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!
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Quality Assurance

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

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Lets consult the literature

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

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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!

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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

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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!
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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

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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!

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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

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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

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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

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

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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!

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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

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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)

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Conformity assessment

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

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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

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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!

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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!

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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

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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

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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

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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

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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!

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Costs to achieve good quality, 1

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

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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
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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

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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!

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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

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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

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

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Levels of Quality Assurance/Management
management circles
RELEASE
Model of the production
PRODUCTION
Production may mean here also a service!
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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

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Certain methods for defect analysis and quality
monitoring

• (examples to understand what we wwere speaking
  about)

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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)

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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

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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?

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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

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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)

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Ishikawas Fishbone diagram method
the main cause
failure
one of causes
what could be the cause of the latter, etc.
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Cause Effect Diagram
The effect
Possible causes
Suitable for systematic retrospective analysis of
quality defects
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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
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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)
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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
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Scatter Diagram
Illustries the connection between quality
improvement and training
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10
No of defects
8
6
4
2
0
0
10
20
30
Time of training (hours)
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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
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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
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UCL, LCL upper and lower conformance limits to
be developed
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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)

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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
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UCL, LCL acceptance limits
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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
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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
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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

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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!

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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

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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!

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Quality and the marketState general
interventions on the market
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Now think a little about that
the quality manifests itself during meeting
personal needs
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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

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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)

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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)

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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

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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

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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

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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

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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

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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.

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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

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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

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What is the C??

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

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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

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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!

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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

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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

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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)

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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)

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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