posted 14 August 2000 03:23 PM               

The procedure must be controlled. As you stated, this procedure could be changed. But .... IMHO a procedure is useless if kept in a binder on a manager's desk, or on a computer that is not accesible to everyone. I think laminating and posting the procedure is an excellent idea. Now you need to find some agreement with the QA Manager on the control of this document.

posted 14 August 2000 05:36 PM               

What i use when i need it...is a tag/label that identifies the document the posting is from, and the current revision level..and that no changes to that information occurred. that gets updated when the SOP does...IF there ever is a change to the gown up protocol...then the posted document will be changed....

Works for me for color coded blown up visual aides mostly, especially when the partial drawing does not show the doc # and rev level....but the principal is the same...just make it easy and do-able

the control belongs to the person that wants it up (ergo LOCAL)...they post it so they take ownership for reviewing changes to the document and updating teh label...and replacing it if needed.

posted 15 August 2000 06:10 AM               

I'll also have to agree with Carol, and would like to extend the discussion a bit.

This way of presentation makes the procedure far more accessible than a binder. Controlling it something else,however...

We have quite a few documents of this kind, and I'll admit that we used to have a very hard time controlling them. More often than not they proved not to be current versions and / or unauthorized copies.

This is no longer a problem: Every copy of a procedure has a registered owner. We make no difference between binders and wall posters in that respect. A database solved that problem.

We also have all procedures available on our intranet. This is very important as it has enabled us to reduce the number of paper copies significantly.

In short we are hard at work getting the relevant information to the right people, and at the same time getting away from the binder terror. It is admittedly simpler to spread binders all over the place, but this approach works far better for us.

posted 16 August 2000 03:37 AM               

Just how detailed do you go with controlling documents? The danger of not controlling is clear, the danger of over- controlling is also clear; people will be petrified of issuing notices/signs/instructions.

What i normally do is create something like a level 4 document called 'Help Instructions'. These fall outside the system and are not signed-off or approved. I just ask that people store them in one folder on a server, so that we can see which is the latest version.
It is amazing how quickly this fills up with useful goodies;
How to get a pool car out.
Which working clothers to wear-when.
How to fill out an expenses form.

Regards

------------------
Andy B

posted 17 August 2000 02:00 AM               

However the next question is what does actually affect quality? If we wanted to be pedantic we could say that everything in the end can eventually affect quality, even down to the use of pool cars.

I firmly beleive that such instructions do have a place and a useful function in 'De-Hasseling' an organisation by providing guidance on the simple annoying small things of working life.
A look through such a folder in the organisation where i am today shows such items as 'how to handle the introduction of the Euro', 'Installation of a new E mail software>' they received last month 'How to create a serial Newsletter' etc.
If i include these in a QMS as a normal controlled document, the system quickly becomes bogged down and unusable.

Yes the customers are happy, as they have a comprehensive system with levels of complexity according to the need, and yes the auditors are happy unless they see in this area any quality related instructions.

posted 17 August 2000 09:23 AM               

This is the heart of it. Where control lies is irrelevant - local or higher. In addition, it is not just whether it affects quality but to what degree (which is why I quoted Andy.

The importance of a document describing suit-up depends upon the specific situation. For example, what class clean room are we talking here? Class 10,000 (e.g www.carrenterprises.com ). Class 1000? (e.g. www.midamericaplastics.com )

I tend to go for the OJT in suit-up. Tell the folks what they need to wear and where and when. Suit-up isn't really that complex, in my opinion, that a planned layout of the dressing area cannot easily address. I think too much is documented, though, in many companies. If I was running a company and we had a clean room for certain processes I would want people working in there who didn't need an instruction at the door telling them how to suit-up. Initial instruction should be enough.

I have to vote for removing the instruction all together and addressing the issue through layout of the dressing area and OJT. Most of the nonconformances I have seen in suit-up were unrelated to the instruction - it was stupid stuff like wearing a mask on the chin for comfort (do it once and if no one complains just keep right on doing it if you want). Or not completely covering the hair. Or wearing makeup or perfume. Stupid stuff like these examples is mostly what I've seen. Sequence of what items have seldom been a significant problem.

But again, in my opinion many (most) companies go way overboard in what they document while doing little or nothing to enforce obvious infractions. I see this in reviewing forms quite often. It's supposed to be initialed and dated by people found that when they 'forgot' no one said anything. After that it's all down hill. I'm a democrat, but I will use a republican complaint: Enforce the rules you have (e.g. OJT compliance) before you draft and issue new rules to enforce (e.g. we need a work instruction on how to suit-up.).

Lastly - I must admit - I agree gowning procedures don't often change much. Unlike many procedures / systems (particularly in manufacturing) gowning is pretty basic and consistent with consideration to the class of clean room. I believe changes in gowning 'procedure' should be communicated during shift change or weekly meetings (depends upon how your company is set up).

posted 17 August 2000 09:48 AM               

"I'm a democrat, but I will use a republican complaint: Enforce the rules you have (e.g. OJT compliance) before you draft and issue new rules to enforce (e.g. we need a work instruction on how to suit-up.)."

Wow, did you hit the nail on the head!!!!!

posted 17 August 2000 10:24 AM               

Upper Management = Politicians

posted 17 August 2000 10:30 AM               

Regards

PS Am i developing a bad attitude? If so it must be all your influence

posted 17 August 2000 03:25 PM               

quote:

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complaint: Enforce the rules you have (e.g. OJT compliance) before you draft and issue new rules to enforce (e.g. we need a work instruction on how to suit-up.).

Lastly - I must admit - I agree gowning procedures don't often change much. Unlike many procedures / systems (particularly in manufacturing) gowning is pretty basic and consistent with consideration to the class of clean room. I believe changes in gowning 'procedure' should be communicated during shift change or weekly meetings (depends upon how your company is set up).

[This message has been edited by Marc Smith (edited 17 August 2000).][/B]

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If I am mis quoting you please let me know.

We are not drafting new rules to enforce, this was in place well before I startd working for my employeer.

Also I never said that gown-up procedures change on a regular basis, what I did say is that if they do change they need to be updated. The gown-up procedures are already in an SOP and have been for years. So if they change they procedure in place would needo be revised. If they are not controlled who is going to know that the changes are made or communicated.

posted 17 August 2000 04:05 PM               

My point is this: Stand back and ask yourself whether you need that procedure. Just because it's there doesn't mean its needed.

You say: "...Lastly it is very important that they follow the proper gown-up procedures..."

I agree that gowning is typically important. That doesn't make it a complex procedure requiring a work instruction (which is what a gowning procedure is). As I said in my post, if it was my company I wouldn't want people working in a clean room who needed an instruction on how to gown after they were instructed how to do it. I've been in many companies in many clean rooms (including medical device assembly clean rooms) and have never seen a seriously complex gowning sequence. Even 'space suits' aren't that complicated. With sub-levels it's a matter of layering sequence.

I liken this to the sign in the bathroom which says: "Wash Hands Before Returning To Work". If you truly need that sign even after you've told your employees, I'd say:

1. If it takes a sign to 'remind' your employees to wash their hands after using the restroom, you may want to rethink your hiring criteria for that position.

2. People won't pay attention to the sign if they didn't listen to you when you told them that is a company policy.

Just my opinion. You must remember I'm a documentation minimalist and am pro-OJT. I simply do not always agree with the level of documentation many companies produce. I believe many documents are unneccessary reactionary reflexes unrelated to solving the root cause of the problem that instigated the reaction to begin with.

You said: "...Also I never said that gown-up procedures change on a regular basis, what I did say is that if they do change they need to be updated...." Yes, to which I responded that these rare occasions can be easily dealt with in communication meetings. My response was in sympathy with the QA Manager who wanted to essentially demote or eliminate the document all together (or to me it sounds like this was the implication).

A last question to you: Is improper gowning a problem now? Can any nonconformances (other than to the gowning procedure its self) be traced to improper gowning?

posted 17 August 2000 11:59 PM               

We have a 35/350 clean room, and have recently revised the gowning procedure (yes we have one). People put their mask on at different stages of the gowning process, which in no way effects contamination, but is a nonconformance against the procedure.

Do we need the procedure? Probably not, as the people who work in there have been doing it for some time, and new people/visitors are taken through the process step by step (OJT).

Is gowning important? Yes.
Do people gown differently? Yes.
Do we have any contamination problems? No. If we did (reactive I know), we'd be looking at numerous things, including the gowning process.
Do we audit the process? Yes.

More important than the gowning procedure is going to the toilet first, so you don't gown up and get in there, only to find you're busting ................