---
kind: "section"
citation: "21 C.F.R. § 117.190"
title: "21"
number: "117.190"
heading: "Implementation records required for this subpart."
url: "https://uscodex.org/cfr/21/117.190"
---

# §117.190. Implementation records required for this subpart.

- (a) You must establish and maintain the following records documenting implementation of the food safety plan:
  - (1) Documentation, as required by [§ 117.136(b)](/cfr/21/117.136.md?p=b), of the basis for not establishing a preventive control in accordance with [§ 117.136(a)](/cfr/21/117.136.md?p=a);
  - (2) Records that document the monitoring of preventive controls;
  - (3) Records that document corrective actions;
  - (4) **Records that document verification, including, as applicable, those related to—**
    - (i) Validation;
    - (ii) Verification of monitoring;
    - (iii) Verification of corrective actions;
    - (iv) Calibration of process monitoring and verification instruments;
    - (v) Product testing;
    - (vi) Environmental monitoring;
    - (vii) Records review; and
    - (viii) Reanalysis;
  - (5) Records that document the supply-chain program; and
  - (6) Records that document applicable training for the preventive controls qualified individual and the qualified auditor.
- (b) The records that you must establish and maintain are subject to the requirements of subpart F of this part.

## Notes

### Authority

Authority: 21 U.S.C. 331, 342, 343, 350d note, 350g, 350g note, 371, 374; 42 U.S.C. 243, 264, 271.

### Source

Source: 80 FR 56145, Sept. 17, 2015, unless otherwise noted.