Food Safety Practices Guidance for Sprout Manufacturers
Chapter 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.

Anticipated Outcomes

  • Records include controls, limits, monitoring results and subsequent follow-up documents. Records include seed sources and lot numbers, water analysis results, sanitation checks, pest control monitoring, sprout lot codes, sprout and spent irrigation analysis results, production volumes, storage temperature monitoring, product distribution and consumer complaints.
  • 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 are signed by a qualified individual designated by management. 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 best before date on the label or container.
  • 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 factors significant to food safety, including Critical Control Points, are adequate in order to produce a safe product.

Anticipated Outcomes

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 materials control.

Rationale

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

Anticipated Outcomes

  • The minimum record requirements for the monitoring of incoming materials are as follows:
    • history of seed suppliers' adherence to specifications, GAP records and analytical results, seed producer/distributor, country of origin, lot number.
    • seed certification records of being pathogen-free.
    • data on antimicrobial agents and food chemicals (e.g. food additives).
    • information confirming acceptability of packaging material

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 Records

Records for factors significant to food safety are maintained and are available on request.

Rationale

Records are necessary to verify that factors significant to food safety during preparation are controlled.

Anticipated Outcomes

The manufacturer has records that demonstrate control of product preparation through adherence to factors significant to food safety where applicable.

7.2.4 Process Control Record

Written records that adequately reflect the control of Critical Control Points and/or factors significant to food safety during processing are available upon request.

Rationale

Records are necessary to verify the safety of the process.

Anticipated Outcomes

  • The manufacturer has records that demonstrate control of Critical Control Points and/or factors significant to food safety during processing.
  • The records of the antimicrobial treatment process include the date, product (including type of seed used), lot, treatment used (including the duration of treatment and the concentration of antimicrobial treatment solution), reference of process, person responsible and microbiological test results.
  • Deviations are noted on the records by the operator during the process, not after the fact.

Note: Minimum information required on records may vary depending on the type of process.

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 required to verify that the manufacturer has control of deviations and that corrective action has been effective.

Deviation/Hold

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 or returned to the supplier, employee sales, distress or salvage, reconditioning, and retail sales;
  • signature of personnel responsible for hold and evaluation; and
  • signed authorization for disposition.

Corrective Action

Corrective action records include information such as:

  • cause of deviation identified;
  • corrective action taken to correct deficiency;
  • follow-up/assessment of effectiveness of corrective action;
  • Preventive measures taken to prevent recurrence of the deviation;
  • date corrective action was taken and verified; and
  • signature of 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 conformance and effectiveness of manufacturing controls.

Anticipated Outcomes

  • Verification records include sprout and spent irrigation analysis results.
  • Records of verification include the methods utilized, the date, the individuals/organizations responsible, the results/findings and the action taken (corrective action when a deviation is found).

7.3 Records on Equipment

7.3.1 Equipment/Instrumentation Maintenance and Calibration Records

Records are available to demonstrate adherence to the maintenance and calibration program for equipment and instrumentation that may impact on food safety.

Rationale

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

Anticipated Outcomes

  • 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 critical 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, ice and steam quality and treatment are available upon request.

Anticipated Outcomes

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 Treatment Records Boiler Feedwater Treatment Records
water source method of treatment method of treatment
sample site sample site analytical results
analytical results analytical results analyst
analyst analyst date
date 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.

Anticipated Outcomes

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 available to demonstrate the effectiveness of the pest control program.

Anticipated Outcomes

  • Minimum pest control records include:
    • the results of the inspection programs (e.g. the findings in traps, the location of insect infestations) and the corrective action taken;
    • 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 available upon request.

Rationale

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

Anticipated Outcomes

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 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 available to enable the manufacturer to recall any lot of food in a timely fashion.

Anticipated Outcomes

  • 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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