Quality Culture:

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 ?

Transforming the Cultural DNA of the Pharmaceutical Industry

Envisions a genetic re-engineering of the cultural DNA of

the pharmaceutical industry from a compliance-led
culture to an excellence-led culture of quality.
The evolution towards a culture of quality will require a
re-ordering of the DNA sequence to build a double helix,
strengthened from a combination of patient focus and
excellence.
Promoting, coaching and leading specific desired behaviours while identifying and
preventing specific undesired behaviours.
An Overview of ISPE’s Cultural Excellence sub-teams activities

…to improve capability in shaping cultural excellence.

Leadership
and Vision
Team
Erika Ballman Team Lead
Leadership and Vision
• Purpose: Identify best-practices and leader-led behaviors most directly linked to positive culture
transformation.
• Shaping Excellence Interviews captured shared stories, successes and learnings in leader’s own
words, with a specific focus on improving Pharmaceutical Quality.

Interview method was one-hour

teleconferences focused on a set of 15 core
questions.

Generated 100+ written transcript pages and

> 11 hours of audio. Findings were presented
June 2016 (ISPE/PQRI Quality Manufacturing
Conference)
Leader 5V: Leader Influence on Culture
Next Steps
Article:
• Shaping Excellence: How Leader Actions and Behaviors
Influence Quality Culture – Target November 2016.

Support for Quality Culture Guidance

Document (Fall 2016) with other
dimension teams.

Share leader self assessment tools within

the guide (self and team-based
assessments) and in-depth findings from
“Shaping Excellence” interviews.
Attitudes
and
Mindsets
Team
Matt Pearson
Team Lead
Shaping Quality Cultural Excellence: Attitudes &
Mindsets
Attitudes & Mindsets drive performance….
Performance Model

Attitudes Mindsets Behaviors Actions Results Performance

Attitudes drive mindsets…

Mindsets drive behaviors…
Behaviors drive actions…
Actions drive results…
Results drive performance

….so our ability to monitor & shape mindsets matter!!

Shaping a Quality Mindset Using Experience Based Approach
Experience Target Belief Target Action Target Result

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

Participation in Belief that I can and Active Improved proactive

multiple facilitated should identify and communication of communication and
Action Oriented risk assessment communicate risks to risks and mitigation mitigation of risks as
events management actions and decisions part of daily activity

Belief that I can and

Direct experiences Improved
should admit Concerns and issues
with their leader prevention and
mistakes, raise are raised
Speak Up encouraging and
issues and immediately to
speed in addressing
acknowledging issues and driving
recommend supervisor
speak up improvements
improvements

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Cultural Excellence Mindset Shift
Lower Maturity Vehicle Higher Maturity

Quality is built in to everything I

I abide by the rules because we
Quality is a do because it is the right thing for Quality is a
have to in order to remain in Accountability
Guidance our patients, my colleagues, and Devotion
business.
the organization

I observe quality in my area — It

is interesting, but it doesn’t have I am responsible for quality in my
Observer anything to do with me. I do Ownership area. I don’t assume that an error Owner
what’s asked and follow the will be caught by someone else.
simple instructions

I spend most of my time

I spend most of my time
identifying issues proactively and
Reactive responding to and fixing Action Proactive
intervening to minimize any
Orientation problems that arise to keep up Orientation potential negative impacts on
Orientation
with production schedules
quality & compliance

When I come across a quality I speak up, bring up quality

Passive risk, issue or an opportunity to Active
Speak Up issues, and regularly challenge
Communication improve it, I may or may not call Communication
status quo for improved quality
it out.

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A Look Ahead at More to Come….
Quality Culture Maturity Tool
21 Question Behavioral Assessment Tool

Recommended Action Options

Recommended Action Options

….to enable assessment and improvement in

cultural excellence

13
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

 Management and customer involvement Team leaders in their area: daily at

different shifts
Area supervisors: multiple times per day
 Frequencies for the various levels of management covering all shifts

involved in GEMBA walks

 “HOW TO” recommendations including a set
of questions to prepare and perform GEMBA
walks
 Defining agreed actions and how to best track
them

All recommendations are based on practical

experiences of team members companies
The GEMBA Best Practice
recommendations are supported by ...
• A case study from a volunteer site to demonstrate
how the concept can be adapted based on the
maturity of a site and the site strategy and
priorities

• Lessons learned from implementing GEMBA in

the laboratories of 50+ pharmaceutical
manufacturing sites in US, Canada, Europe and
Asia describing tangible results, watch-outs, and
surprises
Our conclusions are ...
 GEMBA is a key program to enhance the Quality Culture of a
site by

 Creating visible management commitment to change

 Engaging all employee levels of the organization
 Enhancing communication of priorities, objectives and desired
behaviors
 Engaging customers to allow people to see “the bigger picture“

 GEMBA in itself is not enough to drive culture change but it

is the most immediate and direct intervention that a site can
implement

Implementing GEMBA is the boldest move to make a visible change

 Leading
Quality
Indicators
(LQIs)
Dr. Nuala Calnan
Team Lead
 Question:
How can we design
leading indicators of
quality to measure
outcomes that matter to
our patients?
“Most “quality” metrics do not gauge
quality; rather, they are process measures Answer:
that capture compliance”
“The only true measures of quality are the Focus on driving the
outcomes that matter to patients” “desired” behaviours
through Key Behaviour
Indicators (KBIs)
Changing Behaviours, Measuring Results
• The ABC model holds that
Antecedents lead to Behaviours,
which lead to Consequences.

• Antecedents are events that precede

behaviours and are triggers to what
people say and do. They are enablers
to behaviours however they do not
motivate behaviours.

• It is the consequences that motivate

by either reinforcing or discouraging
the behaviours, i.e. consequences
determine whether desired or
unwanted behaviours occur.

Feedback in the form of

Reinforcement….
not Enforcement
Changing Behaviours, Measuring Results
Use of the IMPACT Tool* for
development of a set of Leading
Quality Indicators (LQI) or Leading
Behavioural Indicators LBI’s

Outlines how to design

quantitative measures of the
behavioural changes which enable
the delivery of enhanced quality
regulated products.

These measures target

behavioural change across the
key operational areas of
Patient, People, Places,
Prevention and Performance © Nuala Calnan PRST-DIT – All Rights Reserved

© Nuala Calnan PRST-DIT – All Rights Reserved

Pinpointing High Impact Behaviours

# Suggestions Successfully Implemented

Share the Publish Attendance Scores for Shop Floor Talks

Near
Misses in
in shop floor morning meetings to proactively Lunch and
review paperwork completion and address Learn
‘near miss’ events root causes sessions
Publish
Campaign
Lessons
Learned and
review at APQR
© Nuala Calnan PRST-DIT – All Rights Reserved
Triggers
Monitoring For Risks in the Manufacturing Network
Oversight
and
Review
Kira Ford
Team Lead
Shaping Quality Cultural Excellence: Oversight and Review
The Oversight and Review Heat Map Tool displays the output from the Quality Culture Behavior
Maturity Assessment to enable the identification of best practices and area of opportunity.
Cultural Behavior
Area

• 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.

Aligned Quality Objectives

Problem Identification, Problem Solving,

Troubleshooting and Investigations

External Party Oversight & Reporting

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:

28
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

….enabling cultural excellence across all dimensions

How Do You Enable teams Culturally?
Cultural Enablement Using the System Improvement/Behavior
Accountability Model: System Improvement and Behavioral Accountability Template

System/Improvement Name: Name Business Process Owner: Owner

• Assess your system Purpose: Business Case/Planned Improvement Reason

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 Key Behavior  List 


Process Map
Schedule, etc.
 What signals good or
bad?
Performance metrics
 List including target

Indicators per role and current condition

Behavioral metrics
 List including target
(KBIs) and current condition

• Set controls
Control System:
 List or description

… through Performance & Behaviors

30
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.)

Cultural Enablement Key Learnings:

• Key Performance Indicators are tied to Key Behavior Indicators for each role in the
organization (Leaders, Managers, Front Line)
• Roadmaps help to build accountability and cultural excellence
• Cultural Enablement tools span all Cultural Excellence Dimensions
• We own the collective Cultural Excellence of our Organization

31
Publication
Plans
• Publish a Cultural Excellence
Comprehensive Six
Dimensions of Cultural Developing and Promoting a Culture of Excellence
Excellence Report Early
2017

• Spring 2017 Conference

on Developing and
Promoting a Culture of
Excellence
Thank You
nuala.calnan@dit.ie