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    Deviations and Non Conformances SOP PDF

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    Deviations and Non Conformances SOP PDF

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    Deviations and Non Conformances SOP PDF

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    Quality Management

    Documents & Templates

    Deviations and non-Conformances


    • Prevent further deterioration and / or
    • Correct the event.

    7.5 Corrective Actions


    The corrective action is the action necessary to recover the product / process / material /
    system, affected by the deviation.

    7.6 Preventative Action


    The preventive action is the action taken to address the root cause of the deviation and prevent
    reoccurrence of the event.

    7.7 Trending of Deviations


    Deviations must be trended to detect/predict reoccurrence problems and to monitor the
    effectiveness of the implementation of the corrective actions. The frequency of the trend
    analysis and reporting must be at least monthly.

    8 PROCEDURE

    8.1 Deviation occurred


    After deviations has occurred discoverer (originator) takes action, where required, in order to
    contain the effects of the event (immediate action).
    The originator informs line manager or supervisor. Originator and supervisor determine if the
    event requires a deviation report. In doubt QA must be consulted.
    Discoverer (originator) records the details of the occurrence in the area logbook.

    8.2 Details of Deviation Section I (attached form)


    The Originator and line manager complete section I of the deviation form. All details of the
    occurrence must be recorded also in the area logbook. This includes the date and time that the
    observation was made, a description of the event (what happened, where and when).
    The immediate action that was taken to contain the event must also be documented.
    Identify all batches affected by the deviation, if applicable.
    Date and sign Section I (originator and line manager).
    QA assigns a unique deviation number added to the top of section I form (QA log file No).

    8.3 QA Confirmation Section II (attached form)


    QA records the date/time of the observation and a description of the non-conformance, together
    with any affected batch numbers (if applicable) in the log / database and confirms that in section
    II.

    Document Type Document ID Version Status Page


    SOP XX_WWW_ZZZ_YYYY 1.0 Approved 9/17

    Copyright © by QMdocs 2010


    Reproduction, photocopying, storage or transmission by magnetic or electronic means strictly prohibited by law. Neither the document
    nor the information contained therein may be reproduced or disclosed without written consent of QMdocs.

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