for 4th yr Medical Technology students, NU at Phayao Lecture on Quality management teaching on 12 July 2010 by Aj. Nantaya Chanarat

1. QC Concepts, Evolution of Quality, QC Tools, GLP, TQM Nantaya Chanarat Department of Clinical Chemistry Faculty of Associated Medical Sciences Chiang Mai university 12 July 2010 [email_address]

2. Objectives To study and practice on : 1. M eaning of quality 2. QC Evolution 3. QC concepts 4. Good Lab Practice (GLP) 5. Total quality managements and Continuous Quality Improvement

5. Why do we need QUALITY ? เดิม -- ผู้ผลิต กำหนดคุณสมบัติ คุณภาพของสินค้า ผลิตตาม คุณลักษณะ ( Specification) ปัจจุบัน - ลูกค้า กำหนดคุณสมบัติ คุณภาพของสินค้า ผลิตตาม ความพอใจ ( Satisfication) ของลูกค้า Motto : คุณภาพต้องมาก่อน ลูกค้าคือพระเจ้า

6. Significance of Quality สร้างความพึงพอใจให้ลูกค้า หรือให้มากกว่าที่ลูกค้าคาดหวัง ลดต้นทุน : พบข้อบกพร่องก่อนส่งมอบ / หลังส่งมอบ ช่วยยกระดับความต้องการของลูกค้า ส่งมอบได้ตามกำหนด โดยมีคุณสมบัติครบถ้วน มีคุณภาพชีวิตที่ดีขึ้น LAB :

7. Quality Control QC in clinical lab. is a process designed to increase probability that each result is VALID and can be used with CONFIDENCE by the physician making a diagnostic or therapeutic decision Continuous monitoring on a batch to batch and day to day basis to decide whether the results are reliable enough to release - IQC

8. Quality Assessment QA in clinical lab. is a process designed to assess the performance of a lab. and to compare the performance with other labs. - EQA QA is a system to ensure reliability of test - “The right result from the right test on the right specimen from the right patient …….”

15. QA chart

16. Quality Management QM in clinical lab. is a process for controlling all parameters affect the quality : man, method, material, equipment, environment Quality system

17. QS in clinical lab. is a constant & continuously process for optimizing productivity communication and value within an organization in order to provide confidence that all processes are established and continuously improved for producing qualified results. - Organization needs - National needs - International needs Quality System QS = QC + QA + QM

18. QC - Quality control - control of each test QA - Quality assurance - control of all tests QM - Quality management - control of the process QS - Quality system = QC + QA + QM Quality mind – QC mind

21. Inspection Quality Control Quality Assurance TQM Salvage, sorting, grading, blending, corrective actions, identify sources of non-conformance Develop quality manual, process performance data, self-inspection, product testing, basic quality planning, use of basic statistics, paperwork control . Quality systems development, advanced quality planning, comprehensive quality manuals, use of quality costs, involvement of non-production operations, failure mode and effects analysis, SPC. Policy deployment, involve supplier & customers, involve all operations, process management, performance measurement, teamwork, employee involvement. Evolution of Quality Management

22. Edward Deming’s view of a production as a system Consumer Research Design & redesign Receipt & test of materials Suppliers, materials & equipment Production, assembly, inspection Distribution Consumers Test of processes, machines, methods, cost

23. Improve Quality Productivity improves Provide jobs and more jobs Cost decreases because of less rework, fewer mistakes, fewer delays, snags, better use of machine time and materials Stay in business Capture the market with better quality and lower price Deming’s Chain Reaction

24. PLAN CHECK (Study) DO ACT Plan a change to the process. Predict the effect this change will have and plan how the effects will be measured Implement the change on a small scale and measure the effects Adopt the change as a permanent modification to the process, or abandon it. Study the results to learn what effect the change had, if any. The Deming Cycle or PDCA Cycle ACT

28. Pareto Chart Percent from each cause Causes of poor quality Machine calibrations Defective parts Wrong dimensions Poor Design Operator errors Defective materials Surface abrasions (64) (13) (10) (6) (3) (2) (2) 0 10 20 30 40 50 60 70

29. ปริมาณการใช้ ABC analysis จาก จตุรพร พรศิลป์ทิพย์ 2553

32. Flowchart Activity Decision Yes No 7 Quality Tools Start Or Finish

34. Flow Diagrams

35. Process Chart Symbols Operations Inspection Transportation Delay Storage

36. Process Chart Step Operation Transport Inspect Delay Storage Distance (feet) Time (min) Description of process 1 2 3 4 5 6 7 8 9 10 11 Unload apples from truck Move to inspection station Weigh, inspect, sort Move to storage Wait until needed Move to peeler Apples peeled and cored Soak in water until needed Place in conveyor Move to mixing area Weigh, inspect, sort Total Page 1 0f 3 480 30 5 20 15 360 30 20 190 ft 20 ft 20 ft 50 ft 100 ft Date: 9-30-00 Analyst: TLR Location: Graves Mountain Process: Apple Sauce

37. Check Sheet                       Shifts Defect Type 7 Quality Tools    

38. Check Sheet COMPONENTS REPLACED BY LAB TIME PERIOD: 22 Feb to 27 Feb 1998 REPAIR TECHNICIAN: Bob TV SET MODEL 1013 Integrated Circuits |||| Capacitors |||| |||| |||| Resistors || Transformers |||| Commands CRT |

40. Cause and Effect “Skeleton” Quality Problem Materials Equipment People Procedures 7 Quality Tools

41. Fishbone Diagram Quality Problem Machines Measurement Human Process Environment Materials Faulty testing equipment Incorrect specifications Improper methods Poor supervision Lack of concentration Inadequate training Out of adjustment Tooling problems Old / worn Defective from vendor Not to specifications Material- handling problems Deficiencies in product design Ineffective quality management Poor process design Inaccurate temperature control Dust and Dirt

42. Scatter Diagram .

44. Control Chart 18 12 6 3 9 15 21 24 27 2 4 6 8 10 12 14 16 Sample number Number of defects UCL = 23.35 LCL = 1.99 c = 12.67

45. Control Charts 7 Quality Tools

46. Good Lab Practice (GLP)

68. 4. Work records/ study file บันทึกการทำงานจะเก็บแยกต่างหาก เช่น มี log book หรืออาจเก็บในรูปแฟ้มข้อมูลในคอมพิวเตอร์ 5. Archieves ที่เก็บเอกสารสำคัญ เอกสารสำคัญต้องเก็บอย่างปลอด ภัย สืบค้นง่าย เช่น กราฟแสดงข้อมูลต่างๆ จะต้องไม่ถูกแสง ทำให้สี จางหายไป หรือมีความชื้นทำให้ขึ้นรา และไม่อยู่ใกล้ความร้อน เป็นต้น 6. Sample retention สารตัวอย่างต้องมีกำหนดช่วงเวลาที่เก็บไว้ สำหรับกรณีที่ต้องมีการทดสอบซ้ำ แต่ถ้าสารไม่คงตัว ก็ไม่ควรเก็บ เพื่อทดสอบใหม่

74. PLAN CHECK (Study) DO ACT The Deming Cycle or PDCA Cycle Plan a change to the process. Predict the effect this change will have and plan how the effects will be measured Implement the change on a small scale and measure the effects Adopt the change as a permanent modification to the process, or abandon it. Study the results to learn what effect the change had, if any.

75. Joseph M. Juran’s Quality Trilogy Quality Planning Establish quality goals Identify customer needs Translate needs into our language Develop a product for these needs Optimise product features for these needs Quality Control Prove the process can produce under operating conditions Transfer process to operation Quality Improvement Seek to optimise the process via tools of diagnosis

76. Juran’s Trilogy Diagram Quality Planning Quality control (during operations) Original zone of quality control Quality improve -ment New zone of quality control Cost of Poor Quality TIME 20 40 0 0 Lessons learned

77. 1) Identify who are the customers 2) Determine the customer’s needs 3) Translate the needs into our language 4) Develop a product to meet those needs 5) Optimise a product so as to meets our needs as well as the customer’s. 6) Develop a process which is able to produce the product 7) Optimise the process 8) Prove the process can make the product under operating conditions Juran’s Quality Planning Road Map

78. 2 types of costs: Unavoidable Costs: preventing defects (inspection, sampling, sorting, QC) Avoidable Costs: defects and product failures (scrapped materials, labour for re-work, complaint processing, losses from unhappy customers) “ Gold in the Mine” JM Juran and the Cost Of Quality

81. 3 วินัย 3 วิสัย วินัย - ทางการเงิน - ทางการบริหาร - ของบุคลากร วิสัย - วิสัยทัศน์ขององค์กร / ผู้นำ - การทำงานเป็นทีม - ความมุ่งมั่น พากเพียร

86. Protection & Prevention การป้องกันและหลีกเลี่ยง ความเอาใจใส่ การกลมกลืน การทำอย่างต่อเนื่องสม่ำเสมอ การมีส่วนร่วม Caring Integration Repetition Participation

87. KAP Knowledge – Use of QC - How to do, prevent mistake, evaluate, solve problems - Continuous improvement Attitude - Willing to do without bias Practice - Regulary perform - Statistics interpretation - Take action immediately

88. Quality is a Journey, not a Destination Q O L O I O GO

89. Quality is a Journey, not a Destination THE END