Overview

Non-Conformance Reports (NCRs) are critical quality management tools used to document deviations from specified requirements, standards, or procedures. In regulated industries such as medical devices (ISO 13485), aerospace (AS9100), automotive (IATF 16949), and general quality management (ISO 9001), proper NCR management ensures compliance with regulatory requirements and maintains product quality integrity.

The 1factory system provides two streamlined methods for creating NCRs, allowing quality to efficiently document and track non-conformances as they are identified during inspection processes or through independent quality reviews.

NCR Creation Methods

1. Method : Creating NCRs from Inspection Activities

This method allows users to create NCRs directly from active inspection sessions, providing immediate traceability between the non-conformance and the specific inspection data that identified it.

From Manufacturing Inspections: When conducting in-process inspections and a non-conformance is identified, users can create an NCR directly from the Manufacturing Inspection interface. This approach ensures that all relevant inspection data, part numbers, lot information, and measurement results are automatically linked to the NCR for complete traceability.

From Receiving Inspections: Similarly, when incoming materials or components fail to meet specified requirements during receiving inspection, an NCR can be generated directly from the Receiving Inspection interface. This immediate linkage captures critical supplier information, purchase order details, and inspection results within the NCR record.

Automated MRB Disposition Generation

The automated generation of MRB Dispositions represents one of the most powerful features 1factory offers users. This capability significantly reduces time consumption and prevents human errors during data input when creating MRB Dispositions. When creating NCRs from inspection activities for features that fall outside tolerance specifications, 1factory automatically creates New NCRs against the out-of-tolerance balloons and populates them into new MRB Dispositions lists. This automated process includes all critical information such as Balloon Number, Requirements, Actual Values, and additional relevant data.

Follow the step-by-step process below to understand how this enhanced feature operates:

Step 1: Navigate to Your Inspection Activity

In this sample inspection activity, balloons 14, 15, and 16 are identified as out of tolerance. Click the NEW NCR button located on the left vertical menu bar.

Step 2: Verify MRB Dispositions in NCR Page

The system will automatically navigate to the NCR page. Scroll down to the bottom of the section where you will observe all MRB Dispositions associated with the number of out-of-tolerance inspection results identified in Step 1.

Step 3: View Out-of-Tolerance Balloons from NCR (Enhanced Feature)

The DRAWING button on the left vertical menu bar provides integrated access to the technical drawing directly from the NCR interface. This feature displays all balloons that were defined in the Manufacturing Plan, including both conforming and out-of-tolerance balloons, enabling quality personnel to review balloon positions on the technical drawing without navigating back to the inspection page.

Pict balloon 14 and 15 and 16(2).png

All balloons show

This streamlined workflow enhances efficiency by consolidating all relevant information within a single interface, enabling quality professionals to make informed disposition decisions while maintaining complete traceability and regulatory compliance.

2. Method : Creating Independent NCRs from Main Menu

This method is used when non-conformances are identified outside of formal inspection activities, such as during production monitoring, customer complaints, supplier issues, or audit findings.

Step 1: Navigate to NCR Creation Interface

From the main dashboard, navigate to the NCRs CAPAs tab

Click the NCRs tile to access the NCR management interface then select the New NCR button to initiate the creation process.

Use the dropdown menu to select the appropriate part number associated with the non-conformance

Select the NCR Type from the available options based on your organization's configured List of Values (LOVs):

Manufacturing NCR Type (for internal production issues)
Receiving NCR Type (for supplier-related issues)
Customer Complaint NCR (for external quality issues)

After completing all required selections, click the Go button to proceed

Step 2: Input NCR Details

In the Facts tab, provide comprehensive details of the non-conformance:

Detected At: Location where the non-conformance was identified
Detected On: Date of non-conformance detection
Customer: Customer associated with this part
Job Number: Internal job/work order number
Batch Number: Internal batch identification number
Supplier: Supplier involved with this part (for Receiving NCRs)
Purchase Order: Purchase order number associated with supplier transaction
Lot Number: Supplier's lot identification number
Lot Qty: Total quantity of parts suspected of non-conformance
Qty Inspected: Number of parts inspected from the lot
Qty Defected: Number of parts found to be non-conforming
Business Impact: Description of how non-conformance affects business operations
Total Cost: Total monetary impact to business
Serial Number: Serial number(s) associated with this lot
Summary: Brief overview of the non-conformance issue
Detailed Problem Description: Comprehensive description of the non-conformance
Corrective Action: Actions required to correct the issue and prevent future occurrences

In the Manage tab, provide comprehensive details of Management of the non-conformance:

The Manage tab provides comprehensive NCR lifecycle management capabilities, enabling quality professionals to assign ownership, coordinate triage activities, monitor linked corrective actions, and control NCR status throughout the resolution process. This centralized management approach ensures compliance with quality system requirements for accountability, traceability, and timely resolution of non-conformances.

Owner Assignment

Purpose: Select the Owner field within the Manage interface, choose the appropriate team member from the available personnel list, The assigned owner becomes primarily responsible for coordinating all NCR activities.

Important note: Only the Owner of the NCR can close the NCR.

NCR Triage Assignment

Purpose: Distribute NCR investigation and resolution activities among qualified team members based on technical expertise, workload capacity or organizational responsibilities.

Automatic Email Notifications

Notification System: Upon assignment of owners or triage personnel, the system automatically generates email notifications to assignee.

Linked CAPA/SCAR Monitoring

Traceability Overview: The Manage interface displays all related corrective actions, providing complete visibility into : View CAPA numbers directly linked to this NCR, Display SCAR numbers associated with NCR.

Step 3: Add new MRB Disposition to define more details of non conformance

MRB Dispositions allow you to define specific details for each non-conformance issue, providing details of documentation for dimensional discrepancies, defect classifications, and cost analysis…etc

Adding New MRB Dispositions

Navigate to the MRB Dispositions section at the bottom of the non-conformance record
Click the Cross symbol (+) to create a new MRB Dispositions

Step 4: Input Detailed Information for Non-Conformance MRB Dispositions

In this step you can document the specific details of each non-conformance issue.

MRB Dispositions Field Details

Balloon Number: The balloon number where the non-conformance occurred
Requirements: The specified requirement or specification that was not met
Actual Value(s): The measured or observed value that caused the non-conformance
Disposition Type: Type of disposition to determine how to handle this transaction
Quantity: Quantity to be handled in this transaction
Serial Number(s): The serial number of the lot
Problem Type: Type of problem (Contaminated, Flash, etc.)
Root Cause: Root cause of non-conformance (Assembly error, wrong drawing, etc.)
Caused by: Source of this non-conformance (Molding, Engineering, etc.)
Notes: Additional notes for this non-conformance
Open/Closed: Change the status by selecting Open/Closed

Editing MRB Dispositions

After creating the non-conformance MRB Dispositions, you can modify or delete it as needed:

Hover over any line in the MRB Dispositions section
Click on the desired MRB Dispositions
The MRB Dispositions details will open, allowing you to:
- Edit the content and save changes
- Click the Delete button to remove the item if no longer needed

Step 5: More Additional Information

1Factory offers you a solution to capture additional information for the non-conformance. Access the More tab to complete supplementary details. After all necessary information is filled, click the Save button.

Additional Information Fields

NCR Type: Type of NCR from Manufacturing or Receiving, Customer
Customer NCR Number: The NCR number of the customer
Inventory Location: The location where the non-conformance was found
RMA Number: The RMA number linked with this NCR number
Customer Identification: Customer identification to be defined in Settings
Supplier Identification: Supplier identification to be defined in Settings
Shipment Number: The shipment number to be shipped to customer
Component Part Master: Part Master linked to this part

Completing the NCR

Once all sections have been completed:

Review all entered information for accuracy
Ensure all required fields are populated
Click the Save button to finalize the NCR record

Step 6: Add Attached Files

Access the Attachment tab to upload external documentation to support this non-conformance such as pictures, audit reports, invoices, etc. By clicking the paper clip icon you can upload files.

File Management Options

Upload Files: Click the paper clip icon to select and upload supporting documentation
Remove Files: 1Factory also allows users to Remove attached files by clicking the X icon to remove files.

Supported Documentation Types

Examples of supporting documentation include:

Photographs of non-conforming parts
Audit reports and findings
Supplier invoices or delivery documentation
Measurement data and inspection reports
Corrective action evidence
Customer correspondence

Click the X button at Manage NCR Documents to return the NCR Facts page.

Step 7: Create New Task

Access the Task tab then click the New Task button to assign this task to an assignee to take over this task. Right after you create and assign the task, the assignee will receive notification via email.

Task Management Features

Task Assignment: Assign responsibility to specific team members
Due Date: Set completion deadlines for task accountability
Status Control: Change the status of this task by Open/Closed by clicking the respective button
Email Notifications: Automatic email alerts sent to assignees upon task creation

Task Workflow

Click the New Task button in the Task tab
Select the assignee who will be responsible for the task
Set the due date for task completion
The assignee automatically receives email notification
Monitor task progress and update status as needed

After all appropriate selections are provided click Save And Notify button.

Step 8: Export the Report

By accessing the Report tab you can export individual Excel reports or packages of reports by Zip file. To do this click the XLSX Report or Report With Attachment (zip file) to download the reporting file.

Export Options

XLSX Report: Download the NCR data in Excel format for analysis and record-keeping
Report With Attachment: Download a complete zip file package containing the NCR report and all attached files

Export Process

Navigate to the Report tab
Select your preferred export format:
- Click XLSX Report for Excel file only
- Click Report With Attachment for comprehensive zip package
The system will generate and download the requested file format

Step 9: Check the History

1Factory provides you a feature to store all history where you can check the history regarding this non-conformance of all activities changed like Field of Value (create on, create MRB Dispositions, upload file, drop files, open/closed...), Revised On, Revised By.

History Tracking Features

Complete Activity Log: View all changes made to the NCR record
Field Value Changes: Track modifications to data fields and values
File Management History: Monitor file uploads and deletions
Revision Information: See when changes were made and by whom

Available History Details

The history feature captures:

Create On: Initial NCR creation date and time
Create MRB Dispositions: MRB Dispositions additions and modifications
Upload File: File attachment activities
Drop Files: File removal activities
Revised On: Date and time of each revision
Revised By: User who made each change

Accessing History

Navigate to the History section to review the complete audit trail of all NCR activities and modifications.

Step 10: Create New CAPA/SCAR Linked to NCR

Once the root cause analysis has been completed and documented within the NCR, quality management teams must determine if formal Corrective and Preventive Actions (CAPAs) or Supplier Corrective Action Requests (SCARs) are required to address the non-conformance.

From within the active NCR record, locate the management options in the left-side navigation menu. This integration ensures complete traceability between the original non-conformance and subsequent corrective actions.

Select Appropriate Action Type

Choose the appropriate option based on your root cause analysis findings:

For Internal Issues:

Click New CAPA to initiate a Corrective and Preventive Action
This creates a formal CAPA record automatically linked to the originating NCR

For Supplier-Related Issues:

Click New SCAR to initiate a Supplier Corrective Action Request
This generates a SCAR automatically associated with the current NCR

Step 11: Status Control the NCR

Status Control: The NCR status field enables quality to control the non-conformance lifecycle: Open/Closed Status, change requirements. After all selections are provided, click the Save And Notify button to complete.

Kindly note that ONLY the Owner of the NCR can Closed or Reopen the NCR.

Step 12: View Out-of-Tolerance Balloons from NCR (Enhanced Feature)

For balloons that are out of tolerance limits from the inspection activity, you can now review the balloon positions on the technical drawing without switching back to the inspection page. Click the DRAWING button on the left vertical menu bar to access this integrated viewing capability.