Axis I: Process Quality System section 1.4. Documentation Quality

1.2.1. Document development

A procedure must be drafted, defining the method to develop in a standardized manner, review, approve and update the manuals, directions, procedures and record forms to be documented and implemented in the EC11R management, operational and technical processes.

Documents must include at least: header with code, version, document name, and in the case of record forms, the document from which it is derived.

Manuals, directions, procedures and record forms must be approved through the signature of elaboration, area manager review and authorization of senior management and/or designated personnel.

1.2.2. Document standardization

A policy to standardize process documentation must be established, indicating that manuals, procedures, record forms and other documents related with the compliance of requirements from the company management system must have the design and the provisions of the document development procedure referring to organization, control, validity and availability. There must be a master list of the current internal documentation.

1.2.3. Records

Records must be generated in order to provide evidence of the activities or results obtained.

The personnel responsible for filling, verifying and safekeeping the records, such as control, inspection and testing, must be linked in each of the procedures.

It is important to ensure that personnel responsible for documenting tests, analysis, observations and other control activities do so in a legible and accurate manner.

To make sure records are not altered, these should be filled out with permanent ink and the blank spaces not used should be cancelled, that is, crossing a line in that blank space.

When mistakes occur while filling out records, these should not be crossed out or covered. The procedure to correct them is to cross the error with a line, writing down the initials or signature of the person making the corrections and writing down the right word or value next to the error.

1.2.4. Safekeeping documents and records

A procedure must be documented, establishing the necessary controls for identification, storage, protection, recovery, retention and disposition of records. These should be maintained in safe condition for two years or adhere to the applicable legal provisions for this particular case.

Documents and records must be at least two months old, before making a certification audit for the first time.

1.2.5 Process quality manual

To develop the EC11R, the participating grower must elaborate and implement the Process quality manual content. Here, the basic criteria for proper application of the management system are established. The Process quality manual has a direct impact in the company management system and contains the EC11R documentary support.

The Process quality manual must document and comply with the following EC11R elements:

  1. Company basic statements
  2. Documentation quality
  3. Human resources
  4. Applicable regulations
  5. Infrastructure
  6. Storage operation
  7. Maintenance
  8. Water quality for human consumption
  9. Management and control of strange matter
  10. Process verification and validation
  11. Allergens
  12. Chemicals
  13. Food defense
  14. Supplies and services
  15. Performance evaluation and ongoing improvement
  16. Crisis management
  17. Traceability

Additionally, the Process quality manual must be complemented with the following operating manuals:

  1. Agriculture Operational Process Manual (AOPM): This is the tool used to facilitate the proper application of axis ll (Agriculture production system).
  2. Packaging Operational Process Manual (POPM): An instrument facilitating the proper application of axis III (Packaging, storage and transportation system).
  3. HACCP-Based Operational Process Manual (HOPM):  Describes the required directions for implementing axis IV of the HACCP-based Eleven Rivers system.
  4. Social Responsibility Operational Process Manual (SOPM): contains the manners in which the company will comply with the established criteria in axis V of EC11R, in social and environmental aspects.

All manuals must be written in a clear and precise manner, to ensure an exact interpretation by the parties involved; they must also be coherent, in order to avoid redundancies and ambiguities.

At the beginning of manuals it is recommended to make an index, to keep the order and facilitate location and review of the same.