identity is part of the brand name) tie a label to it or the container in
8 ~ c3 w2 t+ r5 \537 Chapter j 27 Production and Service Provisionwhich it is placed. You can also use records remote from the product providing they bear2 F. b/ c# F- t
a unique identity that is traceable to the product.
" l* L& ^% X: M9 B- A! g9 LMarking products has its limitations because it may damage the product, be removed. _. _1 M# ?) k# i. H7 A) J
or deteriorate during subsequent processing. If applied directly to the product, the9 ^+ t; K8 f; M: r1 U- j
location and nature of identification should be specified in the product drawings or6 P9 M" `8 X" y
referenced process specifications. If applied to labels which are permanently secured to0 z2 t7 q/ t$ k" h- b3 x. }
the product, the identification needs to be visible when the product is installed so as to- I* O. W; n5 Y& [; @" N: I6 Q: s
facilitate checks without its removal. If the identity is built into the forging or casting, it
, p& o7 A2 M6 \7 v# p' I7 H% ris important that it is legible after machining operations. One situation which can be
% r* ^5 q. f' H+ jparticularly irritating to customers is placing identification data on the back of equip-
/ I; y2 c* k1 o! L/ w- n( rment and then expecting the customer to state this identity when dealing with a service: _5 [: R: E) ^: L6 F
call thus causing delay while the customer dives under the desk to locate the serial
3 y8 `, y7 K4 t R" xnumber and drops the telephone in the panic!" ^; {1 D/ ~3 ` Y2 a
Verification Status (7.5.3)' b5 m! P7 g5 H; N+ \
The standard requires the organization to identify the status of the product with respect3 h, ^2 f/ K& u! X+ a8 H4 A1 Y$ M
to measurement and monitoring requirements throughout product realization.
7 ~% R( P8 R2 n4 EWhat Does this Mean?# k* u, @. @/ u! B9 f
Product status with respect to monitoring and measurement means an indication as to% ~2 T# _0 m5 O& O: _
whether the product conforms or does not conform to specified requirements. Thus, F# P% E8 y0 c
identifying product status enables conforming product to be distinguishable from3 C( U' u" X" s5 ?( X& S- {
nonconforming product.
, J, w8 U" e7 ]* o/ v' f7 ZWhy is this Necessary?/ g2 O& z, ?5 ^9 g9 t! s
This requirement responds to the Factual Approach Principle.# {0 D4 A4 \5 r3 k0 `) T* T
Measurement does not change a product but does change our knowledge of it.* \$ R2 Z( }6 c
Therefore it is necessary to identify which products conform and which do not so that5 s& A9 |4 n: e. r
inadvertent mixing, processing or delivery is prevented.+ c2 i/ [7 g! D
How is this Demonstrated?) ^. c( f" o; f+ k; m, }
The most common method of denoting product status is to attach labels either to the) t! k9 \: `. p3 i
product or to containers holding the product. Green labels for acceptable good and Red
0 ] T+ L& P2 v2 jlabels for reject goods. Labels should remain affixed until the product is either packed or
% o3 s& X, k) Tinstalled. Labels should be attached in a way that prevents their detachment during
" R4 P( k, g- S1 Fhandling. If labels need to be removed during further processing, the details should be2 k7 g; u/ C6 j% i. N# |
transferred to inspection records so that at a later date the status of the components in an
4 E# P( e \0 y8 i( U# |$ h5 wassembly can be checked through the records. At dispatch, product status should be( w, x! N& E8 D+ f2 N+ {; Y3 j
visible. Any product without status identification should be quarantined until re-verified
0 }$ w3 ~7 N; X) f- ?0 cand found conforming. Once a product has passed through the product realization
) W; ~4 [* _8 Z1 N& j3 N" Cprocess and is in use, it requires no product status identity unless it is returned to the3 \/ {9 u8 ^7 @. L
production process for repair or other action.
! C2 i" v2 S; Q4 BIt should be possible when walking through a machine shop for example, to identify3 l" y8 Z( d1 U) d
which products are awaiting verification, which have been verified and found8 j a4 }: j' ^, ?; E9 k
538 PART j 6 Complying with ISO 9001 Section 7 Requirementsconforming and which have been rejected. If by chance, some product was to become
$ S) Y8 _$ L2 Y: Eseparated from its parent batch, it should still be possible to return the product to the, K1 M6 Q" X' v2 k% R- k: I! i- v% V
location from whence it came. A machine shop is where this type of identification is" h6 a$ |9 K% q b
essential – it is where mix-ups can occur. In other places, where mix-ups are unlikely,
. G# Z r; `$ c& ~2 v) xverification status identification does not need to be so explicit.7 q2 n. z; R4 t9 O
Identifying product status is not just a matter of tying a label on a product. The status
% |# F3 P u- M2 ]/ R, eshould be denoted by an authorized signature, stamp, mark or other identity which is
( c; k# u6 `+ `! ?3 `" xapplied by the person making the accept or reject decision and which is secure from
5 C& B5 o/ f9 I+ v1 F) gmisuse. Signatures are acceptable as a means of denoting verification status on paper
+ O6 j8 b0 R8 a+ T( ~4 S9 [7 }records but are not suitable for computerized records. Secure passwords and ‘write only’$ t! T/ D; i1 I
protection has to be provided to specific individuals. Signatures in a workshop envi-
" d# u+ H' ~" ]- I1 B3 A+ |# ~# qronment are susceptible to deterioration and illegibility that is why numbered inspection
* O3 v& D, C4 S* Dstamps with unique markings evolved. The ink used has to survive the environment and
% C9 Z9 C* ^1 ]$ p6 R) hif the labels are to be attached to the product for life, it is more usual to apply an imprint1 Y) O" M6 l) h7 ]- a- }$ Y
stamp on soft metal or bar code.$ x* ^( T! T. q) n# V- q, D, r
Small and fragile products should be held in containers and the container sealed and
8 E- _$ f2 b* Vmarked with the product status. Large products should either carry a label or have
/ V: I! s' U; ?+ L: P+ A/ oa related inspection record.
" `8 p1 _% L+ ?( A; L& p8 yIn some situations the location of a product can constitute adequate identification of
5 A( `/ g4 s5 I" v) E) Qproduct status. However, these locations need to be designated as Awaiting Inspection,: R Y- m1 K; ~' h
Accepted Product or Reject Product or other such labels as appropriate to avoid
3 p( d8 _. e" j: ^. d; ^* Y6 Ethe inadvertent placement of items in the wrong location. The location of product in the1 |: _8 ?: A( w3 ^
normal production flow is not a suitable designation unless an automated transfer route
/ U3 W7 b9 U7 ~/ V: v5 Wis provided.7 B; p1 E, Q5 A/ K1 p
When a service is out of service, tell your customers. Services that rely on products- i& R4 z/ d- ?" @. g+ G" g# z7 N
should carry a label or a notice when accessed. A bank cash machine is one example
* K+ J# X, @$ Y8 ~4 v/ {where a notice is displayed when the machine is out of service. In some cases customers
+ o* Q2 V3 K# [4 M( b5 Fmay need to be informed by letter or telephone./ S. }( l. j% K7 V
With software the verification status can be denoted in the software as a comment or
/ |! K! `4 P) U2 aon records testifying its conformance with requirements., C9 u9 a9 w4 ]) m; h
With documentation you can either denote verification status by an approval signa-. |: h6 ]2 W$ V- ~
ture on the document or by a reference number, date and issue status that is traceable to
' E5 y# _* z* {4 B; z% @records containing the approval signatures.2 g4 Y; U- m# F7 L0 m
If you use stamps, you will need a register to allocate stamps to particular individuals/ C5 I/ F+ P _8 k5 t- L+ w7 K
and to indicate which stamps have been withdrawn.When a person hands in his stamp it! |8 e' L- c- G+ Y2 ~
is good practice to avoid using the same number for 12 months or so to prevent mistaken
1 W3 u5 A4 J# D0 qidentity in any subsequent investigations. P) T3 i% O( `% g" v
Traceability
& O1 Q* A5 E" ^' g4 \9 uWhere traceability is a requirement the standard requires the organization to control the5 t5 J1 v1 u: v5 C$ r6 F
unique identification of the product and maintain records.
. t! ~4 y0 ]) I- t& x0 VWhat Does this Mean?
! `6 y. C5 ^( ^1 g& @Traceability is a process characteristic. It provides the ability to trace something through9 J: Y; h1 e) g: M2 C( h
a process to a point along its course either forwards or backwards through the process6 v9 l$ p D7 e4 T
539 Chapter j 27 Production and Service Provisionand determine as necessary, its origin, its history and the conditions to which it was
; W1 Q" K h! E3 ~* x5 Msubjected. Traceability may be a requirement of the customer, legislation or statutes or
& b) Z. a5 R( O, H2 }- esimply a requirement of the organization in order to conduct investigations when events
" V6 t, U4 |* _* A6 c6 Mdo not proceed as planned.. V) Y, q& ~# c* U B- l
Why is this Necessary? }' T ]6 X4 W
This requirement responds to the Factual Approach Principle.1 H! z1 y) v; |2 F( f8 g$ }
One needs traceability to find the root cause of problems. If records cannot be found
, O9 }/ R# y6 Z; Cwhich detail what happened to a product then nothing can be done to prevent its+ K9 J4 q: X4 ]" z3 T" r$ V4 M
recurrence. Although the standard only requires traceability when required by contract! R* W" J4 _9 o$ `' T/ t
or law, it is key to enabling corrective action.
0 e& K4 u" l" T9 R2 w. y6 V8 KIn situations of safety or national security it is necessary to be able to locate all
, n0 C- K# N0 }2 n" `* nproducts of a batch in which a defective product has been found so as to eliminate them+ L8 q h/ B( P& q$ \+ J" z# A T, }# `
before there is a disaster. It is also very important in the aerospace, automobile, medical# h6 d/ U9 C# k6 u% e) w
devices and food and drugs industries – in fact, any industry where human life may be at
& k1 @& S; e* r/ T. A! ]risk due to a defective product being in circulation.
/ i5 T7 d G0 Z1 JTraceability is also important to control processes. You may need to know which
& }" o. U2 ]" H: }products have been through which processes and on what date if a problem is found
/ T- Q0 P7 m3 Y# Usometime later. The same is true of test and measuring equipment. If on being calibrated
) C0 u2 g) q7 D+ ga piece of test equipment is found to be out of calibration then it is important to track
3 a+ h; d+ X- b0 E: \% mdown all the equipment which has been validated using that piece of measuring
7 ~) B) F! f! s8 B9 k2 \equipment. This in fact is a requirement of ISO 9001 Clause 7.6 but no requirement for5 L/ y; `) M+ h% o9 P9 f9 h
traceability is specified.6 N5 h4 `; [' g, o& z" d/ v% g* [
How is this Demonstrated?
$ r) {2 K& Q2 ~! e% E. V& pProviding traceability can be an onerous task. Some applications require products to
3 ~2 @+ F% i7 i* d9 H7 h: Ebe traced back to the original ingot from which they were produced. Traceability is
; J; q' O {4 x4 H) j- D; oachieved by coding items and their records such that you can trace an item back to3 D# A' V5 X' u5 G) ]. C" N. m
the records at any time in its life. The chain can be easily lost if an item goes
* z2 ?# @* g b+ |outside your control. For example, if you provide an item on loan to a development
. g; G0 L% P% v! n4 vorganization for investigation and it is returned sometime later, without a certified" B. n& m1 S6 q: V4 X# e; U
record of what was done to it, you have no confidence that the item is in fact the
; T3 H* p2 [: Fsame one, unless it has some distinguishing features. The inspection history may* s* x- I V' s0 Z' T% |% B) w/ @
also be invalidated because the operations conducted on the item were not certified.
: z+ ^+ Z! E2 ITraceability is only helpful when the chain remains unbroken. It can also be costly
+ W6 y1 N5 o3 f1 a/ }3 Yto maintain. The system of traceability that you maintain should be carefully; C$ h1 b _- A2 f& g1 s. T8 v
thought out so that it is economic. There is little point in maintaining an elaborate2 q' `" j6 R2 [6 }5 n; o2 x/ o
traceability system for the once in a lifetime event when you need it, unless your( C& k1 `0 @) h. R: g* x4 s
very survival or society’s survival depends on it. However, if there is a field failure,
% E A6 z$ l# M* ?. t4 V2 A1 Tin order to prevent recurrence you will need to trace the component back through
1 B3 e- C4 r9 P4 _" C; [- J& Q/ xthe supply chain to establish which operation on which component was not per-
& j0 N4 A! h' d4 Mformed correctly simply to rule out any suggestion that other products might be
% {) B3 U2 s6 \affected.9 Z8 ?4 v: M" J5 Q
The conventions you use to identify product and batches need to be specified in the
4 p. N* ^% @ `6 @product specifications and the stage at which product is marked specified in the relevant
, X2 Y) ~4 I3 q0 o3 G$ _6 e: kprocedures or plans. Often such markings are automatically applied during processing,8 z7 @$ v7 m1 n
540 PART j 6 Complying with ISO 9001 Section 7 Requirementsas is the case with printed circuits, mouldings, ceramics, castings, products etc. Process
" X* J% b5 [$ msetting up procedures should specify how the marking equipment or tools are to be% g9 B \% z0 O
set up.
9 W) P4 P M5 k4 d; g. \0 m4 YIf you do release a batch of product prior to verification being performed and one out/ ^& D' [" g3 l: j6 T4 i
of the batch is subsequently found to be nonconforming, you will need to retrieve all
& `& y& J- p- h: h9 Yothers from the same batch. This may not be as simple as it seems. In order to retrieve$ I M9 \6 g2 _ m9 O& `
a component which has subsequently been assembled into a printed circuit board, which; K' S, w( @8 y# N* Z0 l* R
has itself been fitted into a unit along with several other assemblies, not only would you
+ A7 |& o) ?* E: j# Vneed a good traceability system but also one that is constantly in operation.( r8 b/ J, D0 ]# e* { o4 T
It would be considered prudent to prohibit the premature release of product if you did7 I0 b3 q1 B- r& i$ N# M& K/ U
not have an adequate traceability system in place. If nonconformity will be detected by; Q. J' I. K3 V5 g# `
the end product tests, allowing production to commence without the receipt tests being
/ v( I. M1 q; T& Q0 vavailable may be a risk worth taking. However, if you lose the means of determining' G X, h* F7 H! ]7 A5 x1 W
conformity by premature release, don’t release the product until you have verified it as
1 j/ Z2 m( b; N! [& j# }& m& g9 @acceptable.
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IP卡
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发表于 7-16 11:18:26
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封喉老师勿拍砖啊。
