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. v8 W- {8 `2 MIDENTIFICATION AND TRACEABILITY (7.5.3)
2 ?& ^1 o3 X" P, ZIdentifying Product (7.5.3.1)
' e3 m* i, m) r2 W# Z; _7 YThe standard requires the organization to identify the product by suitable means
+ g! }, y: g" ?9 j& |8 f0 lthroughout product realization where appropriate.
; a1 S6 F% d# k# G! }' w# uWhat Does this Mean?( ^5 h: X6 k: b8 p: _& i
The requirements for product identification are intended to enable products and services; c8 @, U" J, r- g. h' @
with one set of characteristics to be distinguishable from products or services with5 K V n' q8 g0 S* q+ {9 z
another set of characteristics.
7 r+ @2 ^/ K, Z8 KThe option of applying this requirement ‘where appropriate’ implies that there are% l% @5 X; `" w R9 L. B
situations where product identity is unnecessary. There are of course situations where
% w4 }) @; ~, Q6 C# Dattaching an identity to a product would be impractical such as for liquids or items too
) g/ l! f0 q" h. U8 T2 Z" Q( s1 gsmall but the product nevertheless has an identity that is conveyed through the pack-: N4 z C, K7 {- b5 R; L/ ]
aging and associated information. In the food industry, the biscuits on the conveyor. ^0 d- B& p2 c
might not carry an identity but the box into which they are packed does as does the2 c% \! i7 w" {1 y1 @! s
instruction that ordered the biscuits to be produced. Thus identifying a product by
; g5 g8 G4 c; ~( n+ R, Gsuitable means might require the product to be labelled, or might require the container to( }* @* `) ]8 U! S! d; A4 E
be labelled. Services are somewhat different. Many are not identified other than by the
9 }1 h0 a1 E* }nature of what the organization does by generic categories such as investment, mort-9 C6 F, P3 _+ P/ q0 Q( X; n# J* g
gage, financial planning services of banks. Where there are differences for instance in- G+ q' }' g) a1 _$ [8 ~1 o
interest rates, the ‘products’ are given different names such as Instant Access Account,$ ~! Y8 h" ]+ C
90 Day account and so on.
- s2 d$ c9 P0 a) [( k$ Q: s8 ?9 C) yWhy is this Necessary?
' [+ j9 P0 d4 [& NThis requirement responds to the Process Approach Principle.
" h$ }" t' c0 t U. [+ PProduct identity is vital in many situations to prevent inadvertent mixing, to enable+ b" R5 F6 G( O" c
re-ordering, to match products with documents that describe them and to do that basic of2 ^4 o( e- w0 N; k" s& e; @" B; Z
all human activities – to communicate.Without codes, numbers, labels, names and other
. v! z9 V/ Y( K) d, ]) Y3 Gforms of identification we cannot adequately describe the product or service to anyone
% f, w; _& S; p ~8 kelse or be certain we are looking at the right product. The product must be identified in
6 V4 A+ m' U- F- a4 @( _9 q Aone way or another otherwise it cannot be matched to its specification.
$ L: v8 F1 b, A. Z, g6 f z; \How is this Demonstrated?
. q& i" j' f# w" BSeparate product identity is necessary where it is not inherently obvious. If products are% P ?! u# t! |' Q# z; j
so dissimilar that inadvertent mixing would be unlikely to occur, a means of physically2 I8 d7 v4 t; V$ a4 b' a/ q
identifying the products is probably unnecessary. ‘Inherently obvious’ in this context1 Y! B0 g9 B6 ~3 a3 n
means that the physical differences are large enough to be visible to the untrained eye.
; R. `+ Q ~% h, @Functional differences, therefore, no matter how significant as well as slight differences
' Q8 W2 N2 O" Y7 u# y4 [: Iin physical characteristics such as colour, size, weight and appearance would constitute2 l/ O& i1 o. o( n* U
an appropriate situation for documented identification procedures.7 p, |; X& V/ e4 {
Identifying product should start at the design stage when the product is conceived. The
; l5 ~0 y0 j) E8 X. z1 adesign should be given a unique identity, a name or a number and that should be used on all
9 i" b3 _+ D& L6 N$ U/ Frelated information.When the product emerges into production, the product should carry2 U& o6 g8 V5 j
the same number or name but in addition it should carry a serial number or other iden-
- B$ v' j2 B6 L5 o% htification to enable product features to be recorded against specific products. If verification
$ s, y% ?, |$ ^* z: wis on a go or no go basis, product does not need to be serialized. If measurements are
: y3 K/ Y) j, e: J* B6 arecorded some means has to be found of identifying the measurements with the product5 u- q) c% b; f) x2 Z4 m3 S
measured. Serial numbers, batch numbers and date codes are suitablemeans for achieving+ ^* ?: a8 g2 U: u' C9 q
this. This identity should be carried on all records related to the product.3 S5 I$ G6 F' `; v2 A) j: d
Apart from the name or number given to a product you need to identify the version
: R$ v# f* L! w3 ?2 \: Y' Nand the modification state so that you can relate the issues of the drawing and specifi-
1 l: E6 _6 `: Q9 \* Mcations to the product they represent. Products should either carry a label or markings
s/ _) L# U% j- N( n6 Mwith this type of information in an accessible position or bear a unique code number that$ ^0 l5 g7 ]0 P; P/ ]
is traceable to such information.
9 G7 Q/ E; d6 ]1 t' v1 t+ oYou may not possess any documents that describe purchased product. The only
; b3 o( X3 }: a: d* Didentity may be marked on the product itself or its container. Where there are no
& V4 B! p3 F' F, @6 O. g: Tmarkings, information from the supplier’s invoice or other such documents should be3 d, E1 M: B7 Z& q3 g
transferred to a label and attached to the product or the container. Information needs to( g( l& o8 K9 P1 j
be traceable to the products it represents.3 V& e0 t& |. Y7 q. b, T( Q3 w
The method of identification depends on the type, size, quantity or fragility of the
' i4 U( a1 N Rproduct. You can mark the product directly (provided the surface is not visible to the end. _' Y' R" I0 N2 z
user unless of course identity is part of the brand name) tie a label to it or the container in* I) {0 N, u& l% [
537 Chapter j 27 Production and Service Provisionwhich it is placed. You can also use records remote from the product providing they bear2 [ m0 C; N6 H; Q6 g8 O2 Q: `
a unique identity that is traceable to the product. q4 {9 t# n1 @* Z6 a
Marking products has its limitations because it may damage the product, be removed
+ |$ v6 Y9 V* Wor deteriorate during subsequent processing. If applied directly to the product, the w3 {8 }/ W* R& g* F+ f/ S. k
location and nature of identification should be specified in the product drawings or% k8 D- x! i) Y/ f! x
referenced process specifications. If applied to labels which are permanently secured to
" E& {) i( I8 Cthe product, the identification needs to be visible when the product is installed so as to
$ M7 E! K p0 O' O6 Y; @% w" E6 Gfacilitate checks without its removal. If the identity is built into the forging or casting, it
2 N) Y- M- X' A: t- U5 O- _is important that it is legible after machining operations. One situation which can be' |' {0 [- o+ N1 k9 F' o) S
particularly irritating to customers is placing identification data on the back of equip-$ M: C# f* J g3 B0 E8 `( q+ }5 u
ment and then expecting the customer to state this identity when dealing with a service4 E6 Q+ o9 x, Z" b
call thus causing delay while the customer dives under the desk to locate the serial( i* L) W' e$ k$ b
number and drops the telephone in the panic!# n) O( L6 k, F6 W2 P0 h# }, ]% `
Verification Status (7.5.3)
. p+ X! M# ]. ~ m9 tThe standard requires the organization to identify the status of the product with respect
3 n. h! p" d' Q" E( A; jto measurement and monitoring requirements throughout product realization.* x) U3 z8 H# L
What Does this Mean?7 j) K" a) M# b
Product status with respect to monitoring and measurement means an indication as to$ v/ i- H9 k$ p% T3 n: m
whether the product conforms or does not conform to specified requirements. Thus( |3 ~0 t6 p! {
identifying product status enables conforming product to be distinguishable from$ N( u3 p) O+ [1 |# T: Q y! B" g
nonconforming product.
3 a" w- r, c1 z/ |* \Why is this Necessary?
0 J- S- i$ ?$ a- s) q tThis requirement responds to the Factual Approach Principle.
5 ?; Q, _/ @1 _ b6 T! b7 iMeasurement does not change a product but does change our knowledge of it.
: n2 D0 a3 L" J: Y' a" ]Therefore it is necessary to identify which products conform and which do not so that
% g1 \& e7 E( oinadvertent mixing, processing or delivery is prevented.
+ K% K. i* s7 C. m9 }4 qHow is this Demonstrated?2 {, B0 N6 X, h; a$ f" r% R
The most common method of denoting product status is to attach labels either to the8 Z' z2 k4 q$ t
product or to containers holding the product. Green labels for acceptable good and Red
0 R0 B: w8 s5 g3 h0 T, vlabels for reject goods. Labels should remain affixed until the product is either packed or
' \' [* W- x: hinstalled. Labels should be attached in a way that prevents their detachment during8 C0 y! L& S7 _2 n1 ~% j# ]
handling. If labels need to be removed during further processing, the details should be
3 B" q9 G) y, u7 Mtransferred to inspection records so that at a later date the status of the components in an8 t. e5 f6 K. E- w' A# g0 _0 }
assembly can be checked through the records. At dispatch, product status should be. ]2 k6 T+ ?3 M+ w/ a5 W
visible. Any product without status identification should be quarantined until re-verified* z2 ?) I# N- _9 k$ |8 F
and found conforming. Once a product has passed through the product realization6 ~' q' B0 i$ V1 \( k
process and is in use, it requires no product status identity unless it is returned to the
& x* h' `$ C% Z" ? d. Mproduction process for repair or other action.# q: u2 K; Y3 Y" Q; }/ Q
It should be possible when walking through a machine shop for example, to identify
) j; L" E4 }3 f' _which products are awaiting verification, which have been verified and found
$ X6 K7 c8 V. ~! p( T538 PART j 6 Complying with ISO 9001 Section 7 Requirementsconforming and which have been rejected. If by chance, some product was to become
$ H4 p. f( g0 G- ?" G% m6 u$ Dseparated from its parent batch, it should still be possible to return the product to the2 D$ |2 W6 k V/ u9 ]0 a
location from whence it came. A machine shop is where this type of identification is8 m5 Z0 ~3 ?. g
essential – it is where mix-ups can occur. In other places, where mix-ups are unlikely,
) o R+ O# K, J8 X. L! o' I( everification status identification does not need to be so explicit.9 t! u9 A, T% M! @
Identifying product status is not just a matter of tying a label on a product. The status p9 n3 \4 ]* r W1 x
should be denoted by an authorized signature, stamp, mark or other identity which is
" ?/ P A; H& n8 u; j2 Napplied by the person making the accept or reject decision and which is secure from
4 w+ y7 d: ?5 F1 \! Z) _/ Rmisuse. Signatures are acceptable as a means of denoting verification status on paper1 A% f O. K. g; K
records but are not suitable for computerized records. Secure passwords and ‘write only’1 f; H# C. S2 c, z: {2 o+ n8 k0 N
protection has to be provided to specific individuals. Signatures in a workshop envi-
; | L6 Q B |- F( [' S2 x# yronment are susceptible to deterioration and illegibility that is why numbered inspection4 \% d$ g7 e* R
stamps with unique markings evolved. The ink used has to survive the environment and7 T9 ^& B" n" E: D: S7 G) g5 b
if the labels are to be attached to the product for life, it is more usual to apply an imprint# u. A. [, u5 q" Y# w, `% B' H
stamp on soft metal or bar code.
# U; T4 p# ~) U- L; NSmall and fragile products should be held in containers and the container sealed and0 H; w) x) x& K
marked with the product status. Large products should either carry a label or have
; U5 k5 T8 Z7 J; E6 ]a related inspection record.. N# _) s: @9 ]' w
In some situations the location of a product can constitute adequate identification of
* A3 z1 p. M6 f: @0 @product status. However, these locations need to be designated as Awaiting Inspection,: a* C6 h, Q5 I' [' {( a& b( \1 v8 \
Accepted Product or Reject Product or other such labels as appropriate to avoid- J5 o& @$ P1 m0 X& X' E
the inadvertent placement of items in the wrong location. The location of product in the* G1 i2 \% a6 q9 a# a5 |
normal production flow is not a suitable designation unless an automated transfer route
+ U; t# G6 A' ]& ^is provided.
$ q/ I9 `6 L' z" R1 l; N& V4 p: QWhen a service is out of service, tell your customers. Services that rely on products$ A% `+ ^+ p( J* A
should carry a label or a notice when accessed. A bank cash machine is one example
6 |0 r* C. l; pwhere a notice is displayed when the machine is out of service. In some cases customers) H$ E3 U7 a3 w+ b1 o
may need to be informed by letter or telephone.
5 |* N5 Q+ D7 C# B) j" OWith software the verification status can be denoted in the software as a comment or& S$ Q# c* g2 H6 ] l9 k
on records testifying its conformance with requirements.7 P+ s. Y& C/ |/ p6 J
With documentation you can either denote verification status by an approval signa-- `5 d) j* N1 }6 t: ?( Z7 R+ u( Z
ture on the document or by a reference number, date and issue status that is traceable to
: _8 T3 u0 U+ krecords containing the approval signatures.% K1 Z2 l4 l% m1 _5 Z8 N
If you use stamps, you will need a register to allocate stamps to particular individuals
) v$ _9 u. B% }4 Tand to indicate which stamps have been withdrawn.When a person hands in his stamp it
: E3 S. q" Q, j6 \is good practice to avoid using the same number for 12 months or so to prevent mistaken
$ ]. k5 P2 a2 U4 _5 i+ S- x6 k# P) ^identity in any subsequent investigations.
; I. W& V7 Z7 t& p5 ~$ B( pTraceability
# G3 e, @8 ~( r% k3 j( t+ cWhere traceability is a requirement the standard requires the organization to control the
$ N3 U c& K! b/ l5 lunique identification of the product and maintain records.
+ K+ r; A: m! {7 _What Does this Mean?
8 V/ N% j8 N% F/ t6 u6 v# lTraceability is a process characteristic. It provides the ability to trace something through |4 ]* m; C' q. A9 c! j
a process to a point along its course either forwards or backwards through the process
c) ^ l+ z0 g' \539 Chapter j 27 Production and Service Provisionand determine as necessary, its origin, its history and the conditions to which it was- t! d+ D" K& s& U2 |7 I$ ^
subjected. Traceability may be a requirement of the customer, legislation or statutes or
( H' C. @" T2 h$ Fsimply a requirement of the organization in order to conduct investigations when events
* s Y# t2 \* Q8 K! N" zdo not proceed as planned.: L; X: M9 c' d* u* I) N+ V) j
Why is this Necessary?
+ ~- f; h0 ^4 [! O* M5 zThis requirement responds to the Factual Approach Principle.
1 ]7 @1 A1 ~- T2 uOne needs traceability to find the root cause of problems. If records cannot be found
& V+ U2 a# e$ I- U0 n% `' B. @2 swhich detail what happened to a product then nothing can be done to prevent its" L# y# h! }# x3 H( b
recurrence. Although the standard only requires traceability when required by contract/ v; G6 b1 ?) V& E
or law, it is key to enabling corrective action.; F! E+ l% T2 L7 ~+ f1 k
In situations of safety or national security it is necessary to be able to locate all
) X$ D( X1 P6 T& f4 Iproducts of a batch in which a defective product has been found so as to eliminate them
$ y, h! t% t6 h, Ybefore there is a disaster. It is also very important in the aerospace, automobile, medical
& W( S3 _* G- s \: U) X* ?9 Y* P# {devices and food and drugs industries – in fact, any industry where human life may be at
3 }8 Y) L( ?+ ^; R! irisk due to a defective product being in circulation./ P. v/ I/ }. s( _ C
Traceability is also important to control processes. You may need to know which5 O1 F% J( Q( E+ p
products have been through which processes and on what date if a problem is found" Z6 L) c7 D; I9 E2 }
sometime later. The same is true of test and measuring equipment. If on being calibrated# G2 g+ o4 |. t# T
a piece of test equipment is found to be out of calibration then it is important to track
2 ~2 b# l/ p6 D5 Q6 j3 ~( edown all the equipment which has been validated using that piece of measuring
8 f" J( l# g1 a$ ]# pequipment. This in fact is a requirement of ISO 9001 Clause 7.6 but no requirement for' e4 H% K3 H; Q% z3 k+ `
traceability is specified./ i1 Q" n, A- c
How is this Demonstrated?
' r2 Z, O( V8 zProviding traceability can be an onerous task. Some applications require products to
, O9 G! C. m" I" jbe traced back to the original ingot from which they were produced. Traceability is* k( T$ D' ?" @4 q6 |+ W
achieved by coding items and their records such that you can trace an item back to' d( _1 E* Y3 R5 ?$ n) Z
the records at any time in its life. The chain can be easily lost if an item goes2 W5 x+ i0 c/ n- i
outside your control. For example, if you provide an item on loan to a development& X- M; v/ }& p* R9 m+ S ^
organization for investigation and it is returned sometime later, without a certified
! A" J( }# v6 i2 e. T+ hrecord of what was done to it, you have no confidence that the item is in fact the5 N; b( h/ J Q7 D& A
same one, unless it has some distinguishing features. The inspection history may
$ N! Z' y/ a1 W1 q% p( g- @also be invalidated because the operations conducted on the item were not certified.* l8 \* F' R# H# j/ i
Traceability is only helpful when the chain remains unbroken. It can also be costly
( ~2 ?# i, i+ t; @* N1 ^to maintain. The system of traceability that you maintain should be carefully* o6 D9 O! R8 F# W/ t
thought out so that it is economic. There is little point in maintaining an elaborate; y5 l. s+ A* m! h5 {
traceability system for the once in a lifetime event when you need it, unless your
/ x7 U0 t. v/ C% K* Y/ _very survival or society’s survival depends on it. However, if there is a field failure,, y$ y- z4 n3 S! T Y4 D s; K
in order to prevent recurrence you will need to trace the component back through
; q& N- k6 v" a! K3 x) `the supply chain to establish which operation on which component was not per-
+ e5 `5 K7 |% pformed correctly simply to rule out any suggestion that other products might be
. `1 q: x& d3 \. Faffected.
4 X# W/ G# X3 ]! o: ^, G9 l/ U9 sThe conventions you use to identify product and batches need to be specified in the
8 ~ k- A& `6 Z* Vproduct specifications and the stage at which product is marked specified in the relevant* N) w. [) o1 O- T/ }) [: _
procedures or plans. Often such markings are automatically applied during processing,, _5 `+ w4 t3 g4 O) R3 z" A0 N
540 PART j 6 Complying with ISO 9001 Section 7 Requirementsas is the case with printed circuits, mouldings, ceramics, castings, products etc. Process
! T$ h; ]% U+ ^6 Ssetting up procedures should specify how the marking equipment or tools are to be. F5 j$ P" }2 c3 x) O
set up.
) z4 S2 X0 n) L2 q7 eIf you do release a batch of product prior to verification being performed and one out+ R7 {, J- `4 Q
of the batch is subsequently found to be nonconforming, you will need to retrieve all9 @& b" }1 w, m8 M8 n4 Y a0 W
others from the same batch. This may not be as simple as it seems. In order to retrieve1 Q- Q. _! X7 W/ a5 h2 `: h8 ?- t
a component which has subsequently been assembled into a printed circuit board, which5 r: }1 s0 d- A: a
has itself been fitted into a unit along with several other assemblies, not only would you' X. _5 A' X" c& [# @3 C$ M4 X5 X
need a good traceability system but also one that is constantly in operation.
) I$ P: W0 B; h) c# ]# JIt would be considered prudent to prohibit the premature release of product if you did
# i. f1 W( j4 R" D! \0 jnot have an adequate traceability system in place. If nonconformity will be detected by8 L: w! L [( w# f. q! ~
the end product tests, allowing production to commence without the receipt tests being8 `' s8 L; d; k, L+ D
available may be a risk worth taking. However, if you lose the means of determining
; u Z7 U( y8 T; Xconformity by premature release, don’t release the product until you have verified it as! L- z* h t4 d8 V' Z2 Q* Q9 p( o% O2 ?
acceptable.# u3 I0 J$ c2 c0 C/ q! v& P
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