Part II Appendices2.3.2All relevant information needed to conduct the hazard analysis shall be collected,
2.12 Validate the HACCP plan and establish verification procedures (equivalent to Codex Alimentarius Step 11, Principle 6)
Interpretation
Validation is defined as obtaining evidence through the provision of objective evidence that a control or measure, if properly implemented, is capable of delivering the specified outcome. In other words, it is objectively confirming
Part II Appendic es
monitoring, to determine whether a control or measure is or has been operating as intended. In other words, verification seeks to answer the question, ‘Has it been operating effectively, as intended?’ Codex Alimentarius has published guidelines for the validation of food safety control measures (CXG 69-2008) which can be downloaded from the Codex Alimentarius guidelines page of the FAO’s website.
Clause Requirements
2.12.1 HACCP or food safety plans shall be validated prior to any changes which may affect product safety, to ensure that the plan will effectively control the identified hazards before implementation.
For existing HACCP or food safety plans, this may be achieved using the established processes detailed in clauses 2.12.2 and 2.12.3.
Interpretation Validation of the HACCP or food safety plan
It is important that the site validates the food safety plan to confirm it will perform, effectively, as intended, and therefore prevent food safety hazards from occurring. In other words, the site should assess whether what it intends to put in place will actually work in practice.
Obviously, to be effective this validation needs to be completed before the plan is implemented and before any changes are made (e.g. in production) that could affect food safety.
In some countries (e.g. the US), there is an additional legal requirement for a revalidation after implementation, which must occur within a specified timescale, such as 90 days. This is good practice as it allows sites to consider the effects of upscaling (i.e. moving from trial systems to full production) or any other changes that may have occurred during the first few weeks of production, and therefore ensure that the plan still accurately reflects the actual production. Sites operating in countries where this is not a legal requirement may also find this a useful good-practice addition to their ways of working.
There are a number of aspects of the plan that should be validated, including:
• production process flow
• identification of the correct hazards at the correct steps of the process
• identification of the correct CCPs
• the establishment of monitoring and verification activities, including what to monitor and how frequently
• critical limits and the corrective actions associated with each CCP.
Validation in this context could include a range of activities, depending on the relevant hazards, such as:
• review of literature
• mathematical modelling
• validation studies
• guidance from authoritative sources (e.g. legislation).
It is important that the site has a mechanism to ensure that every subsequent change is captured and reviewed. This might include changes to processes or seasonality.
Where a HACCP plan already exists and has been operating effectively for a period of time the validation may be achieved using established verification and review processes developed in accordance with clauses 2.12.2 and 2.12.3.
2.12.2 Procedures of verification shall be established to confirm that the HACCP or food safety plan, including controls managed by prerequisite programmes, continues to be effective.
Examples of verification activities include:
• internal audits
• review of records where acceptable limits have been exceeded
• review of complaints by enforcement authorities or customers
• review of incidents of product withdrawal or recall.
Results of verification shall be recorded and communicated to the HACCP food safety team.
Interpretation Establish verification procedures
The HACCP or food safety plan, including controls managed by prerequisites, must be verified to ensure that it remains effective.
Verification requires objective evidence that the specified requirements are being met.
This may include verification that monitoring has been completed correctly, that results are understood and that appropriate corrective actions have been completed. Examples of activity that can be included in verification studies are:
• internal audits (e.g. to ensure the correct procedures and work instructions are in use and that monitoring frequencies are correct)
• review and trending of records (e.g. CCP monitoring records)
• review of complaints by enforcement authorities or customers
• review of incidents (e.g. product withdrawal or recall).
The results of this verification must be documented and communicated to the HACCP or food safety team as part of the review process.
Verification should be completed to a planned schedule.
2.12.3 The HACCP food safety team shall review the HACCP or food safety plan and prerequisite programmes at least annually and prior to any changes which may affect food safety. As a guide, these may include the following, although this is not an exhaustive list:
• change in raw materials or supplier of raw materials
• change in ingredients/recipe
• change in processing conditions, cleaning and disinfection procedures, process flow or equipment
• change in packaging, storage or distribution conditions
• change in consumer use
• emergence of a new risk (e.g. known adulteration of an ingredient or other relevant, published information, such as the recall of a similar product)
• review following a significant product safety incident (e.g. a product recall)
• new developments in scientific information associated with ingredients, process, packaging or product.
Appropriate changes resulting from the review shall be incorporated into the HACCP or food safety plan and/or prerequisite programmes. Changes shall be fully documented, and the validation shall be recorded.
Where appropriate, the changes shall also be reflected in the company’s product safety policy and food safety objectives.
Part II Appendic es
Interpretation Review of the HACCP plan
The HACCP or food safety plan and associated prerequisite programmes must be reviewed regularly, at a minimum of once a year, even if there have been no changes to the product range or processing methods. Some or all of the plan should be reviewed whenever there is a significant change.
Changes that may affect product safety, such as those listed in this clause, need to be evaluated in the context of the plan before they are introduced, and the plan amended as necessary.
A procedure could be documented that lists the activities or changes which trigger a HACCP review, but this would have to be backed up by documented evidence that the review has actually been carried out (e.g. by documenting minutes of the meeting or an agreed action plan).
In the case of published incidents (e.g. recalls or media stories), it is good practice to
consider whether the product involved is similar to those produced at the site, and therefore whether a similar problem could occur with the site’s products. Where a genuine risk is identified, the site should complete a review of the existing HACCP controls to establish whether they remain sufficient or whether amendments are required. However, it is not a requirement of the Standard to complete an in-depth analysis of every recall that occurs where no similarity or risk exists.