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)
Fitness for Purpose (Juran) = quality is defined by the customer, not just by defect rates
→ meeting customer needs
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 = about 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
Value-oriented = about the price and effort it took to acquire the product or service
→ from economic point of view
→ more subjective
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 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
● Volume of output
○ Low
■ low repetition
■ variety in activities
■ minimal automation
■ elevated unit costs
○ High
, ■ frequent repetition
■ specialisation
■ requires significant capital
■ low unit cost
● Variety of output
○ Low
■ routine
■ simple
■ standard
■ low unit cost
○ High
■ flexible
■ complex
■ custom-made
■ elevated unit cost
● Variation in demand for output
○ Low
■ stable capacity
■ predictable command
■ high utilisation rate
■ low unit cost
○ High
■ fluctuating capacity
■ anticipate demand
■ low utilisation rate
■ elevated unit cost
● Degree of customer contact/concealment
○ Low
■ customer experience
■ low tolerance for delays
■ customer contact is essential
■ elevated unit cost
○ High
■ time gap between production & consumption
■ customer contact is less important
■ low unit cost
These characteristics have a major impact on process design, efficiency, flexibility & the type of technology or
workforce needed
3.Components of quality management systems
Document control
Primary purpose = maintain the latest, accurate & approved version of documents
Document control is critical in quality management systems to prevent unauthorized changes & ensure the
traceability of revisions
, ISO = international organisation for standardization
→ produce different types of documents
⇒ consensus documents ⇒ different countries are working in the same way
Different types of ISO documents:
● International standard
○ Most common
○ Authoritative
○ Provides requirements, specifications, guidelines or characteristics
● Technical specifications
○ Published when there’s not yet enough consensus for a full standard
○ When technology is still developing
○ Can evolve into an international standard
● Technical report
○ Provides background information, data or explanations
○ No requirements
● Publicly available specifications (PAS)
○ Fast-rack documents for urgent market needs
○ Developed quicker than standards
○ Valid for 6 years without revision
● International workshop agreement (IWA)
○ Developed outside the usual ISO technical committee process
○ Used in emergency fields or urgent global challenges
● Guides
○ Provide guidance to standards developers
○ Focus on methodology for developing or applying standards
Importance of document control:
● Access to current information
● Error minimization
● Regulatory compliance
Key elements:
● Clear roles & responsibilities
● Defined timelines for reviews
● User-friendly procedures
● Simple implementation steps
Document creation → review phase → final approval
Historical archive ⇒ all documents from the past 10 years are in the same place
Each version of a document needs to be tracked
→ changes need to be well documented (what, why, by who)
Strategic access management ⇒ ensure the right people have the right access at the right time
Document control requirements:
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)
Fitness for Purpose (Juran) = quality is defined by the customer, not just by defect rates
→ meeting customer needs
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 = about 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
Value-oriented = about the price and effort it took to acquire the product or service
→ from economic point of view
→ more subjective
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 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
● Volume of output
○ Low
■ low repetition
■ variety in activities
■ minimal automation
■ elevated unit costs
○ High
, ■ frequent repetition
■ specialisation
■ requires significant capital
■ low unit cost
● Variety of output
○ Low
■ routine
■ simple
■ standard
■ low unit cost
○ High
■ flexible
■ complex
■ custom-made
■ elevated unit cost
● Variation in demand for output
○ Low
■ stable capacity
■ predictable command
■ high utilisation rate
■ low unit cost
○ High
■ fluctuating capacity
■ anticipate demand
■ low utilisation rate
■ elevated unit cost
● Degree of customer contact/concealment
○ Low
■ customer experience
■ low tolerance for delays
■ customer contact is essential
■ elevated unit cost
○ High
■ time gap between production & consumption
■ customer contact is less important
■ low unit cost
These characteristics have a major impact on process design, efficiency, flexibility & the type of technology or
workforce needed
3.Components of quality management systems
Document control
Primary purpose = maintain the latest, accurate & approved version of documents
Document control is critical in quality management systems to prevent unauthorized changes & ensure the
traceability of revisions
, ISO = international organisation for standardization
→ produce different types of documents
⇒ consensus documents ⇒ different countries are working in the same way
Different types of ISO documents:
● International standard
○ Most common
○ Authoritative
○ Provides requirements, specifications, guidelines or characteristics
● Technical specifications
○ Published when there’s not yet enough consensus for a full standard
○ When technology is still developing
○ Can evolve into an international standard
● Technical report
○ Provides background information, data or explanations
○ No requirements
● Publicly available specifications (PAS)
○ Fast-rack documents for urgent market needs
○ Developed quicker than standards
○ Valid for 6 years without revision
● International workshop agreement (IWA)
○ Developed outside the usual ISO technical committee process
○ Used in emergency fields or urgent global challenges
● Guides
○ Provide guidance to standards developers
○ Focus on methodology for developing or applying standards
Importance of document control:
● Access to current information
● Error minimization
● Regulatory compliance
Key elements:
● Clear roles & responsibilities
● Defined timelines for reviews
● User-friendly procedures
● Simple implementation steps
Document creation → review phase → final approval
Historical archive ⇒ all documents from the past 10 years are in the same place
Each version of a document needs to be tracked
→ changes need to be well documented (what, why, by who)
Strategic access management ⇒ ensure the right people have the right access at the right time
Document control requirements:
