Brain drain


Laura - 2003

OK peeps, once again the LAu needs your help.

I've just attended a pre-audit meeting.:(

They have four quality procedures and it was suggested that one of the procedures should not be audited because it was written in anticipation of something that is planned to happen and it hasn't happened yet.

I say the procedure should never have been published if this activity hadn't even happened, how do they know that the procedure is correct if they have never done it?

I say the procedure should have been documented as the activity happens (if it ever does). Alternatively, if the procedure had to be documented before the activity occurs then surely the procedure should be tested against the activity prior to publication.

A debate ensued as to whether an n/c should be raised against the procedure. Surely yes, b/c the activity hasn't even happened so there is no evidence that they are acting in accordance with the QP. I can't endorse compliance if they haven't even done the activity yet can I?

OK, boys and gals, I leave this one up to you!

:frust: :frust: :frust:




IMO, I would raise it as an observation the first time.

Best Regards,
Hank Fowler

E Wall

Just Me!
Trusted Information Resource
Catch 22

Lau...As described, I'd have to say that to me this is one of those damned if you do, damed if you don't situations.

My preferred approach is this for implementing a new procedure:
1. Identify what you 'believe' are the critical components.
2. Document and draft a guideline of what must be done, of course leaving room for logical discussion and real-time decision making if there was an error/miscaculation in the planning stage that nullifies a component.
3. Issue guidelines, providing contact listing as needed, under a deviation to be use the first time the procedure is needed. The deviation should direct WHO is to do WHAT and WHEN, including following the guideline, recording actual activities, and submitting data for review.
4. Review the information collected with all relevant parties...what they call in the 2000 version 'stakeholders' include reps from mgmt, supv, qa and operators. Tweek the procedure having it prepared and ready to issue under a deviation for the next time the procedure is used.
5. After repeating steps sucessfully, consider whether it is ready to be published as is, knowing that changes can be made if needed at a later date.

Personally, if the choice is having a unproven procedure or no guideline at all...I'll take the procedure! The key is to work together to fine-tune it for its intended use.

Best Regards, Ei

M Greenaway

Hmmm a bit like the old chicken and egg.

What would you have done if they were performing an activity that they hadnt written a procedure for ?

Both things cannot happen instantaneously.

What clause of the standard would you have cited your NC against ?


Your company?


I assume that this is Internal Auditing. We have the same thing. Procedures have been written referencing other procedures and documents that are in the draft stage. Audit them, write them up and practice your Corrective Action Procedure. It's all practice for the real thing. I get written up for using documentation that we are in the process of making "official". I like it because it means that our auditors know the difference. Nothing personal. Go for it, Fishergirl!
:biglaugh: :ko: :smokin:


No finding. Don't audit to a procedure that isn't implemented. They have just prepared instructions-guidelines-procedures for when the new procedure IS implemented. If the existance of the procedure bothers you then ask for the timetable for implementation and schedule the audit for after that.

We're going to follow the same route that Eileen mentioned; our procedures are already written so that people will know how to do this new thing and released as "draft review". There is nothing that says you can't operate under draft procedures. After kinks are worked out, they are released for "real".

And like energy, in these new procedures we have references to other new procedures that (at this time) are either not written or are still in draft or draft review themselves. What else can you do? You have to start somewhere....



Originally posted by Al Dyer
How about a wrtie-up under 4.2.3 Control of Documents??

That's exactly what we have done. It also forces you to get on the stick in regards to releasing the documents. You get practice in issuing CAR's and measuring "effectiveness". It's like a scrimmage in a football game. And, this is a game. Yes, it is. You know it is. Uh Huh. Yup.:biglaugh: During an interview with a possible Registrar, he expects to see a lot of CAR's during this getting ready process. A lot of em! Over time, they expect to see a decline as procedures take hold. This type of n/c is like a memorandum reminding employees that we have a system and we better start following it! No biggee! :ko: :smokin:

M Greenaway


The control of the procedure wasnt the problem, it was that there was a procedure for an activity that didnt exist.

Laura - 2003

Cheers peeps!

Thanks all,

You've clarified a point for me which got lost in the heat of a debate with people who digress and stray from the can see why I got confused.

MG: I was gonna non-conform them for not doing what their procedure says they were doing because their procedure said they were doing something they weren't doing because they hadn't done it yet! Take a breath, bird

They way I see this should be done is that you document an activity and then test the activity and procedure together, and tweak both until they both work. The 'testing' itself is conducted under audit conditions.

I'm gonna go with Eileen, NRG (Fisherboy!) and Lucinda on this.

Keep 'em coming!
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