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#1 tdunkley

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Posted 23 May 2017 - 03:29 PM

Good Morning,

I need to generate a list of requirements for set-up of a possible in-house accredited food lab for micro and chem. Wondering if anyone out there has done this in the past that might have some initial checklists of preliminary requirements to help kick-start the brainstorming. i.e.: Personnel/Equipment/Accreditation Costs. Cost benefit calculator for in-house vs 3rd Party Lab, etc.

 

Also, what credentials are required to run a micro/chem lab - is there a legal requirement for this?

 

Best Regards,

 

Theresa



#2 FurFarmandFork

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Posted 23 May 2017 - 07:41 PM

In-house micro takes a lot of labor. Make sure you include labor in your ROI calculations. Often people do the math on the media/tools and go "$5 a test!!", and then forget that you need to conduct the tests themselves, manage all documentation for your tests, equipment, and inventory; order and manage inventory, back-up your testing databases, more calibration and verification, accreditiation fees and time, autoclave waste stream, etc.

 

Then there's the liability involved. IMEX in-house testing leads to more false positives with increased time to verify since the samples aren't already at a lab that can do confirmatory testing, and sneaky false negatives unless you are going for an ISO accreditation both in certification and in spirit.

 

The ISO standard likely has some credential information. But basically you need personnel with the experience/education combination to determine proper testing methodologies and interpret the results. Rapid testing tech is making this easier and easier for basic pathogen detection in most foods and environmental surfaces, and they will often provide training and support to make sure you can conduct the testing competently and in-line with an official standard method.

 

Depending on what you're testing, if it's just qualitative indicator organisms for environmental surfaces etc., you could design a validation scheme where you send duplicate samples out to accredited labs at some intervals to make sure your results are reasonable. If you're doing any sort of pathogen testing, I would recommend at minimum doing proficiency testing like AOAC offers and analyzing your performance when the results come in to validate your in-house lab.

 

Some good questions to start with:

 

1. What are the goals of bringing this in-house? Savings, test turn-around time? Could this be done by switching to another outside lab?

2. What tests do you want to do? Indicator organisms for sanitation verification and environmental monitoring? Or Pathogens on Products and FC surfaces?

3. For the tests you want to do, what's the proper equipment, media, and waste stream. Will any of it require refrigeration? How many incubators, homogenizers, water baths, etc.

4. How will you manage the records of incubation times, media lots, etc. for each individual test? With this require database software?

5. If the lab isn't staffed 7 days a week, what days will you not be able to initiate tests? Does that impact your decision based on turnaround time for products produced near the weekend?


Austin Bouck
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Subscribe to the blog at furfarmandfork.com for food safety research, insights, and analysis.

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#3 Charles.C

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Posted 24 May 2017 - 04:25 AM

Good Morning,

I need to generate a list of requirements for set-up of a possible in-house accredited food lab for micro and chem. Wondering if anyone out there has done this in the past that might have some initial checklists of preliminary requirements to help kick-start the brainstorming. i.e.: Personnel/Equipment/Accreditation Costs. Cost benefit calculator for in-house vs 3rd Party Lab, etc.

 

Also, what credentials are required to run a micro/chem lab - is there a legal requirement for this?

 

Best Regards,

 

Theresa

 

Hi Theresa,

 

Just to re-iterate the previous Post.

 

IMO the answers to yr OP initially depend on (a) precisely what you want to do (eg products, analyses, accuracy [internal/contractual]), and (b) how much you are prepared (or in some cases need) to invest.

Titration is not the same as Atomic Absorption. APC plates are not the same as DNA pathogen probes.

 

You really need to supply more details for a meaningful response.

 

Yr legality query may be a simple YES/NO Canadian decision. Or it may relate to satisfying specific requirements, eg "Safety". For example, I believe relatively few (any?) US food manufacturing facilities do in-house full Salmonella analyses due (legal?) fears regarding cross-contamination ?.

 

In a basic layout sense, the installation of an in-house micro (and poss. chemical) lab was evaluated/costed/published a few decades ago by FAO. I think their detailed presentation is still available on-line.


Kind Regards,

 

Charles.C


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#4 tdunkley

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Posted 24 May 2017 - 06:16 AM

Thank you FurFarmandFork and Charles C. for your timely and thoughtful replies!

 

Not sure what is meant by "OP"? The lab would theoretically be performing tests for indicators microorganisms, but it is to be determined whether pathogens would be in scope or not, or if those would still be sent to a 3rd Party accredited lab (always or in certain circumstances). Various chemical/physical analyses would theoretically be performed for verification of conformance to specifications - nutrition facts panel (fat, carb/sugars/fibre, protein, etc), pH, Aw, moisture, density, viscosity, etc...

 

My question regarding credentials is whether a certified/licensed microbiologist is required to oversee a food lab, or if other credentials would be accepted. ...I think this probably depends? I will definitely keep researching and get my hands on the ISO 17025 standard as suggested!

 

Thanks again!

 

Theresa



#5 tdunkley

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Posted 24 May 2017 - 06:59 AM

Also, I just noticed the Lab Management and Testing forum. This will also be a great resource!

Regards,

Theresa



#6 Charles.C

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Posted 24 May 2017 - 07:00 AM

Thank you FurFarmandFork and Charles C. for your timely and thoughtful replies!

 

Not sure what is meant by "OP"? The lab would theoretically be performing tests for indicators microorganisms, but it is to be determined whether pathogens would be in scope or not, or if those would still be sent to a 3rd Party accredited lab (always or in certain circumstances). Various chemical/physical analyses would theoretically be performed for verification of conformance to specifications - nutrition facts panel (fat, carb/sugars/fibre, protein, etc), pH, Aw, moisture, density, viscosity, etc...

 

My question regarding credentials is whether a certified/licensed microbiologist is required to oversee a food lab, or if other credentials would be accepted. ...I think this probably depends? I will definitely keep researching and get my hands on the ISO 17025 standard as suggested!

 

Thanks again!

 

Theresa

 

Hi Theresa,

 

"OP" = Original Post/Poster

http://www.ifsqn.com...ons/#entry24154

 

Canada, per se, i have no idea but, just as one example, IIRC BRC require an in-house lab to have qualifications "equivalent" to iso17025. IMEX this is, for micro, often equated to relevant lab staff having passed an appropriately aligned  course on 17025.

Unfortunately ISO17025 like so many iso documents is a heavy slog to read. :smile:

 

IMO a "qualified" microbiologist is indispensable. "Qualification" as such is a flexible term since many other "Titles" may have micro. as a major component. I personally transited from Chemistry to Micro and one, IMO, major difference is that many text books on micro project an assurance of accuracy/simplicity comparable to that in routine chemistry. The reality is frequently, sadly, IMEX quite different due to the intrinsic ecological nature/variability of most target analytes. Quantitative micro. data typically has large/very large (+/-) Confidence Intervals. The consequence is that at least one lab. Operative with  qualifications + experience is a valuable combination, especially where complex pathogens like Salmonella are concerned.


Kind Regards,

 

Charles.C


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#7 FurFarmandFork

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Posted 24 May 2017 - 03:23 PM

 

 

 For example, I believe relatively few (any?) US food manufacturing facilities do in-house full Salmonella analyses due (legal?) fears regarding cross-contamination ?.

 

Actually, pretty high percentage of companies with in-house labs performing preliminary/presumptive testing. Enrichment methods hurt turn-around time, and presence/absence presumptive testing with PCR or similiar tech doesn't have the (infuriating) nuance that confirmatory testing for salmonella does.

 

You are right though, that the trend is moving towards getting your in-house stuff in a separate building so that there's no concern of contamination from positive controls. Though once again, many of the rapid detection tech out there is now including built-in controls with denatured organisms. There's obviously still a risk of contamination of false positives, but no risk of "inoculating" your plant with live organisms in this way.


Austin Bouck
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Consulting for companies needing effective, lean food safety systems and solutions.

Subscribe to the blog at furfarmandfork.com for food safety research, insights, and analysis.

#8 Charles.C

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Posted 24 May 2017 - 04:17 PM

Actually, pretty high percentage of companies with in-house labs performing preliminary/presumptive testing. Enrichment methods hurt turn-around time, and presence/absence presumptive testing with PCR or similiar tech doesn't have the (infuriating) nuance that confirmatory testing for salmonella does.

 

You are right though, that the trend is moving towards getting your in-house stuff in a separate building so that there's no concern of contamination from positive controls. Though once again, many of the rapid detection tech out there is now including built-in controls with denatured organisms. There's obviously still a risk of contamination of false positives, but no risk of "inoculating" your plant with live organisms in this way.

 

Hi 3F,

 

I deduce you are saying that PCR is frequently available in in-house food production facilities in USA. If so, I am amazed. And envious. :smile:


Kind Regards,

 

Charles.C


#9 Scampi

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Posted 24 May 2017 - 04:28 PM

Theresa, you'll want to make sure that the lab is certified. Contact either Standards Council of Canada or CALA. They should be able to assist you with the Canadian requirements. I would hazard that it will be cheaper and more efficient to have your nutritional panels done by a 3rd party, unless of course you will be employing the full services of a full time lab tech. Generally speaking the QA manager (who has a science background) will oversee the lab as well.


Because we always have is never an appropriate response!


#10 FurFarmandFork

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Posted 24 May 2017 - 05:52 PM

Hi 3F,

 

I deduce you are saying that PCR is frequently available in in-house food production facilities in USA. If so, I am amazed. And envious. :smile:

Yup. And the companies (I've worked with 3 different providers) even come validate that it works with your food matrices and investigate false positives. :) It's pretty legit if it makes sense for your org.


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Subscribe to the blog at furfarmandfork.com for food safety research, insights, and analysis.

#11 Charles.C

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Posted 25 May 2017 - 05:58 PM

Yup. And the companies (I've worked with 3 different providers) even come validate that it works with your food matrices and investigate false positives. :) It's pretty legit if it makes sense for your org.

 

Hi 3F,

 

I still have a suspicion that these 3 were not small Companies (or poor ones).

 

TBH, I cannot recall any US member previously posting here mentioning the use of PCR up till now. Not necessarily a representative sample of course. :smile:


Kind Regards,

 

Charles.C


#12 FurFarmandFork

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Posted 26 May 2017 - 02:58 PM

Hi 3F,

 

I still have a suspicion that these 3 were not small Companies (or poor ones).

 

TBH, I cannot recall any US member previously posting here mentioning the use of PCR up till now. Not necessarily a representative sample of course. :smile:

I was referring to the providers of the PCR equipment, not the food companies. Though the food companies I worked with who have it included small dairies (<100 employees) and some USDA operations of <500 employees. Depends on what you consider small :)


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#13 Charles.C

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Posted 26 May 2017 - 08:54 PM

I was referring to the providers of the PCR equipment, not the food companies. Though the food companies I worked with who have it included small dairies (<100 employees) and some USDA operations of <500 employees. Depends on what you consider small :)

 

Hi 3F,

 

Sorry, my loose use of English. I meant 'not small' as in "Big" Companies willing to protect Brand names at all costs. But I daresay it's also related to an environment where automation/high tech. is a way-of-life and time means (real) money.


Kind Regards,

 

Charles.C





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