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2.4.8. Environmental Monitoring - Packaging


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#26 olshanka

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Posted 22 May 2018 - 07:02 PM

good for you scampi, thanks for nothing



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#27 AKmuz

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Posted 06 June 2018 - 07:17 PM

scampi, please kindly can you share with me how you performed the risk assessment. Any template or what was the elements you considered?

 

Thanks 



#28 Scampi

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Posted 06 June 2018 - 08:22 PM

I have posted my risk assessment here.

 

 

To Previous poster....I was including my situation because not all members have a high risk/high care product that would require environmental swabbing. So i felt it was worth adding

 

Attached File  2.4.8 Environmental Risk Assessment and Program.docx   28.37KB   500 downloads

 

2.4.8 Environmental Monitoring
2.4.8.1 A risk-based environmental monitoring program shall be in place for all food and pet food manufacturing
processes.
2.4.8.2 The responsibility and methods for the environmental monitoring program shall be documented and
implemented.
2.4.8.3 An environmental sampling and testing schedule shall be prepared, detailing the applicable pathogens or
indicator organisms to test for that industry, the number of samples to be taken and the frequency of sampling.

Please stop referring to me as Sir/sirs


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#29 Charles.C

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Posted 07 June 2018 - 12:00 AM

 

I have posted my risk assessment here.

 

 

To Previous poster....I was including my situation because not all members have a high risk/high care product that would require environmental swabbing. So i felt it was worth adding

 

attachicon.gif 2.4.8 Environmental Risk Assessment and Program.docx

 

2.4.8 Environmental Monitoring
2.4.8.1 A risk-based environmental monitoring program shall be in place for all food and pet food manufacturing
processes.
2.4.8.2 The responsibility and methods for the environmental monitoring program shall be documented and
implemented.
2.4.8.3 An environmental sampling and testing schedule shall be prepared, detailing the applicable pathogens or
indicator organisms to test for that industry, the number of samples to be taken and the frequency of sampling.

 

 

Hi Scampi,

 

Just to note that this thread was initiated for Packaging whereas above quote/attachment are Food oriented although the Packaging Code text is anyway very similar.

(Risk matrix/Table in attachment have somewhat unconventional labelling IMO but i daresay this is subjective).

 

There is also a 2.4.8.4 in both Food/Packaging/Standards -

 

2.4.8.4  : Environmental testing results shall be monitored and corrective actions (refer to 2.5.3.1) implemented where unsatisfactory trends are observed.

So many "shalls" to be shortly  ignored !

 

the SQF Manufacturing  Food Guidance has this intriguing comment  -

 

The  reference  to  the  environmental  monitoring  program  is  self-explanatory,  but  is  worth  repeating  as  it  is considered mandatory for areas in which high risk food is processed, handled or exposed.  Failure to have an effective environmental monitoring program will result in a major non-conformance.

 

I agree, as I think you have interpreted, that the above may logically imply  that EMP is not mandatory for "Low Risk Food"( SQF defined as "A food containing high acid that is not known to support the growth of pathogens; a food that is subject to a full cook prior to consumption"). The Guidance should have been more specific regarding EMP for both High and Low Risk Foods IMO. As I understand, IYEX, food auditors accept that "risk-based" can be interpreted to mean that EMP may be omitted for Low Risk foods.

 

Unfortunately there is no Guidance document for SQF Safety Packaging Code afaik so Packaging auditors may not  interpret "risk-based" options as discussed above but only in relation to an implemented EMP sampling/frequency . Especially in view of clause 2.4.8.4.  I guess only time/experience will tell or perhaps an appearance of a Packaging Guidance. Or an SQF site announcement.


Edited by Charles.C, 07 June 2018 - 11:44 AM.
edited

Kind Regards,

 

Charles.C


#30 tezza07

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Posted 16 October 2018 - 02:59 PM

When the code says anything about risk-based then it's really up to you, just make sure the risk assessment is documented. You should do some swabbing to have a baseline negative to back up your risk assessment. As well as document the program so that, if the need comes up, you already have a program in place to do environmental sampling.

 

We recently had our Ed. 8 audit and we had a documented program to test for E. coli and B. cereus (as per our consultant). We have created zones within our facility and will be testing to ensure every zone and equipment area is tested once annually. Once we have a baseline negative we will revisit and see if we can opt out entirely or reduce the frequency of monitoring.

 

Although tbh, the way the industry is moving, it's going to be hard to justify not swabbing occasionally to verify the sanitation program.

 

We are a low-risk dry environment (paper-based packaging manufacturer)



#31 Hoosiersmoker

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Posted 01 November 2018 - 02:28 PM

Kind of late to the party but our HACCP plan includes risks based on biological / environmental risks and we have (successfully) used that as our risk assessment and it has been accepted. I hope the changes to Ed 8 haven't changed that. Other than specifically testing our compressed air (not technically environmental testing) we don't do any other swabbing etc. Now I'm nervous about it! Our audit is next Thursday and Friday, 11/8 & 11/9.



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#32 tezza07

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Posted 02 November 2018 - 01:40 PM

Kind of late to the party but our HACCP plan includes risks based on biological / environmental risks and we have (successfully) used that as our risk assessment and it has been accepted. I hope the changes to Ed 8 haven't changed that. Other than specifically testing our compressed air (not technically environmental testing) we don't do any other swabbing etc. Now I'm nervous about it! Our audit is next Thursday and Friday, 11/8 & 11/9.

 

I wouldn't worry too much about it. If you completely ignored the EMP section and had no documented risk assessment that would be an issue. But because you have a documented risk assessment you should be okay (or maybe get a minor at most). It would be a good idea to swab some areas maybe once a year and test for possible pathogens. Having negative test results to back up your risk assessment would be beneficial.

 

We are a food packaging manufacturer. We recently had our SQF Ed. 8 audit and EMP did come up as a minor, so we introduced a swabbing schedule of product contact surfaces, drains, and floors. We divided our production area into zones (6 zones total), and every 2 months we pick 2 zones and swab floor, drain, and product contact surface in each zone, and we test for B. cereus and E. coli O157:H7. So every zone is tested once every 6 months. I'm hoping that after a year or two of negative swabs we'll be able to dial it back to once a year to save on cost.

 

Also make sure you review your customer requirements to ensure you're meeting them. Beginning in 2019 we have to add a couple more pathogens to our EMP program because one of our major customers requires it for all direct food contact packaging suppliers.



#33 tezza07

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Posted 02 November 2018 - 01:42 PM

Clearly it's been a busy month, I basically posted the same reply twice. Honestly don't remember ever posting the first one. TGIF!!!  :lol:  :lol:  :lol:



#34 Charles.C

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Posted 02 November 2018 - 10:09 PM

Just a comment that auditors will IMEX rarely tell you if you are exceeding the Standard's requirements.

 

There is still afaik no SQF Packaging Guidance so the minimal content for compliance unfortunately remains unknown.

 

It should be re-iterated that no detailed swabbing regimes for validated low risk processes may yet be acceptable.


Kind Regards,

 

Charles.C


#35 Hoosiersmoker

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Posted 09 November 2018 - 05:44 PM

The HACCP risk analysis was rejected - Major non-conformance. Auditor is still here and has systematically disected every element since then with a vengeance. Several minors since then.



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#36 Scampi

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Posted 09 November 2018 - 06:02 PM

Pull up the guidance for food manufacturing and show auditor where is specifically states the risk assessment is what is required.

 

PM me your email and I will forward you the email I received from SQFI in Virginia


Please stop referring to me as Sir/sirs


#37 Scampi

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Posted 09 November 2018 - 06:04 PM

Sorry---reread your post.................auditor rejected your HACCP hazard analysis????????????????

 

I would be stopping and requesting a new auditor (if that's even a possibility for you)


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#38 MsMars

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Posted 09 November 2018 - 06:23 PM

The HACCP risk analysis was rejected - Major non-conformance. Auditor is still here and has systematically disected every element since then with a vengeance. Several minors since then.

 

Did he/she say why? 

Stay calm, roll with it.  Politely ask to see specifics in the code if there is a question.  Once you get your audit report, you can also, in turn, dissect your major/minor non-conformance and raise the issue with the certifying body. 

We are here for you if you need us - keep us updated!



#39 tezza07

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Posted 09 November 2018 - 09:24 PM

Oh no :( I'm so sorry to hear that.

 

Respectfully ask the auditor what their basis is for rejecting the HACCP risk assessment. Specifically ask which clause he's issuing the major NC against.

 

I would at least push that if it must be an NC that it should be a minor, as you do have a documented HACCP-based risk assessment. It's not like you outright ignored EMP.

 

If you are unhappy with the result you can always raise it with the CB and try to have it changed. Our sister plant had one of their majors changed to a minor by doing this.

 

Keep us posted! And try not to stress out about it too much.



#40 Hoosiersmoker

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Posted 09 November 2018 - 10:26 PM

Ok the major was actually for the environmental monitoring. He rejected our risk assessment for our HACCP plan even though it named introduction of biologicals



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#41 Hoosiersmoker

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Posted 09 November 2018 - 10:28 PM

Since we had no elements from the section it was a major. We're were once point from going into surveillance audits



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#42 Charles.C

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Posted 11 November 2018 - 04:36 AM

Since we had no elements from the section it was a major. We're were once point from going into surveillance audits

 

Hi Hoosiersmoker,

 

Sorry for yr troubles. Understandably, above post is a little confusing.

Which "section" do you mean ?

 

You might consider uploading yr haccp plan together with the specific reasons for its rejection to get some advice/opinions.


Kind Regards,

 

Charles.C


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#43 Peak

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Posted 27 November 2018 - 10:09 PM

I have had some good experience with these testing swabs.  Super easy to use and fairly inexpensive.  They are Path-Check Hygiene Surface Swabs.  Cost me about $250 plus the $350 for the incubator off Amazon.  There are a few different sites to get them from online.

Surface Swab Combo Pack

Specialized combination testing kit pack that includes 10 Listeria, 10 Salmonella and 10 coliform broths, along with 30 surface swabs. These kits are highly convenient for the general hygienic maintenance of environmental work spaces susceptible to these strains of bacteria. Store at refrigerated temperature from 2-8 °C.

 

Combo30pk-nobg.jpg


Edited by Peak, 27 November 2018 - 10:10 PM.

Peak Quality Consulting http://peakqualityconsulting.com

Office (414) 909-3249

 

SQF Practitioner

BRC Professional

HACCP Certified

ASQ CQA - Certified Quality Auditor

 


#44 Julie Y

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Posted 08 December 2018 - 07:51 PM

Just a comment that auditors will IMEX rarely tell you if you are exceeding the Standard's requirements.

 

There is still afaik no SQF Packaging Guidance so the minimal content for compliance unfortunately remains unknown.

 

It should be re-iterated that no detailed swabbing regimes for validated low risk processes may yet be acceptable.

 

I was at a training a week ago with NSF and our trainer said SQF will launch the Packaging Guidlines for SQF in January 2019. FINALLY!!! :)


Edited by Julie Y, 08 December 2018 - 07:52 PM.


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#45 Hoosiersmoker

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Posted 11 June 2019 - 03:21 PM

Just an update. As our position on Environmental Monitoring is basically that it doesn't really apply to our specific situation, we applied for an exemption for that and recieved it last week. Future audits will list the element as N/A. I guess I kind of feel a little like Don Quixote. In retrospect, we received a 10 point deduction for an element that has been determined, albeit after the fact, not applicable to us. That really leaves a bad taste in my mouth!



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#46 tezza07

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Posted 11 June 2019 - 03:31 PM

That's awesome! Better late than never :)

 

Do you mind telling me what kind of packaging you manufacture?



#47 Hoosiersmoker

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Posted 11 June 2019 - 04:09 PM

Mostly bakery type paperboard cartons with windows.



#48 MsMars

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Posted 11 June 2019 - 04:45 PM

Just an update. As our position on Environmental Monitoring is basically that it doesn't really apply to our specific situation, we applied for an exemption for that and recieved it last week. Future audits will list the element as N/A. I guess I kind of feel a little like Don Quixote. In retrospect, we received a 10 point deduction for an element that has been determined, albeit after the fact, not applicable to us. That really leaves a bad taste in my mouth!

 

That's a tough one.... but just gotta keep looking forward! Luckily in the future with your exemption it won't be something that's even left up to an auditor's interpretation. 



#49 Charles.C

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Posted 12 June 2019 - 07:42 AM

Just an update. As our position on Environmental Monitoring is basically that it doesn't really apply to our specific situation, we applied for an exemption for that and recieved it last week. Future audits will list the element as N/A. I guess I kind of feel a little like Don Quixote. In retrospect, we received a 10 point deduction for an element that has been determined, albeit after the fact, not applicable to us. That really leaves a bad taste in my mouth!

 

TBH you should probably consider yourself fortunate. Seemingly regardless of the application, most SQF auditors seem to be rigidly falling back onto the numerous "shall" words in the Code's 2.4.8 section.

 

One wonders on what criteria the "SQF Hierarchy" determined that yr situation(?) "doesn't really apply" .

 

Perhaps yr case was the "Straw on the Camel's back".


Kind Regards,

 

Charles.C


#50 Hoosiersmoker

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Posted 12 June 2019 - 11:42 AM

It's a Non-Mandatory element, so I guess if they determine that it does apply to you, you MUST comply with all parts of it and, unfortunately for us, their starting point was that it applies to everyone whether or not it actually does. We were able to demonstrate that our existing efforts and low risk processes adequately eliminate, or reduce to an acceptable level, the risk. I was interested to find that the stated pathogen in (SQF) 2.4.8.3, Bacillus, is not necessarily harmful, it is in fact present in most human digestive tracts naturally and does not typically survive paper making or our printing processes according to a 2015 study: Reference: "Health safety of food contact paper evaluated by in vitro toxicological methods", Adam Vavrouš, Marketa Dvorakova, Kristina Kejlova, Dagmar Jírová September 2015.

 

I do think that elements that are added are added to all codes without proper vetting to determine if they are applicable. I guess the "Shoot first and ask questions later" approach is applied here. Add them and then let the sites prove they are not needed, which is great until it costs someone their certification. It seems to be a somewhat lazy approach on SQF's part.


Edited by Hoosiersmoker, 12 June 2019 - 11:50 AM.





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