4.2.3 (b) Control of Documents

[RCW]

I need to get some ideas on what others are doing out there to address the "to review and update as necessary and re-approve documents" section of 4.2.3.

I have mixed feelings regarding this one. It makes sense to occassional review procedures and work instructions. Are their better ways to perform a task? Is better equipment available now to help? Questioning the process could possible improve it.

BUT the problem I have is drawings and bill-of-materials. For example an angle bracket with three holes in it will most likely never change. Pieces and parts would rarely change in products that have been fabricated for years on end. If change is necessary, the drawing would go through the normal Design review - document change procedure.

Any opinions or suggestions out there?

Could I word my procedure to state that re-approval applies only to procedures and work instructions and not to drawings and bill of materials? Or would I get nailed by Da' Man on this one?

 

[Mike S.]

Since the std. says "review and update as necessary" YOU define what is necesary in your business. Do what works for you. That's my take anyway.

 

[JRKH]

Agree with Mike. You have a lot of leeway. Plus you are probably doing a lot of it anyway. When an order comes in you "review" it. If the order is for the same part at the same rev level, no further review is necessary.

James

 

[E Wall]

My take....Re-approval is only necessary if you update the document; however, some record should be maintained to identify who reviewed what documents (most frequent question I have experienced is - How is that person related to the process and are they authorized to request changes to the document). Even if it just a list identifying who performed review and a yes/no box if any changes were needed. If a change is needed it should be processed by your procedure to handle this.

 

[JodiB]

In the doc control procedure that I wrote for our upper level procedures, forms, etc. I said that documents which had not been reviewed/revised within the previous 12 months would require a formal review for continued suitability.

This won't have to apply to our drawings because our design process will have its own doc control procedure and the design group can spell out whatever terms they wish. I didn't want to try to address every kind of doc control within a single procedure so there are several processes that will have their own procedure/work instruction for the handling of revision control, review, etc. So what I'm getting at is that I don't see any problem with you stating in your procedure that it only applies to procedures and work instructions. That is exactly what I did - and pushed it off into another procedure to cover.

But if you don't have something documented for your drawings with regards to review (whether in the one procedure or more than one) then yes Da Man will get you. Don't just say that your doc control procedure for review and reapproval only applies to procedures and not give info on what you do for drawings. This isn't a procedure that can be given to an assessor verbally. It has to be in writing. If you have two different review mechanisms then simply say that number 1 applies to this and number 2 applies to that.

 

[Anton Ovsianko]

RCW,

I either see no problem in this case. You have to keep your QAS effective, your documentation reflecting what is happening or has to be happening in reality.
My approach is that you do not necessarily have to review each document regularly, unless there are reasons for that. A reason could be an improvement of change in a process described, a decision on need to document a process (previously not documented), changes in policies etc.

My basic idea is that documentation is merely a reflection of reality - processes implemented, policies applied, standards to comply to etc. So, you only change it if the reality requires it.

Of course, there may be situations when a scheduled regular revew of ducumentation is relevant. For instance, if some of the ducuments are not used constantly and may become outdated unnoticed. But then there is a question: are these documents are really necessary; and another question: does the company really manage and control change?

MHO

Anton

 

[M Greenaway]

RCW

I would interpret the 'as necessary' statement as only having to review, update and re-approve documents when things actually change.

I think the concept of scheduling reviews of documents is unnecessary and a waste of effort, and is not a requirement of the standard - as such you can not get nailed on this.

 

[JodiB]

The issue is not whether reviews are "scheduled", it is how the review and reapproval is carried out and how then to document it. If the company conducts reviews on the basis of a "kicker" such as a change in process, etc. then that is what is written in the doc control procedure. What you will be nailed on is not having this in place.

BTW, regarding the scheduled reviews.....as Anton pointed out, if a doc has been hanging around for awhile without being really looked at then it may be considered an unnecessary doc. The point of scheduled review is to look at all docs, such as these, and determine if they are still suitable. Reapprove them if it is determined that the doc is still a good idea and still the way the process is carried out -no matter how infrequently. Revise them if needed. Remove them from use if archaic. This house-cleaning is an important part of overall doc control and should not be neglected. An assessor I know HAS written up clients for not incorporating this function into their doc control program.

(As an aside while I'm on the subject of old docs and whether they are actually necessary, given that they haven't been used in quite some time.....Isn't one of the qualifiying factors for whether a documented procedure is needed, the frequency with which a given task may be done? That infrequent tasks would need instruction since they are out of the ordinary. )

 

[Anton Ovsianko]

Lucinda wrote:

"...Isn't one of the qualifiying factors for whether a documented procedure is needed, the frequency with which a given task may be done? That infrequent tasks would need instruction since they are out of the ordinary. ..."

It may be true, Lucinda. We should not consider a doc unnecessary merely on the basis of it not beeing used or looked at. And I did not ever say it. This fact may be a basis for reviewing of the doc. including the analysis of its necessity.

Probably, the easiest way to do it is carry out the document review within the frame of internal audits. You usually start an audit reading documentation concerning the processes or functions in question. The documents are selected for this purpose according to a master list or a catalogue, which contain all the existing documents. During an audit you may check whether the docs are used; if not, whether they are necessary; if yes, whether they are adequate and comprehensive.

That's my view.

Regards,

Anton

 

[Laura - 2003]

Our assessor (pre me working here) actually told us that we should schedule formal reviews for our procedue, despite already making provision in our quality procedures.

His suggested method was to have a review date in the footer of the procedure with the release date ofthe procedure (of course ) and the review date, which should be around 12 months on.

If the procedure is amended in anyway, then the review date is changed to be12 months on from the new release date.

This has sort of worked in that we have come to a time when a bulk of procedures that was written this time last year need to be reviewed.

This review has fallen on the head of the responsible owner, who, chances are hasn't even looked at the procedures since they were written. Now, the owner is not happy that the review has to be done.

This has worked for me becasue, since I started here, I've been banging in to anyone who will listen that we have far too many procedures. Luckliy, we have an electronic system, because if we were paper-based we would have killed a large part of the rainforest by now.

So, by making people do the review, they realise 'Oh, perhaps we don't realy need the procedure that tells us what we do when we need to have a p***.'

I'm meeting with the owner of the procedures next week where I'll be recommending they look to either make the procedures into work instructions or get rid altogether!

I think, however, that this method of review will need to be scrapped after I've accomplished my objective and do it slightly differently.

L