S
SandyStarkie
Good Afternoon
I also have a question concerning 7.3.3.1. It states "The laboratory shall specify and implement, as a minimum, technical requirements for
adequacy of the laboratory procedures
competency of the laboratory personnel
testing of the product
capability to perform these services correctly, traceable to the relevant process standard and
review of the related records
The two items I have in bold I could not find evidence of during an internal audit. I found a training record from lab tech from 2001 and it was before the word "Competent" was added to training ledgers. I found nothing describing how the lab tech is trained or deemed competent. Does this have to be in the lab scope or procedure?
What is evidence of review of related records?
I also have a question concerning 7.3.3.1. It states "The laboratory shall specify and implement, as a minimum, technical requirements for
adequacy of the laboratory procedures
competency of the laboratory personnel
testing of the product
capability to perform these services correctly, traceable to the relevant process standard and
review of the related records
The two items I have in bold I could not find evidence of during an internal audit. I found a training record from lab tech from 2001 and it was before the word "Competent" was added to training ledgers. I found nothing describing how the lab tech is trained or deemed competent. Does this have to be in the lab scope or procedure?
What is evidence of review of related records?