CAPA Audit Checkpoint

CAPA Audit Checkpoint

 

 

  • How many corrective actions / Preventive actions have been initiated through the period?

  • How many are corrective / preventive action still open?

  • How long have corrective / preventive action been open? Is there any over due dates?

  • Is there a documented procedure for corrective actions / preventive actions?

  • How nonconformities are identified and reviewed, nonconforming product/process reports, customer-returned product, product returned for servicing, customer complaints, etc.?

  • How are causes determined? Are they documented, if documented which form? Is there form is controlled?

  • How the need for corrective actions / preventive action is determined?

  • How are the required actions determined and recorded?

  • Are corrective / preventive action followed up and are their results recorded?

  • Are corrective / preventive action reviewed? When the last management review meeting held? All the CAPA concern review is done? Is there any records?

  • How many preventive actions have been initiated through the period?

  • Are they distinct from corrective actions? How?

  • Is there a documented procedure for preventive actions

  • How potential nonconformities are determined, quality performance trends, customer complaints, service records, etc.?

  • CAPA form & procedures are verified by competence person? Is all requirements are covered in verification format?

CAPA audit Checklist points

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