Issue no: 

02

Code: 

-- PRO-004

Approved By: 

Management Representative

PRO - Corrective and Preventive Action

System: LYRA (PVT) LIMITED Quality Management System

Table of Contents

• PRO - Corrective and Preventive Action
• Purpose
• Scope
• Related Documents
• Terms and Definitions
• Responsibilities
• Procedure
• General Considerations
• Process
• Records

Purpose

This procedure sets out the requirement for defining responsibility and authority for handling and investigating non-conformities. Taking action to mitigate any impacts caused, and for initiating and completing corrective and preventive action.

Scope

This procedure is to be followed by all employees whenever they initiate nonconformity, preventive or corrective action.

Related Documents

• ISO 9001:2008 Standards
• ISO 19011:2011 Standards
• ISO 9000:2005 Standards
• QMS Manual
• Corrective and Preventive Action Record
• CPA Log

Terms and Definitions

• Corrective Action: an action to eliminate the cause of a detected nonconformity.
• Nonconformity: non-fulfillment of a requirement.
• Opportunity: any situation that has potential to be a problem or an improvement.
• Preventive Action: an action to eliminate the cause of a potential problem or to address an improvement.
• QMS: Quality Management System.
• Root Cause Analysis: Root cause analysis is a method used to identify the immediate, underlying and root causes of an incident. The root causes are then used to recommend remedial action that will prevent incidents of a similar nature taking place in the future.

Responsibilities

Management is required to:

• Review summary of the Corrective and Preventive Action Records during the QMS review meeting.

Management Representative is required to:

• Establish and maintain a reporting and record keeping system for non-conformities, corrective and preventive actions.
• Prepare and issue the Corrective and Preventive Action Record on detection of nonconformity or an opportunity.
• Together with the responsible manager, develop and comply with all corrective and preventive actions prescribed within their scope of responsibility, subject to the demands of the service.

All employees are required to:

• Bring suspected non-conformities to the Management Representative .

Procedure

General Considerations

Non-conformities and opportunities can be identified through the following activities :

• Internal audit findings.
• Third party audit findings.
• Complaints (internal or external).
• Observation.
• Incidents.
• Housekeeping inspections.
• Checklist findings.
• Monitoring.
• Agencies Inspections.

Process

All Employees with the knowledge of nonconformity or an opportunity must:

• Immediately take action to correct or mitigate impacts.
• Immediately report the event to a Production Manager or Management Representative .
• Appropriate actions on CPA are jointly initiated by Management Representative CPA Task Record is updated at CompanyCertification® Compliance Management Solution (CC-CMS) in order to ensure that the underlying cause(s) of the nonconformity are investigated.
• Appropriate and timely corrective or preventive action must be taken according to the nature of the finding, such as implementing, modifying or enforcing procedures and controls to avoid the repetition of the nonconformity.
• Any corrective or preventive action taken to address the causes of finding must be appropriate to the magnitude of problems and commensurate with the impact encountered and documented.
• When preventive actions involve long term programming, these will be considered in the setting of objectives or targets.
• After determining the causes of the finding and the actions to take, as well as the deadline, the form and date of verification of the effectiveness of action taken will be defined, in order to ensure that the action has been adequate.
• 

Records