19 replies to this topic

[Jim E.]

Hello IFSQN:

 

We have a small issue that I hope someone can provide direction to a solution. And just so you are aware we are located in western Canada, so I do not get responses to go to Great Britain or anything.

 

We just completed an AIB GMP Inspection and the following non-conformance was given:

 

The facility tested for Listeria spp on site. However, no lab proficiency test or other documented training in place to demonstrate that the individuals who sampling and handling the test are qualified for conducting Listeria spp. test. 

 

 

Now with that being said the employee who is in our micro lab received on the job training from the previous micro lab technician.  Of course we have no records as it was well over 15 years ago. I would say she is quite proficient in her job as she has been there for so long now.  My quest is to find a short training program that they may be able to undertake to become complaint with this NC.

 

Thanks in advance

Jim

 

Baffled in Alberta

[olenazh]

1. Look at this: https://www.nsflearn...biology-virtual

2. Are you sure your tech needs to take courses? Doing micro testing is quite simple and does not require extended education - just sufficient training using guide book. That's what I did at my ice cream factory: I've created the SOP based on the micro testing manual, and trained one of our regular employee to do the testing. So far, CFIA inspectors never objected that practice. However, in-house micro testing does not substitute regular testing done by the accredited lab - just bear that in mind. 

[Rick Reyes]

Good afternoon, you may want to look into ISO/IEC 17043 Conformity Assessment-General requirements for proficiency testing. With a previous employer we used to have Silliker send each of our lab technicians reference samples to plate, you will need to figure out which panel works for your lab requirements since they will require that your panel cover all of the pathogens that you test for in house. You must also verify that your lab system is capable of performing to the testing to the recognized AOAC Performance Tested Method or AOAC Official Method of Analysis for each of the Petrifilms that you use for in house testing. if you use 3M Petrifilm they provide the AOAC standard on their site which you can download for free one time. Just so you know, 3M does not have an AOAC Official Method of Analysis for Environmental Listeria testing, they use an AOAC Performance Tested Method certificate #030601. 3M has more information at 3M.com/PetrifilmValidations. By the way I don't work for anyone associated with 3M, I had to learn this stuff to complete a GAP Assessment on our in house lab prior to an audit. I hope that this helps, these forums were a God send to me when I was going through this since the standards for proficiency testing have changed over the years and I was lost.

[Charles.C]

1. Look at this: https://www.nsflearn...biology-virtual

2. Are you sure your tech needs to take courses? Doing micro testing is quite simple and does not require extended education - just sufficient training using guide book. That's what I did at my ice cream factory: I've created the SOP based on the micro testing manual, and trained one of our regular employee to do the testing. So far, CFIA inspectors never objected that practice. However, in-house micro testing does not substitute regular testing done by the accredited lab - just bear that in mind. 

Hi Olena,

 

Simple !! ??  I respectively beg to differ.

 

I have had more arguments with customers/suppliers over microbiological results/procedures than any other QA topic.

 

IMHO. thinking it's simple probably means one is doing something wrong. Particularly if all the Pathogens are routinely "Not Detected".

[kingstudruler1]

I would recommend a Food Micro short course.    

 

 

There are also companies that have "proficiency testing programs".  training & experience does not necessarily equal proficiency.  

https://www.aoac.org...ciency-testing/

 

 

I've seen degreed personnel (including managers) conducting micro using very erroneous practices / methods.   

[nd01ken]

I would go to the supplier of the test you are using and ask for training and a record of participation. Once someone has this they can train internally. Also do not forget the annual documented observation of the person completing the test.

Edited by nd01ken, 17 March 2022 - 12:10 PM.

[olenazh]

Hi Olena,

 

Simple !! ??  I respectively beg to differ.

 

I have had more arguments with customers/suppliers over microbiological results/procedures than any other QA topic.

 

IMHO. thinking it's simple probably means one is doing something wrong. Particularly if all the Pathogens are routinely "Not Detected".

Hi Charles,

Yes, it's really simple: we're testing in-house for TC & E. Coli using Petrifilms, and the routines are as easy and simple as it could be. It is what it is:) 

[Rick Reyes]

The reason that I recommended that the ISO standard is because there are small elements to standard that can lead to a NC if not observed and you can't check it off as covered if you aren't aware what is required, all the procedural steps are covered in the standard. It is not an easy read by any means but at least you can defend or respond to an NC once you figure out the standard. 

[Charles.C]

Hi Charles,

Yes, it's really simple: we're testing in-house for TC & E. Coli using Petrifilms, and the routines are as easy and simple as it could be. It is what it is:) 

Hi Olena,

 

From 3M's info. brochure -

 

Perform 3M Petrifilm EC Plate testing in a properly equipped laboratory under the control of a skilled microbiologist.
The user must train personnel in current proper testing techniques: for example, Good Laboratory Practices,
ISO 17025 or ISO 7218

 

I assume a skilled microbiologist is available.

 

 I am curious as to what product is being analysed for E.coli and the max. specification ?.

[olenazh]

Hi Olena,

 

From 3M's info. brochure -

 

 

I assume a skilled microbiologist is available.

 

 I am curious as to what product is being analysed for E.coli and the max. specification ?.

Ice cream, less than 10 cfu/g

[Charles.C]

Ice cream, less than 10 cfu/g

 

Thks for Data.

 

So, assuming usual 1st dilution, one strike is out ? Simple =  Russian Roulette ?.

 

Or maybe best of 3 ?

 

PS - afaik some operational/numerical manoeuvring  is possible in such situations but this maybe diminishes the method's commercial promotion as a simple/rapid  direct alternative to the much slower and labour intensive MPN Procedure.

Edited by Charles.C, 17 March 2022 - 10:42 PM.
added PS

[olenazh]

Thks for Data.

 

So, assuming usual 1st dilution, one strike is out ? Simple =  Russian Roulette ?.

 

Or maybe best of 3 ?

 

PS - afaik some operational/numerical manoeuvring  is possible in such situations but this maybe diminishes the method's commercial promotion as a simple/rapid  direct alternative to the much slower and labour intensive MPN Procedure.

Charles, for a company of 6 floor workers, it's quite fine.

[Charles.C]

Charles, for a company of 6 floor workers, it's quite fine.

Hi Olena,

 

I'm guessing the plates are always negative for E.coli so maybe you're right.

[Sam D]

The facility tested for Listeria spp on site. However, no lab proficiency test or other documented training in place to demonstrate that the individuals who sampling and handling the test are qualified for conducting Listeria spp. test. 

 

I feel the key words for the corrective action are mentioned in the NC above. I would go to the supplier of the test you are using. 3M, Neogen, Hygiena or any other company you may be using can do the training with your lab technician and provide the certificate of training to make her qualified. Next, you can do a proficiency testing for the lab technician annually.   You can send a sample to an accredited lab and also test the same sample inhouse. Compare the results and create a proficiency testing report to provide to the auditor. This should take care of your NC.

IMO, testing 'pathogens' in-house creates higher risk of contamination and generates additional scrutiny from auditor. 

[Charles.C]

I feel the key words for the corrective action are mentioned in the NC above. I would go to the supplier of the test you are using. 3M, Neogen, Hygiena or any other company you may be using can do the training with your lab technician and provide the certificate of training to make her qualified. Next, you can do a proficiency testing for the lab technician annually.   You can send a sample to an accredited lab and also test the same sample inhouse. Compare the results and create a proficiency testing report to provide to the auditor. This should take care of your NC.

IMO, testing 'pathogens' in-house creates higher risk of contamination and generates additional scrutiny from auditor. 

Hi Sam,

 

There is commonly a basic misunderstanding over the meaning of "proficiency" testing. I suggest to review previous threads and particularly the SQF guidance material. The last sentences in first paragraph are primarily relevant.

 

PS - apologies that I thought this thread was SQF-oriented, not AIB. There may be some specific differences involved since afaik latter is not GFSI accredited.

PPS - Might help to know what procedure for Listeria was actually implemented (Jim ??)

Edited by Charles.C, 21 March 2022 - 06:45 PM.
added PS

[Jim E.]

Hello all finally had some time to spare to get on and respond to some of the questions.

 

1.  We only conduct a Listeria Environmental test for species indicators only, no specific species is tested for.

2.  3M is our test kit provider and after reaching out to them they have confirmed that they will come on site to conduct training and certification to our team.

3. We do complete the annual proficiency testing where samples are tested both here and at 3rd party.

 

So I think we have gotten a handle on the issue and should be able to close this NCR.

Thanks everyone.

[Miss Frankie]

At my former job, we had a company come on once a month to do listeria swabs.  When COVID hit, they quit coming and asked that I do the swabbing.
I wrote up a paragraph stating that I had been shadowing the other person for 10 years, then watched their on-line video on how to perform swabs.  
I sent it to them, they signed off on it, and said I was able to complete their swabs.
The auditor was fine with that.

[eccl]

Hi all. 

 

When comparing the in-house result vs. the result from the accredited 3rd party laboratory is there a numerical standard requirement on how close the values should be? Let's say there should be only around 5% deviation when comparing both results to identify that our in-house personnel is proficient enough?

Edited by eccl, 13 January 2023 - 02:03 AM.

[Gelato Quality Lead]

Hi all. 

 

When comparing the in-house result vs. the result from the accredited 3rd party laboratory is there a numerical standard requirement on how close the values should be? Let's say there should be only around 5% deviation when comparing both results to identify that our in-house personnel is proficient enough?

Based on my knowledge of the SQF standard, it'll be based on a risk assessment based on your facility, product, process, what is being tested, etc. Definitely conduct and document the risk assessment before the proficiency testing is conducted. And the results for in-house should be determined prior to knowing the external lab results. Definitely check against your audit standard to see if there is a specific requirement for this.

[Charles.C]

Hi all. 

 

When comparing the in-house result vs. the result from the accredited 3rd party laboratory is there a numerical standard requirement on how close the values should be? Let's say there should be only around 5% deviation when comparing both results to identify that our in-house personnel is proficient enough?

If you are talking about APC, 5% would be a Fluke IMO.

One well-known textbook mentions 50-100% variations are not unusual but it may also relate to the specific Product/Procedure.

 

Microbiological counts are not a very exact Science. Hence the mMnc specs typically use 1 log partitions.