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IDENTIFICATION AND TRACEABILITY (7.5.3)& O1 E: E. t4 [+ p& C
Identifying Product (7.5.3.1)
5 u/ _- {2 G8 I% d3 ~- }The standard requires the organization to identify the product by suitable means: G7 N- j. W% Q! M. B$ l
throughout product realization where appropriate.
% B- [6 O; E& n+ w# u, YWhat Does this Mean? R' k* G; _! k) A( k* j5 F3 [6 E
The requirements for product identification are intended to enable products and services
( Y6 m% V$ |0 R8 Swith one set of characteristics to be distinguishable from products or services with
' z# D3 V2 ]3 z: t( Q( w. c! Wanother set of characteristics.
# j6 W! h R2 N, tThe option of applying this requirement ‘where appropriate’ implies that there are& B" | _+ n9 g
situations where product identity is unnecessary. There are of course situations where
{5 v6 k j2 eattaching an identity to a product would be impractical such as for liquids or items too
5 u8 L/ T0 u/ y. gsmall but the product nevertheless has an identity that is conveyed through the pack-( \% p7 P/ O- F8 S8 t9 j( R
aging and associated information. In the food industry, the biscuits on the conveyor9 r" H3 S) A, s; ^+ X0 q% n' o: J
might not carry an identity but the box into which they are packed does as does the
- \: ^# X' p O9 l( U6 g. Hinstruction that ordered the biscuits to be produced. Thus identifying a product by% d& J( l+ e& w3 S! i" }, V
suitable means might require the product to be labelled, or might require the container to
7 d k% W* W& I1 }' n6 R; L$ w, vbe labelled. Services are somewhat different. Many are not identified other than by the- U) X& \ j& R \- v2 z4 H
nature of what the organization does by generic categories such as investment, mort-% j* |9 v6 X1 L
gage, financial planning services of banks. Where there are differences for instance in: i5 S+ f/ ?# ~ O$ y" x4 h) O
interest rates, the ‘products’ are given different names such as Instant Access Account,) k0 F; ]5 n1 ^8 b0 U' l, M6 A
90 Day account and so on.
: J' ^! a# d. c9 f3 ZWhy is this Necessary?
* S$ m; I: p9 N+ G. iThis requirement responds to the Process Approach Principle.
4 o, U9 k( b& T( WProduct identity is vital in many situations to prevent inadvertent mixing, to enable* P( Q' l/ w8 {+ z- d" U/ Z7 k ?
re-ordering, to match products with documents that describe them and to do that basic of( X+ T3 Q) z/ B' t5 v
all human activities – to communicate.Without codes, numbers, labels, names and other7 m: i$ B) O% Y7 o! K3 \% x
forms of identification we cannot adequately describe the product or service to anyone& [5 @. `* m' J% b
else or be certain we are looking at the right product. The product must be identified in2 P6 k ?* [1 @
one way or another otherwise it cannot be matched to its specification.7 j* l ~* F7 q9 Q$ o0 y
How is this Demonstrated?8 W" R5 J5 l* S6 w
Separate product identity is necessary where it is not inherently obvious. If products are7 p3 k+ j+ l6 Q+ j/ G* r
so dissimilar that inadvertent mixing would be unlikely to occur, a means of physically9 A$ E) c# \- b- R9 j
identifying the products is probably unnecessary. ‘Inherently obvious’ in this context
( X) l" S+ Q+ J$ I: Mmeans that the physical differences are large enough to be visible to the untrained eye.
9 b' _$ {+ X: T5 N) r7 u, J& N8 PFunctional differences, therefore, no matter how significant as well as slight differences- @7 C2 B1 G6 E: L/ w3 c
in physical characteristics such as colour, size, weight and appearance would constitute, ~/ N( Z) b, Y6 e, z
an appropriate situation for documented identification procedures.4 @+ i7 I& p! g" B2 Z3 f% I, P5 n
Identifying product should start at the design stage when the product is conceived. The" c4 g% h; P5 x1 m
design should be given a unique identity, a name or a number and that should be used on all3 O" d3 b( ?' R7 E1 Z
related information.When the product emerges into production, the product should carry2 E% T6 _8 @, O) {2 L% \9 W! ^
the same number or name but in addition it should carry a serial number or other iden-% R( S( G" g0 _
tification to enable product features to be recorded against specific products. If verification+ B" L+ {4 N) T2 B {( K
is on a go or no go basis, product does not need to be serialized. If measurements are
$ Z+ h# G2 W% brecorded some means has to be found of identifying the measurements with the product
; W6 u7 U0 L) N6 \7 vmeasured. Serial numbers, batch numbers and date codes are suitablemeans for achieving
\! c g; @; A( a- _this. This identity should be carried on all records related to the product.( X2 `9 I6 D# T& T: p$ Q) ?9 I
Apart from the name or number given to a product you need to identify the version
2 r f+ Z- L( O; q4 R! @. F+ A8 gand the modification state so that you can relate the issues of the drawing and specifi-- \5 M7 \, t" ~9 ]. L7 r% F
cations to the product they represent. Products should either carry a label or markings
2 C* q0 O( b0 l/ Gwith this type of information in an accessible position or bear a unique code number that
. v5 i5 r% r5 ?5 T( s( j i# Ris traceable to such information.9 Y w. p; C: [* x/ Q/ w
You may not possess any documents that describe purchased product. The only3 \( k* {) j# |% I9 i" m
identity may be marked on the product itself or its container. Where there are no
+ O2 D; @: A' @9 f5 q* Z4 P8 Emarkings, information from the supplier’s invoice or other such documents should be" Z B' F6 Z3 J+ t8 y5 v! s! h0 J: x( f
transferred to a label and attached to the product or the container. Information needs to
, V1 Z( b G; j( dbe traceable to the products it represents.$ i- f- E0 r: g6 u# F* ?
The method of identification depends on the type, size, quantity or fragility of the! p u! Y/ O3 L, G$ U2 Z/ J7 l; I* I
product. You can mark the product directly (provided the surface is not visible to the end9 r: f" f7 e& A
user unless of course identity is part of the brand name) tie a label to it or the container in
2 B# i7 X) D5 y, b537 Chapter j 27 Production and Service Provisionwhich it is placed. You can also use records remote from the product providing they bear* C1 Z# q6 V! ^/ ?
a unique identity that is traceable to the product.
7 m' i; T( d$ LMarking products has its limitations because it may damage the product, be removed% t; U. x" u5 j2 s% x
or deteriorate during subsequent processing. If applied directly to the product, the
. F8 Y7 _ _1 m1 n! l& Wlocation and nature of identification should be specified in the product drawings or
`% e' A1 C9 x, ?3 V& }' B8 wreferenced process specifications. If applied to labels which are permanently secured to, w# K4 O0 `( J$ X x) H4 h- s
the product, the identification needs to be visible when the product is installed so as to s9 ^5 S( J3 ^
facilitate checks without its removal. If the identity is built into the forging or casting, it
$ `; g) K7 q9 N) eis important that it is legible after machining operations. One situation which can be
6 W( x1 n/ y& aparticularly irritating to customers is placing identification data on the back of equip-# k: Z9 X3 f3 [6 H
ment and then expecting the customer to state this identity when dealing with a service
0 x1 o1 n1 \6 v( {: lcall thus causing delay while the customer dives under the desk to locate the serial
8 C8 z5 h& c4 w3 t3 G% b/ Hnumber and drops the telephone in the panic!6 n3 F r0 J6 v, _ F
Verification Status (7.5.3)
# |0 \- V" W: Z, |1 r: X* wThe standard requires the organization to identify the status of the product with respect$ x: c" c% Z4 z, v# v
to measurement and monitoring requirements throughout product realization.
, q8 m* R! `7 n/ L4 FWhat Does this Mean?0 i& A2 f" _; B: r2 k. A- }- G
Product status with respect to monitoring and measurement means an indication as to
( p5 ~8 b1 \, Dwhether the product conforms or does not conform to specified requirements. Thus
0 F. \; f1 a) {1 T. xidentifying product status enables conforming product to be distinguishable from5 g9 o; Q* K& K2 i4 U
nonconforming product., P5 w8 g3 C/ j9 a
Why is this Necessary?
- k2 _$ W+ g$ n9 A( b4 LThis requirement responds to the Factual Approach Principle.
% Q. t- C0 D5 I, oMeasurement does not change a product but does change our knowledge of it.
/ B- |5 A8 T4 O# \. bTherefore it is necessary to identify which products conform and which do not so that& ?- {9 i+ \3 T+ v+ Q5 |3 @' `* Q
inadvertent mixing, processing or delivery is prevented.
4 H# @' O3 q$ hHow is this Demonstrated?7 }/ m7 y6 h5 F% `
The most common method of denoting product status is to attach labels either to the9 d1 m; }7 C/ G3 A* z
product or to containers holding the product. Green labels for acceptable good and Red f9 T9 t6 G( n" x. i
labels for reject goods. Labels should remain affixed until the product is either packed or
8 w2 k+ \' g* f+ W+ N9 zinstalled. Labels should be attached in a way that prevents their detachment during
. |& n$ T& U# ^' b7 d& A, khandling. If labels need to be removed during further processing, the details should be
5 _" E3 W3 A) i% _transferred to inspection records so that at a later date the status of the components in an3 D7 |! T* S* s. |1 D& G7 G
assembly can be checked through the records. At dispatch, product status should be3 T. _: z0 L% A2 R+ t
visible. Any product without status identification should be quarantined until re-verified
3 O- X& @* M- j5 @: k' R/ {and found conforming. Once a product has passed through the product realization
5 @8 [+ `8 G: g: r g; Qprocess and is in use, it requires no product status identity unless it is returned to the. E, D6 n# S6 M6 q% \$ q
production process for repair or other action./ _2 t2 z8 o6 @& @
It should be possible when walking through a machine shop for example, to identify
/ j: M) c% U7 \0 T$ T7 n7 awhich products are awaiting verification, which have been verified and found; R2 C+ q, a8 p* `8 D: ], {
538 PART j 6 Complying with ISO 9001 Section 7 Requirementsconforming and which have been rejected. If by chance, some product was to become
; k( Z- Y9 Z9 G! G& }; qseparated from its parent batch, it should still be possible to return the product to the5 D* x j& P- h+ I8 r
location from whence it came. A machine shop is where this type of identification is
) C( V' Q, L/ g) i& E: `/ Kessential – it is where mix-ups can occur. In other places, where mix-ups are unlikely,
2 c+ Q: N9 B# l: \" q% R" Nverification status identification does not need to be so explicit.
& D' @, G4 ]' f+ W% pIdentifying product status is not just a matter of tying a label on a product. The status1 D: B7 y# ~; x/ }$ ~& E9 X
should be denoted by an authorized signature, stamp, mark or other identity which is$ ^: ?% @5 @" |/ I8 s
applied by the person making the accept or reject decision and which is secure from
+ G9 ~, G1 C( z( Q6 smisuse. Signatures are acceptable as a means of denoting verification status on paper
7 g9 T9 I B& J" r% E4 Grecords but are not suitable for computerized records. Secure passwords and ‘write only’8 y- w" j1 a' i, \
protection has to be provided to specific individuals. Signatures in a workshop envi-6 k" y" l9 S, u2 F9 q9 }
ronment are susceptible to deterioration and illegibility that is why numbered inspection
/ |2 s4 R# h, [$ F! ^. ^: [5 astamps with unique markings evolved. The ink used has to survive the environment and
: `/ }+ M& G) n' @2 S, Lif the labels are to be attached to the product for life, it is more usual to apply an imprint
/ \2 ^8 K4 B, s6 t# o- B9 r2 mstamp on soft metal or bar code.
( V9 J9 M& W" ~$ d, XSmall and fragile products should be held in containers and the container sealed and
{! J% N) V( M9 J2 a0 t% Qmarked with the product status. Large products should either carry a label or have: J9 F- T l; K8 i) ?2 b
a related inspection record." Z( B- V! t7 f
In some situations the location of a product can constitute adequate identification of: c* Y, _$ N; p+ ^$ H& e5 ?( k; o
product status. However, these locations need to be designated as Awaiting Inspection,
' T7 ?' |: C+ b+ I! b3 cAccepted Product or Reject Product or other such labels as appropriate to avoid
3 @2 _* Z3 m$ C- J! O, @the inadvertent placement of items in the wrong location. The location of product in the7 S/ f9 @4 w9 Q
normal production flow is not a suitable designation unless an automated transfer route+ c7 \3 ?: [; L
is provided.
" O) |# q6 Y, ~( TWhen a service is out of service, tell your customers. Services that rely on products
7 o; e/ W1 D$ q) g% u; Z Fshould carry a label or a notice when accessed. A bank cash machine is one example: U# e$ U# E# r; K9 _5 d. \1 \1 `0 q
where a notice is displayed when the machine is out of service. In some cases customers
}) h' q" G* h4 omay need to be informed by letter or telephone.( K, \+ }' L; |5 h, o- K. E3 F
With software the verification status can be denoted in the software as a comment or
$ t5 j2 w: g# c4 W+ y1 son records testifying its conformance with requirements.0 o/ n: F4 ]( Q/ n
With documentation you can either denote verification status by an approval signa-
+ }# B0 b( y ]* a2 n8 G0 mture on the document or by a reference number, date and issue status that is traceable to5 [; y$ F7 j8 n7 K" F& D
records containing the approval signatures.
; e* S' r) u9 K. F# w B" F2 m+ oIf you use stamps, you will need a register to allocate stamps to particular individuals3 J; R9 G8 `& j/ D2 {
and to indicate which stamps have been withdrawn.When a person hands in his stamp it a- X7 _3 K6 W0 P
is good practice to avoid using the same number for 12 months or so to prevent mistaken: z' V2 `; q5 M
identity in any subsequent investigations.
% D( ]+ [* k$ ]" @Traceability
0 b7 o/ B4 q" n* v/ T5 bWhere traceability is a requirement the standard requires the organization to control the
' D( V* O3 j8 C9 kunique identification of the product and maintain records.1 m) E0 V/ ]; [7 `
What Does this Mean?
P' o: S1 ~* _6 wTraceability is a process characteristic. It provides the ability to trace something through- s4 I8 ]3 V3 s1 i$ t3 I# r
a process to a point along its course either forwards or backwards through the process
7 A% s( u0 n N3 b) u- [$ b1 ?539 Chapter j 27 Production and Service Provisionand determine as necessary, its origin, its history and the conditions to which it was
3 v+ P" W/ P! I7 K$ y% Nsubjected. Traceability may be a requirement of the customer, legislation or statutes or
" q* [+ Y6 C" R2 vsimply a requirement of the organization in order to conduct investigations when events z1 I0 q7 @9 p$ Z8 l* U
do not proceed as planned.
$ ]7 Y" H- n6 r. y- w# EWhy is this Necessary?
4 m7 D. ?+ ^+ p- t8 a1 KThis requirement responds to the Factual Approach Principle.* Z% d' m% f+ T$ D+ _6 _; H4 f# a! b
One needs traceability to find the root cause of problems. If records cannot be found
( p! m# \! Z3 J+ v# u2 Ywhich detail what happened to a product then nothing can be done to prevent its
/ `/ K" F/ w# s( Y, ?recurrence. Although the standard only requires traceability when required by contract3 b5 M7 Z0 c n3 a
or law, it is key to enabling corrective action.# ]3 @3 p9 Z3 C. A# Z
In situations of safety or national security it is necessary to be able to locate all
: g( p: T/ P4 C. }9 T( lproducts of a batch in which a defective product has been found so as to eliminate them' M/ n3 }( d; G8 E3 _3 N, { u9 z; e
before there is a disaster. It is also very important in the aerospace, automobile, medical8 I* v- {' o4 ?
devices and food and drugs industries – in fact, any industry where human life may be at
+ p+ z3 N8 J1 @5 v R; Mrisk due to a defective product being in circulation.
+ E9 Z) }" T8 _0 {$ DTraceability is also important to control processes. You may need to know which3 g/ k4 }1 _/ a# U# W: V# B* L
products have been through which processes and on what date if a problem is found
) p1 w4 n/ R- a& D1 h; @7 p9 X3 Dsometime later. The same is true of test and measuring equipment. If on being calibrated/ A, l- h q7 n
a piece of test equipment is found to be out of calibration then it is important to track
8 A: E7 N+ S- r7 |7 m7 v) Zdown all the equipment which has been validated using that piece of measuring
& z+ x! q- G3 \/ A r5 hequipment. This in fact is a requirement of ISO 9001 Clause 7.6 but no requirement for# b/ U9 h2 g' i# ?7 b/ O( O
traceability is specified.
. ], t5 w; `- `- J4 gHow is this Demonstrated?4 a1 _8 T( P0 H& e# e
Providing traceability can be an onerous task. Some applications require products to
/ r: S* ~* t9 o$ Abe traced back to the original ingot from which they were produced. Traceability is2 c5 D& j; S+ O% ^
achieved by coding items and their records such that you can trace an item back to2 J/ i$ g: |( i6 h1 _
the records at any time in its life. The chain can be easily lost if an item goes
6 h5 _1 g; x% Houtside your control. For example, if you provide an item on loan to a development
7 h/ w+ ^% @; G# T' ~' H2 Uorganization for investigation and it is returned sometime later, without a certified0 X! B O: G: x2 X, K
record of what was done to it, you have no confidence that the item is in fact the: K* U3 P" {* e4 |) E, B7 J
same one, unless it has some distinguishing features. The inspection history may) c, e8 G2 J. x0 q+ K7 L2 {
also be invalidated because the operations conducted on the item were not certified./ }1 n1 k8 p( O) N1 c7 o4 M
Traceability is only helpful when the chain remains unbroken. It can also be costly* D8 {' d U& l, h* F. ^ `( Y8 q9 j
to maintain. The system of traceability that you maintain should be carefully
u4 Z0 P( [$ K* D x7 athought out so that it is economic. There is little point in maintaining an elaborate
# C/ u6 M7 D$ j9 L. P" dtraceability system for the once in a lifetime event when you need it, unless your
. a: ]5 W+ E0 C# _very survival or society’s survival depends on it. However, if there is a field failure,
' t: x5 }3 y/ l, cin order to prevent recurrence you will need to trace the component back through
5 j( R* f4 b4 m" Sthe supply chain to establish which operation on which component was not per-
4 t' m" k" E1 ~2 Hformed correctly simply to rule out any suggestion that other products might be
5 q! |# V* d. n4 Haffected.
" q% _4 q% J4 a9 p: F: B4 f5 uThe conventions you use to identify product and batches need to be specified in the
( ?1 e6 }, L; b6 [' m; h% lproduct specifications and the stage at which product is marked specified in the relevant
8 S& \# h) a' C' T" _+ ?* B5 Kprocedures or plans. Often such markings are automatically applied during processing,, g& c4 P' E: X. x
540 PART j 6 Complying with ISO 9001 Section 7 Requirementsas is the case with printed circuits, mouldings, ceramics, castings, products etc. Process
% F' Y- ^7 y) W5 vsetting up procedures should specify how the marking equipment or tools are to be: w; G/ @; l9 A2 Q; [0 f4 i
set up.+ E7 f" I2 D+ C7 W
If you do release a batch of product prior to verification being performed and one out
0 m( q; Z4 s& j! A1 T" fof the batch is subsequently found to be nonconforming, you will need to retrieve all# U" a1 [5 S, ^6 w2 H
others from the same batch. This may not be as simple as it seems. In order to retrieve* B1 a, `! M& F1 G! J
a component which has subsequently been assembled into a printed circuit board, which! I3 w! C! D$ y
has itself been fitted into a unit along with several other assemblies, not only would you
5 [ l9 a# ^* e5 R( }; Kneed a good traceability system but also one that is constantly in operation.. F6 [8 d* Q5 \0 V u# n" }
It would be considered prudent to prohibit the premature release of product if you did
3 I8 [% q% T5 ?/ [0 R% anot have an adequate traceability system in place. If nonconformity will be detected by6 Y. j4 N# R& Z y2 Q
the end product tests, allowing production to commence without the receipt tests being
7 \# e! d) h; S$ l1 g) b0 C9 Navailable may be a risk worth taking. However, if you lose the means of determining5 I/ g- p3 \5 a8 m/ v! L- n; P
conformity by premature release, don’t release the product until you have verified it as
$ p. |1 K. V! P6 facceptable.1 S9 u/ X& D" a8 W+ x& R
/ F- H/ ~* \# q2 X9 F" {9 x0 r
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