Good question - many of us likely feel your pain of trying to explain this to your company! I think what you're describing happens quite frequently in small companies at early stages, but it can lead to problems down the line when you need to explain the exact testing that was done and on what test articles.
To add to Kristina's excellent points, I assume what you mean by providing testing instructions via PO is including a test house's internal protocol/procedure number or test code. This might provide enough information, if you have high confidence that their protocols are adequate and that you will be getting a report back that properly documents how the study was performed. However a test house will not know much about the test articles you are sending them, and their reports will typically say that the test article is the responsibility of the sponsor. If the article needs to be prepared in any way, this will not be covered in their internal procedures so you need to document it internally in order to have full traceability to what you tested.
For external testing, I like to have an internal protocol that describes what test articles we are providing (including lot/serial #s, details of any preparation required before sending for testing, and justification of equivalence to clinical/marketed product), what procedures the test house will use, our acceptance criteria, and how we intend to assess/statistically analyze the results. Then when the test report is received by the test house, I like to attach it to an internal report that addresses these more internal aspects of the testing and provides an overall conclusion on the study from our perspective - because generally your test house reports will just state whether you met the requirements of the standard or procedure to which you're testing, without any context.
Additionally, if you haven't seen it, FDA's
guidance on test protocols and reports is helpful in understanding what they, and regulatory authorities in general, expect to see.
I hope this is helpful!
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Jennifer Cabralda, RAC (US, CAN)
Senior Manager, Regulatory Affairs
Richmond, BC, Canada
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Original Message:
Sent: 26-Nov-2019 12:08
From: Kristina Cook
Subject: Protocol and Reports
Hi Anon,
In my opinion, it really depends on the goal of testing. If this is purely early stage R&D or early proof of concept, and you aren't quite sure what you're looking for and what you want to test/vary, it may not always make sense to have a protocol with defined expected outcomes or specific test procedures. That being said, you can't expect these tests and results to serve as objective evidence of having met certain requirements down the line, as there was no control over how they were performed and under what conditions. Rather, these "quick and dirty" tests can provide guidance and direction regarding how you'd want to structure future formal testing, and may provide some direction about possible results.
Without a specific protocol to follow (and likely data sheets to record X critical parameter, test part ID, etc), how would the team defend what was done, and truly trust the results? You can always try asking them to think through how the results of a test would be defended during an audit - this may get them aligned with the importance or proper documentation of tests.
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Kristina Cook
San Francisco CA
United States
Original Message:
Sent: 24-Nov-2019 10:23
From: Anonymous Member
Subject: Protocol and Reports
This message was posted by a user wishing to remain anonymous
Hello -
I am seeking advice on how to clearly explain the importance of conducting testing to an approved protocol. Also, is it ever acceptable to outsource testing to an external testing lab but not have a protocol used for testing but have a Purchase Order give direction on what to test to?
I think I understand and know the answers, I just want to get more supportive information for my conversations.
Thank you!