Why we need to use CAPA?

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Ask: I had already heard about this concept-CAPA for a while. I saw it in ICH Q10 and saw it in the FDA GMP. Is CAPA used to continuously improve the products quality? Is there any other reason for using CAPA in our practise? Re: I think that you miss the point. CAPA is corrective action/preventive action. You do it because you must make absolutely sure that if an unplanned event or deviation occurs, that you investigate it, that you find the root cause and you take action so that it will never happen again.You do not do it because it is in ICH-Q10, you do it because it makes sense. The title CAPA merely describes the two part of the activity. It does not tell you how to do it and there are a number of different approaches.CAPA isn't just a "nice to have" component of a quality system - it's probably the single most powerful tool available to you for quality improvement across the piste:i. Feed actions into CAPA from your deviation management system, from internal and external audits, from complaints, ...ii. Use a simple impact/risk assessment mechanism for prioritising the corrective and preventive actions that have been identifiediii. Establish follow-up to make sure that appropriate actions are implemented in a timely fashion, and are effectiveiv. Set up sensible performance measures so that progress (or lack of it) is visible to everyone (including top management)The alternative is to respond repeatedly to the same problems, recurring regularly (because you've never identified and addressed root cause).  It's a very expensive, inefficient, alternative to CAPA - but if you like fire-fighting ...CAPA makes solid business sense. It prevents errors being repeated, and hence improves productivity and profits.CAPA also ensures patient safety by eliminating inconsistent and poor practices.CAPA is part of Risk Management stated in ICH-Q9, and required by US + EU GMPs.Pick your choice of any, or all, of the rationales you prefer. The purpose of doing a CAPA and making a note of it in the system is to avoid reinventing the tyre and assisting everybody across the board to address similar issues and take effective actions.Everybody on a day-to-day basis makes improvements to or in their area of work. Systematically recording them and analysing the issues helps in improvement which is the be-all and end-all of all QMSs.These are monday morning musings so I might not be very clear in whatI am trying to say.

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