Quick Navigation
Create a Control Plan
Set up a new control plan document and configure the basic structure for your manufacturing controls.
Link to Characteristics
Connect your control plan items to the design characteristics they monitor and verify.
Configure Measurement Methods
Define the inspection techniques, equipment, and acceptance criteria for each control.
Set Sample Frequency
Establish sampling strategies and batch sizes that balance cost with defect detection.
Define Reaction Plan
Specify escalation procedures and corrective actions when control limits are exceeded.
What is a Control Plan?
A control plan (also called a manufacturing control plan or process control plan) is a document that defines:- What to measure — Characteristics linked to design requirements and failure modes
- How to measure — Specific inspection methods, gauges, and acceptance criteria
- How often — Sampling frequency and lot/batch sizes
- What to do — Reaction plan when a part exceeds control limits
Control Plan Workflow Overview
Key Concepts
Control Plan Items
A control plan item is a single row in your control plan risksheet, representing one characteristic or parameter that needs production verification. Each item specifies:- Process Step — The manufacturing step where the control occurs (e.g., “Solder Wave Reflow”)
- Characteristic — The design characteristic being monitored (linked to FMEA failure mode)
- Control Method — The measurement technique or inspection type
- Sample Size — How many parts per batch are inspected
- Sample Frequency — How often samples are collected
- Reaction Plan — What happens if the control fails
SC/CC Classification
Control plan items must align with SC/CC (Special Characteristics / Critical Characteristics) classification:- S (Special Characteristic) — Characteristic critical to safety, emissions, or regulatory compliance
- C (Critical Characteristic) — Characteristic critical to fit, function, or customer satisfaction
- Regular — Characteristic important but not critical
Sampling Strategies
Common sampling plans include:| Strategy | Usage | Example |
|---|---|---|
| 100% | Critical characteristics, first-run parts | Every sensor output value measured |
| AQL (Acceptance Quality Limit) | Repeating production runs | ANSI/ASQ Z1.4 AQL 1.5 |
| Statistical Process Control (SPC) | High-volume, stable processes | Every 50th part for trend analysis |
| Skip-Lot | Verified suppliers with perfect track record | Every 5th lot (not every part) |
Common Tasks
- Create a Control Plan — Set up a new control plan document in Polarion
- Link to Characteristics — Map control plan items to design characteristics and SC/CC classifications
- Configure Measurement Methods — Define inspection procedures and acceptance criteria
- Set Sample Frequency and Size — Establish sampling plans and lot acceptance numbers
- Define Reaction Plan — Create escalation and corrective action procedures
Standards & Compliance
Control plans are required by:- IATF 16949 — Automotive quality management system (Section 8.5.1)
- APQP — Advanced Product Quality Planning (Phase 4: Product and Process Validation)
- ISO 26262 — Functional safety; control plans provide evidence of manufacturing risk mitigation