6Quality Issues and Quality Actions

This chapter contains the following:

Here's an overview of the business objects in quality management - quality issues and quality actions.

A quality issue is a defect, deficiency, or a significant variation in a product's expected appearance or performance. Oracle Product Management Cloud can handle any type of issue, such as:

  • Non-conformance (Outside Processing, Development Item, Audit Finding, Inventory, Receiving, Resource, Work in Process)

  • Design Failure (Item)

  • Problem Report (Item, Supplier)

A quality action is a necessary activity required to mitigate a quality issue and prevent its further occurrences. Oracle Product Management Cloud provides a predefined list of quality action types, which the administrator can configure. These types include:

  • CAPA - Corrective Action

  • CAPA - Preventive Action

  • CAPA - Supplier Corrective Action

  • CAPA - Development Action

  • Failure Analysis - Design

  • Failure Analysis - Manufacturing

  • Audit - Audit Finding

Here are a few things you can do in the Quality Management work area:

Create a quality issue quickly with only essential information such as Organization, Severity and Source. Use the quality issue edit page to add more information such as workflow, proposed dispositions, and descriptions. Mark issues as favorites to find them easily later. Depending on the type of issue, you can manually provide the quality issue number.

Create a quality action quickly with only essential information such as priority and workflow. Use the quality action edit page to add more information such as affected objects, status, and resolution date. Mark quality actions as favorites to find them easily later.

Copy all attachments and affected objects (on the Relationships tab) using the Save As feature on quality issues and actions. All attributes visible on the screen are copied to the new quality object, and the old issue or action is automatically added as a related object. You can select both the object type and the workflow during the Save As process. Remember that a newly created issue or action is always in the Draft status.

You can duplicate existing quality issues or perform a Save As on a quality issue or action or create a quality action from a quality issue remember that the Description field in the Save As dialog is read-only and the text displays in rich text format.

Note: You can't do a Save As for production exceptions, since you can log them only from manufacturing.

Use the side panel tabs to access Product Genealogy, Audit Reports, Clipboard, and Reports and Analytics. Click a component on the infolet to be directed to the respective predefined searches.

Note: The pages and objects you see in the Quality Management work area can be configured and extended using Application Composer. An administrator can modify standard attributes, create additional attributes and modify the search, create, and details pages. For details, see the Oracle SCM Cloud Configuring and Extending PLM guide.

The infolets on the quality issue edit page summarize important data pertaining to the current quality issue. Click each category to see pertinent issues or actions.

The following infolets appear on the overview page in Quality Management:

  • My Favorites

  • My Issues

  • My Actions

  • Open Issues by Severity

  • My Open Issues by Age

  • Unassigned Issues

  • Recent Activity

Note: Issues and Actions in Approval status are included in the respective infolet counts.

My Issues

When you open an issue, you can navigate between the following infotiles - Details, Relationships, Workflow, and Similar Issues. Let's go through each of them briefly.

  • Details: Use this infotile to view the severity of the quality issue and the number of attachments it has. You can add attachments with URL, file, or text formats. Click the tile to open and configure all attributes of the current quality issue.

  • Relationships: Use this infotile to view, add, and remove relevant affected objects and related objects. Related Objects can include business objects from Quality Management, Innovation Management, or Product Development.

  • Workflow: Use this infotile to control the status of the quality issue and add approvers.

  • Similar Issues: Use this infotile to analyze whether you can resolve multiple, related issues together, and to avoid replicating any parallel efforts to resolve an issue. You can also identify trends in quality issues, which may be based on a broader problem and require more attention.

The Similar Issues infotile automatically displays quality issues that have the same affected objects as the current issue. Each time you update the quality issue with new affected objects; the Similar Issues infotile is refreshed. In the Similar Issues list, click any of the quality issues to view them in detail. On the Similar Issues infotile, the count of:

  • Item Match: shows the number of issues that have the same affected items (affected objects of type item).

  • Other Matches: shows the number of issues which have the same affected objects, other than items. For example, work order operations, resources, or inspections.

Since there can be issues that have the same items as well as other objects, the All or Both count isn't necessarily equal to the sum of Item Matches and Other Matches.

My Actions

The infotiles on the quality actions page organizes information about the quality action while helping you navigate between details, relationships, and workflow.

  • Details: Use this infotile to view general information about the quality action. Includes the name, type, priority, and source of the quality action, and the number of attachments it has (attachment formats include URL, File, Text). Click the tile to open and configure all attributes of the current quality action.

  • Relationships: Use this infotile to view, add, and remove relevant affected objects and related objects.

    Affected objects can include Inventory Inspections, Resource Inspections, Receiving Inspections, WIP Inspections, Resources, Work Areas, Work Centers, Work Order Operations, Receipt, and Items.

  • Workflow: Use this infotile to control the quality action status.

Note: The current Relationships infotile of affected objects in quality actions lets you search and add only items as affected objects.

Options on the Actions menu of quality objects help you modify and obtain more details about the object.

  • Send: enables you to notify other users about an issue or action. Select users from the list in the Send dialog box and add a message to the notification, if required, to help solve issues.

  • Launch Graphical Navigator: opens a graphical display of the business object and its related objects.

  • Create Quality Action: creates quality actions that link to the quality issue you're working on. Since affected objects and attachments are copied over from the issue, the quality action gets the same affected objects and attachments as the quality issue from which it's created.

  • Create Change Order: creates a change order where you can define how you intend to resolve the issue. The change order automatically includes a relationship link to the quality issue or action from which it's created.

  • Delete: deletes the selected quality issue or action. Remember that you can't delete nonconformance object types.

In addition to the users and roles in the Security list, by default, the creator and the assignee can always access the quality issues or actions. The Security tab automatically displays the creator and assignee.

FAQs About Clipboard

Use the Clipboard panel tab in the Quality Management work area to add affected items and related objects to your quality issues ad actions. You can copy and paste, drag and drop or select and move multiple items into the Affected Objects table or the Relationships table of an issue or action. The clipboard gets cleared when you log out. You can also do this from the Favorites and Recent Items tabs next to the Clipboard tab. Make sure you click the Refresh icon to update the list in these tabs. Remember that this feature is available to you only if your implementor has opted in for the 'Use Clipboard in Quality Management' feature.

How can I copy items from Product Development into Quality Management?

Clipboard entries are shared across all Product Management work areas. When you copy an item in the Product Development work area, it's automatically available on the clipboard within the Quality Management work area. You can drag and drop or select and move the item from the clipboard into the tables of Affected Objects or Relationships of quality objects.

This topic describes how to view affected objects and other related objects for quality issues and quality actions using the Graphical Navigator.

The Graphical Navigator is a read-only 360-degree view of all the relationships on a quality issue and quality action. Run it from any quality issue or quality action, and click any object in the view for more details.

The graphical view consists of the Dependency Graph and Dependency Map.

  • The dependency map lets you map the data to visualization and configure possible interaction and visual properties. The dependency map appears in the Graphical Navigator window. The connector lines depict the different type of connections between the components. A thick line indicates an affected objects relationship. A dotted line indicates a related objects relationship.

  • The dependency graph displays the visual cards related to the data and the relationship between the data. The dependency graph appears in the center of the Graphical Navigator window. In the dependency graph, when you hover over the visual card, the tooltip displays the name of the component. If the cursor is over the attribute of the component, then the tooltip displays the attribute.

    You can also click the card to view more details, and directly open the Edit screen for some of the objects.

View Changes to Quality Issue Attributes and Attachments Using the Audit Report

An audit trail, provided for changes made to a quality issue is an important function of the quality system controls in any regulated industry. You can configure the attributes in audit trail and view the changes in the audit report.

  • The report is accessible through the side panel and displays all changes to attributes or attachments of a quality issue, including production exceptions. Attribute changes include changes to Application Composer attributes of a quality issue and attachment changes include creation, updates and removals.

  • It also records details of who performed which change and when.

  • The report also promotes accountability, enables traceability, and provides adherence to regulatory compliance across quality issue transactions.

These are the steps to configure which attributes appear in the audit report.

  1. Navigate to the Setup and Maintenance work area.

  2. In the Product Management offering, click the Audit Trail functional area.

  3. Click the Manage Audit Policies task.

  4. In the window that opens, click the Configure Business Object Attributes button.

  5. From the Product list, select Quality Issue and Action Management.

  6. Specify the objects and attributes that must be part of the audit.

  7. Click Save and Close.

This topic describes how workflows ensure a standard and repeatable process for managing quality issues and quality actions.

A workflow is a sequence of steps that a quality issue or quality action follows as it goes through a business process.

Workflow Templates

This topic discusses how you can define workflow templates for a quality action or issue.

Apart from defining workflow templates for Quality Management in the Setup and Maintenance work area, you can also create, edit, view, duplicate and search for them.

Create a Workflow Template

  1. Navigate to the Setup and Maintenance work area.

  2. Select Product Management from the Setup menu

  3. From the list of Functional Areas, click Quality Issue and Action Management.

  4. From the list of Tasks, click Manage Workflow Templates for Product Lifecycle Management.

  5. From the Actions menu, click Create to create a workflow template.

You can define multiple statuses, but you will derive them from the following standard status types:

  • Open

  • Interim Approval

  • Approval

  • Completed

The Approval Details panel appears only for the Approval and Interim Approval status type and not for the Open, Scheduled and Completed status types. You can edit the status sequences and approval details of a workflow template. For the Approval and Interim Approval status, define Ready-to-use approvers and optional approvers. The list of the approvers appear in a table-view. Select One for a single approver and All for all the approvers in the Reviewers list, to approve the workflow. Duplicating a workflow template copies the Workflow Status and the Status Details table. Notifications are sent to approvers, when the workflow reaches a certain status or on its approval or rejection. You can also export the workflow templates to an Excel sheet.

Note: In Quality Management, predefined workflow templates are read-only. However, the end date is editable to enable deactivation of the predefined workflow template.

Workflow Status

Quality teams and interested parties can track the progress of a quality event through its workflow status. You can't edit the quality event when it's in a read-only state like Approval or Closed. When the Approval status of a workflow is rejected, the workflow infotile displays the following message, 'Rejected by <user name>.

The workflow of a quality issue is based on how it's used. A quality issue workflow can be any of the following default workflows or one that your administrator creates:

  • issue expedite workflow

  • issue workflow with review

  • iIssue workflow with approval

  • issue resolution

  • issue exception

  • issue workflow with preapproval and approval.

The figure shows the workflow statuses of the default quality issue workflows, based on usage.

Quality Issues Workflows

The workflow of a quality action is also based on how it's used. A quality action workflow can be any of the following ready-to-use workflows or additional ones that you can define.

  • action expedite workflow

  • action workflow with review

  • action workflow with approval

  • CAPA workflow

  • action workflow with preapproval and approval

  • 8D workflow.

The figure shows the workflow statuses of default quality action workflows, based on usage.

Quality Actions Workflow

Approvals and Notifications

Workflows help you route notifications to the approvers, and document their feedback. For quality objects, you can configure default approvers, and you can add approvers manually as you advance the object through its workflow. If you enable the Signature Password Required feature on issues and actions, ensure that you provide the user name and password during approval.

Add Users to Quality Object Workflows using Advanced Search

Use the Advanced Search to search for and assign approvers to workflows of quality issues and actions. Search operators such as Starts With, Ends With, Equals, and Contains support the feature while allowing additional search fields such as Email or Name, within the search, for selecting approvers. This provides flexibility and an additional means to search for and find the required approvers for a quality issue or action approval. The approvers and security search results lists for quality issues and actions display not only the name but the user name and email.

Let's see how you can create and manage quality issues to study problems in a controlled manner.

  1. Navigate to the Quality Management work area. On the Overview page, select Quality Issue from the Create menu.

  2. Select the type of quality issue you're creating from the Type menu.

  3. Enter a name in the Name field and briefly describe the problem in the Description field.

  4. Search for the Organization from the Organization list.

  5. Select the Severity and the Source of the issue.

  6. Select the appropriate Workflow to route the issue.

  7. Click Save and Close.

You can add affected objects after you create a quality issue. The Affected objects tab lists the following types - All, Inspections, Resources, Work Areas, Work Centers, Work Order Operations, Receipts, and Items.

Note: The Quality Issues Relationships infotile of affected objects lets you search for and add only items as affected objects. However, on related objects, you can add other object types as well.

Quality issues report variations or defects that occur in the performance of a product. This topic describes how you create and route a quality issue.

  1. Navigate to the Quality Management work area.

  2. Go to the Create menu and select the Quality Issue option. For issues relating to a problem with an item, select a quality issue of the problem report type.

    • In the Name field, enter a name for your issue.

    • In the Description field, describe your problem briefly.

    • Search for and find the appropriate organization where the issue occurred.

    • Select values in the Severity and Source fields.

    • Click the Workflow infotile and select a workflow.

    • Click Save and Close. The issue opens on the General Information page.

  3. Click open the Relationships infotile and click the Affected Objects side tab.

  4. Click Select and Add.

  5. Search for and add the affected object that has a problem and click Done.

  6. Click Save. The Relationships infotile refreshes to indicate the issue has an affected object.

  7. To route, the issue, click Change Status or click the Workflow infotile.

Add Attachments to a Quality Issue

Attachments aid in providing additional information to resolve the issue and can be in the form of files, text or URLs.

  1. Navigate to the Quality Management work area.

  2. On the Overview page,

    • Search for quality issues, if you have saved any.

    • Click the Favorites and Recent Items icon to search for any favorite issues.

    • Create a quality issue from the Create list.

    The quality issue opens on the General Information page.

  3. Click the Details infotile.

  4. Click Attachments > Add Attachment.

  5. From the Add Attachments pane, select an Attachment Type, say Files, and a Category from the lists.

  6. Click Choose Files and select the required file.

  7. Click Save. Notice that the Details infotile shows an additional attachment. You have options to download the attachment, delete it or view its contents in detail.

  8. Select the attachment row, and click the Details icon.

  9. To replace the file, click Choose Files. Select the required file and click OK.

  10. Click Update.

This topic describes how you can manage corrective and preventive quality actions. You can create, edit and mark quality actions as favorites to find them easily later.

You can also create a quality action from a quality issue. Using the Actions menu, this process automatically links the quality action to the quality issue and copies attachments and affected objects from the quality issue.

From the Actions menu, you can create change orders that link to the current quality action, to track the resolution of an issue.

Creating a quality action from a quality issue links the action automatically to the issue. Quality actions help to correct and prevent future occurrences of the issue. If you can't resolve a quality issue quickly, use a quality action to conduct a more thorough investigation of the problem and a possible resolution. This topic describes how to create a quality action from a quality issue.

  1. Navigate to the Quality Management work area.

  2. Open an existing issue or select an issue from the Favorites list.

    Note: If you mark an object as a favorite, you can use the Favorites list to find it easily.
  3. From the Actions list of the issue, select Create Quality Action.

    • Depending on the type of action, you want to perform, select a Type.

    • In the Name field, enter a name for the quality action.

    • In the Description field, enter a brief description.

    • Select a workflow.

    • Click Save and Close.

  4. Click the Relationships infotile. In the Affected Objects tab, the item on the quality issue automatically appears as an affected object. Attachments, if any, are also copied to the quality action.

  5. Note that the quality issue appears as a related object in the Relationships tab.

  6. Click the Add icon of the quality issue in the Related Objects tab. A relationship rule between the issue and action is created, such that when the issue is closed, the action closes automatically.

  7. Click Save.

  8. To move to the next status in the workflow, click Change Status.

You can modify the resolution date of a quality action created from a quality issue, which has a past resolution date, after creation.

You can manage change orders to take actions on impacted quality issues. This topic describes how to create a change order from a quality action.

  1. Navigate to the Quality Management work area.

  2. Search for and open a quality action. Alternatively, open a quality action from the Favorites menu.

    • From the Actions list, select Create Change Order.

    • Select a change order type from the list.

    • Enter a number in the Number field. The change order appears as a related object on the Relationships infotile of the quality action.

    • In the Name field, enter a name for the change order.

    • In the Description field, enter a brief description of the change order.

    • Click Save and Edit.

      The change order appears as a related object on the Relationships infotile of the quality action.

  3. Click Relationships and then click the change order to open it.

  4. Within the change order, click the Affected Objects tab.

  5. Click Add Item and search for the item that you want to change.

  6. Mark or redline changes to the item. Redlining is the process of modifying a product structure using a change order.

  7. Click the Relationships tab on the change order. In the window that opens, set a rule to close the quality action on completion of the related change order.

  8. In the related Quality Action, click Select and Add. A Relationship rule moves an object automatically to the next status of the workflow when a related object advances to its specified status. Dependency rules can be set only for next statuses that are allowed in the workflow. For example, if 'Closed' isn't one of the status allowed at this point in the workflow, you can't move the object to that status.

  9. Using the lists on the window create a rule such as: When change order XYZ is Completed, set Quality Action ABC to Closed.

  10. Click OK.

  11. Click Save and Close.

Here we learn how quality issues and inspection results impact each other in Quality Management.

A quality issue is automatically created for failures during inspections of inventory, resource, or work in process. This process helps in the early identification of nonconforming components, and enables you to take quick and necessary corrective actions.

You can log quality issues from manufacturing or from inspections. When you do so, the impacted objects, such as work order operations and receiving inspections are automatically added as affected objects to the quality issue. The lot and serial number of inspected items are specified on the affected items of the quality issue (if the lot or serial is provided in Inspection > Inspections). This helps you to quickly identify the source of the problem.

Defective Material in Receiving

Following are examples of defective material in receiving. A receiving agent can log a nonconformance quality issue for defective material, or an out-of-spec inspection result value generated during inline or process receiving inspections.

Production Exceptions in Manufacturing

A nonconformance quality issue is automatically logged for an out-of-spec inspection result value generated during inline or process manufacturing inspections.

You can provide the resource instance when you log production exceptions from inside manufacturing work execution. The affected objects detail screen displays the resource instance for resources. This provides a better insight into the specific resource instance that the exception was logged for and also enables better resource instance-specific reporting in OTBI.

Let's have a look at how quality issues, quality actions, and change orders work together.

Quality Issues and Quality Actions

You can create and relate a new quality action from a quality issue. This copies affected objects, attachments, and some attributes to the new quality action. You can quickly open a quality action and resolve the issue. Search for and add new item requests in the Draft status, to the affected objects tab of a quality issue or action. You can modify the resolution date of a quality action created from a quality issue, which has a past resolution date, after creation.

Apart from creating relationship rules from actions for related issues, you can create and relate to a quality action from the production exception type quality issue. On the quality action Relationships tab, you can define a dependency rule to close the quality issue upon closing the quality action. If the issue is of the production exception type, the 'Add Rule' button doesn't appear at all and hence you can't add a dependency rule.

Note: At all times, production exceptions are read-only in Quality Management.

Change Orders

You can define a relationship between a quality action and a quality issue, which could also be of type production exception. A seamless approach is provided for quality and research teams to work together to manage the change order and resolve the impacted quality issues. You can also create relationship rules from change orders for related quality actions.

Relationships in Quality Events

Let's see how quality issues and actions work with affected objects, related objects, Innovation Management and Product Development.

Affected Objects

The affected objects screen provides a summary of all the affected objects involved with a specific issue or action. You can view details of the object and gain additional insights into why something has happened. When you log quality issues from Manufacturing or from Inspections, affected objects are automatically added to the issue.

Relate items appearing in the search results of other organizations as affected objects on quality issues and actions and remember that, access to these organizations is mandatory for this. The functionality is applicable to non-engineering items too.

Related Objects

The related objects tab in the edit quality issue and edit quality action pages lists additional objects. These objects can be from Quality Management, Innovation Management, or Product Development, and provide more context about the current quality issue or action. Related objects are the primary means of relating quality issues to quality actions and change orders through dependency rules.

Relationship Rules

Use the Relationship rules or Dependency rules to move an object automatically in its workflow, when the related object moves to its specific status. Relationship rules can close a quality issue upon the closure of its related quality action. It can also close a quality action upon implementation of a related change order.

Use relationship rules to define and manage relationships between quality issues, quality actions, and change orders. Define rules to change the status of one object when the status of a related object is changed to a specific value. For example, you can define that the status of a quality action is set to Closed once the related change order is set to Closed. You can clearly view the status set for each object.

  • Manage privilege on the source objects is mandatory to set rules for those objects. Remember that without this privilege, you can't open the rule editor.

  • You can create a rule only if both related objects have a workflow assigned.

The Relationship rule can only change the status of a target object if the workflow allows it and the rule is applicable only if the target status is the next status of this object. For example, the Relationship rule can't promote an issue from Draft to Closed, if it isn't defined in the workflow.

Note: Don't use the Relationship rule to promote an issue or action to an approval status, if the approvers aren't manually or by default approver status entered in Setup and Maintenance.

How can I create a quality issue or action from an item?

Use the Create Quality Issue or Create Quality Action option from the Actions menu of an item to create a quality issue or action. Once created, the quality issue or action is automatically related to the affected item.

How do I exchange information with design and manufacturing teams on a quality event?

Use Oracle Social Network to start a discussion with internal and external participants on a quality issue or quality action. Click the Social Interaction icon and view details of the quality issue. The issue and action data is copied into the conversation automatically to provide context. You can then collaborate in real time and in multiple threads with key stakeholders to help resolve quality events. For instance, a quality analyst can collaborate with a production supervisor to determine exact details related to the assembly of a failed part. If required, the analyst can reach out to other production facilities (maybe even external manufacturers) to get a second opinion on the problem.