The Quality Tab

NCR and CAPA Permissions

You can assign NCR related permissions to roles so that users can access and process NCR records. You can also update existing custom roles with the required permissions. For more information, see the Quality Management Roles topic.

By default, the following roles are provided with standard permissions:

NCR SetUp

Before users process NCR records, administrators should configure the NCR setup lists. These lists provide values for NCR review, root cause analysis, and CAPA processing. These values appear as dropdown options on NCR records and help standardize how non-conformance details are captured.

The following NCR setup parameters are available:

Common Fields in the NCR Setup List

All NCR setup list records use the following fields:

Configuring NCR Setup List Items

Configure the setup list items before users process NCR records.

Automatically Initiating NCR Records

Check the Required Non-Conformance Register box for a quality specification context to enable automatic NCR creation. The SuiteApp creates an NCR record when a lot-controlled or serialized item fails inspection. For more information, see Creating a Specification Context.

To submit an NCR record creation request:

1. Go to Quality > Non-Conformance Register (NCR) > Create NCR.

2. Click List Quality Inventory Results (QIR) to see the relevant QIRs on the Failed QIRs without NCR tab.

3. Use the available filters to view the relevant QIRs.

4. From the list, select a QIR record and click Create. A banner message confirms the NCR creation request.

NCR Workflow Statuses

The following table explains the NCR workflow based on each status and the action items at that stage.

For instructions to process an NCR record through these statuses, see Processing an NCR Record.

To process an NCR record:

1. Review the initiated NCR record.

   The SuiteApp creates the NCR record and derives applicable information from the source records, including:

   • NCR number

   • Item

   • Specification

   • Lot number or serial number

   • Inspection queue

   • Quality Inventory Result

   • Transaction type

   • Inventory transaction

   • Parent transaction

   • Vendor or customer, when applicable

   • Starting and ending operations, when applicable

   • NCR owner

   • Created date and last-updated audit information

2. Complete the initial review.

   To complete the initial review:

   1. Go to Quality > Non-Conformance Register (NCR) > NCR List.

   2. Click Edit.

   3. In the NCR Title, enter a title that follows your organization's naming standard.

   4. Enter the Quantity Affected field.

   5. In the Initial Findings Summary field, add summary to describe what is observed during inspection.

   6. Review the Inspection Level Findings subtab. Confirm that the inspection, inspection status, reason for failure, and initial finding are correct. You can also add inspection-level findings manually.

   7. (Optional) To add inspection-level findings:

      • In the NCR record, under the Inspection Level Findings subtab, click New QM Inspection Level Findings.

      • Select the Inspection.

      • Select the Reason For Failure.

      • Enter Initial Findings.

      • Click Save.

   8. Click Save.

      The NCR status changes to Initial Review Completed.

3. Complete root cause analysis.

   To perform the root cause analysis:

   Note:

   If RCA is not required, check the RCA Not Applicable box, and proceed to the next stage of the NCR workflow.

   1. On the NCR record, select the Root Cause Analysis subtab to create a root cause analysis record.

   2. Click New QM Root Cause Analysis.

   3. Enter or select values in the following fields:

      • Root Cause

      • Root Cause Assessment

      • Occurrence Frequency

      • Impact

      • Assessed By

      • Assessment Date

   4. Click Save.

      Review the saved analysis on the NCR record.

      The NCR status changes to RCA Completed.

4. Implement Corrective and Preventive Actions.

   To take a corrective or preventive action for an NCR record:

   1. On the NCR record, select the Corrective and Preventive Actions subtab to create a corrective and preventive actions record.

   2. Click New QM Corrective and Preventive Actions.

   3. Enter or select values in the following fields:

      • Disposition

      • Preventive Action

      • Description

      • Assigned To

      • Due Date

      • Priority

      • Status

   4. Click Save.

      Verify that the system records the Completed By and Completed Date fields for audit purposes.

      The NCR status changes to Corrective Action Implemented.

   Note:

   If CAPA is not required, check the CAPA Not Applicable box and proceed to the next stage of the NCR workflow.

5. Verify and close the NCR.

   Before closure, the responsible reviewer verifies:

   • The initial findings are complete and accurately describe the non-conformance.

   • The root cause analysis is complete, or the RCA Not Applicable box is checked.

   • All required corrective and preventive actions are complete, or the CAPA Not Applicable box is checked.

   • The disposition of the affected material is documented. The disposition defines what happens to the affected material, such as hold for review, reinspect, repair, rework, use as-is or deviation approved, scrap, or another configured outcome.

   • Ownership, dates, and completion details are recorded.

   When verification is complete, change the NCR status to Verified & Closed and save the record.

To open an NCR record through a transaction:

1. Go to a source transaction list. For example: go to Transactions > Manufacturing > Enter Work Orders > List.

2. Click View.

3. On the Quality subtab, you can view the NCR records on the QM Non Conformance Register subtab.

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