Validation and Verification are terms of art in the Quality Assurance process as are monitoring and certification.
In the industries with which I am familiar these are the definitions the Canadian Government recognizes.
2. Validation Definition and Procedure
The Codex Alimentarius Commission (2008) defines validation as follows:
- Obtaining evidence that a control measure or combination of control measures, if properly implemented, is capable of controlling the hazard to a specified outcome.
In the US we are advised
Validation is the process of gathering scientific evidence that your process COULD work. That means by controlled and challenged experimentation or by direct reference to challenged and accepted literature.
Verification is an audit process to confirm that your validated process actually works.
Validation is a one time event that confirms the bench mark.
Verification is an ongoing event in a continuous process
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So this ....
I have a problem.
The Good Idea Fairy visits an d I come up with a course of action.
I do a literature search to determine if there is any validity to that course of action.
Having found some challenged and accepted authorities that support my proposed CoA I have now verified that my CoA is valid.
But no product is yet made.
i now need support so I have to convince others that my process is valid.
During my literature review I identify hazards, things that can go wrong. I also identify how to fix them. This is the HA part of HACCP theory - Hazard Analysis - Critical Control Point. Critical Control Points are those points of the process that I will have to closely monitor to ensure that my process stays on track and achieves the desired outcome. They are points where the process can be influenced and hazards mitigated.
Part of the process of getting support to proceed is submitting a HACCP plan. With that information in place then the odds that I can find at least one other person to agree with me that the process might be valid and invest in the process increase.
To advance the process we now need to enter into the experimentation phase.
Typically this goes through three sub-phases
Bench-Top
Pilot
Full Scale
At the Bench Top level we typically invest pennies in equipment, kilograms of material and thousands of hours of time. This is more verfication. Once we have achieved the results we are looking for we have further verified that we are on the right track and this could be a valid CoA.
But before we can get someone to invest millions of dollars we go looking for thousands. That money is used to buy, rent or steal the smallest versions of each of the unit processes we can find. It may be old, outdated equipment that approximates the stuff we are thinking about but it is made to serve. In addition to the thousands in equipment we invest thousand of kilograms, tonnes of material. We also invest more time, but because we are now using someone else's money we are typically on the clock and challenged to verify if we stiil have a valid CoA. On achieving the desired outcome we can now certify to the investors that we have verified that we have a valid CoA worth further investment and sign off on a certficate. That process can take months and sometimes years. Usually the time spent testing is measured in days and weeks but the review period is measured in months and years.
Assuming we get agreement that the certified process is valid then we get the millions of dollars required to build the full scale plant and apply the certified process to the real world. This phase invests millions of dollars and hundreds of tonnes of material. But the time available to invest is reduced to days and hours. This final phase of experimentation is also known as commissioning. This is the process of verifying that the certified process actually gets the job done. It verifies that the Course of Action works. We now have a valid process that works. We can certify that. The client can certify that. The insurers can certify that. Third part validators can certify that. The government can certfy that. The investors and the consumers then have a high degree of probability that they will be satisfied and that the food that we put in their bellies won't kill them. We make no claimss that they will like the product.
At that point we, the supplier, certify the plant and hand it off to the user.
And the experimentation and verification continues. Every batch is monitored as it proceeds through the process past all those Critical Contro Points to ensure that the hazard risk is managed and kept under control. Every batch that is successfully produced further verifies the validity of the process, the Course of Action. It validates the Course of Action and gives sufficient comfort to the user, their investors, their validators and the government that they can certify their product to the the consumer.
In my world verfication is the process of gathering evidence. Observation in Boydian terms.
Validation is the process of determining if the Course of Action achieves the desired outcome. Orientation and Decision.
Certification is the act of guaranteeing to others that you believe they will be happy and they can sue you if they arr not. Action.
Also, in my world, the processes of experimentation, verification and validation never end. They are the key elements in a Continuous Improvement environment. Every day, and every batch, not only do we check our Operating Characteristic charts to see if the results fall within our 6-Sigma bounds we check for slow motion drift that may require us to review our point of aim and rethink our CoA.
And, not infrequently, we may shift the process entirely and move our point of aim right outside our 6-sigma limits and test alternate Courses of Action to verify if they are worth validating.
None of this endears us to accountants. They hate Continuous Improvement because it is not compatible with the clarity associated with fixed end-states. There is no end state. There is only continuous adaptation.
They do love the certification and suing bit though.
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