Know more about Axis I. Process Quality System Section1.10 Process Verification and Validation

1.10. Process verification and validation

 1.10.1. Process verification

The procedure for process verification must state how the ongoing verification of procedures involved in the EC11R implementation will be carried out.

This procedure must focus in at least the following company processes: Training, Pest control, Good Agriculture Practices, Good Management Practices (manufacture), Pesticide application, Fertilizer application, Management of complaints, Preventive and corrective maintenances, Non-compliant products, Corrective actions, Internal audits and Cleaning and Sanitation, to ensure these are being applied exactly as documented, and achieving the results desired. When deviations exist, the necessary corrective actions must be applied so that process are properly documented and implemented again.

A schedule must be established with details of each verification activity, the frequency and the person responsible for each of them. Records must be maintained; in accordance to the established frequency in the schedule, in order to show that verification activities have actually been developed.

1.10.2. Processes validation

A process validation procedure must be carried out, aimed to identify these are effective for the purpose they were created.

This procedure must focus in monitoring the effectiveness of process established in the verification, as well as the food safety controls.

A schedule must be established with details of each verification activity, the frequency and the person responsible for each of them. Records must be maintained; developing a control chart, in order to show that validation activities have actually been developed.

If required, the services of an accredited lab with the ISO/IEC-17025 regulation in the parameters requested must be used, e.g., to validate the cleaning and sanitation processes and the analysis results of water resources.

1.10.3 Microbiological sampling plan

During the course of production, harvest, packaging, storage and distribution of produce and fruits, samples must be taken from soil, water, end product, live contact surfaces (hands of workers) and inert surfaces (bands, tools, containers, etc.); these samples should be analyzed to address the specifications and intervals, according to the laws and compliance criteria of the Eleven Rivers Certification Scheme.

A scheduled plan of sampling for areas and activities must be documented, and use the services of an accredited lab with the ISO/IEC-17025 regulation; as well as keeping records of inspections, tests and analysis performed.