I was wondering if anyone could help me with developing criteria to audit external contract service providers, namely quartlerly maintenance of Getinge sterilizers. The service provider uses a check list to ensure that all areas are covered, however the CEO has requested that I set up some criteria to monitor between services. All ideas would be appreciated very much.

Thankyou Bernadette Stanhope Manager

Hallo Bernadette.

I would suggest you to prepare a comparison Table that will consist of physical (measurable) parameters on one axis (room temperature, hour, no. of the cycle on this day, load description (should be identical every time), program no.(should be identical every time), steam supply pressre, water pressure, compressed air pressure, and of course total cycle period. You can also add the meassured parameters of the Service Engineer.
On the other axis, the dates.
The comparison of identical data is the proof for validity of sterility assurance. If data is not idenical, and you decide to continue working, monitor it, explain your decision.
Please let me know what way you decided to go.

Michael Meyer

thank you for that information Michael. I have followed your suggestion and plan to develop the Comparison table. In investigation I have noted that the service engineer has not regularily been providing us with the pressure readouts. To be able to gather and collate this information will be a valuable tool in our validation process. Thanking you once again. Bernadette