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Verification/Validation of cleaning for non-product contact areas


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#1 ksteele

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Posted 26 February 2016 - 02:47 PM

Ok, So I understand verification and validation of cleaning product contact areas, but what about breakrooms and restrooms? Do we need a validation and verification of non-product contact areas? Floor sweepings? Anyone have any guidance?



#2 ncorliss

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Posted 26 February 2016 - 03:11 PM

Without knowing your product type and facility I could not say confidently. We are a food packaging facility and we do not perform validation other than random inspections and on a maintenance log. We added these areas to our HACCP plan and implemented personnel practices to address any risk of using the facility.



#3 esquef

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Posted 26 February 2016 - 08:05 PM

For SQF you wouldn't need to validate prerequisite programs involving cleaning and sanitation of staff amenity areas such as break rooms, locker rooms, and toilet facilities, but you would need to have these procedures as SSOPs and have them on your Master Cleaning Schedule. I think it's safe to say that you'd need to have someone (your Sanitation Manager for example) verify that these activities are being done as scheduled and per the related SSOPs.

One thing to keep in mind, however, is that if your company has an Environmental Monitoring Program you may have to perform random swabbing of Zone 4 surfaces at defined frequencies and take appropriate corrective action if you get any positives for potential pathogens. Also, if you get any positives on Zone 2 or 3 in you production areas (assuming that you're not swabbing Zone 1 surfaces), in your corrective actions vector those positive results to staff amenity areas which would require effective corrective action(s).

FSMA may be a bit different. I'm not sure that anyone is certain what Preventive Control activities will be necessary with respect to validation/verification of staff amenity areas, but I'm guessing that it'll be similar to current SQF Level 2 and 3 code. The upcoming FSMA Guidance Documents will hopefully clarify this (if FDA ever releases them).



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#4 Charles.C

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Posted 26 February 2016 - 09:36 PM

Hi ksteele,

 

I haven't checked the packaging module but for food, it is currently not required to validate the designated (SQF) Prerequisites at all. This has been discussed previously.

 

The only caveat for above  is that individual SQF auditor's interpretation of the distinction between Codex Validation/Verification can be somewhat "wonky". Also discussed previously at great length.


Kind Regards,

 

Charles.C


#5 ksteele

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Posted 29 February 2016 - 01:13 PM

For SQF you wouldn't need to validate prerequisite programs involving cleaning and sanitation of staff amenity areas such as break rooms, locker rooms, and toilet facilities, but you would need to have these procedures as SSOPs and have them on your Master Cleaning Schedule. I think it's safe to say that you'd need to have someone (your Sanitation Manager for example) verify that these activities are being done as scheduled and per the related SSOPs.

One thing to keep in mind, however, is that if your company has an Environmental Monitoring Program you may have to perform random swabbing of Zone 4 surfaces at defined frequencies and take appropriate corrective action if you get any positives for potential pathogens. Also, if you get any positives on Zone 2 or 3 in you production areas (assuming that you're not swabbing Zone 1 surfaces), in your corrective actions vector those positive results to staff amenity areas which would require effective corrective action(s).

FSMA may be a bit different. I'm not sure that anyone is certain what Preventive Control activities will be necessary with respect to validation/verification of staff amenity areas, but I'm guessing that it'll be similar to current SQF Level 2 and 3 code. The upcoming FSMA Guidance Documents will hopefully clarify this (if FDA ever releases them).

Esquef-

I'm sorry I missed the detail, we produce food packaging so at this point we don't have defined zones or any environmental monitoring protocols. We do, however have a master sanitation schedule where we log cleanings of facilities and equipment and Work Instructions for sanitation. We are exempt from FSMA at this point  :shades:



#6 ncorliss

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Posted 29 February 2016 - 02:46 PM

Following your pre-requisites and having personnel practices that address the use of facilities and appropriate hand washing afterwards should be sufficient. I wasn't with my current employer when they implemented SQF, but I was informed they were required to have a separated pass through into the restroom for facilities that entered in to the plant.  Meaning we had two separate doors, before entering into the bathroom. I can send you pictures if you are interested. We don't do any swab validation / verification, the only verification we do is perform a monthly plant walk through, daily 5s audits, and internal audit of the facility. This has been sufficient so far.

 

In regards to FSMA, so far I am not aware of any swab verification / validation requirements. I know FSMA is not applicable to packaging in some regards, but be mindful of the Foreign Supplier Verification Program. From seminars I've attended, if you buy raw materials from a foreign supplier, you will be required to have a food safety plan to help ensure your supplier is performing and supplying safe product. You may be requested to send documentation to an FDA as an audit. I believe the owner of the raw material when imported to the US is required to have the appropriate evidence of compliance. If you serve a particular food industry, you may want to look at ensuring your suppliers are providing FDA CFR letters for the materials and perform any microbiological testing of your raw materials.



#7 ksteele

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Posted 29 February 2016 - 04:23 PM

Ncorliss- I would be interested in pictures! I will send you a message with my email address. We do not currently have two separate doors, is this required for the break room as well? We saw that in the standard and are investigating affordable ways to address the issue. When you say we added areas to our HACCP plan what do you mean by that? How did you evaluate them? 

 

Again, lucky us, we do not purchase from any foreign suppliers. We will have to add a requirement if we begin purchasing though. And we do currently have CFR letters for all raw materials. Micro testing would be slightly overkill because we mold plastic, so any micro contaminates would be killed at the 500+ degrees we mold at. 



#8 ncorliss

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Posted 29 February 2016 - 04:43 PM

Our break room doesn't open directly into the plant, so this wasn't an issue. For the HACCP, we included the risk of contamination from restroom and lunch breaks. To mitigate the risk, our corrective actions were to have handwashing policy, allergen food brought in from employee policy (ensuring clothing and hands are clean after consuming), and regular cleaning schedule of our facilities.

 

We also mold plastic components, however since we are a an FDA IMS listed supplier under the Pasteurized Milk Ordinance, we are required to perform microbiological testing. I don't know the industry you serve, but just something to look in to. An SQF Auditor may ask you what regulatory and / or testing requirements you are require to perform for your specific industry. You may want to show them you've done your research in to the respective industry you serve. Maybe even include your molding processes at 500+ degrees as a mitigating step. If you're associates do not handle product after molding, you probably are ok.



#9 ncorliss

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Posted 29 February 2016 - 05:32 PM

I just went and checked the code. Section 13.3.8.1 ii. states toilet rooms shall be: "accessed from the manufacturing are via an airlock vented to the exterior or through an adjoining room".






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