No, you probably don’t want to hurt me.  But if your product is used in a safety application, and my job depends on your product doing its job, will it hurt me if it fails?

With so many of us doing more things differently during the COVID pandemic, I wonder if changing work habits (like working from home) are hindering one of the critical verification steps… Reviews.

My main concern is always product changes; to me, this is the most critical part of a good safety lifecycle.  “Oh, it’s just a small change” you say.  “It’s an easy one-line code change; what could go wrong?”  I won’t mention any names, but I often see things while assessing certification renewals that indicate shortcuts are being taken.  I don’t think anyone is deliberately trying to do the wrong thing, but they’re not exactly doing the right thing either if they shuffle through a quick change effort without really looking at all the possible mistakes that could sneak in.  As urgent as it may seem to get the change out the door, it’s more urgent to get it done the right way.

Are you still performing reviews according to your procedures?  Schedule the review meeting in advance so you don’t forget; this also gives everyone the chance to adjust and plan for it.  Working from home should not be an excuse to avoid reviews.  In fact, in can be a nice break from working alone.  Many of you have been doing online collaborative reviews even before the pandemic, so don’t stop now.  

Consider a checklist for your reviews so you don’t miss something that should be checked.  This checklist should include:

  • Get the right people involved, both experts on the product as well as technical experts
  • Create the impact analysis 
  • Make sure the change review board has approved the change
  • Consider the safety implications of the change
  • Determine if any diagnostic capability will be affected
  • User operation or maintenance impact (especially proof test impact)
  • Decide on the re-entry point into the safety lifecycle
  • Determine which documents need to be revised
  • Determine the verification steps to be used (meeting process requirements)
  • Determine the validation steps to be used (meeting product requirements, new tests, modified tests)
  • Record the results of the review (You could even add the results of the review to the impact analysis)

It’s important to close the loop when making changes and to update all the relevant product documents, like requirements, design specs, and test plans.  If you’re making a change to fix a problem, it’s likely that something was missing in one of those documents in the first place.  Don’t make that mistake again.  Remember, you really don’t want to hurt me, do you?

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Tagged as:     john yozallinas     covid19     Certification  

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