Cold chain validation and verification
Hello everyone,
this is my first post here and i hope i am not asking something that has been already asked. Did some digging without any relevant results. In one of my reports on iso 22000 about a distribution company (packed cold/frozen products such as frozen meat & potatoes), the certification body pointed out that the cold chain can be validated by taking a sample of a sensitive product at the time of delivery, for microbiological test. In my report i wrote that the cold chain is being verified by recording the temp upon supplies arrival, storage and delivery which it seems is not enough. Can i have some thoughts/comments on this please. I am relatively new into auditing (1.5 years now) so excuse me if this sounds dumb.
thank you in advance
Hi Louis
There are limitations using data from microbiological testing & the HACCP system was developed to address this issue, the logic being that if there is adequate process control eg. pasteurization, that you don’t have to test every single batch for microbiological compliance because you know that applying X heat for Y minutes will remove any pathogens. Similarly if the correct chilled temperature is maintained, that the growth of relevant bacteria is retarded.
To validate a chilled supply chain using microbiological data you would need to know the microbiological specification and status of the product/products before the chill chain to make any sense of the microbiological results from the end point samples (and this should really be done in triplicate – a single result isn’t statistically valid) and you would need to know the particular spoilage organisms for each product & their growth conditions (eg. Listeria – which can grow at refrigeration temperature).
If I was asked to validate a chilled supply chain I would be more inclined to use strategically placed data loggers & use these to show that the product temperature is maintained throughout the process & possibly confirm/back this up annually with some microbiological test results if necessary. Links below may be useful?.
https://www.loggersh...ation-solution/
Hello Lesley,
thank you for your detailed answer it makes sense now. i will argue with the certification body regarding this and see what happens. The temperature monitoring records have been documented in the report already and will comment the annual micro lab tests in the suggestions for better validation by comparing the results to the supplier's microbiological specifications.
Thank you again! i think i should use more this forum :)
There seems to be confusion in this thread as to the difference between validation and verification.
I am wondering what the OP was specifically trying to validate.
Hello Charles,
thank you for spotting this. I should say verify and not validate. My bad, sorry for the confusion.
Hi Louis.
From my experience, we do verification of cold chain with termologers (from production to stores).
Hello Charles,
thank you for spotting this. I should say verify and not validate. My bad, sorry for the confusion.
Hi Louis,
No problem, I was only seeking clarity. This is first time, I think, I have seen a thread here regarding iso22000 being applied to a product distribution chain. Previous posts here, IIRC, have mostly used SQF.
Is this actually S&D or only "D" ? I assume the former such as, JFexample, this SQF thread -
https://www.ifsqn.co...ion/#entry87786
I am mainly, operationally, familiar with receiving frozen cargo and I haven't checked back but, from long memory, my impression was that the Distribution aspect is typically a relatively minor risk assessment "problem" (and often sub-contracted anyway ?) so that most previous threads had little detail regarding "D".. Accordingly I was curious as to what specific criteria were involved in (a) validation and (b) verification for "D"?
PS - you might find this short thread of some interest -
Hi Louis,
No problem, I was only seeking clarity. This is first time, I think, I have seen a thread here regarding iso22000 being applied to a product distribution chain. Previous posts here, IIRC, have mostly used SQF.
Is this actually S&D or only "D" ? I assume the former such as, JFexample, this SQF thread -
https://www.ifsqn.co...ion/#entry87786
I am mainly, operationally, familiar with receiving frozen cargo and I haven't checked back but, from long memory, my impression was that the Distribution aspect is typically a relatively minor risk assessment "problem" (and often sub-contracted anyway ?) so that most previous threads had little detail regarding "D".. Accordingly I was curious as to what specific criteria were involved in (a) validation and (b) verification for "D"?
PS - you might find this short thread of some interest -
Hey Charles,
thank you for the links they contain good info.
In Cyprus and Greece, most of the small companies, if not all are certified with iso 22000, so you will see it everywhere :). Regarding my question, it involves only local distribution of frozen products shipped from countries within the EU. So, in my report i documented the receiving, the storage and the delivery/distribution temperatures which all are OPRPs. So, i wrote that the cold chain is being verified as the auditee does monitor/log the temperatures. However, i got this comment from the certification body that in order for the cold chain to be verified, you will need to ask them to perform a microbiological analysis of a sensitive product, such as meat, at the distribution stage, and compare the results with the manufacturer/supplier's microbiological analysis of that batch.
it does make sense, however there is not such requirement as far as i know, not even by the law such as 853/2004. The only literature i found on this matter was by the british, FSA, where it says in the meat industry, microbiological analysis may help in verifying the cold chain, but it was never mentioned as a requirement.
best regards
Louis
Hey Charles,
thank you for the links they contain good info.
In Cyprus and Greece, most of the small companies, if not all are certified with iso 22000, so you will see it everywhere :). Regarding my question, it involves only local distribution of frozen products shipped from countries within the EU. So, in my report i documented the receiving, the storage and the delivery/distribution temperatures which all are OPRPs. So, i wrote that the cold chain is being verified as the auditee does monitor/log the temperatures. However, i got this comment from the certification body that in order for the cold chain to be verified, you will need to ask them to perform a microbiological analysis of a sensitive product, such as meat, at the distribution stage, and compare the results with the manufacturer/supplier's microbiological analysis of that batch.
it does make sense, however there is not such requirement as far as i know, not even by the law such as 853/2004. The only literature i found on this matter was by the british, FSA, where it says in the meat industry, microbiological analysis may help in verifying the cold chain, but it was never mentioned as a requirement.
best regards
Louis
Hi Louis,
Thks reply. So I guess this basically is an S&D Standard.
I'm primarily involved with Manufacturing so not particularly familiar with the implementation of iso22000 in respect to S&D however, personally, I would have guessed that the micro. analysis of some products is a logical part of Verification activities relating to PRPs involved in establishment/maintenance of the Cold Chain and the Performance of the System
I anticipate it could relate to Sections 8.8 (eg 8.8.1.a), 9 (eg 9.1.2), and others like Management Review (eg 9.3.2.c.3)
Such a micro. analysis is a typical verification activity within a haccp plan for Manufacturing food and is usually carried out (for Manufacturing) by simply testing (eg annually) a few "representative" samples to demonstrate that the results agree with the micro. specification for the particular food involved.
You might consider that verifying the adequacy of actual achieved temperatures is a fundamental Physical objective of the Operational System while the micro data verifies the (maintained) Biological condition of the Product.
I agree with caveats in Post 2 but you may well find that some documented micro. data is a routine auditorial expectation.
PS - I'm rather surprised at yr comment regarding OPRPs (eg Receiving/Cold Stores are usually PRPs IMEX) but that is another story. :smile: