problem-solving

• Create a Problem Solving process from an existing Problem Solving process by saving the existing process as a new process, and then updating the required details. To investigate repetitive problems or similar problems, you can create a Problem Solving process from an existing one. You can choose which information you require from the existing Problem Solving process and use it in the new Problem Solving process.

• Create a new Problem Solving process.

Procedure

1. From Launcher, click Changes .

If this option is unavailable, search for it. You can pin it from the search results for future access.

2. To derive a Problem Solving process from an issue, do the following:

From the CHANGES folder, select and open the required issue that is the source of the Problem Solving process.

Choose More Commands

New Derive Change.

In the Derive Change panel, select Problem Solving.

By default, the Synopsis and Description fields are populated with the Synopsis and Description of the source issue. You can update these fields as per your requirements.

From the Category list, select the appropriate category.

From the Sub-Category list, select the appropriate subcategory.

Specify a proposed due date.

Some companies use a standard operating procedure where a Problem Solving process must be completed within a specific duration. This duration is based on the Priority of the Problem Solving process. When you derive a Problem Solving process from an issue, it is assigned a Priority of Medium by default. If your company has defined this standard operating procedure for you, you must specify a Proposed Due Date that is 45 days and earlier from the Creation Date of the Problem Solving process. Depending on the Priority of the Problem Solving process, set the Proposed Due Date as follows:

Priority

Duration assigned to Proposed Due Date

High

Proposed Due Date must be set to 30 days and earlier from the Creation Date

Medium

Proposed Due Date must be set to 45 days and earlier from the Creation Date

Low

Proposed Due Date must be set to 60 days and earlier from the Creation Date

After deriving the Problem Solving process, you can edit it to update the Priority as required. If you change the Priority, ensure that you specify the appropriate Proposed Due Date accordingly. Your administrator can configure the duration assigned to the Proposed Due Date as per the business requirements. If the Proposed Due Date is not automatically set to a duration based on the assigned Priority, the administrator has disabled this option for your company. Note The Proposed Due Date of the Problem Solving process must not be later than the Due Date of the assigned chapters, questions, subquestions, and quality actions.

To assign a workflow to the Problem Solving process, select the required workflow from the Workflow list. By default, the Problem Solving Process workflow is assigned to the process. You can choose to use this workflow, assign a different workflow, or remove a workflow from the process.

Do one of the following:

To continue editing later, click Derive. The Problem Solving process is created and displayed in edit mode. You can send it for resolution later.

To send it for resolution immediately, click Derive and Submit. The Problem Solving process is sent through the default workflow for resolution. Reviewers and approvers for the Problem Solving process may be automatically assigned depending on how your organization’s Problem Solving process workflow is configured.

Note You can also derive a Problem Solving process from the symptom defect of an issue.

3. To derive a Problem Solving process from another Problem Solving process, do the following:

From the CHANGES folder, select and open the source Problem Solving process.

Choose More Commands

New Derive Change.

In the Derive Change panel, select Problem Solving.

By default, the Synopsis and Description fields are populated with the Synopsis and Description of the source Problem Solving process. You can update these fields as per your requirements.

From the Category list, select the appropriate category.

From the Sub-Category list, select the appropriate subcategory.

Specify a proposed due date.

Some companies use a standard operating procedure where a Problem Solving process must be completed within a specific duration. This duration is based on the Priority of the Problem Solving process. When you derive a Problem Solving process from another Problem Solving process, it is assigned a Priority of Medium by default. If your company has defined this standard operating procedure for you, you must specify a Proposed Due Date that is 45 days and earlier from the Creation Date of the Problem Solving process. Depending on the Priority of the Problem Solving process, set the Problem Solving as follows:

Priority

Duration assigned to Proposed Due Date

High

Proposed Due Date must be set to 30 days and earlier from the Creation Date

Medium

Proposed Due Date must be set to 45 days and earlier from the Creation Date

Low

Proposed Due Date must be set to 60 days and earlier from the Creation Date

After deriving the Problem Solving process, you can edit it to update the Priority as required. If you change the Priority, ensure that you specify the appropriate Proposed Due Date accordingly. Your administrator can configure the duration assigned to the Proposed Due Date as per the business requirements. If the Proposed Due Date is not automatically set to a duration based on the assigned Priority, the administrator has disabled this option for your company. Note The Proposed Due Date of the Problem Solving process must not be later than the Due Date of the assigned chapters, questions, subquestions, and quality actions.

To assign a workflow to the Problem Solving process, select the required workflow from the Workflow list. By default, the Problem Solving Process workflow is assigned to the process. You can choose to use this workflow, assign a different workflow, or remove a workflow from the process.

To assign a root cause as the problem description defect of the derived Problem Solving process, do the following:

In the Defect section, click Add Defect . In the Add Defect panel, select the root cause, and click Add.

Do one of the following:

To continue editing later, click Derive. The Problem Solving process is created and displayed in edit mode. You can send it for resolution later.

To send it for resolution immediately, click Derive and Submit. The Problem Solving process is sent through the default workflow for resolution. Reviewers and approvers for the Problem Solving process may be automatically assigned depending on how your organization’s Problem Solving process workflow is configured.

Note When you derive a Problem Solving process from another Problem Solving process, the root cause of the source Problem Solving process is added as the problem description defect of the derived Problem Solving process.

You can view the source defect that is the root cause defect in the Derived From field.

In the source Problem Solving process, if you open the root cause defect, you can view the target defect in the Derived To field.

4. To create a Problem Solving process from an existing Problem Solving process, do the following:

From the CHANGES folder, select and open the Problem Solving process that you want to use as the source.

In the Overview tab, choose More Commands

New Save As.

In the Synopsis box, summarize the Problem Solving process.

In the Description box, describe the Problem Solving process.

If the Advanced Copy Options section, select what objects you want to keep, reference, or remove.

You can choose from the following options:

Option

Description

Reference

References the object in the new Problem Solving process.

Remove

Removes the object from the new Problem Solving process.

Save As

Saves a copy of the object in the new Problem Solving process.

Click Save.

The Problem Solving process is created and displayed in edit mode. The following objects are copied from the source Problem Solving process using the following type of copy:

Type of object

Copied as reference or creates a new object of the same type as the related object

Problem Items

Copy As Reference

Affected Items

Copy As Reference

Reference Items such as Item Revisions, FMEAs, Control Plans, Quality Audits, Quality Projects, Quality Programs, or Vendors

Copy As Reference

Dataset Reference Items

Copy As Object

Web Links

Copy As Object

Defective Items of the problem description defect

Copy As Reference

Quality Actions

Copy As Object for the quality action's name and description only. The status of the quality action is set to Draft in the new issue.

Attachments

Copy As Object

Problem description defect

Copy As Reference

Thumbnail

No Copy

Quality Checklist

Copy As Object

Is/Is Not Questions

Copy As Object

Child Causes and child Why Questions

Copy As Object

Note The root causes from the existing Problem Solving process are not marked as root causes in the new Problem Solving process. The associated root causes of planned permanent corrective actions and implemented corrective actions are not copied.

5. To create a new Problem Solving process, do the following:

Choose More Commands

New Create Change.

If you are working in the Quality Management workspace, click the Create Problem Solving Process action.

In the Create Change panel, select Problem Solving.

Select CAPA for Life Sciences to create a new Problem Solving process to investigate problems related to the Life Sciences industry. In these types of Problem Solving processes, you can track the progress through the Progress bar in the Overview tab. Note The CAPA for Life Sciences option is available in the Create Change panel when the administrator installs the Quality Management for Life Sciences Industry template.

In the Synopsis box, summarize the Problem Solving process.

Note If Teamcenter Copilot Quality is available, you can prompt it to create suggestions for your quality data.

In the Description box, describe the Problem Solving process.

From the Category list, select the appropriate category.

From the Sub-Category list, select the appropriate subcategory.

(Optional) Specify a proposed due date.

Some companies use a standard operating procedure where a Problem Solving process must be completed within a specific duration. This duration is based on the Priority of the Problem Solving process. When you create a new Problem Solving process, it is assigned a Priority of Medium by default. If your company has defined this standard operating procedure for you, you must specify a Proposed Due Date that is 45 days and earlier from the Creation Date of the Problem Solving process. Depending on the Priority of the Problem Solving process, set the Proposed Due Date as follows:

Priority

Duration assigned to Proposed Due Date

High

Proposed Due Date must be set to 30 days and earlier from the Creation Date

Medium

Proposed Due Date must be set to 45 days and earlier from the Creation Date

Low

Proposed Due Date must be set to 60 days and earlier from the Creation Date

After creating the Problem Solving process, you can edit it to update the Priority as required. If you change the Priority, ensure that you specify the appropriate Proposed Due Date accordingly. Your administrator can configure the duration assigned to the Proposed Due Date as per the business requirements. If the Proposed Due Date is not automatically set to a duration based on the assigned Priority, the administrator has disabled this option for your company. Note The Proposed Due Date of the Problem Solving process must not be later than the Due Date of the assigned chapters, questions, subquestions, and quality actions.

To assign a workflow to the Problem Solving process, select the required workflow from the Workflow list. By default, the Problem Solving Process workflow is assigned to the process. You can choose to use this workflow, assign a different workflow, or remove a workflow from the process.

To add attachments to the Problem Solving process, do the following:

In the Files section, click Add to . In the Add panel, click Select File to browse to and select the required file, and click Add.

To assign projects to the Problem Solving process, do the following:

Click Add Project . In the Projects panel, search for and select the required projects or subprojects, and click Assign. To remove a project or subproject, select it, and click Remove Project .

While creating a Problem Solving process, to assign the users who will work on the Problem Solving process, click the Participants tab, and do the following:

In the specific section, click Add Participants .
In the search panel, search for and select the user to be assigned, and click Add.
Click the Create tab to enter the remaining properties.

Do one of the following:

To continue editing later, click Create. The Problem Solving process is created and displayed in edit mode. You can send it for resolution later.

To send it for resolution immediately, click Create and Submit. The Problem Solving process is sent through the default workflow for resolution. Reviewers and approvers for the Problem Solving process may be automatically assigned depending on how your organization’s Problem Solving process workflow is configured.