La. Admin. Code tit. 51 § VII-1113

Current through Register Vol. 50, No. 11, November 20, 2024

Section VII-1113 - Verification and Validation

A. Every dairy plant shall verify that the hazard analysis and critical control point (HACCP) system is being implemented according to design:

1. verification activities shall include:

a. the calibration of CCP process-monitoring instruments, (pasteurization tests, thermometers, etc.) and instruments/equipment used to monitor PPs;

b. a review, including signing and dating, by an individual who has been trained in accordance with the training requirements contained in this Part, of the records that document:

i. the monitoring of CCPs. The purpose of the monitoring of CCPs review shall be, at a minimum, to ensure that the records are complete and to verify that the records document values that are within the critical limits. This review shall occur at a frequency that is appropriate to the importance of the record and as specified in the HACCP plan;

ii. the taking of corrective actions. The purpose of corrective actions review shall be, at a minimum, to ensure that the records are complete and to verify that appropriate corrective actions were taken in accordance with the corrective action requirements of §1111 of this Part. This review shall occur at a frequency that is appropriate to the importance of the record. A centralized deviation log is required; and

iii. the calibrating of any process monitoring instruments used at CCPs and the performance of any periodic end-product or in-process testing that is part of the dairy plant, receiving station or transfer station's verification activities. The purpose of the calibrating of any process monitoring instruments used at CCPs and the performance of any periodic end-product or in-process testing that is part of the dairy plant reviews shall be, at a minimum, to ensure that the records are complete and that these activities occurred in accordance with the dairy plant written procedures. These reviews shall occur within a reasonable time after the records are made;

c. the taking of corrective action procedures whenever any verification procedure establishes the need to take a corrective action;

2. the calibration of CCP process-monitoring instruments, and the performance of any periodic end-product and in-process testing shall be documented in records that are subject to the record keeping requirements in this Part.

B. Validation of the HACCP Plan. Every dairy plant shall validate that the HACCP plan is adequate to control hazards that are reasonably likely to occur. This validation shall occur at least once within 12 months after implementation and at least annually thereafter or whenever any changes in the process occur that could affect the hazard analysis or alter the HACCP plan and prerequisite program.

1. Such changes may include raw materials or source of raw materials; product formulation; processing methods or systems, including computers and their software; packaging; finished product distribution systems; or the intended use or intended consumers of the finished product. Consumer complaints may also reveal a need for validation.

2. The validation shall be performed by a qualified individual(s) and shall be subject to the record keeping requirements of §1115 of this Part. The HACCP plan shall be modified immediately whenever a validation reveals that the plan is no longer adequate to fully meet the requirements of this Part.

C. Validation of the hazard analysis. Whenever a dairy plant has no HACCP plan because a hazard analysis has revealed no hazards that are reasonably likely to occur, the dairy plant shall reassess the adequacy of the hazard analysis whenever there are any changes in the process that could reasonably affect whether a hazard exists.

1. Such changes may include raw materials; product formulation; processing methods or systems, including computers and their software; packaging; finished product distribution systems; or the intended use or intended consumers of the finished product and consumer complaints.

2. The validation shall be performed by a qualified individual(s) trained in accordance with the training requirements of this Part.

La. Admin. Code tit. 51, § VII-1113

Promulgated by the Department of Health and Hospitals, Office of Public Health, LR 37:2689 (September 2011).

AUTHORITY NOTE: Promulgated in accordance with the provisions of R.S. 40:4(A)(1)(a). Also see R.S. 40:5(2)(3)(5)(7)(15)(17) and R.S. 40:922.