The basic concept of TQM
Works methods
Processes and practices
If the participants happen to be an instructor, they will become high-quality instructor and will able to develop high-quality students who can be matched with the global standards.
Total Quality Management in Pharma IndustryInthiyazBegum
INTRODUCTION:
Total quality management increases the customer satisfaction by boosting the quality.
In an increasing competitive market firms with a continuous improvement culture and external focus are more likely to survive and prosper.
What is TQM?
TQM is an approach to improving the effectiveness and flexibilities of business as a whole.
It is essentially a way of organizing and involving the whole organization every department, every activity and every single person at every level.
SIGNIFICANCE OF TQM:
The importance of TQM lies in the fact that in encourages innovation, make the organization adaptable to change , motivate people for better quality ,and integrates the business arising out of the common purpose and all those provide the organization with a valuable and distinctive competitive edge.
Elements of TQM :
Be customer focused
Do it right the first time
Constantly improve
Quality is an attitude
Reasons for TQM failure
TQM fails because :
Top management sees no reasons for change
Top management is not concerned for its staff
Top management is not committed to the TQM programmer
The company loses interest in the programmer after six months
The work force and the management do not agree on what needs to happen.
Benefits of TQM:
Improvement of quality
Employee participation
Team work
Working relationship
Customer satisfaction
Employee satisfaction
IMPORTANCE OF TQM IN PHARMA INDUSTRY :
Handling:
Containers should be opened carefully and subsequently resealed in an approved manner.
Highly sensitive materials such as penicillin's and cephalosporin's should be handle in separate production area.
Highly active should be manufacture in a dedicate area and using delectated reagent.
Storage:
Secure storage facilities should be designated for use to prevent damage of materials.
Should be kept clean and tidy and subject to the appropriate pest control measurement.
Environmental conditions should be recorded.
Storage conditions for API should be based upon stability studies taking into account time.
Packaging:
Labelling and packaging processes should be defined and controlled to ensure that correct packaging materials are used correctly and other specified requirements are met.
Printed labels should be securely to avoid mix ups arising store.
Facilities and equipment :
The location ,design, and construction of buildings should be suitable for the type and stage of manufacture involved protecting the product from contamination and protecting operators and the environment from the product.
Equipment surfaces in contact with materials used in API manufacturing should be non reactive.
Conclusion :
Total quality management encourages participation amongst ,employees ,managers ,and organizations whole.
The responsibilities either its professional, social , legal, one that the rest with the pharmaceutical manufacturing for the assurance of quality.
Control should be practiced rigorously.
The basic concept of TQM
Works methods
Processes and practices
If the participants happen to be an instructor, they will become high-quality instructor and will able to develop high-quality students who can be matched with the global standards.
Total Quality Management in Pharma IndustryInthiyazBegum
INTRODUCTION:
Total quality management increases the customer satisfaction by boosting the quality.
In an increasing competitive market firms with a continuous improvement culture and external focus are more likely to survive and prosper.
What is TQM?
TQM is an approach to improving the effectiveness and flexibilities of business as a whole.
It is essentially a way of organizing and involving the whole organization every department, every activity and every single person at every level.
SIGNIFICANCE OF TQM:
The importance of TQM lies in the fact that in encourages innovation, make the organization adaptable to change , motivate people for better quality ,and integrates the business arising out of the common purpose and all those provide the organization with a valuable and distinctive competitive edge.
Elements of TQM :
Be customer focused
Do it right the first time
Constantly improve
Quality is an attitude
Reasons for TQM failure
TQM fails because :
Top management sees no reasons for change
Top management is not concerned for its staff
Top management is not committed to the TQM programmer
The company loses interest in the programmer after six months
The work force and the management do not agree on what needs to happen.
Benefits of TQM:
Improvement of quality
Employee participation
Team work
Working relationship
Customer satisfaction
Employee satisfaction
IMPORTANCE OF TQM IN PHARMA INDUSTRY :
Handling:
Containers should be opened carefully and subsequently resealed in an approved manner.
Highly sensitive materials such as penicillin's and cephalosporin's should be handle in separate production area.
Highly active should be manufacture in a dedicate area and using delectated reagent.
Storage:
Secure storage facilities should be designated for use to prevent damage of materials.
Should be kept clean and tidy and subject to the appropriate pest control measurement.
Environmental conditions should be recorded.
Storage conditions for API should be based upon stability studies taking into account time.
Packaging:
Labelling and packaging processes should be defined and controlled to ensure that correct packaging materials are used correctly and other specified requirements are met.
Printed labels should be securely to avoid mix ups arising store.
Facilities and equipment :
The location ,design, and construction of buildings should be suitable for the type and stage of manufacture involved protecting the product from contamination and protecting operators and the environment from the product.
Equipment surfaces in contact with materials used in API manufacturing should be non reactive.
Conclusion :
Total quality management encourages participation amongst ,employees ,managers ,and organizations whole.
The responsibilities either its professional, social , legal, one that the rest with the pharmaceutical manufacturing for the assurance of quality.
Control should be practiced rigorously.
According to WHO (World Health Organization):
“QA is the activity of providing evidence needed to establish confidence among all concerned that quality related activities are being performed effectively.”
According to ISO:
“All those planned and systematic activities implemented to provide adequate confidence that an entity will fulfill requirements for quality.
Quality control (QC) is a procedure or set of procedures intended to ensure that a manufactured product or performed service adheres to a defined set of quality criteria or meets the requirements of the client or customer. QC is similar to, but not identical with, quality assurance (QA).
QC IN clinical biochemistry labs and hospitals
Wei-Meng fi rst started the iPhone programming course in Singapore and it has since received
much positive feedback. His hands-on approach to iPhone programming makes understanding
the subject much easier than reading books, tutorials, and documentation from Apple.
Contact Wei-Meng at weimenglee@learn2develop.net.
Fundamental knowledge on pharmaceutical
product development and translation from laboratory to market.
Quality management systems: Quality management & Certifications.
Quality concepts in pharmaceutical industry
ICH guidelines and Total quality management
Quality by design and six sigma concepts
ISO standards and series
Good laboratory practice
Basic definition of six sigma, why as it introduced in the first place, the mathematical expression, statistical definition, sig sigma application in clinical laboratory.
According to WHO (World Health Organization):
“QA is the activity of providing evidence needed to establish confidence among all concerned that quality related activities are being performed effectively.”
According to ISO:
“All those planned and systematic activities implemented to provide adequate confidence that an entity will fulfill requirements for quality.
Quality control (QC) is a procedure or set of procedures intended to ensure that a manufactured product or performed service adheres to a defined set of quality criteria or meets the requirements of the client or customer. QC is similar to, but not identical with, quality assurance (QA).
QC IN clinical biochemistry labs and hospitals
Wei-Meng fi rst started the iPhone programming course in Singapore and it has since received
much positive feedback. His hands-on approach to iPhone programming makes understanding
the subject much easier than reading books, tutorials, and documentation from Apple.
Contact Wei-Meng at weimenglee@learn2develop.net.
Fundamental knowledge on pharmaceutical
product development and translation from laboratory to market.
Quality management systems: Quality management & Certifications.
Quality concepts in pharmaceutical industry
ICH guidelines and Total quality management
Quality by design and six sigma concepts
ISO standards and series
Good laboratory practice
Basic definition of six sigma, why as it introduced in the first place, the mathematical expression, statistical definition, sig sigma application in clinical laboratory.
Quality assurance and quality management concepts.pptxGayatriBahatkar1
UNIT – I
Quality Assurance and Quality Management concepts: Definition and concept of Quality
control, Quality assurance and GMP
Total Quality Management (TQM): Definition, elements, philosophies
Total Quality Management (TQM) by Dr Anurag YadavDr Anurag Yadav
Laboratory Total Quality Management, Concept of Laboratory errors, the quality control material, quality assurance program, factors affecting the quality of report, Steps in quality management, PDCA cycle, accuracy, precision, EQAS, IQAS, Proficiency testing.
the details are related to medical laboratory and help MBBS, MD, BSc MLT, MSc MLT, etc
Nursing leadership and management course / Total Quality MnagementMouad Hourani
What is Quality?
Definition of Quality in healthcare?
Quality Evolution .
Quality control.
Quality Assurance.
Total Quality Management.
Old vs. TQM Approach.
The Deming, Juran and Crosby philosophies.
Quality Principles.
Why Quality?
Quality perspectives.
Key Dimensions of Quality.
Good Managers (Leaders)
Earliest Galaxies in the JADES Origins Field: Luminosity Function and Cosmic ...Sérgio Sacani
We characterize the earliest galaxy population in the JADES Origins Field (JOF), the deepest
imaging field observed with JWST. We make use of the ancillary Hubble optical images (5 filters
spanning 0.4−0.9µm) and novel JWST images with 14 filters spanning 0.8−5µm, including 7 mediumband filters, and reaching total exposure times of up to 46 hours per filter. We combine all our data
at > 2.3µm to construct an ultradeep image, reaching as deep as ≈ 31.4 AB mag in the stack and
30.3-31.0 AB mag (5σ, r = 0.1” circular aperture) in individual filters. We measure photometric
redshifts and use robust selection criteria to identify a sample of eight galaxy candidates at redshifts
z = 11.5 − 15. These objects show compact half-light radii of R1/2 ∼ 50 − 200pc, stellar masses of
M⋆ ∼ 107−108M⊙, and star-formation rates of SFR ∼ 0.1−1 M⊙ yr−1
. Our search finds no candidates
at 15 < z < 20, placing upper limits at these redshifts. We develop a forward modeling approach to
infer the properties of the evolving luminosity function without binning in redshift or luminosity that
marginalizes over the photometric redshift uncertainty of our candidate galaxies and incorporates the
impact of non-detections. We find a z = 12 luminosity function in good agreement with prior results,
and that the luminosity function normalization and UV luminosity density decline by a factor of ∼ 2.5
from z = 12 to z = 14. We discuss the possible implications of our results in the context of theoretical
models for evolution of the dark matter halo mass function.
A brief information about the SCOP protein database used in bioinformatics.
The Structural Classification of Proteins (SCOP) database is a comprehensive and authoritative resource for the structural and evolutionary relationships of proteins. It provides a detailed and curated classification of protein structures, grouping them into families, superfamilies, and folds based on their structural and sequence similarities.
Nutraceutical market, scope and growth: Herbal drug technologyLokesh Patil
As consumer awareness of health and wellness rises, the nutraceutical market—which includes goods like functional meals, drinks, and dietary supplements that provide health advantages beyond basic nutrition—is growing significantly. As healthcare expenses rise, the population ages, and people want natural and preventative health solutions more and more, this industry is increasing quickly. Further driving market expansion are product formulation innovations and the use of cutting-edge technology for customized nutrition. With its worldwide reach, the nutraceutical industry is expected to keep growing and provide significant chances for research and investment in a number of categories, including vitamins, minerals, probiotics, and herbal supplements.
THE IMPORTANCE OF MARTIAN ATMOSPHERE SAMPLE RETURN.Sérgio Sacani
The return of a sample of near-surface atmosphere from Mars would facilitate answers to several first-order science questions surrounding the formation and evolution of the planet. One of the important aspects of terrestrial planet formation in general is the role that primary atmospheres played in influencing the chemistry and structure of the planets and their antecedents. Studies of the martian atmosphere can be used to investigate the role of a primary atmosphere in its history. Atmosphere samples would also inform our understanding of the near-surface chemistry of the planet, and ultimately the prospects for life. High-precision isotopic analyses of constituent gases are needed to address these questions, requiring that the analyses are made on returned samples rather than in situ.
Introduction:
RNA interference (RNAi) or Post-Transcriptional Gene Silencing (PTGS) is an important biological process for modulating eukaryotic gene expression.
It is highly conserved process of posttranscriptional gene silencing by which double stranded RNA (dsRNA) causes sequence-specific degradation of mRNA sequences.
dsRNA-induced gene silencing (RNAi) is reported in a wide range of eukaryotes ranging from worms, insects, mammals and plants.
This process mediates resistance to both endogenous parasitic and exogenous pathogenic nucleic acids, and regulates the expression of protein-coding genes.
What are small ncRNAs?
micro RNA (miRNA)
short interfering RNA (siRNA)
Properties of small non-coding RNA:
Involved in silencing mRNA transcripts.
Called “small” because they are usually only about 21-24 nucleotides long.
Synthesized by first cutting up longer precursor sequences (like the 61nt one that Lee discovered).
Silence an mRNA by base pairing with some sequence on the mRNA.
Discovery of siRNA?
The first small RNA:
In 1993 Rosalind Lee (Victor Ambros lab) was studying a non- coding gene in C. elegans, lin-4, that was involved in silencing of another gene, lin-14, at the appropriate time in the
development of the worm C. elegans.
Two small transcripts of lin-4 (22nt and 61nt) were found to be complementary to a sequence in the 3' UTR of lin-14.
Because lin-4 encoded no protein, she deduced that it must be these transcripts that are causing the silencing by RNA-RNA interactions.
Types of RNAi ( non coding RNA)
MiRNA
Length (23-25 nt)
Trans acting
Binds with target MRNA in mismatch
Translation inhibition
Si RNA
Length 21 nt.
Cis acting
Bind with target Mrna in perfect complementary sequence
Piwi-RNA
Length ; 25 to 36 nt.
Expressed in Germ Cells
Regulates trnasposomes activity
MECHANISM OF RNAI:
First the double-stranded RNA teams up with a protein complex named Dicer, which cuts the long RNA into short pieces.
Then another protein complex called RISC (RNA-induced silencing complex) discards one of the two RNA strands.
The RISC-docked, single-stranded RNA then pairs with the homologous mRNA and destroys it.
THE RISC COMPLEX:
RISC is large(>500kD) RNA multi- protein Binding complex which triggers MRNA degradation in response to MRNA
Unwinding of double stranded Si RNA by ATP independent Helicase
Active component of RISC is Ago proteins( ENDONUCLEASE) which cleave target MRNA.
DICER: endonuclease (RNase Family III)
Argonaute: Central Component of the RNA-Induced Silencing Complex (RISC)
One strand of the dsRNA produced by Dicer is retained in the RISC complex in association with Argonaute
ARGONAUTE PROTEIN :
1.PAZ(PIWI/Argonaute/ Zwille)- Recognition of target MRNA
2.PIWI (p-element induced wimpy Testis)- breaks Phosphodiester bond of mRNA.)RNAse H activity.
MiRNA:
The Double-stranded RNAs are naturally produced in eukaryotic cells during development, and they have a key role in regulating gene expression .
Seminar of U.V. Spectroscopy by SAMIR PANDASAMIR PANDA
Spectroscopy is a branch of science dealing the study of interaction of electromagnetic radiation with matter.
Ultraviolet-visible spectroscopy refers to absorption spectroscopy or reflect spectroscopy in the UV-VIS spectral region.
Ultraviolet-visible spectroscopy is an analytical method that can measure the amount of light received by the analyte.
Cancer cell metabolism: special Reference to Lactate PathwayAADYARAJPANDEY1
Normal Cell Metabolism:
Cellular respiration describes the series of steps that cells use to break down sugar and other chemicals to get the energy we need to function.
Energy is stored in the bonds of glucose and when glucose is broken down, much of that energy is released.
Cell utilize energy in the form of ATP.
The first step of respiration is called glycolysis. In a series of steps, glycolysis breaks glucose into two smaller molecules - a chemical called pyruvate. A small amount of ATP is formed during this process.
Most healthy cells continue the breakdown in a second process, called the Kreb's cycle. The Kreb's cycle allows cells to “burn” the pyruvates made in glycolysis to get more ATP.
The last step in the breakdown of glucose is called oxidative phosphorylation (Ox-Phos).
It takes place in specialized cell structures called mitochondria. This process produces a large amount of ATP. Importantly, cells need oxygen to complete oxidative phosphorylation.
If a cell completes only glycolysis, only 2 molecules of ATP are made per glucose. However, if the cell completes the entire respiration process (glycolysis - Kreb's - oxidative phosphorylation), about 36 molecules of ATP are created, giving it much more energy to use.
IN CANCER CELL:
Unlike healthy cells that "burn" the entire molecule of sugar to capture a large amount of energy as ATP, cancer cells are wasteful.
Cancer cells only partially break down sugar molecules. They overuse the first step of respiration, glycolysis. They frequently do not complete the second step, oxidative phosphorylation.
This results in only 2 molecules of ATP per each glucose molecule instead of the 36 or so ATPs healthy cells gain. As a result, cancer cells need to use a lot more sugar molecules to get enough energy to survive.
Unlike healthy cells that "burn" the entire molecule of sugar to capture a large amount of energy as ATP, cancer cells are wasteful.
Cancer cells only partially break down sugar molecules. They overuse the first step of respiration, glycolysis. They frequently do not complete the second step, oxidative phosphorylation.
This results in only 2 molecules of ATP per each glucose molecule instead of the 36 or so ATPs healthy cells gain. As a result, cancer cells need to use a lot more sugar molecules to get enough energy to survive.
introduction to WARBERG PHENOMENA:
WARBURG EFFECT Usually, cancer cells are highly glycolytic (glucose addiction) and take up more glucose than do normal cells from outside.
Otto Heinrich Warburg (; 8 October 1883 – 1 August 1970) In 1931 was awarded the Nobel Prize in Physiology for his "discovery of the nature and mode of action of the respiratory enzyme.
WARNBURG EFFECT : cancer cells under aerobic (well-oxygenated) conditions to metabolize glucose to lactate (aerobic glycolysis) is known as the Warburg effect. Warburg made the observation that tumor slices consume glucose and secrete lactate at a higher rate than normal tissues.
Cancer cell metabolism: special Reference to Lactate Pathway
quality management lec 4 power point
1. 1
From Good Laboratory PracticeFrom Good Laboratory Practice
to Total Quality Management into Total Quality Management in
Medical Laboratories :Medical Laboratories :
The PerspectiveThe Perspective
October, 2002 S ChengOctober, 2002 S Cheng
2. 2
What is QualityWhat is Quality
Quality is the entity of a product ( service )Quality is the entity of a product ( service )
which fulfils the defined and expectedwhich fulfils the defined and expected
requirementrequirement
The customer checks if the product meet theThe customer checks if the product meet the
requirementsrequirements
3. 3
Quality in Medical Laboratory TestingQuality in Medical Laboratory Testing
The right test resultThe right test result, at the, at the
Right time, on theRight time, on the
Right specimen, from the right patient, withRight specimen, from the right patient, with
result interpretation based onresult interpretation based on
Correct reference dataCorrect reference data, and at the, and at the
Right priceRight price
5. 5
Evolution of Quality SystemsEvolution of Quality Systems
Quality
Control
Good
Manufacturing
Practice
Quality Assurance
Quality Management
System
Total Quality Managment
Beyond TQM
1975-90 West
1962-75 Japan
1950-62 TQC
Deming, Juran,
Ishikawa
1942-45 TPC
1930 SPC
Shewart
1920-1945 QC Depts
1915 Gilbreth
1890's Taylor
>2000
1980's ISO9000
1988 EEC
1972 EPIC
1969 WHO
1968 UK
1962 USA
ISO9004:1994
ISO9001:1994
ISO9001:2000
6. 6
Overview on the Functions ofOverview on the Functions of
The Medical LaboratoryThe Medical Laboratory
Reference Standards
and/or Statutory Requirements
Subcontracting
Laboratories
(Tests & Calibration)
Hospital,
Clinicians &
Clients
Medical
Laboratory
GLP/ISO/TQM
8. 8
Quality Management SystemQuality Management System
Achieving customer satisfaction byAchieving customer satisfaction by
meeting customer’s expectation andmeeting customer’s expectation and
preventing non-conformity at all stage ofpreventing non-conformity at all stage of
process from design to service.process from design to service.
Enhance the performance of theEnhance the performance of the
organization through internal and externalorganization through internal and external
auditaudit
9. 9
Quality Management
Quality System
Quality Assurance
Quality
Control
Policy, Objective,
Committent & Direction
Organization Structure,
Responsibility, Accoutability
Operational & Technical
Activities on Fulfilling Quality
Requirements
External QA
Internal QA
QM, QA and QC inter-QM, QA and QC inter-
relationshipsrelationships
10. 10
Why Quality Management isWhy Quality Management is
everybody’s darlingeverybody’s darling
Quality costs, but poor QualityQuality costs, but poor Quality
costs morecosts more
Regulator : reduces workload, ( manpower )Regulator : reduces workload, ( manpower )
Blood Industry Officials: makes theBlood Industry Officials: makes the
environment transparentenvironment transparent
Hospitals : reduces responsibility to patientsHospitals : reduces responsibility to patients
11. 11
Cost of QualityCost of Quality
Appraisal
Failure
Prevention
Appraisal
Failure
Prevention
Before After
gain
12. 12
Demings chain
Improvement of quality Improvement of productivity
Cost-reductionPrice-reductionMarket-share
Secure position Secure jobs
13. 13
Demings chain in Laboratory Service
Improvement of quality Improvement of productivity
Cost-reductionPrice-reductionMarket-share
Secure position Secure jobs
14. 14
My problems with the definitionsMy problems with the definitions
of qualityof quality
Does the customer have all the informationDoes the customer have all the information
he needs to qualify the products? Service?he needs to qualify the products? Service?
Is it his responsibility to check the qualityIs it his responsibility to check the quality
or standards?or standards?
Is’nt there a discrepancy betweenIs’nt there a discrepancy between
customer’s expectations and requirements ?customer’s expectations and requirements ?
15. 15
It is our ethical responsibility toIt is our ethical responsibility to
define the level of qualitydefine the level of quality
A patient is not able to figure all transfusionA patient is not able to figure all transfusion
risks. He might be unconscious on intensiverisks. He might be unconscious on intensive
care.care.
We know all about transfusion risk andWe know all about transfusion risk and
must be responsible for the safety.must be responsible for the safety.
A perfect balance is the major support for aA perfect balance is the major support for a
good quality management.good quality management.
16. 16
Flawless quality management:Flawless quality management:
( Error Management )( Error Management )
Quality management has to be flawless.Quality management has to be flawless.
Discovery of errors in documents, orDiscovery of errors in documents, or
problems must lead to the consideration toproblems must lead to the consideration to
end, or change the process.end, or change the process.
17. 17
Quality LayersQuality Layers
1.1. Minimal requirements “ Bad Quality”Minimal requirements “ Bad Quality”
2.2. Functional Requirement “Quality”Functional Requirement “Quality”
3.3. Non-functional requirements “GoodNon-functional requirements “Good
Quality”Quality”
4.4. Far ahead of customer expectationsFar ahead of customer expectations
“Excellence”“Excellence”
18. 18
Should’nt we achieveShould’nt we achieve
excellence ?excellence ?
Quality = ExcellenceQuality = Excellence
Excellence begins in your mindExcellence begins in your mind
19. 19
Quality PlanningQuality Planning
Part of Quality management focused onPart of Quality management focused on
setting quality objectives and specifyingsetting quality objectives and specifying
necessary processes and related resources tonecessary processes and related resources to
fulfil the quality objectivefulfil the quality objective
20. 20
3 E in quality3 E in quality
EffectivenessEffectiveness (( doing the right thingsdoing the right things))
- extent to which planed activities are realized- extent to which planed activities are realized
and planed results achievedand planed results achieved
EfficiencyEfficiency (( doing things rightdoing things right ))
- relationship between the result achieved and- relationship between the result achieved and
the resources usedthe resources used
ExcellenceExcellence
- Doing the right things right !!- Doing the right things right !!
21. 21
The 8 columns of excellenceThe 8 columns of excellence
Orientation on results
Orientation of customers
Leadership &
consequences of goals
Management of
processes & facts
Involvement of
employees
Continuous learning
Building partnerships
Responsibility for
the community
22. 22
Achieved By Good PracticesAchieved By Good Practices
GLP – Good Laboratory PracticeGLP – Good Laboratory Practice
GCL – Good Clinical PracticeGCL – Good Clinical Practice
GMP – Good Manufacturing PracticeGMP – Good Manufacturing Practice
GTP – Good Transportation PracticeGTP – Good Transportation Practice
GDP – Good Distribution PracticeGDP – Good Distribution Practice
GAMP – Good Automated ManufacturingGAMP – Good Automated Manufacturing
PracticePractice
GRP- Good Regulatory PracticeGRP- Good Regulatory Practice
23. 23
Medical laboratory qualityMedical laboratory quality
systemsystem
A quality system is essential in theA quality system is essential in the
laboratory to ensure the correct resultslaboratory to ensure the correct results
for the correct patient / donorfor the correct patient / donor
By Good Laboratory PracticeBy Good Laboratory Practice
( GLP )( GLP )
24. 24
Good Laboratory Practice( GLP )Good Laboratory Practice( GLP )
Main areas of GLPMain areas of GLP
- Organization and personnel- Organization and personnel
- FacilitiesFacilities
- EquipmentEquipment
- Reagent / test kitsReagent / test kits
- DocumentationDocumentation
- Inter-laboratory comparisonInter-laboratory comparison
25. 25
Organization and PersonnelOrganization and Personnel
Quality management systemQuality management system
On AccountabilityOn Accountability
-Responsibilities-Responsibilities
-Authorities-Authorities
TrainingTraining
- Competency based- Competency based
32. 32
By Other Quality ManagementBy Other Quality Management
SystemSystem
International StandardsInternational Standards
e.g.e.g. ISO 9000 series,ISO 9000 series,
ISO/IEC 17025:1999ISO/IEC 17025:1999
( General Requirements for the Competence of( General Requirements for the Competence of
Testing and Calibration Laboratories )Testing and Calibration Laboratories )
33. 33
ISO1/IEC 17025, ISO15189ISO1/IEC 17025, ISO15189
Development HistoryDevelopment History
ISO
Guide 25
1978
ISO/IEC
Guide 25 1st Ed.
1982
ISO/IEC
Guide 25 2nd Ed.
1990
ISO/IEC 17025:1999
(Standard)
ISO/DIS 15189 (2002)
Medical Laboratories
Particular Requirements for Quality
& Competance
Beyond TQM
ISO9000-2000
ISO9000-1994
ISO9000-1987
NATA ILAC
(1947) (1945)
>2000
Guideline
(Testing)
Requirement
(Testing)
Requirement
(Testing/Calibration)
Requirements for
Competence of
Testing & Calibration
Standards
34. 34
InIn 1985 JCAHO published its 10-step1985 JCAHO published its 10-step
QA monitoring process.QA monitoring process.
1.1. Assign responsibility for QA plan.Assign responsibility for QA plan.
2.2. Define scope of patient care.Define scope of patient care.
3.3. Identify important aspects of care.Identify important aspects of care.
4.4. Construct indicators.Construct indicators.
5.5. Define thresholds for evaluation.Define thresholds for evaluation.
6.6. Collect and organize data.Collect and organize data.
7.7. Evaluate data.Evaluate data.
8.8. Develop corrective action plan.Develop corrective action plan.
9.9. Assess action; document improvement.Assess action; document improvement.
10.10. Communicate relevant information.Communicate relevant information.
35. 35
JCAHO has also establishedJCAHO has also established ninenine
dimensions of performance thatdimensions of performance that
must be included and measured inmust be included and measured in
the design of the organization’sthe design of the organization’s
quality assessment and performancequality assessment and performance
improvement plan:improvement plan:
37. 37
National Accreditation SchemeNational Accreditation Scheme
CAP Laboratory Accreditation ProgrammCAP Laboratory Accreditation Programm
( LAP ), USA( LAP ), USA
CPA , Clinical Pathology AccreditationCPA , Clinical Pathology Accreditation
( UK) Ltd., Standards for the Medical( UK) Ltd., Standards for the Medical
LaboratoryLaboratory
38. 38
ISO/IEC 17025:1999- General RequirementsISO/IEC 17025:1999- General Requirements
for the Competence of Testing & Calibrationfor the Competence of Testing & Calibration
LaboratoriesLaboratories ( Based on ISO9001:1994 )( Based on ISO9001:1994 )
An international standard forAn international standard for
recognising competence in testing &recognising competence in testing &
calibration laboratoriescalibration laboratories
39. 39
ISO/IEC 17025:1999- General RequirementsISO/IEC 17025:1999- General Requirements
for the Competence of Testing & Calibrationfor the Competence of Testing & Calibration
Laboratories con’tLaboratories con’t
Sets out basic quality system requirementsSets out basic quality system requirements
in accordance with ISO9001 or 9002in accordance with ISO9001 or 9002
Laboratories carrying out calibration andLaboratories carrying out calibration and
testing activities and meeting thetesting activities and meeting the
requirements will therefore also operaterequirements will therefore also operate
accordance with the ISO 9000 series qualityaccordance with the ISO 9000 series quality
systemsystem
40. 40
ISO9001:1994 – The Role andISO9001:1994 – The Role and
Function of 20 ElementsFunction of 20 Elements
4.8 4.13
4.104.12 4.11
4.20
4.3 4.194.154.94.6/74.4
Q
4.1
4.2
4.5 4.16 4.18
4.14 4.17
Policy & Organisation
Structure
Control Management &
Training
Measuring, Identification
& Traceability
Essential Processes
41. 41
Management and TechnicalManagement and Technical
criteria for Accreditationcriteria for Accreditation
Compliance with criteria in Section 4,Compliance with criteria in Section 4,
Management Requirements;Management Requirements;
Compliance with the criteria in Section 5,Compliance with the criteria in Section 5,
Technical Requirements ofTechnical Requirements of Technical CriteriaTechnical Criteria
for Laboratory Accreditation HKLAS 003for Laboratory Accreditation HKLAS 003
Compliance with HKLAS 002 – regulationsCompliance with HKLAS 002 – regulations
governing the administration of HOKLAS andgoverning the administration of HOKLAS and
the obligations of accredited laboratories.the obligations of accredited laboratories.
42. 42
UNCERTAINTY OFUNCERTAINTY OF
MEASUREMENTMEASUREMENT
Calibration LaboratoriesCalibration Laboratories
Accredited for calibrations under theAccredited for calibrations under the
“Calibration Service” Test category“Calibration Service” Test category
Refer to ISO “Guide to Expression ofRefer to ISO “Guide to Expression of
Uncertainty in Measurement” (GUM)Uncertainty in Measurement” (GUM)
Refer to EA-4/02, for application of GUMRefer to EA-4/02, for application of GUM
website:www.european-accreditation.orgwebsite:www.european-accreditation.org
43. 43
Testing LaboratoriesTesting Laboratories
Required to estimate the uncertainty ofRequired to estimate the uncertainty of
measurement in accordance with 5.4.6.2 ofmeasurement in accordance with 5.4.6.2 of
the HKLAS 003the HKLAS 003
44. 44
Asia Pacific Laboratory AccreditationAsia Pacific Laboratory Accreditation
Cooperation (APLAC)Cooperation (APLAC)
Established in 1992, Secretary Office in AustraliaEstablished in 1992, Secretary Office in Australia
MRA, Mutual Recognition AgreementMRA, Mutual Recognition Agreement
Members consisted of 7 countries, 13 LaboratoryMembers consisted of 7 countries, 13 Laboratory
accredition bodies (December, 1999 figure)accredition bodies (December, 1999 figure)
1.1. China, China Taipei, China Hong KongChina, China Taipei, China Hong Kong
2.2. AustraliaAustralia
3.3. New ZealandNew Zealand
4.4. KoreaKorea
5.5. SingaporeSingapore
6.6. United StateUnited State
7.7. JapanJapan
45. 45
The Hong Kong LaboratoryThe Hong Kong Laboratory
Accreditation Scheme (HOKLAS)Accreditation Scheme (HOKLAS)
Found in 1985Found in 1985
Function : identifying and recognisingFunction : identifying and recognising
competent testing & calibration laboratoriescompetent testing & calibration laboratories
in Hong Kongin Hong Kong
Expanded in 1998, forming Hong KongExpanded in 1998, forming Hong Kong
Accreditation Service (HKAS)Accreditation Service (HKAS)
46. 46
HKLAS – Scope ofHKLAS – Scope of
AccreditationAccreditation
Electrical and Electronic ProductsElectrical and Electronic Products
Textiles and GarmentsTextiles and Garments
Toys and children productToys and children product
FoodFood
Calibration serviceCalibration service
Construction materialsConstruction materials
Environmental testingEnvironmental testing
Chemical testingChemical testing
MiscellaneousMiscellaneous
Other Test Categories may be added whenOther Test Categories may be added when
significant needs are identified.significant needs are identified.
47. 47
Pathology LaboratoryPathology Laboratory
Accreditation in Hong KongAccreditation in Hong Kong
In year 2003In year 2003
Mandatory orMandatory or
Voluntary ??Voluntary ??
Based on which standard (S ) ??Based on which standard (S ) ??
48. 48
Technical Criteria – ISO/IEC17025:1999Technical Criteria – ISO/IEC17025:1999
4. Management Requirements4. Management Requirements
4.1 Organizaton4.1 Organizaton
4.2 Quality system4.2 Quality system
4.3 Document control4.3 Document control
4.4 Review of request,4.4 Review of request,
tenders or contracttenders or contract
4.5 Subcontracting of tests4.5 Subcontracting of tests
and calibrationsand calibrations
4.6 Purchasing services and4.6 Purchasing services and
suppliessupplies
4.7 Service to the client4.7 Service to the client
4.8 Complaints4.8 Complaints
4.9 Control of NC Testing4.9 Control of NC Testing
and/or calibration workand/or calibration work
4.10 Corrective action4.10 Corrective action
4.11 Preventive action4.11 Preventive action
4.12 Control of records4.12 Control of records
4.13 Internal audits4.13 Internal audits
4.14 Management Reviews4.14 Management Reviews
49. 49
5. Technical Requiremnts5. Technical Requiremnts
5.1 General5.1 General
5.2 Personnel5.2 Personnel
5.3 Accommodation &5.3 Accommodation &
environment conditionsenvironment conditions
5.4 Tests & calibration5.4 Tests & calibration
methods and methodsmethods and methods
validationvalidation
5.5 Equipment5.5 Equipment
5.6 Measurement traceability5.6 Measurement traceability
5.7 Sampling5.7 Sampling
5.8 Handling of test and5.8 Handling of test and
calibration itemscalibration items
5.9 Assuring the quality of5.9 Assuring the quality of
testtest
5.10 Reporting the results5.10 Reporting the results
50. 50
Quality Policy – determined andQuality Policy – determined and
issued by the Top Managementissued by the Top Management
Objectives
Policy Statement, Vision, Mission &
Quality Planning:
Commitment to
Quality of Professional Standards
Quality Standard Requirements
e.g. ISO9000; ISO/IEC17025 etc
Understanding,
Implementation &
Review
Service Standards
and / or Statutory
Requirements
Communication
51. 51
Documentation Structure : hierarchyDocumentation Structure : hierarchy
WI
Records
QP
Quality Manual
(Policy, Vision, Mission, Objectives
and Commitment to Quality)
Structure, Responsibility &
Authority
QM
Quality Procedure
(Guidelines to perform quality
related activities)SOP
Forms, Results, Reference
Standards &
Equipment Manuals
52. 52
Documentation SystemDocumentation System
Quality
Policy
Maintenance
Calibration
Distribution
Training
Quality Policy
Manual
Computer
Quality
Records
Patient / Client
QC/QA Testing
Registers / Log
Other Records
Production
Codes of
Profession
Specifications Directions
Critical Materials
Labels
Process
Quality Control
Reagents / Kits
Equipment
Management QPs
Workplace WIs
Management QMs
Collection
Processing
Testing/
Exam
Storage
Labelling
Personal Data and Testing
Audit
Incident and Complaint
Surveillance QA
Disposal
System Reviews
Organization Reviews
International Standards (ISO
9000)
Service Standards
(ISO 17025)
OS&H Ordinance
Calibration Device
Chemicals (MSDS)
Materials
Organization Background,
Vision, Mission, Objectives, Plans
Responsibilty, Authority
53. 53
Prepare
Documents as
Required in
Standard Format
Authority Use Only
Valid &
Controlled
Documents
Regular
Review,
Revise
Easy Accessible to All
Obsolete Document
Authority
Return &
Destroy
Distribution
Retrieval
Document ControlDocument Control
54. 54
Benefits of Quality SystemsBenefits of Quality Systems
Consistently achieve ‘customers’Consistently achieve ‘customers’
requirementsrequirements
Minimize errors, “waste” and complaintsMinimize errors, “waste” and complaints
Improve efficiencyImprove efficiency
ReducesReduces
- negative impact on customers- negative impact on customers
- likelihood of litigation- likelihood of litigation
- communication breakdown- communication breakdown
55. 55
Con’tCon’t
Improve safety and moraleImprove safety and morale
StandardizationStandardization
Ensure adequacy of resourcesEnsure adequacy of resources
Build-in improvement toolsBuild-in improvement tools
Facilitates changes & easier problemFacilitates changes & easier problem
solvingsolving
56. 56
ISO 15189ISO 15189 Medical Laboratories –Medical Laboratories –
Particular requirements for quality andParticular requirements for quality and
competencecompetence ( Based on ISO9001:2000)( Based on ISO9001:2000)
44 Management requirementManagement requirement
4.1 Organisation and management4.1 Organisation and management
4.2 Quality management system4.2 Quality management system
4.3 Document control4.3 Document control
4.4 Review of requests and contracts4.4 Review of requests and contracts
4.5 Examination by referral laboratories4.5 Examination by referral laboratories
4.6 External services and supplies4.6 External services and supplies
4.7 Advisory services4.7 Advisory services
57. 57
Medical Laboratories – ParticularMedical Laboratories – Particular
requirements for quality andrequirements for quality and
competence (con’t)competence (con’t)
4.8 Resolution of complaints4.8 Resolution of complaints
4.9 Identification and control of nonconformities4.9 Identification and control of nonconformities
4.10 Continual improvement4.10 Continual improvement
4.11 Corrective action4.11 Corrective action
4.12 Preventive action4.12 Preventive action
4.13 Quality and technical records4.13 Quality and technical records
4.14 Internal audits4.14 Internal audits
4.15 Management review4.15 Management review
58. 58
Medical Laboratories – ParticularMedical Laboratories – Particular
requirements for quality and competencerequirements for quality and competence
(con’t)(con’t)
5 Technical requirements5 Technical requirements
5.1 Personnel5.1 Personnel
5.2 Accommodation and environmental conditions5.2 Accommodation and environmental conditions
5.3 Laboratory equipment5.3 Laboratory equipment
5.4 Pre-examination procedures5.4 Pre-examination procedures
5.5 Examination procedures5.5 Examination procedures
5.6 Assuring the quality of examination procedures5.6 Assuring the quality of examination procedures
5.7 Post-examination process5.7 Post-examination process
5.8 Reporting of results5.8 Reporting of results
5.9 Alterations and amendments of reports5.9 Alterations and amendments of reports
61. 61
Seven Determinants in TQMSeven Determinants in TQM
¾
÷
Information
5M
1E
1I
Methods Environment
Monitoring &
MeasuringMan
MaterialsMachine
62. 62
Appropriate Choice of
Tests
Laboratory-clinic
Interface
Testing Sample Transport
Registration (Reconciliation)
Laboratory-clinic
Interface
Patient during at after
Health Service
Dispensing / Archive
Analysis & Testing
Analytical Test Result
Result Verification
ISO15189 (Based
on ISO9001:2000)
NON-COMFORMITYCONTROLS
Feedback
Feedback
Communication
Handling of Test
and Calibration
Items
Storage Security
Disposal
Management
INFORMATION SYSTEM
Security Control
Patient & Laboratory Data
Up-Date, & Storage
Authorization To Release
Patient/Client Seeking
Health Service
Material Control
Acceptance,
Quarantine &
Storage
Inventory
Management
DOCUMENTATION,
RECORD, DATA
CONTROL
Hygiene
Sterility
Control
OS&H
QUALITY SYSTEM
Laboratory
Medical
Testing
ISO17025 (Based
on ISO9001:1994)
Structure
Objective
Policies
Management Review
Personnel
Responsibilities
Corrective Preventive Action
Resources
Accommodation & Environmental Conditions
Quality
Planning
Requirements &
Specifications
Clinical
Diagnosis
Result
Distribution
Logistics
Confirmatory Test
Purchasing
Logistics
Use of
Laboratory Data
Reporting
Request, Tenders & Contract Review
History
File
Collection
Logistics
Monitoring,
Measuring & Testing
Test/Calibration
Results Assurance
Q.C., Q.A.
EQAS
Proficiency Test
(ISO/IEC Guide 43)
Measurement
Traceability
STAFF
TRAINING &
COMPETENCE
ISO17025 (ISO15189) GENERAL LAYOUT
Medical Questioning
& Supplies
SYSTEM
VALIDATION
EQUIPMENT
MAINTENANCE &
CALIBRATION
Contracted
Laboratories
for tests and
calibrations
Re-test
ISO15189
Ethics in Laboratory Medicine
Complaint Audit
ISO15189
(Continual
Improvement)
63. 63
Model for Medical Laboratories withModel for Medical Laboratories with
Patient / Client as “Customer”Patient / Client as “Customer”
Patient/
Client
Seeking
Clinical
Pathology
Service
PATIENT
during &after
Health Service
sampling
testing
MANAGE
result analysis
END-USERS
SUPPLIERS
hardware software consumables
SUBCONTRACTORS
(tests & calibration)
REGULATORY AGENCYLEGISLATURE
FUNDING AGENCY
Medical
Laboratory
reporting
PERSONNEL
Education and Competency
SUPPORT
64. 64
New Rules of the Game…..New Rules of the Game…..
Diminishing ResourcesDiminishing Resources
Lowering of staff levelLowering of staff level
Increasing AccountabilityIncreasing Accountability
Increasing RegulationIncreasing Regulation
Complex RelationshipsComplex Relationships
Rate of changesRate of changes
New value SystemsNew value Systems
The Age of Innocence is overThe Age of Innocence is over
65. 65
The Drive for Public SectorThe Drive for Public Sector
EfficienciesEfficiencies
The quest for balanced BudgetsThe quest for balanced Budgets
Monopolies and monopsoniesMonopolies and monopsonies
PrivatisationPrivatisation
RegionlizationRegionlization
Price signalsPrice signals
66. 66
Some Common GoalsSome Common Goals
Standardize Business SystemStandardize Business System
Standardize System PerformanceStandardize System Performance
Strengthen the Skills of our PeopleStrengthen the Skills of our People
67. 67
Customers Focus andCustomers Focus and
Expectation continue forExpectation continue for
Good Price for Best QualityGood Price for Best Quality
68. Model of process-based quality management systemModel of process-based quality management system
Overview of ISO 9001:2000Overview of ISO 9001:2000
Resource
management
Measurement,
analysis & improvement
Product
Product
Realization
Continual Improvement of
the Quality Management System
Input Output
Management
responsibility
Customers
(and other
interested
parties)
Requirements
Customers
(and other
interested
parties)
Satisfaction
69. 69
Quality Standard Compliance Triangle &Quality Standard Compliance Triangle &
Quality System Accreditation/CertificationQuality System Accreditation/Certification
QMS
Certification
Accreditation
Documentation
Training Audit
70. 70
““The system approach beginsThe system approach begins
when first you see the worldwhen first you see the world
through the eyes of another”through the eyes of another”
C.W. ChurchmanC.W. Churchman
19681968
