22 replies to this topic

[Quality_AF]

Hello all!  

 

We recently had our first (brutal) SQF certification.  We passed(!) but are now working on our non-conformances.  

 

We were dinged on lab proficiency testing.  We do not perform any micro testing, etc, only basic physical and chemical analysis not related to food safety.  The guidance confuses me because it states 'critical to food safety.'  Is this something I can argue?

 

I appreciate this forum's help as it has been a life-saver working towards preparation and correcting the non-conformances.  There just much available for clarification out there.

 

Thanks!

[Scampi]

You've got 2 separate sections of the code confused--you rightly got dinged because proficiency testing is required for ALL internal lab testing

 

 

2.4.4.2   Product analyses shall be conducted to nationally recognized methods or company requirements, or alternative methods that are validated as equivalent to the nationally recognized methods.

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.

External laboratories shall be accredited to ISO/IEC 17025, or an equivalent international standard, and included on the site’s contract service specifications list (refer to 2.3.2.11). 

 

2.4.4.3 On-site laboratories conducting chemical and microbiological analyses that may pose a risk to product safety shall be located separate from any food processing or handling activity and designed to limit access only to authorized personnel.
Signage shall be displayed identifying the laboratory area as a restricted area,
accessible only by authorized personnel.

[SQFconsultant]

Scampi beat me to it!

 

Just curious however. What do you mean by brutal?

[kingstudruler1]

I think you need to expand on what testing you go dinged for.    It might be worth asking about.  The SQFI guidance document indicates the proficiency testing is not for product quality or sensory if you are using the food safety standard.

 

link to guidance:

 

 

https://www.sqfi.com...iciency-testing

Edited by kingstudruler1, 19 November 2024 - 11:33 PM.

[Tony-C]

Hi Quality_AF,

 

Micro proficiency testing isn’t specifically mentioned the SQF Code, it requires testing methods to be in accordance with the applicable requirements of ISO/IEC 17025, including annual proficiency testing for staff conducting analyses. If you don’t do micro and you don’t have a test method, I don’t see how you can be pulled up on a lack of micro proficiency testing.

 

As per kingstudruler1’s post, you need to clarify the wording of the non-conformance, the types of products and who is doing your micro testing? With that information I am sure you will get greater clarity from posters.

 

Kind regards,

 

Tony

Edited by Tony-C, 20 November 2024 - 06:10 AM.

[Quality_AF]

It was brutal because we were not as prepared as we thought we were, the Code (SQF 9 - Pet Food) contradicts the checklist (EMP is mandatory in the checklist but not in the Code), and the auditor constantly interrupted me.  

 

Non-conformance: 2.4.4.2 The site’s onsite lab conducts finished product testing but does not participate in any applicable proficiency testing program.

 

We were under the impression that because we do not perform micro testing we would not be required to conform to this clause.  We blend antioxidants used in pet food.  We test internally for some physical properties (viscosity, specific gravity, and amount of active ingredients) however, any micro testing is sent to a 3rd party laboratory.

 

My confusion with this comes from wording in the guidance document: "This means that a site that conducts laboratory tests, critical to food safety, is required to verify the accuracy and reliability of the testing methods used on site through a proficiency test."

[Scampi]

Hi Quality_AF,

 

Micro proficiency testing isn’t specifically mentioned the SQF Code, it requires testing methods to be in accordance with the applicable requirements of ISO/IEC 17025, including annual proficiency testing for staff conducting analyses. If you don’t do micro and you don’t have a test method, I don’t see how you can be pulled up on a lack of micro proficiency testing.

 

 

OP specifically said NOT micro

 "We do not perform any micro testing, etc, only basic physical and chemical analysis not related to food safety. "

[jfrey123]

Sometimes the language used in SOP's or just statements to the auditor can cause confusion leading to a finding.  My first ever SQF at the spice place, we almost got in trouble for calling a room our "Lab", when all we did was use a rotap machine to test for product yield at different sizes.  Auditor heard "lab" and started really digging for a few minutes, and our consultant quickly figured out what he was going for and had to help us clarify the exact point that none of the testing is for food safety.

 

That said, we were still required to show sufficient training for anyone involved in rotapping for yield analysis, as it had bearing on the specification for the finished product.  They had to be sufficiently trained on our sampling procedure, testing frequencies, calibration of the rotap, proper use of the rotap, etc.  Even where OP's testing is not for food safety purposes, they still can be hit with a finding if they're not proving the proficiency of staff performing these non-food safety related tests.

[kingstudruler1]

It was brutal because we were not as prepared as we thought we were, the Code (SQF 9 - Pet Food) contradicts the checklist (EMP is mandatory in the checklist but not in the Code), and the auditor constantly interrupted me.  

 

Non-conformance: 2.4.4.2 The site’s onsite lab conducts finished product testing but does not participate in any applicable proficiency testing program.

 

We were under the impression that because we do not perform micro testing we would not be required to conform to this clause.  We blend antioxidants used in pet food.  We test internally for some physical properties (viscosity, specific gravity, and amount of active ingredients) however, any micro testing is sent to a 3rd party laboratory.

 

My confusion with this comes from wording in the guidance document: "This means that a site that conducts laboratory tests, critical to food safety, is required to verify the accuracy and reliability of the testing methods used on site through a proficiency test."

 

I have seen alot of confusion on this clause.   The guidance does seem to differ from the standard.  However, you are not audited to the guidance, but the standard.  I did have one auditor tell me that the scope of the audit is food safety (not quality) which is why quality type testing does not need to meet proficiency testing standard.   You obviously found an auditor with a different opinion. 

 

I think it would be wise to have the CB clarify.  I think they might be your best source of reliable / repeatable source of info for your situation.      

 

Or, just apply the standard to all of your testing and be done with it.   More work, but eliminates being subjected to differing opinions in the future.   

[Quality_AF]

Sometimes the language used in SOP's or just statements to the auditor can cause confusion leading to a finding.  My first ever SQF at the spice place, we almost got in trouble for calling a room our "Lab", when all we did was use a rotap machine to test for product yield at different sizes.  Auditor heard "lab" and started really digging for a few minutes, and our consultant quickly figured out what he was going for and had to help us clarify the exact point that none of the testing is for food safety.

 

That said, we were still required to show sufficient training for anyone involved in rotapping for yield analysis, as it had bearing on the specification for the finished product.  They had to be sufficiently trained on our sampling procedure, testing frequencies, calibration of the rotap, proper use of the rotap, etc.  Even where OP's testing is not for food safety purposes, they still can be hit with a finding if they're not proving the proficiency of staff performing these non-food safety related tests.

 

Could 'proficiency training' be completed in house?  I have training records but I don't think they were reviewed.

[Quality_AF]

I have seen alot of confusion on this clause.   The guidance does seem to differ from the standard.  However, you are not audited to the guidance, but the standard.  I did have one auditor tell me that the scope of the audit is food safety (not quality) which is why quality type testing does not need to meet proficiency testing standard.   You obviously found an auditor with a different opinion. 

 

I think it would be wise to have the CB clarify.  I think they might be your best source of reliable / repeatable source of info for your situation.      

 

Or, just apply the standard to all of your testing and be done with it.   More work, but eliminates being subjected to differing opinions in the future.   

 

I did reach out to the CB for clarification; when asked if it mattered the type of testing completed they replied "it does not sound like that matters".

[jfrey123]

Could 'proficiency training' be completed in house?  I have training records but I don't think they were reviewed.

 

2.4.4.2 states "nationally recognized methods or company requirements," so I believe and would defend training my in-house employees to in-house procedures to run non-food safety tests.

 

In my case of the rotap, I had to be able to prove employees knew how to calibrate it and then properly record the results.  "Calibrate" applied loosely here, there's a little arm that smacks the trays to filter the material, and the manufacturer's book stated it has to be x number of mm at the top of it's up and down stroke. 

 

If you're using any machines for the in-house quality analysis, they need to be trained that the machines are functioning within specified parameters (calibrating them can be left to maintenance so long as the employees know what to check).  If they weigh samples for this analysis, training on how and how often to calibrate that scale would need to be included.  So on, so forth.  I only read "physical and chemical analysis," so whatever that entails you need to be able to prove they're trained to do that task and properly use whatever equipment (including what to do if the measurement isn't within spec).

[G M]

... We blend antioxidants used in pet food.  We test internally for some physical properties (viscosity, specific gravity, and amount of active ingredients) however, ...

 

Concentration of metabolically active ingredients for dietary supplement/additive in feed sounds like safety to me.  "not safety related" could be a difficult argument to make.  

[Quality_AF]

Concentration of metabolically active ingredients for dietary supplement/additive in feed sounds like safety to me.  "not safety related" could be a difficult argument to make.  

 

I understand your point, however our antioxidants are used to inhibit oxidation in the food; it is not used as a dietary supplement.

[Tony-C]

Hi Quality_AF,

 

Micro proficiency testing isn’t specifically mentioned the SQF Code, it requires testing methods to be in accordance with the applicable requirements of ISO/IEC 17025, including annual proficiency testing for staff conducting analyses. If you don’t do micro and you don’t have a test method, I don’t see how you can be pulled up on a lack of micro proficiency testing.

 

As per kingstudruler1’s post, you need to clarify the wording of the non-conformance, the types of products and who is doing your micro testing? With that information I am sure you will get greater clarity from posters.

 

Kind regards,

 

Tony

 

OP specifically said NOT micro

 "We do not perform any micro testing, etc, only basic physical and chemical analysis not related to food safety. "

 

  Maybe I'm missing something here Scampi?

 

It doesn't help that you snipped the quote to take my post out of context as I asked for wording of the NC.

 

Quality_AF has now clarified that the NC is because the site does not participate in any applicable proficiency testing program.

 

Kind regards,

 

Tony

[Tony-C]

Could 'proficiency training' be completed in house?  I have training records but I don't think they were reviewed.

 

Hi Quality_AF,

 

Proficiency testing can be carried out in-house by a collaboration of laboratories getting together and comparing results based on analysing a sample split between them (i.e. the same sample) by the same recognised test method. I would normally expect at least one of the laboratories to have ISO/IEC 17025 or for the split sample to be analysed by a third party ISO/IEC 17025 accredited laboratory as well.

 

Some other related forum topics which may have content of interest:

 

Lab proficiency testing

https://www.ifsqn.co...ciency-testing/

 

SQF System elements proficiency testing

https://www.ifsqn.co...ciency-testing/

 

SQF 2.5.4.2 Lab proficiency testing

https://www.ifsqn.co...ciency-testing/

 

SQF 2.4.4.2 - How to Demonstrate Proficiency

https://www.ifsqn.co...cy/#entry176380

 

Kind regards,

 

Tony

Edited by Tony-C, 21 November 2024 - 07:20 AM.

[Quality_AF]

Hi Quality_AF,

 

Proficiency testing can be carried out in-house by a collaboration of laboratories getting together and comparing results based on analysing a sample split between them (i.e. the same sample) by the same recognised test method. I would normally expect at least one of the laboratories to have ISO/IEC 17025 or for the split sample to be analysed by a third party ISO/IEC 17025 accredited laboratory as well.

 

Some other related forum topics which may have content of interest:

 

Lab proficiency testing

https://www.ifsqn.co...ciency-testing/

 

SQF System elements proficiency testing

https://www.ifsqn.co...ciency-testing/

 

SQF 2.5.4.2 Lab proficiency testing

https://www.ifsqn.co...ciency-testing/

 

SQF 2.4.4.2 - How to Demonstrate Proficiency

https://www.ifsqn.co...cy/#entry176380

 

Kind regards,

 

Tony

 

The test method is what concerns me.  We use internally developed methods; as do the ISO accredited laboratories I have found that test for these active ingredients.  

 

Can it be as simple as testing in-house, sending samples off to an ISO accredited laboratory, then comparing results?

 

I'm curious if anyone has an example of proficiency testing for testing OTHER THAN pathogens testing.

[kingstudruler1]

The test method is what concerns me.  We use internally developed methods; as do the ISO accredited laboratories I have found that test for these active ingredients.  

 

Can it be as simple as testing in-house, sending samples off to an ISO accredited laboratory, then comparing results?

 

I'm curious if anyone has an example of proficiency testing for testing OTHER THAN pathogens testing.

Yes, I would do just as you stated.    Send a sample to the certifed 17025 lab and have it tested (or use retains if you have them).    Then have your employees test the sample.    Compare results.   You will need to develope  pass / fail crtiteria (X% +/-, etc) .  Designate / document the employee as proficient or not.   Develope corrective actions as needed.  Repeat at the frequency that you determine.   

 

There are some items I havent used a third party lab for, but just compared results between personnel.  More for organoleptic type items. 

[Quality_AF]

Thanks for the help everyone!  We have created our program.  Now all I need to do is get the 3rd party lab to contact me back about testing.

Edited by Quality_AF, 22 November 2024 - 05:43 PM.

[ewo99]

Hello! I am a little late to this thread, but I think there is a little bit of a misunderstanding about PT. Internal laboratories being held to similar standards as ISO 17025 also applies to proficiency testing processes. ISO 17025 laboratories are required to use PT samples produced from ISO/IEC 17043 accredited producers, therefore, so are SQF accredited sites that perform internal testing.

 

Over the years that PT has been required for SQF sites with internal laboratories, there has been some confusion about the process for auditors and those being audited. I do not recommend testing a sample, sending it to a ISO 17025, and showing an auditor that the results are similar and calling it a proficiency test!

 

I understand that some auditors previously allowed internal PT, but this was likely due to confusion about PT. As time goes on and everyone in the SQF universe becomes more educated, everyone will have to move to acquiring PT samples via an accredited provider.

[TimG]

I take the most 'proficient' person who performs the testing and use them as the 'standard' for testing on a random pull. This person didn't know they were the standard. Everyone else who performs that testing is then tested to that standard on those exact samples.  I have a sheet set up and anyone that is outside accuracy of +/- 5% must retest the sample(s).

It seems to be fairly accurate; I only had 2 people record readings just outside accuracy, and they tested within on their second test of that sample.

I was surprised it was that close to be honest. Handheld moisture readings on honey I've read are pretty notorious for 'drift.'

[Tony-C]

I think SQF have made their expectations quite clear in their Proficiency Testing Edition 9 Guidance Document:

 

Proficiency testing is a round-robin type of test in which duplicate samples are selected in identical fashion and tested via intra-laboratory. The proficiency test samples could either come from the site or the external laboratory. Regardless of the source of the sample, the goal of the proficiency test is to verify the testing methods conducted by the site. When developing a proficiency testing process consider the following:

1. Selection of the external laboratory.

a. The external laboratory is to be accredited to ISO/IEC 17025.

b. The laboratory should be able to demonstrate that they are able to conduct proficiency testing. This could be identified through accreditation to ISO 17043 or included in the scope of accreditation.

c. There are many 3rd party laboratories that conduct proficiency testing.

Laboratory equipment providers or the CB may have suggestions.

2. Handling and testing of the materials

a. Follow the same methods as the identified in-house procedure.

b. Use the same equipment and personnel that routinely perform the task.

c. Determine the acceptability range of the test results. Depending on the test, the results may not be identical, and an acceptable difference should be identified to determine if the proficiency test results would be acceptable or unacceptable.

3. Proper submission of the test results

a. Evaluation should be conducted on the final, not presumptive, results.

b. Both the internal and external laboratories used should not forward or share the results of the tests until after the results have been finalized.

4. Review of the summary reports

a. A review of the results is to be compared to the level of acceptability.

b. Unacceptable results would warrant corrective action that may include:

i. Investigation of unacceptable, trending results.

ii. Review of the sampling and testing process.

iii. Repeat of the proficiency test.

[Dr Vu]

I take the most 'proficient' person who performs the testing and use them as the 'standard' for testing on a random pull. This person didn't know they were the standard. Everyone else who performs that testing is then tested to that standard on those exact samples.  I have a sheet set up and anyone that is outside accuracy of +/- 5% must retest the sample(s).

It seems to be fairly accurate; I only had 2 people record readings just outside accuracy, and they tested within on their second test of that sample.

I was surprised it was that close to be honest. Handheld moisture readings on honey I've read are pretty notorious for 'drift.'

 

Same here, but I realized it's difficult to justify "proficient person". So now I look for a "known" quantity item from the market.  what I do is give the testers mixed samples of products /with controls eg, distilled water, with each sample tested 3 times

 

I give 2 pass scores- % CV (precision) and % Difference (accuracy), both are marked at less than 10% to get a pass. If you fail one, it means you failed.