Validation is the process of demonstrating that the HACCP system as designed can adequately control identified hazards to produce a safe, unadulterated product. There are two distinct elements to validation:
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- The scientific or technical support for the HACCP system obtained from any of the following areas:
- Published processing guidelines;
- A scientific article from a peer-reviewed journal;
- A challenge or inoculated pack study;
- Data gathered in house; or
- Regulatory performance standards.
- The initial practical in-plant demonstration proving that the HACCP system can perform as expected. Examples of some controls that would need validation are CCPs, prerequisite program interventions that reduce the likelihood that a hazard will occur, purchase specifications, product formulations in which the formulation contributes to the safety of the product, and cooking instructions.
Examples of incomplete validation include:
- Presenting documentation that specifies the log reduction achieved by the process but does not include information about parameters, such as pH, that are critical to achieving that reduction. That information must be included in order for the process to be considered validated.
- Having a validated process on file but not following the process described.
- Validating a process for a specific log reduction of a pathogen in a product different than the one being considered. This validation could not be used as supporting documentation.
For example, a process that achieves a 5-log reduction of E. coli O157:H7 in apple cider could not be used as the sole supporting documentation for the reduction of E. coli O157:H7 in a beef product.
Validation and Manufacturing
A validation protocol is a written plan stating how validation will be conducted, including test parameters, product characteristics, production equipment, and decision points on what constitutes acceptable test results.
Generally, in conforming to HACCP validation requirements, every manufacturer must prepare a written validation protocol that specifies the procedures and tests that are conducted, along with the data collected. The purpose for which data are collected must be clear; the data must reflect facts and must be collected carefully and accurately. The protocol should specify a sufficient number of replicate process runs to demonstrate reproducibility and should provide an accurate measure of variability among successive runs.
The test conditions for these runs should encompass upper and lower processing limits and circumstances, including those within standard operating procedures, which pose the greatest chance of process or product failure compared to ideal conditions; such conditions have become widely known as worst-case conditions (they are sometimes called “most appropriate challenge” conditions). Validation documentation should include evidence of the suitability of materials and the performance and reliability of equipment and systems. The scientific support and initial in-plant validation documents that support the decisions made in the hazard analysis, as well as the adequacy of the process used to control those hazards, should be kept for the life of the process.
Validation is an important concept in HACCP systems, yet there are often situations in which it is inadequately implemented, overlooked, or omitted. In the FSMA’s Section 103, the word validation is not even mentioned.
Validation and Auditing
The Global Food Safety Initiative (GFSI) Guidance Document is a benchmark for many major food safety and quality management system schemes in place today. In the sixth edition of the GFSI Guidance Document, Part IV uses the following definitions:
- Audit: A systematic and functionally independent examination to determine whether activities and related results comply with a conforming scheme, whereby all the elements of this scheme should be covered by reviewing the supplier’s manual and related procedures, together with an evaluation of the production facilities.
- Verification: A confirmation, through the review of objective evidence, that requirements have been fulfilled.
- Validation: An activity to obtain evidence that a requirement is controlled effectively.
As defined above, the auditing process involves verification that the requirements of a conforming auditing scheme have been met. When there is a requirement in the auditing scheme that something be controlled effectively, that requirement must be also validated by obtaining evidence through the auditing process.