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来自国外质量手册，与各位分享：7 }7 n: z* X" n' I5 k
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IDENTIFICATION AND TRACEABILITY (7.5.3)
) t9 Z) [8 `# q9 o. Y1 xIdentifying Product (7.5.3.1)
' `, N! a+ a7 a tThe standard requires the organization to identify the product by suitable means
2 V) Y& \& Y2 G' ^throughout product realization where appropriate.
8 e S0 a9 Q( {What Does this Mean?
- _* G# b! |7 @( K7 x/ hThe requirements for product identification are intended to enable products and services
, n8 K0 J$ y6 h0 Nwith one set of characteristics to be distinguishable from products or services with
" ]; U W6 I8 O0 V: k' Aanother set of characteristics.
5 Z$ C* n( d1 ]3 \- @The option of applying this requirement ‘where appropriate’ implies that there are
9 B2 m/ H0 X5 w0 jsituations where product identity is unnecessary. There are of course situations where
! @6 j5 k/ y3 r* F+ @1 G0 Vattaching an identity to a product would be impractical such as for liquids or items too5 i( c* M" O( t( D5 R/ `
small but the product nevertheless has an identity that is conveyed through the pack-
( j5 r2 ^+ G$ `7 ]' naging and associated information. In the food industry, the biscuits on the conveyor2 V7 W: U3 s. G* E6 o
might not carry an identity but the box into which they are packed does as does the
* x" z# `3 u% Q# y& G' k: G g( E# k7 rinstruction that ordered the biscuits to be produced. Thus identifying a product by
4 m6 X2 J" k) ?% Osuitable means might require the product to be labelled, or might require the container to
6 W" b i( a1 ]7 Y8 abe labelled. Services are somewhat different. Many are not identified other than by the: c& r7 N$ i! Z! i2 D
nature of what the organization does by generic categories such as investment, mort-7 q9 f m2 z* G* m9 O! T
gage, financial planning services of banks. Where there are differences for instance in
' O I& \7 ~* v+ Q) ]( j0 P# T! Winterest rates, the ‘products’ are given different names such as Instant Access Account,
`5 q) `6 U) M4 d' S P8 e! ?- ~90 Day account and so on.
6 M% ?2 r! G' n# j4 I# [3 CWhy is this Necessary?& f1 }& Y* J) f7 Z/ t- O2 [) o
This requirement responds to the Process Approach Principle.
9 R) @( s; q* R9 K5 {! h1 mProduct identity is vital in many situations to prevent inadvertent mixing, to enable; T9 z# C( p- a6 F. b. M7 D& R
re-ordering, to match products with documents that describe them and to do that basic of, a) J+ X9 m+ `! x; I' }$ c
all human activities – to communicate.Without codes, numbers, labels, names and other
6 }- p5 F) F. _% Sforms of identification we cannot adequately describe the product or service to anyone3 O# M2 ~% _& W. l2 [& Z
else or be certain we are looking at the right product. The product must be identified in
3 y# Z0 v: X5 Pone way or another otherwise it cannot be matched to its specification." v9 i0 G. O8 b
How is this Demonstrated?
% Q& n2 v2 U GSeparate product identity is necessary where it is not inherently obvious. If products are
' U. n( A( O* F6 ]8 uso dissimilar that inadvertent mixing would be unlikely to occur, a means of physically
% u7 a& J5 W+ y9 s3 {$ Ridentifying the products is probably unnecessary. ‘Inherently obvious’ in this context
* {- A& \/ Z9 k% f. Zmeans that the physical differences are large enough to be visible to the untrained eye.4 p$ H& U2 A7 x% @. ?+ ?- M, G
Functional differences, therefore, no matter how significant as well as slight differences3 V5 o" Y' b+ d$ X; G% {& K0 k
in physical characteristics such as colour, size, weight and appearance would constitute
5 f! B+ A+ j$ @) @0 U& Nan appropriate situation for documented identification procedures.4 a/ a3 f8 U1 e: f% B# w" W* {, H
Identifying product should start at the design stage when the product is conceived. The: j4 D! L' k L0 j
design should be given a unique identity, a name or a number and that should be used on all5 j% u, G3 U, _7 H
related information.When the product emerges into production, the product should carry4 G5 x2 f/ R- c' Q) o2 ~
the same number or name but in addition it should carry a serial number or other iden-/ Q9 R( |5 m7 i) M
tification to enable product features to be recorded against specific products. If verification: }/ x; @! s( Y' V
is on a go or no go basis, product does not need to be serialized. If measurements are+ c" e. G" F* q! ]4 Q
recorded some means has to be found of identifying the measurements with the product
8 K5 A+ Q4 a! Imeasured. Serial numbers, batch numbers and date codes are suitablemeans for achieving
, B9 I) {/ ~% b! f& |9 xthis. This identity should be carried on all records related to the product.4 P8 b6 y$ [0 b$ W0 L
Apart from the name or number given to a product you need to identify the version4 U6 n `# W0 N2 e* I- @
and the modification state so that you can relate the issues of the drawing and specifi-1 A, [) g' ~* c) q# D1 d
cations to the product they represent. Products should either carry a label or markings
) N; q* @6 [# e5 `2 H4 ?, I4 ~with this type of information in an accessible position or bear a unique code number that# s4 Y8 p& r$ R ], O( r5 e: L% U
is traceable to such information.6 A+ ~3 z4 F6 l
You may not possess any documents that describe purchased product. The only
4 N2 ^' k6 @; E& f7 videntity may be marked on the product itself or its container. Where there are no; t: g$ v3 `. F! X3 b9 i
markings, information from the supplier’s invoice or other such documents should be
: I5 v" H' A! S1 mtransferred to a label and attached to the product or the container. Information needs to
6 I" C7 \: g! d* W' z3 hbe traceable to the products it represents.3 h' [4 n p [" f0 e
The method of identification depends on the type, size, quantity or fragility of the0 Q& C6 z% E# }6 Z
product. You can mark the product directly (provided the surface is not visible to the end
5 T. t g6 ^9 duser unless of course identity is part of the brand name) tie a label to it or the container in
- i' D: d0 r' b537 Chapter j 27 Production and Service Provisionwhich it is placed. You can also use records remote from the product providing they bear& W6 X6 q0 Z4 `8 v$ i% b
a unique identity that is traceable to the product.5 x( C7 N3 `: N1 `
Marking products has its limitations because it may damage the product, be removed: N" k3 `6 _+ ^+ h6 v0 Y
or deteriorate during subsequent processing. If applied directly to the product, the1 E& K b8 V$ j
location and nature of identification should be specified in the product drawings or
! L* Y9 T0 i8 a- F' [referenced process specifications. If applied to labels which are permanently secured to( f5 r8 _1 y& c1 J( ]
the product, the identification needs to be visible when the product is installed so as to3 S9 o( n+ s. W% M5 E
facilitate checks without its removal. If the identity is built into the forging or casting, it- U/ a b0 i4 G! P5 _+ D
is important that it is legible after machining operations. One situation which can be
6 ^1 e1 ?4 T0 Cparticularly irritating to customers is placing identification data on the back of equip-$ J" S5 l' E o7 ~" f0 b6 i. ~
ment and then expecting the customer to state this identity when dealing with a service" G8 M$ o3 K1 U4 f+ d
call thus causing delay while the customer dives under the desk to locate the serial
: \6 A1 C% o" Z! _6 _$ Wnumber and drops the telephone in the panic!
# p5 k# L; p8 N% x( R7 `Verification Status (7.5.3)% Y6 R. s7 x# c
The standard requires the organization to identify the status of the product with respect
; A) \( g, P# R5 P4 `" R$ {+ p/ O. Tto measurement and monitoring requirements throughout product realization.
7 \0 Y( q% j* b# E6 s# bWhat Does this Mean?. f0 S/ O: S2 L# L; n* y9 f
Product status with respect to monitoring and measurement means an indication as to/ } G6 D) M$ V/ V) \5 i
whether the product conforms or does not conform to specified requirements. Thus0 J, l V# g; S! m# R) M
identifying product status enables conforming product to be distinguishable from5 y1 n& @: V6 i. e4 w& H
nonconforming product.
. g2 q, D5 S) A0 \$ G: v$ {! b% AWhy is this Necessary?' s/ W' ?8 e: s2 q7 x
This requirement responds to the Factual Approach Principle.3 K( B3 h3 `9 X! R, P
Measurement does not change a product but does change our knowledge of it.: Y" W$ c4 e7 \
Therefore it is necessary to identify which products conform and which do not so that& m' H& G( }- c' i* |, @ x
inadvertent mixing, processing or delivery is prevented." i- {$ ^' I; x+ Y8 Z
How is this Demonstrated?
5 ]6 ?; _3 `! X5 z/ i" U0 |. mThe most common method of denoting product status is to attach labels either to the+ z3 A+ m( ]' \
product or to containers holding the product. Green labels for acceptable good and Red
; M+ R! Q* k7 Q' h0 s. f( ylabels for reject goods. Labels should remain affixed until the product is either packed or/ N$ p7 R2 r! Y, f' |/ N- d9 E
installed. Labels should be attached in a way that prevents their detachment during
: d& e. M1 P2 T6 @' m' W; phandling. If labels need to be removed during further processing, the details should be
! f. V) N( ^) [3 ~transferred to inspection records so that at a later date the status of the components in an! D! U& a" D. @3 ~9 S" P" f. z
assembly can be checked through the records. At dispatch, product status should be
- a; I3 @4 q& G* U. X Evisible. Any product without status identification should be quarantined until re-verified6 A# M i9 ]1 U
and found conforming. Once a product has passed through the product realization3 C% j! S8 O: t
process and is in use, it requires no product status identity unless it is returned to the
8 w2 ~% Y: H, L3 Vproduction process for repair or other action.
* n6 E! [ q* i6 O/ OIt should be possible when walking through a machine shop for example, to identify
. Z6 X1 K! D Y( i G0 b9 F- \& Swhich products are awaiting verification, which have been verified and found1 c# a2 U5 O6 |7 e
538 PART j 6 Complying with ISO 9001 Section 7 Requirementsconforming and which have been rejected. If by chance, some product was to become
" o$ V6 D5 |3 `- Y) M( eseparated from its parent batch, it should still be possible to return the product to the
$ c" B* U' D: @0 H2 ^& ~location from whence it came. A machine shop is where this type of identification is; }, L4 [) g6 M
essential – it is where mix-ups can occur. In other places, where mix-ups are unlikely,
! w, V2 ?9 ~9 I" q- Everification status identification does not need to be so explicit.2 Q. j. Z4 C$ X
Identifying product status is not just a matter of tying a label on a product. The status
6 ~7 Z1 L2 s1 T; _) Gshould be denoted by an authorized signature, stamp, mark or other identity which is7 ~' T' } y% F0 Z* i/ ^. x- @: u
applied by the person making the accept or reject decision and which is secure from. e# }; ?# k( w
misuse. Signatures are acceptable as a means of denoting verification status on paper
9 w1 D ?) M2 @3 rrecords but are not suitable for computerized records. Secure passwords and ‘write only’
$ U" l. m L: N3 b& g# Xprotection has to be provided to specific individuals. Signatures in a workshop envi-
8 l, n' s9 a$ Ironment are susceptible to deterioration and illegibility that is why numbered inspection6 E0 b q+ l: z" v9 g+ ~
stamps with unique markings evolved. The ink used has to survive the environment and
/ [- r2 `. [, r' P V( |7 c* Gif the labels are to be attached to the product for life, it is more usual to apply an imprint6 a- S/ {. Q3 m1 S* h9 b% x5 F! w
stamp on soft metal or bar code.) ?+ {, z6 @: f7 \5 `* t \5 T0 W3 {: U
Small and fragile products should be held in containers and the container sealed and8 K' |' c: K4 K9 U2 _3 E# F
marked with the product status. Large products should either carry a label or have. u) ?- U t7 }8 Y0 y+ a3 F7 I2 h
a related inspection record.$ |/ o# s, X+ G3 h, s* f4 \/ q
In some situations the location of a product can constitute adequate identification of" ^8 n% Z6 X" w$ W
product status. However, these locations need to be designated as Awaiting Inspection,
" v" k$ _$ y" X; M6 a* AAccepted Product or Reject Product or other such labels as appropriate to avoid9 x, o$ w7 C8 m% z5 G P
the inadvertent placement of items in the wrong location. The location of product in the
8 G; ^: ?8 a* X: r, L7 }7 n' Lnormal production flow is not a suitable designation unless an automated transfer route4 S. q8 {7 `' C& K- j2 J
is provided.
* U/ c$ M7 V) n5 h, \When a service is out of service, tell your customers. Services that rely on products3 b& |! m, D* k3 w
should carry a label or a notice when accessed. A bank cash machine is one example5 Y& {$ ?. n- h& X$ s* ^1 V+ z5 T$ `
where a notice is displayed when the machine is out of service. In some cases customers& F5 ?% ~ c% a$ H i/ F9 l
may need to be informed by letter or telephone. v. D: k: K4 R) p* S
With software the verification status can be denoted in the software as a comment or5 s9 g+ v$ Q2 t5 I, H6 L$ X' f
on records testifying its conformance with requirements.* Q: I+ S6 H/ B5 C r- \
With documentation you can either denote verification status by an approval signa-8 c( o5 g- q8 I I% G' E$ D
ture on the document or by a reference number, date and issue status that is traceable to+ M! |, h. V$ K" V$ }
records containing the approval signatures.5 A1 k J% X" j6 `5 R. B8 F- @
If you use stamps, you will need a register to allocate stamps to particular individuals/ y) f" S/ {& ]* |9 V
and to indicate which stamps have been withdrawn.When a person hands in his stamp it
( d( b7 T5 L0 T, v* m8 M+ ois good practice to avoid using the same number for 12 months or so to prevent mistaken
+ F! {/ W& x0 P9 I/ _5 Iidentity in any subsequent investigations.
5 n: z: l0 E+ [% Q OTraceability5 P; C0 h" H0 e9 b& B
Where traceability is a requirement the standard requires the organization to control the5 S% i1 ~! S7 @2 u7 p
unique identification of the product and maintain records.
' C# K# s* e/ j' k2 RWhat Does this Mean?: t- z) e% k$ @; a. C
Traceability is a process characteristic. It provides the ability to trace something through
( E) y) B; |3 K4 i6 X0 ja process to a point along its course either forwards or backwards through the process
, ?5 b. ?2 x6 O539 Chapter j 27 Production and Service Provisionand determine as necessary, its origin, its history and the conditions to which it was
6 {- r7 {! [. } ]9 Y1 R; l% N0 R( dsubjected. Traceability may be a requirement of the customer, legislation or statutes or
1 e& H8 V( B! C* U# h. l) F7 ^simply a requirement of the organization in order to conduct investigations when events
% p' J) ?& _8 O* U" k x" b( Ldo not proceed as planned.: X. [1 T/ B# h2 x/ v9 [# e
Why is this Necessary?2 [! {4 G4 w) @
This requirement responds to the Factual Approach Principle.
! T4 ^7 K; |2 k. n( XOne needs traceability to find the root cause of problems. If records cannot be found R" T0 N* ^* s9 ?$ l. x9 ~
which detail what happened to a product then nothing can be done to prevent its
+ O0 @$ c; Q1 ]) erecurrence. Although the standard only requires traceability when required by contract3 z. j; o Q" ?: G
or law, it is key to enabling corrective action.: F" X7 M! M& J- T) }
In situations of safety or national security it is necessary to be able to locate all
! @; \, [; ~1 j3 H. Wproducts of a batch in which a defective product has been found so as to eliminate them& c6 f4 ]. |0 }$ D
before there is a disaster. It is also very important in the aerospace, automobile, medical
# K3 i- f8 b/ q" sdevices and food and drugs industries – in fact, any industry where human life may be at( c& R, ?3 [7 n3 |# a
risk due to a defective product being in circulation.0 G8 x" P$ z% T
Traceability is also important to control processes. You may need to know which6 [% V5 G% B0 Y1 `
products have been through which processes and on what date if a problem is found2 v0 b# m! m0 D% h
sometime later. The same is true of test and measuring equipment. If on being calibrated9 g2 j2 h! p" H2 T3 G
a piece of test equipment is found to be out of calibration then it is important to track1 w; y9 G6 \" a/ u
down all the equipment which has been validated using that piece of measuring: n4 v! h6 N A! H& D7 E* _
equipment. This in fact is a requirement of ISO 9001 Clause 7.6 but no requirement for
3 f3 x3 G. y0 ?+ Htraceability is specified.4 V1 \3 `- U( `' h
How is this Demonstrated?
+ `7 p& E& n( Q" r2 WProviding traceability can be an onerous task. Some applications require products to
# t3 ?# E" Q+ T/ N+ l: e+ Abe traced back to the original ingot from which they were produced. Traceability is1 ^; S6 j" c5 ^& o8 ]
achieved by coding items and their records such that you can trace an item back to
- @8 Y/ w% r# n4 Y/ K5 Kthe records at any time in its life. The chain can be easily lost if an item goes
, `$ l: l# C j7 loutside your control. For example, if you provide an item on loan to a development
& _$ p. L$ n5 a* Zorganization for investigation and it is returned sometime later, without a certified4 g! f. n) ?7 T1 L! j/ ~/ o: j8 Y
record of what was done to it, you have no confidence that the item is in fact the) ~* }5 V, w" g0 i; k# p: @
same one, unless it has some distinguishing features. The inspection history may
/ R0 a6 J9 S$ f* Q+ m/ Xalso be invalidated because the operations conducted on the item were not certified.
5 n9 [9 ?) O) TTraceability is only helpful when the chain remains unbroken. It can also be costly
( e7 h- |0 a1 v3 o8 ]: ato maintain. The system of traceability that you maintain should be carefully
- p+ U0 Z' k: d7 b7 s1 o9 Y9 Vthought out so that it is economic. There is little point in maintaining an elaborate
' B4 d1 o& ~, }traceability system for the once in a lifetime event when you need it, unless your
+ I! K3 @8 s! l* ~. `very survival or society’s survival depends on it. However, if there is a field failure,
' I0 _* o- `3 a4 c1 ]: Lin order to prevent recurrence you will need to trace the component back through J8 ?: [9 E0 G% }, X
the supply chain to establish which operation on which component was not per-( s1 A) r5 E6 k& r
formed correctly simply to rule out any suggestion that other products might be$ g! Z( s8 b3 y# r; A0 \
affected.
. r0 q/ _; v5 F" y ^The conventions you use to identify product and batches need to be specified in the
- _2 C5 F$ V7 x% T2 W+ I0 I# kproduct specifications and the stage at which product is marked specified in the relevant
- R% M; C2 k( }, c3 a Rprocedures or plans. Often such markings are automatically applied during processing,
; ]6 N8 P! B) H5 X- V) M; P: K540 PART j 6 Complying with ISO 9001 Section 7 Requirementsas is the case with printed circuits, mouldings, ceramics, castings, products etc. Process
; V$ r( r H) Qsetting up procedures should specify how the marking equipment or tools are to be
% [) e# k* X$ A6 H6 dset up.* S8 u/ G9 V+ |, l. \. E9 r1 K% [
If you do release a batch of product prior to verification being performed and one out
/ \+ v$ |0 l$ \4 Rof the batch is subsequently found to be nonconforming, you will need to retrieve all
* y' n" S* e- O) Lothers from the same batch. This may not be as simple as it seems. In order to retrieve
6 s L6 X* S* @8 ]4 P% W' Z! n. Sa component which has subsequently been assembled into a printed circuit board, which5 x' ^! O4 h# n' P$ F. b
has itself been fitted into a unit along with several other assemblies, not only would you
5 s/ ~6 k" o" Vneed a good traceability system but also one that is constantly in operation. W% o2 j4 ^: t. C4 [
It would be considered prudent to prohibit the premature release of product if you did
' f# H& N/ z" i- fnot have an adequate traceability system in place. If nonconformity will be detected by1 }# g2 u+ O: J. m/ m
the end product tests, allowing production to commence without the receipt tests being2 g* s1 W: c) A) C; A' I7 x# e0 Q9 \
available may be a risk worth taking. However, if you lose the means of determining
2 _! x3 v6 E* ]; y/ V; Pconformity by premature release, don’t release the product until you have verified it as% R$ l" p* n0 F2 s0 X! e0 h6 j& ~
acceptable.
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发表于 7-16 11:18:26
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封喉老师勿拍砖啊。
