CAPA Audit Checkpoint
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How many corrective actions / Preventive actions have been initiated through the period?
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How many are corrective / preventive action still open?
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How long have corrective / preventive action been open? Is there any over due dates?
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Is there a documented procedure for corrective actions / preventive actions?
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How nonconformities are identified and reviewed, nonconforming product/process reports, customer-returned product, product returned for servicing, customer complaints, etc.?
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How are causes determined? Are they documented, if documented which form? Is there form is controlled?
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How the need for corrective actions / preventive action is determined?
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How are the required actions determined and recorded?
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Are corrective / preventive action followed up and are their results recorded?
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Are corrective / preventive action reviewed? When the last management review meeting held? All the CAPA concern review is done? Is there any records?
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How many preventive actions have been initiated through the period?
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Are they distinct from corrective actions? How?
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Is there a documented procedure for preventive actions
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How potential nonconformities are determined, quality performance trends, customer complaints, service records, etc.?
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CAPA form & procedures are verified by competence person? Is all requirements are covered in verification format?
