Corrective and Preventive Action

Correction,CorrectiveActionandPreventiveAction

ISO9000Definition

ExpandedDefinitions

DifferencesbetweenCA/PAandCorrection

SimpleExampleofCorrection,CA,andPA

BuyCorrective/PreventiveActionProcedures&Forms

AcriticalrequirementofISO9001iscorrective&preventiveaction(Sec.8.5.28.5.3),and

weareoftenaskedthedifference.Hereisaquickevaluationandexampletohelpyou:

ISO9000:2005Sec.3.6definesthemasfollows:

CorrectionActiontoeliminateadetectednonconformity

CorrectiveactionActiontoeliminatethecauseofadetectednonconformity

PreventiveactionActiontoeliminatethecauseofapotentialnonconformity

Toexpandonthesedefinitionsabit

1. Correction:Whenaproblemoccurs,youneedtokeepseveralaspectsinmind.

Determinethemagnitudeoftheproblem.

Determinehowtopreventitfromgettingbigger.

Howtoaddresscurrentsituation.

YoucouldcallthisDamageControl.Althoughthiscorrectiontakesstepstocorrecttheproblemithasnobearingoncause.

2. CorrectiveAction:Nowdetermineiftheimportanceofthesituationrequiresfurther

action:

Wasitabigdeal?

What'sthechanceitwillhappenagain?

Estimateofanyfuturethreat

Thecausesneedtobelookedintotopreventrecurrenceifitwasabigdeal.

3. PreventiveAction:Firstyouneedtoassesstheriskandmitigateitbaseduponseverity.

Thefollowingtoolsarehelpful:Source:CarnegieMellonUniversity

Checklists

FMEAFailuremode&effectsanalysis

Hazardandoperabilityanalysis(HAZOP)

Faulttreeanalysis(FTA)

Differencebetween:

Correction&CorrectiveAction

HIGHrisk/impact/frequency

CorrectionfixestheCURRENTsetofissues

Correctiveactionpreventsitfromhappeningagainbylookingatcauses

LOWrisk/impactactionsaresimilarsincelikelihoodofrecurrenceislow

Corrective&PreventiveActionthedamageisalreadydoneincorrectiveaction

SimpleExampletodemonstratethedifferences

Acustomerorders500parts,butonly450aredelivered.

CorrectionFixthecurrentissue

getthecustomer50moreparts

CorrectiveActionWhywereweshort?

Operatormiscounted9boxesof50as10boxesof50

PreventiveActionmakesureitdoesn'thappenagain

Weighproductsonscalesoyouknowifquantityismet

ISO9001requirestheorganizationtohaveadocumentedprocedureforcorrectivean

preventiveaction.

Note:Thecombinationofcorrectiveactionandpreventiveactiondocumentedprocedures

intoasingleQMSdocumentisacceptable,butisnotrecommended.Ifthesearecombined,

thenitisimportanttoverifythattheorganizationunderstandsclearlythedifference

betweentheintentofcorrectiveandpreventiveactions.

Corrective and Preventive Action

Documents

Transcript of Corrective and Preventive Action

Corrective & Preventive Action-05

Corrective/Preventive Action and Root Cause/Data Analysis ... · to Corrective/Preventive Action Process 10 Supplier’s Corrective Preventive Action Request form does not identify

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RISK MANAGEMENT final 26June12 - Neville Clarke MANAGEMENT.pdf · facilitate the change to shift the emphasis from Corrective action to Preventive Action. Preventive actions should

Surviving Chromatography Part II Corrective Action...Corrective Action/Preventive Maintenance/ Good Practices Definition: Common Problems Noisy Baselines Possible Causes • Dirty

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HOW TO DEVELOP A CORRECTIVE AND PREVENTIVE ACTION …Clinical Research Seminar HOW TO DEVELOP A CORRECTIVE AND PREVENTIVE ACTION PLAN (THAT EVEN THE IRB AND FDA WILL LOVE) April 11,

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Corrective and Preventive Action Basics fda/published/CDRH-Learn-Presenation... · The Preamble on Procedures ... and preventive action) must provide for control and action to be

Corrective and Preventive Action Subsystem of the Corrective and Preventive Action Subsystem ... • Scrap/Yield Data • Rework ... magnitude of the problem and commensurate with

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Effective Management of Corrective Actions with …...whether corrective / preventive action was adequate IF NOT: Return to Action Details>Add Line to repeat step 3 and add further

Corrective and Preventive Action â€“ Background & Examples

Failure Investigation and Corrective and Preventive …/media/rssl/en/files/documents/...Corrective and Preventive Action Scope This course provides an introduction to the requirements

Corrective and Preventive Action – Background & Examples · CAPA Procedures – 21 CFR 820.100(a) Each manufacturer shall establish and maintain procedures for implementing corrective