Findings from internal audits

NdumisoN

Starting to get Involved
Greetings, our internal audits have revealed several minor findings lately. As per our procedure, all internal audit findings should undergo corrective action. Nevertheless, if a finding can be addressed with a correction action, I am curious to know if ISO 13485:2016 requires the initiation of the full corrective action process.

Step 1: Define the Problem. ...
Step 2: Establish the Scope of the Problem. ...
Step 3: Take Containment Actions. ...
Step 4: Find the Root Cause of the Problem. ...
Step 5: Plan Corrective Actions to Fix the Root Cause. ...
Step 6: Implement the Corrective Action Plan.

Is it possible for you to Stop at step 3?
 

Ed Panek

QA RA Small Med Dev Company
Leader
Super Moderator
Depends what your SOP states. We only perform CAPA for Major or above.
 

Quality-Nation

On Holiday
I’d suggest it’s nothing to do with a “grade” but the nature of the finding and management’s understanding of the need for action which is most important.
 
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