Quality and process management
1. Introduction
Quality management ⇒ an organization’s products or services meet the customers'
requirements & standards
→ checking the end result + embedding quality throughout the process
Process management = designing, analyzing, monitoring & improving workflows to
maximize efficiency, effectiveness & adaptability
Quality is free = prevention is cheaper than correction
→ assumed errors were unavoidable ⇒ high costs of fixing mistakes were normal
⇒ Zero Defects is the new standard (Crosby)
→ not perfection, but a culture where mistakes are not accepted as unavoidable
→ quality is cost-effective & everyone’s responsibility
Fitness for Purpose (Juran) = quality is defined by the customer, not just by defect rates
→ meeting customer needs
⇒ quality is not defined by the producer but by the customer
Quality = the set of features and characteristics of a product or service that are important
for meeting identified or obvious needs
Quality system = the organisational structure with responsibilities, procedures, processes &
facilities to ensure that a delivered product or service always meets the specified
requirements
Product-focused = deals with objective properties of a product that can be measured &
valued
→ from seller’s or supplier’s point of view
Product-oriented = meeting or conforming to user requirements
→ from producer’s or service provider’s point of view
User-centric = meeting needs & expectations of specific users
→ from user’s point of view
→ fitness for purpose
Value-oriented = about the price and effort it took to acquire the product or service
→ from economic point of view to value a product or service
→ more subjective
Quality involves both rational, objective characteristics & relational, subjective experiences
2.The importance of processes in biomedical
sciences
What is a process?
Process = a collection of activities that collectively convert inputs into outputs to achieve a
certain goal
Primary process = operational process = core activities that directly deliver value to the
customer
→ essential to fulfilling the organisation’s mission
→ ex. manufacturing, sales, customer service, product development
,Secondary process = support process that doesn’t add direct value to the customer but
ensures that the primary process can function effectively
→ ex. human resources, IT support, finance & accounting, procurement
Management process = planning, monitoring, & controlling primary & secondary processes,
ensuring strategic alignment & continuous improvement
→ ex. strategic planning, quality management, compliance & risk management,
performance monitoring
Processes are often divided into main processes, work processes & work instructions
→ main processes are often the same as the primary process
→ work processes describe specific actions that are needed in the main process
→ this division describes the abstraction level of the process (how many details)
Processes can also be divided into production, information & service processes
→ this division describes what flows through the process (what’s the input)
What is process management?
Process management = the systematic & controlled influencing of processes to ensure that
organisational goals are met
Applied process management = the systematic & controlled influencing of processes by
applying practical methods & instruments to ensure that organisational goals are met
Plan-do-check-act cycle:
● Plan = describing processes
→ activities are known
● Do = govern processes
→ set goals & targets
● Check = analyzing processes
→ check if processes run as expected
● Act = improving processes
→ adjust processes when required
What is process-based working?
Every organisation is designed to perform certain activities, which collectively form a
process
Common organisation:
● Functional = focus on internal expertise
● Geographic = organised by region
● Process = based on workflows or pathways
● Product = focused on the final product
● Market = aimed at specific customer groups
Improvising Project-based Process-based
When When necessary To be provided Repeating
Results Uncertain Reasonably sure Sure
Awareness New & sudden New & planned Known
,Freedom Lots of freedom Considered in advance Hardly any freedom
Methodology Chaotic Gradually clear Clear & fixed
, Important characteristics of processes
These characteristics have a major impact on process design, efficiency, flexibility & the
type of technology or workforce needed
Volume of output
= the amount of product/service produced
Low:
● Low repetition
● Variety in activities
● Minimal automation
● Elevated unit costs
High:
● Frequent repetition
● Specialisation
● Requires significant capital
● Low unit cost
Variety of output
= range of products/services offered
Low:
● Routine
● Simple
● Standard
● Low unit cost
High:
● Flexible
● Complex
● Custom-made
● Elevated unit cost
Variation in demand for output
= fluctuations in demand over time
Low:
● Stable capacity
● Predictable command
● High utilisation rate
● Low unit cost
High:
● Fluctuating capacity
● Anticipate demand
● Low utilisation rate
1. Introduction
Quality management ⇒ an organization’s products or services meet the customers'
requirements & standards
→ checking the end result + embedding quality throughout the process
Process management = designing, analyzing, monitoring & improving workflows to
maximize efficiency, effectiveness & adaptability
Quality is free = prevention is cheaper than correction
→ assumed errors were unavoidable ⇒ high costs of fixing mistakes were normal
⇒ Zero Defects is the new standard (Crosby)
→ not perfection, but a culture where mistakes are not accepted as unavoidable
→ quality is cost-effective & everyone’s responsibility
Fitness for Purpose (Juran) = quality is defined by the customer, not just by defect rates
→ meeting customer needs
⇒ quality is not defined by the producer but by the customer
Quality = the set of features and characteristics of a product or service that are important
for meeting identified or obvious needs
Quality system = the organisational structure with responsibilities, procedures, processes &
facilities to ensure that a delivered product or service always meets the specified
requirements
Product-focused = deals with objective properties of a product that can be measured &
valued
→ from seller’s or supplier’s point of view
Product-oriented = meeting or conforming to user requirements
→ from producer’s or service provider’s point of view
User-centric = meeting needs & expectations of specific users
→ from user’s point of view
→ fitness for purpose
Value-oriented = about the price and effort it took to acquire the product or service
→ from economic point of view to value a product or service
→ more subjective
Quality involves both rational, objective characteristics & relational, subjective experiences
2.The importance of processes in biomedical
sciences
What is a process?
Process = a collection of activities that collectively convert inputs into outputs to achieve a
certain goal
Primary process = operational process = core activities that directly deliver value to the
customer
→ essential to fulfilling the organisation’s mission
→ ex. manufacturing, sales, customer service, product development
,Secondary process = support process that doesn’t add direct value to the customer but
ensures that the primary process can function effectively
→ ex. human resources, IT support, finance & accounting, procurement
Management process = planning, monitoring, & controlling primary & secondary processes,
ensuring strategic alignment & continuous improvement
→ ex. strategic planning, quality management, compliance & risk management,
performance monitoring
Processes are often divided into main processes, work processes & work instructions
→ main processes are often the same as the primary process
→ work processes describe specific actions that are needed in the main process
→ this division describes the abstraction level of the process (how many details)
Processes can also be divided into production, information & service processes
→ this division describes what flows through the process (what’s the input)
What is process management?
Process management = the systematic & controlled influencing of processes to ensure that
organisational goals are met
Applied process management = the systematic & controlled influencing of processes by
applying practical methods & instruments to ensure that organisational goals are met
Plan-do-check-act cycle:
● Plan = describing processes
→ activities are known
● Do = govern processes
→ set goals & targets
● Check = analyzing processes
→ check if processes run as expected
● Act = improving processes
→ adjust processes when required
What is process-based working?
Every organisation is designed to perform certain activities, which collectively form a
process
Common organisation:
● Functional = focus on internal expertise
● Geographic = organised by region
● Process = based on workflows or pathways
● Product = focused on the final product
● Market = aimed at specific customer groups
Improvising Project-based Process-based
When When necessary To be provided Repeating
Results Uncertain Reasonably sure Sure
Awareness New & sudden New & planned Known
,Freedom Lots of freedom Considered in advance Hardly any freedom
Methodology Chaotic Gradually clear Clear & fixed
, Important characteristics of processes
These characteristics have a major impact on process design, efficiency, flexibility & the
type of technology or workforce needed
Volume of output
= the amount of product/service produced
Low:
● Low repetition
● Variety in activities
● Minimal automation
● Elevated unit costs
High:
● Frequent repetition
● Specialisation
● Requires significant capital
● Low unit cost
Variety of output
= range of products/services offered
Low:
● Routine
● Simple
● Standard
● Low unit cost
High:
● Flexible
● Complex
● Custom-made
● Elevated unit cost
Variation in demand for output
= fluctuations in demand over time
Low:
● Stable capacity
● Predictable command
● High utilisation rate
● Low unit cost
High:
● Fluctuating capacity
● Anticipate demand
● Low utilisation rate
