posted 15 August 2000 04:46 PM               

QUESTION: To what extent does this requirement apply to records that show which individuals are responsible for what inspection stamps when product release is conveyed via that stamp?

At our tier 1 1/2 operation, we had maintained lists of individual stamp authority as controlled records to provide accountability for tracing Customer Claims back to the particular inspectors who may need additional training or determine a pattern of dereliction of duty.

Based on a recent internal audit finding that these lists were not being accurately maintained as called out in the procedures, the audited party (hereafter referred to as 'victim') determined the fix to be removal of lists from the controlled records list and the procedures. Now, it's supposed to be just something that the supervisors maintain if they so desire as 'reference only'. In other words, now it's ok for it to be wrong because it doesn't really mean anything.

posted 16 August 2000 09:10 AM               

I take care of that specific requirements by defining responsebility in the job description. and in our Standard operating procedures.

posted 16 August 2000 11:48 AM               

If not, you don't comply.

posted 18 August 2000 09:37 AM               

Martijn -
When you say - "defining responsibility in the job description" - it sounds like you're listing the responsible function or position. We have a large facility and have multiple people at each inspection function so I'm of the opinion that a more person-specific record is required to tie it all together. Sound reasonable?

Brian, Paul -
Thanks for the support. I just wanted to find out some other QP opinions before I went to battle over this issue. I moved into this Audit Coordinator position from Process Eng and some of our 'Quality Professionals' are lacking somewhat in their confidence (or are trying to take advantage ).

I was also hoping to get one of our esteemed 'Cheech Wizards' to weigh in on this lowly subject (what can I say, I'm gunning for a slam dunk here ). Any takers?

posted 18 August 2000 10:20 AM               

You decide how 'precise' you want traceability to be - to an individual or to a departmental manager, for example. The requirement is to the authority, however, not the individual per se (someone has to ultimately take responsibility be it the individual or the departmental manager).

My opinion: Ditch the stamps, switch to initials and get on with your show. However - if you keep the stamps the wording of your procedure (with consideration of what you intend to achieve with the stamp) is what will define the details. It's your option.