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Electronic Code of Federal Regulations

e-CFR data is current as of November 14, 2019

Title 21Chapter ISubchapter BPart 117Subpart C → §117.145


Title 21: Food and Drugs
PART 117—CURRENT GOOD MANUFACTURING PRACTICE, HAZARD ANALYSIS, AND RISK-BASED PREVENTIVE CONTROLS FOR HUMAN FOOD
Subpart C—Hazard Analysis and Risk-Based Preventive Controls


§117.145   Monitoring.

As appropriate to the nature of the preventive control and its role in the facility's food safety system:

(a) Written procedures. You must establish and implement written procedures, including the frequency with which they are to be performed, for monitoring the preventive control; and

(b) Monitoring. You must monitor the preventive controls with adequate frequency to provide assurance that they are consistently performed.

(c) Records. (1) Requirement to document monitoring. You must document the monitoring of preventive controls in accordance with this section in records that are subject to verification in accordance with §117.155(a)(2) and records review in accordance with §117.165(a)(4)(i).

(2) Exception records. (i) Records of refrigeration temperature during storage of food that requires time/temperature control to significantly minimize or prevent the growth of, or toxin production by, pathogens may be affirmative records demonstrating temperature is controlled or exception records demonstrating loss of temperature control.

(ii) Exception records may be adequate in circumstances other than monitoring of refrigeration temperature.

[80 FR 56145, Sept. 17, 2015, as amended at 81 FR 3716, Jan. 22, 2016]

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