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Workflow Template

Quality Change Control Workflow

Manages a controlled quality change from initial request through quality review, risk-based approval (quality reviewer for low risk, quality manager for high risk), implementation with training if required, verification, and closure, with rejection returning the change to the requester with reasons and notifications to the requester at approval and closure.

Quality changes often stall because approvals are unclear and risk levels get treated the same way regardless of impact. This workflow manages a quality change from initial request through review, risk-based approval, implementation, verification, and closure, routing low-risk changes to a quality reviewer and high-risk changes to a quality manager. Quality teams and requesters run it directly inside assess.one, with notifications keeping requesters informed at approval and closure.

Business Outcomes

  • Helps reduce approval delays by routing changes based on risk level automatically
  • Supports clearer audit trails with recorded rejection reasons and status history
  • Makes it easier to keep requesters informed at every key decision point
  • Designed to improve consistency between low-risk and high-risk change handling
  • Helps teams close out changes faster with built-in verification steps

Workflow Steps

Steps

  1. 1
    Create Change Request Recordcreate record

    Registers the submitted change request as a record.

  2. 2
    Set Status to Submittedupdate record

    Marks the change request as submitted.

  3. 3
    Quality Review of Changecreate task

    Quality reviews the change, determines validation/testing needs, and confirms risk level.

  4. 4
    Set Status to Pending Approvalupdate record

    Updates the record status once quality review is complete.

  5. 5
    Route Approval by Risk Level

    Routes low-risk changes to the quality reviewer and high-risk changes to the quality manager.

    risk_level: "Low"Quality Reviewer Approval
    risk_level: "High"Quality Manager Approval
    DefaultQuality Manager Approval
  6. 6
    Quality Reviewer Approvalrequest approval

    Quality reviewer approves or rejects the low-risk change.

  7. 7
    Route Reviewer Approval Outcome

    Branches on the quality reviewer's approval decision.

    approval_status: "approved"Set Status to Approved
    approval_status: "rejected"Record Rejection Reason
    DefaultEnd
  8. 8
    Quality Manager Approvalrequest approval

    Quality manager approves or rejects the high-risk change.

  9. 9
    Route Manager Approval Outcome

    Branches on the quality manager's approval decision.

    approval_status: "approved"Set Status to Approved
    approval_status: "rejected"Record Rejection Reason
    DefaultEnd
  10. 10
    Record Rejection Reasonupdate record

    Sets the record status to rejected.

  11. 11
    Notify Requester of Rejectionsend email

    Informs the requester that the change was rejected and returns it for revision.

  12. 12
    Restart for Revisionrestart from step

    Restarts the workflow from quality review to allow revision and resubmission.

  13. 13
    Set Status to Approvedupdate record

    Updates the record status to approved.

  14. 14
    Notify Requester of Approvalsend email

    Informs the requester that the change has been approved.

  15. 15
    Implement Changecreate task

    Implements the approved change, including any required training.

  16. 16
    Set Status to Implementedupdate record

    Updates the record status to implemented.

  17. 17
    Verify Implementation Completecreate task

    Quality verifies the change was implemented correctly and training completed if required.

  18. 18
    Set Status to Closedupdate record

    Updates the record status to closed.

  19. 19
    Notify Requester of Closuresend email

    Informs the requester that the change has been implemented, verified, and closed.

  20. 20
    Set Status to Under Reviewupdate record

    Marks the change request as under review at the start of quality review.

Fields

  • Requester Name*
  • Requester Email*
  • Change Title*
  • Proposed Change Description*
  • Reason for Change*
  • Products Impacted*
  • +13 more fields

Forms

Quality Change Request Form

11 fields

Data Views

All Change Requests

change_request_ref, change_title, risk_level, change_status +1 more

Dashboard Widgets

Change Requests OverviewChanges by Risk LevelChange Control Pipeline

Recommended integrations

Setup the following integrations to extend workflow capability.

  • Send email in the workflow

    AWS SES logoAWS SES
quality change controlchange control processQMS change controlGMP change controlquality approval

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FAQs

How do I set up this workflow for our quality team?

Publish the Quality Change Control template inside assess.one and it's live immediately. You can then assign roles for requesters, quality reviewers, and quality managers, and the workflow is ready to run your first change request.

What do I need before I start using this workflow?

You need a list of who holds the quality reviewer and quality manager roles, since approvals route based on risk level. Beyond that, no extra setup or external system is required — the workflow runs entirely inside assess.one.

How long does implementation take?

Publishing the template takes minutes. Once it's live, your team can start submitting and processing quality change requests right away, with no separate implementation project needed.

How does the risk-based approval routing work?

When a change moves to pending approval, the workflow checks the assigned risk level. Low-risk changes route to a quality reviewer for sign-off, while high-risk changes route to a quality manager, so approval effort matches the level of risk involved.

What happens if a change is rejected?

The reviewer or manager records a rejection reason, and the requester is notified automatically. The change then returns to the requester for revision, so it can be updated and resubmitted rather than lost.

Who needs access to this workflow?

Requesters need access to submit and revise change requests, quality reviewers need access to approve low-risk changes, and quality managers need access for high-risk approvals. You can assign these roles directly in assess.one when you publish the template.

Can we customise the approval logic or steps?

Yes. You can adjust risk thresholds, add or remove approval steps, and change notification triggers directly inside assess.one without needing developer support. This makes it possible to tailor the workflow to your organisation's specific quality policies.

How is training handled when implementation requires it?

The implementation step in the workflow can include a training requirement before the change is marked implemented. This helps confirm that affected staff are prepared before the change moves toward verification and closure.

What happens at verification and closure?

After implementation, the workflow moves to a verification step to confirm the change was completed as approved. Once verified, the status is set to closed and the requester receives a closure notification, keeping the full change history in one place.

Does this workflow support compliance and audit needs?

The workflow tracks status changes, approval decisions, rejection reasons, and notifications throughout the change lifecycle. This creates a traceable record that can support internal audits and quality compliance reviews, though it's designed to complement your existing quality management system rather than replace it.

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Quality Change Control Workflow | assess.one