4 replies to this topic

[jcieslowski]

Have a little debate among my team, was wondering what the census of like minds things....

 

We missed our 3rd quarter environmental testing.    We are doing 4th quarter and as a corrective action are updating our master calendar and SOP to ensure we don't miss it in 2024.

 

The debate / question is:  should we also do 1 'additional' test to sort of 'make up' for the missed quarter or just move on going forward?

[kingstudruler1]

Do you test the same sites every quarter or are the unique each quarter?    If they are unique i would get them caught up.   If they are the same, i guess im 50 / 50 on doing additional testing. 

 

Will doing the additional testing further assure or somehow reduce product risk?

 

It might look better to an auditor that you found the problem, did additional testing in the 4th quarter, and developed an action plan to ensure it doesn't happen again.    Either way your not complaint with your program.  

[MDaleDDF]

I don't personally think doing extra does anything at all to make up for missing the 3rd qtr.   If it were me, I'd open a CAR and do a damn good job ensuring it doesn't happen again.   That's a big problem, and how it could be forgotten by everyone in your facility needs to be discovered and corrected. 

 

It'll be interesting to see what your auditor says about it....

[jfrey123]

How do your environmental results look historically?  I don't see much benefit in running the environmental testing as a makeup, and you can further justify it if 4th quarter is clean and a history of clean results are trended.

 

To pile on with everyone else, a solid root cause needs to be documented to justify the corrective actions you've already decided upon.  Your CA's sound reasonable, but your auditors is going to want to see that you've thoroughly checked to how it occurred to begin with.  Additionally, you might want to add some verification step to this calendar you've created.  Maybe at each monthly meeting a signoff to show you've reviewed which activities needed to be performed and that they were actually done.  I did something similar to a couple of master sanitation schedules we had created at my old spice plant, helped us to notice "oh hey we haven't cleaned x area in the past two months, we'd better do it this month to keep it within the quarterly frequency."

[Brothbro]

I'd agree with others that doing an "extra test" doesn't really do anything. To me a better corrective action would be to change your reminder system that tells you the swabbing needs to take place. Calendar meeting invites? Work phone notifications? Notifications that proc within the swabbing software itself? Or perhaps if you use a third party lab, having them send a reminder to hold your site accountable. Basically, next time it comes around you need to make sure it happens. You may even be able to say that you'll step up your reminder game for a year, then go back to the old system if all goes well.