We talked about CAPAs arising from both product and process.  Let’s point out just a few actual sources where Corrective Actions or Preventive Actions can arise.

• Customer complaints – probably the biggest source for product CAPAs. If the complaints are repeated failures, there may be something causing the issue that is likely to recur.  If users are reporting difficulties using the system, the instructions or training may be the cause.
• Yield rates – probably the biggest source for CAPAs arising in manufacturing. As mentioned previously, if there are frequent excursions from process limits, there’s likely a systemic issue.
• Internal or External Audits – probably the biggest source for identifying the need for process-related CAs or PAs.
• Employee feedback – a great source for process issues, product improvements that could prevent problems in the field, etc.
• Vigilance – if your company is making products and there are similar products on the market but have never had any complaints, you can still monitor those other products for issues that may arise with your product. Take the infusion pump problem mentioned previously: if your pump doesn’t have free-flow protection, you’d certainly want to initiate actions to eliminate this now that you’ve learned of it occurring even though it’s in a different product.  Same with the endoscope problem – even if you have a different type of endoscope, you should assess whether your cleaning procedures for yours are adequate.