Clean Room Gowning Work Instruction - Controlled Document or 'Guideline'?


Aaron Lupo

During an internal audit of one of our facilities I cam across something interesting. As I was doing the audit I cam across a page from one of our SOP’s which was so beautifully blown up and laminated. In short the section explained how the employees entering the room were to gown up (i.e. wash hands, put on hair bonnets, coats, etc…). So I checked the revision level that was on this page, then checked it against the actual SOP, and much to my surprise (not really) the nicely laminated document on the wall was a prior revision. When I pointed this out to the QA Manager she agreed that it needed to be removed (which it still has not been removed a month later), but then said well we can put them up as a guideline but leave the control off of it. Which to that I suggested that she not do that. First of all I explained to her that it is in a SOP, secondly it tells the employee what needs to be done, lastly I asked if you leave it up as a guideline with no control if any changes were made who would know to go change the “guideline”. Well she proceeded to argue that gown up procedures will never change they will always be the same. I politely said that gown up procedures may change they could become more or less stringent, and that if they do change that the “guideline” which would be uncontrolled would also need to be updated and revised according to our procedures. My question is am I wrong about wanting this to be controlled or can a guideline on gown up be left up?


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My thoughts on this....

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.

Good Luck and hope I didn't confuse the issue more.

barb butrym

Quite Involved in Discussions
the control needed is local control.

What i use when i need 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.

[This message has been edited by barb butrym (edited 14 August 2000).]
Yes I definitely think it should be controlled.

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.

/ Claes

Andy Bassett

I can agree with everyone on this, but at the same time i do have a certain amount of sympathy for the original problem, as i come across it regularly.

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.


Andy B

[This message has been edited by Andy Bassett (edited 16 August 2000).]

David Mullins

Your external auditors and consultant customers are happy with you creating uncontrolled guidance documents of this nature?
You might get the auditor to laugh a lot while s/he writes out the nonconformance. I'd say your only hope is to prove that not one of them (the examples you cited) affected quality. This being the case you might be confusing the less learned "quality person" as to what is allowable under the requirements.


Andy Bassett

Yes David - You are right, such instructions do need to be related to items that dont affect quality.

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.

Andy B

Aaron Lupo

I just want to say thank you to all that have responded so far. I would have to say that gown up procedures to enter a clean room would affect quality if not done properly.


Fully vaccinated are you?
"...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..."

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 ). Class 1000? (e.g. (broken link removed) )

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).

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


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"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!!!!!

How many times I have seen this occur where I work. Instead of enforcing what we have, upper management wants to create new rules.
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