qc1
DESCRIPTION
for 4th yr Medical Technology students, NU at PhayaoLecture on Quality management teaching on 12 July 2010 by Aj. Nantaya ChanaratTRANSCRIPT
![Page 1: Qc1](https://reader035.vdocuments.us/reader035/viewer/2022081504/5566a706d8b42a643c8b4c0d/html5/thumbnails/1.jpg)
1
Department of Clinical Chemistry Faculty of Associated Medical Sciences
Chiang Mai university12 July 2010
![Page 2: Qc1](https://reader035.vdocuments.us/reader035/viewer/2022081504/5566a706d8b42a643c8b4c0d/html5/thumbnails/2.jpg)
2
To study and practice on :
1. Meaning of quality
2. QC Evolution
3. QC concepts
4. Good Lab Practice (GLP)
5. Total quality managements and Continuous Quality Improvement
![Page 3: Qc1](https://reader035.vdocuments.us/reader035/viewer/2022081504/5566a706d8b42a643c8b4c0d/html5/thumbnails/3.jpg)
3
• Quality is “fitness for use” …..…... (Joseph Juran)• Quality is “conformance to requirements” ….. (Philip B. Crosby)
Quality of a product or services is its ability to satisfy the needs and expectations of the customer
Visible / Objective quality
Subjective quality
![Page 4: Qc1](https://reader035.vdocuments.us/reader035/viewer/2022081504/5566a706d8b42a643c8b4c0d/html5/thumbnails/4.jpg)
4
• Lab results
• Lab quality
![Page 5: Qc1](https://reader035.vdocuments.us/reader035/viewer/2022081504/5566a706d8b42a643c8b4c0d/html5/thumbnails/5.jpg)
5
เดิ�ม -- ผู้�ผู้ลิ�ต กำ �หนดิคุ�ณสมบั�ต� คุ�ณภ�พของส�นคุ� ผู้ลิ�ตต�ม คุ�ณลิ�กำษณะ (Specification)
ปั�จจ�บั�น - ลิ�กำคุ� กำ �หนดิคุ�ณสมบั�ต� คุ�ณภ�พของส�นคุ� ผู้ลิ�ตต�ม คุว�มพอใจ (Satisfication) ของ
ลิ�กำคุ�
Motto : คุ�ณภ�พตองม�กำ#อนลิ�กำคุ�คุ$อพระเจ�
![Page 6: Qc1](https://reader035.vdocuments.us/reader035/viewer/2022081504/5566a706d8b42a643c8b4c0d/html5/thumbnails/6.jpg)
6
สร�งคุว�มพ&งพอใจใหลิ�กำคุ� หร$อใหม�กำกำว#�ที่()ลิ�กำคุ�คุ�ดิหว�ง ลิดิตนที่�น : พบัขอบักำพร#องกำ#อนส#งมอบั / หลิ�งส#งมอบั ช่#วยยกำระดิ�บัคุว�มตองกำ�รของลิ�กำคุ� ส#งมอบัไดิต�มกำ �หนดิ โดิยม(คุ�ณสมบั�ต�คุรบัถ้วน ม(คุ�ณภ�พช่(ว�ตที่()ดิ(ข&/น
LAB :
![Page 7: Qc1](https://reader035.vdocuments.us/reader035/viewer/2022081504/5566a706d8b42a643c8b4c0d/html5/thumbnails/7.jpg)
7
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 decisionContinuous monitoring on a batch to batch and day to day basis to decide whether the results are reliable enough to release - IQC
![Page 8: Qc1](https://reader035.vdocuments.us/reader035/viewer/2022081504/5566a706d8b42a643c8b4c0d/html5/thumbnails/8.jpg)
8
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 …….”
![Page 9: Qc1](https://reader035.vdocuments.us/reader035/viewer/2022081504/5566a706d8b42a643c8b4c0d/html5/thumbnails/9.jpg)
9
Quality assurance
• Quality of design – System design– Parameter design– Allowance design
• Quality of conformance – Process quality control– Acceptance quality control
![Page 10: Qc1](https://reader035.vdocuments.us/reader035/viewer/2022081504/5566a706d8b42a643c8b4c0d/html5/thumbnails/10.jpg)
10
Quality Assurance System
• Technical Management• Data Management• Operations
Management
![Page 11: Qc1](https://reader035.vdocuments.us/reader035/viewer/2022081504/5566a706d8b42a643c8b4c0d/html5/thumbnails/11.jpg)
11
Technical Management
• Introduction of new test or change in assay procedure
• Study plan• Study execution• Evaluation of study results < data
management
• Establishment of SOP• Assay measurement < data management
• Process control < operations management
• Technical corrective action < operations management
![Page 12: Qc1](https://reader035.vdocuments.us/reader035/viewer/2022081504/5566a706d8b42a643c8b4c0d/html5/thumbnails/12.jpg)
12
Data Management: Quality control SOP
• Internal quality control
• External quality control
• Overall assessment
• Control sample• Frequency
distribution• Correlation test• Comparison with
previous data• Questionable data
check
• Control survey• Cross check
![Page 13: Qc1](https://reader035.vdocuments.us/reader035/viewer/2022081504/5566a706d8b42a643c8b4c0d/html5/thumbnails/13.jpg)
13
Operations Management: Quality control check list
• Operations inspection
• Error prevention management
• Technical training
• Instruction for improvement
• Document inspection
• Site inspection• Operations
guidance
• Rapid response• Management to
prevent recurrence• Management
reviewed
• OJT• Academic training
![Page 14: Qc1](https://reader035.vdocuments.us/reader035/viewer/2022081504/5566a706d8b42a643c8b4c0d/html5/thumbnails/14.jpg)
14
ระดมสมอง 30 นาที�
Error prevention for1. Glucose determination2. Lipid – triglycerides determination3. Lipid – HDL-cholesterol determination4. Albumin in serum5. Urinalysis6. Electrolyte and blood gas analysis7. Reporting lab. results 8. Using and reading from spectrophotometer9. Using an automatic pipet
![Page 15: Qc1](https://reader035.vdocuments.us/reader035/viewer/2022081504/5566a706d8b42a643c8b4c0d/html5/thumbnails/15.jpg)
15
QA chart
Managementreview
Design for - planning - inputs - outputs - review - verification - validation
Specificationand SOP
Productionprocess
Monitoring
DataanalysisImprovement
- corrective action - preventive action - customer’scomplaint - internal audition
Training
Marketsurvey
![Page 16: Qc1](https://reader035.vdocuments.us/reader035/viewer/2022081504/5566a706d8b42a643c8b4c0d/html5/thumbnails/16.jpg)
16
QM in clinical lab. is a process for controlling all parameters affect the quality : man, method, material, equipment, environment
Quality system
![Page 17: Qc1](https://reader035.vdocuments.us/reader035/viewer/2022081504/5566a706d8b42a643c8b4c0d/html5/thumbnails/17.jpg)
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
QS = QC + QA + QM
![Page 18: Qc1](https://reader035.vdocuments.us/reader035/viewer/2022081504/5566a706d8b42a643c8b4c0d/html5/thumbnails/18.jpg)
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
![Page 19: Qc1](https://reader035.vdocuments.us/reader035/viewer/2022081504/5566a706d8b42a643c8b4c0d/html5/thumbnails/19.jpg)
19
Goal of quality management• minimize (eliminate) nonconformity • minimize reworking• minimize waste resources• reduce costs, etc
Indicators of quality• accuracy• precision• reliability• repeatability / reproducibility• traceability, etc
![Page 20: Qc1](https://reader035.vdocuments.us/reader035/viewer/2022081504/5566a706d8b42a643c8b4c0d/html5/thumbnails/20.jpg)
20
![Page 21: Qc1](https://reader035.vdocuments.us/reader035/viewer/2022081504/5566a706d8b42a643c8b4c0d/html5/thumbnails/21.jpg)
21
Inspection
Quality ControlQuality 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.
![Page 22: Qc1](https://reader035.vdocuments.us/reader035/viewer/2022081504/5566a706d8b42a643c8b4c0d/html5/thumbnails/22.jpg)
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
![Page 23: Qc1](https://reader035.vdocuments.us/reader035/viewer/2022081504/5566a706d8b42a643c8b4c0d/html5/thumbnails/23.jpg)
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 materialsStay in business
Capture the market with better quality and lower price
![Page 24: Qc1](https://reader035.vdocuments.us/reader035/viewer/2022081504/5566a706d8b42a643c8b4c0d/html5/thumbnails/24.jpg)
24
PLAN
CHECK (Study)
DOACT
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.
ACT
![Page 25: Qc1](https://reader035.vdocuments.us/reader035/viewer/2022081504/5566a706d8b42a643c8b4c0d/html5/thumbnails/25.jpg)
25
• Prevention cost
• Appraisal cost
• Internal failure cost
• External failure cost
“Medicine is a science of uncertainty and an art of probability” …………..Sir William Osler
![Page 26: Qc1](https://reader035.vdocuments.us/reader035/viewer/2022081504/5566a706d8b42a643c8b4c0d/html5/thumbnails/26.jpg)
26
• Pareto Chart– Histogram
• Process flow diagram• Check sheet• Scatter diagram• Control chart• Run Chart• Cause-Effect Diagram/ Ishigawa diagram /
fish bone
![Page 27: Qc1](https://reader035.vdocuments.us/reader035/viewer/2022081504/5566a706d8b42a643c8b4c0d/html5/thumbnails/27.jpg)
27
Pareto Principle
• Vilfredo Pareto (1848-1923) Italian economist– 20% of the population has 80%
of the wealth
• Juran used the term “vital few, trivial many”. He noted that 20% of the quality problems caused 80% of the dollar loss.
7 Quality Tools7 Quality Tools
www.specforexcel.com/onlineexamples.htm
![Page 28: Qc1](https://reader035.vdocuments.us/reader035/viewer/2022081504/5566a706d8b42a643c8b4c0d/html5/thumbnails/28.jpg)
28
Pareto Chart
Pe
rce
nt
fro
m e
ach
ca
us
e
Causes of poor quality
Mac
hine
cal
ibra
tions
Defec
tive
parts
Wro
ng d
imen
sions
Poor D
esig
n
Ope
rato
r erro
rs
Defec
tive
mat
eria
ls
Surfa
ce a
bras
ions
0
10
20
30
40
50
60
70(64)
(13)(10)
(6)(3) (2) (2)
![Page 29: Qc1](https://reader035.vdocuments.us/reader035/viewer/2022081504/5566a706d8b42a643c8b4c0d/html5/thumbnails/29.jpg)
29
ปร�มาณการใช้�
ABC analysis
จาก จตุ�รพร พรศิ�ลป�ที�พย์� 2553
![Page 30: Qc1](https://reader035.vdocuments.us/reader035/viewer/2022081504/5566a706d8b42a643c8b4c0d/html5/thumbnails/30.jpg)
30
Flowcharts
• Flowcharts– Graphical description of how
work is done.– Used to describe processes that
are to be improved.
7 Quality Tools7 Quality Tools
![Page 31: Qc1](https://reader035.vdocuments.us/reader035/viewer/2022081504/5566a706d8b42a643c8b4c0d/html5/thumbnails/31.jpg)
31
Flow Diagrams
" Draw a flowchart for whatever you do. Until you do, you do not know what you are doing,you just have a job.”
-- Dr. W. Edwards Deming.
![Page 32: Qc1](https://reader035.vdocuments.us/reader035/viewer/2022081504/5566a706d8b42a643c8b4c0d/html5/thumbnails/32.jpg)
32
FlowchartFlowchart
Activity
DecisionYesYes
NoNo
7 Quality Tools7 Quality Tools
StartOr
Finish
![Page 33: Qc1](https://reader035.vdocuments.us/reader035/viewer/2022081504/5566a706d8b42a643c8b4c0d/html5/thumbnails/33.jpg)
33
![Page 34: Qc1](https://reader035.vdocuments.us/reader035/viewer/2022081504/5566a706d8b42a643c8b4c0d/html5/thumbnails/34.jpg)
34
Flow Diagrams
![Page 35: Qc1](https://reader035.vdocuments.us/reader035/viewer/2022081504/5566a706d8b42a643c8b4c0d/html5/thumbnails/35.jpg)
Process Chart Symbols
Operations
Inspection
Transportation
Delay
Storage
![Page 36: Qc1](https://reader035.vdocuments.us/reader035/viewer/2022081504/5566a706d8b42a643c8b4c0d/html5/thumbnails/36.jpg)
36
Process ChartS
tep
Op
era
tio
nT
ran
sp
ort
Ins
pe
ct
De
lay
Sto
rag
e
Dis
tan
ce
(fe
et)
Tim
e(m
in)Description
ofprocess
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
TotalPage 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
![Page 37: Qc1](https://reader035.vdocuments.us/reader035/viewer/2022081504/5566a706d8b42a643c8b4c0d/html5/thumbnails/37.jpg)
37
Check SheetCheck Sheet
ShiftsShifts
Def
ect
Typ
eD
efec
t T
ype
7 Quality Tools7 Quality Tools
![Page 38: Qc1](https://reader035.vdocuments.us/reader035/viewer/2022081504/5566a706d8b42a643c8b4c0d/html5/thumbnails/38.jpg)
38
Check Sheet
COMPONENTS REPLACED BY LABTIME PERIOD: 22 Feb to 27 Feb 1998REPAIR TECHNICIAN: Bob
TV SET MODEL 1013
Integrated Circuits ||||
Capacitors |||| |||| ||||
Resistors ||
Transformers ||||
CommandsCRT |
![Page 39: Qc1](https://reader035.vdocuments.us/reader035/viewer/2022081504/5566a706d8b42a643c8b4c0d/html5/thumbnails/39.jpg)
39
Cause-and-Effect Diagrams
Cause-and-Effect Diagrams
• Show the relationships between a problem and its possible causes.
• Developed by Kaoru Ishikawa (1953)
• Also known as …– Fishbone diagrams– Ishikawa diagrams 7 Quality Tools7 Quality Tools
![Page 40: Qc1](https://reader035.vdocuments.us/reader035/viewer/2022081504/5566a706d8b42a643c8b4c0d/html5/thumbnails/40.jpg)
40
Cause and Effect “Skeleton”
Cause and Effect “Skeleton”
QualityProblem
Materials
EquipmentPeople
Procedures
7 Quality Tools7 Quality Tools
![Page 41: Qc1](https://reader035.vdocuments.us/reader035/viewer/2022081504/5566a706d8b42a643c8b4c0d/html5/thumbnails/41.jpg)
41
Fishbone Diagram
QualityProblem
MachinesMeasurement Human
ProcessEnvironment 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
Deficienciesin product design
Ineffective qualitymanagement
Poor process design
Inaccuratetemperature control
Dust and Dirt
![Page 42: Qc1](https://reader035.vdocuments.us/reader035/viewer/2022081504/5566a706d8b42a643c8b4c0d/html5/thumbnails/42.jpg)
42
Scatter Diagram
.
![Page 43: Qc1](https://reader035.vdocuments.us/reader035/viewer/2022081504/5566a706d8b42a643c8b4c0d/html5/thumbnails/43.jpg)
43
Run Charts
• Run Charts (time series plot)– Examine the behavior of a
variable over time.– Basis for Control charts
![Page 44: Qc1](https://reader035.vdocuments.us/reader035/viewer/2022081504/5566a706d8b42a643c8b4c0d/html5/thumbnails/44.jpg)
44
Control Chart
18
12
6
3
9
15
21
24
27
2 4 6 8 10 12 14 16
Sample number
Num
ber
of d
efec
ts
UCL = 23.35
LCL = 1.99
c = 12.67
![Page 45: Qc1](https://reader035.vdocuments.us/reader035/viewer/2022081504/5566a706d8b42a643c8b4c0d/html5/thumbnails/45.jpg)
45
Control ChartsControl Charts Control ChartsControl Charts
7 Quality Tools7 Quality Tools
![Page 46: Qc1](https://reader035.vdocuments.us/reader035/viewer/2022081504/5566a706d8b42a643c8b4c0d/html5/thumbnails/46.jpg)
46
Good Lab Practice (GLP)
![Page 47: Qc1](https://reader035.vdocuments.us/reader035/viewer/2022081504/5566a706d8b42a643c8b4c0d/html5/thumbnails/47.jpg)
47
What do you do before working in the lab ?
• Getting dress – short pants, jeans, sport shoes
- gown / lab coat ?• put on goggles• put on gloves•
![Page 48: Qc1](https://reader035.vdocuments.us/reader035/viewer/2022081504/5566a706d8b42a643c8b4c0d/html5/thumbnails/48.jpg)
48
What do you do during working in the lab ?
• Turn on radio ?• Drink / eat• Discuss about the other problems/
politics/fashion• Wash your hands very oftenly• Pipet without rubber bulb• Mix vigorously without any protection• Centrifuge without balancing ?• Perform lab without labelling each sample ?• Clean the place before and after working ?• Clean up all spill you have made ?• etc.
![Page 49: Qc1](https://reader035.vdocuments.us/reader035/viewer/2022081504/5566a706d8b42a643c8b4c0d/html5/thumbnails/49.jpg)
49
![Page 50: Qc1](https://reader035.vdocuments.us/reader035/viewer/2022081504/5566a706d8b42a643c8b4c0d/html5/thumbnails/50.jpg)
50
![Page 51: Qc1](https://reader035.vdocuments.us/reader035/viewer/2022081504/5566a706d8b42a643c8b4c0d/html5/thumbnails/51.jpg)
51
![Page 52: Qc1](https://reader035.vdocuments.us/reader035/viewer/2022081504/5566a706d8b42a643c8b4c0d/html5/thumbnails/52.jpg)
52
What do you do for manage working in the lab ?
• Study MSDS for each chemical used• purchase fume hood for working
with dangerous reagents• Pour all reagents in the sink and
flush water• Keep MSDS in locked bookcase• Keep door locked during working
hour
![Page 53: Qc1](https://reader035.vdocuments.us/reader035/viewer/2022081504/5566a706d8b42a643c8b4c0d/html5/thumbnails/53.jpg)
53
Goals and indicators of quality management of the
lab
• Efficacy - tests, throughput, profit
• Quality - CV, repeatability• Safety – no. of accidents,
![Page 54: Qc1](https://reader035.vdocuments.us/reader035/viewer/2022081504/5566a706d8b42a643c8b4c0d/html5/thumbnails/54.jpg)
54
• Getting work done through others• Managers are concerned with:
– efficiency• getting work done with a minimum of effort,
expense or waste
– effectiveness• accomplishing tasks that help fulfill
organizational objectives
What management help ?
![Page 55: Qc1](https://reader035.vdocuments.us/reader035/viewer/2022081504/5566a706d8b42a643c8b4c0d/html5/thumbnails/55.jpg)
55
Job Performance = Motivation X Ability X Situational
Constraints
• Job performance– how well someone performs
the job
• Motivation– effort put forth on the job
• Ability– capability to do the job
• Situational Constraints– external factors affecting
performance
Effort and PerformanceEffort and Performance
![Page 56: Qc1](https://reader035.vdocuments.us/reader035/viewer/2022081504/5566a706d8b42a643c8b4c0d/html5/thumbnails/56.jpg)
56
![Page 57: Qc1](https://reader035.vdocuments.us/reader035/viewer/2022081504/5566a706d8b42a643c8b4c0d/html5/thumbnails/57.jpg)
57
![Page 58: Qc1](https://reader035.vdocuments.us/reader035/viewer/2022081504/5566a706d8b42a643c8b4c0d/html5/thumbnails/58.jpg)
58
![Page 59: Qc1](https://reader035.vdocuments.us/reader035/viewer/2022081504/5566a706d8b42a643c8b4c0d/html5/thumbnails/59.jpg)
59
![Page 60: Qc1](https://reader035.vdocuments.us/reader035/viewer/2022081504/5566a706d8b42a643c8b4c0d/html5/thumbnails/60.jpg)
60
GLP for Laboratory work
1 . ช่น�ดิของง�น - method development- routine analysis
2. Study plan - ร�ยลิะเอ(ยดิข�/นตอนของง�น ขอม�ลิคุว�มปัลิอดิภ�ย ว�น เวลิ�น�ดิหม�ย ระยะเวลิ�
3. Reports - ร�ยง�นผู้ลิ - ตรวจสอบักำลิ�บัไดิ4. Work records / study files – บั�นที่&กำกำ�รที่ �ง�น,
log book5. Archieves ที่()เกำ0บัเอกำส�รส �คุ�ญ (– กำร�ฟขอม�ลิ ผู้ลิ
กำ�รปัร�บัเที่(ยบั ) ตองปัลิอดิภ�ย ไม#ซี(ดิจ�ง ช่$/น รอน
![Page 61: Qc1](https://reader035.vdocuments.us/reader035/viewer/2022081504/5566a706d8b42a643c8b4c0d/html5/thumbnails/61.jpg)
61
6. Sample retention – ระยะเวลิ�คุงต�วของส�ร กำ�รเกำ0บัส�)งส#งตรวจเพ$)อตรวจซี /�
7. Equipment – ม(กำ�ร calibrate บั �ร�งร�กำษ�ต�มระยะเวลิ�ที่()กำ �หนดิ ม(บั�นที่&กำผู้ลิกำ�รปัร�บัเที่(ยบั/บั �ร�งร�กำษ�
8. Characterization requirements – ขอม�ลิเกำ()ยวกำ�บักำ�รที่ดิสอบั ส�รที่()ใช่ ตองระบั�ช่�ดิเจน คุรบัถ้วน
OECD guideline 6 ขอ – identifying name or code
- Batch identity ลิ �ดิ�บัช่�ดิ คุว�มบัร�ส�ที่ธิ์�5- คุว�มคุงต�ว แลิะสภ�วะที่()ใช่เกำ0บัร�กำษ�- คุว�มคุงต�วของสภ�วะกำ�รที่ดิสอบั- ร�ยลิะเอ(ยดิคุ�#ม$อกำ�รที่ดิสอบั คุว�มคุงต�วของส�รที่()ที่ดิสอบั- ต�วอย#�งอ�งอ�งแต#ลิะช่�ดิ คุวรม(คุว�มคุงต�วอย#�งนอย 4
ส�ปัดิ�ห7 ม(เอกำส�รอ�งอ�งใหส$บัคุนขอม�ลิต#อไดิ(OECD =Organization for Economic
Cooperation and Development)
![Page 62: Qc1](https://reader035.vdocuments.us/reader035/viewer/2022081504/5566a706d8b42a643c8b4c0d/html5/thumbnails/62.jpg)
62
9. Impurity profile ร�ยลิะเอ(ยดิส�รที่()เจ$อปันม� ซี&)งตรวจพบัโดิยว�ธิ์(ใดิ (: GC, HPLC)
1 0 .คุว�มคุงต�วของส�รคุวบัคุ�มคุ�ณภ�พ1 1 .ร�ยลิะเอ(ยดิว�ธิ์(ว�เคุร�ะห7
– specificity (selectivity) - accuracy - precision - recovery - range of determination of analyte- interferences
12. Specification
![Page 63: Qc1](https://reader035.vdocuments.us/reader035/viewer/2022081504/5566a706d8b42a643c8b4c0d/html5/thumbnails/63.jpg)
63
Auditing system1. Pre-auditing – ขั้��นตุอนเตุร�ย์ม QM, QP, SOP,
WI2. Auditing and procedural audit 2.1 Procedural auditing 2.2 Process inspection 2.3 Data auditing 2.4 Report auditing
- Internal auditing - External auditing
![Page 64: Qc1](https://reader035.vdocuments.us/reader035/viewer/2022081504/5566a706d8b42a643c8b4c0d/html5/thumbnails/64.jpg)
64
![Page 65: Qc1](https://reader035.vdocuments.us/reader035/viewer/2022081504/5566a706d8b42a643c8b4c0d/html5/thumbnails/65.jpg)
65
![Page 66: Qc1](https://reader035.vdocuments.us/reader035/viewer/2022081504/5566a706d8b42a643c8b4c0d/html5/thumbnails/66.jpg)
66
กำ�รปัฏิ�บั�ต�ง�นอย#�งถ้�กำตองต�มว�ธิ์(กำ�รที่() กำ �หนดิที่�กำข�/นตอน (Good Laboratory
Practice, GLP) ไม#ส�ม�รถ้ปัระกำ�นคุว�มถ้�กำตองไดิที่�กำต�วอย#�ง เร�จ&งตองม(กำ�รใช่ต�วแที่นเพ$)อเปั9นต�วบั#งช่(/ว#�กำ�รกำระที่ �ที่�/งระบับั
เปั9นไปัต�มม�ตรฐ�นกำ�รปัฏิ�บั�ต�ง�นที่()ถ้�กำตองที่�/งน(/• ผู้�ปัฏิ�บั�ต�ง�นจะตองไดิร�บักำ�รฝึ<กำใหม(คุว�มช่ �น�ญ ( ดิ�จ�กำคุ#� coefficient of variation) • เคุร$)องม$อที่()ใช่ตองม(กำ�รปัร�บัเที่(ยบั (calibrate) แลิะบั �ร�งร�กำษ�ใหอย�# ในสภ�พที่()ใช่กำ�รไดิดิ(• ข�/นตอนกำ�รที่ �ตองม( Standard Operating Procedures (SOPs) แลิะหร$อ Study plan เข(ยนไวแลิะปัฏิ�บั�ต�ต�มอย#�งเคุร#งคุร�ดิ
![Page 67: Qc1](https://reader035.vdocuments.us/reader035/viewer/2022081504/5566a706d8b42a643c8b4c0d/html5/thumbnails/67.jpg)
67
กำ�รแปัลิผู้ลิ GLP ในง�นดิ�นกำ�รว�เคุร�ะห7ต�มกำ�รแบั#งช่น�ดิของง�น
1. ช่น�ดิของง�น เช่#น กำ�รพ�ฒน�ว�ธิ์(กำ�ร ที่ดิสอบั กำ�รที่ดิสอบัปัระจ �ว�น แต#ง�นบั�ง
อย#�งอ�จไม#ส�ม�รถ้มองเห0นไดิ แต#แสดิงไดิ ใน study plan, study file หร$อใน
ร�ยง�นที่()สอดิคุลิองกำ�บัโคุรงง�นหลิ�กำ(Master schedule)
2.Study plan เปั9นร�ยลิะเอ(ยดิข�/นตอนกำ�รที่ �ง�นต�มที่()ตองกำ�(request form) ที่�/งน(/ รวมถ้&งขอม�/ลิเกำ()ยวกำ�บัคุว�ม
ปัลิอดิภ�ย ว�นเวลิ� น�ดิหม�ย ระยะเวลิ�
3. Reports กำ�รร�ยง�นผู้ลิ โดิยม( หม�ยเลิขใหตรวจสอบักำลิ�บัไดิ ม(ลิ�ยเซีนต7
กำ �กำ�บัที่�/งของผู้�ที่ � แลิะห�วหน�โคุรงกำ�ร(director)
![Page 68: Qc1](https://reader035.vdocuments.us/reader035/viewer/2022081504/5566a706d8b42a643c8b4c0d/html5/thumbnails/68.jpg)
68
4. Work records/ study file บั�นที่&กำ กำ�รที่ �ง�นจะเกำ0บัแยกำต#�งห�กำ
เช่#น ม( log book หร$ออ�จเกำ0บัในร�ปัแฟ>มขอม�ลิในคุอมพ�วเตอร75. Archieves ที่()เกำ0บัเอกำส�รส �คุ�ญเอกำส�รส �คุ�ญตองเกำ0บัอย#�งปัลิอดิ ภ�ย ส$บัคุนง#�ย เช่#น กำร�ฟแสดิงขอม�ลิ
ต#�งๆ จะตองไม#ถ้�กำแสง ที่ �ใหส( จ�งห�ยไปั หร$อม(คุว�มช่$/นที่ �ใหข&/นร� แลิะ
ไม#อย�#ใกำลิคุว�มรอน เปั9นตน6. Sample retention ส�รต�วอย#�ง
ตองม(กำ �หนดิช่#วงเวลิ�ที่()เกำ0บัไว ส �หร�บักำรณ(ที่()ตองม(กำ�รที่ดิสอบัซี /� แต#ถ้�
ส�รไม#คุงต�ว กำ0ไม#คุวรเกำ0บั เพ$)อที่ดิสอบัใหม#
![Page 69: Qc1](https://reader035.vdocuments.us/reader035/viewer/2022081504/5566a706d8b42a643c8b4c0d/html5/thumbnails/69.jpg)
69
7. Equipment ตองปัร�บัเที่(ยบัต�ม กำ �หนดิ แลิะบั�นที่&กำผู้ลิกำ�รปัร�บัเที่(ยบั กำ�รใช่
รวมที่�/งสภ�พที่()เปั9นอย�# เกำ0บัไวในแฟ>ม เอกำส�รส �คุ�ญ
8.Characterization requirements กำ�รที่ดิสอบั หร$อส�รต#�งๆ คุวรม(กำ�รระบั�ช่$)อใหช่�ดิเจน คุรบัถ้วน พรอม
ร�ยลิะเอ(ยดิ เช่#น ผู้ลิ�ตภ�ณฑ์7หน&)ง จะตองม(ร�ยลิะเอ(ยดิต�ม
OECD guideline เปั9นอย#�งนอย 6 ขอดิ�งน(/
![Page 70: Qc1](https://reader035.vdocuments.us/reader035/viewer/2022081504/5566a706d8b42a643c8b4c0d/html5/thumbnails/70.jpg)
70
8.1 ช่$)อส�ร หร$อรห�ส (Identifying name or code)8.2 ลิ �ดิ�บัช่�ดิ (Batch identity) ส#วนปัระกำอบั คุว�มบัร�ส�ที่ธิ์�5
ของส�ร8.3 คุว�มคุงต�วภ�ยใตสภ�วะที่()ใช่เกำ0บัร�กำษ�8.4 คุว�มคุงต�วของสภ�วะกำ�รที่ดิสอบั8.5 ร�ยลิะเอ(ยดิคุ�#ม$อกำ�รที่ดิสอบั คุว�มคุงต�วของส�รที่()
ตองกำ�รที่ดิสอบั8.6 ต�วอย#�งอ�งอ�งของแต#ลิะช่�ดิคุวรม(คุว�มคุงต�วไดิอย#�ง
นอย 4 ส�ปัดิ�ห7
ร�ยลิะเอ(ยดิอ$)นๆ เช่#น คุ�ณสมบั�ต�ที่�งเคุม( ช่(วว�ที่ย� ฟAส�กำส7 ช่$)อ บัร�ษ�ที่ที่()ผู้ลิ�ตแลิะสถ้�นที่()ที่()ต�ดิต#อกำลิ�บัไดิ ส�)งเจ$อปันอ$)น ขอม�ลิ
เปัร(ยบัเที่(ยบัต#�งๆ เอกำส�รอ�งอ�ง เปั9นตน
![Page 71: Qc1](https://reader035.vdocuments.us/reader035/viewer/2022081504/5566a706d8b42a643c8b4c0d/html5/thumbnails/71.jpg)
71
![Page 72: Qc1](https://reader035.vdocuments.us/reader035/viewer/2022081504/5566a706d8b42a643c8b4c0d/html5/thumbnails/72.jpg)
72
Company-wide quality control (CWQC)
การบร�หารจ�ดการแบบองค์�รวม
การบร�หารแบบที�กค์นม�ส&วนร&วม
![Page 73: Qc1](https://reader035.vdocuments.us/reader035/viewer/2022081504/5566a706d8b42a643c8b4c0d/html5/thumbnails/73.jpg)
73
TQM concepts :
1. Commitment to quality2. Customer focus3. Total involvement4. Humanity5. Education & training6. Scientific tools & techniques7. Process-oriented
=== Continuous quality improvement (CQI)
![Page 74: Qc1](https://reader035.vdocuments.us/reader035/viewer/2022081504/5566a706d8b42a643c8b4c0d/html5/thumbnails/74.jpg)
74
PLAN
CHECK (Study)
DOACT
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.
![Page 75: Qc1](https://reader035.vdocuments.us/reader035/viewer/2022081504/5566a706d8b42a643c8b4c0d/html5/thumbnails/75.jpg)
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
![Page 76: Qc1](https://reader035.vdocuments.us/reader035/viewer/2022081504/5566a706d8b42a643c8b4c0d/html5/thumbnails/76.jpg)
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
![Page 77: Qc1](https://reader035.vdocuments.us/reader035/viewer/2022081504/5566a706d8b42a643c8b4c0d/html5/thumbnails/77.jpg)
77
1) Identify who are the customers2) Determine the customer’s needs3) Translate the needs into our language4) Develop a product to meet those needs5) 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 product7) Optimise the process8) Prove the process can make the product under operating conditions
Juran’s Quality Planning Road Map
![Page 78: Qc1](https://reader035.vdocuments.us/reader035/viewer/2022081504/5566a706d8b42a643c8b4c0d/html5/thumbnails/78.jpg)
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”
![Page 79: Qc1](https://reader035.vdocuments.us/reader035/viewer/2022081504/5566a706d8b42a643c8b4c0d/html5/thumbnails/79.jpg)
TQM – Prasit Chanarat’s VersionTQM – Prasit Chanarat’s Version
TQM = ที่ คุ ม
• ที่�กำคุนม�
• ที่�กำคุนม�#ง
• ที่�กำคุนม(
• ที่�กำคุนไม#
![Page 80: Qc1](https://reader035.vdocuments.us/reader035/viewer/2022081504/5566a706d8b42a643c8b4c0d/html5/thumbnails/80.jpg)
80
Principle of TQM achievement
1 .ม�#งส�#คุว�มเปั9นเลิ�ศ2. ว�ส�ยที่�ศน7เปัAดิกำว�ง3. ที่�กำคุนเข�ใจ4. เร(ยนร� ที่ �ง�นเปั9นที่(ม5. คุ�ดิเปั9นระบับั
![Page 81: Qc1](https://reader035.vdocuments.us/reader035/viewer/2022081504/5566a706d8b42a643c8b4c0d/html5/thumbnails/81.jpg)
81
3 ว�น�ย 3 ว�ส�ยว�น�ย - ที่�งกำ�รเง�น - ที่�งกำ�รบัร�ห�ร - ของบั�คุลิ�กำรว�ส�ย - ว�ส�ยที่�ศน7ขององคุ7กำร /ผู้�น � - กำ�รที่ �ง�นเปั9นที่(ม - คุว�มม�#งม�)น พ�กำเพ(ยร
![Page 82: Qc1](https://reader035.vdocuments.us/reader035/viewer/2022081504/5566a706d8b42a643c8b4c0d/html5/thumbnails/82.jpg)
82
กำ�รปัระเม�นองคุ7กำรคุ�ณภ�พ 1. ภ�วะผู้�น � - ห�วหน�
- องคุ7กำร - คุว�มร�บัผู้�ดิช่อบัต#อส�งคุม
2 . ขอม�ลิข#�วส�ร / กำ�รว�เคุร�ะห7 - กำ�รบัร�ห�รจ�ดิกำ�ร - ที่ร�บัขอม�ลิข#�วส�รของคุ�#แข#ง - กำ�รว�เคุร�ะห7 / น �ไปัใช่ปัระโยช่น73. กำ�รว�งแผู้น - แผู้นกำลิย�ที่ธิ์7 + กำ�รน �ไปัใช่4. กำ�รบัร�ห�ร + กำ�รพ�ฒน�บั�คุคุลิ
![Page 83: Qc1](https://reader035.vdocuments.us/reader035/viewer/2022081504/5566a706d8b42a643c8b4c0d/html5/thumbnails/83.jpg)
83
กำ�รปัระเม�นองคุ7กำรคุ�ณภ�พ (ต#อ)
5. กำ�รบัร�ห�รกำระบัวนกำ�ร6. กำ�รบัรรลิ�ผู้ลิขององคุ7กำร
- คุ�ณภ�พผู้ลิผู้ลิ�ต บัร�กำ�ร - ผู้ลิส�มฤที่ธิ์7ของกำ�รใช่งบัปัระม�ณ - คุ�ณภ�พของหน#วยปั>อนว�ตถ้�ดิ�บั
7 . ม�#งสนองคุว�มตองกำ�รลิ�กำคุ�
![Page 84: Qc1](https://reader035.vdocuments.us/reader035/viewer/2022081504/5566a706d8b42a643c8b4c0d/html5/thumbnails/84.jpg)
84
บั�ญญ�ต� 16 ปัระกำ�รของ ที่คุม1 .คุว�มเปั9นผู้�น �2. กำ�รเกำ0บัรวบัรวมแลิะว�เคุร�ะห7ขอม�ลิ3 .กำ�รกำ �หนดิว�ส�ยที่�ศน7 / พ�นธิ์กำ�จ / นโยบั�ย / แผู้นปัฏิ�บั�ต�
กำ�ร4. Human Resource Management (HRM)
5 .กำ�รม(ส#วนร#วมของบั�คุลิ�กำร6 .ระบับัพ�ฒน�บั�คุลิ�กำร7. กำ�รใหขว�ญ กำ �ลิ�งใจ8. กำ�รบัร�ห�รจ�ดิกำ�รที่()เหม�ะสม
![Page 85: Qc1](https://reader035.vdocuments.us/reader035/viewer/2022081504/5566a706d8b42a643c8b4c0d/html5/thumbnails/85.jpg)
85
บั�ญญ�ต� 16 ปัระกำ�รของ ที่คุม (ต#อ)
9. กำ�รบัร�ห�รกำระบัวนกำ�รที่()เหม�ะสม1 0 . คุ�ณภ�พว�ตถ้�ดิ�บั1 1 . Benchmarking
1 2 . Customer focus
13. กำ�รบัร�ห�รคุว�มส�มพ�นธิ์7กำ�บัผู้�ร�บับัร�กำ�ร1 4 . กำ�รพ�ฒน�ผู้ลิผู้ลิ�ต บัร�กำ�ร1 5 . กำ�รม(ส#วนร#วมต#อส�งคุม1 6 . กำ�รปัระเม�นผู้ลิระบับัตลิอดิเวลิ�
![Page 86: Qc1](https://reader035.vdocuments.us/reader035/viewer/2022081504/5566a706d8b42a643c8b4c0d/html5/thumbnails/86.jpg)
86
Protection & Preventionกำ�รปั>องกำ�นแลิะหลิ(กำ
เลิ()ยงคุว�มเอ�ใจใส#กำ�รกำลิมกำลิ$น
กำ�รที่ �อย#�งต#อเน$)องสม )�เสมอ
กำ�รม(ส#วนร#วม
Caring
Integration
Repetition
Participation
![Page 87: Qc1](https://reader035.vdocuments.us/reader035/viewer/2022081504/5566a706d8b42a643c8b4c0d/html5/thumbnails/87.jpg)
87
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
![Page 88: Qc1](https://reader035.vdocuments.us/reader035/viewer/2022081504/5566a706d8b42a643c8b4c0d/html5/thumbnails/88.jpg)
Quality is a Journey, not a Destination
Q O
L O I O
GO
![Page 89: Qc1](https://reader035.vdocuments.us/reader035/viewer/2022081504/5566a706d8b42a643c8b4c0d/html5/thumbnails/89.jpg)
Quality is a Journey, not a Destination