PURPOSE: To ensure that any change in process, manpower, machinery,
instruments, technology, raw materials, suppliers, customer
requirements, legal requirements etc. are managed in a defined
and controlled manner such that the integrity of the quality
management system is not affected.
SCOPE: This covers all changes within the organization that has the
potential of impacting on the integrity of the quality management
system.
RESPONSIBILITY: The Plant Manager
REF: ISO 9001:2015 - Quality Management Systems Requirements
DEFINITIONS: - Change: An addition, modification, or removal of a configuration
item, service, service component, processes and/or it’s associated
elements.
CHANGE MANAGEMENT - FLOW CHART
Start
Identify change requirement
Initiate Request for Change
Conduct Risk Assessment
Is change request No
approved? Re-evaluate
Risk
Yes
Implement Change
Records
End
PROCEDURE DESCRIPTION:
STEP ACTION REFERENCE
1 IDENTIFY REQUIREMENT/NEED FOR CHANGE:
The following are changes that can occur in the ORGANIZATION’S NAME:
Change in the scope of the Quality Management system
Policy change
Product change (technology improvement, raw material change,
change in customer requirement etc.)
Process change (Quality Improvements and Productivity increase)
Procedure change (equipment changes, new equipment, Raw
material changes etc.)
Change in Employees (new positions, New recruitments,
resignations, Long leave etc.)
Change in Management (Mergers, take-overs etc.)
Changes in Requirements (customer requirements, code
requirements, Legal requirements, QMS requirements etc.,
In doing this, the following shall be taken into consideration:
the purpose of the changes and their potential consequences;
the integrity of the quality management system;
the availability of resources;
the allocation or reallocation of responsibilities and authorities.
2 PLAN FOR THE CHANGE
At a minimum, process changes shall include the steps herein:
The request for a process change shall be documented, typically in an
improvement memo. The justification for the change shall be recorded.
Appropriate risk assessment (basic risk assessment or full risk
assessment) shall be done.
The change and the result of the risk assessment shall be reviewed by
plant management, including the managers responsible for the process.
Changes must be approved prior to implementation.
The appropriate documents will be updated to reflect the change. This
document will undergo review and approval per the procedure
(Document Management Program).
The follow-up verification step of the CAR process shall seek to ensure
the change has achieved 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 may arise as a result of the change.
3 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 plant when unforeseen circumstances are encountered.
When changes are initiated by the customer, the new requirements will
undergo the same review and acceptance per the head office
procurement procedure. If the changes cannot be accepted by, a
satisfactory solution will be negotiated with the customer.
When changes are initiated by the Company, the procurement
department will notify the customer and negotiate a resolution.
4. CHANGE COMMUNICATION
Changed responsibilities shall be identified and communicated through out
the organization.
Changes in processes and procedures shall be communicated to all that will
implement the new processes and procedures and where necessary, training
shall be provided to such personnel.
5. MONITORING/REVIEW & REPORTING
All implemented changes shall be monitored to ensure that the
desired effect is achieved.
Result shall be reviewed and where gaps are noticed, corrective
action plan shall be developed to close out the identified gap.
Records of all the process shall be maintained.
TRAINING: Heads of Departments will take associates through the requirements of this
program and ensure that: - members of staff have basic understanding of
the content of this program and know what documents are available to
them.
CORRECTIVE In the event of any deficiency being identified in this program, the Plant
ACTION: Manager will ensure that corrective action is taken.
