Procedure Template Lifecycle & Stages Overview
  • 07 Feb 2024
  • 7 読む分

Procedure Template Lifecycle & Stages Overview


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記事の要約

Who can use this feature?
  🌐 ✔️ MES (v6.5.X, v7.X.X) ✔️ AWI (v6.5.X, v7.X.X) ✔️ LES (v6.5.X, v7.X.X)
  💻 Web app
  👤 Content Creator, System Admin, and procedure template co-author users


This article covers the following topics:

Procedure template lifecycle overview

Procedure templates within Tempo progress through various stages and versions as part of the procedure template lifecycle.

  • Each procedure template begins as a draft and progresses through five Stages: Draft, In Review, Pending Approval, Approved, and Effective.
  • Each procedure template begins as Version 1. Once a procedure template reaches the Effective stage, the current version of the procedure template is locked and cannot be sent back to draft or edited. At this point, a new version can be created as a draft and can progress through the same five stages.

To access a procedure template, click cloud Tempo > Procedures > Templates, then locate or create a procedure template.

Users can review a procedure template's current version and stage or take action on the procedure template by referencing the procedure template lifecycle quick reference card at the top right corner of the page.

6.5.201 Stages
The screenshot above is from 6.5.201; the user interface may display different tab names or other information depending upon your system version and the type of procedure template selected.

The procedure template lifecycle quick reference card displays the current version, stage, and next step for the procedure template. Each section of the card can be clicked to review additional information or take action.

EXAMPLE:

Clicking the stage (middle) section of the procedure template lifecycle quick reference card displays the Procedure Template Details page on the Stage & Users tab.
6.5.201 Procedure Template Details.png

This page can be dismissed by clicking the logout Dismiss icon.

Draft

Upon creation, each procedure template begins in the Draft stage. A procedure template must be in the Draft stage to be edited.

To submit a procedure template draft for review, complete the following steps:

  1. Click the Next Step (right) section of the procedure template lifecycle quick reference card. A Submit for Review popup displays.
  2. Select one or more groups or users to review the procedure template, then click Submit. Once the reviewer information has been submitted, the user(s) receive a procedure review request email, and the procedure template progresses to the In Review stage.
NOTE:

To expedite system testing outside of manufacturing or laboratory system use, the system allows the Review and approval is required for this procedure template configuration setting (more_horiz More Options > Template Configuation Settings) to be disabled. If this setting is disabled, a procedure template can progress directly from the Draft stage to the Effective stage.

In Review

When a procedure template is in the In Review stage, reviewers can review the procedure template within the iOS app or web app following an organization's internal review processes.

NOTE:

If the procedure template requires changes, a user can click the Status (center) section of the procedure template lifecycle quick reference card, then click Send back to Draft. This returns the procedure template to the Draft stage.

To submit a procedure template draft for approval, complete the following steps:

  1. Click the Status (center) section of the procedure template lifecycle quick reference card. The Stage & Users tab of the Procedure Template Details page displays.
  2. Provide a message and select all users responsible for approving the procedure template, then click Submit. Once the approver information has been submitted, each approver receives a procedure approval request email, and the procedure template progresses to the Pending Approval stage.

Pending Approval

When a procedure template is in the Pending Approval stage, approvers can review the procedure template within the iOS app or web app following an organization's internal approval processes.

NOTES:
  • If the procedure template requires changes, a user can click the Status (center) section of the procedure template lifecycle quick reference card, then click Send back to Draft. This returns the procedure template to the Draft stage.
  • If the list of assigned approvers requires change, a user can click the Status (center) section of the procedure template lifecycle quick reference card, then click Edit in the Required Approval Signatures section. This allows the user to remove or assign approvers.

To approve a procedure template, complete the following steps:

  1. Click the Status (center) section of the procedure template lifecycle quick reference card. The Stage & Users tab of the Procedure Template Details page displays.
  2. In the Required Approval Signatures section of the page, click Sign & Approve to the right of your name.
  3. Provide credentials and a comment, then click Submit.

All designated approvers must approve the procedure template. Once all approvers have approved the procedure template, the procedure template automatically progresses to the Approved stage.

Approved

When a procedure template is in the Approved stage, the procedure template can be locked and made effective. This makes the procedure template available for execution.

NOTE:

The Approved stage is the last stage that supports sending a procedure back to draft, if necessary.

If the procedure template requires changes, a user can click the Status (center) section of the procedure template lifecycle quick reference card, then click Send back to Draft. This returns the procedure template to the Draft stage.

To lock a procedure template and make it effective, complete the following steps:

  1. Click the Status (center) section of the procedure template lifecycle quick reference card. The Stage & Users tab of the Procedure Template Details page displays.
  2. Click Lock & Make Effective.
  3. Provide credentials and a comment, then click Submit. The procedure template progresses to the Effective stage.

Effective

When a procedure template is in the Effective stage, it can be assigned for execution or added to a batch template (for customers with the MES package).

To assign a procedure template for execution, complete the following steps:

  1. Click the Status (center) section of the procedure template lifecycle quick reference card. The Stage & Users tab of the Procedure Template Details page displays.
  2. Click Assign users to execute this procedure.
  3. Locate the groups or individuals to assign the procedure; check the checkbox to the right of each user to assign, then click Save. This automatically sends the procedure to that individual's execution interface (e.g., iOS app) to start or preview a procedure run.

Accessing in-Tempo review comments & rationale

Each organization defines their own internal collaboration and review processes.

Within a procedure template, each step supports the capture of stage-specific comments (stored on the step Comments tab) and a Draft-stage rationale (stored on the Compare Versions tab in v7.0+ and on the step Review tab in v6.5.X) that follows the procedure through to the Effective stage.

If a procedure template has available comments or rationale, the following icons display within the Augmented Steps page:

  • Comment: forum
  • Rationale: chat
EXAMPLE:

Step 2 in the screenshot below has two Comments and a Rationale. Step 1 does not have any Comments or Rationale.
6.5 comment and rationale icons

Comments

Comments can be reviewed by any users with access to a procedure template in the relevant stage.

EXAMPLE:

Clicking the step, then clicking the Comments tab displays any comments that have been added to this step and an interface to add an additional comment.

6.5.201 Approval Comments

After the procedure template progresses to a different stage, these comments are removed from the tab and can be referenced in the version revision history, if necessary.

Accessing the Version Revision History

Clicking the version (left) section of the procedure template lifecycle quick reference card displays the Procedure Template Details page on the Versions tab.
6.5.201 Version History

Comments provided on a previous status, as well as other revisions at the procedure template level, can be accessed by clicking View to the right of the relevant version.

Rationale

Rationale can only be added and edited during the Draft stage and is designed to explain what changed between the current version and previous version of the step. Rationale can be reviewed by any users with access to a procedure template.

EXAMPLE:

Clicking the step, then clicking the the Compare Versions tab in v7.0+ (or the step Review tab in v6.5.X) displays any rationale that has been added to this step. If the procedure is in a Draft stage, an interface to add a rationale (if none have been added) or edit the rationale (if a rationale has already been added) is available via the more_horiz More Options icon.

After the procedure template progresses to a different stage, the ability to edit the rationale is disabled. Any changes made to rationale during the Draft stage are tracked in the version revision history. (Additional information about accessing the version revision history is available in the Accessing the Version Revision History note above.)

Next steps


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