How do you improve or fix any issues that come up, either with the manufacture of your medical device or the device itself? Many people see CAPA as one of the most critical processes for medical device manufacturing, yet still there are several concerns with it.
Here are just a few we can highlight:
- CAPA may be overused, perhaps capturing too many things and creating a cumbersome process. This was not its intent.
- CAPA may be underused or treated as an afterthought, leaving the door open to any of a vast number of possible compliance issues.
- Lack of adequate documentation.
- Lack of adequate procedures.
Those last two points are a consistent theme with 483 citations logged for 820:100. You can view a list of citations on this page. CAPA issues are consistently one of the top reasons for 483 observations and warning letters from the FDA.
The key is that you need to prepare early. It shouldn’t be a surprise that you get a FDA inspection because that’s part of the whole deal when you get into the medical device industry. The FDA should be expected every two years if you’re manufacturing class II or III products.
You should operate with the idea that a FDA inspection could happen tomorrow. A common scenario is that a company does have some procedures outlined for CAPA, but perhaps they’ve simply regurgitated regulation, the policy is unclear and/or their procedures are burdensome to follow. This can lead to the “we have a policy, but we don’t follow it” scenario.
The company becomes reactive and tends to try to use their policy to fight the big, obvious fires, while neglecting the rest. What happens next? FDA arrives to inspect and a 483 is issued, or perhaps they even decide to issue a warning letter.
Another common scenario is where companies over-burden themselves by trying to include too many things as part of CAPA that aren’t necessary. An example could be simple changes needed to be made to the dimensions of a drawing. This is relatively minor and could be done via change management as CAPA is not required.
