Post on 26-Dec-2015
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.
Global Quality Operations
The Goal: “Good for Business”
Some Indicators of “Good Business”Customer SatisfactionTop Line GrowthBottom Line GrowthSpeed to Market for New ProductsEmployee Retention
Continuous Improvement
Global Quality Operations
The Quality Strategy for Good Business
Senior Management Involvement
Competency & Governance
Quality “Systems” Thinking
Quality Improvement Model/ Framework
Culture of Commitment to Continuous Improvement
Global Quality Operations
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
Global Quality Operations
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
Global Quality Operations
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…
Global Quality Operations
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
Global Quality Operations
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
Global Quality Operations
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
Global Quality Operations
11/4/04
QSIP
Quality
Systems
Improvement
Process
Identify Process
AppointProcess Owner
MapProcess
Define Requirements
DefineMetrics
Analyze & Challenge
Implement Changes
Verify, Monitor, Control
DefineProcess
Continuous Improvement
Global Quality Operations
7 Attributes of Robust Quality Systems
ProcessProceduresDocumentationQA RoleOrganization InfrastructurePerformance Metrics
Fundamental to sound and robust Quality Systems
Continuous Improvement
Global Quality Operations
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
Continuous Improvement
Global Quality Operations
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
How do we know a Good Quality Management System?
1 2 3 4 5 6 7 8 9
Global Quality Operations
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
How do we know a Good Quality Management System?
Global Quality Operations
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
Global Quality Operations
How do we know a Good Quality Management System?
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 (%)
Global Quality Operations
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
Global Quality Operations
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”
Global Quality Operations
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
Continuous Improvement
+
Well-designed Systems
Committed People
+Methodology for Improvement
Global Quality Operations
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
Continuous Improvement