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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 !!!



#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"?



#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:)



#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 ?


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



#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.


QA Manager and food safety blogger in Oregon, USA.

 

Interested in more information on food safety and science? Check out Furfarmandfork.com for more insights!

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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 :)



#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

 


QA Manager and food safety blogger in Oregon, USA.

 

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#9 FurFarmandFork

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Posted 03 January 2018 - 09:35 PM

One more note for this thread, from FDA's frequently asked questions on whether you have to attend the training or not:

https://www.fda.gov/...559.htm#Recalls

 

PC.8 I have many food safety certifications (HACCP, GFSI, SQF, BRC, etc). Do I still need to take the PCQI training from the FSPCA?

The preventive controls for human food rule specifies that a PCQI is a qualified individual who has successfully completed training in the development and application of risk-based preventive controls at least equivalent to that received under a standardized curriculum recognized as adequate by FDA or be otherwise qualified through job experience to develop and apply a food safety system. Job experience may qualify an individual to perform these functions if such experience has provided an individual with knowledge at least equivalent to that provided through the standardized curriculum.

There are some differences in the requirements of the CGMP & PC rule compared to the requirements of HACCP regulations and other preventive-based food safety programs such that the training provided by the International HACCP Alliance/GFSI/SQF/BRC etc or other institutions might not be equivalent. Such an individual may need additional training specific to the CGMP & PC rule. However, the CGMP & PC rule does not require any specific certifications, including certification by the FSPCA. In general, FDA will assess the adequacy of a facility’s food safety plan rather than an individual’s documented qualifications. Deficiencies in the food safety plan indicate that a PCQI may need additional training specific to the rule, irrespective of documented training and experience.

 


QA Manager and food safety blogger in Oregon, USA.

 

Interested in more information on food safety and science? Check out Furfarmandfork.com for more insights!

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