Global Quality Operations Sustaining Quality ^ : Why is Quality Good for Business? Diane E. Bergeron...

Global Quality Operations

Sustaining Quality ^ :

Why is Quality Good for Business?

Diane E. BergeronVice President Global Quality OperationsSchering-PloughCopyright © 2005 Schering-Plough. All Rights Reserved.


The Goal: “Good for Business”

Some Indicators of “Good Business”Customer SatisfactionTop Line GrowthBottom Line GrowthSpeed to Market for New ProductsEmployee Retention

Continuous Improvement


The Quality Strategy for Good Business

Senior Management Involvement

Competency & Governance

Quality “Systems” Thinking

Quality Improvement Model/ Framework

Culture of Commitment to Continuous Improvement


The Quality Strategy…Senior Management Involvement

Continuous improvement must be driven from the top

Senior Management must be vocal, visible & involved in the change process Timelines Deliverables Accountabilities Competencies Behaviors

Active participation in Leadership and Governance processes


Competency – know how to do things right Problem Solving/ Root Cause Analysis Validation Training Continuous Improvement Tools Cross-functional Teams Project Management

Governance – do the right things Quality Councils Steering Committees

The Quality Strategy… Competency & Governance


The Quality Strategy… Quality Thinking

Set of interrelated processes that working together, assure product safety, strength, identity, purity and quality

Elements that prevent, detect & correct deficiencies in the normal process

Systems depend, interrelate, input/output

Together provide for predictable and consistent performance and responses to adverse situations or changes

A Quality System is…


Some Quality SystemsPrevention Detection Correction

Documentation

Training Regulatory Audits Training

Calibration & Maintenance Complaints Calibration & Maintenance

Technology Transfer Stability Investigations/CAPA

Process Validation Materials & Sampling

Change Management APR’s

Warehousing & Distribution

Line Controls

Contractors & Suppliers

Facility Control

Computers


Quality System Interdependencies

Process Validation

Line Controls

Technology Transfer

Facility ControlComputers

Calibration&

Maintenance

Training

APR’sChange Management

Materials & Sampling

Complaints

Documentation

Contractors& Suppliers Stability

Warehousing &

Distribution

Regulatory Audits

Investigations


ALL WORK IS A PROCESS … and must be made visible

PROCESS is turning inputs from Suppliers into outputs for Customers

REQUIREMENTS must be clearly defined MEASUREMENTS indicate if Requirements are

met OWNERSHIP to assure continuous improvement

S C

M M

R R

R R

M M

The Quality Strategy… Quality Improvement Model/ Framework


11/4/04

QSIP

Quality

Systems

Improvement

Process

Identify Process

AppointProcess Owner

MapProcess

Define Requirements

DefineMetrics

Analyze & Challenge

Implement Changes

Verify, Monitor, Control

DefineProcess



7 Attributes of Robust Quality Systems

ProcessProceduresDocumentationQA RoleOrganization InfrastructurePerformance Metrics

Fundamental to sound and robust Quality Systems



How do we know a Good Quality Management System?

Performance Metrics Deviations

Recurrence CAPA

Training Customer Complaints Change Control Stability Study outcomes Equipment Calibration/PM Annual Product Reviews

These Measurements

tell us



Illustrates the effectiveness of performing root cause analysis and taking appropriate action. Root cause was isolated to a specific component supplier…Corrective Action was to single source with the higher quality supplier. Result was a reduction in complaint activity from 134 per batch to 20 per batch (non-related issues).

Product XYZ CAPA Effectiveness Chart

131

167 168

105

16

43

115116

10

20

40

60

80

100

120

140

160

180

3-IRJ-303

3-IRJ-304

3-IRJ-305

3-IRJ-307

3-IRJ-309

3-IRJ-310

3-IRJ-308

4-IRJ-305

4-IRJ-306

Implementation of 100% New Supplier's Components

Average Number of Complaints per batch Pre Implementation: 134

Average Number of Complaints per

batch Post Implementation: 20


1 2 3 4 5 6 7 8 9


TemodarProduct Quality Complaints Normalized

0

20

40

60

80

100

Jun

-02

Jul-

02

Au

g-0

2

Sep

-02

Oct

-02

No

v-02

Dec

-02

Jan

-03

Feb

-03

Mar

-03

Ap

r-03

May

-03

Jun

-03

Jul-

03

Au

g-0

3

Sep

-03

Oct

-03

No

v-03

Dec

-03

Jan

-04

Feb

-04

Mar

-04

Ap

r-04

May

-04

Jun

-04

Jul-

04

Au

g-0

4

Sep

-04

Oct

-04

No

v-04

Dec

-04

Jan

-05

Feb

-05

Mar

-05

PQ

Cs

per

Ro

llin

g 3

-Mo

nth

Avg

. 100

,000

Un

its

So

ld

CAPA Stage 1 – March 2003

CAPA Stage 2 – 3rd Qtr 2003

CAPA Stage 3 – 2nd Qtr 2004



First-time Approval RateChange Authorizations Approved 2002 thru Q1-2005

62%

65%

73%

78%

50%

55%

60%

65%

70%

75%

80%

2002 (Total 502 CAs) 2003 (Total 491 CAs) 2004 (Total 493 CAs) 2005 (128 CAs in Q1)

Per

cen

tag

e F

irst

-tim

e A

pp

rova

l



Num

ber/

Perc

ent

DEVIATIONS

34

37

10

2 2

9

2

50

39

8

4 4

13

4

0

10

20

30

40

50

60

3Q 2003 4Q 2003 1Q 2004 2Q 2004 3Q 2004 4Q 2004 1Q 2005

PERIOD

NUMBER OF SDIs

NUMBER OF SDIs / TOTAL NUMBER OF BATCHES (%)


Quality Systems … Designed for Commitment

Simple, easily understood

Clear roles & responsibilities & governance/ownership

Controls & checks that help responsible people do their jobs

Reflect Company’s Vision & Values

Promote commitment


The Quality Strategy…Ladder of Commitment

Commitment – “I stand for this”

Support – “I will support the effort”

Compliance – “I will obey the Rules”

Grudging Compliance – “ I will do if I must”


The Quality Strategy

+

Classify &Document

S-P or 3rd Party?Log into Database

Database Review UnitTrends

Forward toSite?

3rd PartyProcess

Site AcknowledgesReceipt

Yes

No

No

Yes

Sustaining Quality is Good for BusinessSustaining Quality is Good for Business


+

Well-designed Systems

Committed People

+Methodology for Improvement


Sustaining Quality Systems… Good for Business

Effective and Efficient Quality Systems lead to: Customer Satisfaction and Top Line Growth

Patients, Doctors Regulators

Contribute bottom line growth Effective and efficient systems Fewer process/ system failures Less Regulatory risk

Speed to Market for New Products Regulatory approvals Successful transfers

Employee retention Commitment to Continuous Improvement Personal and professional growth

Identify Process

AppointProcess Owner

MapProcess

Define Requirements

DefineMetrics

Analyze & Challenge

Implement Changes

Verify, Monitor, Control

DefineProcess


Global Quality Operations Sustaining Quality ^ : Why is Quality Good for Business? Diane E. Bergeron...

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