Beruflich Dokumente
Kultur Dokumente
Tools for a
Stronger
Organization
Dr. Nuala Calnan
Research Fellow
Pharmaceutical Regulatory Science Team
Dublin Institute of Technology, Ireland
What Do We Mean by Cultural Excellence ?
Participation in Continuous
Belief that I can and Active identification
multiple successful incremental
should directly of quality
Accountability Kaizen (quality improvement to
improve quality in improvements and
improvement) processes and
my area acting upon them
events performance
Direct experiences
Decisions are made
with their leader Belief that I can and Increased
promptly by those
empowering and should make ownership, quicker
Ownership closest and
supporting their decisions and own decision making and
knowledgeable to
make decisions quality in my area problem solving
issue
within their area
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Cultural Excellence Mindset Shift
Lower Maturity Vehicle Higher Maturity
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A Look Ahead at More to Come….
Quality Culture Maturity Tool
21 Question Behavioral Assessment Tool
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Gemba
Walks
Dr. Margit
Schwalbe-Fehl
Team Lead
The GEMBA team has developed a Best Practice
Guide for ... Site Support
Functions: 2/year
WHY to do a GEMBA walk Site Internal Customers:
1/quarter
What a GEMBA walk is and what it isn´t Area Mgmt, Site Leadership: daily
at different shifts
• Tool can be applied at either the macro (compare sites across the company) or micro (compare
departments within a site) level.
• Horizontal view indicative of individual area performance. Vertical view indicative of cultural
behavior performance across different areas.
Shaping Quality Cultural Excellence: Oversight and Review
The Oversight and Review Best Practices highlights examples of different governance processes and
approaches that foster leadership engagement in key areas that help reinforce a strong quality
culture.
Leadership Involvement
Cultural
Enablers
Tami Frederick
Team Lead
Shaping Quality Cultural Excellence: Cultural Enablers
Enabling All Dimensions of Cultural Excellence
Cultural Enablement
Best Practices Guide:
Cultural
Enablement
Guide Includes:
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Shaping Quality Cultural Excellence: Cultural Enablers
Cultural Enablement drives alignment and performance….
Enablement Tool Examples Leadership & Attitudes & Gemba Walks LQI's & Triggers Oversight &
Cultural Enablement
Alignment Model: Enablement Toolkit • Toolkit enables employees
Vision (Dimension Mindsets (Dimension 3) (Dimension 4) Review (Dimension
Guide 1) (Dimension 2) 5)
Situational Leadership X X X X
Learning Organization
Coaching/Mentoring
Strategy Deployment
X
X
X X X
X
X
X at all levels in an
Goal Alignment (Top Down) X X X X X
Hiring/Onboarding
System A3
X
X
X
X X X X
organization
• Provides tools that can be
Learning aligned to strategic
Model Behaviors X X X
goals
Leader/Manager/Associates
L/M/A KBI Examples X X X X X
Leader Standard Work
Standard Approach in meeting
X X X X
used across the
Cultural Enablers (Dimension 6)
X X X X X
or communication
People Recognition System
Recognize KBIs
Tie Reward to Recognition
X
X
X
X
X
X
X
X
X
X dimensions
• Best Practices Guide ties
Balanced Scorecard X X X X X
Control Charts X X X
Identify and Recognize Change Statistical/Capability Analysis X X X
Engagement and Enablement
Poke-Yoke
X
X
X
X
X
X
X
performance to behaviors
Kepner Tregoe X X X
Process Mapping
True Root Cause Analysis with Cause and Effect Diagram
X
X
X
X
X
X
• Roadmap examples
Preventive and Corrective Causal Circle (UDEs)
Action
Radar Chart
Risk Assessment
X
X
X
X
X
X
X
X
X
demonstrate how to
5-Whys
PDCA
X
X
X
X
X
X X
implement
DMAIC X X X X
Continuous Problem Solving
Future State Mapping X X X X
Control Systems X X X X
for improvement Expected KPIs or Behavior Expected Behavior Expected Behavior Expected Role
• Determine targeted Result/Outcome (Leadership) (Managers or Area Experts) (Front Line)
List Roles Roles Roles
Results
• Set Key Performance
Indicators (KPIs) Tools Structure/Schedule Signals Measurements
• Set controls
Control System:
List or description
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Shaping Quality Cultural Excellence: Cultural Enablers
Develop Roadmap to get there…
Culture & Continuous Improvement Capability Roadmap
Development Roadmaps Definition: Individual in all
Phases of Operations (e.g., Planning,
Culture and Continuous Improvement Management Process Culture & Continuous Improvement Capability Roadmap
for each role: Manufacturing, Supply Chain,
Quality, etc.) Overall Process PLAN DO/ASSESS CHECK/ACT MONITOR COMMUNICATE
Frontline Person Identify & Analyze Decide & Formulate Review/Control
Appropriate Job Aids / Tools are Readily Available
1. Frontline Desired *Proactively identify and *Work with line *Identify risk, issue, *Decide whether *Provide feedback *Know when to
2. Area Expert Performance or opportunity to act or escalate to supervisors on communicate 1. Reference a) Templates / Checklists
discuss concerns, issues management to
3. Area Manager and risks, and align goals and the identified risk, whether or not the with your Job Aids/Tools b) Proactive Examples
Perform informal *Access root cause, issue or solution worked supervisor and
continuous improvement
improvement develop a plan for
impact and potential opportunity using *KPIs peers c) Case Study Examples
4. Leadership within their work area: opportunities with your specific area
solutions improvement *KBIs
5. Subject Matter Expert supervisor/manager. methodologies *Controls *know what
Provide technical expertise information to Consultation Provided to Frontline on Specific Identified Opportunities/Improvements by
to support continuous *Provide input and/or *Proactively document for the a) Leaders
improvement and cultural propose improvement propose or record or future 2. Consultation
excellence. opportunities solutions as participate in the reference. b) Managers
Roadmaps include: solution Knowledge
Provide information for
experts in the areas they
Management-
c) Subject Matter Experts
1. Role Definitions activities including
are responsible for.
Lessons Learned
2. Behavioral updates to existing culture
and continuous *Engage in improvement *Document event Frontline Provided Frequent Opportunities to Practice Quality Event Identification
Expectations opportunities
3. Training
improvement management and solutions, 3. Practice a) Real Time Quality Event Identification and Communication
documents and/or decisions and
Requirements identification/ *Being aware of the rationale b) Regularly Scheduled Gemba Walks
implementation of new impact of your actions appropriately
Technical Skill controls and potential Coaching Provided to Frontline by Experts on
Soft Skill consequences on the
4. Coaching a) Quality Event Risk Identification and Communication
CI Program quality of the output.
Specific
b) Practical Application of Continuous Improvement
→→→→→→ LEARNING ROADMAP →→→→→→
Advanced Behavioral Requirements Training Supporting Framework
CI Program Advanced
1.Reference Formality Knowledge is Shared and Managed
4. Supporting Frontline/Manager/Leader
Technical Skill Training
Soft Skill
Specific Training Training
Spectrum
Framework
Training
(as needed) (optional)
Job Aids/Tools examples a) Best Practice Sharing
5. Line Sharing
1.1 System Accountability Matrix 1.Continous Improvement 1.PDCA 1.Local Training 2. Consultation With Area Managers b) Lessons Learned
Essentials 2.DMAIC; etc as Material for CI And or Area Experts on
References /Job appropriate Processes the specific improvements c) Appropriate Communication and Documentation
Aids / Tools 2.Root Cause
Analusis & RM
3.Practice Real Time Application
Learning by “doing”
Consultation 3.Decision making 4.Coaching Coaching : Align, Engage, Improve
Practice
5.Line Sharing
Sharing
Best Practice
Reinforcement Elements are Aligned to Support Proactive Improvement
Lessons
Coaching Learned a) Expectations for Proactive Improvement are in place and Managed as Part of Performance Management.
6. Reinforcement
Line Sharing
b) Proactive Improvement discussions integrated into activities (e.g. daily, weekly, quarterly, etc.)
6.Reinforcemet Reinforcement & recognition Expectations
set and c) Recognition and Rewards Aligned to Reinforce Proactive Improvement Behaviors
Reinforcement for proactive improvements & managed as
part of
KBIs from management or peers) performance
management
CI discussions integrated
into activities (daily, weekly, etc.)
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Publication
Plans
• Publish a Cultural Excellence
Comprehensive Six
Dimensions of Cultural Developing and Promoting a Culture of Excellence
Excellence Report Early
2017