Example of Procedure for management of change

Uncategorized 3 Minutes

1.0 PURPOSE

The purpose of the procedure is to maintain a process for management of change (MOC).  XXX ensure that quality management system is maintained when changes to the quality management system are planned and implemented. The potential risks associated with the change and any required approvals prior to the introduction of such changes are identified and addressed.

2.0 SCOPE

This procedure is applicable to all the following systems and standards

  • ISO 29001: 2020/ API Spec Q1, 9th edition
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3.0 RESPONSIBILITY

  1. Management Representative
  2. Quality Systems Manager
  3. All concerned process heads

4.0 INPUT:

Management of Change note, Corrective actions report

5.0 RESOURCES

Competent Manpower, Computers, Printer & Internet connection, XXX Procedures          

6.0 DESCRIPTION

All members of the XXX, including Company, contractors and vendors are responsible for identification, communication and management of change. The changes that might affect quality of the product:

  1. Changes in the organizational structure,
  2. Changes in key or essential personnel,
  3. Changes in crucial suppliers,
  4. Changes to the management system procedures, including changes resulting from corrective and preventive action

It is important when reviewing a potential change, that each of the above ‘Key Areas’ is considered, as each one could be influenced by, and in turn affect, others. Also, the potential changes should be circulated around the company in an expeditious manner so that a positive and prompt response can be issued to the initiator of the change notice.

7.0 PROCEDURE

The early identification, communication of management of change are the responsibility of all members of XXX. The management of change review process is illustrated Figure 1. Once a potential change is identified, the initiator who can be an individual or department shall inform the MR and raise a management of change request form.

7.1 CHANGES TO PROCESSES

  1. 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
    • Customer requirements result in a need to change processes
    • Any other reason determined by management
  2. In such cases, the process must be changed in a controlled manner to ensure proper authorization and implementation of the changes.
  3. At a minimum, process changes shall include the steps herein:
    • The request for a process change shall be documented, in Management of change format XXX/MR/16. The justification for the change shall be recorded.
    • The change shall be reviewed by appropriate management, including the senior most manager responsible for the process. Changes must be approved prior to implementation.
    • The appropriate process will be updated to reflect the change. This document will undergo review and approval per the procedure of Control of Document
    • The follow-up verification step of the CAR process shall seek to ensure the change has had the intended effect, and/or has improved the process. If not, the change may be rolled back or a new change made to correct any new issues that arise as a result of the change.

7.2 CHANGES TO PROCESS OUTPUTS

  1. Where a process output is a document, the rules for changing documents above shall apply.
  2. 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 a 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.

7.3 CHANGES TO DOCUMENTATION

  1. Management system documents undergo changes when there is a need to revise them.
  2. Changes to documentation are done in accordance with the procedure of Control of Document

7.4 CHANGES TO ORDERS OR CONTRACTS

  • Changes to active orders or contracts may occur when the customer changes the requirements after the work has begun, or may be initiated by XXX when unforeseen circumstances are encountered.
  • When changes are initiated by the customer, the new requirements will undergo the same review and acceptance per the procedure for Contract review. If the changes cannot be accepted by XXX a satisfactory solution will be negotiated with the customer.
  • When changes are initiated by XXX the Machine shop Manager will notify the customer and negotiate a resolution.

7.0 OUTPUT:

Management of change form, training plan, related actions

8.0 KEY PERFORMANCE INDICATOR:

Management of change by taking actions.

9.0 ASSOCIATED DOCUMENTS & RECORDS

DESCRIPTIONFORMAT NUMBERRESPONSIBILITY
Record of Management of ChangeXXX / MR / 16MR

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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