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?