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Saturday, 14 October 2017

Unannounced Audits: A Needless Regression

Why is the industry going back to the past days of sneaking up on food operators to catch the deviants?

With all of the growing euphoria around unannounced audits and the fake sense of attainment, here is a reality check question: What will happen differently when operations fail to meet the stated requirements during the unannounced audits that is not already happening without them? This question needs to be examined from two perspectives: From the perspective of operations that can afford and have the setup for unannounced audits and from the perspective of operations that cannot afford and have inadequate setup for unannounced audits. Perhaps a third perspective can be added for an operation that can afford and has the setup for unannounced audits but sufficiently negligent to warrant unannounced audits. From each of these perspectives, what is likely to happen during unannounced audits that is not already happening during announced audits in terms of required follow up actions?
Proceeding with unannounced audits is a regression. In a food industry that claims to have attained higher levels of scrutiny, systems should have also developed to the point where the right things are done as a normalized routine. Incidentally, this normalized routine is the expectation behind the suggestion of unannounced audits. Only a small number of issues are expected to be found during unannounced audits. If only a few issues are expected, it is needless to have such audits. If, on the other hand, things have not developed to the point of expecting only a small number of issues, then it should already be known that significant issues will be found. In that case, unannounced audits are equally redundant.

Where the audited parties cannot be trusted and deemed to need unannounced audits, the battle is already lost. The untrustworthy parties cannot be trusted on the day following the conclusion of the unannounced audit. Keep in mind also that as soon as the auditor arrives, the audit is no longer unannounced. The auditor cannot physically and at once see everything, everywhere in the facility when he or she arrives. Those who cannot be trusted and must be caught red-handed are also predisposed to, and are adept at, cunning ways. They will have tricks that they can play even during unannounced audits. They can still put up appearances. On the other hand, if operations can be trusted because of their integrity and commitment to doing what is right at all times, it is a futile engagement to try to catch them red-handed. They do not need unannounced audits.
  
From all angles of view, unannounced audits do not represent progress. They are a needless regression.

The pursuit of unannounced audits debases the intelligence and level of commitment attained by many food operations, particularly the operations that can afford such audits. The already attained level can and needs to be further raised but it is certainly much higher than is portrayed by the suggestion of unannounced audits.
By the way, the notion of "being audit ready" leads to doing everything only for the audit and only within the narrow confines of stated requirements. Everything should instead be done to consistently ensure the safety and satisfaction of the consumer. With respect to all that must be done by every operation to protect the consumer, the typical audit (announced or unannounced) does not cover nearly enough scope, nor does it proceed with sufficient precision. Even the accuracy of the typical audit in detecting realistic concerns in every situation is, at best, questionable.

It is not disputed that current arrangements are in dire need of modification. However, the proposal of unannounced audits is regressive. If the food industry is to see substantial, meaningful and productive progress, audit proceedings need the infusion of a different kind of thinking. Audit proceedings need different methodologies and different criteria for assessing success or attainments than are currently pursued by many parties in the industry.
Posted by Felix Amiri
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Felix Amiri is currently the chair of GCSE-Food & Health Protection, and a sworn SSQA advocate. 

Friday, 29 September 2017

Another Failure-Revealing Review:

“These standards have both advantages and disadvantages and their effectiveness depends on several factors such as the competency and skills of auditors and the standard used in each case. Although the industry continuously invests in developing and improving these systems, the number of foodborne outbreaks per year appears to be quite stable in both Europe and the United States. This may be an indication that additional measures and techniques or a different approach would be required to further improve the effectiveness of the food safety and quality management systems.”

Kotsanopoulos, K. V., & Arvanitoyannis, I. S. (2017, August 03). The Role of Auditing, Food Safety,and Food Quality Standards in the Food Industry: A Review. Retrieved September 29, 2017, from http://onlinelibrary.wiley.com/doi/10.1111/1541-4337.12293/full

CRF3-2016-0015 Submitted 12/29/2016, Accepted 7/3/2017. Authors are with
Faculty of Agriculture, Univ. of Thessaly, Fytoko St., Nea Ionia Magnesias 38446, Volos,
Greece. Direct inquiries to author Kotsanopoulos (E-mail:
kostaskot@yahoo.gr).
Posted by Felix Amiri
___________________________________________________________
Felix Amiri is currently the chair of GCSE-Food & Health Protection, and a sworn SSQA advocate. 

What food safety and quality management model works?

A post subject to the modification of expressed thoughts depending on productive comments, contradictions, criticisms and conversations:


The question about what food safety and quality management model works best is one of the questions that emerged for me from the recent GMP summit in Chicago. The focus of this question is not on particular schemes since these also fall within the adopted models. The focus is on the external and internal instruments and influences involved in the management and monitoring of systems for ensuring the safety and quality of the food delivered to the consumers. The “model” idea is with the specific consideration of the roles and processes of regulations, industry “standards” (i.e. schemes, industry knowledge and best practices), and other motivating factors that drive what operations do to ensure the safety and quality of food.

The Main Question:
What system management model should a food operation follow for the development, implementation and monitoring of safety and quality assurance measures?

To businesses satisfied with simply following the crowd, this question may be of little significance. For the sake of those running businesses that wish to be leaders in the industry, let’s take what I mean by “system management model” a bit further. One is able to easily see generally, although exceptions are rare, that the food industry only has the following models:

  1. Cottage Industry Model:
Operations adopting this model are often not aware of applicable regulations beyond the powers of local enforcement officers. Though governed by the existing regulations, the operation and assessment activities are not typically designed and carried out in response to the regulations unless they are forced to do so. The predominant motivating influences are the drive to make money and personal concern for the well-being of close friends, customers with a relationship that is on a first-name basis and family who form the consumer base.

  1. Simple Compliance Model:
Operations adopting this model are often aware of applicable regulations and, after doing what they understand to be sufficient for compliance to the minimum requirements, wait to be told about what else to do. These operations may not even be aware of existing industry “standards”. The predominant motivating influence is the drive to make money that is often insufficiently mitigated by concerns for the well-being of consumers.

  1. Sophisticated Compliance Model:
The operations adopting this model are generally aware of applicable regulations and industry “standards”. They often claim to take a proactive approach in ensuring compliance with all requirements. The predominant motivating influence is the drive to make money. The predominant motivating influence is an almost insatiable profit-making drive with consumers seen only as opportunities. The well-being of consumers is the least of the concerns with this model.

Based on simple considerations (since the industry does not customarily measure the relevant assessment criteria), the model with the highest degree of genuine and sustained commitment to the safety and satisfaction of consumers from among the three may surprise you. Likewise, the model that is likely to be the least wasteful in resource utilization versus returns on investment may surprise you.

Sadly though, upon a careful examination of the motivating influences, you will find that none of these models provides sufficient guarantee and consistency of assuring the safety and quality of food. Claims about the commitment of operations and personnel can be made with any of these models. However, the reality often proves contrary to such claims. Besides, the subjects and objects of many an acclaimed commitment are vague. Commitment in what and to what?

As far as you can tell, what model has your operation adopted? Is there a better model? Does the food industry need a better model? Is a better model even possible? To all three questions, I would say: YES. That model has already been developed and only needs an expanded adoption. It is the SSQA model. It respects the need to make money but drives and supports the adoption of principles for doing so in ways that are morally, socially and environmentally responsible. It is inclined to providing more tools than rules. It leads to fortification instead of certification. Adopting operations are commitment-driven instead of compliance-crazed or conformance-confined. With SSQA, the idea of commitment has an unwavering ultimate focus – ensuring the safety and satisfaction of the consumer. The differentiating hallmarks are many.

What do you think? I also welcome your comments or questions.
Posted by Felix Amiri
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Felix Amiri is currently the chair of GCSE-Food & Health Protection, and a sworn SSQA advocate.

Wednesday, 16 August 2017

Wednesday, 21 June 2017

To those for whom Food Safety Certification remains enticing:

Company X has been assessed and "certified as meeting" the food safety and quality management requirements set out in Standard Y by the Standard Owner Z.
Now, who says that Standard Y, when followed, actually achieves safe food any more than simply following the common knowledge of what should be done to prevent food safety risks?
What does “certified as meeting Y Standard” actually mean with respect to any consistency in the production of safe and desirable quality food?
Is it possible that the desired food safety management consistency is actually only achieved through the commitment of Company X in hiring knowledgeable individuals with a focus on working according to the common knowledge of risk prevention, and not through certification?
Could it be that the certification parties are taking unwarranted credit for the success that Company X is able to achieve on its own? Could it be that certification schemes are actually lulling food safety managers into sleeping certified like those who are managing or who have managed these certified failures?
Have the demanding customers become so effectively blindfolded?
Yours truly,
Common-sense
Posted by Felix Amiri
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Felix Amiri is currently the chair of GCSE-Food & Health Protection, and a sworn SSQA advocate.


Thursday, 27 April 2017

Food Safety, Defense and Quality Assurance Workshop


Members of GCSE-FHP who register and attend this workshop will receive a PDF copy of the Safety Security and Quality Assurance (SSQA) Implementation Manual free of charge. If you qualify for this offer, please contact gcse@afisservices.com to confirm your workshop registration and be added to the list of approved recipients.

If you are not a member of GCSE-FHP, you may join hereMembership is free. 

Thursday, 30 March 2017

FSMA - Accredited Third-Party Certification Rule

According to FDA, "The final rule establishes a voluntary program for the accreditation of third-party certification bodies (CBs) to conduct food safety audits and issue certifications for foreign facilities, and the foods – for both people and animals -- that they produce."

You may have already seen the caveats if you have read the rule. The introducing web page states that:

“FSMA also provides FDA with a new tool to require certification as a condition of entry when certain statutory criteria are met. For example, those criteria include:
  • safety risks associated with the food product,
  • food safety risks associated with the country, region, or origin of the food, and
  • the capability of the regulatory system of the exporting nation to ensure compliance with FDA safety standards. FDA intends to use this tool in limited circumstances.”
Can the stated criteria be assessed or measured under current certification schemes? If so, how? The caveats are easy to see: “. . . you may certify but . . .”. The caveats and several hidden expectations within the rule will certainly stretch the industry to break-point if pursued as proposed. Otherwise, the whole affair will end up as another superficial enterprise. With the predictable failure of the proposed third-party certification arrangements to assure safer food, the proponents may be saying: “let’s play this along so we can say we tried”. Meanwhile, the industry will be left to bear the burden of wasted time & resources. This burden will no doubt be shifted to consumers - you and me.

You may also wish to read: Guarding Against Assumptive & Misleading Conclusions 
Posted by Felix Amiri
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Felix Amiri is currently the chair of GCSE-Food & Health Protection, and a sworn SSQA advocate.

Saturday, 25 March 2017

Equipping, Inspiring & Connecting for Food Industry Success


Helping to Spread Practical Knowledge in the Food Industry



The AFISServices Workshops Series are here and gaining strength as part of Equipping, Inspiring & Connecting for Food Industry Success




Tuesday, 10 January 2017

"COMPLIANCE": A Corrupted Good Concept

In its pure and resolute form, "compliance" with food safety standards and regulations can be reassuring to
customers and consumers. Unfortunately, the idea has become dangerously watered down within the food industry. 

Compliance Corruption and Mental Degeneration

Compliance has degenerated to the point of being nothing more than a game with many players who do nothing more than merely conform. Simply complying with the rules has become the only extent to which many food businesses go. The resulting superficial compliance is now endemic and holding many otherwise sharp minds captive. A distinguishing mark of a compliance-captivated mind is the treatment of compliance as a goal. Compliance is also deadly on many levels. On one level, what is done with the idea of compliance has created a system that takes away the individual's responsibility and motivation to think. Many people have been led to almost religiously believe in simply following the rules as if doing so is virtuous. This, unfortunately, is the evidence of something sinister. The expanding corruption of compliance is captivating, subduing, overtaking and enslaving too many minds.

The idea of "conformance" that many system assessment programs appear to revere is worse. While compliance relates to rules set by others, conformance represents an enslavement to the practices of others.  In certain circumstances and/or environments, simply conforming to the practices perceived to be ideal elsewhere could very well produce effects that are the opposite of what is desired. Simply conforming could be outright dangerous for some food businesses. For example, due to the location, circumstance or situations at some sites, dangers that lurk beneath the surface are not listed in the generic rule books, and are therefore not addressed during compliance and conformance assessment activities. Many conformance-enforcing programs do not give sufficient thought or allowance for this possibility.


Commitment is the alternative to compliance or conformance. Commitment, the demonstrated true passion for doing what is right at any time and any place, is rarely sustained by those who have set compliance or conformance as their main goal. 

While personal commitment to doing what is right is adaptive to particular circumstances, situations and environments, people who wish to simply comply or conform tend to adopt an inflexible attitude of simply following the rigid rules even if a cliff is ahead.  Devoid of the freedom or desire to independently think or observe anything besides and beyond the set rules, they may not even see the cliff.


Possibility of Superficial Compliance without Commitment:

Compliance must have a pre-determined (fixed) set of rules as its frame of reference. The necessity of such a fixed frame makes compliance fall short as a satisfactory goal. The fixed frame of reference imposes both limited and limiting boundaries within which compliance takes place. These limiting boundaries, incidentally, pose the greatest danger for a food business that pursues compliance as the only food safety and quality management goal. No set of rules proposed by humans can completely cover the scope of possible situations and circumstances. Thus, when situations that fall outside the scope of the rules are encountered, compliance-focused minds are baffled and they fail. Even when all of the generic rules have been met and both conformance and compliance have been assessed to be excellent, they fail. 


Full compliance is easily achievable on the surface but danger lies beneath the superficiality.

A compliance frame of reference is additionally limiting as problem-solving creativity becomes bound within the limited “frame”. The compliance-focused mind is typically unable to think outside of this frame. Once the compliance-captivated mind has done what the rules say, it rests and seeks to go or do no further. It is not uncommon to find individuals who almost permanently struggle with understanding the rules. Thus, completely engrossed in working to understand and comply with the set rules (often complex rules), they are trapped. Compliance-captivated minds repeatedly fail when the set rules fail to address the contingencies, unscripted and unexpected challenges faced. Sadly, in such instances, the effort and resources spent on correcting the repeating failures are seen by some as "good investments".

Assessment of Compliance and Commitment:
In the food industry, compliance is typically measured through snap-shot regulatory inspections and/or 3rd party audits. While compliance can be measured in this manner, commitment cannot. Both the demonstration and confirmation of commitment require long periods of observation and evaluation. For the evaluation of commitment to be reliable, it must be done by those who have close and enduring connections with, and accessibility to the evaluated parties. The relationship is unlike that of strangers as is the case between the hired hands who conduct inspections or third party audits and the audited parties.

When assessed, commitment is either concluded to be real or it is not commitment at all. Conclusions about compliance from inspections or audits are not so straightforward. They generally produce pseudo-realities on both the failure and success sides of things. Apart from taking away the urge to do more, “success” with a compliance inspection or audit often gives a false sense of goal accomplishment. For example, some food companies erroneously think that by “passing food safety and quality audits” they are ensuring the delivery of safe and quality products. So they set goals like “passing the audits” with specified scores or ratings. They then proceed to spend much resources on “passing” audits. Meanwhile, the actual assurance of product safety and quality on the plant floor suffers from inadequate provision of time and other resources. Examples are numerous of companies with large scale product recalls soon after passing compliance audits with high scores. Some of these examples are provided in the post "What does certification do for a food operation?

On the audit failure side of the pseudo-realities, companies do fail compliance audits. That does not automatically mean that their products are unsafe and are of unacceptable quality. If that was the case, many existing food companies would no longer be in business. 

Compliance Periods of Grace:
Another demonstration of compliance corruption is seen in the time allowance games played by regulatory agencies. For example, compliance date extensions (or periods of grace) are frequently granted if respect of new regulatory mandates. If compliance to the new mandates is as crucial as it should be, why allow companies these “periods of grace” during which they may continue to produce and sell products without the enforcement of compliance? Do such periods of grace (or time extensions) not seriously undermine the protection of consumers? Case in Point: Compliance Date Extensions and Clarifications for FSMA Final RulesOn the other hand, if compliance to the new mandates is not crucial, why bother with them?

The idea of compliance grace periods is also problematic on the legal liability front. Where any length of time is allowed for companies to be out of "compliance", this may be taken to imply that a company is off the hook if, due to a failure to meet regulatory stipulations, the company’s product harms a consumer. Clearly, this is not the case. Which means that a company that may think that it is off the hook due to “compliance date extensions” is deceived and consumers of its products are endangered.

Compliance and Complicity in Negligence:

Current compliance manipulation practices have also given rise a sort of complicity in negligence among various parties. This may be why there are so many recurring food safety failures that could otherwise be stopped. Whether intended or unintended, the periods of grace granted by regulatory bodies is a good example of collusion and complicity in negligence. What happens during product recalls clearly demonstrates this fact. For fear of being wrong and being taken to task, regulatory and 3rd party auditors often choose to “tread carefully” with the publication of recall informationSituations like the one reported by Coral Beach in The Packer, August 08, 2013 do not help matters. In that report, the U.S. Food and Drug Administration (FDA) was said to have erroneously blamed tomatoes for a salmonella outbreak later linked to hot peppers from Mexico. According to the report, the tomato growers proceeded to sue the federal government for $40 million in losses.

On the surface, and for the sake of the companies involved, treading carefully with information provided to the public may seem like a good idea. However, in such instances, the negative reaction of consumers is treated with greater importance than their safety. For similar reasons, 3rd party auditors are also reluctant to publish situations observed that could undermine the safety of consumers. If protecting companies does not take precedence over protecting the consuming public, such findings would be shared publicly. Sadly, many findings are not shared because of company protection (often styled "brand protection"), and the fear of being wrong. This fear raises the question of why those who are unable or afraid to confirm "compliance" and "non-compliance" given the task of doing so? 


The corruption of compliance is happening at many levels and in many places. It must be stopped.


The food industry must refuse to sing the old and worn out
“comply or else” song.

Food businesses must collectively raise the resounding anthem of genuine commitment and collaboration.

For what food businesses should do with the idea of compliance, read "Product Safety - Beyond Compliance".

Posted by Felix Amiri
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Felix Amiri is currently the chair of GCSE-Food & Health Protection, and a sworn SSQA advocate.