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2.4.3.14 compliance with CA's for process controls

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Jamming24

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Posted 16 January 2019 - 11:59 PM

Hi all,

 

I have been beating my brains out trying to figure out what is not in compliance in regards to 2.4.3.14 on SQF.

 

The auditor placed the following comment on one of my plan submissions: provide evidence showing corrective actions for food safety plans were compliant with FSMA requirements of 21 CFR 117.115 (a)(2).   She technically meant 21 CFW 117.150(a)(2), which that alone took me a while to figure out but can anyone assist on what point I am not capturing on my plan?  

 

My plan is regulated by both USDA & FDA.  It might be my plan is missing something but I can't seem to spot it.  Any feedback would be greatly appreciated.  



Charles.C

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Posted 17 January 2019 - 01:09 AM

Hi all,

 

I have been beating my brains out trying to figure out what is not in compliance in regards to 2.4.3.14 on SQF.

 

The auditor placed the following comment on one of my plan submissions: provide evidence showing corrective actions for food safety plans were compliant with FSMA requirements of 21 CFR 117.115 (a)(2).   She technically meant 21 CFW 117.150(a)(2), which that alone took me a while to figure out but can anyone assist on what point I am not capturing on my plan?  

 

My plan is regulated by both USDA & FDA.  It might be my plan is missing something but I can't seem to spot it.  Any feedback would be greatly appreciated.  

 

No Plan Uploaded yet ?


Kind Regards,

 

Charles.C


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Jamming24

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Posted 17 January 2019 - 03:59 AM

Ah yes, that would help.  Thanks Charles!

Attached Files


Edited by Jamming24, 17 January 2019 - 04:00 AM.


Tony-C

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Posted 17 January 2019 - 04:18 AM


 

Hi Jamming24
 
I don't understand the comment either.
 
Requirement for 117.150 a2   Corrective actions and corrections are:
(a) Corrective action procedures. As appropriate to the nature of the hazard and the nature of the preventive control, except as provided by paragraph © of this section:
(2) The corrective action procedures must describe the steps to be taken to ensure that:
(i) Appropriate action is taken to identify and correct a problem that has occurred with implementation of a preventive control;
(ii) Appropriate action is taken, when necessary, to reduce the likelihood that the problem will recur;
(iii) All affected food is evaluated for safety; and
(iv) All affected food is prevented from entering into commerce, if you cannot ensure that the affected food is not adulterated under section 402 of the Federal Food, Drug, and Cosmetic Act or misbranded under section 403(w) of the Federal Food, Drug, and Cosmetic Act.
 
Maybe they are looking for records? but you would of thought they would have mentioned (d)
(d) Records. All corrective actions (and, when appropriate, corrections) taken in accordance with this section must be documented in records. These records are subject to verification in accordance with §117.155(a)(3) and records review in accordance with §117.165(a)(4)(i).
 
I would go back to them and seek clarification.
 
Kind regards,
 
Tony

 



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Scampi

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Posted 17 January 2019 - 02:01 PM

It is your job to make sure you are compliant and your auditors job to ensure you meet the SQF code requirements. It's up to the FDA and the USDA to ensure you meet their requirements and never the twain shall cross.

 

From the auditing guidance:

• Control measures are in place for all identified hazards and procedures/work instructions are effectively implemented; Guidance for Developing, Documenting, Implementing, Maintaining and Auditing an SQF Food Safety System for Manufacturing 

• CCPs are correctly identified using a valid methodology;

• Critical limits are in place for every CCP, and are validated to ensure consistent product safety;

• All critical limits are monitored and test procedures, responsibilities, and frequency fully documented and implemented;

• Corrective actions are documented, are clear and unambiguous, and determine the disposition of product and action required to prevent recurrence (refer to 2.5.3);

• The corrective action procedure has been followed when monitoring shows deviation from critical limits (refer to 2.5.3);

• Staff with responsibility for monitoring, validation, verification of critical limits, or any other food safety control measures are aware of their responsibility, trained, and are carrying out their functions correctly; • The SQF practitioner ensures that the Food Safety Plan is effectively developed, implemented, maintained, and verified (refer to 2.1.2.4 i).

 

There is zero mention anywhere is this element regarding ensuring you meet the countries requirements. I agree with Tony.........ask for clarification


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Jamming24

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Posted 17 January 2019 - 09:54 PM

Thanks all!  I reached out and asked for clarification.  I have a client who is very zoned in on regulation and they were more concerned with my identified hazards.  So I sat with my process authority and re-established the biological hazards for each step.  (Previous QA manager had listed some in plan that was not consistent with the product).  Then I realized I didn't document action to be taken (outside of applying a hold or/and re-cooking).  This time I just don't know if it is what or how I am writing it or if it is just because auditors that have looked at my plan are in hurry due to the amount of plans our site deals with.



Scampi

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Posted 18 January 2019 - 02:07 PM

It sounds like this is a case of a poorly written/research HA.

 

It may be a good idea to produce a new one from scratch and then see the differences between the 2


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Jamming24

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Posted 21 January 2019 - 03:52 PM

This was the response concerning NC:NC talks about corrective actions for both HACCP plans and food safety plans, and meeting regulatory requirements. We have seen the HACCP ones, we need to see what is implemented for FS plans and how they meet FSMA requirements for corrective actions.  

 

I did revise entire plan and saw some errors that needed to be removed, hopefully I am in the clear now.  





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