11/22/2009
A Heuristic Map of Lean and Safety
Engineering Methodologies
The Background
• Patient safety management
– Never really left us but has enjoyed a renaissance
for all the wrong reasons
• ‘Lean’ has become a dominant model
– But there are many purveyors out there
– The high profile US case studies dominate thinking
• Budget/Cost reduction requirements in the UK
will accelerate lean programmes
• Lean and safety management
– Were they friends or foes?
Dr Nick Rich and Dr Mark Alexander Sujan
Warwick Medical School
The pattern of some TQM programmes
which run out of enthusiasm
Effectiveness of the TQM initiative
COST
OUTCOME
QUALITY
TIME
Introduction
Learning and
understanding
Growth
Increasing
enthusiasm
Levelling off
Starting to hit
the more difficult
problems
Disillusionment
Waning
enthusiasm
Source:
Slack
etetalal(2004)
Source:
Slack
(2004)
Source: Cooke, 2009
The Mastery
Process
Lean has given to us?
JIT
Kanban
Level Production Volume
Mixed Model Heijunka levelling
Jidoka
On the spot
Poka Yoke
Inspection
Total Productive Maintenance
Andon
Low Cost Automation
Quality Tools
5S
Set Up Time Reduction
Total Quality Control
Continuous Improvement
Value Stream Mapping
Applied Quality Function Deployment
Single Piece Flow
Policy Deployment
Standard Operating Procedures
U Cells
Cross Functional Management
All of these are SOLUTIONS to problems faced by
Toyota! Lots of management study and an
evolutionary approach
EFFECTIVENESS
Dealer derived
Production
Volumes
Repackaging
Attempts to
revitalize the
programme
Reduce Complexity
Eliminate Duplication
Reduce Waste
Inspection is non-value added
COST DOWN FOCUS (SCM)
COST DOWN FOCUS (by Design)
PROCESS FLEXIBILITY UP = COST DOWN
DELIVERY UP + QUALITY GOOD = COST DOWN
QUALITY UP = COST DOWN
Basic Discipline SAFETY AND MORALE
TIME
(C) Rich et al 2004
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11/22/2009
A Single Organisational System
- Consensus-
QUALITY
DELIVERY
Total Quality Management
Practices and
Problem
Solving by Teams
Toyota Production System
And standardised work
Approach to flow
Total Quality
Management
Approach
Six Sigma
Statistical Process Control
Design of Experiments
Taguchi Methods
Quality
Focus
Problem-Solving
Lean Production
System Design
Level Production
Supplier Pull Systems
Cells & Layout
Quick Changeover
Standardised Work
Mistake Proofing
Brainstorming
Cause and Effect
Pareto
Workplace Organisation
CANDO/5S
Visual Management
Teams
Mistake Proofing
Mistake Proofing
Problem-Solving
Problem-Solving
Delivery
Focus
Autonomous Maintenance
Planned Maintenance
Quality Maintenance
OEE Analysis
Early Equipment Management
Reliability Centred Maintenance
Total Productive Maintenance
And an approach to system
Reliability for interrupted flow
Total Productive Maintenance
Approach
RELIABILITY
© Nick Rich 2000
Lean will address Lapses
Cost
Focus
Lean has also helped improve micro-systems
Thought there was too much
paperwork to complete to
report an incident – so didn’t
Taken a short cut
Poor Handovers
Had a near-miss
Followed ‘Out of Date’
Procedures
Did not gel your hands
Saw something and felt you
should have spoken up
– but did not
Improvements
Source: NHSi
The Challenge
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11/22/2009
Systems Safety (Reason, 1990)
Two Approaches
Individual Approach
• Person is at fault
• Apportion blame
• Punish and remove the
individual
System Approach
• Failure is hidden in the
system of healthcare and
awaits the opportunity to
happen
• Not an individual failure
• Systems must be changed
and improved to manage
safely
Some holes due
to active failures
Hazards
Other holes due
to
Victims
latent ‘pathogens’
Successive layers of defences, barriers, & safeguards
Source: Reason, 1990
The safety world enjoys creating barriers, duplication and redundancy
Organisational Factors
The System
Culture
Defences
Mitigation
Resilience
What the Patient Sees
And Experiences
Practice
Defences
Mitigation
Resilience
Politics
Defences
Mitigation
Resilience
Intervention
INPUT
OUTPUT
Task
Care
Errors Risks Errors Risks Errors Errors Errors Risks
ErrorsRisks
Risks Errors
Risks Errors
Environment
The different
Safety levels
Business
Effectiveness
& Results
Value &
Growth Focus
Full
Potential
Lean and Safety are
not necessarily at
odds.
Past History
(Memory)
Training
Equipment
Source: Jones, 2009
Levels of Analysis
Team Working and Learning Groups
Cognitive – Multi-Disciplinary Team
(Pathway Safety)
Glass Ceiling
Stall Point
Neither can survive
effectively in isolation
Cognitive – Decision Making and situation
Awareness
Safety
Focus
?
People
Clarity of
Roles
Clinical Status and Handovers (Standardised Work and
Information)
Lean
Operational
Excellence
Decline
Capability
Establishing Roles and Responsibilities
Physical Improvement (Workplace, Materials and Equipment)
To Care
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11/22/2009
SAFETY
SAFETY
4
RESIST
RESIST
3
LEARN
LEARN
4
IN THIS ZONE YOU ARE
Spending Effort on
SAFETY MANGEMENT but
low efficiency gain
(safe but slow)
2
2
SOLVE
SOLVE
1
IN THIS ZONE YOU ARE
Spending Effort on
speeding patient FLOW
but systems at risk of
patient harm
(Fast but Fragile)
1
ANALYZE
ANALYZE
IMPROVE
PERFECT
ANALYZE
STABLE
IMPROVE
PERFECT
LEAN
STABLE
LEAN
ANALYZE
3
Methods
Stage One
STAGE ONE
Theme
SAFETY
System Risk Assessment and visualisation
LEAN
Awareness of Value and visualisation
Focus
Understanding of the system (risks) and the
buy in of key stakeholders via participation.
Main Issues
Tools
Risks
System Models, process maps, task analysis
Prioritisation Tool
Measures
FMEA
Risk Scores and quantified levels of risk
(historic data or expert/manufacturer)
Understanding of the system
(wastes) and the buy in of key
stakeholders
Costs, duplication, and delays
Pareto of patient types (families),
flow and cycle times, quality, hours
of operation.
Quick Fixes Basic P/solving
Value added time, distance,
Number of incidents
Typical Stakeholders
Involved in this stage
Clinical experts and human factors/safety
experts with management input
Improvement specialist supported
by clinical, safety, and management
representatives
Education for the clinical
stakeholders
Reflection
Low – active through learning by doing
(building the map)
Current state map - Low because it focuses on
immediate issues. Novelty through thinking
about human factors and taking a systematic
approach to safety.
Low – active through learning by
doing (building the map)
Current state map - Low because it
focuses on immediate issues but
novelty is in ‘seeing the whole’
system
Stage Two
FMEA Template
Part/Product Name and No.:
Process Owner:
Process Name:
Part/
Process
Prepared By:
FMEA Date (Orig):
Failure
Mode
Causes
Sev Occ Det RPN
Audits
Controls
Actions
(Rev.)
Plans
Ow ner and Timing
Severity x Occurrence x Detection = Risk Priority Number
STAGE ONE
Theme
SAFETY
Solve Issues
LEAN
Stabilise
Focus
Identify and eliminate risks
Standardised work/Std documents
Organised environment
Main Issues
Risks
Incident data
Tools
Interventions in the microsystem
SBAR
Prioritisation Tool
Measures
FMEA
Number of incidents and reports
Process standards – Visual Management
- 5 Whys
Quality of Solutions
Interventions in the microsystem. Rapid
Improvement Events
Learning how to do it right
Problem-Solving – flow barriers
Number of events and incidents
Normality vs abnormality
Typical Stakeholders
Involved in this stage
Clinical experts and human factors/safety
experts and teams involved with process
Teams clinical, safety, and management
representatives
Education for the clinical
stakeholders
Reflection
High – Solutions Management
High - learning by doing PDCA
KPIs and human factors.
Incident Review
Standard work and PDCA cycle
Incident review
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11/22/2009
Stage Three
Documentation Project
What Data is Sent
Document
Sender-Receiver
Chart
Stage Four
SAFETY
Resist
LEAN
Perfect
Focus
Creating reliability and systems that.
Understanding of the whole system the buy in of other
depts/organisations
End To End Management
Design of Robust, Resilient and Redundant
System
Design
Mistake Proofing
Advanced situation awareness
LEAN
Improvement
Focus
Training and audits
and the buy in of key stakeholders
Main Issues
Tools
Risks
System Models, process maps, task analysis
Prioritisation Tool
Measures
FMEA
Risk Scores and quantified levels of risk
(historic data or expert/manufacturer)
Costs, duplication, and delays
Pareto of patient types (families),
flow and cycle times, quality, hours
of operation. How to do it better
Quick Fixes Basic P/solving
Value added time, distance,
Number of incidents
Typical Stakeholders
Involved in this stage
Clinical experts and human factors/safety
experts with management input
Improvement specialist supported
by clinical, safety, and management
representatives
Education for the clinical
stakeholders
Reflection
Low – active through learning by doing
(building the map)
Current state map - Low because it focuses on
immediate issues. Novelty through thinking
about human factors and taking a systematic
approach to safety.
Low – active through learning by
doing (building the map)
Current state map - Low because it
focuses on immediate issues but
novelty is in ‘seeing the whole’
system
DETECTED
GP
Hospital Ambulance
Service
Nursing
Home
District
Nurse
Hospital
Med
history
Prioritisation Tool
Measures
P/solve embedded/IR1
End to End Maps - Kaizen
Create and detect
Mistake Proofing
Learning how to learn and do things
differently
Embedded P/Solve
Mean Time Between Failure
Mean Time to Recover
Mean time between failure
Mean Time to Recover (design)
Typical Stakeholders
Involved in this stage
All – proactive risk monitoring
Many
Intermediate
Care
Education for the clinical
stakeholders
Reflection
Group Learning and discourse
Group Learning and discourse
Social Services
Systematic Design for
safety./Preventive/Predictive
Reliability centred management
Design for safety and improved flow
Reliability Centred Management
4
Delays
TTOs
Handovers
No-one to
Receive
Nursing
Home
District
Nurse
Other
THE
RESTORE
CYCLE
Map System
Develop
BestFocussed
Practice
Improvement
Define OEE
1
Assess Criticality
Potential Review
Awareness of Value
Visualisation
Stable
Improve
Perfect
Buy In- Loss and
Standards
Controls
Problem Solve
Economy MDT
Effectiveness
Design
P/S tools
End2End
LEAN
Tools
THE
INNOVATE
CYCLE
Collect Equipment
Formalise Best
Practices
cost Focus
Process & Value
Stream Mapping
Other
Improper
Referrals
Ambulance
Service
THE
VISUALISE
CYCLE
2
Focus
Other
Practically - Making It Happen
3
Focus
Social
Services
Other
SAFETY
Tools
Intmdte
Care
No
History
GP
CREATE
Tools
SAFETY
Learning
Create &
Detect
Chart
STAGE ONE
Theme
Main Issues
STAGE ONE
Theme
Assess the 6 Losses
& Set
Improvement
Define
Potential
Priorities
Appraise Condition/
Set Standards/
Restore
Problem
Prevention
FEEDBACK
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11/22/2009
The Current State
Questions?
• Building the model and testing with our
partners
• Positioning our partners and looking at how
they evolve
• How did they and do they use tools,
techniques and methodologies?
• Can we predict the next stage?
• How are system efficiency and effectiveness
measures used for learning?
6