11 replies to this topic

[mallublackgold]

Hi all, we recently just finished our SQF unannounced audit on Edition 9. Our auditor dinged us on this detail under 2.4.4.2 2.4.4.2 "Where internal laboratories are used to conduct input, environmental, or product analyses, sampling and testing methods shall be in accordance with the applicable requirements of ISO/IEC 17025, including annual proficiency testing for staff conducting analyses" The auditor's claim was that we didn't demonstrate proficiency testing in environmental sample collection.  Here's the backdrop of our company: 1. We are a small company (no more than 9 employees) that primarily specializes in distribution and occasionally repackaging of dry ingredients. 2. We are a low-risk and dry facility. 3. Our EMP program/risk analysis only really needs to monitor for Salmonella and mostly in the packaging room. 4. We use the Hygenia InSite Salmonella environmental test swabs for environmental monitoring. However, we do NOT have any internal laboratories on-site (which is why I did not think this standard applied to us in the first place... because the verbiage is confusing, of course). 5. I'm the SQF practitioner and I am the one who does the environmental swab testing every quarter. I've watched the training videos provided by Hygenia and collect my samples accordingly. I'm also the one who usually does and conducts the food safety trainings at our company (since I'm the lead and practitioner on that) Can you help provide some advice/guidance on the following:

• What would constitute as demonstrating proficiency for environmental monitoring sampling?
• Does anyone know of some cost-effective, on-demand online trainings for environmental monitoring sampling? (I've been sleuthing online for this but most are either not soon enough or they're exorbitantly priced for what I actually need to know) 

[OrRedFood]

We brought in our Hygenia rep to do training for free since we are a customer, and got certificates for all persons doing swabbing. They did allergen, ATP, and listeria swab training.  Neogen will do this for their customers as well.   That has always been sufficient for SQF in my experience, and they both do a really good job.  We send out environmental samples for testing to an outside lab as well. 

[FSQA MKE]

Are the "Hygenia InSite Salmonella environmental test swabs" placed on an incubator on site? Or do you outsource all lab work to an ISO - accredited lab?

[Charles.C]

SQF have succeeded in creating considerable semantic confusion over this (proficiency) topic both for auditees and (I suspect) auditors. Ver9 has rewritten ver8 but IMO has successfully maintained its ambiguity.

Note that SQF define proficiency testing in the ver9 glossary.

Note that there is a specific ver.9 Guidance for this topic. It seems to  contradict some of the previous thread comments, eg training.

 

Can study this earlier ver8 thread which well illustrates the generated confusion.

 

https://www.ifsqn.co...is/#entry158660

 

It is possible that, IMO, some auditor(s) may partially misunderstand SQF requirements or perhaps the OP has not given a complete context to the NC..

[mallublackgold]

We brought in our Hygenia rep to do training for free since we are a customer, and got certificates for all persons doing swabbing. They did allergen, ATP, and listeria swab training.  Neogen will do this for their customers as well.   That has always been sufficient for SQF in my experience, and they both do a really good job.  We send out environmental samples for testing to an outside lab as well. 

Thank you so much for this suggestion! I reached out to Hygiena and they've already helped me schedule trainings!

[mallublackgold]

Are the "Hygenia InSite Salmonella environmental test swabs" placed on an incubator on site? Or do you outsource all lab work to an ISO - accredited lab?

Hi FSQA MKE,

 

We have a little block incubator from Hygiena where we incubate the swabs. But we keep the block incubator in an entirely separate building (far away) from the products. I have also watched the training videos on how to use the incubator as well as how to dispose of the swabs properly, all of which I do in a separate building away from the product. I only swab the product zones with the InSite swab and then promptly walk the swabs over to the other (detached) building where the incubator sits and where I dispose of the swabs. 

[mallublackgold]

SQF have succeeded in creating considerable semantic confusion over this (proficiency) topic both for auditees and (I suspect) auditors. Ver9 has rewritten ver8 but IMO has successfully maintained its ambiguity.

Note that SQF define proficiency testing in the ver9 glossary.

Note that there is a specific Guidance for this topic. It seems to  contradict some of the previous thread comments, eg training.

 

Can study this earlier ver8 thread which well illustrates the generated confusion.

 

https://www.ifsqn.co...is/#entry158660

 

It is possible that, IMO, some auditor(s) may partially misunderstand SQF requirements or perhaps the OP has not given a complete context to the NC..

 

Hi Charles,

 

Thank you for this insight. I actually had been reading through that same thread before I posted my own question, but I have to admit that thread only confused me a little more (which makes me feel better that I'm not the only one confused by this standard). That said, could you clarify what you mean by "It seems to contradict some of the previous training, eg. training." Do you mean that the standard/glossary implies training or do you mean that it does not require official training as per the standard.

 

The part where I'm taking a little issue is that I have in fact watched (and re-watched) several times over the official training videos provided by Hygiena to make sure I know how to use these swabs properly (and I have made my staff also watch and re-watch them, but for good measure, I am the one who's really authorized to do the environmental monitoring swabs because I understand the principle of it best in our company. I've trained the staff as a back-up in case of my absence). When I first purchased the swabs and asked about training, the Hygiena referred me to these very same training videos (in fact, I think I watched those videos first before I even had management purchase them to make sure it would work for our facility and needs). It seems to me the only difference is the piece of paper (i.e. a certificate) that is supposed to verify that I watched the videos, which I wasn't aware that you could get because I just assumed since the training videos are easily accessible online, that there may not be such certificates available. 

 

As for the complete context of the NC, I actually think I did provide all the details and the auditor's remarks/findings as they occurred :). I figured the relevant details are important to gaining clarity.

[FSQA MKE]

Hi FSQA MKE,

 

We have a little block incubator from Hygiena where we incubate the swabs. But we keep the block incubator in an entirely separate building (far away) from the products. I have also watched the training videos on how to use the incubator as well as how to dispose of the swabs properly, all of which I do in a separate building away from the product. I only swab the product zones with the InSite swab and then promptly walk the swabs over to the other (detached) building where the incubator sits and where I dispose of the swabs. 

Yes, I can see that block incubator being considered an in-house/ internal lab by an auditor. Create a training document outlining the videos and steps, procedures, etc. required for sampling collection,holding, and incubating, etc.  Train your subordinate, document this training. Then have your subordinate train you & document this training as well. Ideally the manufacturer, Hygiena, should send someone out to provide hands-on training and provide a certificate of some sort. It seems scummy on behalf of the manufacturer that they do not have the courtesy to send someone out there for a quick demonstration/training.

[OrRedFood]

Thank you so much for this suggestion! I reached out to Hygiena and they've already helped me schedule trainings!

You are very welcome! Our rep did a great job and the production folks were able to officially get training and all questions answered.  They have good people at Hygenia in my experience.  Any product you buy from them, they will provide training.  And they probably have tips on how to audit-proof your procedures for keeping your techs from any risk of cross contamination.    

[Charles.C]

Hi Charles,

 

Thank you for this insight. I actually had been reading through that same thread before I posted my own question, but I have to admit that thread only confused me a little more (which makes me feel better that I'm not the only one confused by this standard). That said, could you clarify what you mean by "It seems to contradict some of the previous training, eg. training." Do you mean that the standard/glossary implies training or do you mean that it does not require official training as per the standard.

 

The part where I'm taking a little issue is that I have in fact watched (and re-watched) several times over the official training videos provided by Hygiena to make sure I know how to use these swabs properly (and I have made my staff also watch and re-watch them, but for good measure, I am the one who's really authorized to do the environmental monitoring swabs because I understand the principle of it best in our company. I've trained the staff as a back-up in case of my absence). When I first purchased the swabs and asked about training, the Hygiena referred me to these very same training videos (in fact, I think I watched those videos first before I even had management purchase them to make sure it would work for our facility and needs). It seems to me the only difference is the piece of paper (i.e. a certificate) that is supposed to verify that I watched the videos, which I wasn't aware that you could get because I just assumed since the training videos are easily accessible online, that there may not be such certificates available. 

 

As for the complete context of the NC, I actually think I did provide all the details and the auditor's remarks/findings as they occurred :). I figured the relevant details are important to gaining clarity.

 

Hi mbg,

 

 

As per Post 8 you probably have an internal "lab". IMO yr auditor should have noted such if this was the case.

 

Please have a look at the Guidance article here which details SQF9 interpretations/requirements-

 

https://www.sqfi.com...and-checklists/

 

(You may consider that the Guidance is mismatched to the text in the Standard ?)

 

As per the Glossary/Guidance, Proficiency testing is multi-pronged.

 

One typical "Proficiency" query  is - Are your "Lab" results actually  correct ?

 

PS - I noticed Neogen provide a "Proficiency Testing Program" for their pathogen kits (eg see link below). Perhaps Hygiena do likewise.

 

https://www.neogen.c...d-listeria-spp/

 

PPS - also see response yr  parallel post, eg -

 

https://www.ifsqn.co...42/#entry176470

[Richaney Impraseuth]

For proficiency testing I suggest the following,

 

1. Train yourself & staff.

2. Take 2 swabs and sample 1 area (use both swabs to swab the same spot)

3. Send one swab off to an ISO Accredited 3rd party lab for the same analysis

4. Test the other swab internally, as you usually would do. 

4.  Compare your internal result to the 3rd party lab result

[Charles.C]

For proficiency testing I suggest the following,

 

1. Train yourself & staff.

2. Take 2 swabs and sample 1 area (use both swabs to swab the same spot)

3. Send one swab off to an ISO Accredited 3rd party lab for the same analysis

4. Test the other swab internally, as you usually would do. 

4.  Compare your internal result to the 3rd party lab result

 

Hi BH,

 

The basic methodology looks compliant with SQF Guidance and is similar to the mini-Ring Test Procedure I have used for BRC/food samples and indicator organisms.

However there may be some operational difficulties for pathogen/Salmonella detection since achieving 2 null results is typically  insufficient for method confirmation. (Although SQF ???). I daresay this is why standardised, spiked, surface samples are apparently commercially available.

 

PS - Even PT methods for swabbing for indicator organisms are apparently not without difficulties, eg -

 Proficiency test samples for Surface swabbing.pdf   762.82KB   118 downloads