The purpose o# this procedure is to de#ine the methodoog" #or corrective action in ESCL processes and activities in order to eiminate the causes o# noncon#ormities%
thereb" preventing recurrence$ $.0
SC)PE
This procedure is appicabe to a noncon#ormities noncon#ormities generated generated in ESCL operations and activities$ .0
RESP RESP)N )NSI SIBI BILI LITI TIES ES AND A+T) +T)RI RIT9 T9
5.#
Ever 6nction:
;as ;as the the dut" dut" and resp respon onsi sibi bii it" t" to repo report rt an" obse observ rved ed
noncon#orming product or service as it reates to his activities (see Form 107)$ +$2
De,"rt4ent3+nit e"d! "nd To, M"n"'e4ent:
Respon Responsib sibe e #or the revie revie! ! and and
determining the causes o# noncon#ormities pertaining to his activities and instituting corrective action$ +$9
Responsibe #or the impementation impementation o# actions actions needed needed to correct correct Proce!! Proce!! )/ner: )/ner: Responsibe the cause o# noncon#ormities in his process/activit"$
+$4
De,"rt4ent3+nit e"d! "nd To, To, M"n"'e4ent: Revie! the resuts o# corrective
on noncon#ormities #ound during interna and e
PR)CED+RE
5$1
Contr"ct!3Proce!!e!
5$1$1 Reported Reported noncon#ormitie noncon#ormities s (incuding (incuding customer customer compaints compaints%) %) are revie!ed revie!ed to determine determine the signi#icance o# the probem (see the appendi< !hich sho!s the #o! chart #or handing handing noncon#ormities% noncon#ormities% customer compaints and corrective corrective action in ESCL)$ 'ee aso document - Re#$ &o$ '3-,'P-004% on ontro o# &oncon#orming Product$ 5$1$2 Immediate positive action (correctio (correction) n) is ta:en ta:en on noncon#ormit noncon#ormities ies (incuding (incuding customer customer compaints) to correct probem% minimi8e ris: or achieve short term bene#it$ 5$1$9 6ppropriate 6ppropriate investigatio investigation n and/or and/or data ana"sis ana"sis is carried carried out to to determine determine the cause(s) o# noncon#ormities that are o# signi#icant e##ect in terms o# costs% product/service per#ormance% sa#et" and customer satis#action$ 5$1$4 5$1$4 The The prop propose osed d corre correcti ctive ve action action #rom the the invest investiga igatio tion n mentio mentioned ned in 5$1$9 5$1$9 above above is evaua evauated ted in con=unct con=unction ion !ith the cient (!hen appicabe) appicabe) in order order to assess assess the impications and ensure that on impementation% the noncon#ormit" does not recur$ 5$1$+ ver" process process o!ner o!ner ensures ensures that an" recommended recommended correctiv corrective e action as as it reates reates to his area o# !or: is impemented$ 5$1$5 5$1$5 The The depa departm rtmen ent/u t/unit nit heads heads and and top manage managemen mentt cose cose" " monito monitorr and and revie! revie! the e##ecti e##ectiven veness ess o# the correct corrective ive actions actions ta:en ta:en on noncon# noncon#ormi ormities ties reated reated to their their processes and ensure a satis#actor" cose out$
5$1$7 Records o# the corrective corrective action and and the resuts resuts o# corrective corrective action ta:en ta:en as it reates to speci#ic processes/contracts are maintained and serve as inputs #or preventive measures in #uture =obs$ 'ee Forms 107 and 10 as appropriate$ (.$ Prc%" Prc%"!in !in' ' of Prodct! Prodct!3Se 3Servi rvice! ce!
orre orrect ctiv ive e
acti action on
on
nonc noncon on#o #orm rmit itie ies s
iden identi ti#i #ied ed
and and
reco record rded ed
on
supp suppi ied ed
products/services b" suppiers is handed through contacts !ith the suppier unti a satis#actor" cose out$ Records are maintained (see Form 10)$ (.
Q"it Adit
Reported noncon#ormities in the ,uait" Management '"stem and its processes #ound during interna and e
;.0
REC)RDS
7$1
orre orrect ctiv ive/P e/Prev revent entive ive 6ction ction Reu Reuest est (For (Form m 107) 107)
7$2 7$2
orr orrec ecti tive ve/P /Pre reve vent ntiv ive e 6ct 6ctio ion n 3og 3og (For (Form m 10) 10)
Client and/or representative is made aware of actions to take care of immediate needs and agrees to accept those actions
Action taken to take care of immediate needs
#etermine and implement the steps necessar$ to deal with the problem% appropriate to the effect of the nonconformities enco!ntered& Appl$ necessar$ controls to ens!re that actions are effective
Client/representative Client/representative is informed of the corrective/preventive action(s)
nform client/ representative if re"!ired
Record the nonconformit$ and the the action action taken
No
Were the actions acceptable?
Yes Yes
Closed
'eriodicall$ 'eriodicall$ anal$e this information for trends and possible areas to address ee* 'reventive Action
