Validation and Verification, what do they mean?

                                                                                                                Sabal Food Safety Consulting's Blog / April 6th, 2014
 
 
Imagine you are going to develop a hand washing procedure for a company that manufactures a ready to eat (RTE) product. This procedure will contain details, not only about the step-by-step to be followed, but the soap and sanitizer and their concentration, any tool required, frequency of the procedure and, all the requirements of a properly developed procedure. The procedure MUST be "valid" before implementing it!.
 
In order for the hand washing procedure to be "valid", it needs to be effective, meaning, it must remove pathogens from the hands of the person that performs it every time a person washes their hands following this procedure. How you prove the procedure is effective? Select several persons working with the product. Swab their hands and test for the pathogen of concern; this procedure must be performed several times and all the results must be analyzed and compared to the “critical limit” that is acceptable by regulation or guidance document(s). If the results of the tests show consistently that there are no pathogens present on the hands, this represents the “scientific evidence” that this is a "valid" procedure.
 
Then, you need to determine what is the right frequency to repeat the above validated procedure. Using the same scenario, you will test for pathogens, for example, every thirty (30) minutes after the initial hand washing. Once you collect and analyze those results, you will be able to determine when (amount of time) the concentration of pathogens reach the “critical limit”. Now, you have “scientific evidence” to validate the frequency of the procedure.
 
Until this point in time, what you have done is the initial validation of a procedure. The procedure can be approved and used to taught the employees during formal training.
 
This is when verification kicks in. You need to demonstrate that those that were trained on following the validated procedure are doing it "precisely" as it is described in the procedure. Trained individuals must also follow the frequency established in the procedure. In summary, you need to verify that, the procedure is being followed exactly as it was developed and, at the right frequency. Normally, this is accomplished by monitoring those two parts, 1) the procedure itself and, 2) the frequency. Random swabbing of hands and analyzing the results will be considered proof of performing the procedure properly and, somehow, there should be a way to verify all trainees are washing their hands at the right frequency. You must check the procedure and its frequency are verified.
 
As you can see, by using the above scenario, if you start with a hand washing procedure that is NOT valid, you can still verify that people is following that procedure exactly as it was written and at the stated frequency but, the hands will be contaminated. Here are a couple more “validation” questions: what about if someone decides to change the soap described in the procedure or its concentration? Will you have a “valid” procedure?
 
Validation and verification are very confusing terms. For those procedures where a scientific tests can be performed, it is not that difficult to define them. However, how can you validate a Customer Complaints Program when you cannot test for pathogens? My advice is to keep the focus on the “hazard(s)” that are the objective of the procedure to be validated and, making sure your procedure really “prevents, eliminates or reduces” the hazard(s) to an acceptable limit.
 
Sabal Food Safety Consulting has helped many companies by providing guidance on how to validate and verify processes and procedures. Feel free to contact us for your validation and verification needs.