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$ N. l5 h% e' aIDENTIFICATION AND TRACEABILITY (7.5.3) B* L- R$ v# I, h- m$ p
Identifying Product (7.5.3.1)6 f9 F- S, E+ _. C# t: t# p- r& N
The standard requires the organization to identify the product by suitable means
1 X' r1 O+ W$ K G3 r$ L& Athroughout product realization where appropriate.
, X8 `( Z( ]3 n( p( M# F* B# ]) VWhat Does this Mean?3 G4 \* a9 X' {1 ~/ @% R
The requirements for product identification are intended to enable products and services8 t! O6 g7 J+ P5 l: u* k
with one set of characteristics to be distinguishable from products or services with
2 [* ?6 Y: g5 tanother set of characteristics.
7 B T1 l( n0 ?" ]The option of applying this requirement ‘where appropriate’ implies that there are
2 T- F% c+ l1 `. i7 Q! `situations where product identity is unnecessary. There are of course situations where
- J* s8 v! G q- Battaching an identity to a product would be impractical such as for liquids or items too
8 v, {: c/ P9 `- l( k9 Q8 Csmall but the product nevertheless has an identity that is conveyed through the pack-9 t3 X7 E8 W: t9 E6 b/ P
aging and associated information. In the food industry, the biscuits on the conveyor0 Y! A% i/ Z+ e8 o* J& D: B/ X
might not carry an identity but the box into which they are packed does as does the! G k0 n$ O+ U$ K( `9 B0 Z
instruction that ordered the biscuits to be produced. Thus identifying a product by5 t0 @, Y6 v* S7 x5 O, i$ _0 H
suitable means might require the product to be labelled, or might require the container to
6 b( Z, N( A; P* z0 \1 [: Kbe labelled. Services are somewhat different. Many are not identified other than by the5 }# n2 U ] O) `- E
nature of what the organization does by generic categories such as investment, mort-
/ @& {3 }# W- s) l7 E" Lgage, financial planning services of banks. Where there are differences for instance in1 ]) b6 H6 k5 l/ X. D
interest rates, the ‘products’ are given different names such as Instant Access Account,1 [* g! G& k/ H* a6 v0 @: M
90 Day account and so on.
2 w _# f7 e% b, G0 ~6 _! UWhy is this Necessary?! W: j6 {* L. Y3 P
This requirement responds to the Process Approach Principle.
0 X) Y9 }! c% ~9 R; F+ o }0 HProduct identity is vital in many situations to prevent inadvertent mixing, to enable. E( |# C( F4 V4 P7 `, \
re-ordering, to match products with documents that describe them and to do that basic of: P. M& f" t" p9 i, u, m
all human activities – to communicate.Without codes, numbers, labels, names and other6 m7 {* I- \& V
forms of identification we cannot adequately describe the product or service to anyone
3 e7 d( V9 o3 B4 D+ @& T6 Qelse or be certain we are looking at the right product. The product must be identified in, u! F6 U* X6 E4 u
one way or another otherwise it cannot be matched to its specification.
4 m" }7 U( p. e9 W% k8 HHow is this Demonstrated?
0 U3 j3 m: o, u" l0 OSeparate product identity is necessary where it is not inherently obvious. If products are
5 S1 U+ q+ ^9 Y7 V( O& V* Lso dissimilar that inadvertent mixing would be unlikely to occur, a means of physically5 B1 C3 @" a- n) Q& i
identifying the products is probably unnecessary. ‘Inherently obvious’ in this context
# \) ~; O& f& N; V& |' N" Kmeans that the physical differences are large enough to be visible to the untrained eye.
I0 I0 J2 ?& r) }, t2 J& CFunctional differences, therefore, no matter how significant as well as slight differences
' |" h4 O+ A# `& @: q+ G! qin physical characteristics such as colour, size, weight and appearance would constitute) }0 }5 x. L$ c
an appropriate situation for documented identification procedures.- s; \% L9 p+ b, c2 ]# ?" H3 k
Identifying product should start at the design stage when the product is conceived. The5 h% r; s& ^. K/ r
design should be given a unique identity, a name or a number and that should be used on all
; h7 g/ z) S) f+ U, H& p$ wrelated information.When the product emerges into production, the product should carry7 e# S \2 b# C' P; B
the same number or name but in addition it should carry a serial number or other iden-
. |( Z( M6 j2 H4 k$ y* E* H7 @tification to enable product features to be recorded against specific products. If verification
) f0 s. x) t3 [3 C B0 vis on a go or no go basis, product does not need to be serialized. If measurements are
. q2 m3 C5 Z' p0 w6 |% k! orecorded some means has to be found of identifying the measurements with the product
; a; u/ S) M, e0 mmeasured. Serial numbers, batch numbers and date codes are suitablemeans for achieving
9 }4 r7 L7 e5 ?3 L; U' U) ?this. This identity should be carried on all records related to the product.. ?+ c9 k5 e t e4 Z: o
Apart from the name or number given to a product you need to identify the version; x' r3 \8 |2 |2 S3 _% Y
and the modification state so that you can relate the issues of the drawing and specifi-5 b1 n$ q1 ^( T6 b6 c. n# i5 K( D
cations to the product they represent. Products should either carry a label or markings/ ] n& U( Z+ Z3 `+ E# X; I
with this type of information in an accessible position or bear a unique code number that& }/ e9 O i4 O$ t) j
is traceable to such information., O) c- B1 H; I! o: L3 A
You may not possess any documents that describe purchased product. The only2 _1 V6 { k$ G- }( M8 ^4 _
identity may be marked on the product itself or its container. Where there are no
2 v% O7 @ g# K, j& A7 s# ]markings, information from the supplier’s invoice or other such documents should be6 \* R4 p& s( j/ L4 X X" f1 x
transferred to a label and attached to the product or the container. Information needs to, k5 y c v9 C
be traceable to the products it represents.
, Y' `; ?0 ?1 l* R/ {The method of identification depends on the type, size, quantity or fragility of the' B+ X1 k- ]6 x
product. You can mark the product directly (provided the surface is not visible to the end
5 q( [, B. h+ V' ]0 Euser unless of course identity is part of the brand name) tie a label to it or the container in5 n1 q3 Y V2 Z2 q3 H1 i
537 Chapter j 27 Production and Service Provisionwhich it is placed. You can also use records remote from the product providing they bear$ M E6 K+ I0 Q$ t/ R
a unique identity that is traceable to the product.& I$ R0 }3 }9 m( @8 c1 W
Marking products has its limitations because it may damage the product, be removed
4 j* X1 v. M+ }6 a1 V aor deteriorate during subsequent processing. If applied directly to the product, the3 K9 k$ E5 \8 ^, L( y
location and nature of identification should be specified in the product drawings or
^/ t* M1 v+ ~( Z2 V( _referenced process specifications. If applied to labels which are permanently secured to
; H- v% c1 T" p9 }9 y' P/ `8 r$ Y" Ithe product, the identification needs to be visible when the product is installed so as to
) Y( ?$ V; c$ A; Ifacilitate checks without its removal. If the identity is built into the forging or casting, it
! R! V, r8 o0 u' a4 f2 b r3 Y$ Eis important that it is legible after machining operations. One situation which can be
: [; V1 c7 s1 t' E. I, S dparticularly irritating to customers is placing identification data on the back of equip-' I0 t$ R& D I0 s
ment and then expecting the customer to state this identity when dealing with a service* `$ a0 H, m X
call thus causing delay while the customer dives under the desk to locate the serial/ E* C# e2 P4 Q9 {
number and drops the telephone in the panic!8 k9 a" Q5 e; R
Verification Status (7.5.3)" F3 n$ g0 U, |% p$ l" t' ^7 r
The standard requires the organization to identify the status of the product with respect
' x7 ]. Z5 h) ^to measurement and monitoring requirements throughout product realization.
6 y3 P* x- D2 c* hWhat Does this Mean?
3 l5 P& @+ y) v. j2 n# F# dProduct status with respect to monitoring and measurement means an indication as to
! W- J3 ^- |& W9 awhether the product conforms or does not conform to specified requirements. Thus
9 l i7 V3 C) h: C) videntifying product status enables conforming product to be distinguishable from
- S1 m+ p% c+ b7 knonconforming product.2 D! M1 d4 o! x" O- i% ^
Why is this Necessary?4 v0 t2 B' |3 T8 O; c
This requirement responds to the Factual Approach Principle.
" b7 D1 O. q. x6 M0 zMeasurement does not change a product but does change our knowledge of it.
' |4 Q! b1 K8 m! L! D* STherefore it is necessary to identify which products conform and which do not so that+ x6 n, a2 d& r4 R
inadvertent mixing, processing or delivery is prevented.
; {: G3 d$ S% hHow is this Demonstrated?! D, U; f) K; \, W
The most common method of denoting product status is to attach labels either to the- S8 }9 v' p1 a# J
product or to containers holding the product. Green labels for acceptable good and Red
( S" b% k' _5 t, Qlabels for reject goods. Labels should remain affixed until the product is either packed or
U( T) u/ V9 ?' r( e: ginstalled. Labels should be attached in a way that prevents their detachment during0 {4 l. ], R7 v% Q: ?, E
handling. If labels need to be removed during further processing, the details should be
6 O4 \# s6 i4 g+ e1 W( stransferred to inspection records so that at a later date the status of the components in an: o% P6 X9 b# b2 Y" [4 b
assembly can be checked through the records. At dispatch, product status should be' B& J9 L" w7 u( u f9 s5 k8 ?
visible. Any product without status identification should be quarantined until re-verified8 T+ R- _$ {% h
and found conforming. Once a product has passed through the product realization
/ O+ l _7 g! F* ~! @4 ]process and is in use, it requires no product status identity unless it is returned to the. e& v+ h( U4 d7 q( m& [* K( y
production process for repair or other action. ~4 k* C; u$ N2 n& m, D4 w
It should be possible when walking through a machine shop for example, to identify- E! c& O% Z, N3 U0 ^6 C
which products are awaiting verification, which have been verified and found$ @; H0 j# T9 w3 r: N! W. \' `# M" u
538 PART j 6 Complying with ISO 9001 Section 7 Requirementsconforming and which have been rejected. If by chance, some product was to become
! Z3 C. h6 r3 Q6 X' ]separated from its parent batch, it should still be possible to return the product to the; H% f) S7 o6 M6 G# X. P
location from whence it came. A machine shop is where this type of identification is
; f: ?9 J* @2 F4 cessential – it is where mix-ups can occur. In other places, where mix-ups are unlikely,
; J5 J9 K; Z8 x2 U4 x, T. s0 Dverification status identification does not need to be so explicit. X3 S' s) C1 j1 M
Identifying product status is not just a matter of tying a label on a product. The status! v! ?- X9 [) V* i& ]6 c5 T7 l: F0 ]" C+ H
should be denoted by an authorized signature, stamp, mark or other identity which is5 B5 U3 K I% w
applied by the person making the accept or reject decision and which is secure from: g$ A* [% ^$ b; y
misuse. Signatures are acceptable as a means of denoting verification status on paper3 u1 J# J+ ~0 E" [ z; V8 q3 A
records but are not suitable for computerized records. Secure passwords and ‘write only’: F' H2 A; \, {
protection has to be provided to specific individuals. Signatures in a workshop envi-
, }( e% W, V/ U) M# H7 T+ A) ^ronment are susceptible to deterioration and illegibility that is why numbered inspection
; U& H. t+ C7 e3 V3 b2 Ostamps with unique markings evolved. The ink used has to survive the environment and
" s' e0 [, \& N% Rif the labels are to be attached to the product for life, it is more usual to apply an imprint8 b6 H. }' A8 ~, E4 _
stamp on soft metal or bar code.# I5 b4 p8 {( e" O p( T
Small and fragile products should be held in containers and the container sealed and
3 G1 l) M. b: H, v2 b# H5 _marked with the product status. Large products should either carry a label or have% y8 M1 Y1 t! K) u( K
a related inspection record.$ V& N: m" X* k
In some situations the location of a product can constitute adequate identification of: W: z: ]! y2 V9 A# D
product status. However, these locations need to be designated as Awaiting Inspection,
! K) I. e; x. _( B* L s" _0 UAccepted Product or Reject Product or other such labels as appropriate to avoid
$ b" f5 h8 y! r2 b3 d; ?8 s& jthe inadvertent placement of items in the wrong location. The location of product in the
, O4 b* T$ ?5 O# P# Vnormal production flow is not a suitable designation unless an automated transfer route
3 K6 @1 l: x/ x# d! J: g* {4 q. ais provided.. u7 U9 V# m5 [0 C' Y; j8 h
When a service is out of service, tell your customers. Services that rely on products; a% C, w' T) R& e- N% n6 F/ c
should carry a label or a notice when accessed. A bank cash machine is one example/ @! W% n4 G" c4 S1 d
where a notice is displayed when the machine is out of service. In some cases customers
" ~1 Z9 B/ Q7 h; l8 i1 ~% M- qmay need to be informed by letter or telephone.$ _. Q s/ M- H
With software the verification status can be denoted in the software as a comment or
4 A: O% J4 W" U- g$ d6 p0 c! R( |2 Eon records testifying its conformance with requirements.0 t! ^- r7 r. r$ b; t
With documentation you can either denote verification status by an approval signa-
6 W6 _, y! s! z8 f2 ^4 b2 n1 f# q$ Hture on the document or by a reference number, date and issue status that is traceable to& K6 R3 b/ Y. g5 W2 @2 R( S+ R
records containing the approval signatures.5 \1 x' f! _0 B, h
If you use stamps, you will need a register to allocate stamps to particular individuals, w3 S& H+ W$ ?4 ]
and to indicate which stamps have been withdrawn.When a person hands in his stamp it6 H! }" L: x" }1 G) t8 M* d
is good practice to avoid using the same number for 12 months or so to prevent mistaken- |* y: @$ H' V2 a" n2 d- W) j0 Q
identity in any subsequent investigations.6 F7 r4 [) T) \" G4 G! h, s$ U
Traceability' p$ |1 [ \" Q
Where traceability is a requirement the standard requires the organization to control the
0 x) |5 o1 d5 h% tunique identification of the product and maintain records. ?. g0 d* ?( y0 ^/ E* t, G9 H' {+ ?
What Does this Mean?# d d# L2 v3 H2 S; I) {% K
Traceability is a process characteristic. It provides the ability to trace something through
; v9 E: G ] X, F& @a process to a point along its course either forwards or backwards through the process, H7 t# X. O& t3 d' w
539 Chapter j 27 Production and Service Provisionand determine as necessary, its origin, its history and the conditions to which it was0 M0 w* q0 z7 Q- |
subjected. Traceability may be a requirement of the customer, legislation or statutes or9 b+ `# [9 j- a, l/ l8 E6 e
simply a requirement of the organization in order to conduct investigations when events6 `4 | `- C4 R* E- P
do not proceed as planned.
) S! g( h; p5 i a2 a+ C1 m. `Why is this Necessary?
* U6 K4 {! t* p" WThis requirement responds to the Factual Approach Principle., s+ ]) v# q, z/ u& F& i
One needs traceability to find the root cause of problems. If records cannot be found" S1 L( T& u1 t/ b( s
which detail what happened to a product then nothing can be done to prevent its8 t" m' K4 S/ T9 F0 m
recurrence. Although the standard only requires traceability when required by contract
; w( P1 T% ?! n7 l8 Jor law, it is key to enabling corrective action.
+ y! C6 ^( R9 ~0 I4 [4 |. XIn situations of safety or national security it is necessary to be able to locate all
6 ?4 a4 J* Y M5 m( yproducts of a batch in which a defective product has been found so as to eliminate them# _3 t! m# G* v
before there is a disaster. It is also very important in the aerospace, automobile, medical
$ x- ]. W. j5 e1 \devices and food and drugs industries – in fact, any industry where human life may be at- t( U1 i" u9 s+ w% a
risk due to a defective product being in circulation.
/ s0 @7 W$ K# H! x9 aTraceability is also important to control processes. You may need to know which- W/ |9 |$ f" I; [; ~
products have been through which processes and on what date if a problem is found
2 Z& |* w+ f2 ~, ~5 Dsometime later. The same is true of test and measuring equipment. If on being calibrated
: s7 n4 A: _+ Za piece of test equipment is found to be out of calibration then it is important to track# F$ o T4 ^8 _3 Z: X
down all the equipment which has been validated using that piece of measuring( r. K5 B. k1 z: A
equipment. This in fact is a requirement of ISO 9001 Clause 7.6 but no requirement for
! M( x$ @" b+ S5 z1 `4 utraceability is specified.
0 I. _" f5 ^* Z8 h$ JHow is this Demonstrated?
; q/ W9 D4 }2 R9 L: tProviding traceability can be an onerous task. Some applications require products to1 W# G7 q9 S; m* y# |& T' H, q6 X% X
be traced back to the original ingot from which they were produced. Traceability is
* V! [2 I; O# ?! K/ o7 \5 k6 Iachieved by coding items and their records such that you can trace an item back to: a( ]( O! L0 h% l. T3 O3 N) k/ N
the records at any time in its life. The chain can be easily lost if an item goes
" D# i" Q. w1 \# R8 A; Moutside your control. For example, if you provide an item on loan to a development
N2 f8 h8 f% m2 f) Z. r _organization for investigation and it is returned sometime later, without a certified
2 U" ?- r# N _) U2 `: grecord of what was done to it, you have no confidence that the item is in fact the
V( m0 y/ Y- H5 msame one, unless it has some distinguishing features. The inspection history may2 G' f% f" z3 E$ [. _
also be invalidated because the operations conducted on the item were not certified.
: w6 p' Q+ m$ f9 i+ X2 z1 L+ ~7 YTraceability is only helpful when the chain remains unbroken. It can also be costly
2 a, }" }6 u( G" y3 _8 ato maintain. The system of traceability that you maintain should be carefully
. P) T( r) [& ]thought out so that it is economic. There is little point in maintaining an elaborate. I1 O0 Z( z/ Y* i+ U
traceability system for the once in a lifetime event when you need it, unless your
9 I# M: n2 f7 Q$ k$ Tvery survival or society’s survival depends on it. However, if there is a field failure,
( A, z4 Z0 Y- b: Yin order to prevent recurrence you will need to trace the component back through: K2 L* j9 w6 g$ h# x9 I3 f
the supply chain to establish which operation on which component was not per-
5 |. v; ^: W7 U6 B3 {& O3 _formed correctly simply to rule out any suggestion that other products might be% h0 `! n- X% m' [- s6 f5 ^
affected.! Y7 R6 l6 c% P& h
The conventions you use to identify product and batches need to be specified in the
6 o* O( z4 `+ U0 ~0 }product specifications and the stage at which product is marked specified in the relevant
! y3 C0 f5 e% t( c4 Oprocedures or plans. Often such markings are automatically applied during processing,
6 ~2 m' r7 `# a- \6 ^3 f" A- P; e540 PART j 6 Complying with ISO 9001 Section 7 Requirementsas is the case with printed circuits, mouldings, ceramics, castings, products etc. Process
+ J4 P- I9 H5 s5 gsetting up procedures should specify how the marking equipment or tools are to be
3 I6 P; i1 ?( `% e; hset up.* R( e/ }$ Q) _
If you do release a batch of product prior to verification being performed and one out* i0 C# I2 R7 O6 ~7 b% E% N
of the batch is subsequently found to be nonconforming, you will need to retrieve all
$ J& @; t2 ] s2 v3 a7 N! l6 Pothers from the same batch. This may not be as simple as it seems. In order to retrieve4 m. \* @" ~* E( Y6 D
a component which has subsequently been assembled into a printed circuit board, which" y% b& H/ k j. \* h6 s
has itself been fitted into a unit along with several other assemblies, not only would you
$ P0 a' c: s: ^0 V- u7 j. Jneed a good traceability system but also one that is constantly in operation.' ^; k" X- j8 ~+ X: t1 k: f: i+ g
It would be considered prudent to prohibit the premature release of product if you did
; b$ v, A& ] Y" a0 unot have an adequate traceability system in place. If nonconformity will be detected by
4 r( l1 Q& g+ u) E0 lthe end product tests, allowing production to commence without the receipt tests being
1 Y+ Y: u1 G- F% o2 G& ?* J5 e6 @ navailable may be a risk worth taking. However, if you lose the means of determining
; i7 D" H9 F2 \( uconformity by premature release, don’t release the product until you have verified it as
4 e _( ] y) dacceptable.
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