Running a risk assessment to prove our company does not need ATP swabs

Hello all,

I am trying to prove that our shop does not need ATP swabbing in its cleaning program.

I have been running tests and the results show the area tested is clean.

Does any one have an example of a risk assessment layout for this. I am new to my role and would appreciate any help.

Thanks in advance,

Chris

Hi Chris,

This decision will be based on the validation work you have done on the effectiveness of your cleaning procedure.

I assume that this is food contact packaging that you are manufacturing? 

What areas did you swab and what were the micro results?

If you are controlling micro by following the cleaning procedure and then a subsequent inspection to check that an item is clean then you need to show that this is effective.

Kind regards,

Tony

I've done it for two separate companies.  You just risk assess it out with scientific evidence and your PRP's.  For example, I asked suppliers if there is any biological risk on their part and what they rate it with and why, I use that as basis for checking our suppliers.  Then go through your process, showing that you follow GMPs, etc.  For scientific evidence, look to the internet, there are several articles showing that there is very very minimal risk and organisms are not show to survive on plastic films.  Using this for your risk assessment should show your risk is very low and thus should justify no need for environmental swabbing.  I would put in there that you will stay updated on any relevant changes and reassess as needed. 

I went a step above then and did some swabbing pre clean and post clean.  Swabs came back showing virtually nothing.  I used that to show that we do not have hardly any risk.  It work for at least 4 different auditors.  Trust your process, walk through it, risk assess and document.  

Thanks everyone for replying, this information is very useful.

Tony-C is correct that we are a food packaging producer.

I have tested:

-material contact rollers

-splice tables

-pre and post processed materials

-and product contact sites in our finishing area

All results came back clean.

I will have to try the pre clean & post clean test that Scotty SQF explained and look for some of those articles today. That should reinforce the data that I have gathered thus far, and having that biological risk question on a supplier approval form would be a good annual check.

I've done it for two separate companies.  You just risk assess it out with scientific evidence and your PRP's.  For example, I asked suppliers if there is any biological risk on their part and what they rate it with and why, I use that as basis for checking our suppliers.  Then go through your process, showing that you follow GMPs, etc.  For scientific evidence, look to the internet, there are several articles showing that there is very very minimal risk and organisms are not show to survive on plastic films.  Using this for your risk assessment should show your risk is very low and thus should justify no need for environmental swabbing.  I would put in there that you will stay updated on any relevant changes and reassess as needed. 

 

I went a step above then and did some swabbing pre clean and post clean.  Swabs came back showing virtually nothing.  I used that to show that we do not have hardly any risk.  It work for at least 4 different auditors.  Trust your process, walk through it, risk assess and document.  

I must have got unluck then. I did roughly the same and even cited the statement from BRC. But my company still received an NC for not doing swab tests without any explanations of what specific risks would remain present. 

It seems likely that you will be reducing the frequency, perhaps a significant reduction, but not eliminating the procedure.

Annual sampling to confirm the validation may be the standard to move toward.

Have you ever tried ATP swabbing equipment after a production run prior to sanitation?  I'd be curious what RLU's look like before and after, and with my lack of experience in packaging manufacturing, I'm imagining they'd be negligible.  Perhaps building a study where you've recorded many pre-clean and post-clean results for comparison, along with notable observations that there isn't visual residue building up during the process, combined with sanitation validations that show pre/post wash control of indicator organisms could be sufficient to justify a visual cleanliness standard.

I feel like you're kind of stuck in the fact ATP is a part of your current program, and you'll need to justify your way out of it.  It's doable, as I worked in a dry spice plant where we got by on visual inspections for cleanliness during dry cleanings.  If you can get to a visual level of cleaning verification being acceptable, you'll still want to document the visual inspection after each cleaning on your sanitation records.

What I have done in several roles/plants is to conduct a cleaning and sanitation validation study.  I have utilized lab swabs, ATP, and protein swabs.   All sites swabbed before and after cleaning, then after sanitizer step.  This has been alluded throughout this thread by others who are more privy to your process than I.  Once you validate your cleaning methods and have determined that they are in fact effective then verifying the process can be done visually or use ATP periodically to confirm results are still favorable.  The study also provides a good basis for the risk assessment of reduction of swabbing (if applicable) to your process as well as gives you a one up during audit time.  Good luck in your endevours!