Certification, Recertification, and Audits of Irradiation Facilities. Domestic Irradiation Treatment Facilities

Transcription

1 Certification, Recertification, and Audits of Irradiation Facilities Domestic Irradiation Treatment Facilities

2 Certification Overview Prerequisites Plan Approval Site Visit

3 Certification Prerequisites Certified by Nuclear Regulatory Commission and/or state. State s support for APHIS irradiation treatment facility certification. International Trade, Export Markets Market Access for Commodities: Framework Equivalency Work Plan Trust Fund Established (if required) Operational Work Plan Commodity-Specific Addenda

4 Plan Approval Prior to the site visit, CPHST reviews the facility plans to verify requirements for certification are met Plans must be submitted using the Plan Approval Application for Irradiation Facilities

5 Plan Approval Application Checklist Facility Location Information License Information Irradiator Information Safety Information SOP Outline Personnel Information Dosimetry Information Facility Schematic Requirements Explanation of Missing Information

6 Plan Approval Application Worksheets Plan Approval Application All information must be submitted, in English Checklist to verify that all forms are completed Each form is described for clarification Fields for total pages and CPHST approval Signature of facility representative required

7 Plan Approval Application After the Plan Approval Application is complete, the facility must send it to CPHST, via local PPQ. After the review is complete, CPHST will send an approval or rejection letter through local PPQ.

8 Certification Site Inspection Staff from APHIS will visit the facility to verify that it meets all requirements. Inspection must take place when articles are available for treatment. Currently this aspect of facility certification is being reviewed.

9 Certification Site Inspection During the site visit: Verify the Plan Approval Application is correct and current Review all SOPs; Verify they re followed Quarantine measures and procedures review Segregation structures and article handling procedures Verify the dosimetry system is reporting accurately Monitor and approve dose mapping of process configurations

10 Certification Site Inspection During the site visit: Verify the high speed internet connection meets the requirements in the workplan. Data management procedures adequate for security & traceability Provide IRADS training to facility personnel who will enter treatment data.

11 Certification Site Inspection Verify the dosimetry system is reporting dose accurately All dosimetry systems used in APHIS programs must be traceable to NIST Irradiate NIST dosimeters alongside facility dosimeters (adjustment factor is calculated and applied during routine processing) NIST calibration of facility dosimeters (calibration curve is calculated and applied during routine processing)

12 Certification Site Inspection APHIS will monitor & approve dose mapping for all process configurations at the facility. Packaging Approval of components Configuration arrangement Insect-free packaging Commodity Article weights Box weights Configuration characteristics will be measured; specifications on these parameters will be set. Box type, stacking arrangement, target dose and other process specifications will be recorded.

13 Certification Site Inspection Monitoring dose mapping of process configurations Dose Mapping Place dosimeters throughout load Focusing on areas expected to receive high and low absorbed doses Includes a reference location, R f

14 Certification Site Inspection Monitoring & approving dose mapping of process configurations The process specifications developed during dose mapping must be followed during routine processing. These specifications may be verified by a PPQ officer as part of the monitoring program. Inspect dosimetry equipment and verify that personnel are proficient in the use of the equipment. Review dose mapping procedures and inspect dose mapping records.

15 Getting Ready for APHIS What should the facility do to prepare for the certification inspection? Test process configurations to be sure they meet the quality and volume goals of the facility, boxing and shipping requirements of the exporters, and APHIS dose requirements. Be sure there are enough dosimeters on hand to perform dose mapping work. Work with fruit suppliers to be sure fruit in the appropriate boxes is available

16 Getting Ready for APHIS What should the facility do to prepare for the certification inspection? Be sure SOPs are up to date; include phytosanitary irradiation SOPs Review data management procedures to be sure they meet APHIS requirements Review safeguarding measures to be sure the facility is secure from pests Train facility staff in PPQ requirements including safeguarding measures, release of products, data management and treatment requirements

17 IRADS Training Data entry for facility personnel Treatment review and certificate creation for APHIS officers (and NPPO preclearance officers information if required by the importing country)

18 Facility Recertification When is Recertification Necessary? Change in management of the facility Operational or structural changes at the facility Radiation producing source is replenished or reconfigured. APHIS or the NPPO determine problems with the treatment process exists Problems detected by preclearance officer or during audit Pest interceptions

19 Facility Audits On-site audit review: Treatment processes Dosimetry and dose mapping Safeguarding measures Record keeping Electronic audit review: Routine dosimetry data; checking for significant variation in dose Treatment failures

20 APHIS Certified Domestic Facilities Food Technology Service Inc. Sadex National Center for Electron Beam Research Gateway America Hawaii Facilities: Hawaii Pride, Pa ina Hawaii

21 ? Questions?