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Title: Pharmaceutical Quality Assurance

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PharmaceuticalQualityAssurance
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Quality Assurance

  • Extremely important nowadays!
  • community pharmacies lt hospital pharmacies ltlt
    industry and distribution
  • It is impossible to learn it
  • It is possible to understand it (this course will
    help)
  • Bad news (as in the last Semester)

Failure is also possible!
3
Quality Assurance

  • Introduction
  • trying to understand what is it all about?

4
Lets consult the literature

  • Not the scientific literature like other times
  • The best literature
  • is not necessarily
  • a scientific paper,
  • but a fairy tale

5
Once, upon a time…

  • There were 4 friends called Somebody, Anybody,
    Everybody and Nobody
  • There was a work that could do Anybody, but
    Everybody thought that Somebody will do it, thus,
    actually Nobody did it…

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and the consequence was that

  • Everybody became very angry blaming Somebody,
    for the work could be done by Anybody, but
    actually Nobody did it
  • No quality assurance operated!

7
What to do to avoid such a situation?Introduce(t
he elements of)Quality Assurance!
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QA introduced

  • Everybody knows his/her job (job description,
    substitution, etc.)
  • Working operations are described in Standard
    Operation Procedures in writing
  • The work is actually done according to these
  • The fact that an actual work has been performed
    is documented together with the result. Documents
    are archived

9
QA introduced what it means?

  • My colleague retires (dies, etc.)
  • I say good bye (crying)
  • I go to his table, read the Standard Operating
    Procedure and his notes/records
  • And I can follow his work exactly where he left
    it!

BYE!
10
Our classic Murphy

  • Murphys laws they emphasise that what can be
    defective that will be defective (as a rule, in
    the wrongest time!)
  • One example
  • if a buttered bread is dropping, it will land
    with its buttered side looking to the carpet
  • if not, it means you buttered the wrong side!

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Example (Our slogen Mr. Murphy may always be
present)

  • Lecture with lap-top projection (as now)
  • Projector where is it held, what happens if the
    key is left home, where is the spare key, who may
    land another projector, etc.
  • Are all these documented in writing?

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Definition of the QUALITY
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Quality

  • It is used in the everyday life, e.g. commodities
    of (good) quality
  • Whatever the quality means we feel that it is a
    positive value
  • (It costs money!)
  • If it is value then it is valued
  • If it is valued this depends on the concrete
    society

14
The quality in the sciences

  • part of the real sciences
  • Decision on the value it means we should
    measure the quality!
  • Galilei Measure everything what is measurable
    and make measurable what is not!

15
What may have a quality?

  • Everything!
  • In general commodities and services
  • Is there any quality of the
  • life?
  • society? (e.g. policy to help the poor, etc.!)

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Product

  • It is used in the quality-oriented sciences in
    the very general meaning!
  • Everything is product, what is consumed
    during meeting some needs
  • In this meaning the services are also products!
  • (At this moment the product is the knowledge I
    am just delivering to you!)

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Production of the product

  • In all cases
  • product (to be consumed)
  • side-product (useful or not useful)
  • waste
  • Also when the product is a service!

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What may affect the quality of a product (using
the natural definition)

  • performance
  • characteristics
  • reliability
  • general suitability (e.g. an electric device may
    be connected to the power supply)
  • durability
  • serviceability
  • esthetics (its appearance)
  • safety during use

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What may affect the quality pf a service (using
the natural definition of quality)

  • time and timeliness
  • completeness
  • politeness
  • continuity (you may have info about it)
  • availability (also price) and comfort
  • accuracy
  • readiness to incorporate new ideas

20
Quality from the point of view of the producer

  • Quality defined through conformity
  • Ability of the technology to assure that the
    product will conform to the requirements
    specified duringplanning
  • It depends on several factors, such as
  • planning and organisation of the production
    technology
  • performance ofthe equipments and of the
    technology
  • the starting materials
  • training of workers and managements control
  • level of final quality control based on
    statitical considerations

21
Quality of a product and its price

  • This evaluation is also important and needed
  • The producers interest to achieve the quality
    with affordable costs
  • It means that the price of the to-be product is
    also an important factor of the quality planning!
  • The quality characteristics of the product and
    the costs of its production must be in equilibrium

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What is quality?

  • Philosophical (natural) definition suitability
    for the intended purpose papaverine smooth
    muscle relactant with a given probability and its
    known side-effects with their known (lower)
    probability

23
According to this definition, Quality is a
phylosophically determined term to what extent
is the product suitable for its intended purpose
24
Other quality definition

  • Quality satisfaction of the stakeholders and
    the organisation itself valued value
  • Generally accepted on the standardised field!
  • Subjective, for
  • a) who are the stakeholders,
  • b) they may not be satisfied at the same time!

25
Stakeholders

  • Small retail shop
  • final costumers (who buy in the shop to consume)
  • other consumers (who buy in the shop to re-sell)
  • vendors whom the shop purchases
  • shop assistants (selling their working power)
  • the Municipality (whom local tax is paid)
  • The State (whom the general tax is paid)

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Stakeholders

  • Travel agencies
  • those who want to travel
  • at the target country hotels, restaurants
  • local guides
  • employees of the travel agency
  • the owner of the building, whom the travel agency
    rents the office
  • Municipality, State

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Stakeholders and their interest in drug retail
The restaurant example

  • Guest orders
  • Guest eats
  • Guest pays
  • 1st people orders
  • 2nd people eats it
  • 3rd people pays it
  • Nonsense?

Doctor
Patient
Insurance company or the State
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Different stakeholders

  • with perhaps different interests
  • If we want to measure the quality as stakeholder
    satisfaction, we should specify
  • points of view of the measurement
  • its methodology
  • the characteristics to be measured
  • the values (what is positive, what is negative)

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Measuring quality? From quality control to
conformity assessment
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Dilemma of measuring the quality – definitions

  • Philosophical (suitable for the intended purpose)
    difficult to measure
  • Stakeholders satisfaction? It seams to be much
    more measurable, but
  • Who writes the novel, the writer or the reader?

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Product and consumer needs

  • They are interrelated!
  • The consumer needs what seems to be realistic on
    the market
  • The market is manipulated (advertising!)

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Conclusion

  • The market not always reflects the real needs
  • There may be value also in cases when there is
    no consumers need
  • One may not relay on the stakeholders
    satisfaction as the sole quality determinant

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We should measure the suitability for the
intended purpose

  • Galilei Measure everything what is measurable
    and make measurable what is not!

34
Quality control?

  • If the philosophical (natural) definition of
    quality applies, can we control it?

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Quality and conformity

  • Do we control the Quality of products? Rarely
    (e.g. assessment of medicines before their
    registration, see the papaverine example before)
  • This philosophical quality should be
    translated to measurable characteristics
    (requirements with limits control methods, e.g.
    legal requirements or standards), and the
    Conformity of the product to these requirements
    is analysed/controlled/measured

36
Actually

  • speaking – both in the everyday life and in the
    profession – about quality control, this is the
    control of the conformity to certain measurable
    requirements (conformity assessment)

37
Conformity assessment

  • It has different types!
  • analytical tests, measurements
  • on-the-spot inspection or documentation audit
  • exam (!)
  • Finally certification of the conformity

38
Introduction of the assured quality besides (or
even instead of) controlled quality
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The quality is, as a rule, not controlled but
assured!

  • In the everyday life, there is
  • no other possibility!
  • The master works in his own shop producing goods
    this, as a rule, assures the quality
  • Small sclae manufacture every manufactured batch
    is checked
  • (contd)

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The quality is not controlled but assured!

  • Large scale manufacture control based on
    (statistical) smapling it has inherent problems
  • In addition to sample control also the control of
    the whole manufacturing process manufactured-in
    quality instead of analysed-in quality

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Problems of the statistical sampling

  • Certain per cent of failures tolerated (depending
    on the statistics used)
  • The whole system is based on the theory that the
    distribution of the defective product units may
    be modelled mathematically (following certain
    rules)
  • e.g. Gaussian distribution

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Issues of the control based on statistical
sampling, 2

  • As it is seen in the health-care industry
  • There is a difference between statistics and
    health-care needs
  • Only 2 dirty infusion bottles among 10,000
  • Only 1 apple with mass phyto protector content
    among others
  • – who is administered to with it or eats it
    represent his/her 100

43
Proper attitude

  • Quality assurance (e.g. GMP) or terminal batch
    quality control (analysis according to a sampling
    plan)? Wrong attitude!
  • When GMP is not applied, the result of
    (statistically taken) sample analysis can not
    taken as reliable!

44
How the quality assurance does work?

  • In general
  • We try to avoid failures (defects)
  • to find them as soon as possible or, at least, to
    prepare ourselves
  • to avoid AD HOC INTERVENTIONS!

45
Quality Assurance its various levels and types
do exists!

  • We think about the quality at all
  • We monitor the qualityand deal with its
    improvement ( this has a close connection with
    the managerial sciences) Total Quality
    Management
  • We prepare process flow technological documents,
    collect minimum requirements and standards
    relating to our activities, develop and assess
    performance indicators (what are they see later)
  • We introduce ISO-based quality assurance and
    certification, although it is not mandatory in
    our case (see later)
  • Introduce mandatory quality assurance and
    certification
  • ISO and standardised certification systems
  • legally required systems GMP, GDP, GLP, GCP

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TQM

  • Total Quality Management
  • Characteristic to the fields where the quality is
    defined by the consumer satisfaction

47
TQM, definition

  • Management of the total organisation with a view
    to every product and service that may be
    important for the consumer

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TQM

  • The consumer determines the quality, his need is
    the highest priority
  • The Managements priority must be the quality,
    not the quantity
  • Thus way,the quality becomes a strategic issue
  • The quality is the responsibility of all
    employeees, independently from their position
    within the organisation

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TQM

  • The Organisation should, in all procedures, focus
    to continuous improvement of the quality
    otherwiseit can not reach its strategic aims
  • Problem solving plus quality improvement uses
    statitical quality control methods
  • The quality problems can be solvedonly through
    collaboration of the employees and the management
  • Continuous education and training of all
    employees means the basis of the continuous
    quality development

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Fromthinking about the quality to TQM

  • How was it introduced and by whom?

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TQM

  • Walter A. Shewhart was the father of the
    statistical process-controll
  • W. Edwards Deming followed and completed this
  • mostly in Japan the quality improvement,
    although costs money, reduces overall costs,
    increases productivity and market share – PDCA
  • then in the USA 14 points for the Management

52
W. A. Shewhart

  • He worked for the Western Electric Company. For
    amplifiers and other equipment had to be buried
    underground, there was a need to reduce the
    frequency of repairs. Until that time the quality
    issues were limited to finl control of the
    end-product and the elimination of substandard
    iems. Sewhart, in the twnties of the last
    century, introduced the concept of the control of
    manufacturing process

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(folytatás)

  • Using the control chart method (see later)
    recognised the difference between chance-cause
    and assignable-cause quality variations
  • He pointed out that every data has bot signal
    and noise, these should be separated

54
W. Edwards Deming

  • Working in the 20th century, mostly in Japan,
    followed Shewharts work
  • The Ford company, after World War Two,
    manufactured cars both in the USA and Japan. The
    Company became realising that more and more
    consumers wanted to buy the models manufactured
    in Japan (where Shewhart acted) for there were
    less problems with them

55
Demings phylosophy

  • If the Management concentrates to the quality in
    the following way
  • results of work efforts
  • quality
  • total costs
  • then,in the long term, total costs will decrease!
  • However, if the Management focus mainly to the
    reduction of the costs, the qulity will decrease
    and, in the long term, the costs increase!

56
Costs to achieve good quality, 1

  • Costs of prevention of wrong quality
  • quality planning costs
  • product planning costs
  • manufacturing costs
  • training costs
  • information costs

57
Costs to achieve good quality, 2

  • Control costs
  • inspection and product analysis costs
  • costs of equipments needed to analyses
  • employment costs of the inspectors and analysts

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Costs connected with wrong quality, 1

  • Internal costs of defective products
  • no profit, wasting
  • re-working costs or
  • losses of decreased price
  • costs of improvement of the defective technology
  • costs of not using the manufacturing equipments
    during this time

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Costs connected with wrong quality, 2

  • External costs of defective products
  • dealing with consumer claims
  • costs of returned goods
  • costs of expired products
  • product liability costs
  • costs of lost partners, buyers

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The price of the quality
61
W. Edwards Deming

  • Plan/Do/Check/Act cycles

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The continuous quality development method
thePDCA cycle (Deming-wheel)
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Continuous quality development

  • How the Management sees the performance of the
    Organisation?
  • the performance, that is continuously challenged
    and should be developed step-by-step
  • How the Management seesits own involvement and
    the role of its work?
  • believes thatinvolvement of the employees and the
    group effortsmay play a key role in the quality
    development

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Deming 14 points for Management a)

  1. Crate constancy toward quality improvement
    measures
  2. Accept that change is necessary and you are to
    manage the change
  3. Do not control in the quality into the product,
    manufacture in it!
  4. Instead of raising the price, get the trust of
    your consumers instead
  5. Improve the quality of the manufacturing process
    continuously

65
Deming 14 points for Management b)

  • 6. Institute training on the job
  • 7. Institut leadership, the aim of the
    supervision must be to help people. Control the
    supervisors!
  • 8. Drive out fear, so that everyone may work
    effectively!
  • 9. Break down barriers between departments.
    People must work in team on projects!

66
Deming 14 points for Management c)

  • 10. Forget slogens asking for zero defect and
    higher productivity
  • 11. Eliminate production quotas
  • 12. Permit workers to be proud to their work
  • 13. Institute of programof education and
    self-improvement
  • 14. Explain that the transformation is
    everybodys job

67
Deming 7 Deadly Diseases

  1. Lack of constancy in purposes
  2. Emphasis on short-term profits
  3. Evaluation by performance of the employees,
    exclusively
  4. Mobility of management
  5. Running a company on visible figures alone
  6. Excessive medical costs
  7. Excessive costs of warranty, fueled by lawyers
    who work for contingency fees

68

  • Now, let us think about how we reach the concept
    of quality improvement and why should we define
    measuring units of the quality?

69
Levels of Quality Assurance/Management
management circles
RELEASE
Model of the production
PRODUCTION
Production may mean here also a service!
70
Levels of QA
No QA
There was a defect but no corrective measures to
avoid it in the future
RELEASE
PRODUCTION
DEFECT
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Levels of QA
Basic QA
RELEASE
CORRECTIVE MEASURES
PRODUCTION
DEFECT ANALYSIS
DEFECT
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Levels of QA
Better QA
RELEASE
CORRECTIVE MEASURES
PRODUCTION
DEFECT POSSIBILITY ANALYSIS
DEFECT
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Levels of QA
Much better QA
improved
RELEASE
not improved
MEASUREMENT OF THE QUALITY
CORRECTIVE MEASURES
PRODUCTION
DEFECT POSSIBILITY ANALYSIS
DEFECT
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How to measure the quality?

  • Production mostly measurable quality
    characteristics
  • Service (e.g. education, regulatory work)
    performance indicators should be developed for
    measurement
  • How to monitor quality?
  • Perform defect analysis

75
Certain methods for defect analysis and quality
monitoring

  • (examples to understand what we wwere speaking
    about)

76
Method Rroot Cause Analysis, RCA)

  • identify and eliminate the root causes of
    problems instead ofaddressing the obviuos
    symptoms merely
  • Consider the same defect may be caused by more
    than one roots
  • It may be reactive (after the defect) and
    proactive (not waiting for the defect)

77
Root Cause Analysis, RCA

  • One intervention is, as a rule, not enough. The
    RCA is like the mathemathical iteration reaching
    the target step by step

78
RCA

  1. Define exactly what the problem (that happened)
    was or could be (if wanted to be avoided)
  2. Gather all information, data about it
  3. Ask why and identify the causal relationships
    associated with the problem
  4. Identify which causes if removed will prevent
    recurrence
  5. Identify effective solutions that prevent
    recurrence and are within your control
  6. Implement them
  7. Observe the solutions were they effective?

79
RCA-technics (examples)

  • Compare what was different when the problem
    manifested itself and when there was no problem?
    (Here comes other defect-analytical methods such
    as
  • Fishbone diagram
  • The five Whys
  • Pareto-analysis

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RCA what to be considered?

  • Starting materials
  • defective raw material
  • wrong type for the job
  • lack of raw material
  • Equipment
  • defective
  • poor placement
  • poor maintenance
  • incorrect tool selection
  • Methods
  • no or poor procedures
  • practices are not the as written procedures
  • poor communication
  • Environment
  • forces of nature
  • wrong layout
  • not orderly workplace
  • surfaces poorly maintained
  • Management
  • poor managers
  • inattention to task
  • task hazards are not guarded properly
  • stress demands
  • lack of process understanding
  • Management system
  • education lacking
  • no local training
  • poor employee involvement
  • poor recognition of hazard
  • previously identified hazards were not eliminated

81
RCA

  • There are different schools, mainly 5
  • Risk (safety) based RCA
  • Manufacture-ased RCA
  • Process-based (manufacture plus business) based
    RCA
  • Failure-based RCA
  • SYSTEM-based RCA (mixture of the previous ones
    plus risk-management, change-management and
    system-analysis)

82
Ishikawas Fishbone diagram method
the main cause
failure
one of causes
what could be the cause of the latter, etc.
83
Cause Effect Diagram
The effect
Possible causes
Suitable for systematic retrospective analysis of
quality defects
84
Process flow diagram
Raw material arrived from the vendor
No, follow it
Check its conformity
Any quality defect?
Yes
Suitable for the identification of a quality
defect
Return to the vendor at his cost
85
Pareto-analysis
20
40
0
60
80
100
Suitable to recognise that 80 of the defects
was caused by 20 of the possible causes
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Root of the defects,
Defect frequency
Other
Plan-ning
Manuf. process
Training
Purchas-ing
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Run Chart
Suitable to recognise that an equipment or
process does not work according to planning
0.58
0.56
Diameter
0.54
0.52
0.5
0.48
0.46
0.44
1
2
3
4
5
6
7
8
9
10
11
12
Time (hours)
87
Hystogram
suitable to show the frequency of occurring
quality defects
No of batches manufactured
0
1
2
3
4
No of defects per batch
Data
88
Scatter Diagram
Illustries the connection between quality
improvement and training
12
10
No of defects
8
6
4
2
0
0
10
20
30
Time of training (hours)
89
Check-sheet
Suitable to remember the failures and shows
whether the employees collect the data properly
Monday
Accounting errors wrong account wrong
quantity Money collecting errors wrong
account wrong quantity
90
Control Charts
quality characteristic
Suitable for study of process performance and
product quality
1020
1010
1000
990
980
970
0
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
UCL, LCL upper and lower conformance limits to
be developed
91
UCL and LCL

  • Frequently the upper and lower quality acceptance
    limits (e.g., for drugs)
  • However purely on statistical basis when
    analysisng all measured quantities continuously,
    one can determine
  • the actual UCL and LCL values (three sigma
    rule)
  • the probability that an outlying value comes ny
    chance (0,27)
  • how many consecutive measured points will not be
    outlayer, if the process is under control
    (1/0,0027 370)

92
Control Charts 1
quality characteristic
(here the process is under control only normal
variation)
1020
1010
1000
990
980
970
0
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
UCL, LCL acceptance limits
93
Control Charts 2
(here the process runs out of the control
unforeseen problem arises)
1020
1010
1000
990
980
970
0
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
94
Control Charts 3
(here the process has become completely
uncontrolled for certain reason)
1020
1010
1000
990
980
970
0
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
95
A Shingo system (Japan)

  • Shingos arguments
  • The quality control methods can not exclude
    defects
  • Defects are caused by human failures
  • This mey be reduced if the workers receive
    information on all such cases

96
The introduction of the Shingo system in Japan

  • Poka-Yoke system adds
  • Check-lists
  • Special devices hindering workers in making
    mistakes
  • e.g. two plugs, with different currents, it is
    important which plug is connected to which
    current? Let one of the plug-in and
    plug-connector triangle-shaped!

97
Why are defect-analysis and QA so important?
Österreichische Kranmenhauszeitung 2004

  • Also in the health-care, no scapegoat (the person
    to blame) should be looked for, perform failure
    analysis instead!
  • It means the failures should not hidden, they
    must be known!
  • USA, UK, Switzerlan Critical Incident Reporting
    System

98
The failures can not be eliminated completely,
but their frequency and seriousness can be
decreased!

  • Most of the serious failures if a human error
    meets a system failure
  • Why is it so important
  • Statistical data show that 1 of the errors made
    in the health-care cause permanent health damage!

99
Quality and the marketState general
interventions on the market
100
Now think a little about that
the quality manifests itself during meeting
personal needs
101
Meeting consumer needs a process

  • Identification of consumer needs
  • Planning of the product and its technology
  • Development of the Manufacturing system
  • its continuous maintenance
  • selling the product
  • facilitation of its consumption

102
Characteristics of the process of meeting
personal (consumer) needs

  • reliability nodefectin the operation of
    meeting needsuntil now
  • safety the extent of the risk caused by
    irregular operation

cyanide in Tisza
103
Meeting consumer needs

  • It occurs on the market. However, many market
    types! Its extremes
  • Demand-driven (free) its players to decide,
    market-driven regulation value for money money
    for value standardised field
  • Offer-driven (State- or public market) athe
    State (or a Donator) purchases, but he affects
    also the contracts regulated field

104
All these have reflections in the quality affairs!

  • What type the regulation is
  • How reliable is it, e.g. reflects only the
    quality affairs!
  • I.e., to what extent are the steakholders
    independent when they express their needs. The
    more the State regulation is the more independent
    is this, The more the market-driven regulation is
    the more manipulated market we see

105
Remember the lecture in the last Semester
Regulated and Standardised fields

  • Both products and services may be classified into
    two distinct types, although a strict borderline
    can not always be drawn

106
Standard? Regulation?

  • Regulated field
  • Regulated by law or authorities decision
  • Law, Register, Pharmacopoeia,
  • Mandatory, enforced
  • Authorisation
  • Standardised field
  • Regulated by the market
  • Standards
  • Agreement among the players
  • Accreditation

107
Regulated by the market agreement among the
players

  • If the players can not agree, some of the
    electric goods can not be sold

?
or
or
108
Levels of market control

  • Higher level State-driven (public) market
  • Lower levels
  • ethical market (in-between)
  • free (demand-driven) market but not completely
    free, distorted by advertising, etc.
  • (As a rule, the mixture occurs, e.g. in the
    health-care there are always ethical elements
    such as work on duty)

109
Market control by the State

  • Its aim is to establish a monitoring system
    suitable to determine the actual state of the
    market to decide whether State intervention is
    needed or not (not only quality, also political
    and economical issue)
  • If intervention it is Quality management of
    the market by the State

110
Quality management

  • Technical-legal rules
  • Consumer protection
  • Market protection
  • Producers interest protection
  • Market-driven (not mandatory and not directly by
    the State)

111
Technical-legal rules

  • Minimum requirements for production or service in
    laws and regulations
  • Measurement policy (e.g. state institution for
    certain measurement unit calibration)
  • National standardisation (also market-driven
    elements)

112
National Consumer Protection

  • Sanctions executed by State organs
  • product libility (e.g. law if a product is
    harmful, the producer must compensate the
    consumer)
  • Recall from the market (of defective products)
  • Consumer Protection Agency sanctions (e.g. when
    misleading advertising)

113
Market protection

  • Also State intervention (official rules)
  • Competition law (the restriction of competition
    by big Firms is forbidden)
  • Misleading marketing is forbidden
  • Laws regulating contracts
  • Market surveillance (e.g. taking and checking
    samples)

114
Producers interest protection

  • Patent law
  • Data Exclusivity (generic medicines!)
  • Authors right
  • Trade mark law

115
Market-driven regulation

  • Accreditation and certification according to
  • technical standards
  • quality assurance standards

116
The organised standardisation

  • gives a forum, where the players can discuss
    and agree

117
Standard

  • Elaborated by a non-profit Body, comprising
    representatives of the players, e.g. Hungarian
    Committee for Standardisation
  • Standards based on the ISO (International
    Standardisation Organisation) standards

118
Standards

  • are elaborated to cover every product and
    activities (except for those on the regulated
    field!). Thus, standards are of general character
  • Unless the law does not require the use of a
    standard, they are not binding (but, if they not
    met, you can not sell your product or service!)

119
In the standardised fields

  • manufacture of products or offering services need
    no prior professional (i.e. checking your
    ability to do so) authorisation (naturally, some
    administrative permission or notification should
    always be done)

120
Accreditation

  • Ministers, etc. may define minimal standards
    necessary for an activity in the regulated field
  • Standardisation organisations may also do the
    same on the standardised field
  • Enterpreneurs may request the official
    Accreditation Body or a Certifying body to check
    it and accredit them according to the requirements

121
Typically

  • There is one Accreditation body in every country
  • It is a non-profit organisation, founded by the
    State
  • It may accredit Conformity assessing and
    Certifying bodies (EU terminology Notified
    Body)
  • These latter are for-profit organisations (as a
    rule) and they are accredited

122
E.g. in Hungary National Accreditation Council,
accredits the following

  • testing laboratories
  • calibrating labs
  • sampling organisations
  • organisations managing proficiency testings
  • notified bodies for product compliance
    certification
  • notified bodies for quality management
    (assurance) system compliance certification
  • notified bodies fot persons compliance
    certification
  • supervising bodies (except auhorities)
  • reference material producers
  • official tender compliance certifying bodies

123
What enterpreneurs can do

  • to prove they are masters in the Art they work
    in?
  • In the EU, there are various quality assurance
    moduls
  • The company, if law does not require one single
    modul for that activity, may chooes between some
    moduls to introduce QA

124
Examples of conformity assessment moduls, e.g. in
the EU

  • A based on its own internal manufacturing
    control (QA based on a standard), the
    manufacturer itself may declare the suitable
    quality of its product and put a C? mark on it)
  • A1 the A plus product conformity assessment by
    a notified body regularly, but still the
    manufacturer declares
  • B a notofied body will assess the prototype or
    the technical plan of the product and the
    notified body issues a certificate on the
    complience with standards
  • etc.

125
Thus, there are 3 types of certification
according to the standard

  • First party the Firm audits itself e.g.
    according to ISO 9000 standard(see later)
  • Second party the purchaser audits the vendor
  • Third party a Notified Body does the audit

126
Certifying bodies certify enterprenuers

  • to certify that the manufacture or service
    complies with existing technical standards, or
  • to certify that the activities are conducted
    according to the relevant quality standards

127
What is the C??

  • Conformité Europenne
  • In the European Union, the commodities with the
    C? sign must not be checked/analysed prior to
    marketing!

128
C?

  • The manufacturer puts on the package
  • It means that he declares the given commodity
    complies with all relevant EU technical standards
  • Only to commodities that are listed in the EU law

129
Do not forget on the fully Regulated Field

  • Everything is quite different!
  • You may not start your business (or sell the
    outcome) without mandatory prior authorisation,
    based on requirements specified by the law
  • The controlling and certifying Bodies
    authorities!

130
Pharmacy and medicine are

  • on the regulated field!
  • Professional activities and products need prior
    authorisation
  • The Quality Assurance systems in the field of
    pharmacy (in the general meaning) are GMP (GDP),
    GLP, GCP

131
Quality systems characteristics, 1

  • Definition of terms!
  • Why?
  • – certain new terms
  • – terms that are also used in the everyday life
    in another meaning
  • – meaning of terms is changing
  • – translation errors

132
Quality System characteristics, 2

  • General requirements (soft law) this and that
    should adequately be done by the manufacturer)
  • Operating procedures
  • To be filled-in records (their name may be
    different in the various systems)
  • archivation (everything that can be important
    from the point of view of the quality)

133
Exam topics
134
Quality versus conformity assessment

  • Definitions of quality (2)
  • What can one control? (Introduction of the
    concept of conformity assessment)
  • PDCA. The levels of QA (the circles)
  • Historical evolution of QA from QC
  • Weaknesses of QC based on statistical sampling
    (particularly in drug quality testing)

135
Regulated and standardised fields

  • Speak about their differences
  • Accreditation, conformity assessing and
    certifying bodies
  • Reason of non-mandatory certification (outline
    the situation when you start new business in the
    standardised or regulated fields)
  • Examples for defect analysis techniques

PharmaceuticalQualityAssuranceQuality AssuranceFailure is also possible!Quality AssuranceLets consult the literatureOnce, upon a time…and the consequence was thatWhat to do to avoid such a situation?Introduce(the elements of)Quality Assurance!QA introducedQA introduced what it means?BYE!Our classic MurphyExample (Our slogen Mr. Murphy may always bepresent)Definition of the QUALITYQualityThe quality in the sciencesWhat may have a quality?ProductProduction of the productWhat may affect the quality of a product (usingthe natural definition)What may affect the quality pf a service (usingthe natural definition of quality)Quality from the point of view of the producerQuality of a product and its priceWhat is quality?According to this definition, Quality is aphylosophically determined term to what extentis the product suitable for its intended purposeOther quality definitionStakeholdersStakeholdersStakeholders and their interest in drug retailThe restaurant exampleDoctorPatientInsurance company or the StateDifferent stakeholdersMeasuring quality? From quality control toconformity assessmentDilemma of measuring the quality – definitionsProduct and consumer needsConclusionWe should measure the suitability for theintended purposeQuality control?Quality and conformityActuallyConformity assessmentIntroduction of the assured quality besides (oreven instead of) controlled qualityThe quality is, as a rule, not controlled butassured!The quality is not controlled but assured!Problems of the statistical samplingIssues of the control based on statisticalsampling, 2Proper attitudeHow the quality assurance does work?Quality Assurance its various levels and typesdo exists!TQMTQM, definitionTQMTQMFromthinking about the quality to TQMTQMW. A. Shewhart(folytatás)W. Edwards DemingDemings phylosophyCosts to achieve good quality, 1Costs to achieve good quality, 2Costs connected with wrong quality, 1Costs connected with wrong quality, 2The price of the qualityW. Edwards DemingThe continuous quality development methodthePDCA cycle (Deming-wheel)Continuous quality developmentDeming 14 points for Management a)Deming 14 points for Management b)Deming 14 points for Management c)Deming 7 Deadly DiseasesLevels of Quality Assurance/Managementmanagement circlesRELEASEModel of the productionPRODUCTIONProduction may mean here also a service!Levels of QANo QAThere was a defect but no corrective measures toavoid it in the futureRELEASEPRODUCTIONDEFECTLevels of QABasic QARELEASECORRECTIVE MEASURESPRODUCTIONDEFECT ANALYSISDEFECTLevels of QABetter QARELEASECORRECTIVE MEASURESPRODUCTIONDEFECT POSSIBILITY ANALYSISDEFECTLevels of QAMuch better QAimprovedRELEASEnot improvedMEASUREMENT OF THE QUALITYCORRECTIVE MEASURESPRODUCTIONDEFECT POSSIBILITY ANALYSISDEFECTHow to measure the quality?Certain methods for defect analysis and qualitymonitoringMethod Rroot Cause Analysis, RCA)Root Cause Analysis, RCARCARCA-technics (examples)RCA what to be considered?RCAIshikawas Fishbone diagram methodthe main causefailureone of causeswhat could be the cause of the latter, etc.Cause Effect DiagramThe effectPossible causesSuitable for systematic retrospective analysis ofquality defectsProcess flow diagramRaw material arrived from the vendorNo, follow itCheck its conformityAny quality defect?YesSuitable for the identification of a qualitydefectReturn to the vendor at his costPareto-analysis20406080100Suitable to recognise that 80 of the defectswas caused by 20 of the possible causes80Root of the defects,Defect frequencyOtherPlan-ningManuf. processTrainingPurchas-ingRun ChartSuitable to recognise that an equipment orprocess does not work according to planning0.580.56Diameter0.540.520.50.480.460.44101112Time (hours)Hystogramsuitable to show the frequency of occurringquality defectsNo of batches manufacturedNo of defects per batchDataScatter DiagramIllustries the connection between qualityimprovement and training1210No of defects102030Time of training (hours)Check-sheetSuitable to remember the failures and showswhether the employees collect the data properlyMondayAccounting errors wrong account wrongquantity Money collecting errors wrongaccount wrong quantityControl Chartsquality characteristicSuitable for study of process performance andproduct quality102010101000990980970101112131415UCL, LCL upper and lower conformance limits tobe developedUCL and LCLControl Charts 1quality characteristic(here the process is under control only normalvariation)102010101000990980970101112131415UCL, LCL acceptance limitsControl Charts 2(here the process runs out of the controlunforeseen problem arises)102010101000990980970101112131415Control Charts 3(here the process has become completelyuncontrolled for certain reason)102010101000990980970101112131415A Shingo system (Japan)The introduction of the Shingo system in JapanWhy are defect-analysis and QA so important?Österreichische Kranmenhauszeitung 2004The failures can not be eliminated completely,but their frequency and seriousness can bedecreased!Quality and the marketState generalinterventions on the marketNow think a little about thatthe quality manifests itself during meetingpersonal needsMeeting consumer needs a processCharacteristics of the process of meetingpersonal (consumer) needscyanide in TiszaMeeting consumer needsAll these have reflections in the quality affairs!Remember the lecture in the last SemesterRegulated and Standardised fieldsStandard? Regulation?Regulated by the market agreement among theplayersororLevels of market controlMarket control by the StateQuality managementTechnical-legal rulesNational Consumer ProtectionMarket protectionProducers interest protectionMarket-driven regulationThe organised standardisationStandardStandardsIn the standardised fieldsAccreditationTypicallyE.g. in Hungary National Accreditation Council,accredits the followingWhat enterpreneurs can doExamples of conformity assessment moduls, e.g. inthe EUThus, there are 3 types of certificationaccording to the standardCertifying bodies certify enterprenuersWhat is the C??C?Do not forget on the fully Regulated FieldPharmacy and medicine areQuality systems characteristics, 1Quality System characteristics, 2Exam topicsQuality versus conformity assessmentRegulated and standardised fields