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Identification of Test Sample in Test Reports?

Ronen E

Problem Solver
Staff member
Super Moderator
#21
"We have a customer who needs more shelf life." "We have some samples aged naturally in a controlled environment for 3 years." "Customer is asking for 6 years. Cant you accelerate it?" "Yes, but..."
I would have answered "Not sure. We'll have to look into that and get back to you, and it's going to take more than 10 minutes." Meaningful accelerated ageing is not always possible or trivial, and there's definitely no magic formula that is right for all designs.
 

Ed Panek

VP QA RA Small Med Dev Company FDA and ISO13485:16
Trusted
#22
I would have answered "Not sure. We'll have to look into that and get back to you, and it's going to take more than 10 minutes." Meaningful accelerated ageing is not always possible or trivial, and there's definitely no magic formula that is right for all designs.
Agreed, but I was a junior QA person at the time and they were not asking me; They were asking the Dir of QA.
 

Ed Panek

VP QA RA Small Med Dev Company FDA and ISO13485:16
Trusted
#23
Ah, that explains all. Still, would probably not recommend a retention policy that dictates retention of samples for all sales and marketing induced tests. :p
Im not sure a meaningful policy is possible. Our company never had an idea of what it would be selling in 5 years so we kept a lot of stuff. The market trends were dictated by Mckesson, GE, Siemens and Philips in Radiology.
 
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