901:11-3-08. Verification

(A) Every frozen dessert manufacturer shall verify that the HACCP plan is adequate to control food safety hazards that are reasonably likely to occur, and that the plan is being effectively implemented. Verification shall include, at a minimum:

(1) A reassessment of the adequacy of the HACCP plan whenever any changes occur that could affect the hazard analysis or alter the HACCP plan in any way or at least annually. Such changes may include changes in the following: Raw materials or source of raw materials, product formulation, processing methods or systems, finished product distribution systems, or the intended use or consumers of the finished product. The HACCP plan shall be modified immediately whenever a reassessment reveals that the plan is no longer adequate to fully meet the requirements of paragraph (C) of rule 901:11-3-06 of the Administrative Code.

(2) Ongoing verification activities including:

(a) A review of any consumer complaints that have been received by the processor to determine whether they relate to the performance of critical control points or reveal the existence of unidentified critical control points;

(b) The calibration of process-monitoring instruments; and,

(c) The performing of periodic end-product or in-process microbial testing.

(3) A review, including signing and dating, by a responsible individual of the records that document:

(a) The monitoring of critical control points. The purpose of this review shall be, at a minimum, to ensure that the records are complete and to verify that they document values that are within the critical limits. This review shall occur within one week of the day that the records are made;

(b) The taking of corrective actions. The purpose of this 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 rule 901:11-3-07 of the Administrative Code. This review shall occur within one week of the day that the records are made; and

(c) The calibrating of any process control instruments used at critical control points and the performing of any periodic end-product or in-process testing that is part of the frozen dessert manufacturer's verification activities. The purpose of these reviews shall be, at a minimum, to ensure that the records are complete, and that these activities occurred in accordance with the frozen dessert manufacturer's written procedures. These reviews shall occur within a reasonable time after the records are made.

(B) Frozen dessert manufacturers shall immediately follow the procedures in rule 901:11-3-07 of the Administrative Code whenever any verification procedure, including the review of a consumer complaint, reveals the need to take a corrective action.

(C) Whenever a frozen dessert manufacturer does not have a HACCP plan because a hazard analysis has revealed no food safety hazards that are reasonably likely to occur, the frozen dessert manufacturer shall reassess the adequacy of that hazard analysis whenever there are any changes that could reasonably affect whether a food safety hazard now exists. Such changes may include, but are not limited to changes in: Raw materials or source of raw materials, product formulation, processing methods or systems, finished product distribution systems, or the intended use or consumers of the finished product.

(D) The calibration of process-monitoring instruments, and the performing of any periodic end-product and in-process testing, in accordance with paragraphs (A)(2)(b) and (A)(2)(c) of this rule shall be documented in records that are subject to the recordkeeping requirements of rule 901:11-3-09 of the Administrative Code.

Five Year Review (FYR) Dates: 3/28/2018 and 03/28/2023
Promulgated Under: 119.03
Statutory Authority: 917.02
Rule Amplifies: 917.02
Prior Effective Dates: 09/20/2004, 06/06/2005, 10/15/2007

Prior History: (R.C. 119.032 review dates: 09/17/2012 and 09/17/2017
Promulgated Under: 119.03
Statutory Authority: 917.02
Rule Amplifies: 917.02
Prior Effective Dates: 9/20/04, 06/06/05 )