{rSOn Sysfemeq c Trou bl esh ooti n g

Figure 2 :TREND ANALYSTS

lcho't, :

w,tivy ni"
Exp[anatory notes on charts
*
Ghart 1

This pattem shorvs a grarJual increase in defect rate. Since the increase in delbct
rate appears logarithmic it is logical to assume that the degree of conramination
also increases. f-irere are nvo exlrlanations for such a pattemi

" eitlier the i'ate of infection at the source increases with time
and/or t tt--)
61s4x t'
k,- n y, T,r'r'.0 L
e substantial rnicrobial growth takes place speyhgle,lnlhg ryllgm

(,\ne area that can be excluded/eliminated from such a

scenario is faulry* CIP or
pre-sterilisatiorr.
^.. -r.^
An e>:arnple ot'a source that coulc give such #ihfifir
filling fronr an -re.-rti4a,-'-k ar
u,ithproductrvhic1rhasbeenstoredforsometimeandthecontaminating
organism has had iime to multiply in the AT, Thg source of the ccniamination
coulci'be the hT or upsream ot'the AT.
-I" this case, and in ail cases.. the
identity* of the contaminating organisms is valuabie information. which,
combined rvith the i<nou,ledge of the naturai habitat of such orsanisms. coulcl
in,:li..o+-
i,,\iiud;E +L^ ^f A,*1-^--^^!:^--
,.iig -^+.-,-
iiai.'r-lie C,rf f:il:er a,:dOnS CI Areas Cif:f.htl inveStig:tit-:l
..
Chari 2

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fnltlrllrr ru!! 1-r rrr=11 S^ll^'..61
L;^L avlruvYrvu l.-,
u,v ^..--.--L
a ,?a}ll u$1 ^.-rt, iilqtr.
^tr^^r. T-- -L:- ------"-:
lti titl-a >Lgii!:i.:1-,,,
iirF r?rip.'i',1n ir/i\
-
nrp('an' oi a- Ai-o^,1!' -+o- ^^,ri-'-^-. ^+,r--iii-^.j^-
--- r_ --"_" 9!.'liarJsl|J:r.

.Thre Source of si:e-li a scenarir: can

r:ten be iin.r-ed to CiF oip,r:-ster:lis:tior
ri'hich dbes not conform to specification or some malfunction jn the start-up

i i-Dec-U4 4U

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process rF"rt Qrn"l Oo:,

.. to, or at the start of production.
In cases like this, microbiological information regarding spoilage flora and
examination of production and QC records may provide furthealeads.

Chart 3
Initially the defect rate is high after which a "wash out" takes place followed by
a constant but low defect rate. The source of such a pattem may be rather
complicated
1

Theinitial high level of unsterility on start up may be interpreted-,the same as

chart2 but the problem continues at low level instead of disappearing;
Such a scenario could indicate the presence of more than one source of
infection. Further information of the tlpe and purity of microbiological spoilage
flora is essential information to indicate further action.

Ghart 4

An intermittent problem which occurs at regular intervals.The level of

unsterility rises sharply to similar levels followed by a .kash out,,.
A pattern like this could correlate with a particular operational event taking
place at regular intervals. Operational records and identification of the
contaminating microflora rvill yield further valuable information.

Ghart 5

Also an ifl)H*S", problem, this time occurring As for

"H$#'nten,ars.
scenario 4 above, a connection to an operational event/s should be investigated
by cor:sulting operator records_
Tlie possibiliqv of more than one source of infection cannot be ercluded in this
voJ!.

Ihe identity of the contaminating microorganisms will provide r.aluable

information to facilitate further investigation.

Chart 6

The chart indicates a lorv but constant level of unsterility throu-ehout the
production. such patterns could be indicative of failure of equipment.
equipment components or equipment settings out of specification. ln such
cases, ralv material related problems canirot be excluded.
.

Again. an indicarion of how to proceed rvill be provided, by the identiq, of the

nn-'^,-i-^+i
L ui.i ciii i,i iii jr i: ijj 1;i00iEallisins.
i. I

Chart 7

i.:: tiiis Suiiiariu. ilc itvci oi ii.r unsreriiiii' is co:::paiativeiy hi;n ani ','eiable.
T!,:
,..
trrlo :-ir -..-^i-^l-i-.-L.
ul.. ltiuJt
yluuau|i --^-a Jj4'/:---r{.-t--r
ull.truulL utr4rt, a.- : -r_._- -a
ru !!rlgtprcL,
y:,! _, ! I, ! !:
ri Siiuuitl Lrc ilaaqu t-i!at,
although r.'anable. the level of unsteriliq.'never drcps to zero. r.\loie Lhan one
source of contamination cannot be exciuded. To investigate this theory, the
nature oithe contaminating microorganisms should be compaied ar the peaks

.I J{ -UVW-Wa
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 FiSQA Systematic Troubteshooting :

and in the troughs and any significant Orf*r"r,

peaks/noughs with operational events should also be investigated.

chart 8
"ffi -kr,!+") r'r*
The chart indicates a single short iiifectibn, taking place at randqm.d,uring a
productionAfter apparently appearing'"at random", tt, .onturr{ihjfi8i
disappears or "washes out"completely. This indicates a single incident during
production which is not repeated. The timing of the contamination and the
level of contamination are critical pieces of information which can be used to
correlate with an event during prodlction. ,

Ifthe source is suspected to be operational, previous and subsequent

production records should be examined to try to discover the hisiory of similar
events- This and the nature of the contaminating microorganisms will provide
important information upon which further investigation can be based.

Chart 9
The problem presents itself midway during production, apparently after the
production has been running "trouble free". The defect rate appears to increase
initially and then stabilise on a low level.
Firstly, it should be established beyond doubt that there has indeed been a
situation of "zero defect" for the first part of the production. If the defect level
has be so lodor intermittent so as to be undetectable during the first part of the
production, the investigation could take an entirely different direction with
incorrect information.
As with the previous sceltario, it should be established whether the problem
has manifested itself in previous(or subsequent) productions to see ,vhether
there is a "history" or rvhetirer the problem is an isolated case.

WHAT INFORMATION CAN YOU RELYOruABSO LITTELY?

Ii is often heipful to decide what facts are "key" facts when the initiai
irrformation has been assembled. "KEY" facts can be <iefined as facts that wiij
determine the further course of the investigation if they are indeed correct.
The converse is also true ie if they are Nor correct, the coune of the
investigation ri'il1 be entirely different.
Depending on the nature of the investigation it is often valuable to revibw and
reconfirm certain key fbcts, especially if they been gained from records or
verbal reports. Never forget what infoniration you hive cqliected yourself and
r,vhat has been obtained from oihers. ,l

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