Staying competitive and providing a safe product that meets customer expectations and regulatory requirements are goals of any manufacturing business. Gone are the days when the only goal was to provide a product. Customers and regulatory agencies require more. Verification and validation are tools used in the food industry to meet these goals. A combination of veriﬁcation and validation activities will help ensure that established programs are correct, effective, and carried out correctly. And, these documented activities will be used to conﬁdently respond to the challenge to “Prove It!”
It's important to know what to do with the results of an internal veriﬁcation and validation audit. If results demonstrate program compliance and effectiveness, then it is successful and program support should continue. For results that demonstrate noncompliance or ineffectiveness, corrective action must be taken. For veriﬁcation, the important question to ask is “Why are the established procedures not followed?” Audit results should be used, not abused. Remember, in most cases it is a system problem, not a people problem. The food safety team may ask the following questions:
- What can be done to improve the chances for compliance to the program?
- Does the program need to change?
- Is additional training required?
- Are additional resources (time, tools) needed?
In some instances, it may be a recordkeeping issue in which the records do not accurately reﬂect the activities that were completed. In this case an appropriate question may be, “Can the record be revised to better reﬂect completed activities?”
For validation results that show the lack of an effective or scientiﬁcally-based program, a root cause analysis must be completed to determine how the program must be modiﬁed. The food safety team should determine what resources are available to determine if established procedures are scientiﬁcally based. These resources often can be found online. If corrective actions were ineffective, it is important to try a different corrective action. A common error is to attempt the same solution repeatedly.
From this, a person learns to continue working toward a solution, but to also try to understand why previous attempts failed. Once the root cause has been determined, it is likely that the procedure or policy will need to be modiﬁed. Personnel must be trained on any changes in procedures. The document control program should ensure that obsolete procedures and forms are removed to a secured area and that revised materials are readily available to responsible personnel.