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ANNEX 2 - Checklist for facility approval

This annex is a prescriptive part of the standard. The following checklist is intended to assist persons inspecting or monitoring facilities seeking to establish/maintain facility approval and certification of irradiated commodities for international trade. The failure to receive an affirmative response to any item should result in the refusal to establish, or the termination of, an approval or certification.




1. Premises

Irradiation facility meets the approval of the NPPO as regards phytosanitary requirements. The NPPO has reasonable access to the facility and appropriate records as necessary to validate phytosanitary treatments

Facility buildings are designed and built to be suitable in size, materials, and placement of equipment to facilitate proper maintenance and operations for the lots to be treated

Appropriate means, integral to the facility design, are available to maintain non-irradiated consignments and/or lots separate from treated consignments and/or lots

Appropriate facilities are available for perishable commodities before and after treatment

Buildings, equipment, and other physical facilities are maintained in a sanitary condition and in repair sufficient to prevent contamination of the consignments and/or lots being treated

Effective measures are in place to prevent pests from being introduced into processing areas and to protect against the contamination or infestation of consignments and/or lots being stored or processed

Adequate measures are in place to handle breakage, spills, or the loss of lot integrity

Adequate systems are in place to dispose of commodities or consignments that are improperly treated or unsuitable for treatment

Adequate systems are in place to control non-compliant consignments and/or lots and when necessary to suspend facility approval

2. Personnel

The facility is adequately staffed with trained, competent personnel

Personnel are aware of requirements for the proper handling and treatment of commodities for phytosanitary purposes

3. Product handling, storage and segregation
Commodities are inspected upon receipt to ensure that they are suitable for irradiation treatment

Commodities are handled in an environment that does not increase the risk of contamination from physical, chemical or biological hazards

Commodities are appropriately stored and adequately identified. Procedures and facilities are in place to ensure the segregation of treated and untreated consignments and/or lots. There is a physical separation between incoming and outgoing holding areas where required

4. Irradiation treatment
Facility is able to perform required treatments in conformity with a scheduled process. A process control system is in place providing criteria to assess irradiation efficacy

Proper process parameters are established for each type of commodity or consignment to be treated. Written procedures have been submitted to the NPPO and are well known to appropriate treatment facility personnel

Absorbed dose delivered to each type of commodity is verified by proper dosimetric measurement practices using calibrated dosimetry. Dosimetry records are kept and made available to the NPPO as needed

5. Packaging and labeling
Commodity is packaged (if necessary) using materials suitable to the product and process

Treated consignments and/or lots are adequately identified or labelled (if required) and adequately documented

Each consignments and/or lot carries an identification number or other code to distinguish it from all other consignments and/or lots

6. Documentation
All records about each consignment and/or lot irradiated are retained at the facility for the period of time specified by relevant authorities and are available for inspection by the NPPO as needed

The NPPO has a written compliance agreement with the facility

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