Edit a Problem Solving process

As a Quality Management Representative (QMR), after you create the Problem Solving process, you can edit it to provide additional details. As you continue updating the Problem Solving process, the updates can be viewed at a single location in the Overview tab.

You can track the progress of the Problem Solving process through these stages in the Progress bar:

1. Initiated

2. Investigate

3. Implement

4. Closed

5. Reviewing

6. Final Review

If you selected CAPA for Life Sciences while creating a new Problem Solving process, you can track the progress of the Problem Solving process through these stages in the Progress bar.

1. Creation & Pre-Investigation

2. Investigation & Planning

3. Execution

4. Review & Verification

5. Closed

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

3. In the Overview tab, choose More Commands

Edit  > Start Edit .

Section

Actions to be performed

Properties

Edit the Synopsis, Description, Category, Sub-Category, and Proposed Due Date of the Problem Solving process.Note The Due Date of the associated quality actions and the associated quality checklists must not be later than the Proposed Due Date of the Problem Solving process.

To make the current Problem Solving process available for searching in Supplier Quality Hub, select Share with Supplier Quality Hub. To specify the source of the Problem Solving process, from the Incident Source list, select the required value: Select Internal to specify that the source of the process is from within the company. Select External to specify that the source of the process is from outside the company, such as from suppliers. In such cases, you can share the process with Supplier Quality Hub.

Incident Details To record details about when the source incident occurred, do the following: In Incident Identified Date, specify the date when you identified that this is a valid incident. In Incident Occurred Date, specify the date when the incident occurred. In Material Details, specify the materials impacted because of the incident.If the source of the incident is an external source, you can specify details, such as purchase order (PO) number, order quantity, and defective quantity. In Delay Reporting Reasons, specify the reasons why there is a difference between the Incident Identified Date and Incident Occurred Date. For example, although the issue occurred on January 1st, it was identified as an incident on January 29th. In this case, you can specify the reasons why there was a delay in reporting the incident. This allows you to detect issues more accurately and perform a better investigation during the Problem Solving process.

Projects

To select additional projects of the Problem Solving process, click Projects . In the Projects panel, search for and select the required projects or subprojects, and click Add Project. To remove a project or subproject, select it, and click Remove Project . After you complete adding the required projects, click Save.

Risk Evaluation

Specify the risk and the priority of the Problem Solving process. Do the following:

Select values for Severity, Probability, and Detectability of the Problem Solving process to calculate the risk level. When you save the Problem Solving process, the risk level is calculated as the product of Severity, Probability, and Detectability, and this value is populated in the Risk field. After reviewing the value of the Risk field, select the priority of the Problem Solving process from the Priority list. 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 assigned Priority. If your company has defined this for you, the Proposed Due Date must be updated when you change the Priority of the Problem Solving process. The Proposed Due Date must be set as follows:

Priority

Duration assigned to Proposed Due Date

High

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

Medium

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

Low

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

If you do not update the Proposed Due Date when you change the Priority, when you save the Problem Solving process, a message appears asking you to make the update. When you click Update, the Proposed Due Date is updated with the new date that matches the new Priority.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 You can search for a Problem Solving process by using Risk and Priority as the search criteria. If your administrator has disabled the risk calculation, you can specify only the Priority for the Problem Solving process. If your administrator has enabled the risk calculation, you can select values for Severity, Probability, and Detectability, and the product of these fields is populated in the Risk field.

The following video shows how to specify the risk and the priority of the Problem Solving process.

Related issues and Problem Solvings

Add the issues and Problem Solving processes that are either implemented by this Problem Solving process or are similar to this Problem Solving process. Note If you have derived the Problem Solving process from an issue, the source issue appears in this section. If you have derived the Problem Solving process from a Customer Complaint Issue or Non-Conformance Issue, the details of these source issues appear in the Related Quality Issues Details (Customer Complaint) or Related Quality Issues Details (Non-Conformance Issue) sections, respectively. This allows you to view the source issue details in Problem Solving without having to open and view the issue details. When you generate a Problem Solving report, the source issue details are added to the report.

If you have added a Problem Solving process, you can select it, and click Information to view the Problem Solving process details, its problem description defect, and its root causes. Click the respective Summary, Problem Defect, or Root Causes tab to view the details. To update the Problem Solving process details and its problem description defect details, click Edit, make the required updates, and click Save.

Problem Defect Overview

View the problem description defect of the Problem Solving process. You can directly open the problem description defect from here and work on it. Note To work on the problem description defect in the Overview tab, select the problem description defect, and click Information, and make the required updates.

Root Causes Overview

View the root causes that have been identified in Root Cause Analysis of the Problem Solving process. You can directly open the root cause from here and work on it. Note To work on the root cause in the Overview tab, select the root cause, and click Information, and make the required updates.

Quality Actions Overview

View all the quality actions that are added to various components of the Problem Solving process, such as containment actions, corrective actions, and preventive actions. You can directly open the quality action from here and work on it. Note To work on the quality action in the Overview tab, select the quality action, click Information, and make the required updates. Dependent quality actions do not appear in this section.

Preview

View all the images and PDF files that are added to the Problem Solving process as attachments. You can also mark up a PDF or an image file within the universal viewer. You can also specify which level of users can view the markups. If you have generated a report in the HTML format, the report is displayed in the Preview section for the current session. Note To increase the work area, you can hide the Preview section by choosing More Commands

View  > Show/Hide Preview . The Preview section is hidden only for the current logged-on user.

4. Choose More Commands

Edit  > Save Edits .