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.
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
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
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 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 is 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)
7. RETAINED DOCUMENTED INFORMATION
7.1 Change Management Request(QMS F 013)
7.12Change Log(QMS F 014)