Leadership SOSTM Turning Failure into Success

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REDICA © 2021. ALL RIGHTS RESERVED. Leadership SOS TM Turning Failure into Success Presented by: Steve Greer GMP Consultant, Leadership Coach, Keynote Speaker and Co-owner at Genesis Assist

Transcript of Leadership SOSTM Turning Failure into Success

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REDICA © 2021. ALL RIGHTS RESERVED.

Leadership SOSTM

Turning Failure into Success

Presented by: Steve Greer

GMP Consultant, Leadership Coach, Keynote Speaker

and Co-owner at Genesis Assist

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Introduction

Steve A. Greer

Consultant, Leadership Coach, & Speaker

Recent “Graduate” of Procter & Gamble QA

External Engagement Leader

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Leadership SOSTM

Turning Failure

into Success

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Boat Captain

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Boat Captain

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Stormy Seas Image

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Success = Ownership + Systems

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PR Map

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▪Cost: $500K+/mo

▪Service: 5% Missed

▪Moral: ?

50%Human

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Toilet Image

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Human Alerts and OOS

0%

20%

40%

60%

11/12 12/13 13/14 14/15

% Human Q Alerts

0%

20%

40%

60%

11/12 12/13 13/14 14/15

% Human OOS

70%

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Business Results

0

5

10

15

20

25

Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec Jan Feb Mar Apr May Jun

$14M

Inventory

Savings

16 pt Increase

in Employee

Survey

Perfect

Customer

Service

Eliminated

Past Due

Investigations

$20M+

Savings

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Next Stop

Quality ManagementMaturity

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Communication and Collaboration

Risk Management

Manufacturing Strategy and Operations

Productivity Optimization (5S)

Customer Experience

Quality Metrics

Advanced Analytics

Quality Culture

Leadership Commitment to Quality

Employee Ownership and Engagement

Sustainable Compliance

Business Continuity

Continual Improvement

Enhanced Pharmaceutical Quality System

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Communication and Collaboration

Risk Management

Manufacturing Strategy and Operations

Productivity Optimization (5S)

Customer Experience

Quality Metrics

Advanced Analytics

Quality Culture

Leadership Commitment to Quality

Employee Ownership and Engagement

Sustainable Compliance

Business Continuity

Continual Improvement

Enhanced Pharmaceutical Quality System

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3 Guaranteed Ways

to Fail

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Approach to Human Error

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Approach to Human Error

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Approach to Human Error

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Quality Our Consumers,

Customers, Regulators

and Employees trust

everywhere, every time.

P&G Quality Promise

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Effective Leadership

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Results

Accountability

Commitment

Conflict

TRUST

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Success = Ownership + Systems

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To make a mistake is

human, but to blame it on

someone else, that's even

more human.

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“In late February, one or more workers somehow confused

the two during the production process, raising questions

about training and supervision.”

FDA 483 4/20/2021

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Blame Cycle

Source: Ginette Collazo

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Whose Fault is it?

Change Our Questions to Change Our Destiny

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What Can I do

Differently?

Change Our Questions to Change Our Destiny

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Success = Ownership + Systems

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96%

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“A bad system will beat a

good person every time”

W. Edwards Deming

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▪ Read a single number wrong 2 10,000

▪ Read a clear 5 letter word wrong 3 10,000

▪ Read a checklist wrong 1 1,000

▪ Perform the wrong visual inspection 3 1,000

▪ Record information wrong 1 100

▪ Read an unclear 5 letter word wrong 3 100

▪ Fail to notice wrong position of valves 5 10

▪ Fail to act after 1 min in emergency 9 10

Human Error Rate

Dr. David J. Smith, “Reliability and Maintainability and Risk”

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Procedures are the

single leading cause

of confusion

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Are Your SOPs “Complete” or Easy to Apply?

Source: Talsico International

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Martin VanTrieste – PDA/FDA 2016

SOPs Reinvented

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Checklists

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GEMBA – Leaders on the Floor

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Solving the Wrong Problem

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Investigate Human Performance DifferentlyInvestigate

technical problem not HP

Human Performance as a

“Root Cause”

Real Root Cause is not identified

Wrong problem is addressed

IA/CA/PA Ineffective

HEHE

5 ERRORS

Root cause analysis for

human error events rarely

gets to the real issues.

Ginette Collazo

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Root Cause

The most basic cause (or causes)

that can reasonably be identified

that leadership has control to fix

and, when fixed, will prevent

(or significantly reduce the likelihood of)

the problem’s recurrence.

Adapted from Mark Paradies,

System Improvements

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51Ginette Collazo

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Human Memory Considerations

Adapted from Ginette Collazo

NOT A MOVIE HIGHLY COMPLEX, INTERCONNECTED

TEND TO ORDER AND STRUCTURE EVENTS

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Interviews

Interviews are not about asking questions …

they are about stimulating memories

Mark Paradies, System Improvements

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Success = Ownership + Systems

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Contact Information

Steve A. Greer

[email protected]

LinkedIn: www.linkedin.com/in/steveagreer

www.GenesisAssistCoaching.com