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Change control

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Change Control Process

Change Control Process

The Change Control Process ensures that every change is systematically reviewed, approved, and implemented to maintain quality, safety, and compliance. Each section of the process represents a specific stage that involves different roles and responsibilities to ensure the change is properly managed. Below is a detailed breakdown of the sections involved in the Change Control Process.



Section 1: Initial Request

The change request process begins with a user in the role of Employees, who creates a new record in the Change Control module. The user is responsible for filling out Section 1: Change Request, where they describe the proposed change in detail, including the nature and rationale for the change. Once the form is completed, the user transitions the record to the "Awaiting Quality Approval" step.


Home screen > Change Control > Add.




Home screen > Change Control > Add.


Home screen > Change Control > Edit. Highlighted is status "Pending aporoval quality" which sends an automated notification to QA Specialists / Managers.

At this point, the system sends an automatic email notification to all users with the QA Specialist and QA Manager privilege, informing them that a new change request has been submitted and requires their review.

A user with QA Specialist / QA Manager privileges then opens the record and accesses the section titled “Review of Documents for Impact of Change”. The QA Specialist reviews the provided documentation and determines if the change will have any significant impact on the process or product. After reviewing, the QA Specialist locks the section by clicking the "Lock Section" button, which ensures that no further changes can be made to the section.


Home screen > Change Control > Edit. Highlighted are the fields that QA Specialists / QA Managers need to check.


Home screen > Change Control > Edit. Highlited is the button that locks the section. 

This locking action automatically generates Section 2, where the next stage of the review and approval process will take place. The QA Specialist's role here is crucial in validating that the initial request is properly documented and ready for further evaluation.


Home screen > Change Control > Edit. Highlighted is the section 2 submodule which is created (it can be seen by the counter of the records in submodules, which show one). 

  • Step 1: The user in the "Employees" role creates a new change control record in the system.
  • Step 2: The user fills out Section 1 with the details of the proposed change and submits the record by transitioning it to the "Awaiting Quality Approval" step.
  • Step 3: The system sends an email notification to all users with the QA Specialist privilege, notifying them of the new change request that requires review.
  • Step 4: A QA Specialist opens the record, reviews the change details in the section "Review of Documents for Impact of Change", and locks the section to complete the review.
  • Step 5: Upon locking, Section 2 is automatically generated, initiating the next phase of the process.


Section 2: Change Coordination

Upon the automatic creation of Section 2, the system immediately sends email notifications to both the manager of the initiating department and the manager of the department where the change will be applied. These managers are required to log into the system and submit their comments on the proposed change.

Once both managers have entered their comments, the system automatically sends notifications to users with the privileges of QA Specialist, QA Manager, and Quality Director. These users are prompted to access the record, review the change, and complete the Approval process in Section 2. During this phase, additional managers from other departments can also log in and provide their assessments on the impact of the change by navigating to Section 2 > Impact Assessment and entering their evaluations.

After the impact assessments from both managers are submitted, the QA Specialist must add the approvers in the Section 2 > Approvers field. At this point, the record is moved to the "For Approval" step, which automatically triggers email requests to all approvers, asking them to either approve or reject the change request.
Note: Approvers receive automated daily email notifications with all unresolved requests.

  • Approvers are required to either approve or reject the change request. If any approver rejects the request, the system moves the change record to the "Rejected" status, and the process ends.
  • If all approvers provide their approval, the record is updated to "Approved" status, and an automatic notification is sent to the Quality Director, Science and Development Manager, and Health and Safety Manager for further evaluations.

Once the Quality Director, Science and Development Manager, and Health and Safety Manager have completed their evaluations and entered their findings in the relevant fields, Section 2 is automatically locked. This action triggers the system to automatically create Section 3 for the next phase of the process.

The section can be unlocked or locked by users with the privileges of QA Specialist, QA Manager, and QA Director. This ensures that only authorized personnel can modify or lock the section as necessary.

  • Step 1: The system automatically generates Section 2 and sends email notifications to both the manager of the initiating department and the manager of the affected department.
  • Step 2: Both managers must enter their comments in the system.
  • Step 3: Once both managers have submitted their comments, the system sends notifications to QA Specialists, QA Managers, and the Quality Director, asking them to review the change and complete the approval process.
  • Step 4: QA Specialist enters approvers in Section 2 > Approvers and moves the record to the "For Approval" step.
  • Step 5: Approvers are notified by email to either approve or reject the request. The process ends if there is any rejection, and the record moves to the "Rejected" status.
  • Step 6: If all approvers approve the request, the system moves the record to the "Approved" status and notifies the Quality Director and the Health and Safety team for further evaluations.
  • Step 7: The Quality Director and Health and Safety team complete their assessments, after which Section 2 is automatically locked, triggering the creation of Section 3.


Section 3: Impact Assessment of the Change

Upon the automatic creation of Section 3, the system sends an email notification to users with the QA Director privilege, prompting them to review the section. The QA Director must log into the system, open the record, and complete the Impact Assessment of the Change, classifying the change based on its potential impact.

During this assessment, the QA Director also determines whether the change needs to be reviewed by the Change Control Committee (CCC). If a CCC review is required, the QA Director must activate the corresponding option in this section.

Once the QA Director completes the impact assessment and locks the section by clicking the "Lock Section" button, the system automatically creates Section 4 for the next phase of the process. Additionally, if the CCC Review option is activated, the system will also automatically generate Section 6 for the committee review.

The section can only be unlocked or locked by users with the QA Director privilege, ensuring that the section is properly managed and only qualified users have access to modify it.

  • Step 1: The system automatically generates Section 3 and sends email notifications to all users with QA Director privileges.
  • Step 2: The QA Director logs into the system, opens the record, and completes the Impact Assessment of the Change based on its effects and classification.
  • Step 3: The QA Director determines if the change needs to be reviewed by the Change Control Committee (CCC) and activates the corresponding option if required.
  • Step 4: Once the QA Director locks Section 3, the system automatically generates Section 4, and if the CCC option is activated, Section 6 is also generated.
  • Step 5: The QA Director has the exclusive ability to unlock or lock Section 3, ensuring that only authorized personnel can access or modify this part of the process.


Section 4: Change Effectiveness Assessment

Upon the automatic creation of Section 4, the system sends an email notification to users with the QA Director privilege, prompting them to complete the section. The QA Director must assess whether an Effectiveness Evaluation is required for the proposed change.

In this section, the QA Director reviews the impact of the change and determines whether it is necessary to conduct an evaluation of the change's effectiveness. The QA Director fills out the appropriate fields, deciding whether the evaluation is needed by toggling the "Effectiveness Evaluation Required" option.

If the QA Director determines that an effectiveness evaluation is necessary, the system automatically creates Section 11 for the effectiveness evaluation process. Once the fields in Section 4 are completed, the QA Director locks the section by clicking the "Lock Section" button.

Upon locking Section 4, the system automatically generates Section 7 to proceed with the next step of the change control process. If the effectiveness evaluation is required, Section 11 will also be created at the same time.

The section can only be unlocked or locked by users with the QA Director privilege, ensuring proper control and oversight of this critical step in the process.

  • Step 1: The system automatically generates Section 4 and sends email notifications to QA Director users.
  • Step 2: The QA Director logs into the system, reviews the change, and assesses whether an effectiveness evaluation is required, filling in the relevant fields in Section 4.
  • Step 3: The QA Director toggles the "Effectiveness Evaluation Required" option if necessary.
  • Step 4: Once the fields are filled, the QA Director locks the section, triggering the system to automatically create Section 7 for the next step.
  • Step 5: If an effectiveness evaluation is required, Section 11 is automatically generated alongside Section 7.
  • Step 6: The QA Director has exclusive control over unlocking and locking Section 4.


Section 5: Implementation Plan

Section 5 is the stage where tasks are added, edited, or removed as part of the implementation plan for the change request. These tasks can be modified continuously until Section 7 is confirmed. Once Section 7 is confirmed, the implementation plan becomes final and can no longer be altered.

The following roles have the authority to add, edit, or remove tasks in Section 5:

  • The Initiator of the change request
  • Users with the QA Specialist and QA Manager privileges
  • The Quality Director
  • The head of the department that initiated the change
  • The head of the department where the change will be applied

Each of the above users can access the change request record, open the Section 5 submodule, and manage the tasks within the implementation plan by adding, editing, or removing tasks as needed. This allows continuous refinement of the plan until it is finalized in Section 7.

Once Section 7 is confirmed, the implementation plan is locked, and no further changes can be made to the tasks. At this point, the tasks become final, and the plan must be executed according to the tasks defined in Section 5.

Task Management is a key part of the implementation phase, ensuring all necessary actions are outlined clearly and approved before execution begins.

There is no specific process for unlocking or locking Section 5, as it remains open for task modification until the confirmation of Section 7.

  • Step 1: Authorized users open Section 5 to add, edit, or remove tasks in the implementation plan.
  • Step 2: The tasks can be modified continuously until Section 7 is confirmed.
  • Step 3: Once Section 7 is confirmed, the plan is locked, and no further changes can be made to the tasks in Section 5.


Section 6: Change Control Committee (CCC) Review

Section 6 is automatically created if the "Change Control Committee Review" option is selected in Section 3. Once Section 6 is created, the system automatically adds the members of the Change Control Committee (CCC) to the "Committee Members" submodule and sends email notifications to all committee members, instructing them to organize a meeting to proceed with the change review process.

During the meeting, committee members must:

  • Open the change record in Section 6.
  • Review the proposed change.
  • Decide whether additional members should be added to the committee.
  • Move Section 6 to the "For Approval" step once the review is complete.

While Section 6 is in the review phase, committee members can fill out important fields such as "Meeting Date", "Resolution", and "Comments/Recommendations". If these fields are not completed before the approval, they can be updated later after reopening the section, if necessary.

Before the change request moves forward for approval, the system automatically checks if tasks have been added in Section 5. If no tasks are found, the system prevents the change request from moving to the approval stage until tasks are defined in Section 5.

Once all CCC members approve the change, Section 6 is automatically updated to either Approved or Rejected. The system sends notifications to the change request initiator and other relevant users. If the request is rejected, the process ends. If the request is approved, Section 6 is locked, and it can only be manually reopened for further comments or updates if needed.

Approval and Rejection Process:

  • CCC members move the section to the "For Approval" step after reviewing the change.
  • The system checks if tasks in Section 5 are complete; if not, the approval process cannot continue.
  • Upon approval by all members, Section 6 is automatically marked as Approved or Rejected.
  • A notification is sent to the initiator, CCC members, QA Specialists, and QA Managers regarding the outcome.
  • If the change is rejected, the process ends.
  • If the change is approved, Section 6 is locked and can only be manually reopened for comments or updates.

Locking and Unlocking Process: Section 6 can only be unlocked or locked by the Change Control Committee (CCC). Members of the CCC are also the only ones authorized to move the section into the "For Approval" stage. Additionally, only the CCC can assign temporary members to participate in the approval process if necessary.



Section 7: Change Request Approval

Upon the automatic creation of Section 7, the system sends an email notification to the Quality Director for approval. The Quality Director must enter a comment and choose either the "Approved" or "Rejected" step.

  • If the Quality Director selects "Rejected", the system marks the main change request as "Rejected", and the process is terminated.
  • If the Quality Director selects "Approved":
    • The system checks:
      • Whether tasks have been entered in Section 5. If no tasks are found, approval is not allowed.
      • Whether Change Control Committee (CCC) Review is required for this change request. If it is required, and it is not approved yet, approval is not allowed. 
    • If tasks are present, the system creates a project linked to the main change request, along with tasks related to both the project and the change request.
    • The plan in Section 5 can no longer be modified, and the tasks from the plan are marked as "In Progress".

Upon approval, the system automatically generates Section 9, which tracks the execution of the tasks created in Section 5.

Process of Locking/Unlocking: This process does not apply to Section 7.



Task Management

After the approval in Section 7, the system automatically generates tasks and assigns them to the respective responsible users. Each assignee receives an email notification regarding their assigned tasks.

Tracking Progress and Status Changes

Task owners can update the status of their tasks by logging their progress in the Comment field. They can change the status to "In Progress", "Pending", or "Testing" when the task is complete. Moving a task to "Testing" requires a mandatory comment and triggers an automatic email to QA Specialists and QA Managers for review.

  • "Assigned": Tasks are assigned to users who can begin execution.
  • "In Progress": The task is actively being worked on by the assigned user.
  • "Pending": Tasks that are blocked or waiting for dependencies are marked as pending.
  • "Testing": When a task is completed and marked as ready for testing. This status change requires a mandatory comment.

When tasks are moved to "Testing", an automatic notification is sent to QA Specialists and QA Managers for review. If the task is approved, the QA Specialist or QA Manager can transition the task to "Completed". If the task is deemed incomplete, it is moved back to the "Assigned" status, and the task owner is notified via email for rework.

Completion of All Tasks

Once all tasks are moved to "Completed", the system automatically sends Section 9 ("Task Execution") for approval, and the process continues from there.

Comment Submission

To post a comment, the user must fill out the Comment field and then click the Save button to log the comment. Each status change must include a comment to track task progress.



Section 9: Task Execution

Section 9 is automatically created after the approval of Section 7 and initially remains in the status "Awaiting Task Execution". During this phase, tasks created in Section 5 are actively worked on and tracked. Once all tasks are either Completed or Rejected but closed, the system automatically transitions Section 9 to the "For Approval" status and sends an automatic email notification to QA Specialists for approval.

At this stage, QA Specialists and QA Managers have the following three options:

  • Approve: The process moves forward to the next stage, and the system automatically generates Section 10.
  • Reject: The process is terminated, and the change request is marked as "Rejected".
  • Request Additional Tasks: The process loops back to Section 5, where new tasks can be added. The cycle repeats until all tasks are completed and approved, or the process is terminated.

If the option "Request Additional Tasks" is selected, the system automatically sends notifications to all users who have the ability to add tasks in Section 5. These include:

  • The Initiator of the change request
  • The Head of the Initiating Department
  • The Head of the Affected Department
  • QA Specialists
  • QA Managers
  • Quality Directors

New tasks are then entered into Section 5, and the process is monitored by QA Specialists, QA Managers, and the Quality Director. Once new tasks are confirmed by the Quality Director, Section 9 is updated to "Confirmed New Activities" status, and the system automatically generates these tasks within the Task Module.

After the newly created tasks are executed and closed, Section 9 transitions back to the "For Approval" step, and QA Specialists and QA Managers again have the three options: approve, reject, or request additional tasks. This cyclic process can repeat multiple times until all tasks are completed and approved, or the process is terminated with a rejection.

This cycle continues until a final decision is reached.

Process of Unlocking/Locking

This section does not involve any unlocking/locking mechanism.



Section 10: Change Finalization

Section 10 is automatically created after the approval of Section 9. At this point, the system sends an automatic email notification to the Quality Director for final approval.

The Quality Director opens Section 10, records a comment in the field "Remarks / Comments / Recommendations", and either approves or rejects the finalization of the change request:

  • Reject: The system updates the main record of the change request to "Rejected" and the process ends.
  • Approve: If Section 11 exists, which happens when the "Effectiveness Evaluation Required" button was activated in Section 4, the system sends Section 11 for approval to QA Specialists to inform them that an effectiveness evaluation of the change is required. Section 11 must then be approved or rejected based on documents verifying the effectiveness of the change in accordance with Section 4 when applicable. This is followed by reporting the completion of all planned activities and receiving feedback from the head of the department where the change was applied.

If Section 11 does not exist, the system updates the main record of the change request to "Completed" and the process is successfully finalized.



Section 11: Change Effectiveness Review

Section 11 is automatically created when Section 4 is locked, provided the "Effectiveness Evaluation Required" button was activated. After the approval of Section 10, the system sends an automatic notification to QA Specialists to inform them that an effectiveness evaluation of the change is required.

The QA Specialist can confirm the evaluation after entering the necessary information into all the activated fields:

  • Confirm: Once the QA Specialist confirms the evaluation, the main record of the change request is moved to the "Confirmed" status and the process is completed.