1A: IMPORTANCE OF QUALITY E L S D EQ UE KER
INTRODUCTION
WHAT IS QUALITY
- Depends on who you ask the question
- Quality of a car?
└ Status features: tinted windows, spoilers, hubcaps
└ Engine power
└ Comfortable suspension
└ Luggage space
└ Economy
└ Environmental aspect
└ Quality aspects conflict with each other ex: Small economical city car Large jaguar
- Quality of air travel?
└ Staff smiles
└ Lunch/coffee free of charge
└ Punctuality
└ The reliability of flight schedules
└ Ticket price
- Quality of a medicine?
└ Which three of the following are the most important properties of a medicine?
└ Depending on the medicine, the purpose, ability,…
• Effectiveness – the medicine should achieve the intended therapeutic effect
• Safety – minimal harmful side effects
• Correct dosage – effective at the recommended amount without being toxic
• Stability – remains effective and safe until the expiration date
• Ease of use – convenient form of administration (tablet, liquid, patch, injection, etc.)
• Affordability – reasonable cost for patients and healthcare systems
• High quality and purity of the active ingredient
1% OF NON-QUALITY
- dangerous effect on big scale
- Producing cars - car industry
└ ± 11.5 million vehicles
└ With a 1% defect rate in the braking system
→ 115,000 dangerous cars on the road per year in Europe
- Flights with commercial air planes
└ ± 39 million flights worldwide.
└ Assume 1% error (crash or serious incident)
→ 390,000 crashes per year, which is >1,000 crashes per day
- Tests in medical laboratories
1
, - Medical diagnostics - COVID-19 PCR tests (Europe, 2020)
└ In 2020, >100 million PCR tests were performed in the EU.
└ With a 1% error rate → 1 million incorrect results in one year (false positive or false negative)
└ Consequence: incorrect quarantine decisions or missed infections
- Financial transactions
└ ± 240 billion payments via banks
└ At 1% error rate → 2.4 billion incorrect transactions per year (≈ 6.5 million per day)
CONCLUSION
→ A 1% error rate seems small, but at large volumes the consequences are huge
Scale examples:
└ Millions of flights
└ Billions of financial transactions
└ Hundreds of millions of medical tests
→ Impact of a 1% error:
└ Thousands of deaths
└ Billions in financial losses
└ Severe social disruption
→ In critical sectors (aviation, healthcare, finance, etc.), such risks are unacceptable
That is why the standard is not 99%, but 99.9999% reliability (Six Sigma or better)
EXAMPLE: BREAST CANCER PATIENT WITH FAMILY HISTORY
Feature: the availability of a carrier status test
Needs:
- appropriate analytical test
- right sample
- TAT (turn around time)
└ TAT something that the customer asks for – can’t wait for one year
- Correct interpretation
DEFINITIONS OF QUALITY (ISO STANDARDS)
QUALITY
= Is the set of features and characteristics of a product or service that are important for meeting identified or
obvious needs
QUALITY SYSTEM
= Is the organisational structure with responsibilities, procedures, processes and facilities to ensure that
a delivered product or service always meets the specified requirements
2
,DEFINITIONS OF QUALITY (GARVIN 1984)
PRODUCT FOCUSED
- Viewed from the seller’s or supplier’s point of view
- Deals with objective properties of a product that can be measured and valued
DEFINITIONS OF QUALITY (COUNTESS 1984)
PRODUCTION-ORIENTED
- Viewed from the point of view of the producer or service provider
- Is about meeting/conforming to user requirements
“Crosby”
USER-CENTRIC
- Viewed from the user point of view to check whether the product or service is ‘fit for use’
- Meeting needs and expectations of specific users
“Juran 2010” “fit for use”
VALUE-ORIENTED
- Viewed from an economic point of view to value a product or service
- And this in relation to the price and effort it took to acquire the product or service
- More subjectivity
“Feigenbaum 1961”
“Making a unique statement is not possible”
TRANSCENDENT
- Viewed from a philosophical standpoint
- We can recognise quality just as we can recognise beauty
- ‘Quality’ is neither part of the mind (subjective) nor part of matter (objective). It is a third entity
independent of both the others
“Prisig 1976”
“You know it, when you see it”
DEFINITIONS OF QUALITY – SUMMARY
Quality involves both rational, objective characteristics and relational, subjective experiences
Whatever definition or angle you choose – inspiration to engage in dialogue about what you mean
- Motivate the way that you look at the story on the exam & paper
- Than write it in the right way
3
,WHAT IS QUALITY MANAGEMENT?
= Ensures that an organization’s products/services meet customer requirements and standards
→ It’s not just about checking the result but embedding quality throughout the PROCESS
WHAT IS PROCESS MANAGEMENT?
→ Process Management involves designing, analyzing, monitoring, and improving workflows to maximize
efficiency, effectiveness, and adaptability
EXAMPLE – PHANTOM OF HEILBRONN
- a mysterious criminal case in Germany and Austria between 1993 and 2009
- ‘woman without a face’ : phantom of Heilbronn
- For years found the same female DNA at more than 40 different crime scenes
└ including burglaries, murders, and robberies
└ Police think: dealing with dangerous serial offender, nicknamed the Phantom of Heilbronn
- What possible explanations could there be for why the same DNA appeared at so many different crime
scenes?
└ She worked in the factory where DNA tests were made, and those tests became
contaminated with her DNA
└ There was an error in the DNA testing technology itself
EXAMPLE – SAMPLING ERRORS IN BIOMEDICAL RESEARCH
- Cardiovascular disease research historically focused on men
- Women were under represented in clinical trials
- Researchers assumed results could be generalized to women (in practice not true)
- Classic sampling error: unrepresentative sample
Problem:
Symptoms of heart disease in women overlooked
Diagnostic criteria based on male biology
Treatments developed without adequate female data
Women’s heart attacks often misdiagnosed or treated late
Public impact:
→ Higher misdiagnosis and treatment delays in women
→ Increased mortality and morbidity
→ Gender disparities in heart disease outcomes
→ Skewed guidelines influenced decades of clinical practice
4
,Key lesson:
- Sampling errors in biomedical research have real-world consequences
- Diversity and representation are essential in clinical trials
- The true cost of bias is measured in patient outcomes
→ Research must reflect the populations it serves
D PHILIP CROSBY & ‘ZERO DEFECTS’
- “ Quality is Free – Doing things right the first time”
- Background:
└ 1970s: defects accepted as part of doing business
└ Assumed errors were unavoidable
└ High costs of fixing mistakes were considered normal
└ Crosby argued: 'Quality is Free' – prevention is cheaper than correction
- Problem:
└ Electronics manufacturer faced high rework and scrap costs
└ Frequent warranty claims
└ Declining customer confidence
└ Employees accepted errors as unavoidable
→ Belief: These were just 'the cost of quality'
CROSBY’S INSIGHT
- Quality = conformance to requirements
- Prevention is the key, not inspection
- Zero Defects is the standard
- Cost of quality = cost of nonconformance
→ Quality is achievable and cost-effective
EXAMPLE ZERO DEFECTS IN A MOLECULAR BIOLOGY LAB
CONTEXT
- A molecular biology research lab was running PCR (polymerase chain reaction) experiments to amplify
DNA
- However, about 5–7% of runs failed due to contamination, pipetting errors, or mislabeled samples
TRADITIONAL MINDSET:
- Failures were accepted as “normal.”
- Scientists repeated PCR runs, wasting time and reagents.
5
,ZERO DEFECT APPROACH
(1) Management/PI Commitment
- Lab head declared that “one failed run is one too many”.
- Introduced a ZD culture: preventing contamination and errors is part of everyone’s responsibility
(2) Prevention measures
└ Standardized sample labeling system with color-coded caps and barcodes to avoid mix-ups.
└ Dedicated pipettes for PCR setup vs. DNA handling (to prevent cross-contamination).
└ Positive-displacement pipettes or filtered tips introduced to minimize errors.
└ Mandatory use of a PCR preparation hood with UV sterilization before setup.
(3) Training and Empowerment
└ All staff retrained in aseptic techniques.
└ Lab members encouraged to stop an experiment immediately if they notice possible
contamination or mislabeling.
(4) Measurement
└ Error rates (failed PCR runs) tracked weekly.
└ Data posted visibly on lab noticeboard.
(5) Recognition
└ Teams that maintained zero failed runs for a month were recognized in lab meetings.
Result:
- Failure rate dropped from ~7% to <1% within 3 months.
- Significant savings in reagents (Taq polymerase, primers, consumables).
- Faster turnaround time for sequencing and downstream experiments
CROSBY AND 'ZERO DEFECTS' SOLUTION & RESULTS
- Solution
└ Defined clear, measurable requirement
└ Trained employees on prevention
└ Launched a 'Zero Defects' campaign
└ Measured the cost of poor quality (COPQ)
└ Built a culture of accountability
- Results
└ Defect rates dropped
└ Rework and scrap costs reduced
└ Warranty claims decreased
└ Customer trust improved
└ Employees gained pride in quality work
- Key lesson
└ Zero Defects is not about perfection
└ It is about a culture where mistakes are not accepted as unavoidable
└ Quality is cost-effective and everyone’s responsibility.
6
,E JOSEPH JURAN AND 'FITNESS FOR PURPOSE'
- Quality defined by the customer, not just by defect rates
- Background
└ Companies once believed quality = zero defects
└ Relied on inspection and control
└ Despite faultless production, customers complained
- Problem
└ Manufacturing company had near-perfect defect rates
└ Machines passed inspection
└ Spare parts matched specifications
└ Manuals were technically accurate
└ Yet customers were dissatisfied, products returned, and sales dropped
JURAN’S INSIGHT
- Issue was usability, not defects
- Machines too complex
- Spare parts hard to fit in real conditions
- Manuals too technical
→ Quality is fitness for purpose — meeting customer needs
MOLECULAR BIOLOGY LAB CASE
- Context: A biotech lab produces plasmid DNA for gene therapy research.
- Customer requirement:
└ DNA must be highly pure (A260/A280 ~1.8–2.0) and endotoxin-free (<0.1 EU/µg DNA)
└ so it can be safely used in cell culture and animal experiments.
FITNESS FOR PURPOSE APPLICATION
Instead of just measuring DNA concentration (quantity), the lab adds QC tests for purity and endotoxin levels.
Only batches meeting both yield and safety specifications are released.
OUTCOME:
Researchers get DNA that is fit for its intended use (cell transfection), avoiding failed experiments due to
impurities or toxicity.
→ Quality is not just “high yield,” but producing DNA that works for its intended research purpose.
7
,J. JURAN AND ‘FITNESS FOR PURPOSE’ SOLUTION & PURPOSE
- Solution
└ Redesign machines for ease of use
└ Simplify spare-part installation
└ Write manuals in plain language
└ Add customer feedback loops
- Results
└ Customer complaints dropped
└ Product returns decreased
└ Customer loyalty and sales increased
└ Achieved long-term competitive advantage
- Key lesson:
→ Quality is not defined by the producer but by the customer.
→ Juran’s 'fitness for purpose' remains a cornerstone of quality management.
8
,1B: IMPORTANCE OF PROCESSES GL Y N IS FR AN S
WHAT IS A PROCESS?
A collection of activities that collectively convert inputs into outputs to achieve a certain goal
Input → activities → output
Processes can be divided into:
- Primary (most important)
└ Customer has expectations and needs to transfer in-out and that adds value
- Management processes
└ Tries to improve/maintain primary & secondary processes in term of quality
└ Third process
Describes the type of process: why is it important?
9
, EXAMPLE 1 – BAKERY
EXAMPLE 2 – HIP FRACTURE
Processes can be divided into (seen from a different angle)
- Main processes : Often same as the primary process
- Work processes : Part of the main process
- Work instructions : Not required for knowledge intensive tasks
✓ Describes the abstraction level of the process: how much details?
10
INTRODUCTION
WHAT IS QUALITY
- Depends on who you ask the question
- Quality of a car?
└ Status features: tinted windows, spoilers, hubcaps
└ Engine power
└ Comfortable suspension
└ Luggage space
└ Economy
└ Environmental aspect
└ Quality aspects conflict with each other ex: Small economical city car Large jaguar
- Quality of air travel?
└ Staff smiles
└ Lunch/coffee free of charge
└ Punctuality
└ The reliability of flight schedules
└ Ticket price
- Quality of a medicine?
└ Which three of the following are the most important properties of a medicine?
└ Depending on the medicine, the purpose, ability,…
• Effectiveness – the medicine should achieve the intended therapeutic effect
• Safety – minimal harmful side effects
• Correct dosage – effective at the recommended amount without being toxic
• Stability – remains effective and safe until the expiration date
• Ease of use – convenient form of administration (tablet, liquid, patch, injection, etc.)
• Affordability – reasonable cost for patients and healthcare systems
• High quality and purity of the active ingredient
1% OF NON-QUALITY
- dangerous effect on big scale
- Producing cars - car industry
└ ± 11.5 million vehicles
└ With a 1% defect rate in the braking system
→ 115,000 dangerous cars on the road per year in Europe
- Flights with commercial air planes
└ ± 39 million flights worldwide.
└ Assume 1% error (crash or serious incident)
→ 390,000 crashes per year, which is >1,000 crashes per day
- Tests in medical laboratories
1
, - Medical diagnostics - COVID-19 PCR tests (Europe, 2020)
└ In 2020, >100 million PCR tests were performed in the EU.
└ With a 1% error rate → 1 million incorrect results in one year (false positive or false negative)
└ Consequence: incorrect quarantine decisions or missed infections
- Financial transactions
└ ± 240 billion payments via banks
└ At 1% error rate → 2.4 billion incorrect transactions per year (≈ 6.5 million per day)
CONCLUSION
→ A 1% error rate seems small, but at large volumes the consequences are huge
Scale examples:
└ Millions of flights
└ Billions of financial transactions
└ Hundreds of millions of medical tests
→ Impact of a 1% error:
└ Thousands of deaths
└ Billions in financial losses
└ Severe social disruption
→ In critical sectors (aviation, healthcare, finance, etc.), such risks are unacceptable
That is why the standard is not 99%, but 99.9999% reliability (Six Sigma or better)
EXAMPLE: BREAST CANCER PATIENT WITH FAMILY HISTORY
Feature: the availability of a carrier status test
Needs:
- appropriate analytical test
- right sample
- TAT (turn around time)
└ TAT something that the customer asks for – can’t wait for one year
- Correct interpretation
DEFINITIONS OF QUALITY (ISO STANDARDS)
QUALITY
= Is the set of features and characteristics of a product or service that are important for meeting identified or
obvious needs
QUALITY SYSTEM
= Is the organisational structure with responsibilities, procedures, processes and facilities to ensure that
a delivered product or service always meets the specified requirements
2
,DEFINITIONS OF QUALITY (GARVIN 1984)
PRODUCT FOCUSED
- Viewed from the seller’s or supplier’s point of view
- Deals with objective properties of a product that can be measured and valued
DEFINITIONS OF QUALITY (COUNTESS 1984)
PRODUCTION-ORIENTED
- Viewed from the point of view of the producer or service provider
- Is about meeting/conforming to user requirements
“Crosby”
USER-CENTRIC
- Viewed from the user point of view to check whether the product or service is ‘fit for use’
- Meeting needs and expectations of specific users
“Juran 2010” “fit for use”
VALUE-ORIENTED
- Viewed from an economic point of view to value a product or service
- And this in relation to the price and effort it took to acquire the product or service
- More subjectivity
“Feigenbaum 1961”
“Making a unique statement is not possible”
TRANSCENDENT
- Viewed from a philosophical standpoint
- We can recognise quality just as we can recognise beauty
- ‘Quality’ is neither part of the mind (subjective) nor part of matter (objective). It is a third entity
independent of both the others
“Prisig 1976”
“You know it, when you see it”
DEFINITIONS OF QUALITY – SUMMARY
Quality involves both rational, objective characteristics and relational, subjective experiences
Whatever definition or angle you choose – inspiration to engage in dialogue about what you mean
- Motivate the way that you look at the story on the exam & paper
- Than write it in the right way
3
,WHAT IS QUALITY MANAGEMENT?
= Ensures that an organization’s products/services meet customer requirements and standards
→ It’s not just about checking the result but embedding quality throughout the PROCESS
WHAT IS PROCESS MANAGEMENT?
→ Process Management involves designing, analyzing, monitoring, and improving workflows to maximize
efficiency, effectiveness, and adaptability
EXAMPLE – PHANTOM OF HEILBRONN
- a mysterious criminal case in Germany and Austria between 1993 and 2009
- ‘woman without a face’ : phantom of Heilbronn
- For years found the same female DNA at more than 40 different crime scenes
└ including burglaries, murders, and robberies
└ Police think: dealing with dangerous serial offender, nicknamed the Phantom of Heilbronn
- What possible explanations could there be for why the same DNA appeared at so many different crime
scenes?
└ She worked in the factory where DNA tests were made, and those tests became
contaminated with her DNA
└ There was an error in the DNA testing technology itself
EXAMPLE – SAMPLING ERRORS IN BIOMEDICAL RESEARCH
- Cardiovascular disease research historically focused on men
- Women were under represented in clinical trials
- Researchers assumed results could be generalized to women (in practice not true)
- Classic sampling error: unrepresentative sample
Problem:
Symptoms of heart disease in women overlooked
Diagnostic criteria based on male biology
Treatments developed without adequate female data
Women’s heart attacks often misdiagnosed or treated late
Public impact:
→ Higher misdiagnosis and treatment delays in women
→ Increased mortality and morbidity
→ Gender disparities in heart disease outcomes
→ Skewed guidelines influenced decades of clinical practice
4
,Key lesson:
- Sampling errors in biomedical research have real-world consequences
- Diversity and representation are essential in clinical trials
- The true cost of bias is measured in patient outcomes
→ Research must reflect the populations it serves
D PHILIP CROSBY & ‘ZERO DEFECTS’
- “ Quality is Free – Doing things right the first time”
- Background:
└ 1970s: defects accepted as part of doing business
└ Assumed errors were unavoidable
└ High costs of fixing mistakes were considered normal
└ Crosby argued: 'Quality is Free' – prevention is cheaper than correction
- Problem:
└ Electronics manufacturer faced high rework and scrap costs
└ Frequent warranty claims
└ Declining customer confidence
└ Employees accepted errors as unavoidable
→ Belief: These were just 'the cost of quality'
CROSBY’S INSIGHT
- Quality = conformance to requirements
- Prevention is the key, not inspection
- Zero Defects is the standard
- Cost of quality = cost of nonconformance
→ Quality is achievable and cost-effective
EXAMPLE ZERO DEFECTS IN A MOLECULAR BIOLOGY LAB
CONTEXT
- A molecular biology research lab was running PCR (polymerase chain reaction) experiments to amplify
DNA
- However, about 5–7% of runs failed due to contamination, pipetting errors, or mislabeled samples
TRADITIONAL MINDSET:
- Failures were accepted as “normal.”
- Scientists repeated PCR runs, wasting time and reagents.
5
,ZERO DEFECT APPROACH
(1) Management/PI Commitment
- Lab head declared that “one failed run is one too many”.
- Introduced a ZD culture: preventing contamination and errors is part of everyone’s responsibility
(2) Prevention measures
└ Standardized sample labeling system with color-coded caps and barcodes to avoid mix-ups.
└ Dedicated pipettes for PCR setup vs. DNA handling (to prevent cross-contamination).
└ Positive-displacement pipettes or filtered tips introduced to minimize errors.
└ Mandatory use of a PCR preparation hood with UV sterilization before setup.
(3) Training and Empowerment
└ All staff retrained in aseptic techniques.
└ Lab members encouraged to stop an experiment immediately if they notice possible
contamination or mislabeling.
(4) Measurement
└ Error rates (failed PCR runs) tracked weekly.
└ Data posted visibly on lab noticeboard.
(5) Recognition
└ Teams that maintained zero failed runs for a month were recognized in lab meetings.
Result:
- Failure rate dropped from ~7% to <1% within 3 months.
- Significant savings in reagents (Taq polymerase, primers, consumables).
- Faster turnaround time for sequencing and downstream experiments
CROSBY AND 'ZERO DEFECTS' SOLUTION & RESULTS
- Solution
└ Defined clear, measurable requirement
└ Trained employees on prevention
└ Launched a 'Zero Defects' campaign
└ Measured the cost of poor quality (COPQ)
└ Built a culture of accountability
- Results
└ Defect rates dropped
└ Rework and scrap costs reduced
└ Warranty claims decreased
└ Customer trust improved
└ Employees gained pride in quality work
- Key lesson
└ Zero Defects is not about perfection
└ It is about a culture where mistakes are not accepted as unavoidable
└ Quality is cost-effective and everyone’s responsibility.
6
,E JOSEPH JURAN AND 'FITNESS FOR PURPOSE'
- Quality defined by the customer, not just by defect rates
- Background
└ Companies once believed quality = zero defects
└ Relied on inspection and control
└ Despite faultless production, customers complained
- Problem
└ Manufacturing company had near-perfect defect rates
└ Machines passed inspection
└ Spare parts matched specifications
└ Manuals were technically accurate
└ Yet customers were dissatisfied, products returned, and sales dropped
JURAN’S INSIGHT
- Issue was usability, not defects
- Machines too complex
- Spare parts hard to fit in real conditions
- Manuals too technical
→ Quality is fitness for purpose — meeting customer needs
MOLECULAR BIOLOGY LAB CASE
- Context: A biotech lab produces plasmid DNA for gene therapy research.
- Customer requirement:
└ DNA must be highly pure (A260/A280 ~1.8–2.0) and endotoxin-free (<0.1 EU/µg DNA)
└ so it can be safely used in cell culture and animal experiments.
FITNESS FOR PURPOSE APPLICATION
Instead of just measuring DNA concentration (quantity), the lab adds QC tests for purity and endotoxin levels.
Only batches meeting both yield and safety specifications are released.
OUTCOME:
Researchers get DNA that is fit for its intended use (cell transfection), avoiding failed experiments due to
impurities or toxicity.
→ Quality is not just “high yield,” but producing DNA that works for its intended research purpose.
7
,J. JURAN AND ‘FITNESS FOR PURPOSE’ SOLUTION & PURPOSE
- Solution
└ Redesign machines for ease of use
└ Simplify spare-part installation
└ Write manuals in plain language
└ Add customer feedback loops
- Results
└ Customer complaints dropped
└ Product returns decreased
└ Customer loyalty and sales increased
└ Achieved long-term competitive advantage
- Key lesson:
→ Quality is not defined by the producer but by the customer.
→ Juran’s 'fitness for purpose' remains a cornerstone of quality management.
8
,1B: IMPORTANCE OF PROCESSES GL Y N IS FR AN S
WHAT IS A PROCESS?
A collection of activities that collectively convert inputs into outputs to achieve a certain goal
Input → activities → output
Processes can be divided into:
- Primary (most important)
└ Customer has expectations and needs to transfer in-out and that adds value
- Management processes
└ Tries to improve/maintain primary & secondary processes in term of quality
└ Third process
Describes the type of process: why is it important?
9
, EXAMPLE 1 – BAKERY
EXAMPLE 2 – HIP FRACTURE
Processes can be divided into (seen from a different angle)
- Main processes : Often same as the primary process
- Work processes : Part of the main process
- Work instructions : Not required for knowledge intensive tasks
✓ Describes the abstraction level of the process: how much details?
10
