IQ OQ PQ Burst Test Machine

[Aqilahsuhaimi]

Does anyone did PQ for a burst test machine before? I'm not really clear of what should i do for the Performance Qualification as it is a destructive test measurement. The only thing I have in mind is that Gauge R&R which I couldn't be certain whether it is acceptable in the context of ISO 13485:2016 or not.


Thanks in advance

 

[Tidge]

Burst testing is a test method, not a (manufacturing) process. The old GHTF concepts of IQ, OQ, PQ don't apply.

Something like a Gage R&R is more appropriate.

 

[Philip B]

We did IQ and OQ on our burst test equipment. We didn't do PQ on the basis that test method validation for each packaging type is effectively a PQ.

 

[Aqilahsuhaimi]

Burst testing is a test method, not a (manufacturing) process. The old GHTF concepts of IQ, OQ, PQ don't apply.

Something like a Gage R&R is more appropriate.

Hi Tidge, thank you for the input. I'm not really familiar with the Gauge R&R. Is there any guidance explaining how can we perform the Gauge R&R? Additionally, does this method accepted by the authorities, especially the conformity assessment body? For your information, the burst unit to be validated is for condom testing.

Appreciate your feedback on this. Thanks!

 

[Tidge]

I'm guessing that you are applying some sort of standardized consensus test from an established organization? If so, then fundamentally you want to generate OE that the various people performing the test get consistent results from homogeneous samples.

Depending on the materials, I suppose there might exist lab services that you can subscribe to where you receive samples and then send the results back. Your results are plotted against the results of all the other subscribers. This can indicate if there is something about the execution of the test process in your lab that is causing wider variation relative to other labs.