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Tuesday, 16 April 2013

Examination of Systems - The True Standard and the Checklist

Beware! Some Product Safety Management Schemes are in fact Schemes:

Who actually dictates the standard of compliance?

A unified global standard (the true standard) has always been with us well before the rise of various highly commercialized checklists that purport to be standards.

Have you ever wondered about why we often speak of the “Principles of HACCP” but rarely about the “Principles” of a "standard"?

It has become obvious that defining the term “standard” is crucial. This term has been misused in some circles. A true standard is not subject to different interpretations leading to different versions of it. Else, it is not the standard. A proper understanding is necessary if there must be proper reactions to situations that do not meet the standard.

The standard and the checklist are valuable, related, but mutually exclusive product safety and quality system assessment tools.
The Currency Example
A key recommendation from the United States Secret Service about spotting counterfeit money is to study the genuine bill – the “standard” bill. This highly effective strategy is based on a simple principle:  A thorough knowledge of the real thing makes it easier to detect the deviating features of any counterfeit. Doing otherwise (i.e. studying the counterfeits) would be a daunting task. It would mostly lead to frustration rather than enlightenment.
Attempting to study all of the possible deviating features of counterfeits in order to detect them is akin to an attempt to study the fine features of a complex mosaic that is constantly changing and fast moving. Besides the impossibility of the task, the information learned soon becomes useless as new features continuously appear in the fast changing mosaic.
What applies to currency bills applies to every true standard. Like the currency bill, a true standard must have specific, unique and exact parameters that will lead every well-trained examiner to the same conclusions. The standard must essentially be the same. Multiple exact copies could be made but each copy must have the exact same features. Otherwise, the copy is not the standard and it is unacceptable as a standard. Guidance checklists based on the standard could be developed and used as tools for the examination of real and counterfeit bills but these checklists could not be viewed as the standard bill.
Irrespective of the application or sector of interest, any standard that permits varying opinions is not a true standard. Where the true standard is used as the basis for comparison or examination of any system, every counterfeit (or deviation), though different from other deviations, can be immediately identified by every trained examiner.
The True Standard for Product Safety and Quality System Assessment
As a genuine currency bill provides a common basis for trained examiners to reach the same conclusions, a true product safety and quality systems assessment standard is expected to provide a similar common basis for reaching conclusions. Several questions immediately arise and much rides on the answers to these:

  1. Is there one true product safety and quality systems assessment standard?
  2. Can there be more than one true standard?
  3. What determines and validates the true standard?
  4. Who determines the true standard?
Answer to Question 1:
1. Is there one true product safety and quality systems assessment standard?
Considering the currency bill example, it is possible to envision a true product safety and quality system standard. However, the stated stipulations for a true standard appear to pose some challenges to the general understanding and approach in the current marketplace. Going by the contemporary food industry approach, for example, different so-called standards are used for assessing the effectiveness of food safety and quality systems in different operations and jurisdictions. So the answer to question 1 could be "no" (there is no single product safety and quality systems assessment standard).

The standard owners and persuaded users consider these to be true standards but, according to the stated stipulations for true standards, they are not. For example they do not have specific, unique and exact parameters that will lead every well-trained examiner to the same conclusions. Different "standard" providers introduce unique twists to their "standards" that sufficiently differentiate them from other “standards”. A seemingly plausible argument in support of the multiplicity of “standards” is the existence of multiple operations and jurisdictions. Yet each of these “standards” is singularly used to examine multiple operations in different jurisdictions. 

There appears to be a clear contradiction between the argument for the need to have multiple standards (for multiple operations) and the reality of using a single checklist to assess different operations in different locations ( a single set of requirements for multiple operations). It is not surprising, therefore, that many users of these so-called standards are confused. Why so many? they ask. 

The use of an assortment of “standards” in the industry is like using currency notes that are actually different to examine and detect a proliferation of counterfeits. It is an ill-advised enterprise. Having many food safety standards is like aiming at a moving target. Perhaps the so-called “standards” are merely checklists. If so they cannot apply universally to all operations in different jurisdictions.

On the other hand, however, the answer to question 1 is “yes” because we have the CODEX guidelines; a knowledge pool of HACCP Principles (including proper and complete hazard analysis/risk assessment methods); scientific knowledge, established food operation principles (Good Manufacturing Practices); scientific studies; catalogued industry best practices; etc. The proper application of this knowledge has historically proven to be effective in producing the desired results – safe and acceptable quality products. It is reasonable, therefore, to conclude that this meeting place, this knowledge pool, constitutes the true standard. Other twists merely introduce unnecessary confusion and they are not the standard. Perhaps the so-called “standards” are merely guidelines as such they cannot be universally mandatory.

Answer to Question 2:
2. Can there be more than one true standard?
The principle of studying the real thing in order to detect counterfeits requires the use of one standard. Otherwise, the necessary exactness is lost. In an application such as the food industry, how can a true standard with such exactness be developed? This question immediately takes us back to the common knowledge pool. A standard based on this knowledge pool can be used to examine the effectiveness of any operation’s product safety and quality management system. This knowledge pool therefore constitutes the true standard. It also forms the basis for assessing the validity of suggested checklists or guidelines. It is the true standard and there cannot be more than one standard if sanity is to be maintained in the systems examination process. Understandably, any general (generic) systems examination guideline is, by default, incomplete since it cannot at the same time address every unique variable for every operation everywhere.
Answer to Question 3:
3. What determines and validates the true standard?
The ability to meet the primary goal determines and validates the true standard. For the currency bill and the food industry scenarios, the secondary goal is to have the correct standard that leads all examiners to the same conclusions about anything that is examined against it. The primary goal is to ensure that whatever is examined against the standard provides the end users with the necessary safeguards and satisfies their needs. The ability to consistently and successfully ensure this primary goal determines and validates the true standard. For food operations that are by default unique in many respects, a generic guideline is not able to fulfill this primary goal. The generic guideline is therefore not the complete and true standard for the unique operations.
Answer to Question 4:
4. Who determines the true standard?
By virtue of what is beneficial to them, the ultimate beneficiaries (members of the public or end users) actually determine the true standard. Even where only a few members of the public constitute the policy making body or voting council, the interests, safety and satisfaction of the general public must be the driving force in the determination and acceptance of the true standard. The mark of a true standard is its proper consideration and response to the real interests of the ultimate beneficiaries (the end users). Consumers dictate the standard of compliance.

For the purpose of examining anything, the true standard needs to be properly defined and developed. If the food industry must be assessed against standards that are truly science-based, these standards cannot be determined simply on the bases of consensus reached by a committee. They must be established through scientific studies based on good experimental design. As such, only those who have conducted scientific studies leading to the establishment of the standards can legitimately claim to be "standard" owners.

Checklists or guidelines based on defined standards may be used as assessment tools but they are not to be independently viewed as the standards. For the food and health product sectors, reliable assessment or evaluation standards must be drawn from the knowledge pool of scientific studies; catalogued industry best practices; actual consumer experiences; etc. Checklists based on the derived standards may be developed to assess the proper application of scientific knowledge in ensuring the delivery of safe and good quality food.

In reality, and as previously stated, the needs of the end users determine the true standard. Any desk-top standard or scheme proposed by members of a committee serves no more than a guideline. The interests, safety and satisfaction of the direct beneficiaries (the users of the resulting products) must be the driving force in the determination and acceptance of the true and applicable standard. Each operation, its customers and consumers are essentially in the best position to determine the true standards to be met. They may use or follow suggested guidelines but such suggested guidelines should not be made mandatory.

Consumer-focused standards need to be consistently enforced with the necessary operational customization to suit the unique variables that are peculiar to each operation. This precludes the need to force the use of generic schemes upon any food business on the basis of commercial convenience. The interests, safety and satisfaction of the direct beneficiaries must remain as the only governing mandate.
Posted by Felix Amiri
Felix Amiri is currently the chair of GCSE-Food & Health Protection, and a sworn SSQA advocate.

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