How Life Science organisations can achieve excellence through Quality Management

Excellence Through Quality

Presented by Christopher EvansDate 29th April 2014

All rights reserved worldwide. Copyright © 2014 Gael Ltd.

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.

[email protected]

@GaelChrisE

Gael Ltd


Why Excellence and why Quality?

Reflection of performance, high standards and service.

A tool to achieve performance excellence.

But what exactly is Quality?


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?

Policies & Procedures

Competency of:

• Staff• Suppliers

Equipment / Facilities

Risks

• understood• quantified• remediated

Risk Assessments

Audits

Test/Analysis

Event/Incident Reporting

Action PlansChange Management

Quality & Compliance Management

• Non Conformances• Laboratory Investigations• Complaints

• Reporting – Adverse/Recalls• Investigation• Learning

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

Claire McCluskie

Again I would re-use Andrew's content here as it would fit in nicely

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

Core Benefits of Quality - 1

External

• Patient/Recipient safety

• Regulatory compliance

• Supports inspections

• Helps to maintain compliance

• Customer satisfaction and confidence

• Supplier management


Internal

• Centralised management of compliance activities

• Ownership

• Effective communication

• Support correct decision making


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

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 ‘Degreetowhichasetofinherentcharacteris

ticsfulfilsrequirements’ !

One word to describe Quality

Claire McCluskie

Sorry, I dont really get this slide.....not sure what you are trying to get across.I would see it better tying in quality to excellence rather than suddenly talking about qaulity right off

Why Excellence?

Reflection of performance, high standards and service.

But what exactly is Excellence?How can you Achieve it?How can you Maintain it?


What is Excellence – mind explosion!!

Employees

IndividualMission

Vision

Quality

Behaviour

Innovation

Flexibility

Defined

Monitoring

Specification

Evaluation

Collaboration

Foundation

Suppliers

Short-term

Culture

Claire McCluskie

I would more say - 'Components that contiribute to Excellence'

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

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

Project Lego

Product Vehicle 4 wheels Carries a

Ninja Fit for

purpose!

Project Completed

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

Project Lego

Product Vehicle 4 wheels Carries a Ninja Fit for purpose!!!

and is the Benchmark!!!

LEGO Excellence

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.

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

Thank you! Any Questions?

Aim for Excellence

How Life Science organisations can achieve excellence through Quality Management

Healthcare

Transcript of How Life Science organisations can achieve excellence through Quality Management