Quality and process management
1
,Chapter 1A: Introduction
1% error rate
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
In critical sectors (aviation, healthcare, finance, etc…) such risks are unacceptable. That’s why the standard is
not 99%, but 99,9999% reliability (six sigma or better)
What is quality management and process management?
Definition quality management: quality management is a structured way of making sure an organization
consistently delivers products or services that meets the customer needs, expectations and regulatory
standards
- It focuses on embedding quality across all activities, not just at the end
- Core elements: planning, assurance (zekerheid), control and continuous improvement (continue
verbetering)
- Goal: deliver reliable (betrouwbaar), safe and high value outcomes to customers
→it’s not just about checking the end result but embedding quality throughout the process!!
Definition process management: Process management is the discipline of designing, analyzing, monitoring
and improving workflows to maximize efficiency, effectiveness (*) and adaptability within an organization to
ensure they are efficient, consistent and aligned with business goals.
- It focuses on how work gets done – the steps, resources and responsibilities
- Core elements: mapping processes, measuring performance, eliminating waste, and optimizing flow
- Goal: achieve efficiency, consistency, and effectiveness in operations
*: what is the difference between efficiency and effectiveness:
- efficiency: doing things right
- Effectiveness: doing the right things
example – Phantom of Heilbronn
what is it?: The “Phantom of Heilbronn” was the nickname given to a mysterious female serial offender
suspected of committing numerous crimes across Germany, Austria, and France between 1993 and 2009. DNA
traces from the same unknown woman were repeatedly found at dozens of crime scenes, including burglaries
and even the murder of a police officer in Heilbronn, Germany. For years, investigators pursued the idea of a
highly elusive criminal. However, in 2009 it was revealed that the DNA actually came from contaminated
cotton swabs used in forensic testing — meaning the “Phantom” never really existed. This case became a
famous example of how procedural errors can mislead large-scale investigations.
→this is an example that illustrates problems with quality assurance, process reliability and traceability
2
,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
→there is a 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
key lesson:
- Sampling errors (steekproeffouten) 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 (onderzoek moet de doelgroepen weerspiegelen die het
bedient)
Zero defects – kwaliteit is goedkoper dan geen kwaliteit – Philip Crosby
Philip Crosby was a quality management expert known for his concept of “Zero Defects.” He argued that quality
means conformance to requirements, not just goodness, and that preventing mistakes is better (and cheaper)
than fixing them later. His Zero Defects philosophy doesn’t mean people never make errors, but that
organizations should set the goal of doing things right the first time. Crosby also introduced the idea that
“quality is free” — investing in prevention saves money by reducing waste, rework, and customer
dissatisfaction.
Crosby’s insight:
- Quality = conformance to requirements
- Prevention is they key, not inspection
- Zero defects is the standard
- Cost of quality = cost of nonconformance
Quality is achievable and cost-effective
3
, Example – zero defects in a molecular biology lab
Context: a molecular biology research lab was running PCR 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
Zero defect approach = zero defect aanpak
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 around 7% tot <1% within 3 months
- Significant savings in reagents (Taq polymerase, primers and consumables)
- Faster turnaround time for sequencing and downstream experiments
Philip Crosby and zero defects – solution and results
Solution: Results:
- Defined clear, measurable requirements - Defect rates dropped
- Trained employees on prevention - Rework and scrap costs reduced
- Launched a zero defects campaign - Warranty claims decreased
- Measured the cost of poor quality (COPQ) - Customer trust improved
- Built a culture of accountability - 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
4
1
,Chapter 1A: Introduction
1% error rate
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
In critical sectors (aviation, healthcare, finance, etc…) such risks are unacceptable. That’s why the standard is
not 99%, but 99,9999% reliability (six sigma or better)
What is quality management and process management?
Definition quality management: quality management is a structured way of making sure an organization
consistently delivers products or services that meets the customer needs, expectations and regulatory
standards
- It focuses on embedding quality across all activities, not just at the end
- Core elements: planning, assurance (zekerheid), control and continuous improvement (continue
verbetering)
- Goal: deliver reliable (betrouwbaar), safe and high value outcomes to customers
→it’s not just about checking the end result but embedding quality throughout the process!!
Definition process management: Process management is the discipline of designing, analyzing, monitoring
and improving workflows to maximize efficiency, effectiveness (*) and adaptability within an organization to
ensure they are efficient, consistent and aligned with business goals.
- It focuses on how work gets done – the steps, resources and responsibilities
- Core elements: mapping processes, measuring performance, eliminating waste, and optimizing flow
- Goal: achieve efficiency, consistency, and effectiveness in operations
*: what is the difference between efficiency and effectiveness:
- efficiency: doing things right
- Effectiveness: doing the right things
example – Phantom of Heilbronn
what is it?: The “Phantom of Heilbronn” was the nickname given to a mysterious female serial offender
suspected of committing numerous crimes across Germany, Austria, and France between 1993 and 2009. DNA
traces from the same unknown woman were repeatedly found at dozens of crime scenes, including burglaries
and even the murder of a police officer in Heilbronn, Germany. For years, investigators pursued the idea of a
highly elusive criminal. However, in 2009 it was revealed that the DNA actually came from contaminated
cotton swabs used in forensic testing — meaning the “Phantom” never really existed. This case became a
famous example of how procedural errors can mislead large-scale investigations.
→this is an example that illustrates problems with quality assurance, process reliability and traceability
2
,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
→there is a 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
key lesson:
- Sampling errors (steekproeffouten) 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 (onderzoek moet de doelgroepen weerspiegelen die het
bedient)
Zero defects – kwaliteit is goedkoper dan geen kwaliteit – Philip Crosby
Philip Crosby was a quality management expert known for his concept of “Zero Defects.” He argued that quality
means conformance to requirements, not just goodness, and that preventing mistakes is better (and cheaper)
than fixing them later. His Zero Defects philosophy doesn’t mean people never make errors, but that
organizations should set the goal of doing things right the first time. Crosby also introduced the idea that
“quality is free” — investing in prevention saves money by reducing waste, rework, and customer
dissatisfaction.
Crosby’s insight:
- Quality = conformance to requirements
- Prevention is they key, not inspection
- Zero defects is the standard
- Cost of quality = cost of nonconformance
Quality is achievable and cost-effective
3
, Example – zero defects in a molecular biology lab
Context: a molecular biology research lab was running PCR 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
Zero defect approach = zero defect aanpak
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 around 7% tot <1% within 3 months
- Significant savings in reagents (Taq polymerase, primers and consumables)
- Faster turnaround time for sequencing and downstream experiments
Philip Crosby and zero defects – solution and results
Solution: Results:
- Defined clear, measurable requirements - Defect rates dropped
- Trained employees on prevention - Rework and scrap costs reduced
- Launched a zero defects campaign - Warranty claims decreased
- Measured the cost of poor quality (COPQ) - Customer trust improved
- Built a culture of accountability - 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
4
