Blank Fields on Manufacturing Work Instructions

[Matt Murdock]

We utilize a generic setup sheet( work instructions) for our machines. Some fields are not applicable for certain machines. Is it necessary for these fields to be identifed as "n/a" or can they just be left blank. This issue has causes us some confusion. Any input is greatly appreciated.

 

[Al Dyer]

Matt,

I don't see it as a major concern although it would be good to have a common methodology. Either on the form or corresponding procedure you could put some type of disclaimer:

ie

"All non-applicable fields must be filled in with N/A"

"Blank fields on this form are considered not applicable"

I think as long as there is a common understanding there would be no internal or external (registrar) concerns, if you can justify and document your position.

ASD...

 

[Dan Larsen]

Generally, I don't like blanks on instructional documents, but as Al mentioned just make sure your system is consistent and understood.

One other thought...you mention "confusion". It might be good to take a hard look at what's causing the confusion with a root cause analysis. Is the root cause a lack of uniform instructions or the presence of the blanks?

 

[Matt Murdock]

The confusion ( better term would be concern) relates to whether the blanks on these instructions can be viewed as a noncompliance by an external auditor.

 

[D.Scott]

Blanks are a big concern to our auditor. Sort of like the basketball ref who watches 3 seconds. We got a nonconformance for ONE. I don't like the idea of stating in the procedure that blank fields are to be considered as not applicable. What if the quality approval of set-up were left blank would it be not applicable? We are stressing that all blanks need to be filled in. If no data is applicable put N/A or - in the space. At least something to show it was addressed. BTW - has anyone else noticed that since "Concerns" were dropped, single observations have become nonconformances and "Opportunities" have become mandatory by next surveillance?