12 replies to this topic

[lauMoH]

Hello, I need help determining if it's sufficient to demonstrate, during an audit, that a product is safe despite not complying with the FDA guidance regarding cooling down a product. I work for a company that produces sauces.

 

When we use frozen product, we leave it in the refrigerator for 5 days, and one day before production, we take it out and leave it in production overnight to ensure it's ready for use (the temperature varies; sometimes the outer boxes reach up to 50 degrees, and the inner boxes are around 30 degrees). 

 

We mix all the ingredients and make the sauce, which then goes through a pasteurizer and subsequently a chiller to lower the temperature. In 30 minutes, the product that was heated to 170 degrees drops to 60 degrees. 

 

Afterwards, the product is packed and then placed in the refrigerator. In the refrigerator, it takes 3 days for the product to reach less than 40 degrees (the inner part of the pallet; the outer part reaches 40 degrees in one day).

 

I'm trying to make senior management understand that the process is not safe because it puts the food at risk, and there is a higher chance of product contamination. 

 

I have sent the product to the laboratory for testing, and the results have come back fine despite this process.

 

Senior management says they won't change the process as they've been doing it this way for over 30 years without any issues.

 

My question is whether an auditor would accept such an explanation. Can I provide laboratory evidence that confirms the product is not contaminated?

I feel we are taking undue risks with the product, but senior management doesn't seem to see it like that. Can someone provide advice on what to do?

Thank you!

[Brothbro]

The right thing to do would be to invest in some kind of blast chiller that can chill the product faster. Or store the sauce in a different shape container, a shape that would also promote faster cooling (e.g. thinner so the distance between the center and outer edge is reduced). Simply put one set of lab results from one batch is not enough to prove that your system is safe. You'd have to do some kind of extensive validation study. An auditor would likely question the system you have in place, citing the FDA cooling guidelines. Also on the subject of your thawing from the freezer, could you not bring the frozen sauce out perhaps 7 days in advance to fully thaw it in the fridge instead of doing that final thaw at room temp?

 

You say they've been doing this forever, but is this the first time your facility is being audited by a third-party? I assume you've been inspected by the FDA before, has this never come up?

Edited by Brothbro, 06 September 2023 - 09:34 PM.

[G M]

...

 

Senior management says they won't change the process as they've been doing it this way for over 30 years without any issues.

...

 

Have they been doing micro testing on the finished product for that amount of time as well?  While I find some of the time frames material is in the "danger zone" temperature range sketchy, if you can produce enough historical data to support your process as validated to be safe, there is little for anyone to argue with.

 

If this testing data doesn't exist yet, start doing so.  Collecting it is likely the only alternative to complying with standard processes that are validated by third parties.

 

Right now that quoted statement above could just as well read "Haven't been caught yet" without the validation.

[lauMoH]

thank you

 

The right thing to do would be to invest in some kind of blast chiller that can chill the product faster. Or store the sauce in a different shape container, a shape that would also promote faster cooling (e.g. thinner so the distance between the center and outer edge is reduced). Simply put one set of lab results from one batch is not enough to prove that your system is safe. You'd have to do some kind of extensive validation study. An auditor would likely question the system you have in place, citing the FDA cooling guidelines. Also on the subject of your thawing from the freezer, could you not bring the frozen sauce out perhaps 7 days in advance to fully thaw it in the fridge instead of doing that final thaw at room temp?

 

You say they've been doing this forever, but is this the first time your facility is being audited by a third-party? I assume you've been inspected by the FDA before, has this never come up?

Hello, I just joined the company, and I'm observing what's going on here. I agree with you that it would be the right thing to do. The problem is that senior management (including the QA corporate manager) agrees that what they're doing is fine because they've been doing it for many years, and that's the only answer, and they don't want to invest in equipment.

 

The company does get audited, but I suppose they've never realized what's happening.

 

Regarding the thawing process, it used to be done entirely outside the refrigerator, in three days. It was difficult to convince them to let it thaw for five days with only one night outside.

 

I don't know what to do to convince them that this isn't right, even if they haven't had any problems. But it's not about waiting for something bad to happen.

[Brothbro]

 

I don't know what to do to convince them that this isn't right, even if they haven't had any problems. But it's not about waiting for something bad to happen.

 

 

Sure, it's a hard situation when you're lower on the totem pole and up against senior staff. If possible I would begin collecting routine micro data on your sauces to begin building a case, like GM mentions. The cost associated with this may be less than a chiller, but still works towards a process improvement. Hard to believe that even senior QA doesn't see a problem with this, they should at least see the benefit in validating your current process.

[lauMoH]

Have they been doing micro testing on the finished product for that amount of time as well?  While I find some of the time frames material is in the "danger zone" temperature range sketchy, if you can produce enough historical data to support your process as validated to be safe, there is little for anyone to argue with.

 

If this testing data doesn't exist yet, start doing so.  Collecting it is likely the only alternative to complying with standard processes that are validated by third parties.

 

Right now that quoted statement above could just as well read "Haven't been caught yet" without the validation.

Hello, I haven't seen that information, and I don't think they have it.
Since I began to understand the process they follow and saw that they simply aren't considering changing it, I started sending samples of all the products to the laboratory, and fortunately, they have come out well (and there have been no customer complaints). That's why I want to know if that would be enough because I work for this company, and I don't want to have problems. I don't agree with how they carry out the process, and I don't think their mindset will change quickly, but for now, I want to do what's within my control.

 

I completely agree when you say "Haven't been caught yet." I feel the same way, like I'm part of it for not being able to change it.

[lauMoH]

Sure, it's a hard situation when you're lower on the totem pole and up against senior staff. If possible I would begin collecting routine micro data on your sauces to begin building a case, like GM mentions. The cost associated with this may be less than a chiller, but still works towards a process improvement. Hard to believe that even senior QA doesn't see a problem with this, they should at least see the benefit in validating your current process.

 

Thank you, I will continue to collect the data. I was worried if it would be deemed acceptable because an auditor might not consider my circumstances or whether I have control over their decisions.

[kingstudruler1]

The frozen ingredients left to thaw at room temp could allow the growing of pathogens that produce toxins that would not be destroyed during pasteurization.

it sounds like this process isn't being controlled.   this is problematic.  especially since it appears it is not being monitored.  

 

while you still do have risks after pasteurization, id also be concerned about spoilage as well.   that might be another angle of approach. 

 

IMO simple testing is meaningless.  it's like finding a needle in a haystack.

 

odwalla made unpasteurized juice for decades before they sickened and killed kids.   History is not an argument for circumventing food safety.

 

 

maybe you could search for 483 or warning letters with similar circumstances.   

[lauMoH]

The frozen ingredients left to thaw at room temp could allow the growing of pathogens that produce toxins that would not be destroyed during pasteurization.

it sounds like this process isn't being controlled.   this is problematic.  especially since it appears it is not being monitored.  

 

while you still do have risks after pasteurization, id also be concerned about spoilage as well.   that might be another angle of approach. 

 

IMO simple testing is meaningless.  it's like finding a needle in a haystack.

 

odwalla made unpasteurized juice for decades before they sickened and killed kids.   History is not an argument for circumventing food safety.

 

 

maybe you could search for 483 or warning letters with similar circumstances.   

Thank you. Trust me, I'm not comfortable with our current mode of operation. I'm eager to shift people's mindset, but I need to begin with something tangible. My primary concern is ensuring people don't fall ill or face potentially fatal consequences, even if they claim everything is fine just because they have over 30 years of experience backing them up.

[Tony-C]

Thank you. Trust me, I'm not comfortable with our current mode of operation. I'm eager to shift people's mindset, but I need to begin with something tangible. My primary concern is ensuring people don't fall ill or face potentially fatal consequences, even if they claim everything is fine just because they have over 30 years of experience backing them up.

 

Hi lauMoH,

 

I appreciate this sort of thing can be quite frustrating.

 

This can be fixed using a relatively cheap and simple solution. If your refrigeration is reasonable then rapid cooling can be achieved by placing product pallets in industrial size boxes with a large fan that blasts cool air in the refrigerator through the pallet.

 

I’m attaching some images to make it easier for you to see what I mean:

 

 Industrial Cooling Box.png   1016.5KB   3 downloads

 

 Industrial Cooling Fan.png   1.19MB   3 downloads

 

Kind regards,

 

Tony

[Charles.C]

Hi lauMoH,

 

From a purely Organisational POV I think I would be somewhat concerned if the responsibility for the final approval of the finished  products being commercialised was nominally yourself. I hope your self-protection is not at risk.

 

From an auditorial POV I fear that some of the previous suggestions may well be an  exercise in futility albeit it with the noblest of intentions. Auditors are typically, professionally  obliged to follow their Regulatory instructions/Procedures and especially where specific, quantitative, safety-related requirements exist. Sampling evidence showing no detected problems can never statistically prove/guarantee that such problems do not exist in the source material. The only IMO potentially useful result of such a study might be if an auditee's proposal of an alternative validation offer is included (detailed?) in FDA's associated Regulatory documentation but I doubt that this exists in the present (repeatedly historically documented) case ?.

 

You can find several analogous Company situations to the current case  discussed in threads on this Forum with requests for possible Personal actions. One often popular suggestion is RUN.

[lauMoH]

Hi lauMoH,

 

I appreciate this sort of thing can be quite frustrating.

 

This can be fixed using a relatively cheap and simple solution. If your refrigeration is reasonable then rapid cooling can be achieved by placing product pallets in industrial size boxes with a large fan that blasts cool air in the refrigerator through the pallet.

 

I’m attaching some images to make it easier for you to see what I mean:

 

Industrial Cooling Box.png

 

Industrial Cooling Fan.png

 

Kind regards,

 

Tony

Thank you, Tony! I will suggest this solution maybe we can achieve the time/temperature with this option.

[lauMoH]

Hi lauMoH,

 

From a purely Organisational POV I think I would be somewhat concerned if the responsibility for the final approval of the finished  products being commercialised was nominally yourself. I hope your self-protection is not at risk.

 

From an auditorial POV I fear that some of the previous suggestions may well be an  exercise in futility albeit it with the noblest of intentions. Auditors are typically, professionally  obliged to follow their Regulatory instructions/Procedures and especially where specific, quantitative, safety-related requirements exist. Sampling evidence showing no detected problems can never statistically prove/guarantee that such problems do not exist in the source material. The only IMO potentially useful result of such a study might be if an auditee's proposal of an alternative validation offer is included (detailed?) in FDA's associated Regulatory documentation but I doubt that this exists in the present (repeatedly historically documented) case ?.

 

You can find several analogous Company situations to the current case  discussed in threads on this Forum with requests for possible Personal actions. One often popular suggestion is RUN.

Thank you, Charles. I have indeed taken into account that suggested idea. However, the issue lies in the fact that senior management will continue to follow their current approach, which could potentially impact individuals negatively. It's necessary to take action to address this situation.