Cleanroom Housekeeping and Personnel Hygiene Audit Checklist

D

Debbie Low

#11
Is the number of sample taken for microbial air and surface cleanroom monitoring the same as non viable particle count test,where the number of sample is obtained from square root of the floor area of the cleanroom? If yes, is the number indicating for each air and surface independently or the combination of both type? May someone please advise:thanx:
 
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Ajit Basrur

Staff member
Admin
#12
Hi Debbie,
not sure if ISO 14644 gives some direction for the first question.
However you can demonstrate by means of Desing of Experiment that a certain number of personnel in square meter can jeopardize material.
Usually we proceed in that sense. At the end you can demonstrate the contamination satures after a certain number of people in two or three tiles on the shop floor.
As to the second part, it is possible the contamination.
You can think about to review layout of the smock room or foresees a bootie change for each clean room entrance in a day shift. Also in this case, you can make an experiment and analyze data
:bigwave:
The Annex E and F in the ISO 14644-5 gives very clear direction on Cleanroom Cleaning
 
D

Debbie Low

#13
Can any one shield some light on how to audit a cleanroom garment laundry company? A checklist would be useful.

Anyone has experience in writing a Quality Agreement for cleanroom garment laundry company?

Advance thanks for your help!
 

qusys

Trusted Information Resource
#14
Can any one shield some light on how to audit a cleanroom garment laundry company? A checklist would be useful.

Anyone has experience in writing a Quality Agreement for cleanroom garment laundry company?

Advance thanks for your help!
You may want to assess from ISO quality standards, so the topica are the same for a quality system audit.
However, I would suggest to also audit vs your requirement if any. In addition you could also start from eventual quality issues that you have experienced with them, checking at the corrective action. I do not know if this is a qualification audit or re-evaluation audit for your supplier, because scope and audit objective should be different.
Some other topics that I have had experience for potential issue could be :
-maintenance of the equipment used in the line as well as change management of the recipe for washing garment ( this could be crucial for garment that you use in your environment, if there are particular requirement to avoid contamination for you )
- control of the eventual outsourced maintenance service ( particular attention to DI Water system, key in this environment)
- control of the cycle of washing of your garment ( evaluate if they follow and have in place a system to monitor the number of washing the same garments before scrap or downgrade it)
- Shipping of the supplied material ( quantity, delivery time etc.)
- visual inspection of the garment before packaging ( check if there issue for garment broken , holes, spots etc...and check for tracking system in place and how they inform you)
- control of the packaging vacuum
- control of their suppliers for material purchasing used in the washer
- existence of contigency plans in case of stop production caused by a disaster, strike etc...
- control of the environment where the service is performed ( contamination control, calibration of their tools, certificates, I guess that supplier clean room should be ISO3 etc...)
- control of their production/service flow ( for instance, check for control of the water resistivity and metallic contamination, these are very important parameters in case of washing with DIW)
- product transportation

Some suggestions for the contract could be directly linked with prior question.Overall you should establish the acceptability level for the service and supplied products.

Hope this may help you with your request.:bigwave:
 
D

Debbie Low

#15
Thanks for the information provided! We has been using this supplier for many years but have never conducted any audit. We would need to start this audit as the cleanliness of the garment is extremely critical. Do u have a template for quality agreement? Pardon me ,as this is the first time I am writing such agreement. Advance thanks!
 
D

Debbie Low

#16
Is anyone able to share the method for AS 1807.19 - Cleanrooms, workstations and safety cabinets - Methods of test - Sizing and counting of particulate contaminants in and on cleanroom garments?

Advance Thanks
 
K

Ka Pilo

#17
Hello Debbie! Welcome to the Cove!:bigwave:

I can't remember if Class 7/8 are Class 100 (EU Grade A; or whatever).
:lol: I wished they would decide on one classification and stay with it. :tg:

Most of what I have seen has been fairly straightforward:

  1. No makeup
...............
No 'heavy' make up is fine, but banning a make up is hard thing for employees (women) to accept. I don't want to soften the rules re hygiene. But you must have your reasons to ban the make-up. Why do you want to ban it?

Imagine a female visitor with a small amount of make up would be advised to remove her make up before entering the factory. It seems humiliating. I don't know.
 
Last edited by a moderator:
D

Debbie Low

#18
Is anyone able to share the method for AS 1807.19 - Cleanrooms, workstations and safety cabinets - Methods of test - Sizing and counting of particulate contaminants in and on cleanroom garments?

Advance Thanks
Is anyone able to share the method for AS 1807.19 - Cleanrooms, workstations and safety cabinets - Methods of test - Sizing and counting of particulate contaminants in and on cleanroom garments?

Advance Thanks
 

qusys

Trusted Information Resource
#19
Thanks for the information provided! We has been using this supplier for many years but have never conducted any audit. We would need to start this audit as the cleanliness of the garment is extremely critical. Do u have a template for quality agreement? Pardon me ,as this is the first time I am writing such agreement. Advance thanks!
Hi,
no particular template.
The advice is to set quality requirements that you would agree for the service and the measurable.
You can also write and agree a statement for the supplier audit.
Clearly , for the economical and commercial aspect ,Putchasing is the owner for P.O. or contract.
:bigwave:
 
D

Debbie Low

#20
Hi,
no particular template.
The advice is to set quality requirements that you would agree for the service and the measurable.
You can also write and agree a statement for the supplier audit.
Clearly , for the economical and commercial aspect ,Putchasing is the owner for P.O. or contract.
:bigwave:
Thanks for the advice.

btw, have you come across the AS 1807.19 std? able to share how is this test method conducted?

advance thanks
 
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