Product and process change management and control...

Introduction to Change Management: All products and all process will undergo change. The reason for the change may arise due to design change associated with the products, change in raw materials, change in technologies, change in regulatory requirements, change in test methods, change in work practices, process improvements, changes that improve environmental, health or safety compliance, etc., etc.. Regardless of the reason for change, it is essential that any change must be controlled and monitored to ensure continued:

 

Health and Safety compliance,

Quality & Reliability expectation achievement,

Regulatory compliance,

Environmental compliance,

Maintenance of cost & pricing targets,

Compliance with company strategy,

Operational performance expectations.

 

There are four fundamental stages associated with a change management process, from the original idea for a change, to the idea being agreed and correctly implemented, namely that the change be proposed, justified, impact assessed and approved.

Change Management

Change Management is one aspect of Quality Management. For full details … …



With change approval there needs to be defined and controlled change implementation and follow-up processes to ensure the change is effectively implemented and that the original objectives associated with the change are achieved. It is important, that the change should not introduce any unexpected impacts. The potential for any unforeseen impact needs to be considered via risk assessment of the change which should be an inherent activity within the change management process.

In summary the basis of change management and control are that change needs to be planned, the activities to be performed prior to implementation need to be identified and addressed, the change will then be implemented and finally there will be monitoring and assessment of the effectiveness of the change.

 

The Change Management Process.
A controlled change management process requires defined processes and procedures that explain how changes are created, reviewed, approved, implemented maintained, and monitored. There should be a requirement for the change originator to explicitly provide a clear statement on the proposed change and the rational behind it (who, what, when, where & why). The originator of the change needs to make an initial assessment and identification of the potential impacts associated with the change. The assessment should confirm that the change will not result in any unanticipated adverse impacts. The change originator needs to consider any potential regulatory impacts, or existing marketing authorizations. The individuals and functions which must input into and ultimately approve the change need to be identified. A schedule for implementation (e.g., training, retrieval of obsolete documents, posting of new documents, etc..) needs to be developed in conjunction with the change review and approval process.

 
MedicalDeviceValidation-small
Quality Assurance. Quality Management Systems. Change Management. Documentation, Supplier Quality. …
 

Change Management phases.
In the introduction previous , the stages associated with a change management and control process were identified as follows: Proposal, Justification, Impact Assessment and Approval. In addition Risk needs to be assessed throughout the change process, also implementation processes needed to be defined.

Change management can now be modified into the following four phases which encompasses all the previously outlined requirements. Namely:

“Plan”, “Perform”, “Implement” and “Check”.

 

The “Planning” stage involves:

Defining and documenting the problem to be addressed. Investigating, analyzing and documenting the cause. Describing the change. Identifying any affected documents and data. Establishing an action plan. Analyzing potential cost impact. Summarizing any verification and validation activities necessary. Establishing objectives & acceptance criteria associated with the proposed change. The risk assessment will be commenced with potential risks identified and initial risk ratings estimated.

The “Perform” stage involves:

Revising, adding and obsolescing specifications. The notification of any affected external parties. Acquiring raw and sample materials. The acquisition of equipment (where applicable). Running production trials. Process validation. Product verification. Staff training. Updating of product development and history files. The risk assessment will continue to be updated.

The “Implementation” stage involves:

Completion and release of new product or processes. Documenting the change. Recording of all change documentation. Again the risk assessment will continue to be updated.

The “Check” stage involves:

Confirmation that the original acceptance criteria have been met. Where the acceptance criteria have not been met, investigating the need for further change. Risk assessment updating.

Manufacturing Change Management

Product and Process Change Management is one aspect of Quality Management. For full details … …



Associated with a change management process will be defined change documentation. In all situations a change request, engineering change order, etc. , will need to be documented. The change order as it progresses through the change approval process will record all four phases associated with a change.

 

Change Management Risk Assessment >>>
Change Management Model >>>
Change Control Board >>>
 

Information & Training Presentation: Quality Management >>>
 

Five Why Problem Solving >>>
Risk Management Plan >>>
Quality Assurance Audit >>>
Manufacturing Quality Control >>>
Applying Risk Management to Quality Management >>>
Quality System Documentation in a digital era >>>
Cause and Effect >>>
Equipment Validation >>>
Validation Gap Analysis >>>
Manufacturing Validation and Quality Management >>>
Lean Business Model >>>
Quality and Competitiveness >>>
The Principles of Quality Management >>>