Who Is This For?
Authors / Process Owners – Draft the CR and define scope and tasks
Reviewers – Validate scope and completeness in the planning phase
Approvers – Authorize the plan before execution begins
QA / Administrators – Configure Change Types and gating behavior
Action Assignees – May be assigned during planning for later execution
How to Do It?
Step 1: Draft the Change Request
The Change Request (CR) remains editable while it is in the Draft state.
Check out the document — it will open in Microsoft Word (or another supported application).
Draft the document, including layout updates, content, and required details.
From the SimplerQMS add-in, select Check In to upload your latest version and save your changes. Then Save and Close the document.
📎 Reference: About SimplerQMS Word Add-In
Step 2: Manage Items to Change (Skip if no controlled items)
Define which controlled items will be affected by this change. If no controlled items are involved, you can skip this step.
Option 1: Add Controlled Items
Option 1: Add Controlled Items
Go to the Items to Change tab.
Click Update Items or Select Documents.
Locate the relevant items using search or sort by ID, Title, State, or Type.
Check the box next to each applicable item and click Save.
For each controlled item, select the appropriate Update Type to reflect the intended change (e.g. Update, Archive).
Option 2: Remove Controlled Items
Option 2: Remove Controlled Items
Go to the Items to Change tab.
Click Update Items or Select Documents.
Locate the relevant items using search or sorting.
Untick the box beside each item you want to remove.
Click Save.
Step 3: Manage Actions (Skip if not tracking tasks)
Break the work into trackable tasks and assign owners with due dates.
Create actions – Add CR Actions for each planned update or verification.
Assign and date – Set assignees and due dates so responsibilities are clear.
💡 Tip: Create one action per discrete deliverable (e.g., “Update SOP-1234 section 5”) to make status unambiguous.
📎 Reference: Managing CR Actions
Step 4: Manage Change Request Attachments (Skip if none)
Add or remove supporting files to ensure all relevant references are available. Download attachments for offline review if necessary.
📎 Reference: Managing Attachments
Step 5: Manage Related Items (Skip if none)
Add related documents, records, or processes to provide full context and traceability. This enhances visibility across all impacted items.
❗Compliance Reminder: Make sure that all linked items, attachments, and approvals follow your organization’s change control and document management procedures. Uncontrolled or incomplete records can lead to compliance risks during audits.
Step 6: Send the Change Request for Review (Planning Phase)
(Skip if no review is needed during the planning phase)
Once drafting and linking are complete, send the CR for Review. The review confirms the scope, accuracy, and compliance of the planned change.
📎 Reference: Reviewing a Change Request
Step 7: Send the Change Request for Approval (Planning Phase)
(Skip if no approval is needed during the planning phase)
After all reviews are completed, route the CR for Approval. Approval formally authorizes the planned changes before execution.
📎 Reference: Approving a Change Request
Tips
💡 Keep the Change Request in Draft until all content and related items are confirmed.
💡 Use clear titles and consistent tags to simplify tracking and reporting.
💡 Ensure all reviewers and approvers are correctly assigned early in the process.