60 lines
No EOL
2.2 KiB
ReStructuredText
60 lines
No EOL
2.2 KiB
ReStructuredText
Corrective Action Procedure
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---------------------------
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.. impl:: Maintain a Corrective Action Procedure
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:links: R_APPB_76
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Since Corrective Actions are directly mentioned in AppB, it's wise
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to have a very clear and direct procedure defining how it will
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be done.
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Measures shall be established to assure that conditions adverse to quality, such
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as failures, malfunctions, deficiencies, deviations, defective material and
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equipment, and nonconformances are promptly identified and corrected.
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Corrective Actions are designed to assure that conditions adverse to quality
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are promptly identified and corrected. Such conditions may include:
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* Failures
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* Malfunctions
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* Deficiencies
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* Deviations
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* Defective material
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* Defective equipment
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* Nonconformances
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.. graphviz::
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digraph G {
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Anyone [label="Anyone",color=green,shape=circle]
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Identify [label="Identify condition \nadverse to quality",shape=box];
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Create [label="Create CAQ ticket",shape=box];
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Notify;
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Classify [label="Classify significance"];
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Significant [label="Significant condition\n adverse to quality?",shape=diamond]
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Cause [label="Determine the cause"];
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Preclude [label="Do Corrective Actions \nto preclude repetition"];
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Stop [label="Close ticket\n and stop",color=red,shape=circle];
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Document [shape=house];
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DCause [label="Document cause \nof condition",shape=note];
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Action [label="Document actions\ntaken",shape=note];
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Report [label="Report to \nappropriate management"];
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Anyone -> Identify -> Create -> Notify -> Classify -> Significant;
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Significant -> Cause [label="Yes"];
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Cause -> Preclude -> Document;
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Document -> {DCause, Action} -> Report -> Stop;
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Significant -> Stop [label="No"];
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}
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In the case of significant conditions adverse to quality, the measures shall
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assure that the cause of the condition is determined and corrective action taken
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to preclude repetition.
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The identification of the significant condition adverse to quality, the cause of
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the condition, and the corrective action taken shall be documented and reported
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to appropriate levels of management. |