QC vs. QA

matrix differentiating Quality Control (QC) and Quality Assurance (QA) activities and results, with a focus on IATF 16949 (automotive industry standard) and regulated industries:

Quality Control (QC) vs. Quality Assurance (QA) Matrix

Aspect	Quality Control (QC)	Quality Assurance (QA)
Primary Focus	Detection of defects in products/services.	Prevention of defects through process improvement.
Key Activities	- Inspection & testing of raw materials, in-process, and finished goods. - Defect identification & segregation. - Statistical Process Control (SPC). - Root Cause Analysis (RCA) with stakeholders. - Recall management & post-delivery defect tracking.	- Developing & maintaining QMS (e.g., IATF 16949 compliance). - Process audits (internal/supplier). - Document control & SOP enforcement. - Risk management (PFMEA, APQP). - Training & competency assurance.
When Applied	Reactive – After production or during delivery.	Proactive – Before and during production.
Tools & Methods	- Sampling plans (AQL). - Measurement systems analysis (MSA). - Control charts. - Non-conformance reports (NCR).	- Process audits (LPA, VDA 6.3). - Failure Mode Effects Analysis (FMEA). - Standard Operating Procedures (SOPs). - Continuous improvement (Kaizen, PDCA).
Outputs/Results	- Defect reports & containment actions. - Corrective Actions (8D, 5Why). - Scrap/rework logs. - Customer complaint resolution.	- Certified QMS (ISO 9001, IATF 16949). - Reduced process variation. - Audit findings & CAPA plans. - Higher first-pass yield (FPY).
Industry Standards	Follows inspection protocols (e.g., ANSI Z1.4, MIL-STD-105E).	Implements management system standards (IATF 16949, ISO 9001).
Regulatory Role	Ensures product compliance with specs/safety standards.	Ensures system compliance with regulatory & customer requirements.

Differences in Regulated Industries (e.g., Automotive, Medical, Aerospace)

1. QC in IATF 16949:

   • Mandates statistical defect analysis (SPC, MSA).

   • Requires containment actions (e.g., sorting, quarantine).

   • Tracks PPM (Parts Per Million) defect rates.

2. QA in IATF 16949:

   • Focuses on process capability (Cp/Cpk).

   • Ensures APQP (Advanced Product Quality Planning).

   • Maintains documented evidence for audits.

3. After-Delivery & Recall:

   • QC handles field failures & recalls (tracking, RCA).

   • QA ensures lessons learned feed back into design/production.

4. Continuous Improvement:

   • QC provides data for improvement (e.g., Pareto charts).

   • QA drives systemic changes (e.g., updating FMEAs).

Summary

• QC = "Finding & Fixing" (Product-focused).

• QA = "Planning & Preventing" (Process-focused).

• Both are essential for compliance (e.g., IATF 16949, FDA, AS9100).

Control Plans for QC or Process Audits for QA

Tools and methodologies used in QC vs. QA, aligned with IATF 16949 and other regulated industry standards:

Quality Control (QC) Tools – "Finding & Fixing Defects"

1. Inspection & Testing Methods

• AQL Sampling (ANSI/ASQ Z1.4):

  • Defines acceptable defect levels in batches (e.g., "AQL 1.0" allows ≤1% defects).

  • Used for finished goods inspection.

• Measurement System Analysis (MSA):

  • Validates accuracy of tools (e.g., calipers, gauges) via GR&R (Gage R&R).

  • Critical for IATF 16949 compliance.

• Destructive/Non-Destructive Testing (NDT):

  • Examples: X-ray (aerospace), pressure tests (automotive).

2. Statistical Process Control (SPC)

• Control Charts (X-bar R, p-chart):

  • Monitors process stability (e.g., detects outliers in machining dimensions).

• Cp/Cpk Analysis:

  • Measures process capability (e.g., Cpk ≥1.33 meets automotive standards).

3. Defect Management

• 8D Problem Solving:

  • 8-step RCA method (e.g., for customer complaints).

  • Includes containment, root cause, and preventive actions.

• Pareto Analysis:

  • Identifies "vital few" defects (80/20 rule).

4. Post-Delivery & Recall

• Traceability Systems:

  • Uses serial numbers/barcodes (e.g., for automotive recalls).

• Field Failure Reporting:

  • Tracks PPM (Parts Per Million) defects from customers.

Quality Assurance (QA) Tools – "Preventing Defects"

1. Process Design & Risk Mitigation

• Advanced Product Quality Planning (APQP):

  • 5-phase framework (Plan → Prototype → Production) for new product launches.

• Process FMEA (PFMEA):

  • Scores risks (Severity/Occurrence/Detection) to prioritize improvements.

  • Example: Reducing weld failures in automotive assembly.

2. Audits & Compliance

• Layered Process Audits (LPA):

  • Frequent checks (daily/weekly) by supervisors to ensure SOP adherence.

• VDA 6.3 (Automotive Process Audit):

  • Evaluates suppliers on 7 modules (e.g., project management, production).

3. Documentation & Standards

• Control Plans:

  • Defines inspection points, methods, and frequencies for production.

• Standard Work Instructions (SWI):

  • Visual guides to reduce human error (e.g., torque specs in assembly).

4. Continuous Improvement

• Kaizen/PDCA:

  • Cyclical improvement (Plan-Do-Check-Act).

• 5S Methodology:

  • Organizes workspaces (Sort, Set, Shine, Standardize, Sustain).

How QC & QA Work Together in IATF 16949

Scenario	QC Activity	QA Activity
Defective Part Found	Inspects batch, quarantines defects.	Updates PFMEA to prevent recurrence.
Customer Complaint	Triggers 8D report.	Reviews Control Plan for gaps.
New Product Launch	Tests prototypes (PPAP submission).	Ensures APQP milestones are met.

Regulatory Spotlight

• IATF 16949: Requires SPC, MSA, and Control Plans (QC) + APQP, FMEA, and LPAs (QA).

• FDA (Medical Devices): QC = 100% inspection of critical features; QA = 21 CFR Part 820 compliance.

• AS9100 (Aerospace): QC = NDT testing; QA = AS9102 FAIR (First Article Inspection).

Note

• QC relies on reactive tools (testing, RCA) to catch defects.

• QA uses proactive tools (FMEA, audits) to build robust processes.

• Both integrate under IATF 16949 for zero-defect goals.