I am urgently looking for a Clean Room audit checklist as per ISO 14644 requirements - does anybody have one ?
Does anyone have a Cleanroom audit checklist?
- Thread starter Ajit Basrur
- Start date
Re: Does anyone have a Clean Room audit checklist ?
Here is one that Google turned up. Does it help?
http://qa.jpl.nasa.gov/PQA/documents/PQA Chcklst Docs_under rev/Clean Rooms1.doc
Here is one that Google turned up. Does it help?
http://qa.jpl.nasa.gov/PQA/documents/PQA Chcklst Docs_under rev/Clean Rooms1.doc
Re: Does anyone have a Clean Room audit checklist ?
By the way, ISO 14644 has 8 (soon to be 9) parts. Are you looking for a specific part? Part 2 includes requirements for testing to verify compliance with part 1. There is no checklist required, but it does require a "comprehensive report" with a statement of compliance or non-compliance with each specified test. Is that what you're looking for?
By the way, ISO 14644 has 8 (soon to be 9) parts. Are you looking for a specific part? Part 2 includes requirements for testing to verify compliance with part 1. There is no checklist required, but it does require a "comprehensive report" with a statement of compliance or non-compliance with each specified test. Is that what you're looking for?
Re: Does anyone have a Clean Room audit checklist ?
Hi howste,
Thanks.
I was basically looking for an audit checklist by which I could audit the clean rooms (ISO Class 8 in particluar) for checking if the installation of clean rooms, checking if the operational procedures viz. entry / exit, hygiene, cleanliness, garments, environmental test conditons (temperature, humidity, particle counts, pressure differentials etc.) and any other requirements as per required, are met satisfactorily.
Hi howste,
Thanks.
I was basically looking for an audit checklist by which I could audit the clean rooms (ISO Class 8 in particluar) for checking if the installation of clean rooms, checking if the operational procedures viz. entry / exit, hygiene, cleanliness, garments, environmental test conditons (temperature, humidity, particle counts, pressure differentials etc.) and any other requirements as per required, are met satisfactorily.
N
NDexter
Re: Does anyone have a Clean Room audit checklist ?
Did you ever find a checklist? The one google related reference was a dead end. Now I too am urgently looking for a checklist to ISO 14644 for a medical device company!
Did you ever find a checklist? The one google related reference was a dead end. Now I too am urgently looking for a checklist to ISO 14644 for a medical device company!
Re: Does anyone have a Clean Room audit checklist ?
Hi NDexter,
Welcome to your first post and hope to have your active participation.
Sorry, I didnot get any speciifc audit checklists but did some compliance checks as per the ISO 14644 requirements.
Did you ever find a checklist? The one google related reference was a dead end. Now I too am urgently looking for a checklist to ISO 14644 for a medical device company!
Hi NDexter,
Welcome to your first post and hope to have your active participation.
Sorry, I didnot get any speciifc audit checklists but did some compliance checks as per the ISO 14644 requirements.
M
MIREGMGR
We have an ISO 14644 certificate of compliance from an appropriately certified service provider for two Class 8 cleanrooms. I don't have a 14644 checklist per se, but here's the contents of the certification report:
(page one)
(certification statement and supporting info)
(page two)
(project numbers)
(page three)
(room and building specifications)
(page four)
Description of pressure differential measurement technique.
Measurement data for pressure differentials between each room and all surrounding spaces, and between the two rooms.
Conclusion as to acceptability of pressure differentials.
(page five)
Description of particle count measurement technique.
Conclusion as to acceptability of particle counts.
(page six)
Measurement data for particle counts at specified locations, cleanroom #1.
(page seven)
Measurement data for particle counts at specified locations, cleanroom #2.
(page eight)
Measurement locations for particle counts at specified locations, cleanroom #1.
(page nine)
Measurement locations for particle counts at specified locations, cleanroom #2.
(page ten)
Statistical analysis of particle counts at specified locations, cleanroom #1.
(page eleven)
Statistical analysis of particle counts at specified locations, cleanroom #2.
(page twelve)
Statement that temperature and relative humidity data are not required for certification.
Description of temperature and relative humidity measurement techniques.
Measurement data for temperature and relative humidity.
(page one)
(certification statement and supporting info)
(page two)
(project numbers)
(page three)
(room and building specifications)
(page four)
Description of pressure differential measurement technique.
Measurement data for pressure differentials between each room and all surrounding spaces, and between the two rooms.
Conclusion as to acceptability of pressure differentials.
(page five)
Description of particle count measurement technique.
Conclusion as to acceptability of particle counts.
(page six)
Measurement data for particle counts at specified locations, cleanroom #1.
(page seven)
Measurement data for particle counts at specified locations, cleanroom #2.
(page eight)
Measurement locations for particle counts at specified locations, cleanroom #1.
(page nine)
Measurement locations for particle counts at specified locations, cleanroom #2.
(page ten)
Statistical analysis of particle counts at specified locations, cleanroom #1.
(page eleven)
Statistical analysis of particle counts at specified locations, cleanroom #2.
(page twelve)
Statement that temperature and relative humidity data are not required for certification.
Description of temperature and relative humidity measurement techniques.
Measurement data for temperature and relative humidity.
Re: Does anyone have a Clean Room audit checklist ?
Btw, are you looking for an audit checklist for any specific standard within the different ISO 14644 standards ?
Did you ever find a checklist? The one google related reference was a dead end. Now I too am urgently looking for a checklist to ISO 14644 for a medical device company!
Btw, are you looking for an audit checklist for any specific standard within the different ISO 14644 standards ?
Re: Does anyone have a Clean Room audit checklist ?
Here is the one that was linked in my post above. It may or may not be useful...
Did you ever find a checklist? The one google related reference was a dead end. Now I too am urgently looking for a checklist to ISO 14644 for a medical device company!
Here is the one that was linked in my post above. It may or may not be useful...
D
divearse
Hi all, I see that the quick way out is to get a check list but this is dangerous if we are using other's check list for doing audit work. I suggest that consultants or quality personnel should do an environmental risk assessment against the product requirements. Microbial or pyrogen acceptable level specified? I have used others created checklist in the past and got into trouble (being lazy) but luckily nothing serious.
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