Need advice regarding a Food Safety Plan Deviation

Hi all. I need to know what others would do if in the position I'm in today. The company I work for has two critical control points, one of which is a validated salmonella thermal kill step for popcorn popping. Our critical limit is 435 °F and our operational limit is 440 °F. The equipment is always set to 440 °F and the equipment's thermometer always reads 440 °F once it heats up from idle/non-operational temperature. Our Food Safety Plan requires the temperature is monitored and recorded every 30 minutes.

Production begins roughly 3 hours before I arrive to work at 9 AM, and by the time I arrived yesterday, the operator of the popcorn popping equipment had already completed the day's run of popcorn for further use in our product however did not have any printed forms to record his temperature checks, so he simply didn't complete them. So now I have an entire day's worth of popcorn which was produced with no monitoring recorded.

The operator stated he still continued to monitor the temperature throughout the run, he just couldn't record it because he didn't have the sheet. However, this is still a deviation as no temperatures were recorded or submitted to me for verification.

Now all the product made yesterday is sitting on hold and the owners of the company are very annoyed at this because in their mind, the checks still occurred, they just weren't recorded, so why hold the product? One of the owners even printed out a new sheet and had the employee fill it out after the checks had all been completed.

I still have the product on hold given the nature of this CCP. I know the product was popped at the right temperature - we just don't have the records to prove it. What do we do in a situation like this? What would other Quality Managers do in this situation?

Check the Quality of the product using sensory evaluation. Document the lot and batch code fill the deviation form and make corrective action then release the product.

I agree, if it's an experienced well trained operator that knows what she/he is doing and whats required.

Make sure you also include some retraining both for the operator and the supervisor about the importance of completing records, particularly when they are CCPs. That should be a portion of the corrective actions.

At such high temperatures that are required for popping corn, I would agree that there is probably no FS risk (and you can back this up with your validation study).  Include that explanation in your corrective action/deviation documentation, include an action plan for keeping extra or backup CCP forms within access to your operator, have your operator sign a statement that the temperature was monitored and did not fall below critical limit.  If your owners will allow it, send product samples out for salmonella testing just to cover your bases.

I agree that some retraining should also be done - your operator/supervisor should know the importance of recording CCP checks.  I've been in a situation where our production personnel ran out of forms but knew the importance of temperature monitoring and so recorded their checks as best they could on scrap paper.  It is not ideal to rely on personnel to do this (nor is it within recordkeeping compliance on multiple levels), but is better than someone just throwing a form at them the next day and expecting them to fill out a record that requires 30 minute monitoring from memory. Retrain on CCPs and find a way that your personnel can have access to critical forms (a master forms binder, etc.) at all times.

Thanks for the insight guys. We've had very few deviations over the years but now that we've ramped up our output, I'm sure this won't be the last.

on the master forms..........I keep a master binder beside the main printer. It is my responsibility to maintain the binder with the most up to date version of documents and ask for the return of old ones.  That way supervisors have access to the forms without requiring access to me!!!

if a deviation accured in one of your CCPS :

get all the HACCP  team together to find the root cause of the problem and the corrective action .

is it deviation ? / or just human error or  may be you need another source of verification not only the operator but also a QC person who will check the temperature log every 30 minute

Hello,

The issue in this question is the CCP. You need to go back to the definition of a CCP:

Critical Control Point = So if it's not controlled, you can never assure the food safety of the product. You define your own criteria and if these are not met, than your product is not conforming.

Of course, there are all such measures as corrective actions and continuous improvement afterwards. However, the basis is the CCP. So I agree that you hold the product.

For rework, you repass it at the required time/temperature combination to kill the Salmonella. Or you give it an equivalent Salmonella killing step in another way, if possible, so you don't damage the product.

Kind regards,

Gerard Heerkens

Hello,

As I read your post, the root cause why the operator didn't have the record because he doesn't have the form. And why you document controller did not give a for your operator? And could be down to your document controller or may be to the purchaser that procure materials formonitoring form. Your problem escalates because of the very simple lapses. CCPs monitoring records are crucial to your operation it must not be overlooked.

The mantra on food safety is "if you didn't write it, you didn't do it". And CCP monitoring and record must be done in real time.

regards,

redfox

Verify safety with a study:

1. Is your CCP a true CCP? What log reduction is it supposed to provide? If it's 7, would a 5 log reduction be sufficient?

2. What temperature is necessary for your popcorn to actually pop? If it reaches a sufficient internal temperature to meet your CCP, then again, no issue if you sort out all unpopped seeds regardless.

Hi all. I need to know what others would do if in the position I'm in today. The company I work for has two critical control points, one of which is a validated salmonella thermal kill step for popcorn popping. Our critical limit is 435 °F and our operational limit is 440 °F. The equipment is always set to 440 °F and the equipment's thermometer always reads 440 °F once it heats up from idle/non-operational temperature. Our Food Safety Plan requires the temperature is monitored and recorded every 30 minutes.

 

Production begins roughly 3 hours before I arrive to work at 9 AM, and by the time I arrived yesterday, the operator of the popcorn popping equipment had already completed the day's run of popcorn for further use in our product however did not have any printed forms to record his temperature checks, so he simply didn't complete them. So now I have an entire day's worth of popcorn which was produced with no monitoring recorded.

 

The operator stated he still continued to monitor the temperature throughout the run, he just couldn't record it because he didn't have the sheet. However, this is still a deviation as no temperatures were recorded or submitted to me for verification.

 

Now all the product made yesterday is sitting on hold and the owners of the company are very annoyed at this because in their mind, the checks still occurred, they just weren't recorded, so why hold the product? One of the owners even printed out a new sheet and had the employee fill it out after the checks had all been completed.

 

I still have the product on hold given the nature of this CCP. I know the product was popped at the right temperature - we just don't have the records to prove it. What do we do in a situation like this? What would other Quality Managers do in this situation?

I think Charles.C is onto something here.  I am inferring that you, idealdreams, are QC/QA, and that Production runs without QC there for some parts of the day.  That's something I would change as a preventive action.  I would make sure that Production always has QC there when running, or otherwise they don't run.  They need that help/oversight there at all times.  That's important for GMP's.

The others addressed what you should do for this lot specifically, so I won't go into that.

Matthew, QA Director

idealdreams has stated that they are the QC manager.....so yes, they need to ensure that someone in an oversight position is there, but I would argue that OPERATIONS needs to be responsible for there stuff. Just because it is a QA/QC policy does not mean that the operations folks shouldn't buy in. 

I have seen countless times where this happens----QC is thrown under the bus when OPERATIONS didn't do there part.

at my pp it took 4 months to implement the knife control program because it was up to OPERATIONS to manage it.......had it been QA it would have taken 2 days.

This sounds like an operations issue to me-----that department must buy in or this failure will just keep reoccuring

Hello,

IMO, their operatives need to be trained/re-trained. It seems they don't care the importance of real-time monitoring. They be told the "WHY" that they should have known. The post #1 of idealdreams stated that they are not sure if there is temp deviation, the deviation is "not recording the temp" in real-time. 

The argument of operator is no printed form available. Investigate if it is true. If found correct, why form are not supplied for the operator readily available? Because draft/temporary records should not be allowed because it might be lost or be thrown away to the trash bins.

regards,

redfox

The CCP here mentioned is 435 and as he have mentioned the equipment is set at 440 all the time, that means temperature cannot be altered and if the machine is ON it has to work at 440 temperature. So the product is conforming as it has attained the working temperature provided there is no machine breakdown. The problem/NC is on the ineffective robust monitoring system of CCP of that particular batch. The conformity of the non-conforming product can be determined through microbial analysis (salmonella). I believe this is a more practical approach.  

At such high temperatures that are required for popping corn, I would agree that there is probably no FS risk (and you can back this up with your validation study).  Include that explanation in your corrective action/deviation documentation, include an action plan for keeping extra or backup CCP forms within access to your operator, have your operator sign a statement that the temperature was monitored and did not fall below critical limit.  If your owners will allow it, send product samples out for salmonella testing just to cover your bases.

 

I agree that some retraining should also be done - your operator/supervisor should know the importance of recording CCP checks.  I've been in a situation where our production personnel ran out of forms but knew the importance of temperature monitoring and so recorded their checks as best they could on scrap paper.  It is not ideal to rely on personnel to do this (nor is it within recordkeeping compliance on multiple levels), but is better than someone just throwing a form at them the next day and expecting them to fill out a record that requires 30 minute monitoring from memory. Retrain on CCPs and find a way that your personnel can have access to critical forms (a master forms binder, etc.) at all times.

Interesting discussion.

Personally, I feel MsMars response was the most comprehensive.

"Food for life" also helped cement this by highlighting the the equipment is set at 440 all the time and cannot be altered.

I agree that the product should be released and an NCN (non conformance notice) issued to the operations team for corrective action.

I would also send out the samples for a Salmonella test just to be in the safe side.