What is Validation?
Validation is a systematic process that collects and evaluates scientific, technical and observable evidence to determine whether the HACCP plan will effectively control hazards to a specified outcome2. Evidence generated during the validation study may also be useful in the development of monitoring and verification procedures2.
Initial validation of control measures, critical limits and other elements of the HACCP plan must be conducted before its implementation1. This task is usually conducted by the HACCP team but may require additional assistance from internal employees and/or external consultants. Any changes, failures or periodic reassessment after the application of HACCP system will involve a review and may require revalidation to demonstrate its validity1.
Guidance published by Codex Alimentarius in 2020 stipulates requirements for validated critical limits for control measures at critical control points (step 8/principle 3) and validation of the HACCP plan (step 11/principle 6)1. Validation of specific prerequisite programs may be required because they could affect decisions made in the hazard analysis for the significance of a hazard.
Validation of Control Measures and Their Critical Limits
Tasks Prior Validation
Validation is a two-stage process. Certain tasks prior to validation of control measures must be completed to ensure validation can be achieved effectively and efficiently2.They can be conducted independently or in combination with establishment of GHPs, GMPs, HACCP, etc.2 Tasks prior to validation can include the following:
- identify the hazards that are to be controlled in the commodity and/or environment2
- identify the food safety outcomes or targets required, which may already be established by a competent authority or identified as industry best practice2
- identify which control measures are to be validated, taking in consideration those that have already been validated2
- focus more attention on hazards with a higher adverse effect2
- consideration in the size of population affected by the hazard and those most at risk2
- potential constraints in scientific and technical feasibility, sufficient resources for validation activities and ability to monitor or verify a control measure2.
The Validation Process
Validation can be achieved through a single approach or a combination of different methodologies. The chosen approach will be dependent on the nature of hazard, raw materials and product, and stringency of control measures2.
An initial step in the validation study could begin with a review of published scientific or technical literature developed by authoritative sources within government, scientific and industry communities. This information must be reliable, reflect current thinking and apply to the specific operation, product or groups of products under consideration1,2. Sources of technical and scientific support include peer-reviewed scientific studies, regulatory requirements, government or industry technical guidance, codes of practice, predictive modelling, challenge testing, etc.
In-plant Validation (Production Trials)
Theoretical scientific and technical support may not be enough to demonstrate control measures within the HACCP system are capable in achieving expected outcomes in a particular production process2.
Production trials can be conducted to determine whether control measures and their critical limits are consistent with those cited in published scientific and/or technical references2.This approach can assess inherent variables and/or abnormal situations that could affect the capability of process to consistently achieve critical operational parameters2. Known variables that could cause a deviation include product (e.g. temperature, size, thickness, cold spots, etc.), equipment (e.g. line speed, make/model, reliability, accuracy, etc.) and production personnel (e.g. error or violation). Worst case scenarios for these variations must also be considered during production trials. Production trials may need to be conducted multiple times to generate sufficient evidence to demonstrate results are reproducible.
Analysis of data collected during in-plant validation, such as observations, measurements and microbiological testing, will show that a control measure or combination of control measures can achieve an expected outcome or not2. If the process is not capable in controlling a hazard, then reassessment of product formulation, process parameters or other decisions/actions may be required2.
All data, analyses and decisions should be documented in a report to demonstrate the validation study is based on sound scientific and technical evidence2. Documentation may refer to published theorical literature, experimental data collected during production trials, and justifications for decisions made during the validation study.
Validation of the HACCP Plan
Validation of control measures and their critical limits is not enough to ensure the operation is capable in controlling hazards. Principle six requires additional validation of other elements within the HACCP plan, such as identifying hazards, determination of CCPs, monitoring activities, corrective actions, verification activities and the type of information to be record1.
Identification of hazards should reference authoritative information and record justifications by the HACCP team. Subsequent evaluation of these hazards must provide written evidence of the process and explanation for the significance of each hazard. Determination of critical control points should specify the method, for example the use of the Codex decision tree. Monitoring activities at CCPs should demonstrate they can continuously detect deviations in critical limits and set frequencies are justified. Corrective actions must be based on sound scientific information to prevent unsafe product reaching the consumer. Approach and frequency of verification activities must show they are capable in detecting deviations in expected outcomes within HACCP plan. Finally, documentation and records must provide suitable and sufficient written evidence that the HACCP plan meets minimum legal compliance and if required additional standards set by codes of practice.
- Codex Alimentarius (2020). General Principles of Food Hygiene. [Online].
- Codex Alimentarius (2008) Guidelines for the Validation of Food Safety Control Measures. [Online]