Corrective Actions and Corrections Workflow

🔧

Corrective Actions and Corrections - Responding When a Preventive Control Fails

When a preventive control is not properly implemented, the facility must act. Under 21 CFR 117.150, a corrective action identifies and corrects the problem, reduces the likelihood of recurrence, evaluates all affected food for safety, and keeps affected food from commerce if it cannot be shown to be safe and properly labeled. A correction is a timely fix for a minor, isolated problem that does not directly affect product safety. This map follows the pathway from detection through classification, evaluation, documentation, and reanalysis.

21 CFR 117.150 · 117.155(a)(3) · 117.165(a)(4) · 117.170

21 CFR 117.150

FSMA Section 103

Affected Food

Corrective Action

Action taken when a preventive control is not properly implemented, to correct the problem, prevent recurrence, and evaluate affected food.

Basis: 21 CFR 117.150(a)

Correction

A timely fix for a minor and isolated problem that does not directly impact product safety, or for certain allergen and sanitation conditions.

Basis: 21 CFR 117.150(c)

Unanticipated Problem

A control with no corrective action procedure, a control or plan found ineffective, or a records review that finds failures.

Basis: 21 CFR 117.150(b)

Affected Food

All food potentially impacted by the problem, evaluated for safety and held from commerce if it cannot be shown safe and properly labeled.

Basis: Evaluation and disposition

Phase 1

Detection and Containment

1Detect and record the problem

A deviation, failed check, test result, or records review finding identified through monitoring or verification and recorded.

21 CFR 117.145 · 117.165

↓

2Contain the situation

The affected process is stopped or controlled, and potentially affected food is placed on hold.

21 CFR 117.150(a)(2)(iv)

↓

3Define the scope of affected food

Lots, time windows, lines, and equipment identified to establish which food could have been affected.

21 CFR 117.150(a)(2)(iii)

↓

4Involve the responsible personnel

The qualified individual and process owner engaged so decisions on food and the control are made by competent people.

21 CFR 117.180

Phase 2

Classification and Response

Is it a minor, isolated problem that does not directly impact product safety?

YES → Correction, timely fix NO → Corrective action procedure

↓

5Apply a correction where it fits

Conditions inconsistent with allergen or sanitation controls, or a minor isolated issue, fixed in a timely manner.

21 CFR 117.150(c)

↓

6Identify and correct the problem with the control

The actual problem with the preventive control found and fixed, not only its symptom.

21 CFR 117.150(a)(2)(i)

↓

7Reduce the likelihood of recurrence

Where necessary, action taken so the same problem is less likely to happen again.

21 CFR 117.150(a)(2)(ii)

Phase 3

Product Evaluation and Records

8Evaluate all affected food for safety

A documented evaluation of every lot and unit that may have been affected, using data and scientific judgment.

21 CFR 117.150(a)(2)(iii)

↓

9Decide disposition

Release, rework, divert, or destroy, with food kept from commerce if it cannot be shown not adulterated or misbranded.

21 CFR 117.150(a)(2)(iv)

↓

10Document the action

All corrective actions, and corrections when appropriate, recorded with the problem, evaluation, and decisions.

21 CFR 117.150(d)

Phase 4

Verification and Reanalysis

11Verify the action was effective

Corrective action records are subject to verification, confirming the problem was resolved and did not recur.

21 CFR 117.155(a)(3)

↓

12Review the records

Corrective action records reviewed to confirm complete records, activities performed as planned, and sound decisions.

21 CFR 117.165(a)(4)

↓

13Reanalyze the food safety plan when appropriate

If a control or the plan is found ineffective, the plan is reanalyzed to decide whether it must be modified.

21 CFR 117.150(b)(2) · 117.170

Triggers for Corrective Action (Overview)

Control Not Properly Implemented

A deviation from a parameter, a missed check, or any case where the preventive control did not operate as the plan requires.

21 CFR 117.150(a)

Positive Test Results

A pathogen or indicator organism found in a ready-to-eat product by product testing, or in the environment by environmental monitoring.

21 CFR 117.150(a)(1)

Ineffective Control or Review Findings

A control or the plan as a whole found ineffective, or a records review finding incomplete records, activities not performed, or inappropriate decisions.

21 CFR 117.150(b)(1)

Corrective Action Content (Overview)

Identify and correct the problem Appropriate action is taken to find and correct the problem with the preventive control.

Reduce the likelihood of recurrence When necessary, action is taken so that the problem is less likely to happen again.

Evaluate all affected food for safety Every unit that may have been impacted is evaluated, not only the unit that tested out of range.

Keep affected food from commerce Food is not released if the facility cannot ensure it is not adulterated or misbranded.

Key Corrective Action Outputs (Overview)

Written corrective action procedures Procedures for each preventive control, including for positive pathogen or indicator results.

Corrective action records The problem, the affected food, the evaluation, the decision, and the actions taken to correct and prevent.

Correction records Records of timely fixes, where appropriate, so the pattern of minor issues is visible.

Reanalysis record Documentation of whether the food safety plan needed to change after a failure.

Corrective Action Quality Elements

Prompt Detection Problems found through monitoring and verification close to when they occur, not at the next audit.

Rapid Containment Affected food held and the process controlled as soon as a problem is suspected.

Clear Classification Defined criteria for a correction versus a corrective action, applied consistently.

Root Cause Understanding The real reason the control failed is understood, not just the visible symptom.

Complete Scope All food that may have been affected is identified, by time, line, and lot.

Sound Product Evaluation Safety decisions made from data and competent judgment and written down with reasoning.

Effective Prevention Actions that reduce the chance of repeat failures and are confirmed to work.

Documentation and Review Complete records, reviewed on time, that show what happened and why decisions were made.

Never do this

Call a real deviation a correction to avoid the paperwork. Release product before evaluating it. Fix the symptom and skip the cause. Close a corrective action without checking it worked. Treat repeated corrections of the same problem as routine instead of a signal to reanalyze.

Correction vs corrective action

A correction is a timely fix for a minor, isolated problem that does not directly impact product safety, or for conditions inconsistent with certain allergen or sanitation controls. A corrective action is required when a preventive control is not properly implemented, and it includes evaluating affected food.

Unanticipated problems

If a control is not implemented and has no corrective action procedure, if a control or the plan is found ineffective, or if a records review finds failures, the facility must take corrective action and, when appropriate, reanalyze the plan.

Key regulations

21 CFR 117.150 - corrective actions and corrections. 21 CFR 117.135(c)(2)(i) and (c)(3)(i)-(ii) - allergen and sanitation controls covered by corrections. 21 CFR 117.155(a)(3) - verification of corrective action records. 21 CFR 117.165(a)(4) - records review. 21 CFR 117.170 - reanalysis.