1/18/2019 A procedure for Change Management – TRACE INTERNATIONAL

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A procedure for Change Management

preteshbiswas Uncategorized December 22, 2018December 22, 2018 2 Minutes

1. SCOPE

The purpose of this procedure is to define the methods for managing changes to processes and other
aspects of the management system in a controlled manner so as to maintain the integrity of the QMS
and the organization’s ability to continue to provide conforming products and services during the
change.

2. PURPOSE

This procedure applies to all the activities within the scope of the XXX Quality Management System.

3. REFERENCE DOCUMENTS

3.1 XXX Quality Manual,

4. TERMS & DEFINITIONS

CM- Change Management
R-Risk
O-Opportunity
SOP- Standard Operating System

5. RESPONSIBILITY AND AUTHORITY

The Management Representative (MR) and HOD’s of all departments are responsible for the effective
implementation of this procedure.

6. DETAILS OF PROCEDURE

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6.1. Properly planning a change by applying risk-based thinking can help to avoid negative
consequences such as rework or cancellation or postponement of service; it can also result in positive
consequences such as reduction of nonconforming outputs; or reduced incidents of human error

6.2 Management system processes will undergo changes, typically when:

Improvement opportunities have been identified, typically to improve process effectiveness.

Nonconformities within a process are identified and require corrective action.
Conditions in the industry or company change, requiring a process to be updated.
New processes are added which impact on existing processes, requiring changes.
Outsourcing important processes.
Persons in key roles leaving the organization.
Customer requirements result in a need to change processes.
Changes to active orders or contracts.
Any other reason determined by management.

6.3 In such cases, the process must be changed in a controlled manner to ensure proper authorization
and implementation of the changes.
6.4 Formal changes to process outputs will be used when the change is significant. Minor changes
may be made without formal control, however, the decision on what constitutes significant vs minor
change must be agreed upon by those involved in the change. If a customer indicates a change is
significant, this will trump any internal decision.
6.5 At a minimum, process changes shall include the steps herein:

The request for a process change shall be documented, typically in a Change Request. The
justification for the change shall be recorded.
Management shall evaluate the merits of the proposed change and determine the actions
necessary to address and implement the intended changes. Wherever it is deemed essential other
departments will be consulted about proposed changes. This may include discussions with
engineers, contractors, consultants, or other relevant parties before according approval for the
proposed change.

6.6 Before authorizing the implementation of changes, the following points shall be verified;

 All necessary technical, safety, security and environmental reviews are completed;
  Risks and consequences identified during the review processes are addressed to the utmost
satisfaction;
Proposed changes comply with regulatory and legal requirements;
Necessary approvals are obtained from the regulatory and/or legal authority wherever required;
All affected personnel are informed of the changes and adequately trained where necessary;
Documentation pertaining to changes and reviews are complete.

6.7 The change shall be reviewed by appropriate management, including the HOD responsible for the
process. Changes must be approved prior to implementation. CEO is authorized to approve the
implementation of proposed changes.
6.8 Upon implementation of change, MR shall verify the following.

Implemented changes are as intended;

Documentations are complete pertaining to changes;
Changes are communicated
Applicable regulatory and legal requirements are fulfilled;
Project Plan and Budget are amended

6.9 All Changes must be logged as per Change Log.(QMS F 014)

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7. RETAINED DOCUMENTED INFORMATION

7.1 Change Management Request(QMS F 013)

7.12Change Log(QMS F 014)

Published by preteshbiswas

Pretesh Biswas has wealth of qualifications and experience in providing results-oriented solutions for your
system development, training or auditing needs. He has helped dozens of organizations in implementing
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