Control Plans
Generate and manage Control Plans directly from your PFMEA data, following the standard automotive Control Plan format.
What is a Control Plan?
A Control Plan is a documented description of the systems and processes required for controlling product quality. It links directly to your PFMEA by translating failure analysis into manufacturing controls.
The standard workflow: PFMEA identifies risks → Control Plan defines how to control them in production.
Control Plans are a core deliverable in IATF 16949 and AIAG APQP. NirmIQ auto-generates them from PFMEA data so your analysis flows directly into production planning.
Accessing Control Plans
Navigate to the Control Plans tab in your project's FMEA Workspace. This tab lists all Control Plans for the project.
Creating a Control Plan
Auto-Generate from PFMEA
The fastest way to create a Control Plan:
- Click "Generate from PFMEA"
- Select the PFMEA analysis to generate from
- NirmIQ creates a Control Plan with one item per failure mode
Auto-populated fields:
| Control Plan Field | Source (from PFMEA) |
|---|---|
| Process Step | Parent Structure Element name |
| Product Characteristic | Failure Effect |
| Process Characteristic | Failure Cause |
| Control Method | Prevention Controls + Detection Controls |
| Classification | Based on Severity (>=9 = Critical, >=7 = Major, else Minor) |
- Review and edit the generated items
- Add sample sizes, frequencies, and reaction plans
Manual Creation
Click "New Control Plan" and fill in:
- Plan Name — e.g., "BMS Assembly Line Control Plan"
- Plan Number — Your organization's numbering (optional)
- Linked FMEA — Select the associated PFMEA analysis
- Revision — Starts at 1.0
Then add items manually using the "Add Item" button.
Control Plan Fields
Each item in the Control Plan includes:
| Field | Description | Example |
|---|---|---|
| Process Step | Manufacturing step being controlled | "Solder paste application" |
| Product Characteristic | What quality attribute is being controlled | "Solder joint strength" |
| Process Characteristic | What process parameter affects it | "Paste volume and temperature" |
| Classification | Criticality level | Critical / Major / Minor |
| Control Method | How the characteristic is controlled | "Automated optical inspection" |
| Sample Size | How many units to inspect | "5 per lot" or "100%" |
| Sample Frequency | How often to inspect | "Every 2 hours" or "Continuous" |
| Reaction Plan | What to do when out of spec | "Stop line, quarantine lot, notify QE" |
Classification Levels
| Level | Criteria | Meaning |
|---|---|---|
| Critical | Severity >= 9 | Safety or regulatory concern — mandatory control |
| Major | Severity >= 7 | Significant customer impact — enhanced control |
| Minor | Severity < 7 | Standard quality control sufficient |
Inline Editing
The Control Plan grid supports inline editing similar to the Worksheet:
- Click any cell to edit
- Changes auto-save on blur
- Tab between cells
- Reorder items using the sort handle
Control Plan Status
| Status | Meaning |
|---|---|
| Draft | Work in progress, not yet approved |
| Active | Approved and in use on the production line |
| Superseded | Replaced by a newer revision |
Exporting
Click "Export" to download the Control Plan as an Excel file in standard automotive format, ready for submission to customers or use on the shop floor.
Linking to FMEA
Each Control Plan item can be linked to a specific failure mode in your PFMEA. This two-way link means:
- Changes to PFMEA failure modes are visible in the Control Plan
- Auditors can trace from Control Plan items back to the risk analysis
- Re-generating the Control Plan updates items while preserving manual edits
Best Practices
- Generate first, refine second — Start with auto-generation from PFMEA, then add sample sizes and reaction plans
- Focus on Critical items — Ensure every Critical classification item has a specific control method and reaction plan
- Keep it current — When PFMEA is updated, regenerate or manually update the Control Plan
- Include reaction plans — Every item should have a clear "what to do when this fails" instruction
- Review with production — Control Plans bridge engineering and manufacturing; involve production staff
What's Next?
- FMEA Worksheet — Edit the underlying PFMEA data
- Import & Export — Import PFMEA data to generate Control Plans from
- Actions and Mitigation — Define actions for high-priority failure modes