CQI , QC and QA.

CQI Tools & Methodologies Matrix

(Sorted by application focus: Problem-Solving, Risk Mitigation, Process Control, and Continuous Improvement)

Tool/Methodology	Purpose	Key Steps/Components	Best For	Industry Examples
PDCA	Cyclical improvement	1. Plan: Identify issue. 2. Do: Implement solution. 3. Check: Measure results. 4. Act: Standardize or adjust.	Small-scale, iterative improvements.	Automotive (Toyota Production System), Healthcare.
Six Sigma (DMAIC)	Data-driven defect reduction	1. Define: Problem scope. 2. Measure: Collect data. 3. Analyze: Root causes. 4. Improve: Solutions. 5. Control: Sustain gains.	Complex processes with high variability (target: ≤3.4 defects per million).	Manufacturing (GE), Electronics, Finance.
5 Whys	Root cause analysis	Repeatedly ask "Why?" (5 times or more) to drill down to the underlying cause.	Simple, quick RCA for known issues.	Automotive (Toyota), Aerospace, Construction.
8D Problem-Solving	Structured corrective action	1. Team formation. 2. Problem description. 3. Containment. 4. Root cause. 5. Corrective action. 6. Validation. 7. Prevent recurrence. 8. Congratulate team.	Customer complaints or major defects (IATF 16949 requirement).	Automotive (Ford, GM), Heavy Machinery.
Kaizen	Incremental process improvement	Small, team-based improvements through: - Gemba walks. - Waste elimination (Muda). - Rapid experiments.	Daily continuous improvement (Lean focus).	All industries (especially Lean Manufacturing).
FMEA	Risk mitigation	1. Identify failure modes. 2. Score severity, occurrence, detection (SOD). 3. Prioritize risks (RPN = S×O×D). 4. Mitigate high RPNs.	Preventing defects in design (DFMEA) or processes (PFMEA).	Medical devices, Automotive (IATF 16949), Aerospace.
SPC	Process stability monitoring	- Control charts (X-bar R, p-chart). - Cp/Cpk analysis. - Reaction plans for outliers.	Real-time quality control in production.	Pharmaceuticals, Food & Beverage, Electronics.

Key Differentiators

Focus Area	Tools	Output
Problem-Solving	5 Whys, 8D, DMAIC	Root causes, corrective actions, reduced defects.
Risk Mitigation	FMEA, Control Plans	Risk priority numbers (RPNs), preventive controls.
Process Control	SPC, MSA	Stable processes, reduced variation, real-time alerts.
Continuous Improvement	PDCA, Kaizen, Six Sigma	Sustained improvements, waste reduction, higher efficiency.

Industry-Specific Applications

1. Automotive (IATF 16949):

   • FMEA + 8D for supplier defect resolution.

   • SPC for machining tolerances (Cp/Cpk ≥1.67).

2. Healthcare (FDA):

   • DMAIC to reduce hospital errors.

   • FMEA for medical device risks.

3. Aerospace (AS9100):

   • 5 Whys for aircraft component failures.

   • Control Plans for welding inspections.

When to Use Which Tool?

• Quick fix? → 5 Whys.

• Customer complaint? → 8D.

• High-risk process? → FMEA.

• Data-heavy problem? → Six Sigma (DMAIC).

• Daily improvements? → Kaizen/PDCA.