Blank Fields on CAPA Form

Marc

Hunkered Down for the Duration
Staff member
Admin
#11
It's not an NC unless a specific documented requirement wasn't fulfilled. What does your own internal documentation say?
Yes. The company's internal procedures should define exactly what is to be filled in on any form. Note that it can happen that a customer specific requirement could affect what is required in the company's procedure and form, and certain standards may have specific requirement(s).
 
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younggun007

Starting to get Involved
#12
You are auditing the Corrective Action process, not forms. If the missing data on the forms impacts negatively the effective operation of the CA process, the finding should definitely be reported as a nonconformity and acted upon, accordingly.
I agree, and not having the "due date" specified is against the procedure. I have issued a minor NC.
 

Jim Wynne

Staff member
Admin
#15
You are auditing the Corrective Action process, not forms. If the missing data on the forms impacts negatively the effective operation of the CA process, the finding should definitely be reported as a nonconformity and acted upon, accordingly.
What requirement would be cited as having not been fulfilled? No need for an NC if there is no explicit requirement. It would be a good idea, however, to suggest that the requirements be reviewed.
 

Golfman25

Trusted Information Resource
#17
I would do your company a favor and actually look at the effectiveness of the CAPA system. Are they hitting a good root cause analysis? Are they taking effective corrective actions? Are things progressing in a timely manner? Is it a consistent and sustainable system? Etc. If you came to me with a NC because someone left a field blank on a form, I would question your value. The form isn't the process.
 

Sidney Vianna

Post Responsibly
Staff member
Admin
#18
What requirement would be cited as having not been fulfilled?
If you are asking about an internally driven requirement that ALL fields in ALL forms have to filled out or N/A'ed, I guess very few organizations would have a requirement such as this. But, I repeat myself: the internal auditor is NOT auditing the form completion activity, he is auditing the CA process. Data capture, timelines, etc. are important for the PROCESS to function effectively. The overarching requirements from the QMS standard should have been made granular in the process definition of the company. I have no idea what the granular requirements for this organization are. But auditing the tree while the forest is on fire, does not add value.
 

younggun007

Starting to get Involved
#19
If you are asking about an internally driven requirement that ALL fields in ALL forms have to filled out or N/A'ed, I guess very few organizations would have a requirement such as this. But, I repeat myself: the internal auditor is NOT auditing the form completion activity, he is auditing the CA process. Data capture, timelines, etc. are important for the PROCESS to function effectively. The overarching requirements from the QMS standard should have been made granular in the process definition of the company. I have no idea what the granular requirements for this organization are. But auditing the tree while the forest is on fire, does not add value.
Excellent points Sidney. Yes the whole CAPA process was audited and reviewed for proper Root Cause identified and implemented. Also looked at preventive actions identified and follow up actions. All were good, some minor discussion points. The blank fields were observations on some of the forms and we are addressing with a NC since the due dates were missing.
 
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