HOUSE OF TQM PHARMA OPC
Building Total Quality Excellence in Pharmaceutical Manufacturing
CUSTOMER SATISFACTION
Safe Product • Effective Quality • GMP Compliance • Fast Delivery • Customer Trust
QUALITY CULTURE
PROCESS QUALITY
- • SOP Standardization
- • Lean Flow
- • Six Sigma
- • SPC / CpK
- • FPY / RTY
- • CAPA System
- • Process Capability
- • Deviation Reduction
COMPLIANCE
- • GMP-WHO
- • GACP-WHO
- • GDP Compliance
- • Data Integrity
- • Validation System
- • Audit Readiness
- • Traceability
- • Risk Management
PEOPLE EXCELLENCE
- • Quality Mindset
- • Skill Matrix
- • Kaizen Culture
- • Cross Functional Team
- • Problem Solving
- • Employee Engagement
- • Training System
- • Leadership Commitment
OPERATIONAL FLOW
- • Value Stream Mapping
- • OEE Improvement
- • SMED
- • Pull System
- • Line Balancing
- • Heijunka
- • Batch Release Leadtime
- • Waste Elimination
SUPPLY CHAIN QUALITY
- • Supplier Quality
- • Incoming Quality
- • FEFO / FIFO
- • Inventory Control
- • Forecast Accuracy
- • Distribution Quality
- • Farm-to-Pharmacy
- • Logistics Performance
CUSTOMER QUALITY
- • Complaint Reduction
- • OTIF
- • Product Reliability
- • Pharmacovigilance
- • Voice of Customer
- • Customer Feedback
- • Service Excellence
- • Brand Trust
MANAGEMENT SYSTEM
Driving Governance, Compliance and Continuous Improvement
FOUNDATION
Building Sustainable Pharma Quality Excellence
HOUSE OF ZERO DEFECT
Built-In Quality Through Lean Six Sigma
A strategic framework for pharmaceutical manufacturing excellence focused on patient safety, defect prevention, process capability, GMP compliance, and sustainable quality culture.
ZERO DEFECT CULTURE
CUSTOMER & PATIENT VALUE
BUILT-IN QUALITY
- • Poka-Yoke
- • Right First Time
- • Standard Work
- • Visual Management
- • Error Proofing
- • Defect Prevention
- • Layered Process Audit
- • Built-In Compliance
PROCESS CAPABILITY
- • SPC Control
- • Cp / CpK
- • Six Sigma
- • FPY / RTY
- • Variation Reduction
- • Stable Process
- • DPMO Reduction
- • Process Validation
GMP COMPLIANCE
- • GMP-WHO
- • Data Integrity
- • Validation
- • Audit Readiness
- • Traceability
- • Risk Management
- • e-QMS
- • Compliance Culture
LEAN FLOW SYSTEM
- • Value Stream Mapping
- • Pull Flow
- • SMED
- • Heijunka
- • OEE
- • Lead Time Reduction
- • Waste Elimination
- • Batch Flow Optimization
PEOPLE EXCELLENCE
- • Quality Mindset
- • Kaizen Culture
- • Skill Matrix
- • Problem Solving
- • Ownership
- • Team Collaboration
- • Leadership Commitment
- • Continuous Learning
SUPPLIER QUALITY
- • Incoming Quality
- • Supplier Audit
- • FEFO / FIFO
- • Herbal Traceability
- • Distribution Quality
- • Material Stability
- • Farm-to-Pharmacy
- • Supplier Partnership
DIGITAL QUALITY SYSTEM
Real-time visibility and data-driven decision making for pharmaceutical quality excellence.
FOUNDATION
Sustainable Quality Culture and Operational Discipline
BSC KPI TREE
ZERO DEFECT PHARMA EXCELLENCE
Strategic Balanced Scorecard framework aligning financial, customer, process, and people excellence toward sustainable Zero Defect pharmaceutical operations.
ZERO DEFECT PHARMA CULTURE
Improve Profitability Through Zero Defect
- • COPQ %
- • Rework Cost
- • Scrap Cost
- • Failure Cost
- • OEE
- • UPH
- • Labor Productivity
- • Yield %
- • RM Days
- • WIP Days
- • FG Days
- • Inventory Turnover
- • EBITDA
- • Revenue Growth
- • Gross Margin
- • ROI Improvement
Build Trust Through Stable Quality
- • CS Score
- • NPS
- • Retention Rate
- • VOC Score
- • Complaint PPM
- • Recall Rate
- • OOS Complaint
- • Product Stability
- • OTIF
- • Fill Rate
- • Lead Time
- • Service Level
- • Market Reputation
- • Compliance Score
- • Audit Pass Rate
- • Patient Safety
Create Built-In Quality Process
- • FPY
- • RTY
- • DPMO
- • Batch Reject Rate
- • Cp
- • CpK
- • Sigma Level
- • SPC Stability
- • Lead Time
- • PCE
- • Waiting Time
- • Changeover Time
- • Deviation Rate
- • CAPA Closure
- • Audit Finding
- • Data Integrity
Build Zero Defect Culture & Capability
- • Skill Matrix
- • Certification Rate
- • GMP Training
- • Multi Skill Ratio
- • Kaizen Count
- • Kaizen Saving
- • DMAIC Projects
- • Improvement Rate
- • e-QMS Usage
- • EBR Adoption
- • Dashboard Accuracy
- • Real-Time Monitoring
- • Engagement Score
- • Ownership Index
- • RFT Mindset
- • Safety Culture
FROM CULTURE → PROCESS → CUSTOMER → FINANCIAL
Build capability, mindset and improvement culture.
Create stable and capable zero defect process.
Deliver safe products with reliable quality.
Reduce COPQ and improve profitability.
TQM HOUSE FOR OPC (PHARMACEUTICAL QUALITY SYSTEM)
Ghi nhận – Cải tiến liên tục – Niềm tin khách hàng
Training
Teamwork
Leadership
Giao tiếp – Sai lệch – Hành động khắc phục – Thay đổi
Tuân thủ – Toàn vẹn dữ liệu – Văn hóa chất lượng
TQM HOUSE MODEL
Total Quality Management – Ngôi nhà Chất lượng Toàn diện
Ghi nhận
Training
Teamwork
Leadership
Đạo đức – Chính trực – Niềm tin
Bạn Đang Bảo Vệ Quan Điểm Gì? -> Quality Manager View
Reverse Thinking: From Satisfaction back to Root Cause
(Self-Check)
(Poka-Yoke)
(Risk-Based Design)
⚠️ Risk-Based Thinking Core:
Thay vì kiểm tra sản phẩm, chúng ta kiểm soát rủi ro của quá trình. Mũi tên đi ngược từ Khách hàng về Nguồn gốc (Source) để đảm bảo lỗi không bao giờ có cơ hội hình thành.
"Don't accept defects, Don't make defects, Don't let defects go out."
Production Manager View
Tập trung tối đa vào việc đẩy hàng ra khỏi xưởng. Càng nhanh càng tốt để đạt doanh số.
Không có rào cản chất lượng, lỗi (Defects) sẽ trôi tự do như những khối màu đỏ trên băng chuyền.
