Food Safety and Environmental Health Blog : Disease Prevention, Public Health, Sanitation Information & Analysis : Environ Health Associates

Validation is a key part of the verification process. Verification in HACCP requires that we first determine if the process has effective controls and secondly that the controls are operating as required. Basically, what every HACCP Plan has required since the inception of HACCP is valid documentation. The concept of validity means much more however, and the world body known as the International Standards Organization in Geneva Switzerland has developed an ISO standard for managing HACCP that requires that the operator not only monitor the system and keep valid records, but that the systems for control have been validated. This means controls must meet a standard that provides assurance that when they are met, hazards are under control. Without such standards there can be no validity to measurements.

Validity means the degree to which an instrument, selection process, statistical technique, or test measures what it is supposed to measure. Without standards it is impossible to measure as there is nothing to compare the measurements to. ISO approaches these issues by providing the definitions below.

Notice the term evidence is used in the definition of validation. Without microbiological, chemical, physical and radiological tests results (evidence), hazards will go unrecognized. Without criteria for the tests they will not provide the evidence required by ISO to ensure safety. Notice also that end products can not be assumed safe simply by monitoring a critical limit like chlorine residual in a water system, verification of the process, validation of the critical limits, and documentation are also necessary.

Notice in verification that specified requirements must be provided.

An example of a problem when validation and verification is ignored might be a situation where a water quality management system has identified that a significant contamination problem exists and assumes that by chlorination the system will be capable of effective control of hazards, but does not validate that the controls are effective. The problem with this is that EPA for example requires not only that the system maintain an FAC between 0.2 ppm and 4.0 ppm but that the water is free (<10) of Legionella species as well as total coliform, and HPC ( below 500 ppm) . Verification of such a system is impossible without testing against these standards (criteria) and the hazards may be there in spite of a predefined upon critical limits, depending on a number of factors, most importantly, dead end loops, chlorine demand and monitoring methods.

Verification and validation are therefore both essential to water quality management systems and all HACCP systems. ISO provides in-depth and clear definitions for these terms below: ISO 22000:2005.