init/tracex_v07/controlled-docs/[ONBTEMP-1] Procedure Template/[ONBSOP-001] Change Management Procedure/[ONBWI-001] Manage a change.md

class, title, template, author, owner, abstract, reviewers, approvers, changeControl

class	title	template	author	owner	abstract	reviewers	approvers	changeControl
documents:class:ControlledDocument	Manage a change	../../[ONBTEMP-1] Procedure Template.md	${creatorName@global}	${creatorName@global}	This Work Instruction provides detailed step-by-step guidance on how to manage a change according to the Change Management Procedure.	${creatorName@global}	${creatorName@global}	description Initial document creation

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Scope

This Work Instruction (WI) provides detailed step-by-step guidance for implementing the Change Management Procedure. It applies to all personnel involved in initiating, documenting, reviewing, approving, and implementing changes to controlled documents, processes, or product specifications.

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Process Flowchart

The following flowchart illustrates the change management process:

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Glossary

Term	Definition
Change Request	A formal proposal to modify a document or process
Impact Assessment	Evaluation of the potential effects of a change
CR Form	Change Request Form used to document proposed changes

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Responsibilities

Role	Responsibility
Change Owner	Completes CR Form and follows up on implementation
QA Reviewer	Performs impact assessment from quality perspective
Technical Lead	Evaluates technical feasibility and implementation
Change Committee	Reviews and makes final approval decision on changes

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Procedure

1. Completing the Change Request Form

1.1. Access the Change Request Form template in TraceX.

1.2. Complete all required fields:

• Change description (be specific and detailed)
• Reason for change
• Systems, documents, or processes affected
• Proposed implementation date
• Your contact information

1.3. Attach supporting documentation as needed (e.g., marked-up documents).

1.4. Submit the form for review.

2. Conducting Impact Assessment

2.1. Quality Assessment:

• Identify any regulatory impacts
• Document compliance considerations
• Evaluate validation requirements

2.2. Technical Assessment:

• Evaluate feasibility of implementation
• Document resource requirements
• Identify potential risks and mitigations

2.3. Documentation:

• Complete the Impact Assessment section of the CR Form
• Recommend approval or rejection with justification
• Sign and date the assessment

3. Obtaining Approval

3.1. Submit completed CR Form with impact assessments to Change Committee.

3.2. Schedule change review meeting if required.

3.3. Present change proposal to stakeholders.

3.4. Document all feedback and decisions.

3.5. Obtain final signatures from all required approvers.

4. Implementing the Change

4.1. Update all affected documents with appropriate revision control.

4.2. Communicate changes to all affected personnel.

4.3. Provide training if required.

4.4. Implement the change according to the approved plan.

4.5. Document evidence of implementation.

5. Closing the Change

5.1. Verify all implementation steps are complete.

5.2. Collect and file all documentation.

5.3. Complete the closure section of the CR Form.

5.4. Obtain final QA verification signature.

5.5. Archive the completed change request.