Food Safety Practices Guidance for Fresh Non-Filled Alimentary Paste Manufacturers
Chapter 7: Records
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7.1 General Records
7.1.1 General Record Requirements
Information is recorded in a manner which represents an accurate history of the product or process. Records are retained for an appropriate period of time.
- Records are legible, permanent and accurately reflect the actual events, conditions or activities.
- Errors or changes are identified so that the original record remains clear (e.g. strike out with a single stroke and initial the correction/change).
- Each entry on a record is made by the responsible person at the time that the specific event occurred. The completed records are signed and dated by the responsible person.
- Critical Control Point records and other records significant to food safety are signed by a qualified individual designated by management prior to distribution of product. All other records are reviewed at an appropriate frequency to provide an early indication of potentially serious deficiencies.
- Records are retained for at least one year after the durable life date on the label or container or if there is no durable life date, for at least two years after the date of manufacture.
- Records are maintained and are available upon request.
7.2 Records on Control of Operation
7.2.1 Process Design Records
Records are kept to demonstrate the adequacy of procedures and methods used in process development.
Records are necessary to verify that factors significant to food safety, including Critical Control Points, are adequate to produce a safe product.
- Records are kept which verify that reliable procedures have been followed in designing the process, e.g. copies of scientific type references, studies containing the information supporting food safety.
- Records are kept which document the required processing, packaging, etc. parameters that need to be in place or followed to attain a safe product. This includes procedures and/or specifications).
7.2.2 Incoming Material Control Records
- The manufacturer keeps records that demonstrate the adequacy of incoming materials control.
Adequate records are necessary to verify the manufacturer's control over biological, physical and/or chemical hazards associated with incoming materials.
- Appropriate records are kept to demonstrate that incoming lots of ingredients were inspected for signs of contamination and adherence to written specifications.
Incoming Packaging Materials
- Appropriate records are kept to demonstrate adherence to written specification.
Non-Conforming Incoming Materials (including ingredients and packaging material)
- The manufacturer has records to:
- identify the material;
- identify the deficiency; and
- specify the preventive measures and corrective actions taken.
7.2.3 Product Preparation/Blending Records
Records for factors significant to food safety and/or Critical Control Points are maintained.
Records are necessary to verify that factors significant to food safety and/or Critical Control Points during preparation are controlled.
The manufacturer keeps records that demonstrate control of product preparation/mixing through adherence to limits of acceptability and/or critical limits where applicable (e.g. allergens, food additives, nutrient addition).
7.2.4 Process Control Records
Written records that adequately reflect the control of factors significant to food safety and/or Critical Control Points during processing are kept.
Records are necessary to verify the safety of the process.
- The manufacturer has records that demonstrate control of Critical Control Points and/or factors significant to food safety during processing. These could include the following:
- records that demonstrate control of physical hazards (e.g. screening of bulk flour, metal detection screening of finished product ).
- records that confirm all processing time and temperature requirements have been met.
- where applicable, records that demonstrate food allergen control.
- Deviations are noted on the records by the operator.
7.2.5 Deviation and Corrective Action Records
Records are kept to demonstrate the control of deviations and the effectiveness of corrective actions taken.
Records are required to verify that the manufacturer has control of deviations and that corrective action has been effective.
Deviation records include information such as:
- product and code;
- date when the product was manufactured, held, released or destroyed;
- description of deviation and reason for the hold;
- amount of product held, e.g. back to the point where the process was last in control;
- results of evaluation/sort, e.g. amount analysed, analysis report of the number and nature of defects;
- disposition of held product, e.g. amount sorted, destroyed, employee sales, distress or salvage, reconditioning, and retail sales;
- signature of personnel responsible for hold and evaluation; and
- signed authorization for disposition.
Corrective action records include information such as:
- cause of deviation identified;
- corrective action taken to correct deficiency;
- preventive measures taken to prevent recurrence of the deviation;
- follow-up/assessment of effectiveness of corrective action and preventive measures;
- date corrective action was taken and verified; and
- signature of person responsible.
7.2.6 Verification Records
Records are kept to demonstrate the adequacy of verification procedures.
Records show the results of verification and confirm the conformance and effectiveness of manufacturing controls.
- Records of verification include the methods utilized, the date, the individuals/organizations responsible, the results/findings and the actions taken (corrective action when a deviation is found).
7.3 Records on Equipment
7.3.1 Equipment/Instrumentation Maintenance and Calibration Records
Records are kept to demonstrate adherence to the maintenance and calibration program for equipment and instrumentation that may impact on food safety.
Records permit verification of the effectiveness of the equipment/instrumentation maintenance and calibration program.
- In Maintenance Records for equipment and/or instrumentation that may impact on food safety, the manufacturer typically includes an identification of the equipment and/or instrumentation, the maintenance activity, the date of maintenance, the person responsible and the reason for the activity.
- In Calibration Records for equipment and/or instrumentation that may impact on food safety, the manufacturer typically includes an identification of the equipment and/or instrumentation, the date of calibration, the person responsible, the calibration results and corrective actions.
7.4 Records on Premises
7.4.1 Water/Ice/Steam Quality Records
Written records that adequately reflect control of water and steam quality and treatment are kept.
- The manufacturer keeps records to demonstrate the adequacy of the microbiological and chemical safety of the water and steam supply as outlined below.
|Water Potability Records||Water Treatment Records||Boiler Feed water
|water source||method of treatment||method of treatment|
|sample site||sample site||analytical results|
|analytical results||analytical results||analyst|
7.5 Records on Sanitation And Pest Control
7.5.1 Sanitation Records
Records are kept to demonstrate the effectiveness of the sanitation program.
- The records of sanitation activities include the date, the person responsible, the findings, the corrective action taken, and the microbiological test results where appropriate.
7.5.2 Pest Control Records
Records are kept to demonstrate the effectiveness of the pest control program.
- Minimum pest control records include:
- the results of the inspection programs and the corrective action taken (e.g. the findings in traps, the location of insect infestations);
- a record of pest control activities (e.g. the pesticide used, the method and location of application, the dates of fumigation); and
- the date and the person responsible.
7.6 Records on Complaint Handling And Recalls
7.6.1 Complaint Records
Records of product complaints, investigation findings and action taken are kept.
Records provide verification that the appropriate action was taken within a reasonable time frame.
- The establishment maintains detailed records of consumer complaints received and of the subsequent investigation, including corrective action taken. Complaint records include the information listed below.
- The manufacturer's records contain, at a minimum:
- the name, address and telephone number of the complainant, and the date the complaint was received;
- details of the complaint and/or illness;
- the product's name, code and size; and
- the retail outlet where the product was purchased.
- The manufacturer's records contain, at a minimum:
- the name of person responsible for the investigation;
- the action taken (concerning the product and/or the process) as a result of the investigation;
- the corrective action taken to prevent a recurrence; and
- a follow-up/assessment of the effectiveness of the corrective action.
7.6.2 Distribution Records
Product distribution records are kept to enable the manufacturer to recall any lot of food in a timely fashion.
Distribution records contain sufficient information to permit traceability to a particular code or lot number. The following minimum information is required for distribution records:
- the product identification and size;
- the lot number or code;
- the quantity; and
- name and type of the account, (e.g. manufacturer, distributor, retailer), addresses and phone numbers of recipients.
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