User's guide /

Change control

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General Information

General Information:

The Change Control Module streamlines the management of change requests, ensuring compliance with both internal and regulatory standards. It automates the review, approval, and execution of changes, guiding the process through multiple sections with automatic notifications.

1. User Roles and Responsibilities

The module assigns specific responsibilities to different roles:

  • Employees
  • QA Specialist
  • QA Manager
  • Quality Director
  • Health and Safety Specialist
  • Change Control Committee (CCC)

Each role contributes to the process at various stages.

2. Process Overview

Section 1: Initial Request

  • Employees initiate the change request and submit it for Quality Approval.
  • QA Specialists review the request, complete the "Impact Assessment," and lock Section 1, which automatically generates Section 2.

Section 2: Manager Review

  • Department managers receive notifications to comment on the impact of the change.
  • Once both managers submit their comments, QA Specialists introduce reviewers and move the request to the approval stage.
  • If any reviewer rejects the change, the request is marked as Rejected and the process ends. If fully approved, the system notifies the Quality Director and Health and Safety Specialist to complete evaluations on regulatory needs and environmental impact.
  • After these evaluations, Section 2 locks automatically, and Section 3 is generated.

Section 3: Quality Director Review

  • The QA Director reviews the change, classifies it, and decides if further review by the Change Control Committee (CCC) is necessary.
  • If CCC review is required, Section 6 is created; otherwise, Section 4 is automatically generated.

Section 4: Effectiveness Evaluation Requirement

  • QA Director determines whether a performance evaluation is needed. If necessary, Section 11 is also generated.
  • Upon locking this section, Section 7 is automatically created to proceed with final approvals.

Section 5: Task Management

  • Tasks related to the change can be added or edited until Section 7 is confirmed. After that, the task plan is finalized and cannot be changed.

Section 6: Change Control Committee (CCC) Review

  • If triggered in Section 3, Section 6 involves an in-depth review by the CCC. Committee members approve or reject the change request.
  • Once decisions are finalized, Section 6 locks, and approval or rejection notifications are sent to relevant parties.

Section 7: Final Department Approval

  • Quality Director reviews all tasks and approves or rejects the plan.
  • Upon approval, the system locks the plan, generates a project tied to the change request, and creates Section 9 for task execution.

Section 9: Task Execution

  • Tasks must be completed and closed before the change request moves to the approval step.
  • Once all tasks are completed, QA Specialists or QA Managers have the option to approve, reject, or request additional tasks.
  • If approved, Section 10 is created.

Section 10: Change Finalization

  • The Quality Director reviews the final implementation of the change and either approves or rejects it.
  • If Section 11 (Effectiveness Evaluation) was triggered in Section 4, it must also be completed before final approval.
  • Upon approval, the system updates the request as Completed, closing the process.

Section 11: Effectiveness Evaluation

  • If triggered, QA Specialists review the effectiveness of the change and approve or reject the evaluation.
  • A rejected evaluation marks the request as Rejected, while approval completes the process.

3. Notifications and Audit Trail

Automated notifications are triggered at each critical stage, ensuring continuous communication among involved parties. An audit trail logs all actions, providing full traceability throughout the change lifecycle.