Module 3.6 Monitoring and Review

Allergen control systems

Allergen control systems should be monitored and reviewed to provide assurance that they are working correctly. This is done most effectively by an audit or ‘health check’ of the system. In addition to routine checks on manufacturing operations, an overall ‘health check’ can find any weaknesses in the system and then corrective actions can be taken. A key benefit of auditing the system is to provide evidence of due diligence in managing allergens.

The ‘health check’ should, as a minimum, include:

  • review and verification of the hazard analysis and hazard management system
  • product and ingredient specifications
  • operating procedures
  • cleaning procedures
  • training records – demonstration of competence
  • analysis of customer complaints
  • good Manufacturing Practices

Review and verification of the hazard analysis and hazard management system

Validation and verification procedures should be implemented to confirm that the hazard control system is working correctly. This might include auditing of control procedures and any tests, random sampling and analysis. The hazard control system should be reviewed regularly and after any changes in the manufacturing process or premises to confirm that all critical control points are under control. Following completion of this hazard assessment, manufacturers should then determine whether allergen advisory statements are appropriate.

Product and ingredient specifications

Manufacturers need to be aware of the presence of the major allergens in all raw materials, particularly the potential for allergen cross-contamination from manufacturing and handling activities on the raw material suppliers sites, as well as earlier in the food chain during harvesting and transport. This might be through audits or from information provided by suppliers.

Manufacturers should ensure that materials are ordered against a clear specification and that they ask appropriate questions of their suppliers. Raw material suppliers (and their agents) should be aware of the hazards arising from contamination by allergens and conform to the manufacturers purchase specification. However, commodity raw material suppliers should only use allergen warning statements on products such as spices and grains, based on an assessment of the risk of cross-contamination. Scientific work currently underway to establish meaningful allergen thresholds and develop appropriate testing methodologies will help in making such assessments.

Ingredients should be fully described in specifications, for example, avoid the use of generic terms such as vegetable oils and fats, by using specified terms such as peanut or rapeseed oil, especially where those allergens are listed in EU Food Information for Consumers Regulation (EU FIC) No.1169/20111.

Cleaning procedures

Very small amounts of some allergens, such as nuts, can cause adverse reactions, including potentially fatal anaphylactic shock. Therefore, thorough cleaning that is effective in reducing the risks of allergen cross-contamination should be used.

Cleaning practices that are satisfactory for hygiene purposes may not be adequate for removing some allergens and their validity for such a purpose should be assessed (for example via residue/environmental swab testing). Equipment might need to be dismantled and manually cleaned to ensure hard to clean areas are free from allergen residues. Particular food materials (such as powders) present significant cleaning problems and any relevant industry guidance should be followed. Adequate procedures must be in place for cleaning both production and packaging machinery. Where adequate cleaning is not possible, then the risk of allergen cross-contamination should be assessed and advisory labelling used, if appropriate.

Care is needed to ensure that the cleaning of one line (for example by using compressed air cleaning) does not contaminate another line or an area that has already been cleaned. It would be a good idea, for example, to clean dry mix areas from the top down.

Any spillages that occur during production, storage and transportation should be cleaned up immediately to ensure that there is no subsequent allergen cross-contamination. Where known allergen contamination has occurred, the contaminated material should be labelled and physically moved away from the non-contaminated ingredients and work-in-progress.

Consideration should be given to maintenance activities, such as the use of dedicated tools or adequate cleaning procedures where tools are not dedicated.

Where adherence to a cleaning regime is part of a separation system, it should be validated as fit for purpose and compliance should be monitored.

Investment in developing and following appropriate cleaning regimes will help to minimise cross-contamination and can reduce the need for product recalls.

Training records

Manufacturers should ensure that their employees receive relevant and structured ongoing training so they remain aware of food allergens and their consequences. Such training should explain the facts as well as highlighting the company’s good manufacturing practice principles and effective food safety system. Manufacturers should keep certificates of registration, qualifications and documents to record training completed by their employees.

Analysis of customer complaints

Customer complaints should be investigated and changes made where necessary. Manufacturers should keep a record of these customer complaints and show what action was taken as a result.

Good manufacturing practices

Most food producers already employ good manufacturing practices (GMP) to ensure that they are able to produce food safely. GMP requires appropriate manufacturing operations, effective food safety systems (using HACCP-based principles), and quality assurance systems, as well as a commitment and discipline to ensure products meet food safety, quality and legal requirements.