14 replies to this topic

[new2fs]

Hello, 

 

I had a question regarding a minor I received from our audit regarding code 2.4.3.11, the auditor was stating that we did not define our limit.  

 

I sent back the NCR stating the National Advisory Committee on Microbiological Criteria for Foods (NACMCF) as well as the fsis/usda food safety information danger zone. 

 

I got a email regarding that my corrective actions are not accept.  Would I be able to write that we are reassessing and revalidating the information as we did switch our haccp plan less than 30 days before the audit for resubmission of my corrective actions?

 

 

 

 

[SQFconsultant]

I got a email regarding that my corrective actions are not accept.  Would I be able to write that we are reassessing and revalidating the information as we did switch our haccp plan less than 30 days before the audit for resubmission of my corrective actions?

 

.......................................................................

 

You can try that, however the big elephant in the room begs to be addressed - why did you switch your haccp plan less than 30 days before the audit - the monkey wrench wants to know why?

[jfrey123]

They might be wanting you to gap assess how your company ended up implementing a new HACCP plan with a CCP that lacked a critical limit.  Your written HACCP program should be instructional as to how to make changes, and as part of those changes there should be a review that eliminates the possibility of the plan being incorrectly written or implemented.

 

A finding in an SQF audit can rarely be address with a corrective action alone:  findings, especially those pertaining to food safety such as your CCP information, require a root cause analysis with a corrective action plan.  In this case, you'll want to address how you prevent a future HACCP revision from missing critical information.

[Scampi]

I'm assuming that your user name means New to Food Safety 

 

Do you or do you not have a critical limit attached to your CCP? If NOT (and i'm assuming from your NCR that is the problem)  you need a plan to A) determine what it should be an B) validate that it is effective to control the hazard YOU determined required this step to be a CCP

 

 

And ya, a new HACCP plan 30 days before an audit (scheduled or otherwise) was not a wise choice

[new2fs]

 

I got a email regarding that my corrective actions are not accept.  Would I be able to write that we are reassessing and revalidating the information as we did switch our haccp plan less than 30 days before the audit for resubmission of my corrective actions?

 

.......................................................................

 

You can try that, however the big elephant in the room begs to be addressed - why did you switch your haccp plan less than 30 days before the audit - the monkey wrench wants to know why?

 

 

 

There were couple factors that made us change it, unfortunately, we are a new plant and thought we would have things more in advance but it didn't work out as I had planned. 

[new2fs]

They might be wanting you to gap assess how your company ended up implementing a new HACCP plan with a CCP that lacked a critical limit.  Your written HACCP program should be instructional as to how to make changes, and as part of those changes there should be a review that eliminates the possibility of the plan being incorrectly written or implemented.

 

A finding in an SQF audit can rarely be address with a corrective action alone:  findings, especially those pertaining to food safety such as your CCP information, require a root cause analysis with a corrective action plan.  In this case, you'll want to address how you prevent a future HACCP revision from missing critical information.

 

I did have data that I showed during our actual audit plus the references but the auditor doesn't agree with it, I did talk to a consultant when I did my NCR but doesn't want to accept my response.  

[new2fs]

I'm assuming that your user name means New to Food Safety 

 

Do you or do you not have a critical limit attached to your CCP? If NOT (and i'm assuming from your NCR that is the problem)  you need a plan to A) determine what it should be an B) validate that it is effective to control the hazard YOU determined required this step to be a CCP

 

 

And ya, a new HACCP plan 30 days before an audit (scheduled or otherwise) was not a wise choice

 

 

 

Yes, I am new, and I did have a critical limit it wasn't accepted, at this point I think stating that we will have to reassess our plan is my go to response as I showed the auditor the data we have been collecting.  Definitely not wise and as I am new to running the SQF audit we did have consultants help, our HACCP plans had to change as our products being made were changed as well.  Multiple factors but trying to take in and understand everything, this forum definitely helps a ton!

[kingstudruler1]

You might need to provide more information.  

 

For instance, what is the process/ccp, what did you say the limit is, what exactly did the NC say, and any other info that the auditor stated.   

 

I'm not sure what the statement below means.  What information are you reassessing and revalidating?   but it doesn't sound like something that would be acceptable for a corrective action.   

 

Would I be able to write that we are reassessing and revalidating the information as we did switch our haccp plan less than 30 days before the audit for resubmission of my corrective actions?

[kingstudruler1]

Perhaps you could share what the CCP and critical limit is.   

[jfrey123]

I did have data that I showed during our actual audit plus the references but the auditor doesn't agree with it, I did talk to a consultant when I did my NCR but doesn't want to accept my response.  

 

I'm with Kingstudruler, we might need to ask what the CCP and critical limits were at this point.  Also might need to ask whether you had written those limits into your program or just had a CCP and a standalone document you pulled out to state the limit.  The limits should be clearly defined in your program document.  Posting your response and their reply might help give us context too.

 

And it's very well possible that either your data is not sufficient to support the limits you want to set, while equally possible the auditor isn't being reasonable which would take us into the realm of challenging the finding with SQF directly.  Boss of mine successfully downgraded a published critical finding at one of my plants to a minor last year when an auditor spotted an employee not meeting a critical limit.  But more info would be needed for anyone here to debate whether you need to consider that route.

[new2fs]

I'm with Kingstudruler, we might need to ask what the CCP and critical limits were at this point.  Also might need to ask whether you had written those limits into your program or just had a CCP and a standalone document you pulled out to state the limit.  The limits should be clearly defined in your program document.  Posting your response and their reply might help give us context too.

 

And it's very well possible that either your data is not sufficient to support the limits you want to set, while equally possible the auditor isn't being reasonable which would take us into the realm of challenging the finding with SQF directly.  Boss of mine successfully downgraded a published critical finding at one of my plants to a minor last year when an auditor spotted an employee not meeting a critical limit.  But more info would be needed for anyone here to debate whether you need to consider that route.

Critical Limit for CCP of Raw Not Ground HACCP has not been properly determined as it was described as: “Refrigerated Cold Storage Temperature Range shall be between 40 °F to 45 °F, without exceeding 40 °F for more than 2 hours” (Minor).

 

Our CCP's were listed under cold storage but it is what I was working with at the time of the audit. 

 

We had actually switched from paper logs to electronic and I had shown the auditor both.  We used the National Advisory Committee on Microbiological Criteria for Foods (NACMCF) and the USDA and FDA regulations. 

 

The auditor was more confused that we put a range vs a actual exact temperature as well. 

 

Thank you for the responses. I appreciate it so much. 

[Tony-C]

Hi new2fs,

 

The requirements for this section of the SQF Food Safety Code: Food Manufacturing – System Elements 2.4.3 Food Safety Plan (Mandatory) are:

2.4.3.11 For each identified CCP, the food safety team shall identify and document the limits that separate safe from unsafe product (critical limits). The food safety team shall validate all of the critical limits to ensure the level of control of the identified food safety hazard(s) and that all critical limits and control measures individually or in combination effectively provide the level of control required (refer to 2.5.2.1).

 

So, the requirement is to have defined limits in your food safety plan. This is an example of a HACCP Worksheet from CODEX:

 

 CODEX General Principles of Food Hygiene Example of a HACCP Worksheet.png   181.87KB   0 downloads

 

Referencing documentation is useful part of validation but you will also need to clearly define the specific critical limits for your critical control points. See this FDA explanation for Establishing critical limits (Principle 3). In this example, the HACCP team concluded that a thermal process equivalent to 155° F for 16 seconds would be necessary to assure the safety of this product.

 

Note that sometimes a minimum core temperature is acceptable for example when cooking joints.

 

My question would be, have you clearly defined your critical limits as above?

 

Kind regards,

 

Tony

[Tony-C]

Critical Limit for CCP of Raw Not Ground HACCP has not been properly determined as it was described as: “Refrigerated Cold Storage Temperature Range shall be between 40 °F to 45 °F, without exceeding 40 °F for more than 2 hours” (Minor).

 

Our CCP's were listed under cold storage but it is what I was working with at the time of the audit. 

 

We had actually switched from paper logs to electronic and I had shown the auditor both.  We used the National Advisory Committee on Microbiological Criteria for Foods (NACMCF) and the USDA and FDA regulations. 

 

The auditor was more confused that we put a range vs a actual exact temperature as well. 

 

Thank you for the responses. I appreciate it so much. 

 

Hi new2fs,

 

I don’t understand this limit as it doesn’t make sense: “between 40 °F to 45 °F, without exceeding 40 °F for more than 2 hours” (Minor).” Clearly if you have a range 40 °F to 45 °F it is almost certain that you are going to exceed 40°F for more than 2 hours.

 

I see a lot of references to Refrigeration at 41°F or below so I’m not sure about your 45°F? Also there is no reference to the hazard and time limit?

 

Kind regards,

 

Tony

[kingstudruler1]

I'm with tony and probably the auditor on this as well.   It should not be a range.    40 or 41 makes more sense to me.   (based off of your validation data)

 

Your corrective actions could address deviations for short amounts of time above the limit.   I keep thinking of this as  step as storage, but you havent provided that information.   That might make a difference in how the ccp is documented.   thawing, chilling, storage, etc.  

 

Was it written that way because you routinely deviate from 40 F?

[new2fs]

I'm with tony and probably the auditor on this as well.   It should not be a range.    40 or 41 makes more sense to me.   (based off of your validation data)

 

Your corrective actions could address deviations for short amounts of time above the limit.   I keep thinking of this as  step as storage, but you havent provided that information.   That might make a difference in how the ccp is documented.   thawing, chilling, storage, etc.  

 

Was it written that way because you routinely deviate from 40 F?

 

Hi new2fs,

 

I don’t understand this limit as it doesn’t make sense: “between 40 °F to 45 °F, without exceeding 40 °F for more than 2 hours” (Minor).” Clearly if you have a range 40 °F to 45 °F it is almost certain that you are going to exceed 40°F for more than 2 hours.

 

I see a lot of references to Refrigeration at 41°F or below so I’m not sure about your 45°F? Also there is no reference to the hazard and time limit?

 

Kind regards,

 

Tony

Hello, 

 

The critical limit for was for identified as 40 to 45 as it was the temperature of the environment vs the product. 

We use the cold storage as the CCP hence the temperature range, we have used consultants and since then there have been many changes and adjustments, it has been an ongoing process. 

 

Thank you for your responses so far.