General Principles of Food Hygiene, Composition and Labelling
7 - Records

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7.1 General Records

7.1.1 General Record Requirements

Information is recorded in a manner that represents an accurate history of the product or process. Records are retained for the required period of time.

Assessment Criteria

  • 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.
  • A qualified individual, designated by management, signs all critical records (e.g. records related to the adequacy of the thermal process and the achievement of a hermetic seal) 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 expiry date on the label or container or if there is no expiry 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 available to demonstrate the adequacy of procedures and methods used in process development.

Rationale

Records are necessary to verify that critical factors and critical limits are adequate to produce a safe product.

Assessment Criteria

  • Records are available upon request to verify that reliable procedures have been followed in designing the process.

7.2.2 Incoming Material Control Records

The manufacturer keeps records that demonstrate the adequacy of incoming material control.

Rationale

Records are necessary to verify the manufacturer's control over biological, physical and/or chemical hazards.

Assessment Criteria

  • The minimum record requirements for the four monitoring and/or certification options (periodic evaluations, 100% lot inspection, vendor certification and non-conforming incoming materials) are outlined below.

Periodic evaluations

  • The manufacturer has records to:
    • document the history of adherence to specifications (i.e. analytical results);
    • state the results of spot checks (i.e. analytical results).

100% Lot inspection

  • The manufacturer has analytical results for each incoming lot.

Vendor certification

  • The manufacturer has records that:
    • demonstrate knowledge of the supplier's process (e.g. process flow charts, critical control point identification, process specifications, critical limits, monitoring and verification reports, corrective action plans and reports, and on-site evaluation reports);
    • demonstrate the capability of supplier's process (e.g. capability studies), with statistical process control charts available upon request;
    • provide an historical data base (e.g. analytical results on consecutive lots);
    • record results of periodic monitoring (e.g. analytical results); and
    • state the results of supplier audits (e.g. audit reports).

Non-conforming incoming materials

  • The manufacturer has records to:
    • identify the material;
    • identify the deficiency; and
    • specify the preventive and corrective action taken.

7.2.3 Product Preparation and Blending Records

Critical factor control records are maintained and are available on request.

Rationale

Records are necessary to verify that critical factors in preparation and blending are controlled.

Assessment Criteria

  • Records are available upon request to demonstrate control of product preparation and blending, through adherence to critical limits specified in the formula (e.g. records for critical factors specified in the process, for fillings, and for nutrients in foods).

7.2.4 Process Control Records

Written records that adequately reflect the control of critical processing factors are available upon request.

Rationale

Records are necessary to verify the safety of the process and product composition.

Assessment Criteria

  • The manufacturer has records that demonstrate control of the critical processing factors and the composition of the product.
  • Deviations are noted on the records by the operator.

7.2.5 Deviations and Corrective Action Records

Records are available to demonstrate the control of deviations and the effectiveness of corrective actions taken.

Rationale

Records are necessary to verify that the manufacturer has control of deviations and that corrective action has been effective

Assessment Criteria

The manufacturer supplies records of deviations and corrective action that contain the information specified below, at a minimum.

  • Deviation and hold
    • Records contain the product and code, the date the product was produced, held or released, the reason for the hold, the amount of product held (e.g. back to the point where the process was last in control), the results of the evaluation or sort (e.g. the amount analyzed and an analysis report of the number and nature of defects).
    • The records further contain information about the disposition of the held product (e.g. amount sorted; amounts destroyed; amounts reconditioned; amounts disposed of through employee sales, distress or salvage; and retail sales).
    • Records include the signature of personnel responsible for the hold and evaluation, and the signed authorization for disposition.
  • Corrective action
    • Records identify the cause of deviation, the corrective action taken to correct the deficiency and a follow-up/assessment to gauge the effectiveness of the corrective action.
    • Records include the date that the corrective action was taken and verified, and the signature of the person responsible.

7.2.6 Verification Records

Records are available to demonstrate the adequacy of verification procedures.

Rationale

Records show the results of verification and confirm the effectiveness of manufacturing controls.

Assessment Criteria

  • Records of verification include the methods utilized, the date, the individuals or organizations responsible, the results or findings and the action taken.

7.3 Records on Equipment

7.3.1 Equipment Maintenance and Calibration Records

Records are available to demonstrate adherence to the maintenance program for critical equipment.

Rationale

Records permit verification of the effectiveness of the equipment maintenance and calibration program.

Assessment Criteria

  • Maintenance records for critical equipment typically include an identification of the equipment, the maintenance activity, the date of maintenance, the person responsible and the reason for the activity.
  • Calibration records for critical equipment typically include an identification of the equipment, the date of calibration, the person responsible and the calibration results.

7.4 Records on Premises

7.4.1 Water, Ice and Steam Quality Records

Written records that adequately reflect control of water, ice and steam quality and treatment are available upon request.

Assessment Criteria

  • The manufacturer has records available upon request to demonstrate the adequacy of the microbiological and/or chemical safety of the water, ice and steam supply as outlined below.
    • Water Potability Records
      • water source
      • sample site
      • analytical results
      • analyst
      • date
    • Water Treatment Records
      • method of treatment
      • sample site
      • analytical results
      • analyst
      • date
    • Boiler Feedwater Treatment Records
      • method of treatment
      • analytical results
      • analyst
      • date

7.5 Records on Sanitation and Pest Control

7.5.1 Sanitation Records

Records are available to demonstrate the effectiveness of the sanitation program.

Assessment Criteria

  • The records of sanitation activities include the date; the person responsible; a list of the equipment, floors, etc. being cleaned; the corrective action taken; and the microbiological test results, where appropriate.

7.5.2 Pest Control Records

Records are available to demonstrate the effectiveness of the pest control program.

Assessment Criteria

  • 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);
    • 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 available upon request.

Rationale

Records provide verification that the appropriate action was taken within a reasonable time frame.

Assessment Criteria

  • 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.

Consumer information

  • 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.

Investigation

  • The manufacturer's records contain, at a minimum:
    • the name of the 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
    • follow-up/assessment of the effectiveness of the corrective action.

7.6.2 Distribution Records

Product distribution records are available to enable the manufacturer to recall any lot of food in a timely fashion.

Assessment Criteria

  • Distribution records contain sufficient information to permit traceability to a particular code or lot number. The distribution records contain, at a minimum:
    • the product identification and size;
    • the lot number or code;
    • the quantity; and
    • customer names, addresses and phone numbers to the initial level of product distribution.
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