Quality Management System Workflow

Owned by Robert Alexander Marshall
Last updated: Feb 06, 2024
5 min read

Quality Management System (QMS) workflow

A compliance review focussed workflow that has four states.

  • Documents start in Draft, transition to In Approval and then Approved

  • The fourth state Obsolete is used to indicate that the document is retired - no new versions are expected

  • This workflow uses an e-signature process (user email and one-time password authorization) for each approval

  • Users or group of users that are allowed to approve the In Approval state content can be restricted. This list is configured at space level, by the space administrators and the workflow will assign these reviewers

  • Assigned reviewers receive an email notification on the workflow transition to the In Approval state

Comala Document Control workflows



Workflow States

This workflow is ideal for teams that need to demonstrate compliance with guidelines, rules, or standards. This could include ISO standards, FDA regulations, or even internal corporate standards. The workflow utilizes multiple states.


Workflow State

Description

Workflow State

Description

Draft

  • if no one has been assigned to review the document then any user can give approval or rejection

  • if someone (with Confluence edit permission) has assigned reviewers then only those specifically assigned users can approve or reject

  • all reviewers will be prompted to enter their email and One-time Password (OTP) to complete their approval/rejection (see OTP and e-signatures)

  • if all reviewers provide their approval, then the state transitions to In Approval

  • if all reviewers reject, then the state transitions to Obsolete

In Approval

  • space admins set reviewers that are required to approve the content review by adding user and/or group values to workflow parameters in the space tools Document Control dashboard

  • reviewers assigned by the workflow from the user and/or group workflow parameter values must undertake the review

  • workflow assigned reviewers can only be removed from the content review by editing the workflow parameter values

  • all assigned reviewers are required to undertake and agree on the content review decision for the workflow to transition

  • users who are not assigned as reviewers will not be able to access the workflow popup

  • all reviewers will be prompted to enter their email and One-time Password (OTP) to complete their approval/rejection (see OTP and e-signatures)

  • if all reviewers provide their approval, then the state transitions to In Approval

  • if all reviewers reject, then the state transitions to Obsolete

  • any update on the document transitions it back to the Draft state (updated transition)

Assigned reviewers are emailed when the state changes to In Approval. These notifications are created by the workflow on the transition into the state.

Published

  • this is the final state

  • any update on the document transitions it back to the Draft state (updated transition)

Obsolete

  • the content of the document is obsolete

  • any update on the document transitions it back to the Draft state (updated transition)

Adding or removing a label or attachment does not action the updated transition when the content is in the In Approval, Obsolete or Published state. The updated transition only occurs if the content is edited and published (changing the Confluence page version).

E-signature in the Quality Management System workflow

All the approvals in this workflow (in the Draft , the In Approval and the Published state) require users who have been assigned to the content review to use their email and a one-time password (OTP) to confirm their identity when registering an approval.

Approvals (content reviews) are disabled in the workflow popup until the email and a token are entered.

Reviewers are prompted to setup a personal code when they first visit a page in the content review state and access the workflow popup.

As a reviewer, to be able to electronically sign for Document Approvals you will need:

  • your mobile device with a 2 Factor Authentication (2FA) app

  • your email address that you use to login to Confluence

This setup only needs to be undertaken by a user once in each instance. However, the 2FA app tokens are time-limited.

You need to use a time-based token generated by the authentication app each time you approve a page that requires an e-signature approval.

Entering the email address and token activates the approval buttons for the reviewer. These are validated when the Approve or Reject decision is made by the reviewer for the content review.

Set approvers using space parameters

The Quality Management System workflow automatically assigns reviewers to the content review in the In Approval state.

A space admin can set the list of users or groups as controlled document approvers for the content review by choosing Set Parameters in the space document control dashboard.

Add users and/or user groups as parameter values to the dialog box.

The parameter values are the users assigned as reviewers by the workflow for the In Approval state review.

These reviewers undertake the final approval for the documents before reaching the workflow final end state Published.

The individual users listed (and/or users who are members of a listed group) are automatically assigned to the approval on transition to the In Approval state.

All assigned reviewers must undertake the content review and agree to Approve or Reject the content for the workflow to transition.

Workflow assigned reviewers are changed by editing the workflow parameters in the space tools Document Control dashboard. New values for the reviewers are used on the next transition to the In Approval state.

If the Quality Management System workflow is applied to a single document as apage workflow the users to be assigned to the review in the In Approval state are added as document parameters.

  • these values are set when initially adding the workflow

  • they can be amended using the Manage Page Parameters option in the page tools menu