Informational MDSAP Audit Findings - Document change orders

Jean_B

Trusted Information Resource
Note I do mean capa as the full vehicle including problem definition, root cause analysis and action planning, not only the correction and corrective action.
Initiation is then problem definition being triggered within the capa process so it can be properly controlled and administrated instead of headless chicken behaviour with after the fact ratification and document scrounging.
Given the regulatory pressure to respond swiftly over quality, this is what you get. Just look at the tendency for such reports to use the simplest of RCA in depth and breadth, with sometimes ridiculously narrow 5-why being accepted or even preferred because it must be clear and agreed between not only your lead auditor but also peer reviewers hundreds of miles away. All while obviously fitting on an a4 sheet of paper, preferably no more than 2 sheets per nc.
 

Ronen E

Problem Solver
Moderator
"initiate CAPA's the day after the audit"

Nice to know that actions taken to address deficiencies critical to patient safety will be carefully thought through and not just slapped together. :sarcasm:
I don't see what's wrong with that. CAPA initiation can be a purely administrative action, and any real content may follow. It just means you set things in motion without procrastinating.
 

Ronen E

Problem Solver
Moderator
Note I do mean capa as the full vehicle including problem definition, root cause analysis and action planning, not only the correction and corrective action.
Initiation is then problem definition being triggered within the capa process so it can be properly controlled and administrated instead of headless chicken behaviour with after the fact ratification and document scrounging.
Given the regulatory pressure to respond swiftly over quality, this is what you get. Just look at the tendency for such reports to use the simplest of RCA in depth and breadth, with sometimes ridiculously narrow 5-why being accepted or even preferred because it must be clear and agreed between not only your lead auditor but also peer reviewers hundreds of miles away. All while obviously fitting on an a4 sheet of paper, preferably no more than 2 sheets per nc.
While I do get the general sentiment, let's please not forget that these are repeated NCs we're talking about. Had an org been honestly striving to resolve identified issues (no offence to anyone), these should be quite rare (understatement) to begin with.
 
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