Change Order Process Steps

The Process Steps page for change orders lists the controlled document associated with the change order and shows the process steps that must be completed to close the change order to release the controlled document.

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This page discusses:

Proposed Changes

Column Name Description
Title The name of the file associated with the controlled document.
Type The type of controlled document; for example, Quality System Document or Technical Document.
Name The controlled document associated with the change order.
State The current lifecycle state of the controlled document associated with the change order.
Rev The revision number of the controlled document associated with the change order.
Actions The actions that you can perform on the controlled document associated with the change order:

Icon Action Description
Subscription Options

View and select subscriptions for the controlled document. See Collaboration and Approvals User's Guide: Subscription Management.



Viewer Download the files attached to the controlled document to your local computer so that you can open them for viewing.
Download a copy of the file but keep it unlocked

Download the files attached to the controlled document to your local computer. Browse to the directory or folder in which you want to download the files.

If the controlled document has more than one file attached, the files are all added to a single ZIP file, which is downloaded to your local computer.

Download and lock the file, prohibiting others from editing it

Check out the native-format files attached to the controlled document to your local computer and lock the files for editing by other users who cannot unlock them. Navigate to the folder or directory you want to contain the files.

If the controlled document has multiple files attached, they are added to a single ZIP file, which is downloaded to your local computer.

Upload a new or additional file Checks in an updated native-format file to the controlled document from your local computer.

Change Information Links to the change order and change action associated with the controlled document.

Process Steps

The process steps for releasing a controlled document correspond to the controlled document's lifecycle states. In the step graph, each step circle has a step title and detailed information about that step. Click the caret to expand the view to see the step details. Click the caret again to collapse the view.

Process Step Process Step Description
1 Define Scope of Change Associate items, such as a controlled document, with the change order.
2 Perform Change Implementation Perform the implementation of the changes to the controlled document.
3 Change Implementation Perform the changes to the items for the controlled document.
4 Implementation Approval Approve the changes to the items for the controlled document.
5 Approve Change Order Approve the change order to indicate that the changes to the controlled document are acceptable and complete.
6 Close Change Order Close the change order to release the controlled document.

The completed process steps are shown in green. The active process steps are shown in blue. The process steps that are not yet available are shown in gray. The selected process step is shown with darker text and border. Each process step consists of several tasks that are optional or mandatory, and some that may be dependent on the completion of others. Complete all mandatory tasks for a process step before you can start the next process step.

An icon shows the status of each process step task:

Icon Process Step Task Status
The process step task is complete.
The process step task is optional, but not completed. You can work on this task, but you are not required to complete it to move to the next process step.
The process step task is mandatory and pending. You can begin working on this task, but you must complete it to move the next process step.
The process step flow is blocked by this incomplete mandatory or dependent task.

Process Step Column Name Description
1 Define Scope of Change Activities

and

Activity Type

The activities that can be completed for this process step and an indication of whether it is mandatory that they must be completed:

Activity Activity Type Description
Identify Change Implementation Mandatory Add an existing change action.
Define Scope & Description of the Change Mandatory Add a description of the change.
Specify the Severity of the Change Optional Specify a severity for the change.
Specify Change Implementation assignee Mandatory Specify the change implementation assignee.
Answer Impact Questionnaire

Only appears if there is an impact questionnaire associated with the change template from which the change order was created.

Optional Answer the questions in the impact questionnaire.
Add Approval List Mandatory Add an Approval List to the change order to define who must approve the changes before the change order can be closed.
Start Implementation Planning Mandatory Complete this task to activate the Implementation Planning process step.
You must complete the all of the mandatory tasks in Step 1 before you can start this task.

Actions

The actions that you can perform while completing this process step task:

Activity Icon Description
Identify Change Implementation Add an existing change action.
Define Scope & Description of the Change (Define Scope & Description of the Change) Enter a description of the change.
Specify the Severity of the Change (Specify the Severity of the Change) Select a severity from the list.
Specify Change Implementation assignee - Enter the change implemenation assignee.
Answer Impact Questionnaire

Only appears if there is an impact questionnaire associated with the change template from which the change order was created.

(Impact Questionnaire) Answer the questions in the impact questionnaire and submit it when complete. See Completing an Impact Questionnaire.
Add Approval List (Add Approval List) Search for and add a route template that has associated approvers. If the change order already has a route template associated with it, the Approval List field is automatically populated when you select it.
Start Implementation Planning (Promote) Promote the change order from the Prepare state to the In Work state.

Related Data

A link to other data that is relevant for or related to this process step task:

Activity Icon Description
Define Scope & Description of the Change (Change Order number) Opens the change order displaying the Content category.
Specify the Severity of the Change (Change Order number) Opens the change order displaying the Content category.
Specify Change Implementation assignee Opens the change action displaying the Properties tab.
Answer Impact Questionnaire

Only appears if there is an impact questionnaire associated with the change template from which the change order was created.

- -
Add Approval List (Change Order number) Opens the change order's Properties page to show the associated Approval List. See Change Management User's Guide: Change Order Properties Page.
Start Implementation Planning (Change Order number) Opens the change order displaying the Content category.

Owner The person assigned to complete this process step task. If the user has a profile image available, it displays before the name; otherwise, a default profile image displays. If the user has an email defined, click the user's profile image to send an email to the user using your default email client. The user's name and address are prefilled in the To: field and the task title is prefilled as the Subject: field of the email message.
Role The role of the person assigned to complete this process step task.
2 Perform Change Implementation Activities

and

Activity Type

The activities that can be completed for this process step and an indication of whether it is mandatory that they must be completed:

Activity Activity Type Description
Provide a Due date for Change Completion Optional Specify the date by which the change action should be completed so that the change can be implemented.
Configure Document Effectivity Settings Optional Set the controlled document's effectivity by selecting whether it will be made effective on a specific date or by a specified date.
Assign Change Implementation Approvers Optional Assign the individuals or a route task with an associated approval list to the change action to review and approve the change implementation.
Start Change Implementation Mandatory Start the change implementation process.

Actions

The actions that you can perform while completing this process step task:

Activity Icon Description
Provide a Due date for Change Completion (Edit Change Action) Select a Due Date for the change action associated with releasing the controlled document.
Configure Document Effectivity Settings (Document Effectivity) Select the Effectivity Type that determines whether the controlled document will be made effective on a specific date or by a specified date. Select the Implementation Type that determines whether the implementation will be by a specified date or a specified period, or will be the default period.
Assign Change Implementation Approvers (Edit Change Action) Search for and select people or route templates with an associated approval list to review and approve the change implementation.
Start Change Implementation (Promote) Progress the process so that the change implementation for the controlled document can begin.

Related Data

A link to other data that is relevant for or related to this process step task:

Activity Icon Description
Provide a Due date for Change Completion (Change Action number) Opens the change action's Properties page to show the associated Due Date. See Change Management User's Guide: Change Action Properties Page.
Configure Document Effectivity Settings (Document Effectivity) Open's the Structure View page to show the selected Effectivity Type and Implementation Type for the controlled document.
Assign Change Implementation Approvers (Change Action number) Opens the change action's Properties page to show the Approvers assigned to the peer review task for the controlled document. See Change Management User's Guide: Change Action Properties Page.
Start Change Implementation (Change Action number) Opens the change action's Properties page to show the associated Actual Start date for the implementation. See Change Management User's Guide: Change Action Properties Page.

Owner The person assigned to complete this process step task. If the user has a profile image available, it displays before the name; otherwise, a default profile image displays. If the user has an email defined, click the user's profile image to send an email to the user using your default email client. The user's name and address are prefilled in the To: field and the task title is prefilled as the Subject: field of the email message.
Role The role of the person assigned to complete this process step task.
3 Change Implementation Activities

and

Activity Type

The activities that can be completed for this process step and an indication of whether it is mandatory that they must be completed:

Activity Activity Type Description
Assign Change Implementation Approvers Mandatory Assign the individuals or a route task with an associated approval list to the change action to review and approve the change implementation.
Assign Content Reviewer for Controlled Document Optional Create a peer review and assign it to the person who will review the controlled document.
Start Document Approval Mandatory Promote the controlled document from the In Work state to the In Approval state to start the controlled document approval process.
You must complete the Assign Change Implementation Reviewers task before you can start this task.
Start Implementation Approval Mandatory Promote the change action from the In Work state to the In Approval state to start the implementation process for the controlled document.
You must complete the all of the mandatory tasks in Step 3 before you can start this task.

Actions

The actions that you can perform while completing this process step task:

Activity Icon Description
Assign Change Implementation Approvers (Edit Change Action) Search for and select people or route templates with an associated approval list to review and approve the change implementation.
Assign Content Reviewer for Controlled Document (View or Edit Peer Reviewers) Give the peer review a title. Select the date by which it should be completed. Search for and select the person to complete the peer review. Specify any instructions for the peer review. Select whether the assigned peer reviewer can delegate the task to another person. See Creating a Peer Review.
Start Document Approval (Promote) Promote the controlled document from the In Work state to the In Approval state.
Start Implementation Approval (Promote) Promote the change action from the In Work state to the In Approval state.

Related Data A link to other data that is relevant for or related to this process step task:

Activity Icon Description
Assign Change Implementation Approvers (Change Action number) Opens the change action's Properties page to show the Approvers assigned to the peer review task for the controlled document. See Change Management User's Guide: Change Action Properties Page.
Assign Content Reviewer for Controlled Document (Content Reviewers) Opens the Action Tasks page to show information about the peer review for the controlled document. See Tasks.
Start Document Approval (Controlled Document number) Opens the controlled document's Properties page to show that it is in the In Approval state. See Quality System Document Properties.
Start Implementation Approval (Change Action number) Opens the change action's Properties page to show that it is in the In Approval state. See Change Management User's Guide: Change Action Properties Page.

Owner The person assigned to complete this process step task. If the user has a profile image available, it displays before the name; otherwise, a default profile image displays. If the user has an email defined, click the user's profile image to send an email to the user using your default email client. The user's name and address are prefilled in the To: field and the task title is pre-filled as the Subject: field of the email message.
Role The role of the person assigned to complete this process step task.
4 Implementation Approval Activities

and

Activity Type

The activities that can be completed for this process step and an indication of whether it is mandatory that they must be completed:

Activity Activity Type Description
Submit Change Order Questionnaire

Only appears if there is a change questionnaire associated with the template from which the change order was created.

Mandatory Complete and submit the change order questionnaire.
Approval task to review changes done on Change Action: <Change action number>, entitled: <Change action title> Mandatory Approve or reject the changes specified on the change action.

Actions

The actions that you can perform while completing this process step task:

Activity Icon Description
Submit Change Order Questionnaire

Only appears if there is a change questionnaire associated with the template from which the change order was created.

(Submit Questionnaire) Complete and submit the change order questionnaire. See Responding to a Change Questionnaire.
Approval task to review changes done on Change Action: <Change action number>, entitled <Change action title> (Approve)
Note: Click Edit Details to provide comments on the changes before you approve the controlled document for release.

Enter your User Name and Password, then select the check box to provide your electronic signature for the review task approval.

(Reject)
Note: Click Edit Details to provide comments on the changes before you reject the controlled document for release.

Enter your User Name and Password, then select the check box to provide your electronic signature for the review task rejection.

(Edit Details) Click Edit Details to provide approval or rejection comments before you approve or reject the changes to the controlled document.

Completing this task promotes both the change order and the controlled document from the In Approval state to the Approved state.

Related Data A link to other data that is relevant for or related to this process step task:

Activity Icon Description
Submit Change Order Questionnaire

Only appears if there is a change questionnaire associated with the template from which the change order was created.

(Change Order Questionnaire) Opens the Questionnaire page to show the completed change questionnaire. See Questionnaire Tab for Responses.
Approval task to review changes done on Change Action: <Change action number>, entitled <Change action title> (Route Task Name) Opens the Tasks page to show the approval task and all other incomplete tasks associated with the controlled document's release. See Collaboration and Approvals User's Guide: Tasks Page for a Route.

Owner The person assigned to complete this process step task. If the user has a profile image available, it displays before the name; otherwise, a default profile image displays. If the user has an email defined, click the user's profile image to send an email to the user using your default email client. The user's name and address are prefilled in the To: field and the task title is prefilled as the Subject: field of the email message.
Role The role of the person assigned to complete this process step task.
5 Approve Change Order Activities

and

Activity Type

The activities that can be completed for this process step and an indication of whether it is mandatory that they must be completed:

Activity Activity Type Description
Complete Impact Questionnaire

Only appears if there is an impact questionnaire associated with the change template from which the change order was created.

Mandatory Complete the impact questionnaire if it was not completed in Step 1.
Approval Review Task Title Due Date:<Date> Mandatory Approve or reject the changes specified on the change order.

Actions

The actions that you can perform while completing this process step task:

Activity Icon Description
Complete Impact Questionnaire

Only appears if there is an impact questionnaire associated with the change template from which the change order was created.

(Impact Questionnaire) Complete the impact questionnaire associated with the change order. See Completing an Impact Questionnaire.
Approval Review Task Title Due Date:<Date> (Approve)
Note: Click Edit Details to provide comments on the changes before you approve the controlled document for release.

Enter your User Name and Password, then select the check box to provide your electronic signature for the review task approval.

(Reject)
Note: Click Edit Details to provide comments on the changes before you reject the controlled document for release.

Enter your User Name and Password, then select the check box to provide your electronic signature for the review task rejection.

(Edit Details) Click Edit Details to provide approval or rejection comments before you approve or reject the changes to the controlled document.

Completing this task promotes both the change order from the Approved state to the Complete state, but does not affect the state of the controlled document.

Related Data A link to other data that is relevant for or related to this process step task:

Activity Icon Description
Complete Impact Questionnaire

Only appears if there is an impact questionnaire associated with the change template from which the change order was created.

Impact Questionnaire Opens the Impact Questionnaires page to show the completed impact questionnaire. See Questionnaire Tab for Responses.
Approval Review Task Title Due Date:<Date> (Route Task Name) Opens the Tasks page to show the approval task and all other incomplete tasks associated with the controlled document's release. See Collaboration and Approvals User's Guide: Tasks Page for a Route.

Owner The person assigned to complete this process step task. If the user has a profile image available, it displays before the name; otherwise, a default profile image displays. If the user has an email defined, click the user's profile image to send an email to the user using your default email client. The user's name and address are prefilled in the To: field and the task title is prefilled as the Subject: field of the email message.
Role The role of the person assigned to complete this process step task.
6 Close Change Order Activities

and

Activity Type

The activities that can be completed for this process step and an indication of whether it is mandatory that they must be completed:

Activity Activity Type Description
Release Controlled Document Effective On Date: <Date>

or

Release Controlled Document Effective By Date: <Date>

Mandatory Implement the change to release the controlled document.

Actions

The actions that you can perform while completing this process step task:

Activity Icon Description
Release Controlled Document Effective On Date: <Date>

or

Release Controlled Document Effective By Date: <Date>

(Promote Document To Release) Promote the change order from the Complete state to the Implemented state, which promotes the controlled document from the Approved state to the Released state.
Note: This action is available only if the controlled document has its effectivity configured for a Effective By Date; otherwise, the controlled document will be automatically released on its Effective On Date.

Completing this task promotes the change order from the Complete state to the Implemented state, and the controlled document from the Approved state to the Released state.

Related Data A link to other data that is relevant for or related to this process step task:

Activity Icon Description
Release Controlled Document Effective On Date: <Date>

or

Release Controlled Document Effective By Date: <Date>

(Controlled Document number) Opens the controlled document's Properties page to show that it is in the Released state if its effectivity is configured for a Effective By Date; otherwise, it shows that the controlled document is still in the Approved state if its effectivity is configured for a Effective On Date, when it will be automatically released.

Owner The person assigned to complete this process step task. If the user has a profile image available, it displays before the name; otherwise, a default profile image displays. If the user has an email defined, click the user's profile image to send an email to the user using your default email client. The user's name and address are prefilled in the To: field and the task title is prefilled as the Subject: field of the email message.
Role The role of the person assigned to complete this process step task.