Information & Training. | Quality Assurance. Quality Management.

Change Management and Control – Model for Change Management.

Change management is about identifying a need for change, having clear objective(s), understanding the potential impacts associated with the change, obtaining agreement for the change, creating a plan of action, implementing and monitoring the change. All change be it minor or major follows a similar format.

The key elements of an effective and comprehensive change management model are as follows:

– Identify the need for a change (may be a problem to be solved, may be an opportunity for improvement, etc.)

– Define the desired outcome or objective. There should be a clearly defined goal associated with implementing a change.

– Define or estimate the expected time scale to achieve the end goals.

– Identify the resource requirements to achieve the goals, this includes, people, finances, materials, facilities, competencies, etc..

– Identify constraints, e.g. space, parallel commitments, regulatory requirements, etc..

– Gather the change team and create the vision.

The Principles of Quality Management
The Quality Manual
Quality Standards and Specifications
The Quality Management System
Revised requirements of ISO 9001: 2015
Design Quality – Products & Processes
Good Manufacturing Practice (GMP)
Documentation
CAPA – Corrective And Preventative Action
Calibration Certification
Change Management and Control
Quality Management Training
Product and Process Validation
Supplier Quality Assurance
Audits & Auditing
Ensuring the Quality Management System is Risk based
Etc. …. Etc. …. Etc. …
Information & Training presentation >>>

– Obtain input from potentially affected stakeholders.

– Commence the change process, communicate with stakeholders, create project plans, confirm resource availability, etc..

– Revisit time-line, resource, constraint estimates and revise into change plan.

– Identify change risks and develop an ongoing risk management plan.

– Continually communicate with stakeholders.

– As the change progresses, identify the critical change milestones.

– Understand the critical stakeholder inputs and plan accordingly to address.

– As the change comes close to implementation, ensure all requirements are being addressed, e.g. documentation updates, test completions, individual qualification sign-off’s, …

– When the change is approved, the process moves onto the change implementation stage.

– The change needs to be continually monitored to ensure the original goals are achieved and remain in place.

In developing a model for change, the are effectively four phases. The first phase is “preparing” for the change. In many change projects, the team tasked with implementing the change may be different to the individuals who have identified the need for the change. For example, in a manufacturing organization, the marketing function based on customer feedback may identify a need for an enhancement to a product. Those primarily tasked with designing and verifying the change request from the marketing function, may come from a technical product development group with input from the marketing personnel.

With the initial preparation phase completed, the change request will be broadly understood, the scope will be known, the extent of resource requirements will be known. The change now moves onto a second phase.

Here a change team is formally established. The change objectives are defined and documented. The potentially effected stakeholders are identified and communication commences with the critical stakeholders. The time-lines, resource requirements and constraints are revisited and further defined.

The change team now moves onto the implementation phase. A risk assessment if not already initiated is drafted and continually developed until change project completion. Detailed project plans and implementation schedules are drafted. The various requirements associated with the change are implemented. These may involve the drafting of revised operating procedures, performing test and validation protocols, the purchase of new equipment, the identification of training needs, etc.. As the various requirements are prepared the change will be subject to an “approval” or “sign-off” process. The approval process will involve competent individuals reviewing the proposed change to ensure the original objectives and all potential impacts have been considered and addressed, prior to implementing the change. Once approval is obtained the change can be implemented.

The final phase is monitoring the change to ensure objective achievement and to confirm that there have been no unforeseen consequences associated with implementing the change. Where problems are identified in terms of non-achievement of the original change objectives or in terms of unforeseen consequences, then the change team may need to revisit the change process and revert back to an earlier stage in the change process.

Information & Training. | Quality Assurance. Quality Management.

- - - The Principles of Quality Management
    - The Quality Manual
    - Quality Standards and Specifications
    - The Quality Management System
    - Revised requirements of ISO 9001: 2015
    - Design Quality – Products & Processes
    - Good Manufacturing Practice (GMP)
    - Documentation
    - CAPA – Corrective And Preventative Action
    - Calibration Certification
    - Change Management and Control
    - Quality Management Training
    - Product and Process Validation
    - Supplier Quality Assurance
    - Audits & Auditing
    - Ensuring the Quality Management System is Risk based
    - Etc. …. Etc. …. Etc. …
    - Information & Training presentation >>>