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.
This procedure is applicable to all the following systems and standards
- ISO 29001: 2020/ API Spec Q1, 9th edition
- API Spec …
- API Spec ….
- API Spec ….
- API Spec …..
- API Spec …..
- Management Representative
- Quality Systems Manager
- All concerned process heads
Management of Change note, Corrective actions report
Competent Manpower, Computers, Printer & Internet connection, XXX Procedures
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:
- Changes in the organizational structure,
- Changes in key or essential personnel,
- Changes in crucial suppliers,
- 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.
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
- 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
- In such cases, the process must be changed in a controlled manner to ensure proper authorization and implementation of the changes.
- 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
- Where a process output is a document, the rules for changing documents above shall apply.
- 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
- Management system documents undergo changes when there is a need to revise them.
- 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.
Management of change form, training plan, related actions
8.0 KEY PERFORMANCE INDICATOR:
Management of change by taking actions.
9.0 ASSOCIATED DOCUMENTS & RECORDS
|Record of Management of Change||XXX / MR / 16||MR|