5 replies to this topic

[delta_seven]

Good morning, experts,

 

I’m seeking your expert opinion regarding our environmental monitoring program (EMP) for microbiological testing.

 

During our recent BRC audit, we presented our EMP, which is based on a risk assessment. According to our risk matrix, swabbing of food-contact surfaces for micro testing is conducted weekly during pre-operational inspections.

However, the auditor suggested that swabbing should instead be performed during production, and raised this as a minor non‑conformance.

 

Upon reviewing clause BRCGS 4.11.8.1, I could not find any specific requirement regarding when the sampling must occur.

 

 

thank you very much!

[Ishau]

Good question. I would agree that the non-conformance, at least based on how you have described it, sounds a bit odd.

Are you able to share the exact wording with us?

 

Clause 4.11.8.1 simply requires that the environmental monitoring programme is risk-based and includes the documented sampling procedures, locations, frequency, target organisms, methods, and recording/evaluation of results. No where does it actually specify when sampling must occur (e.g. pre-operational, during production, or post-production) nor does it specify a frequency.

 

The key question should really be whether the risk assessment supports your chosen approach, rather than whether the sampling is conducted at a particular point in time.

 

In my experience pre-operational swabbing is commonly used to verify the effectiveness of cleaning and sanitation before start-up, and this can be perfectly reasonable depending on the product and process risk. Sampling during production tends to be more in situations where the objective is to detect contamination introduced during processing (for example personnel activity, product contact, or environmental transfer), particularly in high-risk/high-care ready-to-eat environments. Again there is no specific requirement, it's based on the output from the risk assessment.

 

For the non-conformance to be justified the auditor would need to demonstrate that your risk assessment is insufficient and/or does not adequately justify why sampling is limited to pre-operational inspections, rather than simply stating that swabbing should be conducted during production.

 

If they have actually raised this as a non-conformance, then depending on the wording I'd be exploring the appeal route and highlighting that it is not possible to raise a non-conformance against something that is not a requirement.

[GMO]

Hmm.

 

Is this Listeria swabbing?

How much do you want to protect your consumers?
 

Ok I'm in a feisty mood this morning perhaps! But if this is Listeria swabbing then you can probably argue the non con is not valid vs. the standard and you might get it removed.

BUT is it a good idea to swab during production for Listeria? HELL YES and failing to do so will put your consumers at risk.

 

Ok, think about it. Listeria is one of those lovely organisms which sometimes gets embedded into machines in chilled food factories. You clean it, you disinfect it then you swab it and prove it's not there before production starts. Great. Problem is that as the machine moves during production, contamination deep within that machine will slowly seep out and if you're not doing any testing to detect that, you won't find it. You won't know. It's relying on post clean swabs passing which was a contributory factor to the deaths in Maple Leaf.

 

I also know of another supplier who had Listeria in a spiral chiller. They only found it when they swabbed those rollers over the shift. It took 5 hours before the listeria was detectable but at the end of shift they were always positive. If they'd only swabbed after cleaning, they'd have missed the harbourage which was making their food unsafe.

 

All in all if the non con was to the spirit or letter of the BRCGS requirements, you can argue the toss if you want but has the auditor raised a point which does speak to how you've risk assessed your testing? Yes I'd say so. I think that's a really good non conformance which, if you address it, will help the food safety of your product. And isn't that why we're doing GFSI audits? Not just for compliance?

 

I'd buy that auditor a cup of tea and a cake and say thank you.

[MDaleDDF]

I'd tend to agree with Ishau.    If you're doing pre-op swabs, and testing finished product, you should be good.   As stated previously it depends on your product and RA though.   For our place I have it written up that we only swab after cleaning SSOP's have been run.   I don't swab anything that hasn't been cleaned.   

GMO has some valid points as well though, and they may be spot on depending on your product/process.

 

But the day I buy an auditor tea and cake it'll be snowing in hades.....lol.   If anyone is getting tea and cake, it's me.

[Scampi]

Depending on your product risk, here's some food for thought (pardon the pun)

EMPs: When to Sample and Why Pre-Operation When: After cleaning & before sanitation Why: Verify cleaning efficacy First Shift When: 3-4 hours into production Why: Verify that GMPs are effective; verify absence of embedded bacteria in equipment not reached by cleaning and sanitation that are exposed by the movement of equipment during production. Second Shift When: Prior to clean-up Why: Verify GMPs are effective; verify equipment does not have embedded bacteria that are exposed by the movement of equipment during production. Investigation When: Before cleaning and sanitation to identify harborage​ sites and determine how they are spreading via vector sample collection. Why: Usually done in response to multiple positives in a given area and when you need to determine the origin of contamination.

[tahoeskier]

The most important time to collect environmental samples is at a time that is several hours into production (e.g., 3 to 4 hours) or preferably just prior to cleanup, because this allows time for L. monocytogenes (if present) to work its way out of harborage sites and contaminate the environment, the processing line (including FCS sites), and, potentially, RTE product.

 

Except above is from Control of Listeria monocytogenes in Ready-To-Eat Foods: Guidance for Industry Draft Guidance

Guidance for Industry

 

Best to read the guidance and then you can reference it in your procedures.