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Saturday, 31 January 2015

Readiness for FSMA, SFCR and Similar New Regulations

Are you ready? Food companies in the US need to comply with the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food rule." This was initially set to be by September 19, 2016

Right on the heels of the Food Safety Modernization Act (FSMA) in the US, Reuters US reported that lawmakers propose bill to create single food safety agency. 

In Canada, the Safe Food for Canadians Act and Regulations (SFCA/Rs) are gathering momentum. These are only examples of the head-spinning changes that the food industry can expect in the next few years. The food regulations landscape worldwide will continue to change at dizzying speed as unfortunate food safety failures and food fraud events continue to occur around the world. 

The best that a business can do is retain a regulatory affairs manager who can get the business to a point of reasonable comfort about what is going to satisfy these new rules. More so since the rules themselves are continuing to undergo changes. Visiting inspectors are bound to have varying interpretations and the fun begins.

With the proposed mandatory registration and licensing, and the anticipated rush to obtain required licenses & comply with the new rules, Tiger Tamers are out in full force, armed with training sessions, seminars, webinars, et cetera. In the rush, none of these can even come close to covering the details in these new rules to which a company must pay close attention.

Everything that you need to know to prepare is provided in the Acts and Regulations. The SSQA Implementation Manual provides additional guidelines for getting the most out of any set of regulations. At no extra charge, the SSQA Manual also provides guidelines for developing a regulatory compliance and commitment program that equips you to address even future changes to regulations that are yet to be considered by the regulators.

Beware of Snake Oil Solutions:

Publicly offered webinars, seminars and training sessions are more likely to overwhelm you with copious ramblings about the new rules. They are not likely to provide any meaningful compliance or commitment strategy for your company. In fact, I am almost certain that they cannot. Such a compliance and commitment program is most effectively customized. No rushed generic training can effectively achieve such customization.

For several of the new rules, you need to carefully read between the lines (Food Law Page, Post 4) to cover the considerations that are specific to the type, size and scope of  your operation. The promises of getting your company ready to comply that may be offered by outside parties need to be carefully assessed to determine what they are actually able to deliver. I personally believe that you may be able to get more from participating in the public consultation invitations from the regulatory bodies than from any outside "consultant"or "trainer". Many of these are themselves trying to understand the rules.

Posted By Felix Amiri

Felix Amiri is the current Food Sector Chair of GCSE-Food & Health Protection

Wednesday, 28 January 2015

SFCRs & FSMAs Coming into Force

FSMA Public Meeting: Focus on Implementation Strategy for Prevention-Oriented Food Safety Standards
April 23 & 24, 2015

FSMA - Key Dates Presentation - Download PDF Copy  

SFCA enforcement draws near for Canadian operations:
Download the Presentation by Colleen Barnes, Executive Director, Food Regulatory Modernization, CFIA, to the Canadian Meat Council (CMC) on May 8, 2014  

Where does your establishment fall?

The table illustrates the coming into force of the SFCA by the different levels of readiness between industries that are:

Fresh Fruit and Vegetable
2015 (June)
2015 (June)
2016 (June)
2015 (June)
2016 (June)
2017 (June)
       Minimal changes for industry
       Do not have substantive food safety provisions
       FDA applies
       FDA still applies
       Licensing first enables compliance promotion

Find out more about the Proposed Canadian Regulations

You may also read the ARCHIVED-Discussion Paper on the Integrated Agency Inspection Model (iAIM) on which the Improved Food Inspection Model (Final Model) is based.

Monday, 19 January 2015

Global Food Safety and Quality Assurance Schemes

Recently, the food industry has witnessed the release of new 7th versions by GFSI-benchmarked schemes like SQF and BRC. Did you also know that GFSI Technical Working Groups are currently “reviewing the GFSI Guidance Document 6th Edition to identify areas for elaboration in the 7th Edition, to be released in 2015/16”? 

A Small Test:
When the food safety and quality auditing sector says it is taking auditing requirements to a new level, what is the most likely new level that the industry sees?
      (a)   A new level with more paperwork than the level prior?
(b)   A new level of effectiveness that sees products being actually and measurably safer and of higher quality than the level prior?
            (c) Both (a) and (b)?

Now Evaluate you scheme using the Grading Scale

In addition to clear reactions to recent food fraud events, it appears that some GFSI folks are beginning to pay attention to at least some of the GCSE-Food and Health Protection SSQA Proposals. Take for example these subjects on which the Scheme Management Sub Working Group has been charged to direct its focus:

“. . .  Integrity programs - to decide upon the development of a ‘measurable end result’ approach to allow for effective benchmarking;
Key Elements - to decide if the GFSI benchmarking criteria can be reduced in size and eliminate redundancy;”

I am eager to see what measurable end results are identified. I am also very interested in seeing how redundancy will be eliminated and what sort of things will be cut out.
Great steps but still missing some key considerations:
1. The question of unnecessary distrust-driven and time-wasting unannounced”audits is yet to be addressed as proposed under the GCSE-Food and Health Protection SSQA concept – which is to abandon the idea of unannounced audits and do something more trust-building and effective. 

2. Nothing is said of the misapplied notion of avoiding conflict of interest.

3. The issue of the ever-mounting paperwork burden has also not been addressed. The older versions of "standards" (schemes, as I prefer to describe these) already place a heavy burden of paperwork on subscribers. The newer version 7s and even future versions come with a universal guarantee - more paperwork burden. None has taken the same approach as the Paperwork Reduction MUD Scale strategy that includes practical guidance and tool for reducing the paperwork burden on companies and system managers.  

Feel free to share any thoughts that come to mind about the emerging requirements such as the new fraud tracking, supplier traceability requirements, etc. in the version 7s.  

GFSI Information Reference:

MyGFSI. (2014, September 07). Guidance Document TWG Progress | Sept 2014. Retrieved from

GCSE-Food and Health Protection Blog Post References:

Amiri, F. (2014, February 27). Common Assumptions about Food Safety and Quality Management:. [GCSE-Food and Health Protection blog post]. Retrieved from

GCSE-Food and Health Protection. (2012, November 17). What a value-added audit system is, has or does. Retrieved from

Amiri, F. (2013, October 29). Unannounced Audits and the Issue of Distrust. [GCSE-Food and Health Protection blog post]. Retrieved from
Posted By Felix Amiri

Felix Amiri is the current Food Sector Chair of GCSE-Food & Health Protection

Saturday, 17 January 2015

The Right Metrics and Assessment of FSQA, FSQMS or FSMS Success

FSQA = Food Safety and Quality Assurance
FSQMS = Food Safety and Quality Management System
FSMS = Food Safety Management System

How do you know if you are looking at the right metrics in your company’s management of its FSQMS or FSMS?

When a food safety battle is won, how do you know? What information, data or reality confirms this for you?

Have you measured the success rates before and after?

You may be seeing one or more of the following achievements as evidence of success. The system adopted and managed by your company has led to, and is maintaining:
  1. Consistently high external audit scores in 5 or more years
  2. A decreasing number of food safety or quality incidents due to employee negligence or disregard 
  3. A steady reduction in failure incidents
  4. A steady reduction in the number of customer complaints 
  5. Zero customer complaints in 2 or more years (not the "zero" from not diligently checking and tracking complaints and their causes)  
  6. A steady increase in positive consumer feedback
  7. A decreasing cost of system management
  8. A steady increase in system management work-load efficiency
  9. A decreasing need for enforced motivation by outside parties 
  10. No market recalls

·     Which of the above is (or are) true for your company with verifiable data and trend analysis?
·     For which of them is your assessment of success simply a guess or based on paper reports?
·     If you are one of the managers, to which of these are you most proud to have made some contributions and why?
·     Are there any that you have not measured and/or achieved?
·     How do the ones you happen to have achieved and not achieved relate?

Cut the chains, implement SSQA and properly assess your success.
SSQA  (Safety, Security and Quality Assurance) provides an escape from the confusion & stress of unattainable moving targets imposed by parties that do not know anything about your company’s unique situations. 

You can start by reading: "Adopting the GCSE-Food & Health Protection SSQA"

Posted By Felix Amiri

Felix Amiri is the current Food Sector Chair of GCSE-Food & Health Protection

Tuesday, 13 January 2015