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YNA QA

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Posted 01 July 2020 - 01:32 PM

Hello All,

 

We perform pre-operational ATP swabs on our equipment.  Currently we have a pass/ fail, with 50 being our limit and any results of 50+ must be re-cleaned with a passing re-swab prior to use.  Our sanitation on our equipment is performed nightly, and they are allowed to dry overnight before swabs are performed. If they fail prior to production, they must be cleaned, swabbed, sanitized and then dried as our product is all dry mixture.  It's quite a process, and can get tedious.  

 

We are currently in the process of trending our results for this quarter and I need some opinions.  We previously swabbed 4 separate spots on our mixers/ hoppers, and the process was slowing production and often yielding some strange results- fail a spot for example, re-clean and fail with a larger number.   We moved to composite swabs because whenever they would come back with a failing swab, they would only re-clean the one are on the mixer that failed- ie one corner.  However, while that was our standard process for years (prior to myself filling the position), I actually don't think it was a best practice as to me if one corner failed, they all are likely bad and need re-cleaned.  So now we have one swab for all parts of the equipment, so that when the swab fails the whole piece of equipment is re-cleaned, which to me is the safest method- and will yield the most accurate results.

 

My issue comes with the fact that if we only swab each piece of equipment once weekly, and there are 12 swabs in a quarter, one failure could have us at a low passing percentage >90 for example.  No equipment will pass 100% of the time, especially with human error always being a factor.  So, how do I handle this when trending my results.  What does everyone else do, I can't increase the cleans, as that would have us ATP swabbing each piece daily, and we'd likely never get to producing, and I can't imagine that any company does that.

 

Can anyone share any opinions on an acceptable pass/fail percentage for equipment cleaning? We trend each specific piece individually, so each mixer, hopper etc.

 

Thanks!



Charles.C

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Posted 01 July 2020 - 01:55 PM

Hello All,

 

We perform pre-operational ATP swabs on our equipment.  Currently we have a pass/ fail, with 50 being our limit and any results of 50+ must be re-cleaned with a passing re-swab prior to use.  Our sanitation on our equipment is performed nightly, and they are allowed to dry overnight before swabs are performed. If they fail prior to production, they must be cleaned, swabbed, sanitized and then dried as our product is all dry mixture.  It's quite a process, and can get tedious.  

 

We are currently in the process of trending our results for this quarter and I need some opinions.  We previously swabbed 4 separate spots on our mixers/ hoppers, and the process was slowing production and often yielding some strange results- fail a spot for example, re-clean and fail with a larger number.   We moved to composite swabs because whenever they would come back with a failing swab, they would only re-clean the one are on the mixer that failed- ie one corner.  However, while that was our standard process for years (prior to myself filling the position), I actually don't think it was a best practice as to me if one corner failed, they all are likely bad and need re-cleaned.  So now we have one swab for all parts of the equipment, so that when the swab fails the whole piece of equipment is re-cleaned, which to me is the safest method- and will yield the most accurate results.

 

My issue comes with the fact that if we only swab each piece of equipment once weekly, and there are 12 swabs in a quarter, one failure could have us at a low passing percentage >90 for example.  No equipment will pass 100% of the time, especially with human error always being a factor.  So, how do I handle this when trending my results.  What does everyone else do, I can't increase the cleans, as that would have us ATP swabbing each piece daily, and we'd likely never get to producing, and I can't imagine that any company does that.

 

Can anyone share any opinions on an acceptable pass/fail percentage for equipment cleaning? We trend each specific piece individually, so each mixer, hopper etc.

 

Thanks!

So what kind of product/process ? RTE ?

 

Offhand it all sounds like major overkill but my experience is totally with micro. verification which is a bit more informative and somewhat escapes the immediate response syndrome.


Kind Regards,

 

Charles.C


YNA QA

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Posted 01 July 2020 - 02:08 PM

Dry mixes.  None are RTE, most require further processing and some are add water only.  Our add water only are mostly sugar/sugar alternative and some flavors and process additives etc.  We do Zone 2-4 Environmental on those areas monthly and have never had an issue.



zanorias

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Posted 01 July 2020 - 06:25 PM

Could you increase the number of swabs? That would lessen the impact of an anomaly fail on your %, but at the same time provide greater data and better reveal if there is an issue with the cleaning.

Alternatively review your acceptance limit of 50 if there is feasibility to do so? IME sometimes set levels are a bit arbitrary.



LostMyMind

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Posted 01 July 2020 - 09:51 PM

First, IMO, the value of ATP system is mixed at best.  Please understand this as you read the following:

 

At its root, an ATP system provides a numeric value that equates to a specific measure of cleanliness.  The numbers assigned for a pass/fail from these manufacturer are typically arbitrary and, in my experience, become problematic when the same set of values is utilized across multiple materials/surfaces, etc. (See Hygiena's take on it: https://www.hygiena....imits-food.html).

 

The level of cleanliness you need is specific to your environment, risks, etc.  That level of cleanliness obtainable is also dependent upon the materials being cleaned, time/resources/methodologies involved in the cleaning, etc.  People expect perfect; that doesn't happen, so what is realistic and reasonable given the underlying risks involved?  (And all the auditors cringe here.)  

 

Personally I conduct a series of studies to determine ranges (literally green, yellow and red) of results for the materials and cleaning processes in place.  A 0-50 range might be too high for one surface, but too low for another.  These studies should be material type specific (group results as much as you can; KISS methodology).  I know that a stainless steel surface can routinely be cleaned to a lower ATP result than the weird, ridged, non-smooth packaging belt that we have on one machine that was added before my time.  Both surfaces need to be cleaned, but the ATP ranges I use to check those efforts are different. 

 

I would also caution you about being too stringent on the ranges and make sure that realistic figures are in place and then hold people accountable to those.  Constantly being over isn't going to get management to invest in more resources.  Involving them in the new logic, showing them how it is more reasonable/realistic means that later on showing them a negative trending line will help you get action.  Also, you can, later on, set a goal of reducing the average ATP scores by X% over the next Y months.  (Audit schemes and auditors love goals).

 

I did my studies without the C&S team knowing about the project.  That way I could see what was really occurring; that created the baseline.  ATP swabs are cheap enough to burn through a box or two.  Just make to document it all because you will get questioned about the logic and your sanity during an audit.

 

As I said, I take our ATP results with a grain of salt.  It doesn't mean that everything is good, but will possibly help you to document when things aren't.  A flashlight is a better tool and cheaper, but using one isn't graded on an audit; hence ATP swabs.

 

My, not sure if this helps, two cents....

 

Good Luck,

 

LostMyMind


Edited by LostMyMind, 01 July 2020 - 09:52 PM.


Ryan M.

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Posted 01 July 2020 - 10:48 PM

I hate relying on ATP swab results for equipment cleanliness.  In my experience there is too much variability and I don't care what the swab vendors say sanitizer does have an affect on the results giving many false positives.

 

A much better method is to use microbial swabbing studies over a period of time in defined locations on each piece of equipment.  When I've done this I have always looked at the most difficult part of the equipment to clean and use that as the key test, of course I've used many different locations on a piece of equipment for the study.  Once the study is complete and you have expectations of micro load after sanitation then you can monitor it periodically.

 

Personally I prefer visual inspection, but this is only as effective as the person doing the inspection and their knowledge and training.  It is much more difficult to train persons to do adequately than to just take some ATP swabs on a piece of equipment and get pass / fail.

 

As you probably have read in other responses by now is that the answer really "depends". You need to be able to justify with is a "good" or "acceptable" number for your process and facility.  But, if you can try to do more with microbial swabbing and results.  You will get much better bang for your buck with those.



Charles.C

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Posted 02 July 2020 - 02:46 AM

As per my previous post, I'm not an ATP user but I agree with, at least, an appraisal such as in  Ryan's Post/last paragraph although ATP is surely a simpler, faster, day-by-day option if  it  can be "pragmatically"  implemented.

 

afaik generally, and particularly in a "questionable" situation, ATP references recommend to establish a "baseline". This corresponds to a compromise between (a) what yr cleaning process can actually, realistically, achieve and (b) what you consider is an acceptably clean surface. One ATP equipment manufacturer offers a simple statistical procedure to generate a baseline, eg do 5 routine cleaning/sanitising runs to produce an "acceptable" surface and calculate pass/fail limits for your associated ATP data.

(b) can be interpreted micro-wise and a look in the Literature will reveal considerable variation of opinion regarding acceptable limits (just like ATP). Logically the particular choice has "some"  relationship to yr process, eg product-surface type/NRTE/RTE/actual operation but an idea can be extracted from this compilation -

 

https://www.ifsqn.co...ces/#entry60958


Kind Regards,

 

Charles.C


foodguy63

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Posted 02 July 2020 - 11:36 AM

Here is my ten cents worth, but really just agreeing with everything said above:

 

I would highly recommend taking the time to set a baseline for your equipment rather than the standard "50". Your ATP system supplier should be able to help you with that process. This will help set realistic limits that have micro data to back it. I also trend/compare ATP and APC results biannually to confirm the results are relevant.

 

We perform all of our ATP swabbing pre-sanitizer application. It is my experience as well that sanitizer can and will skew results.

 

Lastly, ATP testing is a tool that should always be used in conjunction with a visual pre-op inspection performed with a good flashlight and a qualified individual. We never rely on ATP results by themselves and are trying to break the old habit of spot cleaning a line clean.

 

Hope this helps!


Best,

 

foodguy63


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