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. 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.
HACCP Principles
The seven principles of HACCP are:
· Conduct a hazard analysis
· Determine CCPs
· Establish critical limits
· Establish monitoring procedures
· Establish corrective actions
· Establish verification procedures
·
Establish recordkeeping and documentation procedures
Types of HACCP Records
Various types of records are required to properly document the HACCP system. Examples of HACCP records include:
- 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
HACCP Record Keeping Best Practices
1. Summarize Hazard Analysis
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:
- 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
2. Include HACCP Plan in Records
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:
- 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
- Plant schematic
- 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
3. Maintain Records Generated During HACCP System Operation
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:
· CCPs monitoring records
· Deviation and corrective action records
· Validation and verification records
Following are the components that should be included in the CCP monitoring 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
Deviation and corrective action records should include:
· Product identification
· Deviation description
· Information on the disposition of product
· Person responsible for corrective action
· Results of evaluations (if necessary)
Validation and verification records should include the following components:
· 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
4. Ensure Electronic Records Comply with 21 CFR Part 11 Requirements
Under
record keeping requirements of HACCP principles, the use of electronic
records is acceptable, 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:
· Authentic,
· Accurate, and
· Protected from unauthorized changes
5. Conduct Regular Record Reviews and Keep Records for Prescribed Periods
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:
· 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."
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:
· 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.
