1
QPM
Chapter 1A
Quality management
Ensures that an organization’s products/services meet customer requirements and
standards.
Process management
Designing, analysing, monitoring and improving workflows to maximize efficiency,
effectiveness and adaptability to ensure that organisational goals are met.
Crosby’s Insight – Zero Defects = standard
Quality is free, prevention is key
Quality = conformance to requirements
Cost of quality = cost of nonconformance (to requirements)
Quality is achievable and cost effective – everyone is responsible
Culture where mistakes aren’t accepted as unavoidable
Juran’s Insight – Fitness for Purpose
Quality is not only zero defects
Quality = fitness for purpose – meeting customer needs
Quality is defined by the customer, not the producer
Quality
A set of features and characteristics of a product or service that are important for
meeting identified or obvious needs.
- Product focused (suppliers pov, objective properties of a product)
- Production oriented (producer/providers pov)
- User centric (users pov, meeting user’s needs)
- Value centric (economic pov, in relation with price and effort to acquire product
or service, subjective)
- Transcendent (philosophical pov)
Quality system
The organisational structure with responsibilities, procedures, processes and facilities
to ensure that a delivered product or service always meets the specified requirements.
,2
Chapter 1B – Importance of processes
Process
A collection of activities that collectively convert inputs into outputs to achieve a
certain goal.
TYPES of processes
Primary process/operational process
Secondary process/support process (supports the primary process)
Management process/enabling process (maintain and improve primary and secondary
process)
Primary processes Secondary processes Management processes
Core activities Support primary Planning, monitoring,
Deliver value to processes controlling P & S
the customer No direct value to processes
Fulfil mission the customer Strategic alignment
Continuous
improvement
Manufacturing, product HR, IT support, finance & Strategic planning, quality
development, sales, accounting, procurement management, compliance,
customer service (inkopen) risk management,
performance monitoring
ABSTRACTION LEVEL – how detailed are the processes described
Main process ~ primary process
Work process (part of the main process (vaguely defined))
Work instructions (detailed description of the process)
INPUT of the process – what flows through the process
Production process – product
Information process – information
Service delivery process – customer
PDCA cycle – process management
Plan: describing processes, activities are defined
Do: govern processes, set goals/targets
Check: analysing processes, how well are the processes running
Act: improving processes, make adjustments when required
Different ways organisations are organised
- Functional: focus on internal expertise (purchasing, sales, production…)
- Geographic: organised by region
- Process: based on workflow (design process, production process…)
- Product: focused on final product (medical devices, medicines…)
- Market: focus aimed at specific customer groups (businesses, citizens…)
Four important characteristics of processes
Description HIGH example LOW example
Volume of output Amount produced Routine Rare surgeries
vaccinations
Variety of output Range of products/ Personalized Standardized
services offered treatment plans vaccination
procedure
Variation in Fluctuations in ER visits Scheduled follow-
,3
demand demand over time (unpredictable) ups
Degree of Visibility of the Clinical Laboratory tests
customer process to the examination (back-office)
contact/concealm patient/customer (front-office)
ent
Impact the process design, efficiency, flexibility and used workforce/technology
, 4
Chapter 2 – Components of Quality Management Systems
Document control
ISO – International Organization for Standardization
Different kinds of standards depending on the sector
- IS – International Standards
= most common and authoritative
Provides requirements, specifications, guidelines or characteristics to ensure
materials,
products, processes and services are fit for purpose
e.g. ISO 9001 Quality Management System standard, globally applied
- TS – Technical Specifications
Standard still in development, not an ISO yet
- TR – Technical Reports
Informative; provides background information, data, explanations; without
setting requirements
ISO sharing knowledge without making it a standard
- PAS – Publicly Available Specifications
Quick, temporary specifications for urgent market needs
Can be the first step towards a future IS
Valid up to 6 years, after it must be revised, confirmed or withdrawn
- IWA – International Workshop Agreements
Developed outside the usual ISO technical committee process
Created in workshops involving stakeholders who need a rapid solution
Used in emerging field or urgent global challenges (e.g. Covid)
- Guides
Provide guidance for developing or applying standards
When working with an ISO document, it is important to know what kind of document
you are working with.
Document control
- Gives access to current information
- Error minimization: accurate documentation catches problems before they
become costly defects or recalls
- Regulatory compliance: systematic documentation helps organisations meet
industry requirements and avoid penalties
Document control is the backbone of your organization and quality
management system
Document control procedure
A foundational document, SOP of the SOPs: standard operating procedure, on
document control
- Clear roles and responsibilities
- Defined timeline for reviews
- User-friendly procedures
- Simple implementation steps
Document identification & organisation
- Comprehensive document inventory: all QMS documents from across the whole
company
- Centralized repository: all documents stored in one secure, accessible location,
prevents duplication
QPM
Chapter 1A
Quality management
Ensures that an organization’s products/services meet customer requirements and
standards.
Process management
Designing, analysing, monitoring and improving workflows to maximize efficiency,
effectiveness and adaptability to ensure that organisational goals are met.
Crosby’s Insight – Zero Defects = standard
Quality is free, prevention is key
Quality = conformance to requirements
Cost of quality = cost of nonconformance (to requirements)
Quality is achievable and cost effective – everyone is responsible
Culture where mistakes aren’t accepted as unavoidable
Juran’s Insight – Fitness for Purpose
Quality is not only zero defects
Quality = fitness for purpose – meeting customer needs
Quality is defined by the customer, not the producer
Quality
A set of features and characteristics of a product or service that are important for
meeting identified or obvious needs.
- Product focused (suppliers pov, objective properties of a product)
- Production oriented (producer/providers pov)
- User centric (users pov, meeting user’s needs)
- Value centric (economic pov, in relation with price and effort to acquire product
or service, subjective)
- Transcendent (philosophical pov)
Quality system
The organisational structure with responsibilities, procedures, processes and facilities
to ensure that a delivered product or service always meets the specified requirements.
,2
Chapter 1B – Importance of processes
Process
A collection of activities that collectively convert inputs into outputs to achieve a
certain goal.
TYPES of processes
Primary process/operational process
Secondary process/support process (supports the primary process)
Management process/enabling process (maintain and improve primary and secondary
process)
Primary processes Secondary processes Management processes
Core activities Support primary Planning, monitoring,
Deliver value to processes controlling P & S
the customer No direct value to processes
Fulfil mission the customer Strategic alignment
Continuous
improvement
Manufacturing, product HR, IT support, finance & Strategic planning, quality
development, sales, accounting, procurement management, compliance,
customer service (inkopen) risk management,
performance monitoring
ABSTRACTION LEVEL – how detailed are the processes described
Main process ~ primary process
Work process (part of the main process (vaguely defined))
Work instructions (detailed description of the process)
INPUT of the process – what flows through the process
Production process – product
Information process – information
Service delivery process – customer
PDCA cycle – process management
Plan: describing processes, activities are defined
Do: govern processes, set goals/targets
Check: analysing processes, how well are the processes running
Act: improving processes, make adjustments when required
Different ways organisations are organised
- Functional: focus on internal expertise (purchasing, sales, production…)
- Geographic: organised by region
- Process: based on workflow (design process, production process…)
- Product: focused on final product (medical devices, medicines…)
- Market: focus aimed at specific customer groups (businesses, citizens…)
Four important characteristics of processes
Description HIGH example LOW example
Volume of output Amount produced Routine Rare surgeries
vaccinations
Variety of output Range of products/ Personalized Standardized
services offered treatment plans vaccination
procedure
Variation in Fluctuations in ER visits Scheduled follow-
,3
demand demand over time (unpredictable) ups
Degree of Visibility of the Clinical Laboratory tests
customer process to the examination (back-office)
contact/concealm patient/customer (front-office)
ent
Impact the process design, efficiency, flexibility and used workforce/technology
, 4
Chapter 2 – Components of Quality Management Systems
Document control
ISO – International Organization for Standardization
Different kinds of standards depending on the sector
- IS – International Standards
= most common and authoritative
Provides requirements, specifications, guidelines or characteristics to ensure
materials,
products, processes and services are fit for purpose
e.g. ISO 9001 Quality Management System standard, globally applied
- TS – Technical Specifications
Standard still in development, not an ISO yet
- TR – Technical Reports
Informative; provides background information, data, explanations; without
setting requirements
ISO sharing knowledge without making it a standard
- PAS – Publicly Available Specifications
Quick, temporary specifications for urgent market needs
Can be the first step towards a future IS
Valid up to 6 years, after it must be revised, confirmed or withdrawn
- IWA – International Workshop Agreements
Developed outside the usual ISO technical committee process
Created in workshops involving stakeholders who need a rapid solution
Used in emerging field or urgent global challenges (e.g. Covid)
- Guides
Provide guidance for developing or applying standards
When working with an ISO document, it is important to know what kind of document
you are working with.
Document control
- Gives access to current information
- Error minimization: accurate documentation catches problems before they
become costly defects or recalls
- Regulatory compliance: systematic documentation helps organisations meet
industry requirements and avoid penalties
Document control is the backbone of your organization and quality
management system
Document control procedure
A foundational document, SOP of the SOPs: standard operating procedure, on
document control
- Clear roles and responsibilities
- Defined timeline for reviews
- User-friendly procedures
- Simple implementation steps
Document identification & organisation
- Comprehensive document inventory: all QMS documents from across the whole
company
- Centralized repository: all documents stored in one secure, accessible location,
prevents duplication
