Correc recti tive ve Action n Requests uests (CARs) s) Major - - PowerPoint PPT Presentation

Instr structi uction

• n for Writing

ng and Analyzin zing Correc recti tive ve Action n Requests uests (CARs) s)

Major r nonconform conformity: ity:

A major jor nonc

• nconfo

nform rmit ity is one ne or more

• re of:

f: a. a. the e absence ence of, or tota tal l breakdow kdown of, a system em to meet et a SAAS AS requir uirem emen ent.

• t. A number

umber of mino inor non

• nconformi

formiti ties es against ainst one ne requir quirem emen ent t can n represen esent a tota tal l breakdow kdown

• f

f th the e system tem and d th thus us be con

• nsi

sidered dered a major jor noncon

• nconfo

formi rmity; y; b. b. a noncon

• nconfo

formi rmity y that t judgm gmen ent t and d exper perien ience e indica dicate te is likely kely either ther to resul ult in the failu lure re of the e CB managem anagemen ent t system tem in meet etin ing g its ts goal als and d expec ectatio ations s or to to materia teriall lly reduce uce its abili lity ty to assure ure control

• ntrol of its

poli lici cies es and nd directiv ectives es; c. c. a noncon

• nconfo

formi rmity y that t poses es an immin mminen ent threat eat. .

Minor

• r nonconformi

conformity: ty:

A mino inor nonco

• nconform

rmity ity is a fa failu lure re to to comply

• mply with SAAS

AS requirem uiremen ents s whic hich, , based ed on n judgme dgment and d exper erie ience, ce, is not

• t likely

kely to resul ult in the failu lure re of the e mana anagem gemen ent system em

• r reduce

uce its abili lity ty to assur ure e the e ongo ngoing ng vi viabil bilit ity and d eff ffecti ectiven enes ess s of f poli licies ies and nd proc

• cedu

edures.

• es. It ma

t may y be one ne of f the e follo lowin ing: g: a. a. a failu lure re or ove vers rsigh ight in some me part of the organi ganizati zation' n' managem anagement nt system em whic hich is not t systemic emic in nat ature; ure; b. b. a single ngle obser erved ved lapse se in fo foll llow

• win

ing g one ne item tem of f a company

• mpany's

s managem anagemen ent t system em;

 How to ca

categori gorize ze:

 Coll

llect ct and d examin amine e adequ quat ate e objectiv jective e evi viden dence ce and d determi ermine e what hat type e of AR will ll be raised.

• ed. This

his inc nclu ludes des revi view ewin ing; g;

• an adequa

equate e sample mple size e of reco cord rds, s,

• num

umber ber of occ ccurren rence ces within thin the e system em

• noncon
• nconfo

forman rmance ce exis isten tence e in mult ltipl iple e function nctions s and d areas as, , and d

• othe

her indicato dicators s of a prevale valent issue ue affec ectin ing g the managem anagement nt system. em.

 When

n are CARs Rs raised: d:

• Doc
• cum

umen ent t revi view ews: s: Cars s are not t raised ed – defic icien iencies ies are identifie entified in doc c review view repor port

• Off

ffic ice e - CARs Rs may be raised sed and nd expla lain ined ed to to CB when hen found und before

• re mov
• vin

ing g on n to next xt topic ic

• Witness

tness – related ated to:  plann annin ing g process cess or related ted to audit dit proce cedures dures that at are identified during the audit of the CB’s audit planning and prepara arati tion n shall all be reviewe viewed with th the CB audit ditor

• r(s)

(s) at the e time me that t they y are fou

• und.

 conduct of the audit, including validity of the CB auditor’s CARs ARs, , shall all be commu

• mmunica

icated ed to the e CB audit ditor at the time me of the e aud udit it at the discret cretio ion of the e SAAS AS aud udit itor. . What hat does es this is mean ean?

 CARs

ARs shoul

• uld

d be written tten so that t they y are addressed ressed by the e con

• ntr

trollin

• lling

g offic ice e of the e Certif ifica icatio ion Body dy.

 Each

ch CAR AR issued ued shall ll cont

• ntain

ain suffi ficien ient but concise

• ncise

informa

• rmatio

tion to to ve verify y and nd subs bstan antia tiate e th the e nonco

• nconformi
• rmity

ty identifie entified durin ing g the aud udit it.

 Each

ch CAR AR must st be under nderst standa andable le by the CB and d SAAS AS staff. f.

Summa mmary: ry: An audit t nonconform conformity ity (Corre rectiv ctive Act ction

• n Re

Request st – CAR) R) finding ing shall have e three ee distinct inct parts ts:

• a. a stateme

tement nt of noncon

• nconfo

formi rmity, y,

• b. the requirem

uiremen ent, , or specific cific referen ence e to the e requirem uiremen ent

• r norma
• rmativ

ive e elem emen ent,

• c. the

e objec jecti tive e evi viden dence ce obser served ed that t suppo ports s the e statem emen ent t of noncon

• nconformi

formity. ty.

Exampl mple:

 Sce

cenar ario io:

:

An HQ off ffic ice e audit dit is being ing con

• ndu

ducted cted and d 7 audit dit packa kages ges have e been en selec ected ted for revi view ew. . Th Three ee were re initia itial l audits, dits, two

• were

re surveilla veillance ce witn tness ess audit dits and d two

• were

re surveilla veillance ce

• ffic

ice e audits.

• dits. Two

wo of the e stage e 1 audit dits did not t have e an audit dit agenda enda in th the e packa kages ges and nd one ne surveil eilla lance e off ffic ice e audit dit did not

• t have

e an audit dit agenda. enda.

Using ng Form m 41 415A 5A:

 Detail

ils s Of Of Nonconformi conformity ty for CAR: R: Th There is no ev eviden dence ce that at al all SA80 8000 00 au audits ts hav ave e au audit it plan ans s

 Guide

deline lines s for writing ing the Nonc nconfo

• nformit

rmity y for the CAR: R:

• Use the

e wordi rding ng from

• m the requirem

uiremen ent when hen possibl sible

• Do not
• t inc

nclude lude evi viden dence e in the e wor

• rdin

ding g of the e noncon

• nconfo

formi rmity y – state e as a noncon

• nconfo

formi rmity y to an identifie entified requirem uiremen ent.

 Guide

deline lines s for writing ing the Nonc nconfo

• nformit

rmity y for the CAR: R:

• Use the

e wordi rding ng from

• m the requirem

uiremen ent when hen possibl sible

• Do not
• t inc

nclude lude evi viden dence e in the e wor

• rdin

ding g of the e noncon

• nconfo

formi rmity y – state e as a noncon

• nconfo

formi rmity y to a stated ed requirem uiremen ent.

• Use wor
• rdin

ding g that t suppo ports s the e class assifica ificati tion of the CAR AR – Majo jor r or Minor, nor, for exam ample: ple:

 Major – The management t review ew process ess is not effecti ectivel vely implemen ented ted  Major – There re is no e eviden dence e that lead auditors rs are adequatel tely qualified ed prior to conducti cting ng certifi ficatio tion n audits. s.

Using ng Form m 41 415A 5A:

 Detail

ils s Of Of Nonconformi conformity ty for CAR: R: Th There is no ev eviden dence ce that at al all SA80 8000 00 au audits ts hav ave e au audit it plan ans s

 Detail

ils s Of Of Support porting ng Evide denc nce e for CAR: R: S Seven en audit t pack ckages ges were revie iewe wed d for (list t seven n audits ts revie iewe wed d incl cluding uding the name of the audite itee e and the date and type of audit t co conducted) ducted). . Tw Two of the three e stage ge 1 1 audits ts did not have ve audit t plans s (identi ntify fy cl client t names es) ) and one of two survei rveilla llanc nce e

• ffice

ice au audits ts (identif entify y cl client ent nam ame) e) did not hav ave e an an audit t plan.

 Guide

deline lines s for reco cording rding the Support porting ng Evide denc nce e for a CA CAR: R:

• Each

ch CAR AR issued ued shall ll cont

• ntain

ain suffi ficien ient but concise

• ncise

informa formatio ion to ve verify fy and nd subs bsta tantia iate te the e noncon

• nconformi

formity y identifie entified durin ing g the aud udit it, , such ch as:

 procedur ure numbers bers and references ferences to re records rds review iewed should ld be includ uded, if a applicabl ble.  Sample e si size ass ssess essed, ed,  number ber of persons

• ns interview

viewed,  observa rvati tions

• ns made,

Using ng Form 415A 5A:

 Detail

ils s Of Nonconformi

• nformity

ty for CAR: There ere is n no eviden ence ce that all SA800 000 0 audit its have ve audit it plans s

 Deta

tail ils s Of Suppor

• rting

ting Eviden ence ce for

• r CAR: Seven

en audit it packages ages were reviewe iewed d for (list st seven n audit its review iewed ed inclu cluding ing the name me of the audit itee ee and the date and type

• f a

audit it conduc ducte ted). d). Two of the three ee stage 1 audits ts did not have ve audit it plans ns (ident entif ify y client ent names) mes) and one

• f t

two surveill veillanc ance e office e audits ts (ident entif ify y client ent name) me) did not have ve an audit it plan. n.

 Text of R

Requir uired ed Normative ative Element ment for CAR: The certificat ification ion body shall ll ensure ure that an audit it plan n is establis lished hed for each h audit it

Using ing Form rm 415 15A:

 Detail

ails s Of Non

• ncon

confo formi rmity y for CAR: AR: Ther here e is no evi viden dence e that at all l SA800 A8000 0 audit dits have e audit dit plans ans

 Details

tails Of f Suppo pporting ing Evi viden dence e fo for CAR: AR: Seven ven audit dit packa kages ges were re revi view ewed ed for (list st seven ven audits dits revi view ewed inc nclu luding ding the e name ame of the audit ditee ee and d the e date e and d type of audit udit con

• ndu

ducted). ed). Two wo of the e three ee stage ge 1 audit dits did not

• t have

e audit dit plan ans (iden entify tify clien ient name ames) s) and d one ne of f tw two

• surveill

veillance ce

• ffic

ice e audits dits (iden entif ify clien ient t name) ame) did not

• t have

e an audit dit plan. an.

 Text

xt of Requi quired ed Normat rmativ ive e Elem emen ent t for CAR: AR: The he certi tifi ficatio cation body dy shall all ensure sure that t an audit dit plan an is estab abli lished shed for each ch audit dit

 Normat

rmativ ive e Docum cumen ent Refer feren ence ce: ISO SO 170 7021- 9.1 .1.2 .2

 CB Doc

• cumen

ent Refer ference: ence: SOP P XXX XX

 Guide

deline lines s for identif tifyi ying ng the Normative mative Eleme ment nt for the CAR: R:

• CARs

ARs can an be issued ued by grou

• upin

ping indiv dividua idual l findin dings gs as lon

• ng

g as th they y are again inst st th the e same me norma

• rmative

tive requir uireme ement.

• t. A CAR

AR may y only ly ident entif ify a nonc

• nconformi

formity ty to a single ngle requirem uiremen ent (Clau lause e num umber ber). ).

• When

en mor

• re

e than an one ne requireme uirement may y appear pear to be appropria ropriate, te, th the e most st appropria ropriate e requirem quiremen ent shoul

• uld

d be referen rence ced. . For

• r example,

ample, a Procedur cedure e 200 00 requir uirem ement nt shoul

• uld

d be identified entified over ver a 17021 7021 requirem uiremen ent if appli licable able. .

• If the CB has

as a requir quirem emen ent t with thin in their ir SAMS MS certi tific icat atio ion proc

• ces

ess s th that at is not

• t being

ing com

• mpli

plied ed with, h, it sh t shou

• uld

ld also so be referen rence ced.

 Exampl

mples: s:

• For

r the e foll llowin wing, g, what hat woul

• uld

d be the stateme tement nt of noncon

• nconfo

formi rmity y (if any) y) and d what hat is the e requir uirem ement nt not

• t

met? ? Also so, are th they ey mino inor or major? jor?

 During ng a w witness ness audit, , a SAAS S auditor r noted that t the CB auditor r did no not react ct to c conditi tions ns found nd during ng the facility ty tour that the SAAS auditor

• r felt

t were re nonco conform nformit ities. ies.  During ng a w witness ness audit, , a SAAS S auditor r noted that t the CB auditor r did not intervi erview ew employee yees in a se secur cure e location. ion.  During ng a m managing ging office ce audit , there re were re no re recor

• rds of

management gement review iews or in intern rnal al audits availab able le for the past two years.  During ng a m managing ging office ce audit, the review iew of auditor r records rds indicate ate that t 4 o

• f 9

9 a audito tors from three ree differen rent regions

• ns do not

meet minimum m qualific icati ation

• n requir

irements. ments.

CAR N R Numbe mbering: ring:

 The

he numberin umbering sche heme me used d to identif entify a CAR AR after init itial ial acc ccredit editation ation shall all ident entif ify the e seque uentia ial l num umber ber of CARs Rs written en agai ainst th the CB sinc nce e accredi creditatio ation

 CAR R

R Response

• nse Ti

Times:

Minor nor CAR AR Corrective rrective Acti tion

• n Plan

an Co Correc ecti tive ve Acti tion Com

• mple

lete te 3 mon

• nth

ths 6 mont

• nths

hs Majo jor r CAR R Correc rrective tive Action ion Plan an Co Correc ective ive Actio ion Com

• mple

lete 1 mon

• nth

th 3 mont

• nths

hs SAAS AS must st be not

• tif

ified ied as soon

• n as possibl

sible e by the e audit ditor

• r that

that a majo major r CAR AR has as been en raised. sed. No Norm rmal ally, , a major jor CAR AR shoul

• uld

d be ve verifie fied by an n on-si site e revi view ew at t th the HQ (man anagi aging) g) offic ice e at CA com

• mplet

pletion ion date e (3 mont

• nths)

hs)

 Analysi

ysis s of CAR r R response ponses: s:

• CB sho

hould ld util ilize ize their eir inter ternal nal cor

• rrecti

rective e actio ion proce cess s required uired by ISO O 170 7021 clau ause e 10. 0.2 / ISO O 900 001- 8.5 .5.2 .2 or ISO SO 170 7021 clau ause se 10.3.7 0.3.7 to to manag anage e correc rrective tive action ions s fo for SAA AAS S CARs ARs

• The

he CB shall all respond pond to SAAS AS usin ing g the e form m 415B 15B  All l sections ctions must st be com

• mple

leted. ted.  Majo jor r CAR R respon ponses ses shoul

• uld

d be analyze nalyzed fo for effectiv ectiven enes ess s on-site at the CB’s HQ office (special asses essm smen ent). ).  Con

• nta

tain inmen ent acti tions (Cor

• rrec

rectio ion) ) shoul

• uld

d be includ cluded ed with th cor

• rrec

ectiv ive e acti tions ns as appropr ropriat iate

• SAAS

AS shall ll not

• t close
• se the

e CAR AR unless nless ther ere e is evi viden dence ce that at the e root

• t cause

ause has been en effec ectiv ively ely elim imin inat ated. ed.

 ANAB Heads

s Up, Issue ue 13 137 7 – Impro proved d Correctiv ctive Act ction

• n Re

Response nses may prov

• vide

ide appropri

• priate

ate guida danc nce e as to when an acc ccredit ditati ation

• n auditor

tor may cl close se a CA CAR r R raised d against nst a CB CB.

HEADS UP

Issue: 137 Date: 2008/12/03 To: ANAB Applicant and Accredited CBs and Accreditation Assessors From: Randy Dougherty, Vice President, ANAB Re: Improved Corrective Action Responses The ANAB process for CBs to respond to nonconformances involves several steps, including correction, root cause analysis, corrective action, evidence

• f implementation, and verification of effective implementation.

NCR responses should be reviewed in three parts; correction, root cause analysis and corrective actions. These three parts are linked as outlined below.

• 11. In order to accept the plan it shall include;
• a. actions to address the root cause(s)
• b. Identification of responsible parties for the actions and
• c. a schedule (dates) for implementation.
• 12. In order to accept the evidence of implementation:
• a. Enough evidence is provided to show the plan is being

implemented as outlined in the response (and on schedule).

• b. Note; Evidence in full is not required to close the NCR;

some evidence may be reviewed during future assessment when verifying the corrective actions.

That’s it folks! An Any que uestion stions? s?