Samenvatting quality and process management
CHAPTER 1: the importance of quality and processes in biomedical sciences
What is Quality? Core Concepts and Impacts
Quality means that a product or service meets the needs and expectations of the customer, it’s not
just about being error-free but about being fit for purpose
The same product can have different quality aspects depending on who evaluates it (for example, a
car might be judged on comfort, price, or safety)
Different perspectives on quality
• Product-based:
• Viewed from the seller’s or supplier’s point of view
• objective, measurable features (power, purity, stability)
• Production-based:
• Viewed from the point of view of the producer or service provider
• conformity to requirements (Philip Crosby’s “Zero Defects”)
• Crosby
• User-based:
• Viewed from the user point
• fitness for use, meeting user needs (Joseph Juran)
• Value-based:
• Viewed from an economic point of view
• balance between quality and cost (value for money)
• subjectivity
• Feigenbaum
• Transcendent/philosophical:
• Viewed from a philosophical point of view
• quality is recognized intuitively, like beauty: you know it when you see it
• prisig
Why quality matters
A 1% error rate might seem low → on a large scale → catastrophic
Examples from the slides:
• Aviation: a 1% failure rate would mean thousands of plane crashes daily
• Finance: billions of incorrect transactions
• COVID-19 testing: 1 million wrong PCR results at a 1% error rate
In critical sectors like healthcare, aviation and finance → errors must approach zero (Six Sigma =
99.9999% reliability)
- Faults here can lead to death, financial chaos and loss of trust
,Biomedical application
Sampling bias (like underrepresentation of women in cardiac studies) skews results → cause real
harm:
- late diagnoses
- poor treatment
- mortality differences
Good quality ensures valid, representative data
Key thinkers: Crosby and Juran
Philip Crosby:
• “Quality is conformance to requirements.”
• Prevention > inspection
• “Quality is free”: it costs less to prevent errors than to fix them later
• The “Zero Defects” culture: everyone is responsible for quality
Example: A molecular biology lab achieves a zero-defect mindset by color-coded labeling, sterile
technique, and immediate error detection → dramatically reducing failed PCR runs
Joseph Juran:
• “Quality is fitness for purpose.”
• A product can meet technical specs but still fail if users find it impractical
• Introduced customer-focused quality: meeting true needs, not just specifications
Example: A biotech lab ensures DNA purity (A260/280 ratio, low endotoxin) so researchers can safely
use it for experiments: quality defined by usability, not just yield
What is a process?
A process is a set of related activities that transform inputs into outputs to achieve a specific goal.
Example: blood sample → laboratory analysis → diagnostic report
Three main types:
- Primary processes:
o deliver value directly to the customer/patient (surgery, production, bread baking)
o Essential to fulfill the organization’s mission
o E.g. Manufacturing, Sales, Customer service, Product development
- Secondary/support processes:
o Support the primary processes
o Do not directly add value to the customer
o E.g. Human resources, IT support, Finance and accounting, Procurement
- Management/tertiary processes:
, o Involve planning, monitoring, and controlling of both primary and secondary
processes
o Ensure strategic alignment and continuous improvement.
o E.g. Strategic planning, Quality management, Compliance and risk management,
Performance monitoring, Planning and monitoring
Other distinctions
• By content:
• production (materials flow)
• information (data flow)
• service (patient interaction)
• By detail level:
• Main processes (e.g., “treat patient”),
• Work processes (screening, surgery, aftercare),
• Work instructions (protocols, checklists)
Process management and process-oriented working
Process management means describing, controlling, analyzing, and continually improving
organizational workflows to meet goals effectively and efficiently.
The PDCA cycle (Plan–Do–Check–Act) ensures continuous improvement:
1. Plan: define goals and processes.
2. Do: execute as planned.
3. Check: monitor results using data/KPIs.
4. Act: make improvements where needed
Organizational forms
Organizations can be structured around:
• Functions (HR, R&D, production)
• Specialization
• silo risk (silos between departments can slow collaboration)
• Geography (regions)
• local flexibility
• Duplication of functions (e.g., multiple HR or compliance teams per region)
• Risk of inconsistent standards across regions
• coordination issues
• Products (pharma vs diagnostics)
• focused
• may duplicate resources
• Risk of competition between product groups
• Processes (patient care pathways)
• high integration
• Focus on efficiency and patient outcomes
• potentially rigid (processes outdated)
• Markets/customers
• customer focus
, • costly to maintain multiple structures
What is processed-based working?
Process-based working does not equal project-based working!
- Improvising = how should I make the protocol, which papers will I read, ... → very broad and
much freedom
- Project based working = project that arises from an improvement, needs to be implemented
in daily practise before you can speak from project based
- Routine = very standarised (not much freedom)
Four key process characteristics
1. Volume of output
- how much is produced
- volume high: requires significant capital, low unit cost, frequent repetition, specialization
- volume low: low repetition, variety in activities, minimal automation, elevated unit cost
2. Variety
- how many different types of output
- high variety: Flexible, Complex, Custom-made, Elevated unit cost
- low variety: Routine, Simple, Standard, Low unit cost
3. Variation in demand
- stability vs fluctuations
- high variation in demand: Fluctuating capacity, Anticipate demand, Low utilization rate,
Elevated unit cost
- low variation in demand: Stable capacity, Predictable demand, High utilization rate, Low unit
cost
4. Customer contact/concealment
- visibility of the process to the customer
- low concealment: Customer experience, Low tolerance for delays, Customer contact
essential, Elevated unit cost
- high concealment: Time gap between production and consumption, Customer contact less
important, Low unit cost
These factors determine efficiency, cost, automation level and flexibility.
For instance, routine lab tests (high volume, low variety) can be automated, while rare transplants
(low volume, high variety) require expert human handling
CHAPTER 1: the importance of quality and processes in biomedical sciences
What is Quality? Core Concepts and Impacts
Quality means that a product or service meets the needs and expectations of the customer, it’s not
just about being error-free but about being fit for purpose
The same product can have different quality aspects depending on who evaluates it (for example, a
car might be judged on comfort, price, or safety)
Different perspectives on quality
• Product-based:
• Viewed from the seller’s or supplier’s point of view
• objective, measurable features (power, purity, stability)
• Production-based:
• Viewed from the point of view of the producer or service provider
• conformity to requirements (Philip Crosby’s “Zero Defects”)
• Crosby
• User-based:
• Viewed from the user point
• fitness for use, meeting user needs (Joseph Juran)
• Value-based:
• Viewed from an economic point of view
• balance between quality and cost (value for money)
• subjectivity
• Feigenbaum
• Transcendent/philosophical:
• Viewed from a philosophical point of view
• quality is recognized intuitively, like beauty: you know it when you see it
• prisig
Why quality matters
A 1% error rate might seem low → on a large scale → catastrophic
Examples from the slides:
• Aviation: a 1% failure rate would mean thousands of plane crashes daily
• Finance: billions of incorrect transactions
• COVID-19 testing: 1 million wrong PCR results at a 1% error rate
In critical sectors like healthcare, aviation and finance → errors must approach zero (Six Sigma =
99.9999% reliability)
- Faults here can lead to death, financial chaos and loss of trust
,Biomedical application
Sampling bias (like underrepresentation of women in cardiac studies) skews results → cause real
harm:
- late diagnoses
- poor treatment
- mortality differences
Good quality ensures valid, representative data
Key thinkers: Crosby and Juran
Philip Crosby:
• “Quality is conformance to requirements.”
• Prevention > inspection
• “Quality is free”: it costs less to prevent errors than to fix them later
• The “Zero Defects” culture: everyone is responsible for quality
Example: A molecular biology lab achieves a zero-defect mindset by color-coded labeling, sterile
technique, and immediate error detection → dramatically reducing failed PCR runs
Joseph Juran:
• “Quality is fitness for purpose.”
• A product can meet technical specs but still fail if users find it impractical
• Introduced customer-focused quality: meeting true needs, not just specifications
Example: A biotech lab ensures DNA purity (A260/280 ratio, low endotoxin) so researchers can safely
use it for experiments: quality defined by usability, not just yield
What is a process?
A process is a set of related activities that transform inputs into outputs to achieve a specific goal.
Example: blood sample → laboratory analysis → diagnostic report
Three main types:
- Primary processes:
o deliver value directly to the customer/patient (surgery, production, bread baking)
o Essential to fulfill the organization’s mission
o E.g. Manufacturing, Sales, Customer service, Product development
- Secondary/support processes:
o Support the primary processes
o Do not directly add value to the customer
o E.g. Human resources, IT support, Finance and accounting, Procurement
- Management/tertiary processes:
, o Involve planning, monitoring, and controlling of both primary and secondary
processes
o Ensure strategic alignment and continuous improvement.
o E.g. Strategic planning, Quality management, Compliance and risk management,
Performance monitoring, Planning and monitoring
Other distinctions
• By content:
• production (materials flow)
• information (data flow)
• service (patient interaction)
• By detail level:
• Main processes (e.g., “treat patient”),
• Work processes (screening, surgery, aftercare),
• Work instructions (protocols, checklists)
Process management and process-oriented working
Process management means describing, controlling, analyzing, and continually improving
organizational workflows to meet goals effectively and efficiently.
The PDCA cycle (Plan–Do–Check–Act) ensures continuous improvement:
1. Plan: define goals and processes.
2. Do: execute as planned.
3. Check: monitor results using data/KPIs.
4. Act: make improvements where needed
Organizational forms
Organizations can be structured around:
• Functions (HR, R&D, production)
• Specialization
• silo risk (silos between departments can slow collaboration)
• Geography (regions)
• local flexibility
• Duplication of functions (e.g., multiple HR or compliance teams per region)
• Risk of inconsistent standards across regions
• coordination issues
• Products (pharma vs diagnostics)
• focused
• may duplicate resources
• Risk of competition between product groups
• Processes (patient care pathways)
• high integration
• Focus on efficiency and patient outcomes
• potentially rigid (processes outdated)
• Markets/customers
• customer focus
, • costly to maintain multiple structures
What is processed-based working?
Process-based working does not equal project-based working!
- Improvising = how should I make the protocol, which papers will I read, ... → very broad and
much freedom
- Project based working = project that arises from an improvement, needs to be implemented
in daily practise before you can speak from project based
- Routine = very standarised (not much freedom)
Four key process characteristics
1. Volume of output
- how much is produced
- volume high: requires significant capital, low unit cost, frequent repetition, specialization
- volume low: low repetition, variety in activities, minimal automation, elevated unit cost
2. Variety
- how many different types of output
- high variety: Flexible, Complex, Custom-made, Elevated unit cost
- low variety: Routine, Simple, Standard, Low unit cost
3. Variation in demand
- stability vs fluctuations
- high variation in demand: Fluctuating capacity, Anticipate demand, Low utilization rate,
Elevated unit cost
- low variation in demand: Stable capacity, Predictable demand, High utilization rate, Low unit
cost
4. Customer contact/concealment
- visibility of the process to the customer
- low concealment: Customer experience, Low tolerance for delays, Customer contact
essential, Elevated unit cost
- high concealment: Time gap between production and consumption, Customer contact less
important, Low unit cost
These factors determine efficiency, cost, automation level and flexibility.
For instance, routine lab tests (high volume, low variety) can be automated, while rare transplants
(low volume, high variety) require expert human handling
