Understanding Ctq Injection Molding CTQ,
Critical-to-Quality. The dimensions that matter. The characteristics that, if wrong, will get your parts rejected or cause field failures. I’ve seen CTQ lists that included everything. I’ve seen CTQ lists that missed the critical dimension. Here’s how to identify and control what matters.
Understanding CTQ
Definition CTQ characteristics are product requirements that are critical to quality, safety, or regulatory compliance.
Failure to meet these requirements results in unacceptable risk.
CTQ Categories
| Category | Definition | ExamplesSafetyFailure causes harm | Load-bearing hasRegulatoryLegal requirements |
|---|
| Medical device hasFunctionPart won’t work | Fit, assembly, performanceCosmeticCustomer rejects | Visible surfacesAssemblyWon’t assemble | Interference fits |
CTQ vs. Non-CTQ CharacteristicCTQ?
ReasonPart fits assemblyYesFunctionScrew boss holds fastenerYesFunctionSnap-fit flexes correctlyYesFunctionNon-visible rib strengthMaybeDepends on loadOverall lengthYesAssembly referenceHole diameter (fit)YesAssemblyHole diameter (not critical)NoReference onlyCosmetic surface finishYesAppearanceHidden surface finishNoNot visible
CTQ Identification Process
Step 1: Drawing Review
| Activity | Output | Review all dimensions |
|---|
| Complete dimension list | Identify GD&#x | 26;T symbols |
| Tolerance requirements | Note special notes | Critical requirements |
Step 2: Function Analysis
Does this feature fit with another?
Yes/NoIf yes → CTQDoes this feature support load?
Yes/NoIf yes → CTQIs this visible to customer?
Yes/NoIf yes → CTQDoes failure cause hazard?
Yes/NoIf yes → CTQIs this a reference dimension?
Yes/NoIf yes → Not CTQ
Step 3: Risk Assessment
| Factor | High Risk |
|---|
| Medium Risk | Low RiskFunction impactWon’t work |
| Degraded | No impactSafety impactDangerous |
| Minor | NoneCustomer visibilityVisible |
| Sometimes | HiddenAssembly impactWon’t assemble |
| Difficult | EasyRegulationRequired |
| Recommended | None |
CTQ Classification Matrix Risk
| Level | Function | Safety |
|---|
| Visibility | Assembly | Regulation |
| Result | High | High |
| High | High | High |
| High★ CTQ | High | High |
| Medium | Medium | Medium |
| Low★ CTQ | Medium | Medium |
| Low | High | Medium |
| Low | Major | Low |
| Low | Low | Low |
| Low | Low | Minor |
CTQ Documentation
CTQ Register CTQ
| #Feature | Specification | Tolerance | Measurement |
|---|
| Method | FreqCTQ-001 | Overall width | 50.00mm±0.20CMM100%CTQ-002 |
| Boss diameter | 12.50mm±0.05 | Gage | 100%CTQ-003 |
| Hole position | 25.00mm±0.10CMM | SampleCTQ-004 | Surface finish |
| Ra 0.8 | Max | Profilometer | Sample |
CTQ Specification
| Field | InformationCTQ Number | Unique identifier |
|---|
| Feature name | Descriptive name | Drawing reference |
| Dimension number | Specification | Nominal value |
| Tolerance | Upper/lower limits | Measurement methodCMM, gage, visual |
| Sample size | How many | Frequency |
| How often | Control methodSPC, attribute, etc. Responsible | Who measures |
Measurement Strategy for CTQs
Measurement Method Selection CTQ
| Type | Method | Accuracy |
|---|
| Speed | Precision fitCMM | Excellent |
| Moderate | Position GD&#x | 26;TCMM |
| Excellent | Moderate | Functional fit |
| Functional gage | Very good | Fast |
| Surface finish | Profilometer | Excellent |
| Moderate | Visual cosmetic | Visual inspection |
Sample Size Determination CTQ
| Type | Criticality | Sample Size |
|---|
| Frequency★ Safety | Highest | 100% |
| Every part★ Regulatory | Highest | 100% |
| Every part★ Function | High | 100% or 5/hour |
| Hourly | Major | Medium |
| 5/hour | Hourly | Minor |
| Low | 1-2/hour | Periodic |
SPC Requirements CTQ LevelSPC Required?
Chart Type★ CTQYesX-bar/R or I-MRMajorYesI-MR for weightMinorNoMonitoring only
Control Methods
Incoming Control
| Control | Method | Acceptance |
|---|
| Material certsCOA review | Verify spec | Incoming inspection |
| Key tests | Sample | Supplier monitoring |
In-Process Control
| Control | Method | Reaction |
|---|
| Process monitoringSPC charts | Investigate signals | First/last piece |
| Full inspection | Hold if fails | Periodic checkCTQ measurement |
| Adjust if drifting | Statistical inspection | Sample |
Final Inspection
| Control | Method | CoverageCTQ verification |
|---|
| Per control plan | 100% or sample | Visual inspection |
| Standard | 100% | Functional test |
Inspection Planning CTQ
| #Feature | Method | Equipment |
|---|
| FrequencyCTQ-001 | WidthCMM #1 | HourlyCTQ-002 |
| Boss ID | Go/ | No-go |
| Ring gage | Every 5 partsCTQ-003 | PositionCMM #1 |
| SampleCTQ-004 | Finish | Visual |
Control Plan Integration
Control Plan Elements
| Element | Contents | Operation |
|---|
| Manufacturing step | Characteristic | What is being controlled |
| SpecificationCTQ requirements | Evaluation method | Measurement technique |
| Sample size | How many | Frequency |
| How often | Control methodSPC, inspection, etc. Reaction plan | What if out of spec |
Control Plan Example
| Operation | Characteristic | Spec | Method |
|---|
| Sample | Freq | Control | 20 |
- Injection Part weight25.0g ±0.5g Scale115 min I-MR chart20
- Injection Width50.0mm ±0.2mm CMM5 Hourly X-bar/R25
- Ejection Flash None Visual100% Continuous Stop if flash30
- Trim Gate vestige<0.5mm Gage5 Hourly Go/No-go
CTQ Validation
Risk-Based Validation CTQ
| Category | Validation Scope | Documentation |
|---|
| Safety | Full FAI | Complete |
| Regulatory | Full FAI | Complete |
| Critical function | Full FAI | Complete |
| Standard function | Partial FAI | Key dimensions |
Validation Methods
| Method | Use | Confidence |
|---|
| Full dimensionalCTQ list | High | Capability studyCTQ parameters |
| High | Design verification | Critical features |
| High | Production validation | Actual conditions |
Common CTQ Mistakes
Mistake 1: Too Many CTQs Problem:
Listing every dimension as CTQ dilutes focus. Solution: Classify properly. Only true CTQs get full control.
Mistake 2: Missing Critical Dimensions Problem:
The one dimension that matters isn’t on the list. Solution: Thorough function analysis. Include failure mode review.
Mistake 3: Wrong Measurement Method Problem:
Using slow method on high-frequency CTQ. Solution: Match method to production needs. Functional gages for 100%.
Mistake 4: No Reaction Plan Problem:
CTQ found out of spec but no plan to respond. Solution: Document reaction in control plan. Train operators.
Mistake 5: Forgetting Cosmetics Problem:
Focusing only on dimensions, ignoring appearance. Solution: Include cosmetic CTQs. Visual standards, AAI.
CTQ Checklist
Identification Drawing reviewed completely All dimensions listed Function analysis completed Safety requirements identified Regulatory requirements identified Customer requirements incorporated CTQ classification complete CTQ register created
Implementation Measurement methods selected Equipment calibrated Control plan updated SPC charts created (if applicable) Sampling plan defined Reaction plan documented Operators trained First articles verified
Validation CTQs measured on production parts Results within specification Capability calculated (if applicable) Control methods verified Documentation complete Customer submitted (if required)
The Bottom Line CTQ is about focus,identifying what matters and controlling it rigorously.
Too many CTQs means nothing gets proper attention. Too few means critical things get missed. The drawing tells you what’s specified. The function analysis tells you what’s critical. The risk assessment tells you how to classify. Don’t call everything CTQ. Don’t miss the critical dimensions. That’s how you build quality into the process instead of inspecting it in.