Additional Windchill Capabilities > Windchill Quality Management Solutions > The Windchill Nonconformance Process > Create a New Nonconformance
  
Create a New Nonconformance
To begin the nonconformance process, you first enter general information and item information. This is called the intake step. Intake can come exclusively through an electronic interface, but is typically a manual data entry process, such as a paper form from a manufacturing floor. Before you enter a new nonconformance, verify that this new information does not represent a nonconformance that has already been entered into the system.
During intake, you can save changes to the nonconformance, close it, open it, and make more changes until the intake information in the nonconformance is complete. Once you mark the intake step complete, the system moves it to the evaluation step.
If you are assigned to the nonconformance creator role, use the following procedure to create a new nonconformance:
1. On your Home page, click the new nonconformance icon .
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• At any time, you can click Save and continue working on the nonconformance later. The nonconformance moves to an intake workflow state. To edit the item, right-click the Update Nonconformance task, select Enter Nonconformance details, and complete the rest of the information. Click Finish to move the nonconformance to the evaluation workflow state.
• Use the step navigator at the top of the screen to quickly move to a different step in the procedure.
• If your site has security labels enabled, you might see the Set Security Labels step. For more information about setting security labels, see Setting Security Labels while Creating an Object.
2. In the New Nonconformance window, under Request, enter information in the following fields:
Field
Description
Requested By
Your system user name is automatically added to this field.
Date File Opened
Date that the nonconformance was entered or opened
Name
Required. Enter a name for the nonconformance. This name appears in the system as the nonconformance moves through the workflow.
Number
A nonconformance number is automatically generated after you finish creating the nonconformance.
Originated By
User originating the nonconformance
Nonconformance Type
Type of nonconformance
Originating Location
Originating location of the nonconformance, such as the manufacturing site
Shift
Operating shift when the nonconformance occurred
Occurrence Date
Date that the nonconformance occurred
Process Type
Select the process type for the nonconformance:
• Manufacturing
• Quality Assurance
• R&D
3. Under Nonconformance Information, enter information in the following fields:
Field
Description
Nonconformance Category
Click Find, select a code from the table that appears, and click OK.
Description
Enter a description of the nonconformance.
Additional Details
Enter any additional details relevant to the nonconformance.
4. Optionally, use the Related Personnel and Locations table to enter the names of people and places relevant to the subject of the nonconformance.
◦ If you enter information in this table, the Type, Name, and Primary fields are required for each row.
◦ Under the Primary column, select one person or place as primary by changing the value to Yes.
Icon
Description
Add people and places that exist in your system. These are already loaded in the People and Places Administration utility in the current quality context. In the People and Place Picker window, search for and select one or more people and places.
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If you know the name or number of your person or place, you can do a quick lookup by alternate identifier or name in the quick search boxes at the bottom of the table, instead of using this icon.
Remove rows by selecting them and clicking the icon.
Enter a free-form person or place that does not exist in the system.
To save time entering similar new contacts, select one or more rows and click the icon to duplicate the selected rows into the table. For example, use this icon when the contact is the initial reporter but is also a patient. You can copy the contact and set the Type field to an additional value.
Remove a row and replace a contact. For example, use this icon when a contact was originally entered as a free-form contact but was later added to the People and Places Administration utility, allowing the contact to be found in a search. You can replace the free-form contact with the new contact from the system.
After you have added a row, enter additional information about the person or place. For example, if a contact has a Type of Patient, you can add more information, such as the age of a patient, to the Patient Details section of the Edit Details window.
5. Use the Affected Objects table to add objects affected by this nonconformance.
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To create a nonconformance, you must complete either the Affected Objects table or the Other Items table.
a. Do one of the following:
▪ If you enter information in this table, the Type, Quantity and Unit fields are required for each row. If there are subtypes available for the Containment Details type, additional rows for the subtypes are displayed. Select the applicable subtype objects.
▪ Click the add icon to search for and add objects as needed.
▪ Enter information in the Add by Number or Add by Name fields to add an object. Begin typing in the field and objects matching the information entered appear in a list from which you can select an object. You must enter a minimum of three characters for the list to appear.
Field
Description
Type
Required. Select a subtype for the Containment Details type.
Number
The nonconformance number.
Name
Required. Enter a name for the nonconformance.
Lot/Serial Number
Enter the lot or serial number.
Unique Identifier (UDI)
Enter the unique identification number (if applicable).
Other Lot/Batch Number
Enter the lot or batch number (if applicable).
Quantity
Required. Quantity affected. This value is used when dispositioning the nonconformance.
Unit
Required. Unit type.
Purchase Order Number
Purchase order number (if applicable).
Organization
Auto populated field (reflects the organization from which the changeable belongs to).
b. Click the edit details icon to enter additional information in the Edit Details window.
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You can also enter the quantity and unit information in the Affected Objects table row.
Field
Description
Purchase Order Number
Purchase order number (if applicable).
Supplier Number
Supplier number (if applicable).
Item State
State of the item as it relates to the nonconformance.
Lot Controlled
Select Yes if the item is lot controlled.
Lot/Serial Number
Lot or serial number.
Quantity
Required. Quantity affected. This value is used when dispositioning the nonconformance.
Unit or Unit of Measure
Required. Unit type.
Manufactured From
Date manufacturing started.
Manufactured To
Date manufacturing ended.
Manufactured Quantity
Total quantity manufactured.
Manufactured Units
Unit type.
c. Under Trending Categories, click the add icon , select a code from the table that appears, and click OK. Trending categories are intended to be used for surveillance monitoring and reporting of the affected object.
d. If any immediate action needs to be considered for the affected object, under Immediate Actions, click the add icon and enter the following information:
Field
Description
Reference ID
Reference ID or code for the immediate action.
Immediate Action Type
Required. Type of immediate action.
Quantity
Required. Quantity involved in the immediate action.
Cost
Cost involved with the immediate action.
Completed Date
Date the immediate action was completed.
Immediate Action Text
Description or supporting information about the immediate action.
e. Click OK to save and close the Edit Details window.
6. Use the Other Items table to add objects stored outside of Windchill that are involved in the nonconformance.
a. Click the add icon and enter the following information in the table row:
Field
Description
Type
Required. Select a subtype for the Containment Details type.
Item ID
Required. Item or product ID for the other item.
Description
Required. Description of the other item.
Quantity
Required. Quantity affected. This value is used when dispositioning the nonconformance.
Purchase Order Number
Purchase order number.
Unit ID
Unit ID (if applicable).
Unit
Required. Unit type.
b. Click the edit details icon . In the Edit Details window, add information in the following fields:
Field
Description
Item ID
Required. Item or product ID for the other item.
Quantity
Required. Quantity affected. This value is used when dispositioning the nonconformance.
Unit ID
Unit ID (if applicable).
Unit of Measure
Required. Unit type.
Item State
State of the item as it relates to the nonconformance.
Item Type
Item type.
Purchase Order Number
Purchase order number.
Description
Required. Description of the other item.
Comments
Description or supporting information about this other item.
c. In the Edit Details window, under Trending Categories, click the add icon , select a code from the table that appears, and click OK. Trending categories are intended to be used for surveillance monitoring and reporting of the item.
d. If any immediate action needs to be considered for the item, in the Edit Details window, under Immediate Actions, click the add icon and enter the following information:
Field
Description
Reference ID
Reference ID or code for the immediate action.
Immediate Action Type
Required. Type of immediate action.
Quantity
Required. Quantity involved in the immediate action.
Cost
Cost involved with the immediate action.
Completed Date
Date the immediate action was completed.
Immediate Action Text
Description or supporting information about the immediate action.
e. Click OK to save and close the Edit Details window.
7. Under Nonconformance Trending Categories, click the add icon and select a code from the table that appears. Trending categories are intended to be used for surveillance monitoring and reporting.
8. Click Next.
9. In the Set Attachments step, use the Attachments table to associate any additional documents with the nonconformance. The following table describes the available icons:
Icon
Description
Remove the selected attachment.
Add a local file attachment. Local file attachments are files that you upload from your local machine to Windchill.
Click Browse to select a file on your local machine. You can also drag and drop one or more files onto the action window to upload them as attachments.
For more information, see About Drag-and-Drop.
Add a URL attachment. URL attachments are hyperlinks to content stored on a website outside of Windchill. For example, this can be a wiki page or product help site.
Add an external storage attachment. External content attachments are items that cannot be attached as local files or URL links because they are physical objects or places. For example, this can be a three-dimensional item such as a product model or prototype, or highly sensitive data stored in a secure location. An externally stored content attachment describes the content and refers the user to its location.
10. Click Next.
11. In the Select Associations step, complete the Associated Process Objects table and the Associated Reference Objects table to link the nonconformance to other objects. Available objects depend on the business rules defined in your system.
Do one of the following:
◦ Click the add icon to search for and add objects as needed.
◦ Enter information in the Add by Number or Add by Name fields to add an object. As you type in the field, objects matching the information appear in a list from which you can select an object. You must enter a minimum of three characters for the list to appear.
◦ Select items in a table and use the copy and paste icons to copy and paste the items from one table to another.
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For customers using a standalone Windchill Quality Management Solutions server, the functionality for flexible links is not available. The Select Association step does not appear on the windows for creating and editing CAPAs. These windows include the Associated Reference Objects and Associated Process Objects tables.
12. Click Finish. The nonconformance moves to the evaluation workflow state.