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Cooling CFIA Regulatory Cold spot Validation

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#1 psunjka

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Posted 01 March 2017 - 09:27 PM

One of regulatory requirements for the meat industry in Canada is to follow the cooling step of the process. There are certain requirements that must be met, e.g. slow cooling: product must cool from 49C to 4C within 20 hours. Now, when we validated our cooling rooms (refrigerators), we encountered a problem which spot should be considered a "warm" spot.

 

1. The spot that reaches 4C the last, or

2. The spot that has the longest cooling time (for example 19 hours from 49C to 4C).

Very often these spots match, but not all the time.

 

Have you encountered a problem like this? How did you solve it? Which spot is the official "warm" spot in your validation?


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#2 Charles.C

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Posted 02 March 2017 - 03:45 AM



One of regulatory requirements for the meat industry in Canada is to follow the cooling step of the process. There are certain requirements that must be met, e.g. slow cooling: product must cool from 49C to 4C within 20 hours. Now, when we validated our cooling rooms (refrigerators), we encountered a problem which spot should be considered a "warm" spot.

 

1. The spot that reaches 4C the last, or

2. The spot that has the longest cooling time (for example 19 hours from 49C to 4C).

Very often these spots match, but not all the time.

 

Have you encountered a problem like this? How did you solve it? Which spot is the official "warm" spot in your validation?

 

Hi psunjka,

 

i presume you are referring to -

 


4.5.1.1

………..

………..

Requirement for slow cooling:

Condition 1 and one of the two options in condition 2 must be met:

Condition 1:

The internal temperature does not remain between 49°C and 4°C for more than 20 hours;

and

Condition 2:

The cooling process:

causes a continuous drop in product's temperature; or

controls the product's surface temperature so that it does not stay between 49°C and 20°C for more than two (2) hours

 

(internal temperature above should refer to the maximum value, ie that at the slowest cooling point, often referred to as core temperature,eg center or thickest part)

 

IMO, No.2 is a logical interpretation but maybe depending on what you mean by "spot" (see [a,b] below).

 

IMEX you typically require 2 investigations so as to -

 

(a) determine the location of core temperature

(b) establish a temperature profile of the cooling arrangement.system. Depending on the situation, this may take some effort. CFIA do not appear to suggest any Procedure/detailed requirements. To illustrate the activity can see this short thread -

 

http://www.ifsqn.com...ion-monitoring/


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#3 Charles.C

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Posted 02 March 2017 - 07:24 AM

addendum

 

Several queries such as this one but for other locations have been posted on this Forum. Most have been inconclusive from a detailed procedure POV.

 

Each situation tends to have its own varying time/temperature cooling requirements but procedures for validating/temperature mapping (TM) of chillers seem elusive(?). Possibly CFIA's expectations for the cooling stage will be less exacting than (I presume) for the cooking step.

 

Hopefully the OP has already passed the TM stage but JFI the first attached file has a detailed procedure for TM in a cooking chamber (Pg 35). i speculate that a similar logic would apply to chilling for the particular geometry shown.

 

Second attachment discusses various process factors which may influence a chiller's performance / its validation.

 

Attached File  Guidance - Industrial Processing of heat-chill foods,2006.pdf   514.16KB   14 downloads

Attached File  validation chillers.pdf   879.83KB   23 downloads


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#4 psunjka

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Posted 02 March 2017 - 02:46 PM

I appreciate the answers and I believe I should give more info. Our product are cretons (pork spread), in different formats (from 150gr to 3kg), cooled on racks. We are already well into our validation process, we established what is our worst case scenario (it is not the largest product format :), as racks are placed at different times in the refrigerator, we decided to follow each rack separately. Horizontal placement is validated (center of the rack is the warm spot). All is well except vertical position of the warm spot: in some racks we had the last level (tray) cool down the slowest (in terms of time), but the level above reached 4C the last. Even though we are well within safety margin, we have to decide which position on the tray should be monitored: center of the last tray or the center of the tray above.

Attached Files


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#5 Charles.C

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Posted 02 March 2017 - 03:33 PM

Hi psunjka,

 

Thanks for the expansion.

 

It might have been interesting to know the quantitative differences.

 

You may have too many unknown variables as per yr description.

 

Is there a limitation in available thermocouples.?

 

I assume there are numerous (fully loaded) movable objects (trolleys) as in yr picture being cooled at the same time in a normal run.

 

Regardless, IMO it is logical for a test run to use a representative number of fully loaded trolleys ( ~max. system load) all starting to be cooled approx at the same time.

 

It seems logical to determine if one floor position/trolley consistently gives the slowest time from  49 to 4 degC

 

If so, can  focus on racks in that trolley again started at the same time.

 

Then repeat the exercise, eg in triplicate.

 

Just speculating. :smile:


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#6 scampi

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Posted 03 March 2017 - 01:27 PM

Ok, so assuming that your processing room temperature is below 10 degrees C, it is then fair to state that your product is already beginning to chill prior to entering the chiller which would explain the difference between bottom and rack above cooling time. 

 

My official warm spot is the far back corner, but my product all weighs in at about 150 grams. Your validation (to meet CFIA requirements) must be able to be repeatable and it is up to you to justify your validation with data. So depending on volume of production in a day, your study should also reflect that. There is no reason that you cannot include both points, but I would take LONGEST to 4 degrees as my worst case scenario. 

 

Are you using air movement in the fridge? Is your finished good RTE?


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#7 scampi

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Posted 03 March 2017 - 04:15 PM

The ONLY way to validate the blast freezer is to collect reams and reams of data. You do not need an expert you can and should do this yourself. You can purchase wireless data loggers and/or multiple thermometers for way less than a consultant will charge you for this study.

Begin day one with a probe in top/middle and bottom layer as close to the middle as you can..............continue to monitor until product has reached the temperature you require/are mandated to be at. Repeat this for EACH cart that goes into the blast while recording WHERE and WHEN each cart went. Now, in order to be statistically sound, you will also need the temperatures of the same three locations/cart PRIOR to going into the blast.

You should already have enough data from your chilling records to know approximately how long your product needs to cool, and that will dictate how much time this will take.

I performed my validation study over the course of one week. The put a grid on the floor so I knew where each cart needed to go by each day. The other portion of the validation will be the actual blast freezer temperatures, again, a data logger is required.

DO not make this process more complex than it is, you just the need time to complete

 

I hope this helps


Edited by Charles.C, 04 March 2017 - 05:21 AM.
moved to this current thread ex 24400

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#8 Charles.C

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Posted 04 March 2017 - 04:35 AM

Hi psunjka,

 

CFIA seem to offer remarkably little tech. info. on this, by no means unimportant, topic. Perhaps they assume you will use a consultant. Or i have missed it.

 

In comparison USDA/FSIS offer voluminous guideline material although their interpretations/temps/time criteria are somewhat different.

After scanning the FSIS guidelines, Scampi's opening comments (post 7) look well-justified. I suspect the simplicitly or otherwise may depend on yr system.

 

If interested, FSIS-related validation support files are available here -

http://meathaccp.wis...on/cooling.html

 

This, IMO, quite impressive US document contains examples of methods/profiles for temperature mapping as applied to processes for cooking and chilling[see end section] meat products - 

 

Attached File  Temperature Mapping in RTE meat heating-chilling processes.pdf   1.28MB   9 downloads

(Figures are repeated, enlarged, at end)

 

As noted by Scampi, the monitoring of the chilling stage can be, ultimately, relatively simple but this may depend on yr specific installation/usage.


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#9 psunjka

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Posted 06 March 2017 - 01:40 PM

We are well advanced in our validation studies, we finished temperature mapping in the empty refrigeration room (blast, cooler, chiller, potato-patato...), we have ton of data on full room (different products, types of racks/chariots/trolleys,...), all is well and fine except one small thing: location of the warm spot when the room is full for some product, as I explained in the original post. About 80-85% of time we have the same spot reaching 4C the last, AND be the longest to cool, so choice is simple there, but when it comes to 15-20% of results, these two points may differ a bit. We have hard time convincing CFIA auditor that we will monitor one spot per rack as we are well within the limit and there should be no risk of going over 20 or 7 hours.

One of references that Charles C. posted was quite helpful in this case (thank you); it mentions that the best practice is to follow the cold spot (in cooking, but it is translatable to cooling) which is at the required temperature and meets time/temperature requirement. Now, I interpret this as having the required temperature as a primary condition, and meeting time/temperature the secondary.


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#10 scampi

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Posted 06 March 2017 - 03:56 PM

FYI to all who read this thread. CFIA is switching from prescriptive to outcome based oversight, there will be even LESS information available to manufactures who must follow the MOP (meat manual of procedures) everything will be outcome based. So if you feel that you can SAFELY chill your product in more OR less time than the current regulation, you will be able to do so PROVIDED you can validate your process which will also have to include (in your particular case) shelf life studies should you decide to change anything. 

 

I will however, caution from going to far outside of the box......the prescriptive in the MOP right now will be considered "safe harbours" which means any point that has been validated to the regulation will allow to move forward under that validation without it needing to be re done..........any changes you make will require a re-validation and we all now that the CFIA inspectors will not like the change and/or be able to make a decision about a CVS tasks if your information is not complete, repeatable and without questions of any kind.

 

 

The warm spot when the room is full IMHO would be from not enough air moving for the amount of product in the cooler.......consider extra fans if you believe it will help


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#11 psunjka

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Posted 06 March 2017 - 04:19 PM

FYI to all who read this thread. CFIA is switching from prescriptive to outcome based oversight, there will be even LESS information available to manufactures who must follow the MOP (meat manual of procedures) everything will be outcome based. So if you feel that you can SAFELY chill your product in more OR less time than the current regulation, you will be able to do so PROVIDED you can validate your process which will also have to include (in your particular case) shelf life studies should you decide to change anything. 

 

I will however, caution from going to far outside of the box......the prescriptive in the MOP right now will be considered "safe harbours" which means any point that has been validated to the regulation will allow to move forward under that validation without it needing to be re done..........any changes you make will require a re-validation and we all now that the CFIA inspectors will not like the change and/or be able to make a decision about a CVS tasks if your information is not complete, repeatable and without questions of any kind.

 

 

The warm spot when the room is full IMHO would be from not enough air moving for the amount of product in the cooler.......consider extra fans if you believe it will help

Hello Scampi

 

Thanks for all the posts. I'm fully aware of the SFCA, as a matter of fact, I will be attending a webinar on this in a few hours. My problem here is much more specific than going over validation procedures and methods, or discussing about shifting CFIA approaches. Unfortunately, we stumbled upon a detailed 4000-task CFIA auditor, in her opinion, we can't prove that we can control the cooling process by monitoring the cold spot that reaches 4C the last. In her opinion, we haven't proven beyond doubt that we have control over process by monitoring only one cold spot, I believe she is expecting us to follow both spots as I described in my original post. We would like to avoid this as it doubles the work and number of probes we use (we can have up to 25 racks per day, times two probes per rack...). We consider that having 80-85% accuracy AND having a relatively safe process (all products cool in almost half of the allotted time, no pathogen hits as long as we remember, cooking has been validated, no major issues with the HACCP system and local CFIA...) we validated the process and have good control over it.

But as you point out, less prescriptive approach can be even worse than MOP: it leaves more room to personal interpretation of both sides: industry and CFIA.


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#12 scampi

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Posted 06 March 2017 - 04:37 PM

Oh I understand now, you're in the middle of a section 4 audit......give her what she wants right now to close the audit.....it's your program you can always change it later....if you don't have shelf life data etc that you can quickly add to your written program I can assure you this is the only way out..............................my last section 4 audit took 6 months to close 

Good Luck


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#13 Charles.C

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Posted 06 March 2017 - 04:39 PM

Hi psunjka,

 

It sounds like the auditor is requiring rigorous validation of the data complying with the (2) numbers in yr OP, my post 2 and as illustrated in my attachment of post 8.

 

Offhand, that does not seem so unreasonable ?

 

PS - i deduce SFCA is the Safe Food for Canadians Act.

 

PPS - Frankly, it seems amazing to me that it is possible to precisely fix one slowest location for every lot/every day. Even 85% of the time.


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#14 scampi

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Posted 06 March 2017 - 05:04 PM

Oh Charles, you don't know the joys of working with a CFIA auditor!! If they say jump, most of the time you'd best be asking how high. I'm not totally being tongue in cheek here either, if you are in a Section 4 audit, they can REMOVE your license to operate temporarily or otherwise


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#15 psunjka

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Posted 06 March 2017 - 05:34 PM

100% agree with scampi, I don't want to discuss the competency/knowledge/experience/soft skills of some CFIA auditors here in an open forum. And Charles, your "PPS" above hits is right on the spot. With 85% I would say we have magnificent results. For some people this is inconclusive, they would rather see 100% even though it is virtually impossible in the real world.


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