Establish Documentation and Record Keeping Principle

3.9.1. Documentation and Record Keeping

A record shows the process history, the monitoring, the deviations, and the corrective actions (including disposition of product) that occurred at the identified CCP. It may be in any form, e.g., processing chart, written record, computerized record. The importance of records to the HACCP system cannot be overemphasized. It is imperative that the producer maintain complete, current, properly filed, and accurate records. Four types of records should be kept as part of the HACCP program:

• Support documentation for developing the HACCP plan.

• Records generated by the HACCP system.

• Documentation of methods and procedures used.

• Records of employee training programs.

3.9.2. Support Documents

The HACCP plan support documents include information and support data used to establish the HACCP plan such as the hazard analysis and records documenting the scientific basis for establishing the CCPs and critical limits (31). Examples include:

• Data used to establish the control measures to prevent microbiological growth.

• Data used to establish the shelf life of the product (if age of the product can affect safety).

• Data used to establish the adequacy of critical limits in ensuring the safety of the product.

The HACCP plan support documents should also include a list of the HACCP team members and their responsibilities, as well as all the forms produced during the preparation of the HACCP plan, showing:

• Product description and intended use.

• Hazard analysis.

• Identification of CCPs.

• Identification of the critical limits for each CCP, including data from experimental studies or information collected to support the critical limits.

• Documented deviation and corrective action plans

• Planned verification activities and procedures.

• Identification of the preventive measures for each hazard.

3.9.3. Records Generated by the HACCP System

HACCP system records are kept to demonstrate adherence of the HACCP system to the HACCP plan. These records are used to demonstrate control at CCPs in the food process. The records generated by the HACCP system include all activities and documentation required by the plan.

3.9.3.1. Monitoring Records for All CCPs

All HACCP monitoring records should be kept on forms that contain the following information:

• Product identification (including product type, package size, processing line, and product code).

• Critical limits.

• Monitoring observation or measurement.

• Operator's signature or initials.

• Corrective action taken, where applicable.

• Reviewer's signature or initials.

3.9.3.2. Deviation and Corrective Action Records

• Identification of the deviant lot/product.

• Amount of affected product in the deviant lot.

• Nature of the deviation.

• Information on the disposition of the lot.

• Description of the corrective action.

3.9.3.3. Verification/Validation Records

• In-house on-site inspection.

• Equipment testing and evaluation.

• Accuracy and calibration of monitoring equipment.

• Results of verification activities, including methods, date, individuals and/or organizations responsible, results or findings, and action taken.

3.9.4. Documentation of Methods and Procedures Used

The producer should maintain records of the methods and procedures used in the HACCP system.

• Description of the monitoring system for the critical limit of each CCP, including the methods and equipment used for monitoring, the frequency of monitoring, and the person performing the monitoring.

• Plans for corrective actions for critical limit violations or situations resulting in potential hazards.

• Description of record-keeping procedures, including copies of all record forms.

• Description of verification and validation procedures.

3.9.5. Records of Employee Training Programs

Records should be kept of all employee training. This is of particular importance for employees involved in monitoring critical limits for CCPs and those involved with deviation review, corrective actions, and verification. These employees must be trained to understand fully the appropriate procedures/methods and actions to be taken regarding control of CCPs (Table 22).

4. Notes

1. The intent of the HACCP system is to focus control at CCPs. Redesign of the operation should be considered if a hazard that must be controlled is identified but no CCPs are found.

2. The HACCP application should be reviewed and necessary changes made when any modification is made in the product, process, or any step. It is important when applying HACCP to be flexible when appropriate, given the context of the application, taking into account the nature and the size of the operation.

3. Prior to application of HACCP to any sector of the food chain, that sector should be operating according to the Codex General Principles of Food Hygiene, the appropriate Codex Codes of Practise, and appropriate food safety legislation. Management commitment is necessary for implementation of an effective HACCP system.

4. HACCP should be applied to each specific operation separately. CCPs identified in any given example in any Codex Code of Hygienic Practice might not be the only ones identified for a specific application or might be of a different nature.

5. During hazard identification, evaluation, and subsequent operations in designing and applying HACCP systems, consideration must be given to the impact of raw materials, ingredients, food manufacturing practices, role of manufacturing processes to control hazards, likely end-use of the product, categories of consumers of concern, and epidemiological evidence relative to food safety.

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