6 replies to this topic

[RazM4tt]

Now that 2023 is over, im looking at all of the data we have gathered from our production rooms (powders and liquids for consumption) and need to create a trend report and identify areas of concern. I was not managing the program last year, so im only working with what I was given. The program needs some attention as data was being gathered but it is not consistent/frequent enough. Here are the parameters im working with, along with my concerns and questions:

 

-16 production rooms (8 of these rooms are the exact same type of room, similar equipment and same products are produced in them, all powders)

-of course we are testing 3 zones. Zone 1 and 3 are tested 1/mo (in 1 room) and zone 2 is tested 2/month for a total of 4 rooms being swabbed per month. That gives us 48 sets of swabbing data over 12 months across 16 rooms. Thats only 3 sets of data per room per year and not even in the same zone. Each round of swabbing (zone 1,2,3) consists of 10 sample sites which is difficult to get in smaller rooms or more limited zones.

-Swabbing is done after sanitation (before production)

 

This being said, Id like to INCREASE how often we swab but DECREASE the amount of samples taken.

-Is there a minimum amount of samples required for swabbing? I feel 6-8 is appropriate for the size of our production rooms (some are as small as 10x10).

-For auditing, does data NEED to be trended or could the data simply be reported in a way that allows it to be analyzed (such as a bar graph or pie chart). I don't have enough data over time to create an actual trend for each room.

-Is it appropriate to group rooms that are similar in nature together (same product/equipment/processes) for trending purposes

 

Most of the stuff that Ive seen about EM is simply "do what you feel is right", "risk assessment for your facility". Are there any quantitative requirements for these programs (such as minimum amount of samples per room per zone).

 

Thank you for all the help, I hope I provided enough context to understand what I need. 

[jfrey123]

Does your certified lab offer an online portal for you to download data into Excel?  You'd be surprised what you can do with it once you start playing with pivot tables.  I trend the EMP results for 10 different plants each month, typically just a bar graph showing the total swabs with a second line showing the total out-of-spec.  It lets us monitor whether a plant starts increasing their swabs (then we check if they're hunting for something or trying to increase total swabs to decrease their out of spec %).  If something visually starts to look off, increased out of specs over a period or repeat out of specs in a 3 month window, we'll dive deeper into the trend analysis.  Note that I help report on this at a corporate level; our plant QA's are still keeping a closer eye on their specific facility.

 

On an annual basis, I will go through the past year's data and do a deeper dive.  I'm doing it right now actually lol.  I pull up the out of spec findings into their own specific chart with the location codes and identify where the hottest spots have been.  I'll do a write up about how frequently the most common sites hit, and whether there's anything to suggest there was transmission within the plant or the spot just needs more frequently cleaning.

 

Example:  one of my plants hit for a suspect listeria 7 times in one spot in 2023.  3 of those hits were in the same month (1 original swab, two additional suspects during the vector swab monitoring of the area).  The fact it hit 4 additional times over the year made it something worth discussing in their annual report.  We're expecting plant QA to update their sanitation to focus on that area.  But luckily, review of the adjacent locations on their map showed no suspects by proximity and we're confident we don't have a situation where listeria on the floor is being tracked around the facility.

[RazM4tt]

Does your certified lab offer an online portal for you to download data into Excel?  You'd be surprised what you can do with it once you start playing with pivot tables.  I trend the EMP results for 10 different plants each month, typically just a bar graph showing the total swabs with a second line showing the total out-of-spec.  It lets us monitor whether a plant starts increasing their swabs (then we check if they're hunting for something or trying to increase total swabs to decrease their out of spec %).  If something visually starts to look off, increased out of specs over a period or repeat out of specs in a 3 month window, we'll dive deeper into the trend analysis.  Note that I help report on this at a corporate level; our plant QA's are still keeping a closer eye on their specific facility.

 

On an annual basis, I will go through the past year's data and do a deeper dive.  I'm doing it right now actually lol.  I pull up the out of spec findings into their own specific chart with the location codes and identify where the hottest spots have been.  I'll do a write up about how frequently the most common sites hit, and whether there's anything to suggest there was transmission within the plant or the spot just needs more frequently cleaning.

 

Example:  one of my plants hit for a suspect listeria 7 times in one spot in 2023.  3 of those hits were in the same month (1 original swab, two additional suspects during the vector swab monitoring of the area).  The fact it hit 4 additional times over the year made it something worth discussing in their annual report.  We're expecting plant QA to update their sanitation to focus on that area.  But luckily, review of the adjacent locations on their map showed no suspects by proximity and we're confident we don't have a situation where listeria on the floor is being tracked around the facility.

 

Unfortunately our certified lab does not have that, we are looking to switching labs soon though because the one the company has been using for the past 10 years is many states away and shipping is a nightmare. In addition, 6 months into 2023 they switched from swabbing before sanitation (i dont know why they were doing this) to swabbing after sanitation. That means my data is split down the middle and im basically having to do 2 reports. We are switching to using a software that will allow us to trend and analyze the data as we put it into the system, so that will help for 2024. For now, im on my own doing it manually.

[liberator]

"-Swabbing is done after sanitation (before production)"

All your doing here by swabbing after sanitation is verifying that your cleaning program  is effective, i.e. has it done it's job. You may as well just do some ATP swabs to show that the cleaning has been effective or have the cleaning program validated. If you have a product microbial failure you may start to ask how, our plant was swabbed and clean.

 

You're not really seeing what risk there are during production. Typically swabbing is recommended at some point during the production process, i.e. after four hours or so and then you then swab the plant under normal/typically operating parameters. If you find evidence of counts then you can act on that. Dirty equipment with product hang up, water dripping onto a line, cross contamination, employee hygiene, dirty floors, boots, equipment,  the list is endless. The point of swabbing is to find the issue before it gets into your product.

[RazM4tt]

"-Swabbing is done after sanitation (before production)"

All your doing here by swabbing after sanitation is verifying that your cleaning program  is effective, i.e. has it done it's job. You may as well just do some ATP swabs to show that the cleaning has been effective or have the cleaning program validated. If you have a product microbial failure you may start to ask how, our plant was swabbed and clean.

 

You're not really seeing what risk there are during production. Typically swabbing is recommended at some point during the production process, i.e. after four hours or so and then you then swab the plant under normal/typically operating parameters. If you find evidence of counts then you can act on that. Dirty equipment with product hang up, water dripping onto a line, cross contamination, employee hygiene, dirty floors, boots, equipment,  the list is endless. The point of swabbing is to find the issue before it gets into your product.

From what I understand that would be the best way to do things. Unfortunately at this facility, it would only be possible to do that in about 3 / 16 of the rooms. We do product and ATP testing, so the "after sanitation" swabbing that we do is assessing the status of the rooms before production. Im also very open to changing this process to "during production" for zone 1 and 2 items. What im currently trying to assess is - Is it normal for an EM program to do swabbing in each room once / year for each zone? I feel like it should be much more than that. In any given room, only have 1-2 sets of data for 1 out of 3 of the zones. 

 

Im trying to find out what the minimum number of swabs is, so that I can reduce the number of swabbing done in a room and put the cost of testing towards something more important. ie if a room that is 10x10 is getting 10 swabs, can i reduce it to 6? We literally dont have enough swab points for 10 swabs so we end up doing different sides of the same leg of a table or frame of an air vent. Thanks for the feedback.

[liberator]

I should have asked, what are you swabbing for, pathogens or indicator organisms?

 

It's always difficult to say how many swabs you should be taking as it all depends on the product, the plant, the process and the defined risk. I don't think enough swabbing is been undertaken but I could be wrong as I don't know your process.

 

What's the history, what's been detected? I'm guessing very little as the swabs are taken post clean/sanitising.  I would also suggest swabbing like areas (e.g. conveyor, swab the top and bottom of the belt, the guides etc - 4-5 swabs in total and test that as a composite, then if any high counts/positives come back from the test, then test the same areas again but individually.

[RazM4tt]

I should have asked, what are you swabbing for, pathogens or indicator organisms?

 

It's always difficult to say how many swabs you should be taking as it all depends on the product, the plant, the process and the defined risk. I don't think enough swabbing is been undertaken but I could be wrong as I don't know your process.

 

What's the history, what's been detected? I'm guessing very little as the swabs are taken post clean/sanitising.  I would also suggest swabbing like areas (e.g. conveyor, swab the top and bottom of the belt, the guides etc - 4-5 swabs in total and test that as a composite, then if any high counts/positives come back from the test, then test the same areas again but individually.

Im doing coliform, APC Salmonella and for zone 3 only do listeria as well.