53 replies to this topic

[Quality Is the Goal]

Hello,

 

Please Advice.

 

My company producing food packaging material wax paper ( patty paper). We are preparing to our first SQF audit (transition from AIB GMP audit).  SQF Packaging material guidelines not posted yet, so im really confused.

 

We are dry facility, so limiting the introduction and use of water is one of the primary means of controlling pathogens,  low moisture food packaging facility.

 

2.4.8. Environmental Monitoring - it is not a mandatory element, so should we still develop environmental program and perform swabbing? 

 

We never had any environmental swabbing in the facility, daily cleaning and per-operational inspections, we constantly cleaning the facility and maintaining master sanitation schedule, there was no customer complaints about any types of bacteria on our product.

 

 

Thank You for Your help!

[ctzinck]

I just had my sqf audit last week and got a minor non-conformance for not having a procedure in place, we did some swabs to establish a baseline and were in process of putting policy in place. auditors are looking for this now that its in version 8

[Quality Is the Goal]

I just had my sqf audit last week and got a minor non-conformance for not having a procedure in place, we did some swabs to establish a baseline and were in process of putting policy in place. auditors are looking for this now that its in version 8

Thank You so much for reply! So thats mean i need to do the swabbing. I have the program in place, but we did not do any swabbings yet, i just wanted to know if auditors looking for that.

[adelk2202]

I would definitely develop the program and do some swabs before your audit to show a baseline of negative results. Since you are a low risk facility you would probably only have to swab quarterly after you have developed your baseline. I work in a high risk environment so hopefully someone else can give you a more detailed response. Good luck!

[hbrannan]

I'd like to jump in on this thread if I may...I've been doing some research for my facility as well - we are also a dry facility, manufacturing plastic injected molded items for open-food containers.  What research I've been able to perform has told me we should probably be looking to swab for Salmonella and perhaps e.Coli, as that can come in on a person's hands.  Any advice on other indicators or pathogens we should be swabbing/testing for?

[ctzinck]

I'd like to jump in on this thread if I may...I've been doing some research for my facility as well - we are also a dry facility, manufacturing plastic injected molded items for open-food containers.  What research I've been able to perform has told me we should probably be looking to swab for Salmonella and perhaps e.Coli, as that can come in on a person's hands.  Any advice on other indicators or pathogens we should be swabbing/testing for?

 

our consultant suggested we swab for Enterobacteriaceae.

 

The Enterobacteriaceae are a large family of Gram-negative bacteria that includes, along with many harmless symbionts, many of the more familiar pathogens, such as Salmonella, Escherichia coli, Yersinia pestis, Klebsiella, and Shigella. Other disease-causing bacteria in this family include Proteus, Enterobacter, Serratia, and Citrobacter. This family is the only representative in the order Enterobacteriales of the class Gammaproteobacteria in the phylum Proteobacteria.^[2] Phylogenetically, in the Enterobacteriales, several peptidoglycan-less insect endosymbionts^{[citation needed]} form a sister clade to the Enterobacteriaceae, but as they are not validly described, this group is not officially a taxon; examples of these species are Sodalis, Buchnera, Wigglesworthia, Baumannia cicadellinicola, and Blochmannia, but not former Rickettsias.^[3] Members of the Enterobacteriaceae can be trivially referred to as enterobacteria or "enteric bacteria",^[4] as several members live in the intestines of animals. In fact, the etymology of the family is enterobacterium with the suffix to designate a family (aceae)—not after the genus Enterobacter (which would be "Enterobacteraceae")—and the type genus is Escherichia

[Cravin' Cajun?]

We are a dry seasoning company that has a AA BRC rating.  I have been assured by both BRC auditors that have been through here, as well as an FDA inspector, that no environmental monitoring program is needed for a facility that produces very low risk, shelf-stable products. 

[hbrannan]

Interesting.  I greatly appreciate the information.  However, we are heading for SQF Level 2, and per the SQF Code, Edition 8:

 

2.4.8.1 A risk-based environmental monitoring program, for known or expected concerns, shall be in place for all processes in the manufacture of food packaging.  

 

Although we would be considered very low risk due to the nature of our product and the processes used in our facility(very dry environment, no wet processing, injection molding at very high heat that would kill anything sitting in our raw materials - which may be rare in any case since the raw materials consist mainly of polypropylene resin), I'm still inclined to want to create a program that would satisfy this section of the code.  

 

If anyone else out there has a facility or process similar to ours, I would love to hear what you have in place, or are putting in place for this.  From what I am hearing this shouldn't be too hard to implement, just a matter of zoning and swabbing frequencies combined with potential corrective action and increased/decreased cleaning and sanitization, correct?

[Quality Is the Goal]

Interesting.  I greatly appreciate the information.  However, we are heading for SQF Level 2, and per the SQF Code, Edition 8:

 

2.4.8.1 A risk-based environmental monitoring program, for known or expected concerns, shall be in place for all processes in the manufacture of food packaging.  

 

Although we would be considered very low risk due to the nature of our product and the processes used in our facility(very dry environment, no wet processing, injection molding at very high heat that would kill anything sitting in our raw materials - which may be rare in any case since the raw materials consist mainly of polypropylene resin), I'm still inclined to want to create a program that would satisfy this section of the code.  

 

If anyone else out there has a facility or process similar to ours, I would love to hear what you have in place, or are putting in place for this.  From what I am hearing this shouldn't be too hard to implement, just a matter of zoning and swabbing frequencies combined with potential corrective action and increased/decreased cleaning and sanitization, correct?

I wrote the procedure for direct contact swabs and non contact swabbing, i have the register of all the direct contact surfaces and non direct contact surfaces in the facility. According to my program i took random samples from direct contact surfaces,  non contact surfaces - machines, non direct contact surfaces work areas and non direct contact surfaces plant in general ( restroom, office, etc.)

So yesterday was my first time swabbing the equipment in the facility, we send all the samples  to outside lab for APC and now we are waiting for the results. When i will receive the result i will be able to see if the cleaning in the facility is effective and then i will determine the  frequency of the swabbing.

 

See attached files. Its an example of my procedures. I know its not perfect but this is what i come up with and it was good for USDA Inspector and SQF Auditor in RTE  facility (my previous job).

Attached Files

•  SSOP 6.0 NC APC sampling Program.docx   34.21KB   1104 downloads
•  SSOP 6.1 DC APC sampling Program.docx   32.05KB   932 downloads

[Quality Is the Goal]

I wrote the procedure for direct contact swabs and non contact swabbing, i have the register of all the direct contact surfaces and non direct contact surfaces in the facility. According to my program i took random samples from direct contact surfaces,  non contact surfaces - machines, non direct contact surfaces work areas and non direct contact surfaces plant in general ( restroom, office, etc.)

So yesterday was my first time swabbing the equipment in the facility, we send all the samples  to outside lab for APC and now we are waiting for the results. When i will receive the result i will be able to see if the cleaning in the facility is effective and then i will determine the  frequency of the swabbing.

 

See attached files. Its an example of my procedures. I know its not perfect but this is what i come up with and it was good for USDA Inspector and SQF Auditor in RTE  facility (my previous job).

Forgot to mention that on my previous job we were testing for listeria not  for APC.

[hbrannan]

Fantastic, thank you for the sample document and info, that will be very helpful!

[Quality Is the Goal]

Fantastic, thank you for the sample document and info, that will be very helpful!

No problem if You need anything else let me know. I have no problem with sharing :)

[Charles.C]

No problem if You need anything else let me know. I have no problem with sharing :)

 

Hi QITG,

 

Thks for the input.

 

I hope you inform the lab as to surface area sampled.

 

It will be interesting as to how the lab evaluate/inform the APC results.

[Quality Is the Goal]

Hi QITG,

 

Thks for the input.

 

I hope you inform the lab as to surface area sampled.

 

It will be interesting as to how the lab evaluate/inform the APC results.

Lab provides a transmittal form, so all the information is listed on it, also before scheduling the lab i had a conversation with lab manager to arrange the sampling. 

Lab will provide the report and it will show if APC testing are <100 or <500  or <1000 CFU etc., According to the FDA, normal plate testing is <25 -250 CFU, over 250 CFU its mean TNTC (too numerous to count).

 

FDA website: https://www.fda.gov/...s/ucm063346.htm

[Loni Banaszak]

Lab provides a transmittal form, so all the information is listed on it, also before scheduling the lab i had a conversation with lab manager to arrange the sampling. 

Lab will provide the report and it will show if APC testing are <100 or <500  or <1000 CFU etc., According to the FDA, normal plate testing is <25 -250 CFU, over 250 CFU its mean TNTC (too numerous to count).

 

FDA website: https://www.fda.gov/...s/ucm063346.htm

Hi Quality is the Goal, 

 

Can you provide the name of the lab you use to complete the testing from the swabs? 

[Quality Is the Goal]

Hi Quality is the Goal, 

 

Can you provide the name of the lab you use to complete the testing from the swabs? 

Im using Certified Laboratories http://certified-laboratories.com/

Really like this lab, stuff always ready to help and always helping if i have any questions, also their pricing is really good.

They have a lot of services and testings, one of them is compressed air testing and their tech performing the test, so no need to buy any kits and spend many for shipping the samples. 

[Scampi]

please remember this element is RISK based

[Charles.C]

JFI there is another related thread here -

 

http://www.ifsqn.com...food-packaging/

[Loni Banaszak]

please remember this element is RISK based

 

Im using Certified Laboratories http://certified-laboratories.com/

Really like this lab, stuff always ready to help and always helping if i have any questions, also their pricing is really good.

They have a lot of services and testings, one of them is compressed air testing and their tech performing the test, so no need to buy any kits and spend many for shipping the samples. 

 

thank you so very much! 

[Loni Banaszak]

please remember this element is RISK Based

 

please remember this element is RISK based

 

So I could conduct a risk assessment and figure out that I might not even need to test? 

[ctzinck]

So I could conduct a risk assessment and figure out that I might not even need to test? 

 

the auditor we had back in January suggested we do random testing around the plant once a quarter for a year, if everything comes out OK then use that data to prove we are low risk and should not have to test anymore but if a test comes back positive to test that same spot once a month for 3 months to see if it tests positive again.

[Loni Banaszak]

shouldnt have to test anymore

you have just saved my life! I have had nightmares about 2.4.8!!!! I think we will go this route and see how that holds up to the jury of SQF! 

[Charles.C]

the auditor we had back in January suggested we do random testing around the plant once a quarter for a year, if everything comes out OK then use that data to prove we are low risk and should not have to test anymore but if a test comes back positive to test that same spot once a month for 3 months to see if it tests positive again.

 

Hi ctzinck,

 

I mostly liked yr SOP using Enterobacteriaceae (ETB) in the parallel post/thread -

http://www.ifsqn.com...ng/#entry121599

 

from the SQF8 Code -

2.4.8        Environmental Monitoring   
2.4.8.1     A risk-based environmental monitoring program, for known or expected concerns, shall be in place for all processes in the manufacture of food packaging.
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,  appropriate  to  the  nature  of  the  product,  shall  be prepared,  detailing  any  applicable  pathogen  (s),  (i.e.,  Bacillus  spp. in  paper  or  paper  products),  the  number  of samples to be taken, and the frequency of sampling.
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.

 

 

As I interpret the above It would appear the first requirement is to do a risk assessment regarding pathogens. I assume this gave a negative result. (And why not indeed !) (or perhaps the choice of  ETB was a "compromise" in view of its partial pathogen associations [see below])

 

Unlike the auditor I do not see any suggestion of criteria so as to discontinue the sampling/testing program. More the opposite (see red above).

 

IIRC BRC provide a simple decision tree for the user to decide if their Product is high/low risk. Seems a worthwhile route IMO to help guesstimate reasonable sampling procedures / frequencies (cf the non-SQF post 7).

 

ETB is an indicator test.  A positive result for ETB is not regarded as a positive pathogen detection (although it could be). Whether it is more "appropriate" than other indicators, eg APC/Coliform/E.coli  measurements is subjective, ie a matter of opinion. Strictly speaking one probably needs more than one of the above-mentioned 4 options to get a meaningful hygiene evaluation. (Y&M might also be a further option for Packaging systems ?)

 

The limits for Food EMP indicators are typically based on just cleaned/sanitised scenarios or similar criteria.(see the food link in parallel post/thread -

http://www.ifsqn.com...ng/#entry122998

 

The usual approach to developing monitoring procedures like EMP is to do a Zoning analysis + use a boosted sampling/testing scan-frequency which can then be scaled down if results are adequately "compliant". However a simple production layout should not necessarily need a "full-blown" zoning analysis IMO.

 

JFI I attach the GFSI Benchmarking Food Packaging Criteria - seems no specific mention of EMP testing  Thank you SQF.

 GFSI Food Packaging,Benchmarking_Requirements_v7.1_Part3_m.pdf   407.96KB   430 downloads

[olshanka]

Would you say testing the finished product that has gone through the ENTIRE production process cover this element?

[Scampi]

I've done a risk assessment and WILL NOT be swabbing....our product is pasteurized and shelf stable, so anything that may be there will not be present between pasteurization and finished pH