Blank Fields on CAPA Form

younggun007

Starting to get Involved
#1
Hello all... I'm performing an internal audit (ISO 9001:2015) on Corrective Action system and found some CAPA forms missing due dates and some fields not filled in. Would you say this is a NC or a observation. Found 8 out of 20 with unfilled fields. Thank you
 
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L.Soad

Involved In Discussions
#2
Due dates seems kinda important for me on a CA form, it could be a problem when you have to « review the effectiveness of any corrective action taken» (10.2.1d).
I would consider this a NC.
 

GStough

Staff member
Super Moderator
#4
Also, if you are seeing unfilled blanks on forms used in other areas of your organization, this could be a NC under document/record control and/or record-keeping practices.
 

blackholequasar

Involved In Discussions
#7
To be safe, and as part of GDP, I would say if there is a blank line that does not apply then it should have an "N/A" or something to that effect to denote that data is not required. But I agree with @Jim Wynne -- if a requirement wasn't fulfilled, then it's not really an NC. (Though dates are pretty pertinent to CAPAs)
 

younggun007

Starting to get Involved
#8
It's not an NC unless a specific documented requirement wasn't fulfilled. What does your own internal documentation say?
There is no documented requirement specifically requiring all fields to be filled out. The CAPA procedure does require the due date to be entered.
 

Sidney Vianna

Post Responsibly
Staff member
Admin
#9
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.
 
#10
Forms which have been developed internally usually require information to be posted for a number of reasons: target completion dates, counts, trend analysis, reasoning for making decisions, etc. The value of having all this information is to perform data analysis down the line of the processes being performed and validating the QMS processes. If your review of other documentation reveals this is a trend, then you run the risk of short changing the effectiveness of the QMS and its processes. If the field information on the form not needed, then enter "N/A" in the empty field. At this point it may be an observation, but may result in a N/C if a trend is apparent.
 
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