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Problem report workflow overview

You can use a problem report to document, analyze, and resolve issues. When you use a problem report, there is an initial review and an optional technical analysis. It can also be used to start a change request. Users with the roles Problem Reports [C] or Problem Reports [R/W] can create a problem report.

Problem reports involve three stakeholders.

  • The creator/owner of the report who provides all relevant details. The person notified about the report's progress automatically at defined transitions.
  • A reviewer who analyzes the report in a define time frame. The reviewer decides about next steps and may also request more details from the problem report creator/owner.
  • A technician may be involved if there is a technical problem. This person provides feedback and may initiate a follow-up CAPA or change request if needed.

Creating a problem report

When you're creating a problem report, you can refer to the information below to understand the sections of the problem report.

Section Purpose
Header This section captures the key information about the problem. You must enter a Title, Description, Priority, Type, and Source for the problem. The selected Type and Source can be used to determine proper actions in the next step.

A number is generated automatically upon report creation.
Details This optional section provides additional fields to capture more details about the problem including an affected product, item, and quantity. You may also describe the circumstances that lead to the problem as well as possible actions to resolve the issue.

If a Target Resolution Date is selected, the Days Remaining counter in the Status section will indicate the remaining days.
Images Upload images to describe the issue and its possible solution. Make use of the comments fields of each image to provide even more information.

Further files may be uploaded in the Attachments tab if required.
Status This section contains automatic indicators about the progress, priority, and schedule of the report. These fields are especially useful when reviewing a list of problems by using the workspaces views.

The Progress bar reflects the report’s progress based on its workflow status. The Flag field indicates the priority of the report (based on Priority field of section Header). The Days Remaining field indicates the number of days that remain until the Target Resolution Date that may be provided in the Details section. If the report is overdue, this counter is shown in red. If it is due in the next three days, it is shown in orange. Otherwise it is shown in green. If the report is complete, it is shown in gray with label “Done”.

The remaining sections of the problem report are filled in as the report progresses, and are described in next steps of the process.

Once all details have been captured and additional files have been uploaded in the Attachments tab, you may perform the Submit workflow action to submit the report to responsible reviewers. This automatically notifies all users who hold the Problem Reports [REVIEW] role about this new report. Additionally, the system creates a milestone for this report’s review to be finished within three business days.

If the report is no longer valid, the creator may also close the report to prevent further actions to be taken.

Reviewing a problem report

All team members holding the Problem Reports [REVIEW] role will find reports awaiting review in their My Outstanding Work list. An automatic milestone defines a target date for this review.

If information is missing for further processing, the reviewer may return the report to the creator to request additional details. If the report does not appear to be a valid problem, the reviewer can close it.

To capture review findings, the reviewer may use the Review section in the report’s details. This section also contains the fields Reviewed By and Review Date, which are set automatically once the review is complete.

During the review, while collaborating with the process creator and other stakeholders, the reviewer can use the Notes tab to capture any relevant information in the context of this process.

Once the review is complete and if the problem is resolved, the reviewer can set the report to the Complete status. However, if a technician is required for problem resolution, the report must be assigned to a technician in the Technical Analysis of the report.

A Target Date for the technical analysis can also be set, which will create an automatic milestone. The report can only transition to Technical Analysis if a technician has been assigned.

Performing a technical analysis

The assigned technician is responsible for performing an analysis to assess the potential impact on product design. The technician is notified by email and will find the report in their My Outstanding Work list.

If no further action is required, the technician may set the report as Completed.

If changes are required for specific items, these items may be attached to the Affected Items tab of the problem report. In the case of a subsequent change request, this list of items is copied to the change request.

Alternately, the technician may first initiate a CAPA (Corrective and Preventive Action) process before creating a change request to prevent the problem from recurring in the future.

Regardless of the decision, the system automatically initiates the appropriate subsequent business process and links it to the problem report in the Related Processes section. This section also stores information about the requested processes and their creation dates automatically.

Once the Technical Analysis is completed, the system captures the completion date and workflow comments in the Technical Analysis section. The technician may add additional comments.

Completing a problem report

Once all information has been captured and a decision has been made, the problem report remains in the Change Request in progress state until the change request is complete. There is no further user interaction required. Once the change request is closed, the problem report is set to Completed automatically.

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