A procedure for Change Management

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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

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)

Published by Pretesh Biswas

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 effective management systems to a number of standards. He provide a unique blend of specialized knowledge, experience, tools and interactive skills to help you develop systems that not only get certified, but also contribute to the bottom line. He has taught literally hundreds of students over the past 5 years. He has experience in training at hundreds of organizations in several industry sectors. His training is unique in that which can be customized as to your management system and activities and deliver them at your facility. This greatly accelerates the learning curve and application of the knowledge acquired. He is now ex-Certification body lead auditor now working as consultancy auditor. He has performed hundreds of audits in several industry sectors. As consultancy auditor, he not just report findings, but provide value-added service in recommending appropriate solutions. Experience Consultancy: He has helped over 100 clients in a wide variety of industries achieve ISO 9001,14001,27001,20000, OHSAS 18001 and TS 16949 certification. Industries include automotive, metal stamping and screw machine, fabrication, machining, assembly, Forging electrostatic and chrome plating, heat-treating, coatings, glass, plastic and rubber products, electrical and electronic equipment, assemblies & components, batteries, computer hardware and software, printing, placement and Security help, warehousing and distribution, repair facilities, consumer credit counseling agencies, banks, call centers, etc. Training: He has delivered public and on-site quality management training to over 1000 students. Courses include ISO/TS -RAB approved Lead Auditor, Internal Auditing, Implementation, Documentation, as well as customized ISO/TS courses, PPAP, FMEA, APQP and Control Plans. Auditing: He has conducted over 100 third party registration and surveillance audits and dozens of gap, internal and pre-assessment audits to ISO/QS/TS Standards, in the manufacturing and service sectors. Other services: He has provided business planning, restructuring, asset management, systems and process streamlining services to a variety of manufacturing and service clients such as printing, plastics, automotive, transportation and custom brokerage, warehousing and distribution, electrical and electronics, trading, equipment leasing, etc. Education & professional certification: Pretesh Biswas has held IRCA certified Lead Auditor for ISO 9001,14001 and 27001. He holds a Bachelor of Engineering degree in Mechanical Engineering and is a MBA in Systems and Marketing. Prior to becoming a business consultant 6 years ago, he has worked in several portfolios such as Marketing, operations, production, Quality and customer care. He is also certified in Six Sigma Black belt .

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