Blank Fields on CAPA Form

Bill Levinson

Industrial Statistician and Trainer
#21
There is no documented requirement specifically requiring all fields to be filled out. The CAPA procedure does require the due date to be entered.
I was told (long ago, when working in a then-QS 9000 system) that a blank space in a form (subordinate or 4th tier document) is an implied instruction to do something, and it cannot contradict the controlling procedure (2nd tier) or work instruction (3rd tier). If it does contradict the superior document, there are 2 different ways to do the job which is a nonconformance. In this case, if the CAPA procedure does not require the due date to be entered, there should not be a place for it on the form (which is an implied instruction that it is required).

The same principle applied to a visual aid for a job; the visual aid (subordinate document) could not instruct somebody to do something not in the work instruction. In addition, subordinate forms and visual aids were supposed to reference their controlling procedures and work instructions from which they derive their authority.
 
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Al Rosen

Holed-up in a Hotel in South Florida
Staff member
Super Moderator
#22
Blank fields raise the question of, was it missed/over looked? Good quality records procedure does not allow blank fields. If it is not applicable, it should be identified as such along with the reason. Just my :2cents:
 
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