NCR/CAPA/Complaint Workflow

Overview

In regulated manufacturing environments, consistent assignment of owners, timely notifications, and documented task completion are central to maintaining compliance. The NCR/CAPA/Complaint Workflow feature addresses this by automating the routing and assignment logic that quality teams would otherwise perform manually each time a new record is created.

This system works across all organizations with the Manufacturing Quality (QC) and or the Quality Manager (QMS) modules. Organizations certified to ISO 9001, ISO 13485, AS9100, and IATF 16949 will find the workflow tools directly support auditability, traceability, and timely corrective action requirements.

Key Benefits

• Automated Triage Assignment: Eliminates manual owner and triage assignments at NCR creation.
• Standardized Process Flow: Ensures consistent notification to quality personnel based on predefined NCR type.
• Role-Based Task Distribution: Automatically delegates responsibilities to qualified users based on configured role assignments.
• Configurable Lead Times: Calculates due dates per CAPA and Complaint section from the record creation date.
• Audit Traceability: Maintains a complete audit trail for all workflow-driven assignments and task completions.

System Configuration Requirements

Step 1: Configure Types in List of Values (LOV)

Before configuring workflows, define the record types that will drive workflow routing. Navigate to Master Data, then select the List of Values tile. Define entries for each of the following groups:

• NCR Type (e.g., Manufacturing, Receiving, Customer, Deviation)
• CAPA Type (e.g., Machining, Assembly)
• Complaint Type (e.g., Delivery Delay, Field Failure, Poor Service)

These types will appear as selectable options during record creation and when configuring workflow rules. Click Save after defining each group.

NCR Type

CAPA Type

Complaint Type

Step 2: Define MRB Disposition Parameters

Within the same List of Values interface, navigate to the MRB Disposition group. These values define the disposition options available to team members during the Material Review Board process. Each disposition type can be mapped to automated tasks in the workflow configuration.

Standard dispositions include: Use As-Is, Rework, Scrap, Return to Supplier, and Engineering Review. Complete all required fields and click Save.

Workflow Configuration Implementation

Navigate to Master Data and select the Workflow tile. This tile contains separate tabs for each workflow type: NCR Triage, MRB Disposition, CAPA, and Complaint.  

NCR Triage Configuration

The NCR Triage workflow pre-configures owner and triage assignments by NCR Type. When an NCR is created, the system automatically populates the Manage tab with the configured personnel, eliminating manual selection.

Open the NCR Triage tab and configure the following for each NCR Type:

• Default Owner: The user automatically assigned as owner when an NCR of this type is created. Only the Default Owner can close an NCR.
• Triage Users: Personnel who receive automatic notifications when an NCR of this type is created, enabling prompt investigation and response.

Note: Only the Default Owner assigned through the workflow has authority to close an NCR.

MRB Disposition Workflow Setup

The MRB Disposition workflow automates task generation based on the disposition type selected during NCR processing. When a quality engineer selects a disposition such as Rework or Scrap, the system creates predefined tasks with assigned roles and lead times.

Open the MRB Disposition tab and configure the following for each disposition type:

• Task Description: A clear description of the required activity for this disposition.
• Role Assignment: The role responsible for completing the task. Only users belonging to the configured role will appear as selectable assignees when a task is opened.
• Lead Time: Maximum number of days allowed for task completion.

Note: All disposition tasks must be closed before the NCR can be finalized. 
 

CAPA Workflow Setup

The CAPA workflow drives role-based section ownership and automatic due date calculation. Configuration is organized by CAPA Type, supporting different workflows for different categories of corrective action.

Open the CAPA tab and select a CAPA Type to open the Define Workflow slideout. Configure the following three sections for each CAPA Type:

Owners Role

These two fields apply to the overall CAPA record, not to individual sections.

• Owners Role: The role assigned as the overall CAPA owner. When a CAPA of this type is created, the system pre-filters the owner selection to users within this role.
• Lead Time: The number of days from the CAPA creation date by which the overall CAPA record must be completed.

Stage Owner

A Stage Owner ties a specific CAPA section to a Role and a Lead Time. When a CAPA is created, the system automatically assigns the configured role to each section and calculates the section due date based on the lead time from the creation date. Only the sections you configure will be pre-assigned. Empty fields are ignored.

• Section: The CAPA stage being configured: D2 Problem Definition, D3 Containment Plan, D4 Root Cause Analysis, D5 Corrective Actions, D6 Implementation Actions, D7 Future Prevention, D8 Verify and Recognize.
• Role: The role pre-assigned to this stage. Users selected as stage owners must belong to this role.
• Lead Time: Number of days from the CAPA creation date by which this section must be completed.

Stage Actions(Tasks) 

Stage Actions are auto-generated tasks tied to a specific CAPA section. Multiple tasks can be defined per stage. Each task includes a stage, a description, an assigned role, and a lead time. All tasks for a stage must be closed before the CAPA can be finalized.

• Stage: The CAPA section this task belongs to (e.g., D2, D3).
• Description: A clear description of the required activity for this task.
• Role: The role responsible for completing the task. Only users belonging to this role will appear as selectable assignees when the task is opened.
• Lead Time: Number of days from the CAPA creation date by which this task must be completed.

Complaint Workflow Setup

The Complaint workflow drives role-based section ownership and automatic due date calculation for each stage of a Complaint record. Configuration is organized by Complaint Type, allowing different workflows for different categories of customer complaints.

Open the Complaint tab and select a Complaint Type to open the Define Workflow slideout. Configure the following three sections for each Complaint Type:

Owners Role

These two fields apply to the overall Complaint record, not to individual sections.

• Owners Role: The role assigned as the overall Complaint owner. When a Complaint of this type is created, the system pre-filters the owner selection to users within this role.
• Lead Time: The number of days from the Complaint creation date by which the overall Complaint record must be completed.

Stage Owner

A Stage Owner ties a specific Complaint section to a Role and a Lead Time. When a Complaint is created, the system automatically assigns the configured role to each section and calculates the section due date based on the lead time from the creation date. Only the sections you configure will be pre-assigned. Empty fields are ignored.

• Section: The Complaint stage being configured: 1 Description, 2 Containment, 3 Documentation Review, 4 Failure Analysis, 5 Risk Assessment, 6 Correction.
• Role: The role pre-assigned to this stage. Users selected as stage owners must belong to this role.
• Lead Time: Number of days from the Complaint creation date by which this section must be completed.

 Stage Actions(Tasks)

Stage Actions are auto-generated tasks tied to a specific Complaint section. Multiple tasks can be defined per stage. Each task includes a stage, a description, an assigned role, and a lead time. All tasks for a stage must be closed before the Complaint can be finalized.

• Stage: The Complaint section this task belongs to.
• Description: A clear description of the required activity for this task.
• Role: The role responsible for completing the task. Only users belonging to this role will appear as selectable assignees when the task is opened.
• Lead Time: Number of days from the Complaint creation date by which this task must be completed.

 

Note:

• For users with a Role configured, each MRB Disposition, CAPA, and Complaint workflow requires: a task description, a role assignment, and a lead time. This ensures that disposition decisions and corrective action stages automatically trigger appropriate tasks with predetermined accountability and timelines.
• For users without a Role configured, task descriptions and lead times are still required. Role assignment is not applicable. Tasks will be visible to all users within the organization.
• The CAPA or Complaint Type cannot be changed in the Manage tab if a Stage Owner has already been assigned.

Operational Implementation

Creating NCRs with Workflow Integration

Once configuration parameters are established, the workflow system operates seamlessly during standard NCR creation processes. 

Step 1: NCR Initiation

Navigate to the QMS module and select the NCRs tile. Create a new NCR by selecting the appropriate Type (e.g., Manufacturing) and completing all required information fields. The system will automatically reference your predefined workflow configurations. 

 

Step 2: Automatic Assignment Verification

Access the Manage tab within the newly created NCR to observe automatic assignments. The Default Owner and Triage personnel appear automatically based on your workflow configuration, eliminating manual selection requirements while ensuring appropriate quality oversight. 

Step 3: MRB Disposition Processing

When creating MRB Dispositions within the NCR, select the appropriate Disposition Type (e.g., Use As-Is). The system automatically triggers predefined workflow actions based on your configuration parameters. 

Step 4: Automated Task Generation

Navigate to the Task tab to observe automatic task creation corresponding to your disposition selection. The system generates tasks with predetermined descriptions, role assignments, and lead times as configured in the workflow setup phase. This automation ensures consistent quality response protocols while maintaining comprehensive documentation for regulatory compliance. 

 

By clicking on each Task number you will open an assignment to select the appropriate assignee.

• For users with a Role configured, navigating to the Task of an MRB Disposition will display only users within the assigned role.
• For users without a Role configured, navigating to the Task of an MRB Disposition will display all users within your organization.

Creating CAPA with Workflow Integration

Once configuration parameters are established, the workflow system operates seamlessly during standard CAPA creation processes. 

Step 1: CAPA Initiation

Navigate to the QMS module and select the CAPA tile. Create a new CAPA by selecting the appropriate Type (e.g., Machining, Assembly) and completing all required information fields. The system will automatically reference your predefined workflow configurations. 

Step 2: Automatic Assignment Verification

Access the Manage, Sections, and Task tabs within the newly created CAPA to observe automatic assignments. The Role and Due Date appear automatically based on your workflow configuration, eliminating manual selection requirements while ensuring appropriate quality oversight. 

Owners Role: Within the CAPA, click the Manage tab to verify that the CAPA Type, Role, and Due Date are predefined per the workflow. 

Note: The CAPA Type cannot be changed in the Manage tab if a Stage Owner has already been assigned. 

Stage Owners: Within the CAPA, click the Sections tab to verify that the Role and Due Date are predefined per the workflow. 

Stage Actions (Tasks): Within the CAPA, click the Task tab to verify that the Role and Due Date are predefined per the workflow. 

Creating Complaint with Workflow Integration

Once configuration parameters are established, the workflow system operates seamlessly during standard Complaint creation processes. 

Step 1: Complaint Initiation

Navigate to the QMS module and select the Complaints tile. Create a new Complaint by selecting the appropriate Type (e.g., Delivery Delay, Field Failure, Poor Service) and completing all required information fields. The system will automatically reference your predefined workflow configurations. 

Step 2: Automatic Assignment Verification

Access the Manage, Sections, and Task tabs within the newly created Complaint to observe automatic assignments. The Role and Due Date appear automatically based on your workflow configuration, eliminating manual selection requirements while ensuring appropriate quality oversight. 

Owners Role: Within the Complaint, click the Manage tab to verify that the Complaint Type, Role, and Due Date are predefined per the workflow. 

Note: The Complaint Type cannot be changed in the Manage tab if a Stage Owner has already been assigned. 

Stage Owners: Within the Complaint, click the Sections tab to verify that the Role and Due Date are predefined per the workflow. 

Stage Actions (Tasks): Within the Complaint, click the Task tab to verify that the Role and Due Date are predefined per the workflow. 

Regulatory Compliance Benefits

The NCR/CAPA/Complaint Workflow system supports compliance requirements across multiple manufacturing standards by providing:

• Systematic Documentation: Complete audit trails for all quality decisions.
• Consistent Process Execution: Standardized responses to non-conformances, corrective actions, and complaints.
• Timely Corrective Action: Automated task assignments with defined completion deadlines.
• Role-Based Accountability: Clear assignment of responsibilities for quality resolution activities.
• Traceability: Comprehensive linkage maintained between NCRs, CAPAs, SCARs, Complaints, and corrective actions.

This workflow automation reduces administrative overhead while strengthening quality management system effectiveness, supporting organizations in maintaining certification requirements across ISO 9001, ISO 13485, AS9100, IATF 16949, and other applicable regulatory frameworks.