Any good examples of CAPA forms that include a risk based approach?

#1
I need help with coming up with an easy to follow CAPA form that meets the necessary requirements of the standard. Anybody have any examples? We are a very small business and the less complex the better.
 
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William55401

Involved In Discussions
#3
I have no forms. But, a good practice is to assess both product risk as well as QMS risk in your process. Keep these items separate to drive prioritization.
 

Ed Panek

QA RA Small Med Dev Company
Trusted Information Resource
#4
Classify it based on:

High Risk -

This change will impact a high number of users;

or impact a smaller number of users in a significant manner for the intended use of the device;

or this affects in any manner the safety of the device/device user.

Else; Low Risk

Something like this.
 

yodon

Staff member
Super Moderator
#5
Realize that risk, per the standard, "pertains to safety or performance requirements of the medical device or meeting applicable regulatory requirements." So my hierarchy is along the lines of the product risk rankings with regulatory folded in. I generally use: death (if you have a CAPA that deals in this, you probably have bigger issues), serious injury, non-serious injury / major noncompliance, inconvenience / minor NC, annoyance.

You can try to fold in impact to number of users (patients) but an annoyance that may affect a broad population would need to be lower on the risk scale than something that potentially causes death, for example.

Possibly the more challenging aspect than ranking the risk is how that affects the CAPA process. For High risk, for example, do you set a target of establishing the root cause(s) and defining the action plan for, say 1 week? Whereas low risk maybe gets 30 days? (Please avoid a pre-defined target closure period as you can never hard-code the time it takes to establish effectiveness.)
 

Bev D

Heretical Statistician
Staff member
Super Moderator
#6
Our system includes two elements of risk. We use it for both our quality system compliance (which includes USDA regulations, etc.) and our product quality performance. The vast majority of our corrective actions (8D) are for product quality simply because these are the higher risk (effect and actual occurrence or defect rates). We use a simple 1-5 scale - although a 1-3 scale might work for you - for severity of effect and then we list the actual defect rate.

The key we have found is to keep it simple, don't guess, and be honest in your assessment.
 
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