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Wednesday, 25 November 2015

Process Validation versus Scheme Certification

Any food business that feels lost without a food safety scheme certification is a food business that is lost and is in need of rescue.

If lost without certification, that business will remain lost with certification because what is lost is direction; not the corroboration of external parties.

Never mind a possible overnight improvement within the entire food industry, the rate of progress in your food business operation could increase exponentially if good process validation is done instead of scheme certification.

What are the differences?
Under the SSQA concept, process validation is the confirmation that a process actually achieves its purpose. Unlike the generalized approach of "one audit checklist fits all" in scheme certification programs, the proper validation of an operation’s processes relate directly and specifically to that operation. Therefore it allows the operation to implement real time corrections and improvements that are relevant to that operation.
The rules that must be followed under scheme certifications are not specific to any particular operation. Therefore they can lead only to operation improvements that are generic in nature. Such improvements may or may not even be relevant to the operation simply because they are based on generic theories that may not apply to the operation. For example, all operations under a scheme certification program may be required to have scheduled management meetings with recorded minutes. However, in some operations where the managers are also the plant floor supervisors and operators, such meetings sometimes end up doing more harm than good since the customers want products; not meeting minutes delivered on time. A scheme certification auditor would want to see the minutes to confirm that management meetings are taking place regularly. On the other hand, a process validation approach examines the real-life outcomes to verify that all company personnel are collaborating and cooperating to achieve the continuous improvement of the operation.

Scheme certification is pre-occupied with policing and reporting on defaulting or complying operators according to the generic (often irrelevant) requirements of the scheme. Process validation, through the examination of outcomes, causes and effects, provides real-time guidance to an operation. This guidance covers the entire scope of considerations that are directly related to the operation, its experiences, obligations and goals.

The food supply chain is presently a highly fragmented system with a growing number of subversive elements who are getting increasingly sophisticated in their evasive ways as they seek furiously after financial gains. They have, and continue to put on well camouflaged superficial performances to pass scheme certification audits. This is only possible with assessments that are conducted against generic sets of requirements because compliance to those kinds of requirements can be easily faked. Certification and the adopted policing approach can only go so far because it does not even make any attempt to detect real causes and effects.

Process validation, on the other hand, focuses on the actual accomplishment of the desire goals. It looks at the causes and effects. Therefore, it naturally discourages subversive behaviour. Actual outcomes cannot be faked. Besides, many reasonable operators want and do validate their processes against the desired outcomes. They recognize that scheme certification is only a window-dressing activity that helps them retain the customers requesting such certifications.

Comparative chart of key characteristics:

Scheme Certification
Process Validation
(under the SSQA Concept)
The goal is the certification;
The goal is the validity of processes;
Assumes that if food safety management systems are in place, the ultimate goal of food safety would be met;
Confirms that the ultimate goal of food safety has actually been met;

Superficially assesses how the certified organization does its scientific validation tests without conducting any actual tests;
Through actual tests, confirms the accuracy of an organization’s scientific validation tests  to show that all processes are achieving the desired practical (real life) outcomes;
Verifies that applicable validation tests or evaluations are conducted but does not actually conduct tests to validate the validation test results;
Determines if the scientific validation test or evaluation parameters are the right kinds for the processes in question and actually conducts tests to validate the validation test results;
Limits its examination and conclusions to the test results as the ultimate validity;
Does not limit its examination and conclusions to the test results, but considers both the validity of the test results and the practical (the real life) outcomes linked to the processes as the ultimate validity;
Operation records are mostly examined as proof of compliance;
Operation records are mostly analyzed used as gathered intelligence for operation improvement.
Allows certification bodies to stand aside and apart as spectators of actual improvement plans and activities (through the avenue of disclaimers that certification auditors are not consultants and that certification provides no guarantees);
Engages validation partners  as direct participants in the development and implementation of improvement plans and activities (through the proper interpretation of validation results);
Under the guise of conflict of interest avoidance, does not take part in the correction of detected ineffectiveness and completely ignores the efficiency of processes. It merely provides “compliant” and “non-compliant” criticism without providing direct assistance.
Cuts the chains of misapplied conflict of interest rules and provides direct assistance in the correction of process ineffectiveness and inefficiencies. It provides the relevant solution information and data needed for the proper re-tooling that ensures improved effectiveness and efficiencies where weaknesses are detected.

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

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