Corrective Action Procedure Example

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QUALITY SYSTEM

PROCEDURE

QP5

CORRECTIVE ACTION

[Your Company]

Signature Position Date

Prepared By

Reviewed By

Approved By

COMPANY PROPRIETARY INFORMATION

This document is an uncontrolled copy of a controlled document held by the Quality Management System. Prior to use, ensure this document is the most recent revision by checking the Master Document List. To request changes, submit a Document Change Request to the Document Control Representative.

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1. Introduction

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Purpose

The purpose of this procedure is to establish and define the process for identifying, documenting, analysing and implementing corrective actions in order to eliminate actual non-conformances.

2. Terms & Definitions

Corrective action is taken upon detection of a non-conformance to prevent it from

happening again; we act to ‘prevent’ a repeat of a detected non-conformance.

Preventive action is taken when we anticipate a potential problem and take action to

eliminate the possible causes and prevent the occurrence a non-conformance.

Non-conformance is taken to mean an observation or finding that indicates a policy or

practice is contrary to the requirements of ISO 9001 or the documented procedures. The following terms and definitions are taken from ISO 9000:2005:

Term Clause Definition

Document 3.7.2 Information and its supporting medium

Procedure 3.4.5 Specified way to carry out an activity or a process Quality Manual 3.7.4 Document specifying the QMS of an organization

Record 3.7.6 Document stating results or evidence of activities performed Specification 3.7.3 Document stating requirements

3. Application

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Scope

This procedure is applicable to all corrective actions related to non-conforming products, services and audit results.

This procedure works in conjunction with: Internal Audit Procedure QP3

Non-conformance Procedure QP4 Preventive Action Procedure QP6

Any corrective action taken to eliminate the causes of actual non-conformances will be appropriate to the magnitude of the problem whilst also being in proportion to the risks presented by the non-conformance.

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4. Requirements

4.1 Responsibility

Personnel & Process Owners are required to:

Highlight suspected non-conformances to their Line Manager/Supervisor Follow this procedure upon detection of a non-conformance

Quality Management Representative is required to: Ensure adherence to this procedure

Maintain a system for reporting and record keeping Determine the causes of non-conformances Top Management is required to:

Implement necessary actions to achieve resolution Review the effectiveness of corrective actions taken

5. Process

5.1 Review Non-conformances

Non-conformances or opportunities for improvement will be identified either by employees, customer complaints or by quality management system audit reports.

By whichever means a non-conformance is identified, the underlying cause(s) of the non-conformance will be investigated.

5.2 Determine Causes

Quality Management Representative will review any issues raised and complete a non-conformance report (Form F104.1) to identify root cause and level of action required.

Repeated non-conformances of the same nature or significant deviations from procedures or quality policy will be reported to Top Management Team for action and resolution.

5.3 Evaluate Need for Action

If corrective action is necessary then (Form F105.1) will be developed and appropriate personnel assigned tasks.

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5.4 Implement Action

Designated personnel must implement agreed level of action within agreed timescale.

Quality Management Representative will follow up all corrective actions to ensure effective and timely responses are achieved.

Quality Management Representative will close out the corrective action when satisfactory resolution has been achieved and when objective evidence of close out has been obtained through inquiry or audit.

Preventive action such as, implementing, modifying or enforcing procedures or controls will be taken to avoid repetition of the non-conformance where necessary.

5.5 Record the Results

Any changes to the quality management system of its procedures, as a result of corrective actions, will be recorded.

All documentation and records generated by the corrective action process will be managed in accordance with ISO 9001:2008 Clauses 4.2.3 & 4.2.4.

5.6 Management Review

A review of corrective actions will be undertaken by top management to verify the performance and effectiveness of corrective actions taken.

The Quality Management Representative and top management will determine if action taken could potentially improve other areas of the organization.

6. References

Quality Management Systems Manual Section 8.5.2 Internal Audit Procedure QP3

Internal Audit Report F103.4 Non-conformance Procedure QP4 Non-conformance Report F104.1 Non-conformance Report Log F104.1 Corrective Action Request F105.1 Corrective Action Request Log F105.2

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