ISO 14644-5 section C3 - ISO Class 7 question

J

Jshene

ISO 14644-5 section C3 states:

Personal items should be left outside the cleanroom In a secure area. Jewelry, such as rings, watches, and chains, can puncture cleanroom gloves or dangle outside facemasks, hoods, or sleeves of the clothing and should be avoided.

My question/ argument is...

I created a procedure for our new clean room currently producing medical devices that says no personal items, jewelry rings watches etc.

I am getting a lot of opposition from management... Arguments consisting of what if people are married and wedding rings that people don't want to take off blah blah blah,
My position is that I am not concerned if someone is married or not... My job is in the best interest of the customer and the quality of the product. Also ensuring our operations are in compliance with the standard.

Any thoughts on this?

Much appreciated!!
 

Ronen E

Problem Solver
Moderator
Re: ISO Class 7 question

ISO 14644-5 section C3 states:

Personal items should be left outside the cleanroom In a secure area. Jewelry, such as rings, watches, and chains, can puncture cleanroom gloves or dangle outside facemasks, hoods, or sleeves of the clothing and should be avoided.

My question/ argument is...

I created a procedure for our new clean room currently producing medical devices that says no personal items, jewelry rings watches etc.

I am getting a lot of opposition from management... Arguments consisting of what if people are married and wedding rings that people don't want to take off blah blah blah,
My position is that I am not concerned if someone is married or not... My job is in the best interest of the customer and the quality of the product. Also ensuring our operations are in compliance with the standard.

Any thoughts on this?

Much appreciated!!

In principle you are right and the standard is very clear.

But...

We are dealing with people here. If you pose requirements that are perceived as unreasonable or outrageous to the average employee (and let's not forget that most of them are not quality gurus :)) you will get enforcement issues, guaranteed.

In a company that I worked for the policy has been wedding rings are the only exception, and that was conditioned that they are plain, with no sharp edges. It was the shift supervisor's responsibility to verify compliance, and I never saw or heard about any deviations (mind you, I was in quality and not routinely present on the production floor).

I think that in the facilities used for aseptic packaging (within the general cleanroom) even wedding rings were not allowed, but I can't remember for sure. Only very few workers would enter those rooms, and only after completing thorough training. Working there posed some very strict procedures that went much further than taking off all jewellery, in terms of burden / inconvenience. Workers beginning to train for working in these facilities were made aware of them all in advance, and have expressed their consent before proceeding. Normally, it was only offered to more experienced staff, already known as ones with the right attitude to GMP. I think it was associated with a pay raise so it was made attractive, and workers took care not to lose this position. Workers in those special facilities were routinely audited (internally) so it was quite easy to timely detect deviations in that regard.

:2cents:

Cheers,
Ronen.
 
J

Jshene

Thank you for the reply!

I understand dealing with people haha not so easy! I guess I will present this to management again and see what they are deeming "acceptable" and write it in to the procedure that way.

It's just frustrating for management to criticize a procedure when in fact they do not know what the standard says :) and then it will be me arguing the point in an audit someday.... But that's life :deadhorse:
 

Ajit Basrur

Leader
Admin
Its been practised in Pharmaceuticals and some other industries for a long, long time ... I do agree that you would meet a stiff opposition but its a standard requirement and has to be followed.

I liked when you said, "My job is in the best interest of the customer and the quality of the product. Also ensuring our operations are in compliance with the standard" :)
 

qusys

Trusted Information Resource
ISO 14644-5 section C3 states:

Personal items should be left outside the cleanroom In a secure area. Jewelry, such as rings, watches, and chains, can puncture cleanroom gloves or dangle outside facemasks, hoods, or sleeves of the clothing and should be avoided.

My question/ argument is...

I created a procedure for our new clean room currently producing medical devices that says no personal items, jewelry rings watches etc.

I am getting a lot of opposition from management... Arguments consisting of what if people are married and wedding rings that people don't want to take off blah blah blah,
My position is that I am not concerned if someone is married or not... My job is in the best interest of the customer and the quality of the product. Also ensuring our operations are in compliance with the standard.

Any thoughts on this?

Much appreciated!!

I personally think that the rings with smooth surface could be allowed because they do not puncture the cleanroom gloves. Besides, I think that the secret is in the people awareness with respect to their behavoir , paying attention to small thing such as cover the watch with gloves.
Suggestion is to involve personnel personnel in procedure improvement with their own suggestion .
 
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