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( s Q- C( I4 ]4 t8 a# VIDENTIFICATION AND TRACEABILITY (7.5.3)
! D; Q0 v. j; \& X. M. L, h4 B& T6 |5 rIdentifying Product (7.5.3.1)
: N, ~# f( g# m. M" }" [The standard requires the organization to identify the product by suitable means
( E& }3 ]* [) h$ o" N5 D6 Tthroughout product realization where appropriate.5 F0 ^. o$ z& B& T
What Does this Mean?
# F; U; K2 s6 R+ h3 p/ KThe requirements for product identification are intended to enable products and services
1 f2 f0 M( V: y, O4 Dwith one set of characteristics to be distinguishable from products or services with
9 h. _* L y4 I6 w% s7 B, c& qanother set of characteristics.2 D3 n. X+ {( I: a; r" J% G/ [
The option of applying this requirement ‘where appropriate’ implies that there are
# b2 a! I& g0 a8 A% s+ Asituations where product identity is unnecessary. There are of course situations where1 e' Z5 s" P! S8 g0 d6 B
attaching an identity to a product would be impractical such as for liquids or items too) O4 b* @" j1 r$ y( A. P# k1 F
small but the product nevertheless has an identity that is conveyed through the pack-1 N; A# |. r3 u+ ~* Z- A
aging and associated information. In the food industry, the biscuits on the conveyor
- j0 G: ]4 `$ R* O/ Umight not carry an identity but the box into which they are packed does as does the
% o6 n6 L9 |% Z/ `9 ]# I; R4 einstruction that ordered the biscuits to be produced. Thus identifying a product by
0 X0 e" t% h# i/ m% W+ zsuitable means might require the product to be labelled, or might require the container to
( P3 D I, l0 W. u+ I# {, S2 D: Hbe labelled. Services are somewhat different. Many are not identified other than by the
6 A) `3 _2 _7 k" ~2 x. Cnature of what the organization does by generic categories such as investment, mort-2 V# C/ W, E0 N: \$ |) S) |: }
gage, financial planning services of banks. Where there are differences for instance in
* K4 u/ `9 j# m. Vinterest rates, the ‘products’ are given different names such as Instant Access Account,
! w, g9 F$ e. H/ U" w$ i90 Day account and so on.
; V2 {4 z% Q' ]% w4 TWhy is this Necessary?2 n7 C6 U2 {+ |6 \! {" e
This requirement responds to the Process Approach Principle.
+ @$ N0 X1 N9 _2 ]$ c( `: n( h! ~Product identity is vital in many situations to prevent inadvertent mixing, to enable s$ \3 i, }, J2 m- k8 W% O
re-ordering, to match products with documents that describe them and to do that basic of
; X5 N" J7 ^* e f7 ^all human activities – to communicate.Without codes, numbers, labels, names and other
; y% ?$ u) \) gforms of identification we cannot adequately describe the product or service to anyone5 M9 d% J& f4 J
else or be certain we are looking at the right product. The product must be identified in
) ?6 z% n$ |1 u2 }' U: D3 m9 R0 Bone way or another otherwise it cannot be matched to its specification.
+ G2 Q, v8 N$ PHow is this Demonstrated?$ h2 n% `2 Y2 ?; U
Separate product identity is necessary where it is not inherently obvious. If products are5 j& l& U& a% x8 r
so dissimilar that inadvertent mixing would be unlikely to occur, a means of physically
- T. H' t: G3 }6 p9 ?identifying the products is probably unnecessary. ‘Inherently obvious’ in this context
7 i5 u4 @+ l' P6 o& j" Ameans that the physical differences are large enough to be visible to the untrained eye.
8 L6 r9 b- g* h8 B6 C# U) b. Q; s8 wFunctional differences, therefore, no matter how significant as well as slight differences
# I P5 {' U$ zin physical characteristics such as colour, size, weight and appearance would constitute
( E- ?& g, q1 ^9 h+ Zan appropriate situation for documented identification procedures.
! I; k1 {- K: [4 c" q5 a3 HIdentifying product should start at the design stage when the product is conceived. The
1 q( D( r: \0 U4 Bdesign should be given a unique identity, a name or a number and that should be used on all: J- E9 F* f. Q9 g2 `" e
related information.When the product emerges into production, the product should carry
( H3 {6 d- h% s4 V% U, Ethe same number or name but in addition it should carry a serial number or other iden-7 v, P- \9 a6 f0 }( \/ s
tification to enable product features to be recorded against specific products. If verification
% l. i' S, w$ Sis on a go or no go basis, product does not need to be serialized. If measurements are/ R" }% p( J; q5 B7 _& D8 Z- K
recorded some means has to be found of identifying the measurements with the product
3 c9 [! P j! B/ Bmeasured. Serial numbers, batch numbers and date codes are suitablemeans for achieving
/ W8 |; s* R5 D. `3 r @' vthis. This identity should be carried on all records related to the product.- L' q1 m8 ]# Q4 U
Apart from the name or number given to a product you need to identify the version! F; X0 J3 @: M Y: V
and the modification state so that you can relate the issues of the drawing and specifi-) n6 I5 H) _$ }$ m. r
cations to the product they represent. Products should either carry a label or markings l6 a7 H: s" \- @1 g
with this type of information in an accessible position or bear a unique code number that: \) H `+ H+ h( |) X. y" L# f: k
is traceable to such information.
9 p; W; v4 @4 t. P( BYou may not possess any documents that describe purchased product. The only1 z0 _8 x! n# B9 T7 ~3 x' {
identity may be marked on the product itself or its container. Where there are no
y/ X4 C- i7 C5 f3 l7 omarkings, information from the supplier’s invoice or other such documents should be& U0 W, f/ U/ S8 G5 D
transferred to a label and attached to the product or the container. Information needs to8 Z ^; S; @# z. z, m
be traceable to the products it represents.
\/ Y8 Y7 B8 e7 `The method of identification depends on the type, size, quantity or fragility of the
" J% j- h6 l( L$ c2 zproduct. You can mark the product directly (provided the surface is not visible to the end" K/ _& d9 |* @% V1 `; D5 Z) J) f" [! u2 g
user unless of course identity is part of the brand name) tie a label to it or the container in
! U+ {6 s8 N+ B/ n# s3 ~2 } d$ a* @537 Chapter j 27 Production and Service Provisionwhich it is placed. You can also use records remote from the product providing they bear
7 U# N; v& l# `9 d9 D% ]a unique identity that is traceable to the product. ~) g2 h) m3 S/ J
Marking products has its limitations because it may damage the product, be removed- q( o! o/ i m0 t7 v! y
or deteriorate during subsequent processing. If applied directly to the product, the
' Q1 p: A; o+ |- P I1 Mlocation and nature of identification should be specified in the product drawings or* L* ~ ?/ F1 S5 X
referenced process specifications. If applied to labels which are permanently secured to
; l) P i$ x$ l! X6 S0 ?' N tthe product, the identification needs to be visible when the product is installed so as to
0 i# W5 ^' t& i: l1 ~! rfacilitate checks without its removal. If the identity is built into the forging or casting, it R5 j8 e: }- @
is important that it is legible after machining operations. One situation which can be" @" a: V) i0 X1 H. G
particularly irritating to customers is placing identification data on the back of equip-+ m: a5 Y/ O# S+ b) |4 X
ment and then expecting the customer to state this identity when dealing with a service
/ q! q2 g4 r( Ycall thus causing delay while the customer dives under the desk to locate the serial
7 C6 Z+ _/ O* W% ]# `9 ^' anumber and drops the telephone in the panic!4 ~* \1 _7 w* x3 q
Verification Status (7.5.3)
7 p! c$ U* q& {: d; T+ gThe standard requires the organization to identify the status of the product with respect
8 h1 ]) o3 E: |' {to measurement and monitoring requirements throughout product realization. z1 q) V. ?8 p, Z; S
What Does this Mean?2 I+ ^6 j* l3 L, e
Product status with respect to monitoring and measurement means an indication as to5 T! x r6 x; a0 K4 a
whether the product conforms or does not conform to specified requirements. Thus1 F" x* R' j( k" L4 g4 k
identifying product status enables conforming product to be distinguishable from* B3 H* ^$ J# C$ D2 r$ u+ F
nonconforming product.9 X5 C9 t, ]6 W" u1 n1 u0 f% c
Why is this Necessary?8 o6 f+ X9 ?: X# Q
This requirement responds to the Factual Approach Principle.
: i3 `- r" T& b; B# {# ~5 J- X5 j" \: iMeasurement does not change a product but does change our knowledge of it.8 \' A& [3 G P4 `+ x
Therefore it is necessary to identify which products conform and which do not so that
! y- q6 B1 P; j8 X' Oinadvertent mixing, processing or delivery is prevented.2 z4 W) o. R; k1 n% ~4 }7 j9 x
How is this Demonstrated?
3 ~ a) t" f6 V5 c: r/ BThe most common method of denoting product status is to attach labels either to the
B! |7 l+ u; W) P+ q+ A+ ~5 xproduct or to containers holding the product. Green labels for acceptable good and Red
4 r" l; n2 d G2 }. plabels for reject goods. Labels should remain affixed until the product is either packed or7 q" L- {9 W4 g: L, T
installed. Labels should be attached in a way that prevents their detachment during
& M. m" r0 }- O6 Y& Q# v% O( y: }" j/ _handling. If labels need to be removed during further processing, the details should be
7 a+ `; g- T- H4 u7 C h9 gtransferred to inspection records so that at a later date the status of the components in an
2 C0 I" ?5 p0 @( V, gassembly can be checked through the records. At dispatch, product status should be6 T) r# H# k! Y
visible. Any product without status identification should be quarantined until re-verified g2 W; S- I/ I( ?$ a ^4 l- Y$ X
and found conforming. Once a product has passed through the product realization
2 r2 N$ G0 d/ j0 Z2 iprocess and is in use, it requires no product status identity unless it is returned to the
& E" r: {' P- P& [production process for repair or other action.
$ L& f, `- _/ Y) d# t7 J3 S, d+ RIt should be possible when walking through a machine shop for example, to identify
* U7 W2 I, |8 @8 H; k# O- i; qwhich products are awaiting verification, which have been verified and found
6 k& c. n6 N) V538 PART j 6 Complying with ISO 9001 Section 7 Requirementsconforming and which have been rejected. If by chance, some product was to become
V. M- h; |2 f3 f3 _; Z5 |# _separated from its parent batch, it should still be possible to return the product to the `1 I+ T8 w( i L: \) l
location from whence it came. A machine shop is where this type of identification is
5 R; l7 F: U9 \% G. Z6 Xessential – it is where mix-ups can occur. In other places, where mix-ups are unlikely,- e7 G$ D; L2 ~
verification status identification does not need to be so explicit.1 `. S* K1 [0 O3 `4 t, a
Identifying product status is not just a matter of tying a label on a product. The status, u. l( }* c9 X O* }& G0 [# U
should be denoted by an authorized signature, stamp, mark or other identity which is/ H8 q* k' k' j. a+ }1 y
applied by the person making the accept or reject decision and which is secure from
) K$ u+ x$ j; w# u$ Z p) C7 \misuse. Signatures are acceptable as a means of denoting verification status on paper
- J% j8 ^4 ]2 f8 D, o) o' Mrecords but are not suitable for computerized records. Secure passwords and ‘write only’0 @1 {. j) L9 z) w' V4 c
protection has to be provided to specific individuals. Signatures in a workshop envi-
$ W$ R' q, z! z9 I5 C/ z l2 E3 }: Sronment are susceptible to deterioration and illegibility that is why numbered inspection
- P, \( E; Y" T! k$ Dstamps with unique markings evolved. The ink used has to survive the environment and& n# L: R5 G5 l& L1 R, b. o6 O5 ^
if the labels are to be attached to the product for life, it is more usual to apply an imprint1 [# o/ E6 f( L! V7 O
stamp on soft metal or bar code.
) B2 a0 A4 } P5 v0 wSmall and fragile products should be held in containers and the container sealed and5 f8 y9 e9 `/ ?7 B3 q
marked with the product status. Large products should either carry a label or have0 ]7 b0 w& | B. z6 b% D2 Y
a related inspection record.- f: E! j4 f! V- Q8 Y7 i% i
In some situations the location of a product can constitute adequate identification of5 N( [7 Z" K4 Y9 v1 h) c
product status. However, these locations need to be designated as Awaiting Inspection," F+ C: Z2 s) E0 j0 n g" |) ^
Accepted Product or Reject Product or other such labels as appropriate to avoid0 H! x9 g$ P$ R, n
the inadvertent placement of items in the wrong location. The location of product in the* e9 `! h3 L9 |( |) J) l" U
normal production flow is not a suitable designation unless an automated transfer route
. X2 g2 E; r% x! t$ I( zis provided.
8 s1 o( V1 R d( _' _& u" ^1 G2 }When a service is out of service, tell your customers. Services that rely on products$ d/ I% `- d; Q- S8 k5 `2 i
should carry a label or a notice when accessed. A bank cash machine is one example/ _% j* q. D; V9 d# J
where a notice is displayed when the machine is out of service. In some cases customers7 |6 A; v4 K. h! O
may need to be informed by letter or telephone.
" G# \+ Y6 d3 HWith software the verification status can be denoted in the software as a comment or- C" \* T, P1 G2 A g
on records testifying its conformance with requirements.
9 g! |# F" u8 X! c, `With documentation you can either denote verification status by an approval signa-
+ j# T+ V$ t: r2 B ~' n# Ature on the document or by a reference number, date and issue status that is traceable to9 u( Z! j6 H- T: e5 G
records containing the approval signatures.5 R6 G1 m8 e4 A- K
If you use stamps, you will need a register to allocate stamps to particular individuals
4 W' W+ }& P0 m- K! e0 E( B* Zand to indicate which stamps have been withdrawn.When a person hands in his stamp it
8 Z- g3 t2 M u5 M5 Vis good practice to avoid using the same number for 12 months or so to prevent mistaken- ?3 j; R; G! j8 X
identity in any subsequent investigations.& y' s7 @8 e% X7 a" T: A7 [
Traceability9 m3 l6 y" D t0 k' j
Where traceability is a requirement the standard requires the organization to control the
. R' X. O j# L' n, dunique identification of the product and maintain records.
, l7 o O* f; R5 K2 IWhat Does this Mean?
6 s. }' u d: V6 s7 p% K |Traceability is a process characteristic. It provides the ability to trace something through, v# w$ W9 d4 t8 p1 Z
a process to a point along its course either forwards or backwards through the process
* j+ S; v+ O4 f! C2 _539 Chapter j 27 Production and Service Provisionand determine as necessary, its origin, its history and the conditions to which it was
. R; J; B: z# T# x" Qsubjected. Traceability may be a requirement of the customer, legislation or statutes or
- w2 c+ b$ z. ?* ?6 _% csimply a requirement of the organization in order to conduct investigations when events6 I# y, p5 Q' t# t7 n
do not proceed as planned.1 z0 O3 k. I1 u$ W9 z. w
Why is this Necessary?
7 S+ n/ l, Z: f4 E* @& o. sThis requirement responds to the Factual Approach Principle.
( F, x" _) R8 q5 l% r5 vOne needs traceability to find the root cause of problems. If records cannot be found' t; w% E5 o" }; N, i# p* W. V
which detail what happened to a product then nothing can be done to prevent its* Z1 V, x, K0 ~6 P
recurrence. Although the standard only requires traceability when required by contract
9 A2 N( [$ e4 k) [2 ? u: w+ `or law, it is key to enabling corrective action.! F) [+ ?# V9 V$ [3 i
In situations of safety or national security it is necessary to be able to locate all0 B5 z3 L7 A% J" C3 O3 t0 ?
products of a batch in which a defective product has been found so as to eliminate them3 `6 q l# E9 H) F, U
before there is a disaster. It is also very important in the aerospace, automobile, medical
' v) w1 o4 s% M. w. W( Ddevices and food and drugs industries – in fact, any industry where human life may be at
3 Y: J" }; }. vrisk due to a defective product being in circulation.
; \. m" v) N9 L0 s9 b# ~9 }0 J' rTraceability is also important to control processes. You may need to know which+ F) Z9 X( L. d# _" `
products have been through which processes and on what date if a problem is found) i+ L8 _4 r. t9 ]0 J- k0 k
sometime later. The same is true of test and measuring equipment. If on being calibrated* q K) }7 _$ l! o' ^- P2 V
a piece of test equipment is found to be out of calibration then it is important to track
! M3 Y0 q7 T$ V2 W4 p1 }down all the equipment which has been validated using that piece of measuring5 o0 z6 k5 X# M% g/ Y
equipment. This in fact is a requirement of ISO 9001 Clause 7.6 but no requirement for
2 D9 _# _) ~1 {) Ztraceability is specified.5 P8 V) W! e2 \2 f2 p# a
How is this Demonstrated?: q/ W& [2 L- \- O1 @+ B
Providing traceability can be an onerous task. Some applications require products to
9 u5 j2 `0 s8 \7 M) M, o3 f7 W0 u0 Ybe traced back to the original ingot from which they were produced. Traceability is
! l; X0 w- |' Q9 g4 H1 C0 ], C3 oachieved by coding items and their records such that you can trace an item back to& Z" I# j* x$ E f9 k
the records at any time in its life. The chain can be easily lost if an item goes
( G( c( f& o; }' h/ O: youtside your control. For example, if you provide an item on loan to a development6 M1 T$ C- h7 k l$ m3 p
organization for investigation and it is returned sometime later, without a certified) |2 ]. ^, `. G/ d0 Y( j
record of what was done to it, you have no confidence that the item is in fact the4 s; b- V( {9 n
same one, unless it has some distinguishing features. The inspection history may
% M u# ^& H# X& Q1 f5 @also be invalidated because the operations conducted on the item were not certified.9 S. _" n! b. x8 L9 C6 a* c# ]
Traceability is only helpful when the chain remains unbroken. It can also be costly8 w' S1 f3 t! R9 k) @4 ]
to maintain. The system of traceability that you maintain should be carefully4 ~3 k- t/ G6 r1 a' C Y/ D
thought out so that it is economic. There is little point in maintaining an elaborate* v3 O2 Z. O: m; W7 j
traceability system for the once in a lifetime event when you need it, unless your. ?0 {# L T: m3 k: Y/ x
very survival or society’s survival depends on it. However, if there is a field failure,- D' f! A% V, l2 e
in order to prevent recurrence you will need to trace the component back through% m. l: @( {6 f0 J2 T/ e* ?- b
the supply chain to establish which operation on which component was not per-
, j$ _2 v' ] Z2 _formed correctly simply to rule out any suggestion that other products might be" c/ J4 \4 {) W/ Z
affected.6 u$ ?7 C1 |# ^; w& t' @" C
The conventions you use to identify product and batches need to be specified in the( a) q: {' |1 J! Q& ]; G8 z* k& a
product specifications and the stage at which product is marked specified in the relevant
8 X6 t- g9 v: |, R$ ~1 {procedures or plans. Often such markings are automatically applied during processing,
% D: b# L& j# J" c6 _; |: _" M540 PART j 6 Complying with ISO 9001 Section 7 Requirementsas is the case with printed circuits, mouldings, ceramics, castings, products etc. Process
2 g' L3 G$ g2 x& |3 ]setting up procedures should specify how the marking equipment or tools are to be
* E+ Z& `5 q O6 Mset up.4 ?+ ^9 j' {9 i. ~) @+ q9 u4 i
If you do release a batch of product prior to verification being performed and one out. L/ D9 X& k) c) a; l
of the batch is subsequently found to be nonconforming, you will need to retrieve all9 x+ J5 S7 H- R$ k- [% A
others from the same batch. This may not be as simple as it seems. In order to retrieve2 ~( `( r0 m# [) N
a component which has subsequently been assembled into a printed circuit board, which
/ N( B, P. Z5 h) X( O+ v. Y8 Ihas itself been fitted into a unit along with several other assemblies, not only would you z( u4 F! |$ ^7 ?' L7 V! h$ ]
need a good traceability system but also one that is constantly in operation.; z0 j# e! e" W5 o1 `: S* P K
It would be considered prudent to prohibit the premature release of product if you did8 ~' ], b) ~) E1 v( D
not have an adequate traceability system in place. If nonconformity will be detected by
% ^% V& F! B; c4 I$ b. J) dthe end product tests, allowing production to commence without the receipt tests being1 @+ Q l$ ~4 L* b& v; a
available may be a risk worth taking. However, if you lose the means of determining3 ?9 B8 Y; C& J( _5 Y
conformity by premature release, don’t release the product until you have verified it as
. P, T7 k( p0 i* M; y2 n* Y @acceptable.
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