Or. Admin. Code § 603-029-2635 - Record Review And Maintenance

(1) Process records. Charts from temperature/time recording devices must be identified by production date, container code, processing vessel number or other designation, and other data as necessary to enable correlation with the records required in OAR 603-029-2630. Each entry on a record must be made at the time the specific event occurs, and the recording individual must sign or initial each record form. No later than 1 working day after the actual process, the state-inspected establishment must review all processing and production records to ensure completeness and to determine if all product received the process schedule. All records, including the temperature/time recorder charts and critical factor control records, must be signed or initialed and dated by the person conducting the review. All processing and production records required in this OAR 603-029-2600 to 603-029-2655 must be made available to the Department for review.

(2) Automated process monitoring and recordkeeping. Automated process monitoring and recordkeeping systems must be designed and operated in a manner that will ensure compliance with the applicable requirements of OAR 603-029-2630.

(3) Container closure records. Written records of all container closure examinations must specify the container code, the date and time of container closure examination, the measurement(s) obtained, and any corrective actions taken. Records must be signed or initialed by the container closure technician and must be reviewed and signed by the state-inspected establishment within 1 working day after the actual production to ensure that the records are complete and that the closing operations have been properly controlled. All container closure examination records required in this subpart must be made available to the Department for review.

(4) Distribution of product. Records must be maintained by the establishment identifying initial distribution of the finished product to facilitate, if necessary, the segregation of specific production lots that may have been contaminated or are otherwise unsound for their intended use.

(5) Retention of records. Copies of all processing and production records required in OAR 603-029-2630 must be retained for no less than 1 year at the establishment, and for an additional 2 years at the state-inspected establishment or other location from which the records can be made available to the Department within 3 working days.

Notes

Or. Admin. Code § 603-029-2635

DOA 19-2022, adopt filed 07/27/2022, effective 7/28/2022

Statutory/Other Authority: ORS 603.085, ORS 619.042 & ORS 619.046

Statutes/Other Implemented: ORS 619.042, ORS 619.046, ORS 603.055, ORS 619.026 & ORS 619.036