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.
