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Workflow Template

Quality Change Control Workflow

Manages the end-to-end lifecycle of a controlled quality change: intake, quality review and risk-based approval, validation/testing, implementation, verification, and closure, with status tracking and notifications throughout.

Quality change requests often stall because approvals, testing evidence, and sign-off status get scattered across emails and spreadsheets, making it hard to know where a change stands or prove what happened. This workflow takes a submitted change through quality review, risk-based approval by a quality reviewer or quality manager, validation and testing, implementation, and verification, with the requester notified by email at each key stage. Quality reviewers, quality managers, and change owners each act on their assigned tasks, and every decision, result, and status change is saved to the change record's timeline.

Business Outcomes

  • Faster turnaround on change requests with automatic routing by risk level
  • Clearer visibility into where every change sits, from submission to closure
  • Reduced manual chasing thanks to built-in requester notifications at each stage
  • More consistent handling of validation, implementation, and verification steps
  • A traceable record of reviews, approvals, and rework for each change

Workflow Steps

Steps

  1. 1
    Create Change Recordcreate record

    Registers the submitted change request as a record.

  2. 2
    Set Status to Submittedupdate record

    Sets the change status to Submitted.

  3. 3
    Send Acknowledgement Emailsend email

    Emails the requester an acknowledgement with their reference number.

  4. 4
    Set Status to Quality Reviewupdate record

    Sets the change status to Quality Review.

  5. 5
    Quality Reviewer: Review Changecreate task

    Quality reviewer assesses whether validation or testing is needed and records the plan, training and comments.

  6. 6
    Save Review Outcome to Recordupdate record

    Persists the quality reviewer's findings to the change record.

  7. 7
    Route by Risk Level

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

    risk_level: "Low"→Quality Reviewer Approval
    risk_level: "High"→Quality Manager Approval
    Default→Quality Reviewer Approval
  8. 8
    Quality Reviewer Approvalrequest approval

    Requests the quality reviewer's approval for this low-risk change.

  9. 9
    Route Quality Reviewer Approval Outcome

    Routes based on the quality reviewer's approval decision.

    approval_status: "approved"→Set Status to Implementing
    approval_status: "rejected"→Set Status to Rejected
    Default→End
  10. 10
    Quality Manager Approvalrequest approval

    Requests the quality manager's approval for this high-risk change.

  11. 11
    Route Quality Manager Approval Outcome

    Routes based on the quality manager's approval decision.

    approval_status: "approved"→Set Status to Implementing
    approval_status: "rejected"→Set Status to Rejected
    Default→End
  12. 12
    Set Status to Rejectedupdate record

    Sets the change status to Rejected.

  13. 13
    Send Rejection Emailsend email

    Emails the requester that the change was not approved.

  14. 14
    Set Status to Implementingupdate record

    Sets the change status to Implementing.

  15. 15
    Send Approval Emailsend email

    Emails the requester that the change has been approved.

  16. 16
    Route on Validation Needed

    Routes to a validation/testing task if it was determined to be needed.

    validation_needed: "Yes"→Quality: Perform Validation/Testing
    Default→Change Owner: Implement Change
  17. 17
    Quality: Perform Validation/Testingcreate task

    Quality performs the required validation or testing and records the results and report.

  18. 18
    Save Validation Results to Recordupdate record

    Persists the validation results and report to the change record.

  19. 19
    Change Owner: Implement Changecreate task

    Change owner implements the change, recording documents updated and confirming training completion.

  20. 20
    Save Implementation Details to Recordupdate record

    Persists the documents updated and training completion status to the change record.

  21. 21
    Quality Reviewer: Verify Implementationcreate task

    Quality reviewer verifies the implementation is complete and records notes.

  22. 22
    Save Verification Outcome to Recordupdate record

    Persists the verification outcome and notes to the change record.

  23. 23
    Route Verification Outcome

    Routes to closure if verified, or back to implementation for rework if not complete.

    verification_outcome: "Verified"→Set Status to Closed
    verification_outcome: "Not complete"→Loop Back to Implementation
    Default→End
  24. 24
    Loop Back to Implementationrestart from step

    Restarts the workflow from the implementation task since verification found the work not complete.

  25. 25
    Set Status to Closedupdate record

    Sets the change status to Closed.

  26. 26
    Send Closure Emailsend email

    Emails the requester that the change is closed.

Fields

Show all 21 fields

FormQuality Change Request Form

  • Requester Name*· Text
  • Requester Email*· Email
  • Change Title*· Text
  • Proposed Change*· Long text
  • Reason for Change*· Long text
  • Products Impacted· Long text
  • Processes Impacted· Long text
  • Documents Impacted· Long text
  • Risk Level*· Choice
  • Risk Assessment*· Long text

TaskQuality Reviewer: Review Change

  • Is validation or testing needed?*· Choice
  • Validation Plan· Long text
  • Training Needed· Long text
  • Reviewer Comments· Long text

TaskQuality: Perform Validation/Testing

  • Validation Results*· Long text
  • Validation Report*· File upload

TaskChange Owner: Implement Change

  • Documents Updated*· Long text
  • Training Complete· Checkbox

TaskQuality Reviewer: Verify Implementation

  • Verification Outcome*· Choice
  • Verification Notes· Long text

Other fields

  • Change Status· Choice
  • Requester Name*
  • Requester Email*
  • Change Title*
  • Proposed Change*
  • Reason for Change*
  • Products Impacted

Forms

Quality Change Request Form

10 fields

Data Views

Change Requests

change_title, risk_level, validation_needed, change_status

Dashboard Widgets

Changes by Status

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 team?

Publish the template in your workspace and it's ready to run immediately, no installation needed. You'll want to make sure your quality reviewer, quality manager, and change owner roles are assigned to the right team members so tasks and approvals land with the correct people.

How does the workflow decide who approves a change?

After the quality reviewer's initial assessment, the workflow checks the Risk Level entered on the request form. Low-risk changes route to the quality reviewer for approval, while high-risk changes route to the quality manager, so approval effort matches the level of risk.

What happens if a change is rejected?

If either the quality reviewer or the quality manager rejects the change, the status is set to Rejected and the requester automatically receives an email letting them know the change was not approved. The rejection decision and any comments are saved to the change record's timeline.

Is validation or testing always required?

No. During the quality review step, the reviewer records whether validation or testing is needed. The workflow then routes accordingly, only sending the change to the validation/testing task if that was marked as required.

What happens if verification finds the implementation isn't complete?

The quality reviewer records a Verification Outcome of Verified or Not complete, along with notes. If it's marked Not complete, the workflow loops back to the implementation task so the change owner can rework it before verification runs again.

Can we customise the steps or forms in this workflow?

Yes. You can describe the change you want in plain English, or edit the steps directly in the workflow editor. Earlier versions of the workflow are kept, so you can see what changed over time.

Do requesters need an account to submit or track a change?

No. Requesters submit changes through the public request form and respond to any emailed forms without ever needing to log in. They receive email updates at acknowledgement, approval or rejection, and closure.

Where is the information from each task stored?

Answers on tasks the workflow waits for, such as the quality review, validation results, implementation details, and verification outcome, are saved directly to the change record. This gives each change a full timeline of what was decided and recorded at every stage.

Can we track how many changes are open, in review, or closed?

Yes. Each change is a record with a reference number, a status such as Submitted, Quality Review, Implementing, or Closed, and a timeline of everything that happened. Table views and dashboards let you see records grouped by status across your workspace.

Does this workflow make us compliant with quality regulations?

The workflow tracks statuses, approvals, validation results, and verification notes on each record's timeline, which supports your documentation efforts. Each business should confirm its own regulatory obligations, since compliance depends on more than the workflow itself.

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Quality Change Control Workflow | assess.one