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2 [" |4 b9 ]6 p. ~8 t4 } IIDENTIFICATION AND TRACEABILITY (7.5.3)
/ I& H% X7 C0 R) M; {Identifying Product (7.5.3.1)
9 O* ]" d, O, MThe standard requires the organization to identify the product by suitable means: k5 V0 [9 s$ |* H
throughout product realization where appropriate.
1 e; F9 l0 l6 k2 |5 N+ x( h# }4 `What Does this Mean?' N/ }6 I- `( z5 q2 t# p
The requirements for product identification are intended to enable products and services( L' ?1 J+ ?9 s, X5 m$ P
with one set of characteristics to be distinguishable from products or services with D2 h9 |: n9 a: `& S0 e* h. e1 z
another set of characteristics.
. m8 x1 [9 J9 F. z0 E: |The option of applying this requirement ‘where appropriate’ implies that there are
9 |+ `( r' E, l6 h) I$ Vsituations where product identity is unnecessary. There are of course situations where% j; I9 q7 y+ N# i
attaching an identity to a product would be impractical such as for liquids or items too
; f1 g2 z$ @, R0 ], v1 Y$ q/ fsmall but the product nevertheless has an identity that is conveyed through the pack-, F. ~5 M# H- h7 X6 i7 V
aging and associated information. In the food industry, the biscuits on the conveyor8 t; @$ m, V0 A( T' e, S7 _
might not carry an identity but the box into which they are packed does as does the2 [5 F W5 Q( k8 Y/ {
instruction that ordered the biscuits to be produced. Thus identifying a product by; d- I7 }2 f. r$ q/ s7 q. I- i
suitable means might require the product to be labelled, or might require the container to
. j7 M6 ~; s9 a6 m# U7 E3 w- Kbe labelled. Services are somewhat different. Many are not identified other than by the
. `& z2 C- g& \) I- R; mnature of what the organization does by generic categories such as investment, mort-6 ?- }/ k- Q) h9 e: W/ p
gage, financial planning services of banks. Where there are differences for instance in2 D+ E3 \* b5 B$ _' K# X# |
interest rates, the ‘products’ are given different names such as Instant Access Account,
# C- i/ K3 z& _: a6 \90 Day account and so on.
+ @6 i$ i& w! [1 @& ~9 t( PWhy is this Necessary?1 T( m5 f! I4 m5 C
This requirement responds to the Process Approach Principle.% B" V" h: ^4 O* K
Product identity is vital in many situations to prevent inadvertent mixing, to enable
& k8 P6 ?6 z6 F! mre-ordering, to match products with documents that describe them and to do that basic of1 b3 U: C, F6 V' B* X$ N4 F, `' x
all human activities – to communicate.Without codes, numbers, labels, names and other
& u) I* [1 e- y: z0 B9 k% t/ |. ]forms of identification we cannot adequately describe the product or service to anyone0 ~5 M2 w8 N8 B |: d: p$ U0 j4 o
else or be certain we are looking at the right product. The product must be identified in
: @- v( w' ?; Z: ]' J mone way or another otherwise it cannot be matched to its specification.; k* X4 k( M3 F- R
How is this Demonstrated?% p: A6 ^. i& [5 {4 f7 j) R
Separate product identity is necessary where it is not inherently obvious. If products are
) N) a$ G6 D: A4 Iso dissimilar that inadvertent mixing would be unlikely to occur, a means of physically
C2 n/ B; X8 |( ~identifying the products is probably unnecessary. ‘Inherently obvious’ in this context
% n. C6 m7 w, g9 kmeans that the physical differences are large enough to be visible to the untrained eye.
( a: t& s6 x2 ~2 tFunctional differences, therefore, no matter how significant as well as slight differences
1 @# M" _7 ^1 {0 a( iin physical characteristics such as colour, size, weight and appearance would constitute
) ~( }' y3 \# Q; U. Han appropriate situation for documented identification procedures." a! s( v I* T' {
Identifying product should start at the design stage when the product is conceived. The3 P) B# i: k: k* I. C8 x: b' _1 D
design should be given a unique identity, a name or a number and that should be used on all9 ~4 [: j# h: ~0 t( E( K
related information.When the product emerges into production, the product should carry
6 O, ]; x u- W" mthe same number or name but in addition it should carry a serial number or other iden-- W9 h! N- [: D5 @/ ?
tification to enable product features to be recorded against specific products. If verification
/ o2 Y5 [' b9 nis on a go or no go basis, product does not need to be serialized. If measurements are
: k4 j6 u4 }# j* x# {recorded some means has to be found of identifying the measurements with the product) O7 F( y, K' i+ Y7 a4 l
measured. Serial numbers, batch numbers and date codes are suitablemeans for achieving
& H9 H; t& M0 z0 J1 U9 h1 Vthis. This identity should be carried on all records related to the product.0 u* r& g+ n$ c/ s! r
Apart from the name or number given to a product you need to identify the version7 V/ |% `; p7 D* M
and the modification state so that you can relate the issues of the drawing and specifi-
( L, d5 l6 B) v5 F" ]cations to the product they represent. Products should either carry a label or markings" D' F8 V& q1 y* @" \; r. ^
with this type of information in an accessible position or bear a unique code number that
7 p: M% _. z9 ~2 }7 \# pis traceable to such information.. i% _5 E/ z2 k% a6 f
You may not possess any documents that describe purchased product. The only
; `' K7 L, x5 M- j. lidentity may be marked on the product itself or its container. Where there are no
, d' r# o1 x- Q! s2 O& rmarkings, information from the supplier’s invoice or other such documents should be
b- L% F2 U4 Y" `' stransferred to a label and attached to the product or the container. Information needs to
* H) d! X H1 K8 Sbe traceable to the products it represents.
! h& b x( H' ^( J9 M4 s+ ~3 oThe method of identification depends on the type, size, quantity or fragility of the
- C/ [6 U3 }5 \: J1 m0 zproduct. You can mark the product directly (provided the surface is not visible to the end
: R4 I- b/ w3 J5 `6 t; t& Xuser unless of course identity is part of the brand name) tie a label to it or the container in" G3 ^5 ^) h8 ^ l# C; A4 X
537 Chapter j 27 Production and Service Provisionwhich it is placed. You can also use records remote from the product providing they bear! |. G9 A# y1 H% U
a unique identity that is traceable to the product.
! G q0 f- m7 M0 ZMarking products has its limitations because it may damage the product, be removed
2 c% A& y7 w9 p2 r6 @4 `3 D/ qor deteriorate during subsequent processing. If applied directly to the product, the
5 b( H8 y5 C' S t& i8 Vlocation and nature of identification should be specified in the product drawings or
+ s; t8 x3 \# M% Kreferenced process specifications. If applied to labels which are permanently secured to: A1 ]% Y# H' f' |: t
the product, the identification needs to be visible when the product is installed so as to
0 K* |2 m' q$ F0 _facilitate checks without its removal. If the identity is built into the forging or casting, it2 r8 [5 B: Z% y2 p9 R9 k
is important that it is legible after machining operations. One situation which can be s1 G1 _% `: [+ C2 {3 \
particularly irritating to customers is placing identification data on the back of equip-1 S C& q$ a0 p" m e, i
ment and then expecting the customer to state this identity when dealing with a service
1 |6 Q2 l1 y# q$ ]) j4 [call thus causing delay while the customer dives under the desk to locate the serial) w( R# C. c' t
number and drops the telephone in the panic!
7 T$ Q8 g% a* v; k8 _8 a3 dVerification Status (7.5.3)
" z: U% D0 w% A/ N: wThe standard requires the organization to identify the status of the product with respect! z" Y: t% s1 X4 k" n, b
to measurement and monitoring requirements throughout product realization.
) M) M K+ i M2 c% r+ i1 sWhat Does this Mean?* f% c) s$ @4 s' u
Product status with respect to monitoring and measurement means an indication as to- g% V8 ` [6 Q! Z5 ^
whether the product conforms or does not conform to specified requirements. Thus
$ u/ L. L2 Z0 yidentifying product status enables conforming product to be distinguishable from! ~& M: f) C9 V/ ^7 Z
nonconforming product.
/ s! N' _ j" l& @* M$ l; yWhy is this Necessary?
; W) k1 e5 ], ~; t3 GThis requirement responds to the Factual Approach Principle.& Y/ l$ J/ Y& g( r* M% J1 W
Measurement does not change a product but does change our knowledge of it.
( F" |& ~+ ~' ^. d! }Therefore it is necessary to identify which products conform and which do not so that$ t9 }9 T y) V' c- c; L
inadvertent mixing, processing or delivery is prevented.; ?" |: v! y6 s2 V5 m' u
How is this Demonstrated?! ?, i( ?: G2 a) U0 i: ^& [
The most common method of denoting product status is to attach labels either to the
' k& a8 U! F, h6 m/ o6 ]6 ?product or to containers holding the product. Green labels for acceptable good and Red3 L# B& i/ s& R: E# P/ G; o
labels for reject goods. Labels should remain affixed until the product is either packed or2 C# a% E2 |" t% v
installed. Labels should be attached in a way that prevents their detachment during
/ w: ^% r7 D) yhandling. If labels need to be removed during further processing, the details should be
% R3 X7 K9 s% `6 c( h, n8 `: b7 D% itransferred to inspection records so that at a later date the status of the components in an
# n: G) O0 t9 n) @7 W; Zassembly can be checked through the records. At dispatch, product status should be
% a: Q+ i; T2 \- K L8 N- z6 uvisible. Any product without status identification should be quarantined until re-verified" ^* z( `! {. i3 A, m; s. \# l
and found conforming. Once a product has passed through the product realization2 J5 L; a4 n( ~5 I3 N- |+ O
process and is in use, it requires no product status identity unless it is returned to the) H) e3 I( `7 D- Z3 {& u/ ~1 D& u
production process for repair or other action.
' i9 s2 B# P6 @8 I7 X& SIt should be possible when walking through a machine shop for example, to identify3 _- {- _3 S, n% ?, y8 K: a5 s
which products are awaiting verification, which have been verified and found# ^1 h" s: B% H) ~6 l1 l |
538 PART j 6 Complying with ISO 9001 Section 7 Requirementsconforming and which have been rejected. If by chance, some product was to become
6 _0 R9 H% l( y+ F* n& |% V' vseparated from its parent batch, it should still be possible to return the product to the% V6 o6 i8 `0 q1 Q5 i& |* H
location from whence it came. A machine shop is where this type of identification is" o4 l9 i; s3 J8 W
essential – it is where mix-ups can occur. In other places, where mix-ups are unlikely,
; ]$ i5 k5 i1 Hverification status identification does not need to be so explicit.( F6 B0 Z0 t$ j+ k! ^. k
Identifying product status is not just a matter of tying a label on a product. The status
0 w$ q% U# Z1 A( z/ i/ Hshould be denoted by an authorized signature, stamp, mark or other identity which is. O: Z# b2 T( A/ f& N6 f( z5 K) S
applied by the person making the accept or reject decision and which is secure from1 K6 u* n/ l+ M7 E
misuse. Signatures are acceptable as a means of denoting verification status on paper; M$ L2 e; a6 f" W+ j/ l* G B
records but are not suitable for computerized records. Secure passwords and ‘write only’: k/ t- X4 z' M6 j9 C. B
protection has to be provided to specific individuals. Signatures in a workshop envi-
5 ]) i3 {% l; M5 U/ j) s9 ]ronment are susceptible to deterioration and illegibility that is why numbered inspection2 P& h1 T" q1 U
stamps with unique markings evolved. The ink used has to survive the environment and
, N( O6 I. i5 pif the labels are to be attached to the product for life, it is more usual to apply an imprint
8 R0 W4 M* w) Y! w0 ?# r& _) q' Qstamp on soft metal or bar code.
( E3 p# ~( w) k O: k7 ]Small and fragile products should be held in containers and the container sealed and" g) _5 q' Y+ t% }4 h
marked with the product status. Large products should either carry a label or have6 K' `+ |6 G5 v* s
a related inspection record.
1 B; e$ W0 k2 kIn some situations the location of a product can constitute adequate identification of
0 g8 z, t2 P0 E: R/ h. X" E$ \product status. However, these locations need to be designated as Awaiting Inspection,
" o4 a8 m+ }4 f* o- |0 r4 K2 NAccepted Product or Reject Product or other such labels as appropriate to avoid
. v/ b8 @7 m2 @$ e, m! Othe inadvertent placement of items in the wrong location. The location of product in the! o1 t5 L I* g0 I, c/ D s
normal production flow is not a suitable designation unless an automated transfer route8 g d; h0 l) z% z
is provided.4 {3 }6 A' R- h: n f
When a service is out of service, tell your customers. Services that rely on products
. _# U5 i# u$ M% Q, _3 i6 J {' D$ xshould carry a label or a notice when accessed. A bank cash machine is one example
: d' G ?- ]* E1 dwhere a notice is displayed when the machine is out of service. In some cases customers
7 |& z& \; ?" w# M& cmay need to be informed by letter or telephone.& F3 g* F" N+ Q
With software the verification status can be denoted in the software as a comment or
, n1 ?$ L- |8 Mon records testifying its conformance with requirements.# V# n p1 }5 J6 Q2 N
With documentation you can either denote verification status by an approval signa-
$ u# R" z8 P. ], d Jture on the document or by a reference number, date and issue status that is traceable to9 K9 m6 N! p! f7 j
records containing the approval signatures.
, J/ I; M5 u w2 E/ G6 i9 Q/ cIf you use stamps, you will need a register to allocate stamps to particular individuals
w5 K8 l# Q/ S# U2 Oand to indicate which stamps have been withdrawn.When a person hands in his stamp it
- J, r% `/ D4 G8 Xis good practice to avoid using the same number for 12 months or so to prevent mistaken
( K% _9 n! V# g# k- `identity in any subsequent investigations.
( }- i }. t) O' E7 G& FTraceability
. W# |2 ]) L8 `1 |( X" k) TWhere traceability is a requirement the standard requires the organization to control the2 M+ ]# E; L. T8 [; O. B
unique identification of the product and maintain records.8 A) U Y/ H0 r
What Does this Mean?
3 D2 K4 K& P7 FTraceability is a process characteristic. It provides the ability to trace something through/ _6 w) P; T, c4 w* f; M: X3 i
a process to a point along its course either forwards or backwards through the process% Q! f; m9 A& z- K( [
539 Chapter j 27 Production and Service Provisionand determine as necessary, its origin, its history and the conditions to which it was$ k1 M0 O0 k4 h
subjected. Traceability may be a requirement of the customer, legislation or statutes or
, |. d/ z+ s3 S4 L( Usimply a requirement of the organization in order to conduct investigations when events. O i) a5 _1 ` \ u
do not proceed as planned., x. n+ n7 V) o/ e
Why is this Necessary?
, X& I# J/ ^0 z5 `+ q% z2 KThis requirement responds to the Factual Approach Principle.0 m& k1 J) n- q& F5 ?1 v
One needs traceability to find the root cause of problems. If records cannot be found
* u! E: o: l8 vwhich detail what happened to a product then nothing can be done to prevent its" _4 y$ c, C# k, c6 j
recurrence. Although the standard only requires traceability when required by contract4 y" F0 K9 i- H" T7 V, H9 _- a
or law, it is key to enabling corrective action.; O: H' s: R) N" R7 S
In situations of safety or national security it is necessary to be able to locate all
+ V4 A$ D3 y2 e5 O/ ~# d! Mproducts of a batch in which a defective product has been found so as to eliminate them+ g' A$ i v' v
before there is a disaster. It is also very important in the aerospace, automobile, medical
7 \& m) D2 F. S5 A; w- [1 v: J/ Hdevices and food and drugs industries – in fact, any industry where human life may be at( B+ v4 }$ v- y# f7 Z L; n
risk due to a defective product being in circulation.6 \9 m9 E4 V3 b4 E9 U2 E
Traceability is also important to control processes. You may need to know which/ Z6 {/ ^7 Q' H# l2 ]. Z
products have been through which processes and on what date if a problem is found! i/ P# H, m* S9 s8 h
sometime later. The same is true of test and measuring equipment. If on being calibrated$ T6 Q4 ?) m% H! ]
a piece of test equipment is found to be out of calibration then it is important to track
; t, ^9 [- x' _( U$ wdown all the equipment which has been validated using that piece of measuring; k* c# J( }1 U
equipment. This in fact is a requirement of ISO 9001 Clause 7.6 but no requirement for
], F+ s3 ~7 V, ]traceability is specified.
3 {5 v1 @: X: M# j, iHow is this Demonstrated?5 l1 I% i$ g6 G3 Z8 p1 U
Providing traceability can be an onerous task. Some applications require products to# c$ m% [; w4 M0 w7 G. ]6 d7 F% H Z- \
be traced back to the original ingot from which they were produced. Traceability is
4 f# {/ K4 ? r& Tachieved by coding items and their records such that you can trace an item back to
) q- ^3 O9 t) i: W# Mthe records at any time in its life. The chain can be easily lost if an item goes
, }3 {0 x+ o6 c) q' K: Youtside your control. For example, if you provide an item on loan to a development5 S8 h! ~; s6 U; b- p
organization for investigation and it is returned sometime later, without a certified* ~) h4 z9 M: u) l0 m2 u
record of what was done to it, you have no confidence that the item is in fact the' J: h+ j% l' f8 f/ Z9 o+ @
same one, unless it has some distinguishing features. The inspection history may6 `6 L) k5 E0 K& x0 ^
also be invalidated because the operations conducted on the item were not certified.6 t9 P! {+ S9 Q) G
Traceability is only helpful when the chain remains unbroken. It can also be costly
: t) a' R8 B: J0 tto maintain. The system of traceability that you maintain should be carefully
- u* a: _. y: Fthought out so that it is economic. There is little point in maintaining an elaborate
* b, k d$ C1 Q) s& d4 dtraceability system for the once in a lifetime event when you need it, unless your
* |, W a7 _0 S- ?very survival or society’s survival depends on it. However, if there is a field failure,
, m7 D" y+ S0 v' I- din order to prevent recurrence you will need to trace the component back through
0 \" `+ ?3 c0 h/ J' ?the supply chain to establish which operation on which component was not per-
, E- H. I3 j7 I4 ?2 zformed correctly simply to rule out any suggestion that other products might be/ v2 u+ [9 B) a2 b( e' x
affected.
7 f+ B$ M9 X$ o4 g( KThe conventions you use to identify product and batches need to be specified in the
, \4 u$ h+ B, B/ b& mproduct specifications and the stage at which product is marked specified in the relevant
+ D0 b9 G: I! G, K; fprocedures or plans. Often such markings are automatically applied during processing,
& ?( w3 `4 H# c8 z& Q: F8 Y540 PART j 6 Complying with ISO 9001 Section 7 Requirementsas is the case with printed circuits, mouldings, ceramics, castings, products etc. Process
N# k. R! j5 vsetting up procedures should specify how the marking equipment or tools are to be
8 i5 Y& `6 C0 ]' yset up.
$ N# g. w! X8 ~If you do release a batch of product prior to verification being performed and one out6 ?; A, S3 ]6 N& ^7 t# Q1 z- z
of the batch is subsequently found to be nonconforming, you will need to retrieve all
, i# i/ _$ p: S- N: p4 ?others from the same batch. This may not be as simple as it seems. In order to retrieve
3 A [+ B2 Q5 `0 k- ka component which has subsequently been assembled into a printed circuit board, which
* @0 V2 X* a2 t) ^7 E& Jhas itself been fitted into a unit along with several other assemblies, not only would you8 J" ^+ b' ]% H6 U) S1 p
need a good traceability system but also one that is constantly in operation. E: X2 k u" { n
It would be considered prudent to prohibit the premature release of product if you did
/ v. [' F. H: cnot have an adequate traceability system in place. If nonconformity will be detected by1 [5 ^$ {, ~0 @ O; {
the end product tests, allowing production to commence without the receipt tests being
# a: |% M. O: M: ~available may be a risk worth taking. However, if you lose the means of determining, e7 B, j, r; D7 U, m
conformity by premature release, don’t release the product until you have verified it as5 u- D2 K; A" |0 l
acceptable.# a, S2 d: [3 h: X! J3 `3 K2 I; _
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