It has long been said that food safety cannot be inspected into a product. This was a key element of why Hazard Analysis and Critical Control Points (HACCP) plans were developed by NASA, U.S. Army Natick Research Labs and the Pillsbury Company. In 1985, the National Academy of Sciences stated in its final report, “HACCP provides a more specific and critical approach to the control of microbiological hazards than is achievable by traditional inspection and quality control.”[1]
As a result, food safety is ensured by developing, implementing, managing and improving processes used to produce safe food. Process control strategies and validation are critical to build both quality and safety attributes into food processes and products. These are effective tools that form a systems approach, to ensure that safety is properly addressed in food production.
Validation and verification may be confusing subjects. Part of this confusion goes back to some of the original publications on HACCP. The National Advisory Committee on Microbiological Criteria for Foods (NACMF) states that validation is “that element of verification focused on collecting and evaluating scientific and technical information to determine whether the HACCP plan, when properly implemented will effectively control the hazards.”[2]
Over the years, food safety professionals have questioned whether validation is an element of verification.[3–5] Some food safety experts have proposed that verification should be a separate principle of HACCP, an eighth principle, so to speak. Recently, it was suggested that a new paradigm be considered that validating, monitoring and verifying form part of a continuum that addresses activities at different stages of the food manufacturing process.[5] Using this approach, food manufacturing is seen as a system. During the development of a food process, the focus is on validation. The goal of the organization is the development of a reliable process that can consistently manufacture safe food. Included in the design part is the evaluation and selection of suppliers. During this time, organizations are applying design principles, which include developing a food safety management system or HACCP plan. In addition, during the development and initial operational phases, the organization may conduct various validation studies. Once the process is fully operational, the organization ensure that the process is operating as intended. The requirements are described in either the food safety or HACCP plan. In addition, both during and after processing, the organization will also verify that requirements of either the food safety or HACCP plan have been fulfilled.
Table 1. Definitions Used in Validation, Monitoring and Verification
NACMCF2
Validation is “that element of verification focused on collecting and evaluating scientific and technical information to determine whether the HACCP plan, when properly implemented, will effectively control the hazards.”
Monitoring is “to conduct a planned sequence of observations or measurements to assess whether a CCP is under control and to produce an accurate record for future use in verification.”
Verification is “those activities, other than monitoring, that determine the validity of the HACCP plan and that the system is operating according to the plan.”
ISO 220003
Validation is “obtaining evidence that the control measures managed by the HACCP plan and by the operational PRPs [prerequisite programs] are capable of being effective.”
Monitoring is “conducting a planned sequence of observations or measurements to assess whether control measures are operating as intended.”
Verification is “confirmation, through the provision of objective evidence, that specified requirements have been fulfilled.”
Codex6
Validation is “obtaining evidence that a control measure or combination of control measures, if properly implemented, is capable of controlling the hazard to a specified outcome.”
Monitoring is “the act of conducting a planned sequence of observations or measurements of control parameters to assess whether a control measure is under control.”
Verification is “the application of methods, procedures, tests and other evaluations, in addition to monitoring, to determine whether a control measure is or has been operating as intended.”
FDA7
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.”
Monitoring means “to conduct a planned sequence of observations or measurements to assess whether control measures are operating as intended.”
Verification means “the application of methods, procedures, tests and other evaluations, in addition to monitoring, to determine whether a control measure or combination of control measures is or has been operating as intended and to establish the validity of the food safety plan.”