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Projects in the CAPA system

contigo123

Starting to get Involved
#1
Hello! We would like to start using our CAPA system to track some of our bigger projects, so that we can keep track of due dates, etc.
My question is, for a project such as revising procedures and processes to meet an updated ISO standard, would you consider that a corrective or preventive action? We are an ISO 13485 medical device manufacturer.
Thank you!
 
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Jim Wynne

Staff member
Admin
#3
The reason for your dilemma is that you're trying to put a round peg into a square hole. What you need is some form of project management software, be it a dedicated software package or a well-crafted spreadsheet. In my own view, corrective and preventive actions should be kept separate as they are in entirely different categories, but to try and shoehorn project management into the system is entirely inappropriate.
 

contigo123

Starting to get Involved
#4
The reason for your dilemma is that you're trying to put a round peg into a square hole. What you need is some form of project management software, be it a dedicated software package or a well-crafted spreadsheet. In my own view, corrective and preventive actions should be kept separate as they are in entirely different categories, but to try and shoehorn project management into the system is entirely inappropriate.
Yes, I agree, but we are a small company with limited resources. I can also create a project plan and then execute and document as a report, but I wanted to put it into the QMS somehow. Thanks for the input!
 

Johnnymo62

Haste Makes Waste
#5
I had a COO that directed a company I used to work for to use an APQP project if we were going to be spending $5000 or more. He wanted to ensure the cross functional team was reviewing the project at every phase. We even used the APQP process to decide and then launch our office upgrades.
 

Ed Panek

QA RA Small Med Dev Company
Trusted Information Resource
#6
You are following your QMS> Likely in your quality manual you state you review regulatory requirements and keep them up to date. These would be routine QMS changes.

Add the item to your quality plan as a task. Open a QMS Change, title it "Updates to QMS documents, forms and procedures to align with ISO XXX," rev all the items with the required changes, review old/new risks and release them. Train, etc. Done. An auditor is not likely to look in your CAPA log to see if you are compliant with the ISO standard; they will start with your Quality Manual and go through your QMS overall.
 
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