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    SOP-03 RA Procedure

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    Shakti Shukla
    This document outlines the procedure for risk assessment at APAR. It involves identifying risks related to quality, analyzing them based on probability and severity, treating risks that exceed acceptable levels, and reviewing the risk register every six months. The process includes identifying risks, evaluating them using a risk matrix, establishing controls, and documenting opportunities that may arise.

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    SOP-03 RA Procedure

    Uploaded by

    Shakti Shukla
    128 views3 pages
    This document outlines the procedure for risk assessment at APAR. It involves identifying risks related to quality, analyzing them based on probability and severity, treating risks that exceed acceptable levels, and reviewing the risk register every six months. The process includes identifying risks, evaluating them using a risk matrix, establishing controls, and documenting opportunities that may arise.

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    This document outlines the procedure for risk assessment at APAR. It involves identifying risks related to quality, analyzing them based on probability and severity, treating risks that exceed acceptable levels, and reviewing the risk register every six months. The process includes identifying risks, evaluating them using a risk matrix, establishing controls, and documenting opportunities that may arise.

    Copyright:

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

    SOP-03 RA Procedure

    Uploaded by

    Shakti Shukla
    This document outlines the procedure for risk assessment at APAR. It involves identifying risks related to quality, analyzing them based on probability and severity, treating risks that exceed acceptable levels, and reviewing the risk register every six months. The process includes identifying risks, evaluating them using a risk matrix, establishing controls, and documenting opportunities that may arise.

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    You are on page 1of 3

    LOGO LOGO

    ORGANISATION NAME

    Doc. No. XXX/MR/SOP/03


    TITLE: PROCEDURE FOR RISK ASSESSMENT Rev. No. 00
    Date.
    Quality Management System Manual Page No. Page 1 of 3

    1.0 Objective:

    To ensure proper steps to manage risk and opportunity related to quality at APAR.

    2.0 Scope of application:

    All quality related risk and opportunity at APAR.

    3.0 Process:
    A. Identification of Risk
    i. The Head Function shall establish a Risk Register XXX/MR/RD/12, in which
    through a team effort, all risks related to quality of work shall be identified.
    ii. The risk identification should be done by brainstorming, research on the
    subject, interactions with interested parties or any other suitable means.
    iii. The following shall be taken care during risk identification
    a. The Risk should be practical or potentially real
    b. It should be related to the effect of not meeting customer requirements.
    iv. Each risk should be associated with an outcome(s) that is essentially related to
    not meeting a legal, business or customer requirement.

    B. Analysis & Evaluation of Risk


    i. All risks shall be analyzed by providing a rating to it in terms of probability of
    occurrence and severity of the outcome. (Refer Table A).
    ii. Controls on the risk shall be identified, if existing.
    iii. The risk shall then be quantified by establishing a mathematical product of the
    ratings of probability and severity.
    iv. The risk shall be evaluated in terms of being acceptable / not acceptable
    through reviews and comparison against agreed threshold of risk (Documented
    within the Risk Assessment Register) XXX/MR/RD/12.

    C. Treatment of Risk
    i. All risks shall have suitable controls to have the overall risk level in acceptable
    range.
    ii. Wherever risks exceed acceptable range suitable actions / controls shall be
    established and implemented within specified time frame to control the risks.
    iii. Where no actions can be taken due to any constraints (technical, feasible or
    others) the same shall be documented within the risk register.

    PREPARED BY: ISSUED BY:


    LOGO LOGO
    ORGANISATION NAME

    Doc. No. XXX/MR/SOP/03


    TITLE: PROCEDURE FOR RISK ASSESSMENT Rev. No. 00
    Date.
    Quality Management System Manual Page No. Page 2 of 3

    D. Review of Risk
    i. As a minimum, every six months the Risk Registers shall be reviewed to
    update them based on all inputs received over the period.
    ii. These inputs shall include non-conformities, customer complaints and other
    suitable sources.
    iii. The risks shall then be updated suitably in the Risk Register and appropriate
    actions taken.

    E. Opportunities
    i. Every six months each Function Head shall establish any opportunities that
    may arise and review whether any actions can be implemented to integrate
    them into the QMS.
    Such actions shall then be planned, executed and monitored for effectiveness and
    detXXXs shall be recorded in the Management program.

    Table A

    1 - Low (May occur rarely / control is very good)

    Probability of 2 - Medium (may occur occasionally / control may be


    Occurrence of Risk weak )

    3 - High (may occur regularly / control is ineffective)

    1 - Low (minor setback / discomfort / non financial loss


    etc.)

    Severity of 2 - Medium (significant operational / reputational /


    Consequence contractual impact etc.)

    3 - High (legal / customer Dissatisfaction / major


    financial losses etc)

    P x S (Refer Risk Analysis Matrix)


    Minimum = 1 x 1 = 1
    Risk No Maximum = 3 x 3 = 9

    Max 6 is acceptable (This could be jointly decided by


    Acceptable Risk the management)

    PREPARED BY: ISSUED BY:


    LOGO LOGO
    ORGANISATION NAME

    Doc. No. XXX/MR/SOP/03


    TITLE: PROCEDURE FOR RISK ASSESSMENT Rev. No. 00
    Date.
    Quality Management System Manual Page No. Page 3 of 3

    Risk Analysis Matrix

    Probability

    1 2 3

    1 1 2 3

    2 2 4 6

    Severity 3 3 6 9

    Low Risk

    Medium Risk

    High Risk

    PREPARED BY: ISSUED BY:

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