Managing design verification regression testing of design changes

J

jddad19

Registered
Hi,
Just curious how others manage regression testing for design changes relative to their original design verification protocol/report.

For example, a design change is assessed to affect tests #1, 2, 3 on DVT protocol so we want to repeat those tests to document the results following design change. Do you leave protocol as-is (no revision) and revise test report with new results? If so do you maintain the original results in addition to the new results? And where do you document some background on the design change?

Alternatively I've seen use of addendum reports (keep original report as-is, add standalone addendum report to document new results) as well as entirely new protocol/report to describe the change and subset of testing to be performed/results. To me it seems each has its upside and downside so curious to know how others manage this and what they've found to be best.
Thanks
 
E

ECHO

Involved In Discussions
I feel like regression testing is one of those topics where if you asked a 100 people, you should get a 100 answers. It is also difficult to say since I don't know anything about your product or your Quality System.

That said, I won't approach it your way. When you make a design change, every requirement pertaining to your system should be tested. If you happen to have a previously executed Verification Report and if that result is sufficient for your testing purposes, that's great! Reference the Verification Report and document your justification.
As for the tests that were re-executed, this depends on your doc control system. I have seen all the methods you mentioned above. My advice is think of what your trace matrix would look like once you are done.

All that said, if you are complying to IEC 62304, Section 5.6.6 Conduct Regression tests is for integration testing and not Verification testing. Note 1 for Section 5.1.5 does say integration testing and system testing can be combined so again, reference your procedure.

I recommend taking a look at Appendix B.5.7 of IEC 62304.

Lastly, the background on the design change should be documented in the DDP.
 
D

d_addams

Involved In Discussions
I would add, it depends on the specific product/protocol. If its a really complex system, it can be hard to isolate change impacts to a very small test set. But other times it may be quite easy to do so. If you are confident in your isolation, I'm a fan of revising the report where each test item has the applicable results reported. But for those X repeated/new test results, the refer to the new source of data (presumably a new technicians data sheet or other source of data). So the report revision will now have both data sheets as references (or attachments).

The reason I support this method is for overall clarity/simplicity. The plan is to show the latest design meets all the latest requirements. If those requirements haven't changed, why are I writing a new plan? If there are new results, just revise the report with the new results (why keep that old version as the 'latest' and have a 2nd report). In the report change management section you can note why X number of tests were rerun. This would include the rationale as to why the change only required these X tests to be run (or reference to an external analysis/rationale if its complex/detailed).

This lets you present one plan and report in a review/audit which helps keep the story clean and straight forward. There is still just one report to bring up when asked to review the DVT evidence. You're not sending a reviewer to multiple documents during an audit nor having the back room frantically looking for two different reports (or plans).
 
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