CAPA and other Log Requirements

joemar

Involved In Discussions
#1
Hi Everyone,

I recently had an ISO 13485 Audit and the auditor gave me a Cat 3 finding (opportunity for improvement) that "The firm does not keep a traditional CAPA Log, but there is evidence of active tracking of CAPA performance both at management reviews and in Quarterly Data Analysis Reports."

This is true of us, we do track CAPAs and other type of reports in a quarterly meeting and the meeting notes, but we dont keep traditional logs. I was wondering, which documents do you keep traditional logs of?

Our auditor recommended at least:
(1) CAPAs
(2) Engineering Change requests
(3) Maintenance events
(4) Customer complaints

I am trying to consider what is useful to implement and what would just be a pain in the ass. Can someone give me their input on which logs they find useful and which are just more work and reporting than necessary? Is there anything you'd add or subtract to that list?

Thanks
 
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normzone

Trusted Information Resource
#2
Re: CAPA and other Logs

How modern is your system? Do you have a piece of software that automatically issues the next number in sequence for a CAR or an ECR?

Or is it " let me see, what was the last CAR number ? ... " The answer to that question determines whether it makes sense for you to keep a log.
 

joemar

Involved In Discussions
#3
Re: CAPA and other Logs

Paper system. No software (so yes, we look and say, "let me see, what as the last CAR number...").
 
Last edited:

Bev D

Heretical Statistician
Staff member
Super Moderator
#4
Re: CAPA and other Logs

why do you need to have a number for the CAR?
How do you know how many active CARs you have? How do you know what they are? How do you know who 'owns' them?

what will a log do for you that your current system doesn't?

In our system we have hundreds of active "CARs" at any time. no single person knows how many there are. nor does anyone really care. the really high risk ones are monitored by QA and they know which ones they are by their name. (the problem statement) and they are important enough that we know who owns them. we know how much progress is being made because we have regular update meetings and the right people are on the cross functional team. the same happens within every functional area. we don't even have a common storage location for the results, let alone a log.

If you have a healthy corrective action system, problems will be identified and solved as a routine manner. Areas that have a lot of problems (defects, waste, slow processes, late deliveries high customer complaints, etc.) are the areas that have a poor corrective action system. A log can't help you with that...
 

joemar

Involved In Discussions
#5
Re: CAPA and other Logs

I dont know that there is an absolute need to have them numbered. And you're right that different situations can necessitate different structures of ownership over them.

In our case, we are a small company and we only generate a few CAPAs a year. I think the recommendation was that of basic organization. Without a log, it's easier to forget one, or for it to just kinda vanish. We currently number them, but at times we find ourselves with two different CAPAs with the same number because someone was using the paper form of one while someone else was writing a new one. This isnt a huge problem and we correct it, but I can see the usefulness of a formal log. And it will help in closeouts too, as we can just look at the log and see what's upcoming, rather than going back to read through the entire list of CAPAs.

So I can see the value. Im just trying to understand how and when other people use logs so I can best understand what is worth implementing.

Thanks,
 

Ronen E

Problem Solver
Staff member
Moderator
#6
Re: CAPA and other Logs

they are important enough that we know who owns them.
I would suggest that those that aren't shouldn't have been opened in the first place. Not every problem identified justifies a corrective action.
 

TWA - not the airline

Trusted Information Resource
#7
I would add non-conformances to the list, however imho a log is mainly an administrative tool that can make your life much easier, especially regarding trending as part of keeping the QS effective...
 
#9
We have a log for CAPA's, ECN's, Customer Complaints, Maintenance, RMA's & NCR's and Quality is responsible for all except the ECN/s, which Engineering handles. All the logs are numbered by year and then number in that given year, ex: 17-001 etc. and hyperlinked to the form. All this information is provided to the management team monthly in a Quality Dashboard Report and also during the Management Review Meeting. Section 8.0 of ISO 13485:2003 covers this and doesn't change in ISO 13485:2016.
 
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