Corrective and Preventive Action

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Correction, Corrective Action and Preventive Action ISO 9000 Definition Expanded Definitions Differences between CA/PA and Correction Simple Example of Correction, CA, and PA Buy Corrective/Preventive Action Procedures & Forms A critical requirement of ISO 9001 is corrective & preventive action (Sec. 8.5.28.5.3), and we are often asked the difference. Here is a quick evaluation and example to help you: ISO 9000:2005 Sec. 3.6 defines them as follows: Correction Action to eliminate a detected nonconformity Corrective action Action to eliminate the cause of a detected nonconformity Preventive action Action to eliminate the cause of a potential nonconformity To expand on these definitions a bit 1. Correction: When a problem occurs, you need to keep several aspects in mind. Determine the magnitude of the problem. Determine how to prevent it from getting bigger. How to address current situation. You could call this Damage Control. Although thiscorrection takes steps to correct the problem it has no bearing on cause. 2. Corrective Action: Now determine if the importance of the situation requires further action:

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Corrective and Preventive actions explained.

Transcript of 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 (CAPA)

Corrective and Preventive action (CAPA)

ISO 14001 4.5.2 NON-CONFORMANCE, CORRECTIVE AND PREVENTIVE ACTION.

ISO 14001 4.5.2 NON-CONFORMANCE, CORRECTIVE AND PREVENTIVE ACTION.

OP 14.1 Corrective and Preventive Action Rev M 20150505 draft · Title: Microsoft Word - OP 14.1 Corrective and Preventive Action Rev M 20150505 draft.docx Author: TCovino Created

OP 14.1 Corrective and Preventive Action Rev M 20150505 draft · Title: Microsoft Word - OP 14.1 Corrective and Preventive Action Rev M 20150505 draft.docx Author: TCovino Created

Corrective and Preventive Action – Background & Examples

Corrective and Preventive Action – 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

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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

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

Corrective and Preventive Actions - PDA

Corrective and Preventive Actions - PDA

Wagons Corrective and Preventive Maintenance

Wagons Corrective and Preventive Maintenance

Corrective or Preventive?...corrective or preventive. The debate is pointless because what really matters is whether the action would attack a root cause. To add even more confusion,

Corrective or Preventive?...corrective or preventive. The debate is pointless because what really matters is whether the action would attack a root cause. To add even more confusion,

FACTORYTALK PRODUCTIONCENTRE - Rockwell … closed-loop process management system with enterprise-wide access for Corrective Action/Preventive Action and Complaint Handling. Create

FACTORYTALK PRODUCTIONCENTRE - Rockwell … closed-loop process management system with enterprise-wide access for Corrective Action/Preventive Action and Complaint Handling. Create

Corrective and Preventive Action - FDAnews · PDF fileCorrective and Preventive Action Jay Jariwala ... • Review CY2012 and CY2013 Quality System (QS) ... “BIG C” CAPA SYSTEM

Corrective and Preventive Action - FDAnews · PDF fileCorrective and Preventive Action Jay Jariwala ... • Review CY2012 and CY2013 Quality System (QS) ... “BIG C” CAPA SYSTEM

Corrective Action Plan 2 Corrective Action Areas I and II ... · CAP Corrective Action Plan (2018) CAP2 Corrective Action Plan 2 (2019) CAP2 OUB Corrective Action Plan for Operable

Corrective Action Plan 2 Corrective Action Areas I and II ... · CAP Corrective Action Plan (2018) CAP2 Corrective Action Plan 2 (2019) CAP2 OUB Corrective Action Plan for Operable

CAPA Performance CAPA Outcomes - NHS Wales - Ken Peterson.pdf · • Corrective action? • Preventive action? • What about “no action”? 6 CAPA & Issue Review • Define the

CAPA Performance CAPA Outcomes - NHS Wales - Ken Peterson.pdf · • Corrective action? • Preventive action? • What about “no action”? 6 CAPA & Issue Review • Define the

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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Corrective Action and Preventive Action Procedure Start.

Corrective Action and Preventive Action Procedure Start.

Preventive Action / Corrective Action / Root Cause ...

Preventive Action / Corrective Action / Root Cause ...

Maximising success –marginal gains concept · Procedures (SOP) Patients Suppliers Satisfied Patients Preventive Action Monitor, Measure analyse Corrective Action s Consistent INPUTS

Maximising success –marginal gains concept · Procedures (SOP) Patients Suppliers Satisfied Patients Preventive Action Monitor, Measure analyse Corrective Action s Consistent INPUTS

Corrective & Preventive Action (CAPA) with LIGHTHOUSE ... · with LIGHTHOUSE Instrument Purnomo P Negoro Sales Manager. Purpose of the Corrective and Preventive Action Subsystem |

Corrective & Preventive Action (CAPA) with LIGHTHOUSE ... · with LIGHTHOUSE Instrument Purnomo P Negoro Sales Manager. Purpose of the Corrective and Preventive Action Subsystem |

Corrective Action Investigation Plan for Corrective Action Unit .../67531/metadc785059/...DOE/NV--1029 CORRECTIVE ACTION INVESTIGATION PLAN FOR CORRECTIVE ACTION UNIT 309: AREA 12

Corrective Action Investigation Plan for Corrective Action Unit .../67531/metadc785059/...DOE/NV--1029 CORRECTIVE ACTION INVESTIGATION PLAN FOR CORRECTIVE ACTION UNIT 309: AREA 12

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,

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,