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Sunday, 10 January 2016

Validation: An under-utilized and Misapplied Food Safety Assurance Concept

First Published June, 2013, updated January 10, 2016.
What are you validating and why? Are you validating and re-validating everything when and where it matters?

As I have listened to different arguments and observed how the idea of food safety validation has been pursued, I have reached these conclusions:

  1. The idea is confusing to many people. Therefore the concept is ignored or incorrectly applied.
  2. Validation is not sufficiently done where it matters and wrongly applied where it does not fit.
Ignored Application of the Validation Process

Food Safety validation is somewhat ignored in some clever but potentially misleading industry mantras. You may have heard these clever sayings about how to proceed with food safety management:

First Mantra: “Say what you do, do it, and prove it”
Merely saying it, doing it and proving that you have done it with supporting records must not ignore the necessity to confirm that what is said, done and recorded is actually valid. By actual validity, I mean that what is done actually ensures the safety of food. Otherwise, it is a useless engagement. Where possible, what is said, done and recorded needs to be validated before, during and after the saying, doing and recording. In other words,  pre-; during-;  post-  and continuing- validation must be done at all times and for all things related to food safety and quality management.

A grievous mistake that continues to captivate many food safety management and assessment approaches is the after-the-fact syndrome. The food safety management and assessment industry appears to be pre-occupied with seeking solutions and conducting so-called validation exercises after buildings are completed and systems are established. This syndrome is why most certification and non-certification audits are conducted after everything is in place and the operations have been running for a while. A wrong approach indeed. The usual argument is that sufficient operating  records need to be accumulated for auditors to see. 

After-the-Fact Testing

Closely related to the "everything in place before audits" is waiting to conduct after-the-fact testing of end products. There appears to be an assumption that safety or quality can be tested into finished goods. John Hunter, in his November 8, 2012 blog wrote: “Inspection does not improve the quality, nor guarantee quality. Inspection is too late. The quality, good or bad, is already in the product. As Harold F. Dodge said: ‘You cannot inspect quality into a product.’”
Hunter, J. (2012, November 8). Inspection is too late. The quality, good or bad, is already in the product. Retrieved January 10, 2016, from http://blog.deming.org/2012/11/inspection-is-too-late-the-quality-good-or-bad-is-already-in-the-product/

In contrast to the assumptions that lead to the after-the-fact mistakes described above, and as provided under the SSQA Concept, the testing, verification and validation of systems, provisions and controls must begin right from the onset of things. Validation activities do not have a specified time window that requires waiting or "black-out" periods". With the help of true expertise, testing, verification and validation exercises must start with the development of business ideas. Testing, verification and validation must continue through the  facility design and building stages; through the development and implementation of operating systems and programs; during the day-to-day running of the business; during operation, production or manufacturing processes; after unusual events; etc.

Second Mantra: “If it is not written or recorded, it is not done.” The completion of records which is sometimes done after-the-fact (at the end of production operations) because of an externally imposed mandate could be counter-productive in terms of ensuring that the right things are done, and that whatever is done is valid with respect to food safety. The mere availability of documentation and consistent records does not prove the food safety validity of what is documented and recorded. Where possible and applicable, a validation process is needed before and after the activity that must be written or recorded.


Records may be kept to “prove that the recorded actions were completed”. Unfortunately, this causes the neglect of a more significant reason for keeping correct, complete and consistent records. As provided under SSQA, records are to be kept, analyzed and used as gathered intelligence for operation improvement. 


No Exemptions in the Validation Process

Examples abound of where ignoring the validation process is generally accepted in food safety management. For want of a better description, let’s call this the “committee of experts exemption”. This kind of exemption is driven by the misconception that if a committee of food safety experts comes up with suggested proposals or solutions, the suggested proposals or solutions are automatically valid and are exempt from further assessment to confirm their validity in ensuring the safety of food. The use of food auditing schemes appears to belong in this category of “beyond validation” activities (or validation untouchables). How do you validate your current food safety auditing program? How do you measure this against what it is expected to address – which is the actual safety of food? Do you have quantitative data to support the gains you have made in the actual production of safe food since enrolling in your auditing program and because of it? This validation of the audit program must not be ignored.

Insufficient Application of the Validation Process

Through the many years that I have conducted food safety and quality management audits, I have seen ideas that were borrowed from somewhere and simply adopted without the proper or sufficient site-specific validation. In these instances, the system managers involved wrongly assumed that doing things “correctly” according to the borrowed ideas automatically meant that the right things were done. This is COMPLIANCE VALIDATION with the faulty argument that "it complied with the borrowed idea or the opinion of a committee therefore it is valid". Common wisdom reveals otherwise: Just as it is possible to wrongly implement the correct things; it is possible to correctly imitate the wrong things. The validation of any borrowed idea must be done at the specific places where it is to be adopted or implemented. Validation must be thoroughly done by qualified and competent personnel, through actual scientific methods, and through testing of the specific local processes. Validation must be done to confirm repeatability of successful control measures. To do otherwise is to fail in the proper use of validation where it matters. Even with scientific testing, the validation attainable is only partial since only a partial sampling can be tested. Resting with 100% confidence that a control measure is 100% valid can only come from 100% testing. Only one point offers the opportunity for 100% validation. At the point of consumption, the validity of the applied food safety control measures to every unit produced is tested and ideally proven to be effective. This is ASSURANCE VALIDATION meaning that the desired outcome is proven to have been achieved.

Incorrect Application of the Validation Process

Validation is also often applied where it does not fit. For example, validation does not apply where there is inevitable variability. You also cannot validate subjective conclusions. Certain things such as employee beliefs and attitude towards food safety fall into the category of things that have inevitable variability within an organization. Observers of employee behaviour are also led only to subjective conclusions. Thus, employee beliefs, attitude and behaviour within an operation, although can be verified, do not lend themselves to a true validation process. Hence to require the validation of acceptable employee beliefs, attitude and behaviour towards food safety in an establishment is to require validation where it does not fit because it is impossible.

Certain things are also beyond validation or even verification. Where things (not monitored or observed) have already occurred, it is impossible to verify, much less validate them. For example, how can the source of food-borne illness affecting a single victim be confirmed, verified or validated where the victim did not know what or where he or she ate, and has died?

Posted by Felix Amiri
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Felix Amiri is currently the chair of GCSE-Food & Health Protection

2 comments:

  1. With permission from Elis M. Owens, B.Sc. Ph.D., his explanation of Validation and Verification is posted here in two parts for the benefit of anyone who may not be clear about the relationship:

    PART I:
    "Since the introduction of HACCP to the meat industry in the 1990s, there has been a fair amount of confusion over the terms “validation” and “verification.” Although the meanings are seemingly quite close, Webster defines “validate” as “to support or corroborate on a sound or authoritative basis,” or “to recognize, establish, or illustrate the worthiness or legitimacy of.” The word “verify” is defined as “to establish the truth, accuracy, or reality of.”

    When it comes to HACCP the terms have specific meanings and both “validation” and “verification” are important components of any HACCP Plan.

    From a HACCP standpoint, there are slightly different definitions of “validation” and “verification,” as defined by the National Advisory Committee for Microbiological Criteria of Foods. Validation is “the element of verification that focuses on collecting and evaluating scientific and technical information to determine if the HACCP plan, when properly implemented, will effectively control the identified hazards.”

    Verification is those activities, other than monitoring, that determine the validity of the HACCP plan and ensure that the HACCP system is operating according to the plan."

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  2. Validation and Verification, Elis M. Owens, B.Sc. Ph.D

    PART II:
    "To put these into simpler terms, validation is the supporting documentation, consultation and testing done in your plant to give you a scientific basis to support the actions contained in your HACCP plan. There are several goals for the initial validation:
    •To provide assurance that the plan is adequate for controlling the food safety hazards that may be present
    •To determine whether the specified parameters can be consistently adhered to in your process
    •To confirm that the plan is being correctly implemented
    •To allow the plan to be adjusted if problems are found

    Verification, on the other hand, is the ongoing continuous process that demonstrates that the HACCP plan is being correctly implemented in your facility.

    If, for example, your facility is producing cooked meat pies, initial validation activities might include collecting scientific reports that cooking food to a specific temperature for a specific time will kill any pathogens that may be present in the item. A second step in the validation process might involve specific testing using your equipment and product to determine the procedures that are needed to cook product for the required time and temperature in your process. Other validation activities might include microbiological testing to confirm that the conditions are sufficient to kill pathogens.

    Once you have established the parameters needed for your process, verification becomes the ongoing program of checks, audits and testing that is intended to demonstrate that the specific process conditions are being met on a daily basis. So for example, verification of the pie cooking process might include checking the temperature of the pies, and timing how long they are kept at that temperature. Similarly, periodic calibration of the thermometer could be a verification activity, along with audits of production records to provide a paper trail that demonstrates that the procedures defined in the HACCP plan are being adhered to. An important part of this documentation is to trend and track all verification data to show that the process is still statistically capable of preventing or eliminating a food safety hazard. Trending also helps to show if your process is drifting away from the intended operating parameters, alerting you to the need for corrective action before you have a food safety failure.

    While seemingly complicated and confusing, recognizing that validation and verification are related yet separated components of the HACCP plan can make the task of developing an effective food safety plan a lot more straightforward.

    (Thank you to Amy Armstrong, a Birko technical rep, for reviewing this information. Amy is a certified HACCP trainer and can help with upgrades/evaluations of HACCP programs.)

    Elis Owens
    Senior Chemist/Microbiologist
    BIRKO, Henderson CO
    1-800-525-0476
    www.birkocorp.com"

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