This document summarizes a presentation titled "Excellence Through Quality" given by Christopher Evans. The presentation discusses the relationship between quality and excellence, defining quality as meeting customer needs and expectations through consistency, value, reliability, and products being fit for purpose. It notes key aspects of quality include regulatory compliance, standards, and guidelines. The presentation outlines factors that contribute to quality like policies, procedures, staff competency, and communication. It discusses benefits of quality both externally in ensuring safety, compliance and customer satisfaction, and internally in effective management and decision making. Finally, it presents a model for achieving excellence through a philosophy of values, employees, commitment and continuous improvement.

1. Excellence Through Quality
Presented by Christopher Evans
Date 29th April 2014
All rights reserved worldwide. Copyright © 2014 Gael Ltd.

2. Quality management professional with 20
years experience working in GLP, GMP and
ISO regulated industries. Expertise in
Operational, Quality Assurance and Project
Management positions within Healthcare and
Global Life Science organisations.
Responsible for the business strategy within
the Life Sciences sector at Gael.
chrise@gaelquality.com
@GaelChrisE
Gael Ltd
Excellence Through Quality

3.  Why Excellence and why Quality?
 Reflection of performance, high standards
and service.
 A tool to achieve performance excellence.
 But what exactly is Quality?
Excellence Through Quality

4.  Quality is a bit like Lego??
 Quality is about meeting the needs and
expectations of customers?
 Key aspects of quality for the customer include:
 Consistency, Value for money, Reliable, Fit for
purpose
 In Life Science - this "fit for purpose" also
brings in Regulatory Compliance
 Customers may be patients/recipients
 Regulatory bodies FDA, MHRA
 Standards and guidelines GMP, GLP, ISO
What is Quality?

5. Policies & Procedures
Competency of:
• Staff
• Suppliers
Equipment / Facilities
Risks
• understood
• quantified
• remediated
Risk Assessments
Audits
Test/Analysis
Event/Incident Reporting
Action Plans
Change Management
Quality & Compliance Management
• Non Conformances
• Laboratory Investigations
• Complaints
• Reporting – Adverse/Recalls
• Investigation
• Learning

6.  Of course get your compliance activities
organised!
 Defined Quality Management System
 Implement Plan Do Check Act
 Understanding where flexibility is required
 Make your quality management processes
work for your organisation. Do not over-
complicate them
 But there is more, I promise!
There is still more to Quality

7. What are the factors that contribute to Quality?
Ownership & Responsibility
• Team effort
• Staff ‘buy-in’
• Base knowledge
• Knowing their contribution matters
Commitment
• Business
• Business Plan
• Investors
• Company performance
• Quality Policy
• Internal
• Employees
• External
• Regulatory agencies
• Suppliers
• Customers
Communication

8. Core Benefits of Quality - 1
External
• Patient/Recipient safety
• Regulatory compliance
• Supports inspections
• Helps to maintain compliance
• Customer satisfaction and confidence
• Supplier management

9. Core Benefits of Quality - 2
Internal
• Centralised management of compliance activities
• Ownership
• Effective communication
• Support correct decision making

10. Core Benefits of Quality - 3
Business
• Ensures and maintains consistency of quality
processes and procedures
• Competitive advantage (especially for start ups/spin
offs/university collaborations/'service providers)
• Investment and sustainability
• Drives Performance Improvement
• Reduction in risk

11. Discussion on “Linked In”
in 2014
Most common word
associated with Quality
was Excellence
 %5 risk = shared fourth
 %5 perceptiveness = shared
fourth
 %5 perfection = shared fourth
 %7 satisfaction = third
 %10 quality = second
 %15 excellence = the leader
 ‘Degreetowhichasetofinherentcharacteri
sticsfulfilsrequirements’ !
One word to describe Quality

12.  Why Excellence?
 Reflection of performance, high
standards and service.
 But what exactly is Excellence?
How can you Achieve it?
How can you Maintain it?
Excellence Through Quality

13. What is Excellence – mind explosion!!
Employees
Individual
Mission
Vision
Quality
Behaviour
Innovation
Flexibility
Defined
Monitoring
Specification
Evaluation
Collaboration
Foundation
Suppliers
Short-term
Culture

14. The Excellence Model - philosophy for achieving excellence
Philosophy
• Values/Mission
• Employees
• Commitment
• Performance
Implementation
• Systems
• Processes
• Effectiveness
• Consistent
Improvement
• Doing things better
• Change and Innovation
• Long term

15.  Me
 Name: Christopher
 Age: 21 (and a bit )
 Role in business:
Daddy
 Aim – to build a vehicle
Project Lego

16.  Product
 Vehicle
 4 wheels
 Carries a
Ninja
 Fit for
purpose!
Project Completed

17.  My son
 Name: Callum
 Age: 8 (well nearly)
 Role in business:
Lego builder
 Aim – to be the best
Project Lego

18.  Product
 Vehicle
 4 wheels
 Carries a Ninja
 Fit for purpose!!!
and is the
 Benchmark!!!
LEGO Excellence

19. Outputs of excellence:
 Benchmarking
 Staff
 Reputation
 Customers
 Growth
 Success – perceived value
 Recognition
 Collaboration
 Worth and Value
Are they the same?
Outputs of quality:
 Regulatory compliance
 Reduction in risk
 Ownership
 Effective communication
 Consistency of processes
 Suppliers
 Customer satisfaction
 Sustainability
No - I see quality as a tool to achieve performance excellence.
It helps you to do the right thing, and do things right.

20. What exactly is Excellence?
 Not perfection, not static
 Vision – to be the best, to set the benchmark of performance for others to
aspire and follow
 To sustain that performance
How do you Achieve?
 Start with a vision – define philosophies by which your business will succeed
 Create a culture
 Implement, and optimize processes
 Expect high standards and demand the same from your suppliers
 Strive to do the right things right the first time
 Embrace Quality to help you achieve excellence
How do you Maintain it?
 Monitor and evaluate
 See how things can be done better - Strive for innovation and challenge your processes
 Embrace continuous improvement to solve the problems of tomorrow today
 Raise the bar
Achieving Excellence Through Quality

21. Thank you! Any Questions?
Aim for Excellence