Can quality metrics drive quality culture?€¦ · Benefits –Understanding Synergy of metrics & culture • Protects patient safety • Drives behaviors and ensures decision-making

Slide 1 © PharmOut 2017

Can quality metrics drive quality culture?

Jeney Isbel, Site Quality DirectorPGS MelbourneTuesday 25th July 2017, 10:00 – 10:30am


About Pfizer – Who We Are and What We Do

• One of the world’s leading biopharmaceutical companies

• Make many different kinds of products, including OTC, SOD, creams, solutions, sterile injectables

• Selling to greater than 170 markets

• Around 64 manufacturing sites around the world with 4 manufacturing sites in Australia

• Pfizer Australia employs 1,700 colleagues in a variety of fields

• Located in Mulgrave is Pfizer Global Supplies Melbourne manufacturing facility


Pfizer Fundamental Value Proposition

We make difficult choices, but we never compromise

Quality, Compliance or Safety.


PGS Melbourne 100 Years of Sterile Medicines Manufacturing Heritage

1900’s

1973 Mulgrave site established and ampoule manufacture commences

2001Mayne acquires FH Faulding. (generic oral business sold to Alpharma)

2000s

2007Hospira acquires Mayne Pharma

1915David Bull Laboratories (DBL) starts manufacturing injectable pharmaceutic-als in Melbourne

2012Hospira inducted into Manufactur-ing Hall of Fame Victoria

2013Hospira approves investment in new Oncology capacity

2015Pfizer acquires Hospira

1984FH Faulding acquires DBL and in 1985 launches 1st

cytotoxic drug (Cisplatin)

2017Site secures $20 million Pfizer investment


Overview

• What is Quality Culture?

• Considerations when setting Metrics

• Industry/ Regulatory Expectation?

• Business Priorities?

• What do metrics drive?

• Understand the “message”

• Impact of Changing metrics/targets

• What is the benefit?


Quality Culture – What is it?

• Various definitions of Quality Culture in the literature..

• Consists of the opinions, beliefs, traditions and practices concerning product and service quality

• The beliefs, behavior, norms, dominant values, rules and the climate within the organization.

• The organization’s value system, its collection of guiding beliefs and daily beliefs backed by policies, programs and top management’s action

• A subset of an organization's overall culture. It reflects the general approach, the values, and the orientation toward quality that permeate organizational actions

• “How things are around here"

Combination of Quality values and demonstrated behaviors of management and employees


In Pfizer, one common definition of a robust Quality Culture is: “an environment in which each and every person understands and embraces their responsibility for protecting product quality and patient safety”


Considerations

A company can have all the SOPs, systems and controls required but,

without quality culture, product quality and business continuity are not

assured

Industry and Regulatory

Greater focus in top Pharma companies and global regulatory agencies.

ICH Q10 focuses on critical area of management responsibility and reinforces importance of senior management in establishing and maintaining a companywide quality culture.

Typical Metrics

• Investigation Timeliness• Errors per batch• Rejected batches• Schedule adherance• CAPA

Robustness/Effectiveness• Wrong First Time Vs Right

First Time• Cycle Time

Attainment at any cost

Cost of QualityResourcing/Budgets – reward & recognition


What do metrics drive?

• Understand the why & the message

• Do they drive or do they just ‘tell’ of an issue?

• Why, why, why….the conversation….

• Changing Metrics?

• Can’t decide?

• Need to measure something else?

• Established Sustainable ways of working

• Time to shift gears?

• Specific Focus?


Key behaviours behind metrics

Five key behaviours demonstrating a robust Quality Culture1:

1. Create and maintain an awareness of quality, disseminating information on current quality results to all management and personnel.

2. Provide real evidence of management leadership on quality. Managers should be involved in strategic planning and providing resources for deploying quality goals.

3. Encourage self-development and empowerment and personal commitment for quality.

4. Provide opportunities for employee participation and quality ownership by taking part in process design or making presentations on quality.

5. Provide public recognition and financial and/or non-financial rewards. 1 Gryna and Juran and Godfrey

10

A robust Quality Culture is aligned and consistent with our OWN IT culture


A Culture of Ownership

In 2012 Pfizer introduced OWNIT! to create a culture

where colleagues are accountable for their decisions,

take appropriate risks, and deliver on their

commitments to impact business performance.

OWNIT! represents the five dimensions of an ownership culture:


Benefits – Understanding Synergy of metrics & culture

• Protects patient safety

• Drives behaviors and ensures decision-making is based on what is best for product quality and patient safety

– Colleagues will do the right thing at all times

– Ensures continuous improvement

– Fosters staff engagement

• Protects company reputation and business

A Robust Quality Culture: Our patients and customers deserve it; regulators require it; and Pfizer OWNS IT !


ANY QUESTIONS?

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Can quality metrics drive quality culture?€¦ · Benefits –Understanding Synergy of metrics & culture • Protects patient safety • Drives behaviors and ensures decision-making