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

Marc

Hunkered Down for the Duration with a Mask on...
Staff member
Admin
#11
IMHO -- Typically:

Upper Management = Politicians

They rarely address the root cause. They typically address the symptom(s). And even when they address the symptom they quite often are far off base there as well. OOh well...
 
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A

Andy Bassett

#12
Dont complain too much Marc. That and unreadable standards probably keeps the likes of us in business.

Regards

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

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Andy B
 

Marc

Hunkered Down for the Duration with a Mask on...
Staff member
Admin
#13
I'm not really complaining. I can't even say this is fact. It is, however, my perception... And I do qualify with the word 'typically' as its not always the case. Just most of the time....

And you're gona blame me for bad habits you develop???
 
T

Tom W

#14
Documents need to be available where the absence could affect quality. Controlling the documents needs to be done. It can be done a hundred diffrent ways but, it should be done. Depending on your company how critical is the gown up process? Decide if done wrong could it affect quality? If yes then control a posting and update it as needed. I have seen where a list is made of all postings that are controlled with the revision level and serial number if applicable.
 
A

Aaron Lupo

#15
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]

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.

Lastly it is very important that they follow the proper gown-up procedures, since what they are doing is packaging sterile edical devices, unless of course you don't care if the Doctor uses a sterile device on you, I guess that would be your call.
 

Marc

Hunkered Down for the Duration with a Mask on...
Staff member
Admin
#16
You say: "...The gown-up procedures are already in an SOP and have been for years...." I'm sorry, but I don't buy the old "...we've been doing it this way for years so it must be right..." arguement.

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?

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

David Mullins

#17
Geez Marc, you do pretty good for an old bloke. Your last entry is not only on the mark, it was too close to home.

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 ................

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A

Aaron Lupo

#18
I have to laugh. I have watched employees miss the most basic things when they gown up i.e. wash hands first. You say would you want to hire someone who needs a procedure to follow on gown-up. Well I am in no way putting these employees down, but i do not think you are going to find rocket scientest to do the job these people are doing. They are not paid very well ( I think they make about $8/hour)

I do not belive just because we have the procedure that it must be right, but I do step back and ask myself why did they put this in place in the first place?? Then look at past history and see maybe there was a problem. Yes the employees have OJT as you like to say, but there is also a very high turn over rate. I personaly feel much more comfortable with the controlled sign hanging reminding people step by step on how to gown up. I also know that our customers feel much more comfortable with it this way also, and you know what they say "The Customer is Always Right".
 
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