6 replies to this topic

[tezza07]

Hi everyone!

 

I just have a quick question re: the crisis management exercise. Since we've already deployed our crisis management plan during the pandemic, do we still need to meet to conduct a mock exercise? Or can we skip the mock exercise meeting and just provide the auditor with documented evidence of our plan in action over the last few months?

 

Thanks!

[SQFconsultant]

You need to do a mock exercise.

[CMHeywood]

You do a mock exercise when you haven't had a real incident.  It is meant to test your system to see if it will still function properly.

 

I don't see why doing real crisis management due to CoVid-19 is not a sufficient test of your system, as long as you do some sort of review to evaluate if your response was adequate or anything needs to be changed or improved.

[FurFarmandFork]

Probably going to come down to the auditor. The system requires a "test" so certainly an actual event counts as a test of the sytem IF you followed up and analyzed where you can improve the system based on the results of the test.

 

I've foregon mock traces/recalls in years where the company had an actual withdrawal event. The key to a successful audit is to show that you used the event to test and improve your system, not just use it.

[sqflady]

I believe the test must include evaluation of product.  The COVID-19 doesn't affect product that we know of so there is nothing to evaluate at this time.

[SQFTIRED]

If Covid-19 affected the ability to continue to manufacture a a safe product due to limited staff, or re imagining a way to manufacture a safe product within the confines of employee safe distancing and reduced staff numbers wouldn't this be something that could be "tested"?

[Charles.C]

The issue of whether Covid-19 can/cannot be  interpretable in respect to a Crisis Management (Mock or not) Exercise has been debated at some length already, eg -

 

https://www.ifsqn.co...omes-to-covid-1

https://www.ifsqn.co...20/#entry159672

https://www.ifsqn.co...on/#entry159896

 

The conclusion appeared to be - No Consensus. Just like this thread.