Do we document operating limits in our Food Safety Plan alongside the CCP limits?
Hi,
We have established critical limits for a CCP (time/temperature) but want to have tighter operational limits. Do we call out our operating limits in our Food Safety Plan alongside the CCP, or where do we document them?
Thanks,
Steph
On FS plan, process flow charts, Quality Manual, SOPs, operational/production forms, etc. - wherever it's necessary, it's up to you.
Hi,
We have established critical limits for a CCP (time/temperature) but want to have tighter operational limits. Do we call out our operating limits in our Food Safety Plan alongside the CCP, or where do we document them?
Thanks,
Steph
Is there a specific FS Standard involved ?
afaik, for most traditional Codex haccp plans, so-called operating limits are not specifically required to be documented. (iso-haccp standard is different, as are also some contractual agreements).
Otherwise, I agree with Olena.
I have encountered a number of auditors who take the view that what it says in the HACCP plan should reflect what is physically happening on site. Whether this is "right" is alas a separate issue to whether it's easiest to take an approach that minimises debates during audits, particularly in circumstances where having consistency between parts of the FS system is only going to make it easier for the people using it to understand it.
I agree with Olena's approach and indeed have done precisely this for processes where the critical limit for food safety is broader than we need for quality purposes, so e.g. a HACCP plan CCP summary may show that the critical temp limit for a process is 70C, but it also shows that the operating limit is 90C. The associated procedures, against which the operators are trained, reflect the operating limit and so do any automated control systems in the equipment. I did also add a supplemental "discussion" document to the HACCP folder just to explain the rationale behind the discrepancy between operational and critical limits, which I've found to be a useful approach as you've then got a ready-made "answer" if you get any queries about it.
I have encountered a number of auditors who take the view that what it says in the HACCP plan should reflect what is physically happening on site. Whether this is "right" is alas a separate issue to whether it's easiest to take an approach that minimises debates during audits, particularly in circumstances where having consistency between parts of the FS system is only going to make it easier for the people using it to understand it.
I agree with Olena's approach and indeed have done precisely this for processes where the critical limit for food safety is broader than we need for quality purposes, so e.g. a HACCP plan CCP summary may show that the critical temp limit for a process is 70C, but it also shows that the operating limit is 90C. The associated procedures, against which the operators are trained, reflect the operating limit and so do any automated control systems in the equipment. I did also add a supplemental "discussion" document to the HACCP folder just to explain the rationale behind the discrepancy between operational and critical limits, which I've found to be a useful approach as you've then got a ready-made "answer" if you get any queries about it.
pHruit, I'm really impressed by your detailed, precise and professional explanations! I've been reading your comments throughout topics, and just out of curiosity: what's your background?
I have encountered a number of auditors who take the view that what it says in the HACCP plan should reflect what is physically happening on site. Whether this is "right" is alas a separate issue to whether it's easiest to take an approach that minimises debates during audits, particularly in circumstances where having consistency between parts of the FS system is only going to make it easier for the people using it to understand it.
I agree with Olena's approach and indeed have done precisely this for processes where the critical limit for food safety is broader than we need for quality purposes, so e.g. a HACCP plan CCP summary may show that the critical temp limit for a process is 70C, but it also shows that the operating limit is 90C. The associated procedures, against which the operators are trained, reflect the operating limit and so do any automated control systems in the equipment. I did also add a supplemental "discussion" document to the HACCP folder just to explain the rationale behind the discrepancy between operational and critical limits, which I've found to be a useful approach as you've then got a ready-made "answer" if you get any queries about it.
I don't quite understand how an operating limit would be 20degC above a critical limit of 70 degC ?
IMEX the auditor may ask the Production operator as to the significance of the critical limit which after all is the safety criterion. This can cause confusion if the operator is focussed solely on a control limit.
I agree with the concept but IMO It is important that the control limit is understood to be an accessory to the critical limit rather than the primary target.
Document where you see fit, but you need to make sure all the areas where it is documented are clearly spelled out and it is consistent.
One of the pitfalls with critical versus operational limit is the operator understanding of the difference. Lots of focused training on this is needed to ensure operators understand the difference and what to do if they are outside the operational limit versus the critical limit.
I don't quite understand how an operating limit would be 20degC above a critical limit of 70 degC ?
Hi Charles, I changed the values for the post just as an example - I didn't want to give the actual ones as it potentially makes me identifiable, although FWIW if I gave the true time/temp combinations then the disparity between critical and operating limits would probably look even more significant, as if defined in terms of pasteurisation units it is several orders of magnitude!
One could be handling a product with a pH range that isn't particularly conducive to pathogen survival, in a product matrix that generally makes it relatively easy to achieve the desired log kill with a thermal process. That product may however be quite susceptible to a range of spoilage organisms that are far more resilient in the matrix and likely to be present at higher levels, and thus require a more substantial process to address them. My view is that in a strict HACCP sense, the "true" critical limit should be that which is required to achieve a safe product, but a higher operating limit may be needed because having a safe product is not all that useful if it's going to go mouldy before it gets to even 10% of shelf life.
pHruit, I'm really impressed by your detailed, precise and professional explanations! I've been reading your comments throughout topics, and just out of curiosity: what's your background?
Thanks, that's very kind of you to say :blush:
I used to be a research scientist in a discipline that is not at all related to food, and accidentally stumbled into the industry nearly 15 years ago.
Hi Charles, I changed the values for the post just as an example - I didn't want to give the actual ones as it potentially makes me identifiable, although FWIW if I gave the true time/temp combinations then the disparity between critical and operating limits would probably look even more significant, as if defined in terms of pasteurisation units it is several orders of magnitude!
One could be handling a product with a pH range that isn't particularly conducive to pathogen survival, in a product matrix that generally makes it relatively easy to achieve the desired log kill with a thermal process. That product may however be quite susceptible to a range of spoilage organisms that are far more resilient in the matrix and likely to be present at higher levels, and thus require a more substantial process to address them. My view is that in a strict HACCP sense, the "true" critical limit should be that which is required to achieve a safe product, but a higher operating limit may be needed because having a safe product is not all that useful if it's going to go mouldy before it gets to even 10% of shelf life.
Thanks, that's very kind of you to say :blush:
I used to be a research scientist in a discipline that is not at all related to food, and accidentally stumbled into the industry nearly 15 years ago.
Hi pHruit,
OK, thks, I get yr point but IMO any quality-related "extension" of the critical limit is unrelated to the haccp/FS plan and should be documented separately.
In the current context a "control limit" is afaik only intended to avoid failure of a safety criterion, ie the critical limit. Personally I have always avoided implementing "control limits" for reasons such as in my previous Post although I daresay that if utilising automatic diverters etc I might have a different viewpoint.
TBH I have never encountered such a "quality" addition included in a haccp plan Such a feature was specifically included in the original design style of haccp plans but was subsequently deemed confusing and soon dropped. I suppose SQF's 2-tier approach is the nearest official alternative although I find their (and others) subsequent introduction of terms like "quality hazard", CQP, etc to be highly debatable.
Hi pHruit,
OK, thks, I get yr point but IMO any quality-related "extension" of the critical limit is unrelated to the haccp/FS plan and should be documented separately.
In the current context a "control limit" is afaik only intended to avoid failure of a safety criterion, ie the critical limit. Personally I have always avoided implementing "control limits" for reasons such as in my previous Post although I daresay that if utilising automatic diverters etc I might have a different viewpoint.
TBH I have never encountered such a "quality" addition included in a haccp plan Such a feature was specifically included in the original design style of haccp plans but was subsequently deemed confusing and soon dropped. I suppose SQF's 2-tier approach is the nearest official alternative although I find their (and others) subsequent introduction of terms like "quality hazard", CQP, etc to be highly debatable.
This is a debate I've enjoyed (genuinely - I don't mean that to sound sarcastic) a number of times with auditors, although many have also accepted it without comment. Whilst I agree that purely in terms of principle it is cleanest to keep HACCP focussed on "actual" HACCP, I've found it to be a more pragmatic approach in my scenario (which is possibly a bit unusual) to have consistency between what the CCP summary states, what the work instruction for the equipment/process states, and how the automatic diverts etc are set up. It wasn't the original approach but it proved to be more confusing in practice having two sets of limits for the same process step.
As others here have mentioned, they can be placed in many different areas. Keep in mind, though, that if they are mentioned in your overall Food Safety Plan, they are subject to being audited under FSMA. I would look to include them only on the manufacturing procedure/recipe batch sheet for this reason. Also, do you need to have tighter operating limits due to a large degree of variability in your process? If so, this might raise a red flag during an audit since it is a CCP.
As others here have mentioned, they can be placed in many different areas. Keep in mind, though, that if they are mentioned in your overall Food Safety Plan, they are subject to being audited under FSMA. I would look to include them only on the manufacturing procedure/recipe batch sheet for this reason. Also, do you need to have tighter operating limits due to a large degree of variability in your process? If so, this might raise a red flag during an audit since it is a CCP.
Hi Ted,
I suppose one might argue (as ISO-haccp does) that significant variability is one of the factors promoting use of a CCP in the first place. :smile:
Hi Charles.
Good point. Thank you for your thoughts.
I understand your need as we also have a similar issue and are in the process of separate out operational temperature limits from the true critical limits. The true critical limit for pathogens (a real food safety hazard) is much lower than our operational limit which we need to use to control general quality (including ensuring TVC counts with USP/EP limits) and were actually advised by a feed certificate auditor that this would probably avoid some awkward questions and unneccessary effort if we were to seperate the two.
Historically I established the operational limit as the critical limit because Quality is critical to us but now I am tied in knots trying to produce the validation data for these operational limits for the feed and food safety certification requirements. Don't get me wrong we are not going to reduce our standards and will continue to operate well above the appropriate critical limit for pathogens of which there is loads of scientific information to provide validation.
I understand your need as we also have a similar issue and are in the process of separate out operational temperature limits from the true critical limits. The true critical limit for pathogens (a real food safety hazard) is much lower than our operational limit which we need to use to control general quality (including ensuring TVC counts with USP/EP limits) and were actually advised by a feed certificate auditor that this would probably avoid some awkward questions and unneccessary effort if we were to seperate the two.
Historically I established the operational limit as the critical limit because Quality is critical to us but now I am tied in knots trying to produce the validation data for these operational limits for the feed and food safety certification requirements. Don't get me wrong we are not going to reduce our standards and will continue to operate well above the appropriate critical limit for pathogens of which there is loads of scientific information to provide validation.
Hi PQE,
IMO this is conceptually a corruption of current HACCP.
However I would have thought that from a haccp POV the validation aspect would be trivial inasmuch as there is surely no objection to exceeding a minimum safety requirement.
Hi Charles,
Corruption a bit harsh ;-) but i understand your point.
Our material used interchangeably in food, feed and cosmetic industry. HACCP provides a platform to fulfill also the requirements Quality Risk Assessment for the cosmetic industry whose concern not just safety hazards but quality hazards (e.g. visible contamination). Using one approach saves time and provides consistency for operations team.
Hi Charles,
Corruption a bit harsh ;-) but i understand your point.
Our material used interchangeably in food, feed and cosmetic industry. HACCP provides a platform to fulfill also the requirements Quality Risk Assessment for the cosmetic industry whose concern not just safety hazards but quality hazards (e.g. visible contamination). Using one approach saves time and provides consistency for operations team.
Hi PQE,
To quote a well known soothsayer - It is what it is. :smile:
Out of curiosity, does the resultant "HACCP" have to comply with any particular Standard ?
If your operational limit is for quality then it should fall under your Quality Plan, not your HACCP plan. You should not intermingle your Quality Plan with your Food Safety Plan.
Charles and Ryan,
So to date the HACCP plan has passed muster against ceritifcations we've held for over 5 years, specifically;
EFfCI GMP
FAMI-QS
EU Food/Feed Safety Regs
But in preparation for certification to FSSC22000 we'll need to be careful and this is where your views are useful. Our aim still remains to maintain, as much is possible a one size fits all (including FSMA), to avoid unneccessary duplication.
Regards
John
Charles and Ryan,
So to date the HACCP plan has passed muster against ceritifcations we've held for over 5 years, specifically;
EFfCI GMP
FAMI-QS
EU Food/Feed Safety Regs
But in preparation for certification to FSSC22000 we'll need to be careful and this is where your views are useful. Our aim still remains to maintain, as much is possible a one size fits all (including FSMA), to avoid unneccessary duplication.
Regards
John
Hi John,
As you are no doubt aware FSSC22000 utllizes iso22000 which pioneered iso-haccp.
afaik, iso-haccp is focussed solely on safety although it does contain its own variation of operational limits for OPRPs.
I predict you are likely to have some interesting auditorial "discussions". :smile: