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FDA Preventive Control Program ?


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#1 chenyunl

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Posted 06 October 2017 - 08:39 PM

Hello everyone, 

 

We just passed our forth SQF Level 2 Audit, which was unannounced with a new auditor. I thought that I was so ready for it, but actually lots of non-conformance were found by the auditor :(  One of them is " The facility manufactures fully cooked-not shelf stable vegetable rolls which fall under FDA inspection. The facility has not yet developed a Preventive Control program to address these items". Because we never had this problem before, now I really have no clue about this one. We definitely have HACCP plan for our vegetable rolls. In addition, we have Allergen Control, GMPs, SSOP and almost everything required by SQF code. So, what does this one really mean and what should I do about it ?  Please give me some suggestions, thank you !!!


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#2 Sanitation

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Posted 06 October 2017 - 09:21 PM

Did you do hazard analysis on your processes?  CCP's?  I really do not know what they are poking at either, maybe they "just had to mark something to show that they were there"?


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#3 chenyunl

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Posted 06 October 2017 - 09:29 PM

Did you do hazard analysis on your processes?  CCP's?  I really do not know what they are poking at either, maybe they "just had to mark something to show that they were there"?

Yes. We did it. In addition, for our fully-cooked products, we have cooking and cooling as CCPs. When the auditor asked me for this program, I was just stunned there:)


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#4 Charles.C

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Posted 06 October 2017 - 09:56 PM

Hello everyone, 

 

We just passed our forth SQF Level 2 Audit, which was unannounced with a new auditor. I thought that I was so ready for it, but actually lots of non-conformance were found by the auditor :(  One of them is " The facility manufactures fully cooked-not shelf stable vegetable rolls which fall under FDA inspection. The facility has not yet developed a Preventive Control program to address these items". Because we never had this problem before, now I really have no clue about this one. We definitely have HACCP plan for our vegetable rolls. In addition, we have Allergen Control, GMPs, SSOP and almost everything required by SQF code. So, what does this one really mean and what should I do about it ?  Please give me some suggestions, thank you !!!

 

Hi chenyuni,

 

Which SQF clause was the auditor's comment related to ?


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Kind Regards,

 

Charles.C


#5 chenyunl

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Posted 06 October 2017 - 10:03 PM

Hi chenyuni,

 

Which SQF clause was the auditor's comment related to ?

Hi, it is clause 2.4.3.1 Thanks


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#6 FurFarmandFork

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Posted 09 October 2017 - 02:59 PM

2.4.3.1 A food safety plan shall be developed, effectively implemented, and maintained and outline the means by which the organization controls and assures food safety. The food safety plan shall:

i. Be prepared in accordance with the steps identified in the Codex Alimentarius Commission or NACMCF HACCP guidelines. Primary producers and feed manufacturers may utilize a HACCP-based reference food safety plan developed by a responsible authority.

ii. Cover a product or product group and the associated processes.

iii. Describe the methodology and results of a hazard analysis conducted to identify food safety hazards associated with all inputs and process steps including rework. Animal feed and pet food safety plans must include hazards associated with animal safety as well as the safety of consumers of animal products. iv. Prescribe those measures taken to apply the controls implemented that are critical to assuring, monitoring and maintaining food safety.

v. Process controls at control points in production to monitor product safety, identify when a process is deviating from set parameters and make corrections to keep a process under control; and vi. Include documented Standard Operating Procedures (SOPs) and Work Instructions

 

 

First off, the code references Codex, not FDA's preventive controls rule for a food safety plan. So the section of code they cited is incorrect. This finding should have been 

2.4.1.1

 

 

2.4.1.1 The organization shall ensure that, at the time of delivery to its customer, the food supplied shall comply with the legislation that applies to the food and its production in the country of its origin and destination. This includes compliance with legislative requirements applicable to maximum residue limits, food safety, trade weights and measures, packaging, product description, nutritional, allergen and additive labeling, and to relevant established Industry codes of practice.

 

The FSMA Preventive controls rule compliance date for small manufacturers was last month (9/19/17), that's why this was never a finding before. You need to update your food safety plan to be in compliance with the rule. If you do not know what the FSMA preventive controls rule is, you need to educate yourself as soon as possible by attending a class to make you a "Preventive Controls Qualified Individual" (PCQI) to get acquainted with the new requirements and how your HACCP plan needs to change to comply with the rule. FDA approved course material is taught through FSPCA. By attending that course you will attend the same material that FDA auditors will and have the best chance to feel out how it will be enforced moving forward.

 

You could also give the food safety plan builder a shot to try and generate a compliant plan even though you do not yet know/understand how to implement the rule.


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For discussions related to food safety, production, and agriculture. Check out my blog at http://furfarmandfork.com/.

 


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#7 chenyunl

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Posted 09 October 2017 - 03:09 PM

First off, the code references Codex, not FDA's preventive controls rule for a food safety plan. So the section of code they cited is incorrect. This finding should have been 

2.4.1.1

 

 

The FSMA Preventive controls rule compliance date for small manufacturers was last month (9/19/17), that's why this was never a finding before. You need to update your food safety plan to be in compliance with the rule. If you do not know what the FSMA preventive controls rule is, you need to educate yourself as soon as possible by attending a class to make you a "Preventive Controls Qualified Individual" (PCQI) to get acquainted with the new requirements and how your HACCP plan needs to change to comply with the rule. FDA approved course material is taught through FSPCA. By attending that course you will attend the same material that FDA auditors will and have the best chance to feel out how it will be enforced moving forward.

 

You could also give the food safety plan builder a shot to try and generate a compliant plan even though you do not yet know/understand how to implement the rule.

Thank you !!!  This really helped me a lot :)


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#8 FurFarmandFork

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Posted 09 October 2017 - 03:56 PM

Thank you !!!  This really helped me a lot :)

You're very welcome.

 

Not to kick you for your NC, we all get them, but as a US manufacturer, to not know of the rule's existence is a huge thing your your QA department to miss. Do you subscribe to the FDA's email listserv with regulatory updates? If I was a shrewd auditor, I would also cite you on management commitment for failing to remain current on regulation changes etc. This rule was originally passed in 2011, and the final rule was published two years ago. Make sure you have people in your department responsible for keeping up on this stuff and know what is happening in your industry.

 

2.4.1.2 The methods and responsibility for ensuring the organization is kept informed of changes to relevant legislation, scientific and technical developments and relevant industry codes of practice shall be documented and implemented

 


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For discussions related to food safety, production, and agriculture. Check out my blog at http://furfarmandfork.com/.

 


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