Prerequisites
Before creating a control plan, you should have:
- A completed Process FMEA (PFMEA) identifying process failure modes
- Defined process steps in your manufacturing workflow
- Identified product and process characteristics requiring control
Steps
1. Navigate to the Risks Space
From the Polarion home page, navigate to Risks space → Process & Manufacturing Risk section. You’ll see three related documents:
- Process Flow (prerequisite input)
- PFMEA (source of failure modes)
- Control Plan (what you’re creating)
2. Create the Control Plan Document
Click Create New Document and configure:
- Document Type: Control Plan
- Title: Control Plan - [Product Name]
- Space: Risks
- Template: RiskControlPlanTemplate (from RiskTemplates space)
The template initializes the Risksheet configuration with the standard three-level hierarchy.
3. Understand the Control Plan Structure
Control Plans use a three-level hierarchy in Risksheet:
Process Step (Level 1)
└─ Characteristic (Level 2)
└─ Control Method (Level 3)
Example:
Sensor Assembly (process step)
└─ Camera Lens Focus Tolerance (characteristic)
└─ Automated Optical Measurement (control method)
| Level | Work Item Type | Purpose |
|---|
| 1 | Process Step | Manufacturing operation |
| 2 | Characteristic | Quality parameter to control |
| 3 | Control Plan Item | How to measure and react |
4. Add Process Steps
Click Add Row in Risksheet to create a Level 1 process step:
- Process Step ID: Matches your process flow diagram
- Equipment: Link to systemElement work items representing manufacturing equipment
- Operation Description: What happens in this step
Process steps should mirror your process flow diagram 1:1. If you have 10 steps in the flow, create 10 Level 1 rows in the control plan.
5. Add Characteristics
Expand a process step and click Add Child to create Level 2 characteristics:
- Product Characteristic: Link to characteristic work items (dimensional, functional)
- Process Characteristic: Link to process parameter work items (temperature, pressure)
- Classification: SC (Special Characteristic) or CC (Critical Characteristic)
- Target Value: Specification nominal
- Tolerance: Allowable variation range
The Characteristic picker is dynamically filtered by equipment. If you don’t see expected characteristics, verify they are linked to the equipment selected in the parent process step.
6. Define Control Methods
Expand a characteristic and click Add Child to create Level 3 control methods:
- Control Method: Measurement technique (CMM, optical scan, functional test)
- Sample Size: How many parts per inspection
- Sample Frequency: How often to inspect (per hour, per lot, 100%)
- Control Type: Prevention, Detection, or Both
| Control Type | When to Use |
|---|
| Prevention | Poka-yoke, jig/fixture |
| Detection | Post-process inspection |
| Both | In-process SPC + final |
- Reaction Plan: Stop line, 100% sort, notify supervisor, adjust process
- Responsible Role: Who takes action
Reaction plans should be specific and actionable. “Stop line and notify shift supervisor for process adjustment” is better than “Take corrective action.”
8. Link to PFMEA Failure Modes
For characteristics derived from PFMEA analysis:
- Open the characteristic row
- In the Failure Mode column, link to the corresponding PFMEA failure mode
- This establishes traceability from risk identification (PFMEA) to risk control (Control Plan)
9. Apply Visual Coding
The Control Plan Risksheet automatically applies color coding:
| Classification | Badge Color | Row Background |
|---|
| SC (Special) | Orange | Light orange |
| CC (Critical) | Red | Light red |
10. Review Column Grouping
The Control Plan organizes columns into four color-coded sections:
Verification
You should now see:
- A hierarchical control plan with process steps, characteristics, and methods
- SC/CC badges and row highlighting for critical characteristics
- Complete traceability from PFMEA failure modes to control methods
- Actionable reaction plans for out-of-spec conditions
Navigate to Documentation space → Control Plans Report to see your control plan in the project-wide manufacturing quality dashboard showing total control plan items and process steps.
See Also
