FDA defines validation as:
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Explore this issueDecember/January 2019
“Validation means obtaining and evaluating scientific and technical evidence that a control measure, combination of control measures, or the food safety plan as a whole, when properly implemented, is capable of effectively controlling the identified hazards.”
In those cases where validation is required, the FDA intends for the approach to be as rigorous as possible. Gathering any relevant data, regulatory guidance, and additional resources ensure that processes and the food safety plan as a whole are valid.
Let’s use metal detection as a simple example, since it’s a common control and would typically be considered a process preventive control (it’s often designated as a critical control point). Some companies have their detector checked by a qualified third party, which is often referred to as “calibration,” and based on those results they will consider it validated. But what’s missing? They didn’t conduct a thorough yearly review of consumer complaints. They didn’t examine their internal process data, looking for trends in equipment performance. They didn’t review finished product inspection results, if those are available, for any indicators of a potential problem.
These are all valid pieces of information needed in a proper validation to ensure the device is working correctly. In other words, when it comes to validation (effectiveness), things aren’t always as simple as they may appear, and we really need to dig below the surface to be as detailed and comprehensive as possible, focusing on avoiding “worse-case” outcomes.
GFSI’s Broader View
Global Food Safety Initiative (GFSI) programs, which are HACCP (Hazard Analysis and Critical Control Points)-based but also contain additional requirements, take a similar view of validation as the FDA but are typically much broader. The schemes often require companies to have a documented process for validation of the things FDA would look for. For example, validation of: the food safety plan, critical control points, changes to food safety programs, CIP systems, shelf life, rework activities, and product cooking instructions (if present).
Notably, under the Safe Quality Food (SQF) standards, all elements of the program are required to be validated, as a whole. Any of the GFSI programs require this, in spirit, but the SQF requirements make it a bit more rigorous.
Help with Equipment Validation
Many industries have established experts who are referred to as “process authorities” and assist companies with validation of certain critical processes. This is typically limited to processes intended to control pathogens, such as canning processes and pasteurization. There aren’t always official recognition processes for these individuals, but some industries and trade associations may be able to make recommendations.
In absence of this option, there are other ways to get help. The FDA has a Technical Assistance Network (referred to as TAN) on its website, where visitors can ask questions about how to validate their processes, or who might help do so. University extension agents can be contacted at universities such as UC Davis, Cornell, and Kansas State that may facilitate connections to an expert.
The Role of Internal Audits
Internal audits are a great tool, and an important part of a program. As with any other program, they can be done well or they can be approached with a “check the box” mentality—simply getting them done to satisfy the requirements of certification. If done properly, in many cases an internal audit can also function as validation of a program; killing two birds with one stone.
An internal audit completed to simply meet the requirements of certification might include one visit to the production floor, watching the activity for a few moments, and reviewing a few records. This might be considered an internal audit, but so much more can be done to validate.