Use of "N/A" in a Document - Is an explanation a requirement?

Marcelo

Inactive Registered Visitor
#11
Anyway, although I used the auditing as a justification, in my opinion it?s more important to the company that people do know what they are doing, including justifying why something is non-applicable. Recording it or not is less important than the knowledge.
 
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Marc

Hunkered Down for the Duration with a Mask on...
Staff member
Admin
#12
One more thought came to me from the past (working at the torpedo facility) - we pushed on the procedure writers to add when a step or signature would be applicable in the procedure itself rather than leaving it to the memory of the workers/inspectors doing the job, for procedures that could be N/A for the same reason on multiple occasions. Then if the procedure already had printed in it "applicable only to Type B parts" or "Not applicable to type D and E parts" then all you had to do was circle that statement and annotate N/A.
The main problem I see is, if it?s not recorded, and an auditor asks why, will someone be able to clearly justify? I see this every time in audits, people say something is not applicable, but when asked why, they tremble and gag and do not give an answer. To an auditor, this clearly smells like a good audit trail for more problems.

If you can guarantee that people can justify on the spot if asked for a rationale, surely you do not need to record. Otherwise...
Anyway, although I used the auditing as a justification, in my opinion it?s more important to the company that people do know what they are doing, including justifying why something is non-applicable. Recording it or not is less important than the knowledge.
I agree with all of the above. Just to add :2cents:

My first thought is to ask yourself how critical it is in your specific situation. In some cases, especially regulated industries, there is a potential risk factor *in some cases* where there is an NA in a space on a form without an explanation as to why it is NA. But then again, it may be that your company procedure for that form says a simple NA is OK without explanation.

In most companies I think allowing an NA is relatively standard on forms which are "multi-use". If the form is not for multi-use, that field would not be there to begin with.

Since you say your GMP procedure states that any time "N/A" is used in any document, it must be followed with an explanation of why the field is marked "N/A" it says to me that at some time someone in your organization, for what ever reason, put that clause in and probably did so because of a risk factor, real or perceived. Technically you should be able to track back through the change history of your GMP procedure to see when that clause was put in and by whom. Then ask the person for the reason for the clause.

Or in short - Someone in your company "owns" the company GMP procedure. Ask that person why that clause is there.
 

SRQAAuditor

Starting to get Involved
#13
Hi Peter,
So, the two medical device companies I have worked for have both had a document called Good Documentation Practice. That document is part of the documented quality manual, and has the requirement for proper use of "N/A".
 

SRQAAuditor

Starting to get Involved
#14
Hi Pete,
I have been with two medical device manufacturers. Both companies have had a Good Documentation Practice document, which states the requirement for giving an explanation when using N/A on quality records. Best of luck in your new company.
 
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