Quality Management System QMS Workflow



Quality Management System QMS Workflow

Overview

The Quality Management Systems Workflow is a four-state compliance review-focused workflow. Reviewers are managed in the app space settings and automatically assigned to each approval.

  • documents start in Draft

    • transition to In Approval 

    • then transition to Approved

  • a 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 groups that are used to define users that are allowed to approve the In Approval state content are restricted

  • this list of users is configured at the space level by the space administrators

  • the users are added as a value for a workflow parameter

  • the workflow uses the workflow parameter values when assigning users as reviewers for the In Approval state approval

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

A Comala Document Management workflow can be applied to pages and/or blog posts.

 

Workflow states

This workflow is ideal for teams 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 page then any user can give approval or rejection

    • only one user approval decision is required if no users are assigned as a reviewer

  • if a user has assigned reviewers then only those specifically assigned users can approve or reject

    • user assigning the reviewers requires at least page edit permission

  • all reviewers are prompted to authenticate their identity to undertake and complete their approval/rejection decision

    • authentication requires user to enter their email and One-time Password (OTP) (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

All reviewers must have Confluence edit permission for the page.

In Approval

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

  • reviewers are automatically assigned by the workflow

    • users assigned are the user and/or group workflow parameter values

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

The users to be assigned as reviewers by the workflow are only changed by editing the workflow parameter values for the space before the workflow transitions to the In Approval state.

  • users who are not assigned as reviewers are not able to access the workflow popup approval buttons (these are disabled for these users)

  • all users assigned must undertake the review

  • all reviewers are 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

Assigned reviewers are emailed when the state changes to In Approval.

These custom email notifications created by a JSON trigger in the workflow.

Published

This is the final state in the workflow.

  • on the transition to this workflow state, the page is the final approved content

  • an update on the page (page edit) transitions the applied workflow back to the Draft state

Obsolete

The content of the page is considered as obsolete.

  • any update on the page transitions it back to the Draft state

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

E-signature in the QMS workflow

Both approvals in this workflow require users 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

  • the 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 from the OTP provider are time-limited.

The global administrator can configure the app use for the OTP provider and, if required, mandate that all users using an e-signature reset their user approval tokens.

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.

All the approvals in the workflow (in both the Draft and In Approval states) in the default workflow requires each reviewer to confirm their identity using their email and a third party generated token.

The added credentials enable the approval user decision buttons. However, the credentials are only validated when an approval decision is undertaken.

If the e-signature requirement is not required, the QMS workflow can be copied and the copy customized. The custom workflow is edited to configure the e-signature requirement for either or both approvals (or any other changes using workflow builder). This new custom workflow is enabled in your space.

Set approvers using space parameters

The QMS workflow automatically assigns reviewers to the content review in the In Approval state.

A space admin is able to set a list of users or groups as controlled document approvers for the content review by adding values using Edit Parameters option in the document management dashboard.

This setting cannot be changed per page and allows admins to manage who can give the final approval to the documents, before reaching the end state Published.

The parameter values are set by the space admin using the @ Parameters button option for the workflow in the space document management dashboard.

cdmc_qms_wf_enabled_documentmanagementdashboard_extract.png

The @ Parameters button option is only displayed when the current workflow has one or more parameters defined in the workflow and the workflow is enabled as the active space workflow in the space.

Choose the @ Parameters button to open the Parameters dialog box.

parametersbutton_dashboard_qms_wf_2parameters.png

Set the workflow parameter value(s) in the space using the Parameters dialog box.

Add one or more usernames to Document User Reviewers parameter and/or one or Confluence user groups to the Document Group Reviewers parameter. A workflow parameter value set in the dashboard is only retrieved by the workflow on a workflow event, for example, on creating a new page.

The individual users listed (and/or users who are members of a listed group) are automatically assigned to the approval in 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 to the destination state for the approval decision.

When the QMS workflow is applied to an individual page or blog post the users to be assigned to the review in the In Approval state are added as page parameters. They can be amended using the Manage Page Parameters option in the page tools menu.


Workflow custom email notification

The workflow includes a workflow trigger that listens for the change of the workflow state to the In Approval state.

On this change of state, a custom email notification is sent to each user assigned as a reviewer for the approval in the In Approval state.

The users who receive an email are

  • one or more users added as a value for the workflow parameter, Document User Reviewers

  • one or more users who are members of the Confluence user group(s) that are added as a value for the workflow parameter, Document Group Reviewers

At the time of the transition to the In Approval workflow state, the user(s) must be a value for one of the workflow parameters used to assign the reviewers.