Section 136. Verification and validation

A. Each person operating a milk plant, receiving station, or transfer station and participating in the voluntary HACCP program shall verify that the HACCP system is being implemented according to design, except that critical factors for aseptically processed and packaged grade A milk and milk products, as determined by the process authority and listed on the scheduled process under 21 CFR Part 113 shall be managed separately from the voluntary HACCP program, even if identified as a critical control point in the hazard analysis. Critical factors identified in the scheduled process shall be monitored under the operating supervision of an individual who has successfully completed an approved course of instruction in low-acid canned foods as required by 21 CFR 108.35.

B. Each person operating a milk plant, receiving station or transfer station and participating in the voluntary HACCP program shall include in their verification activities:

1. The calibration of critical control point process-monitoring instruments;

2. At the option of the person operating a milk plant, receiving station, or transfer station, the performance of periodic end-product or in-process testing;

3. A review, including signing and dating, by an individual who has been trained in accordance with the training requirements of this chapter, of the records that document:

a. The monitoring of critical control points;

b. The taking of corrective action; and

c. The calibrating of any process monitoring instruments used at critical control points and the performance of any periodic end-product or in-process testing that is part of HACCP plan verification activities;

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

5. The calibration of critical control point process-monitoring instruments, and the performance of any periodic end-product and in-process testing, in accordance with subdivisions 3 a and b of this subsection, shall be documented in records and maintained as required by this chapter.

C. Each person operating a milk plant, receiving station, or transfer station and participating in the voluntary HACCP program shall:

1. Validate that the HACCP plan is adequate to control hazards that are reasonably likely to occur at least once within 12 months after implementation of the HACCP system and annually thereafter or whenever any changes in the process occur that could affect the hazard analysis or alter the HACCP plan;

2. Ensure the validation is performed by a qualified individual or individuals trained in accordance with the requirements of this chapter;

3. Ensure the validation is documented and the records maintained as required by this chapter; and

4. Ensure the HACCP plan is modified immediately whenever a validation reveals that the HACCP plan is no longer adequate.

D. Whenever a milk plant, receiving station, or transfer station does not have a HACCP plan, because a hazard analysis has revealed no hazards that are reasonable likely to occur, the person operating the milk plant, receiving station, or transfer station and participating in the voluntary HACCP program shall reassess the adequacy of the hazard analysis whenever there are any changes in the process that could reasonably affect whether a hazard exists.

Historical Notes

Derived from Volume 23, Issue 20, eff. May 23, 2007; amended, Virginia Register Volume 31, Issue 12, eff. January 21, 2015.

Statutory Authority

§ 3.2-5206 of the Code of Virginia.