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Risk analysis on visitors and employees wearing lab coats and uniforms

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#1 MommaJones

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Posted 02 March 2020 - 09:01 PM

New to this forum but not to quality. Almost 20 years now. I'll be looking through the forums because I have some specific questions regarding visitors, lab coats and uniforms but will also post it here.

 

I'm new to this company. They bought lab coats that haven't been worn once and are about 8 months old. Would like to hear about risk analyses done that allowed you to not use lab coats. Coats not just for visitors but do you allow non-production personnel to not wear them when they go to the floor? The coats were bought but the previous QAM never set a policy in place nor coached anyone on when to use them and on using an acknowledgement with visitors. 

 

Thanks!



#2 kfromNE

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Posted 02 March 2020 - 09:37 PM

New to this forum but not to quality. Almost 20 years now. I'll be looking through the forums because I have some specific questions regarding visitors, lab coats and uniforms but will also post it here.

 

I'm new to this company. They bought lab coats that haven't been worn once and are about 8 months old. Would like to hear about risk analyses done that allowed you to not use lab coats. Coats not just for visitors but do you allow non-production personnel to not wear them when they go to the floor? The coats were bought but the previous QAM never set a policy in place nor coached anyone on when to use them and on using an acknowledgement with visitors. 

 

Thanks!

 

Wearing lab coats or as well call them - smocks, it depends. The problem with the facility I work in - there are front and back offices with the plant/production area in the center. If an employee is going straight through - entering the dock and walk in cooler only then only hairnets, safety boots and safety glasses required and not the smock. If entering the production rooms - a smock is required of everyone including visitors. We have separate uniforms for our shipping & receiving and maintenance since the smocks do pose a risk for them. They were jackets. All are washed by our laundry company.

 

If your process is completely an enclosed system, you may be able to prove smocks aren't needed. The other option - disposable ones.



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#3 MsMars

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Posted 04 March 2020 - 09:46 PM

What type of industry/process? Like K stated above, if it's an enclosed process you might be alright.  If it's a slaughter facility, a different story.  It's all dependent on your risk analysis, third party certifications, customer requirements, etc.  Does your facility employ uniforms as well? 



#4 zanorias

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Posted 05 March 2020 - 06:29 AM

The coats were bought but the previous QAM never set a policy in place nor coached anyone on when to use them and on using an acknowledgement with visitors. 

 

 

I'd recommend putting a PPE policy in place as a starting point, in line with your legal, customer and accreditation (if any) requirements. You should then have a clearer idea of whether the lab coats are acceptable for your operation.

 

P.s. welcome to the forum :welcome:



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#5 MommaJones

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Posted 05 March 2020 - 12:59 PM

What type of industry/process? Like K stated above, if it's an enclosed process you might be alright.  If it's a slaughter facility, a different story.  It's all dependent on your risk analysis, third party certifications, customer requirements, etc.  Does your facility employ uniforms as well? 

We're a Level 2 direct-contact food packaging supplier. My last job was Level 3 and were adamant about wearing lab coats but even for Level 3 seemed like overkill. A good friend works for a Level 2 place and they don't. We did a risk analysis and all felt like the risk was low. We're thinking now to not use them and see what the auditor says



#6 MommaJones

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Posted 05 March 2020 - 01:01 PM

Wearing lab coats or as well call them - smocks, it depends. The problem with the facility I work in - there are front and back offices with the plant/production area in the center. If an employee is going straight through - entering the dock and walk in cooler only then only hairnets, safety boots and safety glasses required and not the smock. If entering the production rooms - a smock is required of everyone including visitors. We have separate uniforms for our shipping & receiving and maintenance since the smocks do pose a risk for them. They were jackets. All are washed by our laundry company.

 

If your process is completely an enclosed system, you may be able to prove smocks aren't needed. The other option - disposable ones.

We're not  food manufacturer. We make food-contact packaging and at an SQF Level 2 we think that they might be overkill. We did a risk analysis and deemed the risk low and will use that as justification in our audit. At least that's the plan



#7 kfromNE

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Posted 05 March 2020 - 01:27 PM

We're not  food manufacturer. We make food-contact packaging and at an SQF Level 2 we think that they might be overkill. We did a risk analysis and deemed the risk low and will use that as justification in our audit. At least that's the plan

If you can show proof with your risk analysis - you should be fine.



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#8 MommaJones

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Posted 05 March 2020 - 01:52 PM

If you can show proof with your risk analysis - you should be fine

Thank you!



#9 Charles.C

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Posted 05 March 2020 - 01:53 PM

Hi MJ,

 

A Risk assessment should have included data.

And a cleaning.Program.

I presume you have swabbed the coats. What were the results ?

 

 I don't entirely understand who is currently using these coats other than visitors.

Might add that afaik SQF levels 2 and 3 no longer exist.


Kind Regards,

 

Charles.C


#10 MommaJones

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Posted 05 March 2020 - 02:03 PM

Hi MJ,

 

A Risk assessment should have included data.

And a cleaning.Program.

I presume you have swabbed the coats. What were the results ?

 

 I don't entirely understand who is currently using these coats other than visitors.

Might add that afaik SQF levels 2 and 3 no longer exist.

I know the levels don't exist. It's just easier to refer to them that way. Occasionally I'll refer to them as "formerly known...".

 

We definitely have a cleaning program. We have not swabbed the coats because the have never been used. Not by visitors nor any office personnel. They're still in plastic in a closet. The last QAM had them purchased but never rolled out a program or parameters when they were supposed to have been used and by whom.

 

My last company (Level 3) had visitors as well as office personnel not in uniform use them all the time. A good friend at another company (Level 2) does not use them at all. That was why I was in a quandary on whether we needed to use them and hence why we conducted a risk analysis. 



#11 MsMars

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Posted 05 March 2020 - 05:27 PM

I know the levels don't exist. It's just easier to refer to them that way. Occasionally I'll refer to them as "formerly known...".

 

We definitely have a cleaning program. We have not swabbed the coats because the have never been used. Not by visitors nor any office personnel. They're still in plastic in a closet. The last QAM had them purchased but never rolled out a program or parameters when they were supposed to have been used and by whom.

 

My last company (Level 3) had visitors as well as office personnel not in uniform use them all the time. A good friend at another company (Level 2) does not use them at all. That was why I was in a quandary on whether we needed to use them and hence why we conducted a risk analysis. 

 

Not to get off in the weeds, but to clarify -  I think Charles is making the point that levels are irrelevant as well as obsolete.  I've worked at a facility that could be classified as "high risk", however we were what was formerly known as SQF Level 2 certified and did not seek the Quality component (that would make it Level 3) simply because it was not required by customers and we did not want to bear the cost pointlessly.  However, we DID wear smocks because of our product/process risk.  So, what "level" a company is (or formerly was) has nothing to do with whether or not you're required to wear smocks or protective overgarments. 

 

Re-stating again - it's all in the risk assessment.  Sounds like you may not need them.  Could you return them to the manufacturer or re-sell them? 


Edited by MsMars, 05 March 2020 - 05:27 PM.


#12 MommaJones

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Posted 05 March 2020 - 05:34 PM

Not to get off in the weeds, but to clarify -  I think Charles is making the point that levels are irrelevant as well as obsolete.  I've worked at a facility that could be classified as "high risk", however we were what was formerly known as SQF Level 2 certified and did not seek the Quality component (that would make it Level 3) simply because it was not required by customers and we did not want to bear the cost pointlessly.  However, we DID wear smocks because of our product/process risk.  So, what "level" a company is (or formerly was) has nothing to do with whether or not you're required to wear smocks or protective overgarments. 

 

Re-stating again - it's all in the risk assessment.  Sounds like you may not need them.  Could you return them to the manufacturer or re-sell them? 

Unfortunately no. They have our name and logo on them.

 

That's interesting point about the what section you're certified to. Not to get tangential but the 3 companies to which I referred (current job, last job and friends job) are all basically doing the same thing. But only one added the quality component, the other to did not. Nor do they feel the need. 



#13 MsMars

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Posted 05 March 2020 - 06:03 PM

Unfortunately no. They have our name and logo on them.

 

That's interesting point about the what section you're certified to. Not to get tangential but the 3 companies to which I referred (current job, last job and friends job) are all basically doing the same thing. But only one added the quality component, the other to did not. Nor do they feel the need. 

 

I daresay that the mis-association with product/process risk level was partially why SQF went away from classifying their certifications with "levels". 



#14 MommaJones

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Posted 05 March 2020 - 06:13 PM

I daresay that the mis-association with product/process risk level was partially why SQF went away from classifying their certifications with "levels". 

Yes that does make sense



#15 Charles.C

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Posted 06 March 2020 - 06:27 AM

New to this forum but not to quality. Almost 20 years now. I'll be looking through the forums because I have some specific questions regarding visitors, lab coats and uniforms but will also post it here.

 

I'm new to this company. They bought lab coats that haven't been worn once and are about 8 months old. Would like to hear about [any] risk analyses done that allowed you to not use lab coats. Coats not just for visitors but do you allow non-production personnel to not wear them when they go to the floor? The coats were bought but the previous QAM never set a policy in place nor coached anyone on when to use them and on using an acknowledgement with visitors. 

 

Thanks!

 

Comments

 

To return to the OP, i deduce the opening query is ^^^^(red)

 

I, initially, interpret the query as seeking a justification for certain personnel to not require the use of an "over-garment" when entering the Production arena.

 

It seems to me the answer for (Observing) Visitors, non-Production Personnel (other than Lab/Engineering Personnel)  will be "None". (IMEX  Engineering Personnel have their own [designated acceptable] uniforms already and Lab personnel have IMEX distinct [designated appropriate] overalls for internal/external lab work ).

 

The reason for "None" is that  IMEX  the "usage'" requirement will typically be a Factory  Prerequisite Requirement for GMP.

 

Further, IMO, -

 

"Over-garments"  used for visitors should be separated for this specific activity (or be disposable).

"Over-garments" for non-Production personnel (see above) should also be separated for this specific activity (or be disposable).

 

As far as the, so-called "lab coats" are concerned, a decision will presumably have to be made as to which of the above functions (if any) are considered suitable for their potential usage based, perhaps,  initially on their unknown specific characteristics, eg colour, appearance, buttons, pockets.

 

In the event that a "usage' possibility is envisaged and since the microbiological condition/history of the, 8-month stored, so-called "lab coats" is afaik indeterminate, I suggest that a preliminary swab test(s) / micro. analysis(es) be carried out to verify that the "cleanliness" of the "lab coats"  is adequate.

 

PS - a possible exception to the above is for non-Observing Visitors such as external maintenance operatives whose activities may demand specific segregational requirements.


Edited by Charles.C, 06 March 2020 - 06:45 AM.
emended

Kind Regards,

 

Charles.C


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#16 Ryan M.

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Posted 06 March 2020 - 03:42 PM

The risk is with the employee clothing and potential contact with primary food contact packaging you produce.  If you can show, through data and evidence, the employee clothing does not pose a risk to the food contact packaging with a risk assessment then you should be fine.

 

But, you need to show the data and evidence.



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