Registrar Finding - Hair Nets and Beard Covers

R

rdesmond

#1
Hello! We just completed Stage I of our ISO13485 registration audit. We had one finding & I do not agree with it but want input. The short of it - we cannot have hair nets in our main mfg. area w/o beard covers. We have no cleanliness requirements. We do not have a clean room. Based on our experience, however, we find an improvement in particulate reduction with some minimal protection, including hair nets. I understand the path of least resistance is to just do what he asked, however I hate doing something just because an auditor said so. Although the write-up seems to give some options, he clearly told us, "you do both or none." If we can find perhaps a white paper & show our own justification (in addition to the documented procedures we have), I want to consider challenging this.

It was written up under Infrastructure section 6.3 which he quoted verbatim.

His 'details:' Documentation for controls over the equipment maintenance and the work environment incomplete or conflicting."

-"The posted procedure for personnel gowning shows a requirement for hair covers, but not any similar requirement for beard covers."

Thanks!!
 
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Randy

Super Moderator
#2
Re: Help Needed with Registrar Finding

Common sense...What's the purpose of the hair covers if they are not required?

If you're trying to prevent "hair" from getting into anything with a hairnet, and a beard is made of "hair" your auditor is politely saying "DUH"

Either change your procedure and eliminate the hairnet or include the beard cover, one or the other....Apparently it's your decision, so make it
 

Jim Wynne

Staff member
Admin
#3
Hello! We just completed Stage I of our ISO13485 registration audit. We had one finding & I do not agree with it but want input. The short of it - we cannot have hair nets in our main mfg. area w/o beard covers. We have no cleanliness requirements. We do not have a clean room. Based on our experience, however, we find an improvement in particulate reduction with some minimal protection, including hair nets. I understand the path of least resistance is to just do what he asked, however I hate doing something just because an auditor said so. Although the write-up seems to give some options, he clearly told us, "you do both or none." If we can find perhaps a white paper & show our own justification (in addition to the documented procedures we have), I want to consider challenging this.

It was written up under Infrastructure section 6.3 which he quoted verbatim.

His 'details:' Documentation for controls over the equipment maintenance and the work environment incomplete or conflicting."

-"The posted procedure for personnel gowning shows a requirement for hair covers, but not any similar requirement for beard covers."

Thanks!!
To exapand a bit on Randy's observation--that if you're trying to prevent hair getting into stuff, you should be consistent about it--you say "...we find an improvement in particulate reduction with some minimal protection, including hair nets..." It seems to me that you need to (a) decide if the improvement in particulate reduction is worth the trouble, and if it is, (b) you need to actually justify, with data, the lack of need for beard covers. In other words, before anything else you need to establish a reasonable threshold for particulate contamination, then decide what's necessary to remain at or below the threshold.
 

somashekar

Staff member
Super Moderator
#4
Hello! We just completed Stage I of our ISO13485 registration audit. We had one finding & I do not agree with it but want input. The short of it - we cannot have hair nets in our main mfg. area w/o beard covers. We have no cleanliness requirements. We do not have a clean room. Based on our experience, however, we find an improvement in particulate reduction with some minimal protection, including hair nets. I understand the path of least resistance is to just do what he asked, however I hate doing something just because an auditor said so. Although the write-up seems to give some options, he clearly told us, "you do both or none." If we can find perhaps a white paper & show our own justification (in addition to the documented procedures we have), I want to consider challenging this.

It was written up under Infrastructure section 6.3 which he quoted verbatim.

His 'details:' Documentation for controls over the equipment maintenance and the work environment incomplete or conflicting."

-"The posted procedure for personnel gowning shows a requirement for hair covers, but not any similar requirement for beard covers."

Thanks!!
You seem to have dug it yourself, for some reason.
He is just telling you now dig better.
 

ScottK

Not out of the crisis
Staff member
Super Moderator
#5
I agree with the auditor in that it's a conflict.
Every place I've worked or visited if you have hair nets, you have beard nets too.

And we can even dig a little deeper and require long sleeves to cover arm hair... so most often in my device, drug, and food experience - if hair/beard nets are required, so are lab coats or uniforms with long sleeves.
 
I

isoalchemist

#7
I'm going to be a contrarian here. If there are no requirements for product protection and a company decides on a policy an auditor should not have the right to claim it is insufficient or conflicting unless they can point to a regulation.

I agree with all the statements about best practices, but I was in a similar situation where an auditor thought something more was required until they were walked through the science and why what their past experience and viewed practices were not applicable.

Unless the auditor can pull up a regulation ISO 13485 does not require it.
 

Jim Wynne

Staff member
Admin
#8
I'm going to be a contrarian here. If there are no requirements for product protection and a company decides on a policy an auditor should not have the right to claim it is insufficient or conflicting unless they can point to a regulation.

I agree with all the statements about best practices, but I was in a similar situation where an auditor thought something more was required until they were walked through the science and why what their past experience and viewed practices were not applicable.

Unless the auditor can pull up a regulation ISO 13485 does not require it.
there doesn't necessarily have to be a 13485 or regulatory requirement. Note that the OP said, "Based on our experience, however, we find an improvement in particulate reduction with some minimal protection, including hair nets." This evinces some level of concern for contamination from hair. In other words, the OP has apparently found it useful in terms of contaminant reduction to require hair nets. Note also that the auditor cited a documented requirement for use of hair nets. As I said earlier, it seems to me that the OP should be able to objectively justify why hair nets are requirement but not beard covers, and it also seems to me (although I would defer to the opinions of people with more experience than I in this area) that the auditor was justified.
 

Kales Veggie

People: The Vital Few
#9
I'm going to be a contrarian here. If there are no requirements for product protection and a company decides on a policy an auditor should not have the right to claim it is insufficient or conflicting unless they can point to a regulation.

I agree with all the statements about best practices, but I was in a similar situation where an auditor thought something more was required until they were walked through the science and why what their past experience and viewed practices were not applicable.

Unless the auditor can pull up a regulation ISO 13485 does not require it.
The auditor does not have to. The auditor would cite the organizations's documented QMS.
 

Kales Veggie

People: The Vital Few
#10
Hello! We just completed Stage I of our ISO13485 registration audit. We had one finding & I do not agree with it but want input. The short of it - we cannot have hair nets in our main mfg. area w/o beard covers. We have no cleanliness requirements. We do not have a clean room. Based on our experience, however, we find an improvement in particulate reduction with some minimal protection, including hair nets. I understand the path of least resistance is to just do what he asked, however I hate doing something just because an auditor said so. Although the write-up seems to give some options, he clearly told us, "you do both or none." If we can find perhaps a white paper & show our own justification (in addition to the documented procedures we have), I want to consider challenging this.

It was written up under Infrastructure section 6.3 which he quoted verbatim.

His 'details:' Documentation for controls over the equipment maintenance and the work environment incomplete or conflicting."

-"The posted procedure for personnel gowning shows a requirement for hair covers, but not any similar requirement for beard covers."

Thanks!!
Sorry. I agree with the auditor.

I would compare to an organization's requirement to wear only one glove to cover the right hand to reduce finger prints. Of course there are left handed people.

(side note: why would men be treated differently than women?)
 
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