Approaching Compliance Turbulence

How much product safety enforcement by how many outside agencies is sufficient for each establishment?

Although a much calmer and efficient route can be taken to achieve consumer protection, regulators and corporate customers have elected to take a route with unavoidable turbulence. They are sticking with the current methods of policing food safety.

Heard about the person whose house caught fire and they set up a fan "to blow the flames out"?


The Coming FSMA Fee Bite:

From the answer to the Frequently Asked Question F1.2 posted by the FDA, a reasonable deduction could be that a company would be able to minimize the fees it pays by complying and avoiding re-inspection. Unfortunately, a level of compliance that precludes re-inspection is almost impossible to achieve, given how the U.S. Food Safety Modernization Act (FSMA) and similar initiatives are currently setup.

Intensifying Turbulence:

Food businesses of all sizes must brace themselves as they approach the intensifying turbulence ahead. With the U.S. FSMA, the Canadian Safe Food for Canadian Regulations (SFCRs), and similar new food safety rules in other jurisdictions, confusion expands and the pressure is mounting for food businesses everywhere. Meanwhile, customers are increasingly demanding food safety certification by outside parties. With all of these demands and developments, suppliers must adapt their systems to meet expanding expectations (even the unreasonable ones) while fully absorbing the costs of implementing various programs plus inspection/audit fees. If you have not already done so, this is the time to lay solid foundations and implement strategies that will enable your business to withstand the approaching compliance turbulence. 


The wind is picking up. The U.S. FDA under the Food Safety Modernization Act (FSMA) and the Canadian Food Inspection Agency under the new Safe Food for Canadians Act (SFCA) do not accept third party food safety certifications as equivalent compliance. In other words, a food business cannot be certified to a third party food safety scheme and expect to have met regulatory requirements without further regulatory scrutiny. The regulators are essentially saying that a food business may certify to whichever scheme it wishes, that does not preclude regulatory scrutiny according to established regulatory requirements. The obvious implication is that operations wishing to certify have to simultaneously ensure compliance to third party schemes as well as to regulatory requirements.

Keep in mind that beyond compliance, there can be another cause of uncomfortable or even deadly turbulence. This has to do with actual product failures. Such failures tend to readily and disastrously clip the wings of a company's business jet.

Some bosses are currently towing the hard line and saying to their front-line managers: ". . . don't care how you comply with the rules coming from different directions, just comply". Smart bosses, on the other hand, are helping their front-line managers by consolidating their food safety and quality accountability to external parties. They are doing this in order to ensure that their systems managers are not drawn haggard in different directions resulting in frequent product failures instead of a sustained success beyond the "audit pass". They are shunning all window-dressing enterprises and building new foundations or at least shoring up what exists.

With new regulatory rules emerging everywhere, and the ever-evolving versions of confusing and often redundant third party requirements, smart operators are increasingly focusing on meeting regulatory obligations while concentrating on satisfying essential customer obligations such as product specifications and performance expectations. They are returning to the basics of assuring consumer safety and product quality. They are realizing that some redundant things like make-work certification programs must simply go for the sake of maintaining sanity and realistically ensuring business survival. They are no longer yielding to the empty threats of business loss if they do not have redundant certificates.They know that businesses that efficiently concentrate their resources in the actual fortification of their product safety and quality assurance measures are the ones that will survive. For them, paper certificates no longer hold the power that they appeared to have held in the past. As more certificates are crumpled and thrown in the trash during published court cases, more operators will abandon the certification craze and "fortify" rather than superficially "certify".

Start the ascent now if you wish to rise above the turbulent clouds.

While superficial compliance is possible on paper, the real test of a company’s success in food safety assurance is the actual elimination of product failure turbulence. So, here is my often repeated advice: Just because you will be quite busy trying to comply with the mounting regulatory and customer demands, do not let this drive you into finding ways to superficially comply. You will make friends of the inspectors and auditors but they are fair-weather friends. They will abandon you to face the turbulence alone as soon as you suffer a significant product failure. Take the withdrawn certification of Sunland Inc. for example: You must build strong product safety, quality assurance programs for the protection and satisfaction of consumers in order to avoid the discomforts of turbulent times. Start the ascent now!  You need to take your operation beyond "compliance".

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Posted By Felix Amiri

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