HACCP - 5 Record Keeping Best Practices to Ensure Compliance
- Conduct a hazard analysis
- Determine CCPs
- Establish critical limits
- Establish monitoring procedures
- Establish corrective actions
- Establish verification procedures
- Establish recordkeeping and documentation procedures
- Ingredients for which critical limits have been established
- Supplier certification records documenting compliance of an ingredient with a critical limit
- Processor audit records verifying supplier compliance
- Storage records (e.g., time, temperature) for when ingredient storage is a CCP
- Processing, storage and distribution records
- Information that establishes the efficacy of a CCP to maintain product safety
- Data establishing the safe shelf life of the product - if age of product can affect safety
- Records indicating compliance with critical limits when packaging materials, labeling or sealing specifications are necessary for food safety
- Monitoring records
- Verification records
- Deviation and corrective action records
- Employee training records that are pertinent to CCPs and the HACCP plan
- Documentation of the adequacy of the HACCP plan from a knowledgeable HACCP expert
- Providing evidence of product safety
- Tracing the history of an ingredient, in-process operations, or a finished product, when problems arise
- Reviewing the effectiveness of HACCP plan
- Identifying and narrowing a product recall
- Employee training
- Passing an audit
- Summarize Hazard Analysis
- Microbiological contamination
- Parasites
- Chemical contamination
- Unlawful pesticides residues
- Decomposition in food where a food hazard has been associated with decomposition
- Natural toxins
- Unapproved use of food or color additives
- Presence of undeclared ingredients that may be allergens
- Physical hazards
The written hazard analysis should consist of the following:
- Identification of food hazards
- An evaluation of each food hazard identified to determine if the hazard is reasonably likely to occur and thus, constitutes a food hazard that must be addressed in the HACCP plan
- Identification of the control measures that can be applied to control the food hazards
- Review of the current process to determine whether modifications are necessary
- Identification of critical control points
- Include HACCP Plan in Records
- List of the HACCP team and assigned responsibilities
- Description of finished product, including its distribution, intended use and target consumer
- List of product ingredients and incoming materials
- Verified flow diagram
- List of hazards identified
- Critical control point determination - decision tree
- HACCP Plan Summary Table that includes information for:
- Steps in the process that are critical control points
- the hazard(s) of concern
- Critical limits
- Monitoring
- Corrective actions
- Verification procedures and schedule
- Record keeping procedures
- Maintain Records Generated During HACCP System Operation
- CCPs monitoring records
- Deviation and corrective action records
- Validation and verification records
- Form title
- Organization name and location
- Time and date
- Product identification (including product type, package size, processing line and product code, where applicable)
- Actual observation or measurement
- Critical limits
- Corrective action taken, where applicable
- Operator's signature or initials
- Reviewer's signature or initials
- Date of review
- Product identification
- Deviation description
- Information on the disposition of product
- Person responsible for corrective action
- Results of evaluations (if necessary)
- In-house inspections
- Validation of hazard analysis
- Validation of HACCP plan
- Accuracy and calibration of monitoring equipment
- Equipment testing and evaluation
- Results of verification activities
- Ensure Electronic Records Comply with 21 CFR Part 11 Requirements
- Authentic,
- Accurate, and
- Protected from unauthorized changes
- Conduct Regular Record Reviews and Keep Records for Prescribed Periods
- Must be reviewed within seven days of generation of the original record.
- The U.S. Department of Agriculture requires a review of HACCP records prior to shipment of any finished products. This is often referred to as the "pre-shipment review."
- One year for perishable or refrigerated items
- Two years or shelf life of the product (whichever is greater) for frozen, preserved, or shelf-stable products.
- Offsite storage of records required is permitted after six months following the date that the monitoring occurred, if such records can be retrieved and provided onsite within 24 hours of request for official review.
Implement the right documentation procedures to comply with the HACCP record keeping requirements related to food safety management systems.
Recent events have shown that in an increasingly globalized food production environment, food safety has emerged as a vital public issue. Food manufacturers are increasingly under scrutiny both from governments and consumers regarding their production methods, quality practices and commitment to product safety. One of the cornerstones of a strong food safety management system is HACCP. It is a systematic approach to the identification, evaluation, and control of food safety hazards based on seven core principles. The seventh HACCP principle focuses on setting up record keeping and documentation procedures to ensure compliance with food safety regulatory requirements. For the successful implementation of HACCP, appropriate documentation and records must be kept and be readily available. This article describes some of the record keeping best practices that will help food manufacturers ensure compliance with HACCP requirements related to food safety management systems.
What is HACCP?
The Hazard Analysis and Critical Control Point (HACCP) system is a systematic approach to identify, assess and control of hazards in the food production process. HACCP is a seven-step process that monitors the performance of food safety management systems.
Hazard
A hazard is a biological, chemical, or physical agent that is reasonably likely to cause illness or injury in the absence of its control.
Critical Control Point (CCP)
A CCP is a step at which control can be applied and is essential to prevent or eliminate a food safety hazard or reduce it to an acceptable level.
Critical Limit
A critical limit is a maximum and/or minimum value to which a biological, chemical or physical parameter must be controlled at a CCP to prevent, eliminate or reduce to an acceptable level the occurrence of a food safety hazard.
Corrective Action
A corrective action is a procedure that should be followed when a deviation occurs.
Monitoring
Monitoring is necessary to conduct a planned sequence of observations or measurements to assess whether a CCP is under control and to produce an accurate record for future use in verification.
HACCP Principles
The seven principles of HACCP are:
Types of HACCP Records
Various types of records are required to properly document the HACCP system. Examples of HACCP records include:
Why HACCP Record Keeping Is Important
Efficient and accurate record keeping is an essential component of an organization's HACCP plan. Maintaining proper records is useful for:
HACCP Record Keeping Best Practices
The records maintained for an HACCP system should include a summary of the hazard analysis, including the rationale for determining hazards and control measures.
The purpose of the hazard analysis is to develop a list of hazards which are likely to cause injury or illness if not effectively controlled.
In evaluating what food hazards are reasonably likely to occur, consideration should be given, at a minimum, to the following:
Besides maintaining the summary of hazard analysis as described above, the records for an HACCP system must include a detailed HACCP plan. Following components should be included in the HACCP plan:
Records that are generated during the operation of the HACCP system should be maintained to comply with the record keeping requirements of HACCP. These include:
Following are the components that should be included in the CCP monitoring records:
Deviation and corrective action records should include:
Validation and verification records should include the following components:
Under record keeping requirements of HACCP principles, the use of electronic records is cceptable, provided that appropriate controls are implemented to ensure the integrity of the electronic data and signatures.
The electronic records maintained must comply with the requirements of 21 CFR Part 11. When using electronic records, include controls to ensure that records are:
The HACCP principle of establishing record keeping procedures require that records such as CCP monitoring records, corrective action records and verification records must be reviewed on a routine basis. The HACCP team must comply with regulatory requirements for review of HACCP records.
The following are the US FDA requirements regarding review of HACCP records:
All records documenting the HACCP system should be retained at the processing facility or at the importer's place of business to ensure compliance with the regulatory requirements.
The following are the current regulations regarding retention of records in the US:
Maintain Proper HACCP Records to Avoid Regulatory Enforcement
As explained in this article, HACCP record keeping requirements are extensive. These records should include a summary of the hazard analysis, a detailed listing of the HACCP plan, verification and validation records and any other documentation generated during the HACCP plan operation. These requirements must be met for the successful implementation of HACCP and to ensure regulatory compliance of an organization's food safety management system. The five best practices described in this article are some of the important methods that food manufacturers can adopt to ensure that their food safety management system is effective and avoid product recalls and regulatory enforcement.
How can compliance training help? The areas highlighted above are just a small part of the wide range of practices and processes that ensure food safety compliance. Subjects such as HACCP compliance are multi-faceted and complex and can be better understood after attending a training course such as the ones offered by ComplianceOnline. Our courses are available as live webinars, training recordings and seminars. We also offer customized training courses developed in conjunction with organizations that wish to train large groups of their employees.
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