THIS DOCUMENT IS A SAMPLE OF A CORRECTIVE AND PREVENTIVE ACTION PROCEDURE
USED AS PART OF AN ORGANIZATION’S QUALITY MANAGEMENT SYSTEM.
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Table of Contents
Purpose ......................................................................................................................................................... 1
Scope/Application ......................................................................................................................................... 1
Roles and Responsibilities ............................................................................................................................ 1
Procedure ...................................................................................................................................................... 1
Documentation .............................................................................................................................................. 3
References .................................................................................................................................................... 4
Definitions...................................................................................................................................................... 4
Purpose
The purpose of this procedure is to provide for a system and instructions, and to assign responsibilities
for initiating, requesting, implementing, and verifying the effectiveness of corrective and preventative
actions.
Scope/Application
This procedure applies to preventing and correcting nonconformities related to resources, components,
subassemblies, completed services, operational processes, and the quality system.
Roles and Responsibilities
List the titles of individuals responsible for specific tasks and describe their roles and responsibilities.
Roles – Title of
Responsible
Personnel
Responsibilities
Chief Operating Officer
(COO)
Approving and allocating company resources to
ensure all preventative and corrective actions,
when necessary, are carried out throughout
[COMPANY NAME].
Compliance Coordinator
(CC)
Authorization of CAR forms.
Review and approval of corrective and
preventative actions and implementation timelines.
Ensures action implementation and conducts
necessary follow-up reviews.
Director/Manager
Completing CAR forms when necessary.
Implementing corrective actions and
communicating changes to necessary external
bodies.
Procedure
1. Corrective actions
1.1. Corrective actions are implemented to address actual nonconformities.
1.1.1.Corrective action requests (CAR) may be proposed by any [COMPANY NAME] staff
member, but all CARs must be authorized by the Quality Department.
1.1.2.This is to prioritize and direct resources where corrective actions are most urgent.
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[COMPANY NAME] Standard Operating Procedures
January 15, 2013
1.2. CARs can be directed to [COMPANY NAME]’s internal departments as well as to its
subcontractors.
1.3. Corrective actions may be requested in the following cases:

Identification of a nonconforming process or work operation;

A nonconformity identified during a regulatory or third-party audit, or internal audit;

Customer or regulatory complaint;

Nonconforming operation delivery from a subcontractor;

Identification of any other component, device, process or condition that does not conform to
specifications, documented quality system, or requirements of the ISO 17024 or ANSI
Essential Elements or applicable regulations.
2. Preventative Actions
2.1. Preventative actions are implemented when there is an increased risk for a potential
nonconformity.
2.1.1.The need is identified on the basis of information regarding capability and performance of
processes and business operations, service and user feedback, customer complaints, and
effectiveness of the quality system.
2.2. Compliance coordinator is responsible for collecting, compiling and reviewing the pertinent
information, to include:

Service nonconformity reports;

Customer complaints; and

Quality system audit record.
2.3. Preventive actions are initiated when quality performance data indicates that there are trends of
decreasing quality capability and/or effectiveness of the quality system.
For example: increasing incidence of service nonconformities traceable to the same common
cause or increasing number of audit findings against the same quality system process or
department.
2.4. When a problem requiring preventive action is identified, the process of dealing with the problem
follows the same steps that apply to corrective actions, as described in this procedure in Section
3, Requesting and Processing CARs.
2.4.1.In subsequent processing stages both types of actions are referred to as corrective actions.
3. Requesting and processing CARs (applies also to preventative actions)
3.1. Corrective and preventive actions are requested using the CAR form.
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[COMPANY NAME] Standard Operating Procedures
January 15, 2013
3.1.1.The requests include description of the unsatisfactory condition that needs to be corrected
and are addressed to the director/manager responsible for the condition.
3.1.2.The same CAR form is also used to request corrective actions from [COMPANY NAME]’s
subcontractors.
3.2. Upon receiving a request for corrective action, the responsible director/manager investigates the
cause of the problem that initiated the request.
3.2.1.Responsible director/manager then proposes a corrective action to be taken, and indicates
the date by which the corrective action will be fully implemented.
3.2.1.1.
Corrective CAR forms that result from a nonconformance found during an audit
shall take priority and be resolved within 45 days of issuance.
3.2.1.2.
Preventative CAR forms that result from an audit will be resolved as soon as
possible with progress monitored every quarter during Quality Meetings (CC and
COO).
3.3. The causes of the nonconformity and the proposed corrective action are documented in the CAR
form.
3.4. The CAR form is then forwarded to CC for review and approval of the proposed action and
implementation timeline.
3.5. Any implemented changes are reviewed with respect to their impact on current documentation,
and the documentation is updated as appropriate. Documentation changes, if any, are recorded
in the CAR form and follow all Document Control Policies and Procedures.
3.6. On, or immediately after the due date for the implementation of the corrective action, the auditor
follows up with an inquiry or an audit to determine if the CAR has been implemented and
sufficiently effective.
3.6.1.Nonconformity reports are closed out by the auditor, only when there is objective evidence
that the corrective action is effective.
3.6.2.If more work/time is needed to fully implement the corrective action, then a new follow-up
date is agreed upon.
Documentation
1. The CAR form documents:

Request for corrective or preventative action;

Implementation of corrective/preventative actions; and

Any necessary follow-up actions.
1.1. CAR forms will be stored as a [COMPANY NAME] record; and be held for review and
maintenance.
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[COMPANY NAME] Standard Operating Procedures
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1.2. Data will be posted for staff to view, and be used during [COMPANY NAME]’s Internal Audit,
Management Review process and Quality Meeting reviews.
2. Documentation revisions will be logged into the Document’s History; and be subjected to all other
Document Control Policies and Procedures.
References
[COMPANY NAME]Quality Management Plan
Definitions
Nonconformity – is a deviation from a specification, a standard, or an expectation; or the nonfulfilment of
a requirement.
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