Inquiry about the Qualification Procedures in autoclave
During the regular requalification assessment, Air leakage test and bowie dick test, Heat distribution test
were performed in July, and the remaining heat penetration test needs to be performed.
However, due to pure water construction work, the remaining test will start in October.
The expiration date is august.
Question:
Is it okay If I don’t write the qualification report for the results up to Air leakage test and bowie dick test, Heat distribution test?
I mean, I will write the qualification report after completing heat penetration test in October.
(For your information, I have already completed a deviation report for exceeding the qualification period.)
Yes, it is ok if you issue the report until you have executed all tests entailed by the corresponding protocol, that way you can make a conclusion in the report of wether or not the requalification was successful (passed) or not (failed). If you issue a report before executing the heat penetration test, you would have to document a deviation, since the protocol was not executed with all the tests required by it, and the conclusion (if any) would be of failure, even if all other tests were successful.
When you write the report, also reference the the deviation you mentioned for exceeding the qualification period, which shouldn’t have had been difficult since I assume the autoclave was put out of use until water system is restablished and requalification can be performed.