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

[peter_traina]

I am with a new company that is Certified ISO 13485. Their 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"...?? Is this some new requirement that I don't know about? I know you must initial and date but, since when do you have to explain why you used "N/A"?? Thanks!

 

[liuyy]

See 4.2.2a) and 1.2 of ISO 13485:2003.

 

[Marcelo]

Generally, it?s a good practice to justify why things are non-applicable.

 

[Steve Prevette]

My last job in the Navy was in a torpedo maintenance shop. We would run into problems with QA Hold Points showing up with a penned in "N/A". This definitely caused us problems with paperwork reviews, and sometimes we would discover the QA Inspector did not buy in that the hold point was indeed N/A. The QA Inspectors all had stamps for when they annotated a QA hold point as complete. We eventually went to getting all the inspectors an extra set of stamps that said "N/A" along with their inspector number so we could at least be sure that the inspector was certifying the hold point was NA.

 

[Marc]

See 4.2.2a) and 1.2 of ISO 13485:2003.

I think 4.2.2 a) is only for stating exclusions to any part of ISO 13485 in the quality manual.

 

[somashekar]

I am with a new company that is Certified ISO 13485. Their 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"...?? Is this some new requirement that I don't know about? I know you must initial and date but, since when do you have to explain why you used "N/A"?? Thanks!

Hi Peter.
Since it is about your new company GMP procedure, it is entirely up to your company systems to have such conditions, and I am sure you have the necessary field in all such places to write the rational.
In any case the entry in any field will be a valid entry or a NO or a N/A depending upon what is requested to be input. As long as it makes a direct sense and meaning, the person who signs off will be responsible to explain (when necessary) why a field is N/A. Explaining "Why" within your procedure for any N/A is only bringing clarity.
Please tell me if you are following this in any of your external documents / formats that you are supposed to fill in and respond ?

 

[Marc]

It appears ISO 13485 doesn't require a written explanation, but I can see where a company may have identified putting in an N/A on a document (it's going to be on a form of some kind) without an explaination would be a risk, and as such they require it and ensure it's understood that it is company policy by putting it in their GMP procedure.

 

[peter_traina]

First, thanks to all of you who responded to my question!!
So, I want to clarify a little... The company added the requirement of adding an explanation each time "N/A" is used, based on the verbiage in 13485.
I believe, as Marc stated, "I think 4.2.2 a) is only for stating exclusions to any part of ISO 13485 in the quality manual" and "It appears ISO 13485 doesn't require a written explanation...", that the requirement to add an explanation each and every time you use "N/A" is a little much or a lot of overkill.
I do understand the reasoning when it pertains to an exclusion to the requirements of ISO 13485...that makes sense. As for the daily use in company forms and docs, it seems it's mostly self evident and no explanation is necessary...??

Thanks once again for everyone's input! This Forum has been my BFF for years and you guys (and gals) always come through for me!

Easy, Pete T.

 

[Marcelo]

As for the daily use in company forms and docs, it seems it's mostly self evident and no explanation is necessary...??

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...

 

[Steve Prevette]

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.