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    Sop Capa PDF

    Uploaded by

    nakul tiwari

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd

    Sop Capa PDF

    Uploaded by

    nakul tiwari
    135 views3 pages

    Original Title

    sop-capa.pdf

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    © © All Rights Reserved

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    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    135 views3 pages

    Sop Capa PDF

    Uploaded by

    nakul tiwari

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    of 3
    At a glance
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    The key takeaways are that this SOP describes how CAPAs are implemented and tracked according to ISO 13485:2016. Various events can trigger a CAPA and the QMO is responsible for creating and tracking CAPAs to resolution.

    The process for creating a CAPA involves various triggers being received and the QMO creating the CAPA and tracking it in the CAPA list. Immediate actions may need to be taken in consultation with the regulatory compliance officer.

    The steps involved in a root cause analysis according to this SOP are that the QMO coordinates a root cause analysis using the Five Whys method with the person closest to the issue and documents the results in the CAPA list.

    SOP Corrective and Preventive Action (CAPA)

    ISO 13485:2016 Section Document Section


    8.5.1 (All)
    8.5.2 (All)
    8.5.3 (All)

    Summary
    This SOP describes how CAPAs are implemented and tracked.

    Process Owner <enter role of process owner>


    Key Performance <enter KPIs to be tracked for the Management
    Indicators Review>

    Process Steps
    1. Input for CAPA
    Various events may lead to creation of CAPA. Examples include:
    • Product or QMS non-conformities
    • Customer complaints
    • Internal bug reports, e.g. by developers
    • Audit findings
    • Post-market surveillance findings, including trends
    • Management review findings, including trends
    These inputs may be received from any person inside or outside the company.
    The QMO is responsible for creating the CAPA and tracking its resolution.
    CAPAs are tracked in the CAPA list.

    Participants
    QMO

    Input Output
    Non-conformity, complaint, etc. CAPA created

    1
    2. Decision on Next Steps, Immediate Action
    If immediate action is necessary (e.g. product recall, notification of authorities),
    the QMO consults the Person Responsible for Regulatory Compliance. Immediate
    action is carried out without undue delay (see ISO 13485 para. 8.5.2).
    In any case, the QMO discusses the next steps with the person closest to the
    issue, e.g. for software bugs, the Head of Software Development.

    Participants
    QMO
    Medical Device Safety Officer / Person Responsible for Regulatory Compliance
    (optional)

    Input Output
    CAPA CAPA, updated with action

    3. Root Cause Analysis


    The QMO coordinates a root cause analysis with the person closest to the issue.
    The preferred method for this is Five Whys. The result is added to the CAPA
    list.

    Participants
    QMO
    Other people in company (optional)

    Input Output
    CAPA CAPA, updated with root cause

    4. Implementation of Action
    The QMO coordinates defining and implementing corrective and preventive
    action. Additionally, the QMO takes into account adverse negative implications
    and verifies that the actions do not adversely affect the ability to meet applicable
    regulatory requirements or the safety and performance of the medical device.
    Outcomes are documented in the CAPA list.

    Participants
    QMO

    2
    Participants
    Other people in company (optional)

    Input Output
    CAPA CAPA, updated with action plan

    5. Verification and Check of Effectiveness


    The QMO conducts the verification and effectiveness review of the implemented
    action. These are defined as below. Thereafter, the QMO closes the CAPA.
    • Verification: Documenting proof of implementation of actions taken.
    • Effectiveness: Review of the effectiveness of actions taken.

    Participants
    QMO

    Input Output
    CAPA CAPA, updated with verification, effectiveness review, closed date

    Template Copyright openregulatory.com. See template license.


    Please don’t remove this notice even if you’ve modified contents of this template.

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