We Owe It to Patients To Embrace a Modern Quality System “An...
25
We Owe It to Patients To Embrace a Modern Quality System “An ounce of prevention is worth a pound of cure” –Benjamin Franklin Martin VanTrieste, R.Ph. SVP Quality, Environment, Health and Safety Conference on Quality in the Space and Defense Industries
Transcript of We Owe It to Patients To Embrace a Modern Quality System “An...
We Owe It to Patients To Embrace a Modern Quality System ldquoAn ounce of prevention is worth a pound of curerdquo ndashBenjamin Franklin
Martin VanTrieste RPh
SVP Quality Environment Health and Safety
Conference on Quality in the Space and Defense Industries
Serving Patients Is a Privilegehellip This Privilege Comes with
Significant Responsibilities
The Current Industry Quality System Is Outdated
Foundation formed in the early 1900rsquos
Developed in response to tragic events
Globalization has caused fragmentation and patchwork of requirements
GMPs tacitly promote a ldquotest and inspect in qualityrdquo approach
So what does an ideal quality system look like
Results of a Typical Pharmaceutical Quality Management Systems
lsquoToo slowrsquo and lsquoSales Preventionrsquo or
lsquoToo many recallsrsquo and lsquoNot Keeping up with Sciencersquo
Confusing SOPs and inefficient processes
People dependent quality
Relies on extensive inspection and testing
No formal risk program
Multiple internal reviews and rework
Unpredictable inconsistent output
Continuous fixes to product and processes
Quality System
An Ideal
Is Simple Robust
and Sustainable
Quality System
Define
customer
requirements
Plan
activities to
consistently
produce
desired result
Measure
performance
make
corrections and
improvements
Identify
monitor and
control
characteristics
important to
quality
Motivate and
engage staff
A Well Designed QMS Promotes Accountability
Transparency and Continuous Improvement
A Simple Example of Simple Robust and Sustainable
Stacks Of Paper
Standard Operating Procedures
OR
What Does SOP Mean
Uses Proven Tools such as Information
Mapping
Uses Pictures and Symbols
Clear Concise and Accurate
Written for the Userrsquos Benefit
A Simple Example of Simple Robust and Sustainable
OR
A Good Standard Operating Procedure
Stacks Of Paper
Standard Operating Procedures
Consequences of Poor Quality Can Be Significant
These ramifications are not insignificant and must
not be viewed as a ldquocost of doing businessrdquo
Harms patients
Incurs regulatory sanctions
Loss of business
Incurs Liability
Decreases Productivity
Increases cost
Why Have Others Implemented an Effective Modern QMS
A common thread was to satisfy the customer
and achieve a competitive advantage
Semi-
Conductor
Industry Survival
Consumer
Electronics Reduce defects
Automotive
Industry Competitive advantage
The US Nuclear Navy Also Implemented an Ideal QMS
Clear concise
and accurate
procedures
Train on what
to do what can
go wrong and how
to respond
Qualifications
required
Repeat back
process
Immediate
irreversible with
significant
consequences
Not fully automated
Victims of
success
High barriers to
entry and change
Isolation from
economic
downturns
Accept
variability
Blind compliance If it isnrsquot broke
donrsquot fix it
Fear of gaining
regulatory approval
Inspect and test in
quality approach
What Keeps the Pharma Industry From Changing There Has Not Been Sufficient
Pain Creating Pressure to Force Us to Change
Is the Perfect Storm Brewing Successful companies will batten down
the hatches today to weather the storm tomorrow
Cost pressures Easy to copy High capital Raw material
variability
Health
care cost Look-a-likes High capital
Raw material
variability
Reliable
Safe
ELECTRONICS INDUSTRY
BIO-PHARMA INDUSTRY
How to Develop an Ideal Quality Management System
Rome was not built in a day and building an
effective QMS is a journey that never ends
Create a culture of quality
Promote the benefits of quality
Tailor the message for the audience
Gain executive support
Work cross-functionally
Drive operational excellence
Implement new techniques and technologies
Implement
Management
Review
Focus
on CAPA (Corrective Action
Preventive Action)
Identify track
and control
variation
Obtain process
product
knowledge and
understanding
Conduct risk
assessments to
focus effort
Where to Start
Management Needs to Know When Stuff Happens
Remember serving patients is a privilege
The outcome of management reviewhellip
a Improvements
b Resources
c Revisions to quality policy and objectives
d Timely and effective communication of the results of the management review
A Simple CAPA System That Is Commonly Used Today
However this is not enough for an
effective and efficient CAPA system
Utilizes a risk based approach
Determines root cause
CAPA
Requires an Exception
Happens in manufacturing
Initiates an Investigation
Implements a corrective action
CAPA
Must look for and address weak signals
An Advanced CAPA System Will
CAPA
Respond to data trending and holistic data reviews
Document continuous improvement projects
Provide feedback throughout the
lifecycle of a project
Implement CAPA earlier in the
development process
Address industry and regulatory surveillance
Utilizes a risk based approach
Determines root cause
Requires an Exception
Happens in manufacturing
Initiates an Investigation
Implements a corrective action
Identify track and control variation
Obtain process product knowledge and understanding
Conduct risk assessments to focus effort
Three Other Important Things to do
Current Quality Management System Ideal Quality Management System
Multiple internal reviews and ldquore-dosrdquo Get it right the first time
Unpredictable inconsistent output Consistency in quality
Continuous fixes to product
and processes Build in Quality from the start
Confusing SOPs and
inefficient processes
Clear SOPs and more simple
and robust process
People dependent quality Overall culture of quality
Relies on extensive inspection
and testing
Leverages process knowledge
and understanding
No formal risk program Addresses risks leading to
fewer issues
lsquoToo slowrsquo lsquoRisk Aversersquo
lsquoNot Risk Averse Enoughrsquo Satisfied customers
Reduced Errors
What to Expect When You Succeed
The Power of Error Reduction Improved Quality and Lower Cost
Cu
mu
lati
ve S
avin
gs (
M)
Sin
ce 2
006
Err
ors
per
Lo
t
00
05
10
15
20
2006 2007 2008 2009 2010 2011 2012
$0
$50
$100
$150
Year
Cum Savings Error Rate
95
Faster Cycle Times
Reduced Errors
What to Expect When You Succeed
Disposition Cycle Time Days
0
20
40
60
80
2006 2012
Da
ys
Drug Substance Drug Product
64
64
What to Expect When You Succeed
Less Scrap Rework
and Rejects
Faster Cycle Times
Scrap Reduction
0
50
100
150
200
250
300
350
2006 2012
Do
llars
Year
92
Reduced Errors
This All Happened While
What to Expect When You Succeed
Less Scrap Rework
and Rejects
Lower Cost
Robust Reliable Supply
Faster Cycle Times
Reduced Errors
Sales Increased
Headcount Decreased
Cost Decreased
And we supplied every patient every time
Serving Patients Is a Privilegehellip
We must be there for every patient every time
Serving Patients Is a Privilegehellip This Privilege Comes with
Significant Responsibilities
The Current Industry Quality System Is Outdated
Foundation formed in the early 1900rsquos
Developed in response to tragic events
Globalization has caused fragmentation and patchwork of requirements
GMPs tacitly promote a ldquotest and inspect in qualityrdquo approach
So what does an ideal quality system look like
Results of a Typical Pharmaceutical Quality Management Systems
lsquoToo slowrsquo and lsquoSales Preventionrsquo or
lsquoToo many recallsrsquo and lsquoNot Keeping up with Sciencersquo
Confusing SOPs and inefficient processes
People dependent quality
Relies on extensive inspection and testing
No formal risk program
Multiple internal reviews and rework
Unpredictable inconsistent output
Continuous fixes to product and processes
Quality System
An Ideal
Is Simple Robust
and Sustainable
Quality System
Define
customer
requirements
Plan
activities to
consistently
produce
desired result
Measure
performance
make
corrections and
improvements
Identify
monitor and
control
characteristics
important to
quality
Motivate and
engage staff
A Well Designed QMS Promotes Accountability
Transparency and Continuous Improvement
A Simple Example of Simple Robust and Sustainable
Stacks Of Paper
Standard Operating Procedures
OR
What Does SOP Mean
Uses Proven Tools such as Information
Mapping
Uses Pictures and Symbols
Clear Concise and Accurate
Written for the Userrsquos Benefit
A Simple Example of Simple Robust and Sustainable
OR
A Good Standard Operating Procedure
Stacks Of Paper
Standard Operating Procedures
Consequences of Poor Quality Can Be Significant
These ramifications are not insignificant and must
not be viewed as a ldquocost of doing businessrdquo
Harms patients
Incurs regulatory sanctions
Loss of business
Incurs Liability
Decreases Productivity
Increases cost
Why Have Others Implemented an Effective Modern QMS
A common thread was to satisfy the customer
and achieve a competitive advantage
Semi-
Conductor
Industry Survival
Consumer
Electronics Reduce defects
Automotive
Industry Competitive advantage
The US Nuclear Navy Also Implemented an Ideal QMS
Clear concise
and accurate
procedures
Train on what
to do what can
go wrong and how
to respond
Qualifications
required
Repeat back
process
Immediate
irreversible with
significant
consequences
Not fully automated
Victims of
success
High barriers to
entry and change
Isolation from
economic
downturns
Accept
variability
Blind compliance If it isnrsquot broke
donrsquot fix it
Fear of gaining
regulatory approval
Inspect and test in
quality approach
What Keeps the Pharma Industry From Changing There Has Not Been Sufficient
Pain Creating Pressure to Force Us to Change
Is the Perfect Storm Brewing Successful companies will batten down
the hatches today to weather the storm tomorrow
Cost pressures Easy to copy High capital Raw material
variability
Health
care cost Look-a-likes High capital
Raw material
variability
Reliable
Safe
ELECTRONICS INDUSTRY
BIO-PHARMA INDUSTRY
How to Develop an Ideal Quality Management System
Rome was not built in a day and building an
effective QMS is a journey that never ends
Create a culture of quality
Promote the benefits of quality
Tailor the message for the audience
Gain executive support
Work cross-functionally
Drive operational excellence
Implement new techniques and technologies
Implement
Management
Review
Focus
on CAPA (Corrective Action
Preventive Action)
Identify track
and control
variation
Obtain process
product
knowledge and
understanding
Conduct risk
assessments to
focus effort
Where to Start
Management Needs to Know When Stuff Happens
Remember serving patients is a privilege
The outcome of management reviewhellip
a Improvements
b Resources
c Revisions to quality policy and objectives
d Timely and effective communication of the results of the management review
A Simple CAPA System That Is Commonly Used Today
However this is not enough for an
effective and efficient CAPA system
Utilizes a risk based approach
Determines root cause
CAPA
Requires an Exception
Happens in manufacturing
Initiates an Investigation
Implements a corrective action
CAPA
Must look for and address weak signals
An Advanced CAPA System Will
CAPA
Respond to data trending and holistic data reviews
Document continuous improvement projects
Provide feedback throughout the
lifecycle of a project
Implement CAPA earlier in the
development process
Address industry and regulatory surveillance
Utilizes a risk based approach
Determines root cause
Requires an Exception
Happens in manufacturing
Initiates an Investigation
Implements a corrective action
Identify track and control variation
Obtain process product knowledge and understanding
Conduct risk assessments to focus effort
Three Other Important Things to do
Current Quality Management System Ideal Quality Management System
Multiple internal reviews and ldquore-dosrdquo Get it right the first time
Unpredictable inconsistent output Consistency in quality
Continuous fixes to product
and processes Build in Quality from the start
Confusing SOPs and
inefficient processes
Clear SOPs and more simple
and robust process
People dependent quality Overall culture of quality
Relies on extensive inspection
and testing
Leverages process knowledge
and understanding
No formal risk program Addresses risks leading to
fewer issues
lsquoToo slowrsquo lsquoRisk Aversersquo
lsquoNot Risk Averse Enoughrsquo Satisfied customers
Reduced Errors
What to Expect When You Succeed
The Power of Error Reduction Improved Quality and Lower Cost
Cu
mu
lati
ve S
avin
gs (
M)
Sin
ce 2
006
Err
ors
per
Lo
t
00
05
10
15
20
2006 2007 2008 2009 2010 2011 2012
$0
$50
$100
$150
Year
Cum Savings Error Rate
95
Faster Cycle Times
Reduced Errors
What to Expect When You Succeed
Disposition Cycle Time Days
0
20
40
60
80
2006 2012
Da
ys
Drug Substance Drug Product
64
64
What to Expect When You Succeed
Less Scrap Rework
and Rejects
Faster Cycle Times
Scrap Reduction
0
50
100
150
200
250
300
350
2006 2012
Do
llars
Year
92
Reduced Errors
This All Happened While
What to Expect When You Succeed
Less Scrap Rework
and Rejects
Lower Cost
Robust Reliable Supply
Faster Cycle Times
Reduced Errors
Sales Increased
Headcount Decreased
Cost Decreased
And we supplied every patient every time
Serving Patients Is a Privilegehellip
We must be there for every patient every time
The Current Industry Quality System Is Outdated
Foundation formed in the early 1900rsquos
Developed in response to tragic events
Globalization has caused fragmentation and patchwork of requirements
GMPs tacitly promote a ldquotest and inspect in qualityrdquo approach
So what does an ideal quality system look like
Results of a Typical Pharmaceutical Quality Management Systems
lsquoToo slowrsquo and lsquoSales Preventionrsquo or
lsquoToo many recallsrsquo and lsquoNot Keeping up with Sciencersquo
Confusing SOPs and inefficient processes
People dependent quality
Relies on extensive inspection and testing
No formal risk program
Multiple internal reviews and rework
Unpredictable inconsistent output
Continuous fixes to product and processes
Quality System
An Ideal
Is Simple Robust
and Sustainable
Quality System
Define
customer
requirements
Plan
activities to
consistently
produce
desired result
Measure
performance
make
corrections and
improvements
Identify
monitor and
control
characteristics
important to
quality
Motivate and
engage staff
A Well Designed QMS Promotes Accountability
Transparency and Continuous Improvement
A Simple Example of Simple Robust and Sustainable
Stacks Of Paper
Standard Operating Procedures
OR
What Does SOP Mean
Uses Proven Tools such as Information
Mapping
Uses Pictures and Symbols
Clear Concise and Accurate
Written for the Userrsquos Benefit
A Simple Example of Simple Robust and Sustainable
OR
A Good Standard Operating Procedure
Stacks Of Paper
Standard Operating Procedures
Consequences of Poor Quality Can Be Significant
These ramifications are not insignificant and must
not be viewed as a ldquocost of doing businessrdquo
Harms patients
Incurs regulatory sanctions
Loss of business
Incurs Liability
Decreases Productivity
Increases cost
Why Have Others Implemented an Effective Modern QMS
A common thread was to satisfy the customer
and achieve a competitive advantage
Semi-
Conductor
Industry Survival
Consumer
Electronics Reduce defects
Automotive
Industry Competitive advantage
The US Nuclear Navy Also Implemented an Ideal QMS
Clear concise
and accurate
procedures
Train on what
to do what can
go wrong and how
to respond
Qualifications
required
Repeat back
process
Immediate
irreversible with
significant
consequences
Not fully automated
Victims of
success
High barriers to
entry and change
Isolation from
economic
downturns
Accept
variability
Blind compliance If it isnrsquot broke
donrsquot fix it
Fear of gaining
regulatory approval
Inspect and test in
quality approach
What Keeps the Pharma Industry From Changing There Has Not Been Sufficient
Pain Creating Pressure to Force Us to Change
Is the Perfect Storm Brewing Successful companies will batten down
the hatches today to weather the storm tomorrow
Cost pressures Easy to copy High capital Raw material
variability
Health
care cost Look-a-likes High capital
Raw material
variability
Reliable
Safe
ELECTRONICS INDUSTRY
BIO-PHARMA INDUSTRY
How to Develop an Ideal Quality Management System
Rome was not built in a day and building an
effective QMS is a journey that never ends
Create a culture of quality
Promote the benefits of quality
Tailor the message for the audience
Gain executive support
Work cross-functionally
Drive operational excellence
Implement new techniques and technologies
Implement
Management
Review
Focus
on CAPA (Corrective Action
Preventive Action)
Identify track
and control
variation
Obtain process
product
knowledge and
understanding
Conduct risk
assessments to
focus effort
Where to Start
Management Needs to Know When Stuff Happens
Remember serving patients is a privilege
The outcome of management reviewhellip
a Improvements
b Resources
c Revisions to quality policy and objectives
d Timely and effective communication of the results of the management review
A Simple CAPA System That Is Commonly Used Today
However this is not enough for an
effective and efficient CAPA system
Utilizes a risk based approach
Determines root cause
CAPA
Requires an Exception
Happens in manufacturing
Initiates an Investigation
Implements a corrective action
CAPA
Must look for and address weak signals
An Advanced CAPA System Will
CAPA
Respond to data trending and holistic data reviews
Document continuous improvement projects
Provide feedback throughout the
lifecycle of a project
Implement CAPA earlier in the
development process
Address industry and regulatory surveillance
Utilizes a risk based approach
Determines root cause
Requires an Exception
Happens in manufacturing
Initiates an Investigation
Implements a corrective action
Identify track and control variation
Obtain process product knowledge and understanding
Conduct risk assessments to focus effort
Three Other Important Things to do
Current Quality Management System Ideal Quality Management System
Multiple internal reviews and ldquore-dosrdquo Get it right the first time
Unpredictable inconsistent output Consistency in quality
Continuous fixes to product
and processes Build in Quality from the start
Confusing SOPs and
inefficient processes
Clear SOPs and more simple
and robust process
People dependent quality Overall culture of quality
Relies on extensive inspection
and testing
Leverages process knowledge
and understanding
No formal risk program Addresses risks leading to
fewer issues
lsquoToo slowrsquo lsquoRisk Aversersquo
lsquoNot Risk Averse Enoughrsquo Satisfied customers
Reduced Errors
What to Expect When You Succeed
The Power of Error Reduction Improved Quality and Lower Cost
Cu
mu
lati
ve S
avin
gs (
M)
Sin
ce 2
006
Err
ors
per
Lo
t
00
05
10
15
20
2006 2007 2008 2009 2010 2011 2012
$0
$50
$100
$150
Year
Cum Savings Error Rate
95
Faster Cycle Times
Reduced Errors
What to Expect When You Succeed
Disposition Cycle Time Days
0
20
40
60
80
2006 2012
Da
ys
Drug Substance Drug Product
64
64
What to Expect When You Succeed
Less Scrap Rework
and Rejects
Faster Cycle Times
Scrap Reduction
0
50
100
150
200
250
300
350
2006 2012
Do
llars
Year
92
Reduced Errors
This All Happened While
What to Expect When You Succeed
Less Scrap Rework
and Rejects
Lower Cost
Robust Reliable Supply
Faster Cycle Times
Reduced Errors
Sales Increased
Headcount Decreased
Cost Decreased
And we supplied every patient every time
Serving Patients Is a Privilegehellip
We must be there for every patient every time
Results of a Typical Pharmaceutical Quality Management Systems
lsquoToo slowrsquo and lsquoSales Preventionrsquo or
lsquoToo many recallsrsquo and lsquoNot Keeping up with Sciencersquo
Confusing SOPs and inefficient processes
People dependent quality
Relies on extensive inspection and testing
No formal risk program
Multiple internal reviews and rework
Unpredictable inconsistent output
Continuous fixes to product and processes
Quality System
An Ideal
Is Simple Robust
and Sustainable
Quality System
Define
customer
requirements
Plan
activities to
consistently
produce
desired result
Measure
performance
make
corrections and
improvements
Identify
monitor and
control
characteristics
important to
quality
Motivate and
engage staff
A Well Designed QMS Promotes Accountability
Transparency and Continuous Improvement
A Simple Example of Simple Robust and Sustainable
Stacks Of Paper
Standard Operating Procedures
OR
What Does SOP Mean
Uses Proven Tools such as Information
Mapping
Uses Pictures and Symbols
Clear Concise and Accurate
Written for the Userrsquos Benefit
A Simple Example of Simple Robust and Sustainable
OR
A Good Standard Operating Procedure
Stacks Of Paper
Standard Operating Procedures
Consequences of Poor Quality Can Be Significant
These ramifications are not insignificant and must
not be viewed as a ldquocost of doing businessrdquo
Harms patients
Incurs regulatory sanctions
Loss of business
Incurs Liability
Decreases Productivity
Increases cost
Why Have Others Implemented an Effective Modern QMS
A common thread was to satisfy the customer
and achieve a competitive advantage
Semi-
Conductor
Industry Survival
Consumer
Electronics Reduce defects
Automotive
Industry Competitive advantage
The US Nuclear Navy Also Implemented an Ideal QMS
Clear concise
and accurate
procedures
Train on what
to do what can
go wrong and how
to respond
Qualifications
required
Repeat back
process
Immediate
irreversible with
significant
consequences
Not fully automated
Victims of
success
High barriers to
entry and change
Isolation from
economic
downturns
Accept
variability
Blind compliance If it isnrsquot broke
donrsquot fix it
Fear of gaining
regulatory approval
Inspect and test in
quality approach
What Keeps the Pharma Industry From Changing There Has Not Been Sufficient
Pain Creating Pressure to Force Us to Change
Is the Perfect Storm Brewing Successful companies will batten down
the hatches today to weather the storm tomorrow
Cost pressures Easy to copy High capital Raw material
variability
Health
care cost Look-a-likes High capital
Raw material
variability
Reliable
Safe
ELECTRONICS INDUSTRY
BIO-PHARMA INDUSTRY
How to Develop an Ideal Quality Management System
Rome was not built in a day and building an
effective QMS is a journey that never ends
Create a culture of quality
Promote the benefits of quality
Tailor the message for the audience
Gain executive support
Work cross-functionally
Drive operational excellence
Implement new techniques and technologies
Implement
Management
Review
Focus
on CAPA (Corrective Action
Preventive Action)
Identify track
and control
variation
Obtain process
product
knowledge and
understanding
Conduct risk
assessments to
focus effort
Where to Start
Management Needs to Know When Stuff Happens
Remember serving patients is a privilege
The outcome of management reviewhellip
a Improvements
b Resources
c Revisions to quality policy and objectives
d Timely and effective communication of the results of the management review
A Simple CAPA System That Is Commonly Used Today
However this is not enough for an
effective and efficient CAPA system
Utilizes a risk based approach
Determines root cause
CAPA
Requires an Exception
Happens in manufacturing
Initiates an Investigation
Implements a corrective action
CAPA
Must look for and address weak signals
An Advanced CAPA System Will
CAPA
Respond to data trending and holistic data reviews
Document continuous improvement projects
Provide feedback throughout the
lifecycle of a project
Implement CAPA earlier in the
development process
Address industry and regulatory surveillance
Utilizes a risk based approach
Determines root cause
Requires an Exception
Happens in manufacturing
Initiates an Investigation
Implements a corrective action
Identify track and control variation
Obtain process product knowledge and understanding
Conduct risk assessments to focus effort
Three Other Important Things to do
Current Quality Management System Ideal Quality Management System
Multiple internal reviews and ldquore-dosrdquo Get it right the first time
Unpredictable inconsistent output Consistency in quality
Continuous fixes to product
and processes Build in Quality from the start
Confusing SOPs and
inefficient processes
Clear SOPs and more simple
and robust process
People dependent quality Overall culture of quality
Relies on extensive inspection
and testing
Leverages process knowledge
and understanding
No formal risk program Addresses risks leading to
fewer issues
lsquoToo slowrsquo lsquoRisk Aversersquo
lsquoNot Risk Averse Enoughrsquo Satisfied customers
Reduced Errors
What to Expect When You Succeed
The Power of Error Reduction Improved Quality and Lower Cost
Cu
mu
lati
ve S
avin
gs (
M)
Sin
ce 2
006
Err
ors
per
Lo
t
00
05
10
15
20
2006 2007 2008 2009 2010 2011 2012
$0
$50
$100
$150
Year
Cum Savings Error Rate
95
Faster Cycle Times
Reduced Errors
What to Expect When You Succeed
Disposition Cycle Time Days
0
20
40
60
80
2006 2012
Da
ys
Drug Substance Drug Product
64
64
What to Expect When You Succeed
Less Scrap Rework
and Rejects
Faster Cycle Times
Scrap Reduction
0
50
100
150
200
250
300
350
2006 2012
Do
llars
Year
92
Reduced Errors
This All Happened While
What to Expect When You Succeed
Less Scrap Rework
and Rejects
Lower Cost
Robust Reliable Supply
Faster Cycle Times
Reduced Errors
Sales Increased
Headcount Decreased
Cost Decreased
And we supplied every patient every time
Serving Patients Is a Privilegehellip
We must be there for every patient every time
Quality System
An Ideal
Is Simple Robust
and Sustainable
Quality System
Define
customer
requirements
Plan
activities to
consistently
produce
desired result
Measure
performance
make
corrections and
improvements
Identify
monitor and
control
characteristics
important to
quality
Motivate and
engage staff
A Well Designed QMS Promotes Accountability
Transparency and Continuous Improvement
A Simple Example of Simple Robust and Sustainable
Stacks Of Paper
Standard Operating Procedures
OR
What Does SOP Mean
Uses Proven Tools such as Information
Mapping
Uses Pictures and Symbols
Clear Concise and Accurate
Written for the Userrsquos Benefit
A Simple Example of Simple Robust and Sustainable
OR
A Good Standard Operating Procedure
Stacks Of Paper
Standard Operating Procedures
Consequences of Poor Quality Can Be Significant
These ramifications are not insignificant and must
not be viewed as a ldquocost of doing businessrdquo
Harms patients
Incurs regulatory sanctions
Loss of business
Incurs Liability
Decreases Productivity
Increases cost
Why Have Others Implemented an Effective Modern QMS
A common thread was to satisfy the customer
and achieve a competitive advantage
Semi-
Conductor
Industry Survival
Consumer
Electronics Reduce defects
Automotive
Industry Competitive advantage
The US Nuclear Navy Also Implemented an Ideal QMS
Clear concise
and accurate
procedures
Train on what
to do what can
go wrong and how
to respond
Qualifications
required
Repeat back
process
Immediate
irreversible with
significant
consequences
Not fully automated
Victims of
success
High barriers to
entry and change
Isolation from
economic
downturns
Accept
variability
Blind compliance If it isnrsquot broke
donrsquot fix it
Fear of gaining
regulatory approval
Inspect and test in
quality approach
What Keeps the Pharma Industry From Changing There Has Not Been Sufficient
Pain Creating Pressure to Force Us to Change
Is the Perfect Storm Brewing Successful companies will batten down
the hatches today to weather the storm tomorrow
Cost pressures Easy to copy High capital Raw material
variability
Health
care cost Look-a-likes High capital
Raw material
variability
Reliable
Safe
ELECTRONICS INDUSTRY
BIO-PHARMA INDUSTRY
How to Develop an Ideal Quality Management System
Rome was not built in a day and building an
effective QMS is a journey that never ends
Create a culture of quality
Promote the benefits of quality
Tailor the message for the audience
Gain executive support
Work cross-functionally
Drive operational excellence
Implement new techniques and technologies
Implement
Management
Review
Focus
on CAPA (Corrective Action
Preventive Action)
Identify track
and control
variation
Obtain process
product
knowledge and
understanding
Conduct risk
assessments to
focus effort
Where to Start
Management Needs to Know When Stuff Happens
Remember serving patients is a privilege
The outcome of management reviewhellip
a Improvements
b Resources
c Revisions to quality policy and objectives
d Timely and effective communication of the results of the management review
A Simple CAPA System That Is Commonly Used Today
However this is not enough for an
effective and efficient CAPA system
Utilizes a risk based approach
Determines root cause
CAPA
Requires an Exception
Happens in manufacturing
Initiates an Investigation
Implements a corrective action
CAPA
Must look for and address weak signals
An Advanced CAPA System Will
CAPA
Respond to data trending and holistic data reviews
Document continuous improvement projects
Provide feedback throughout the
lifecycle of a project
Implement CAPA earlier in the
development process
Address industry and regulatory surveillance
Utilizes a risk based approach
Determines root cause
Requires an Exception
Happens in manufacturing
Initiates an Investigation
Implements a corrective action
Identify track and control variation
Obtain process product knowledge and understanding
Conduct risk assessments to focus effort
Three Other Important Things to do
Current Quality Management System Ideal Quality Management System
Multiple internal reviews and ldquore-dosrdquo Get it right the first time
Unpredictable inconsistent output Consistency in quality
Continuous fixes to product
and processes Build in Quality from the start
Confusing SOPs and
inefficient processes
Clear SOPs and more simple
and robust process
People dependent quality Overall culture of quality
Relies on extensive inspection
and testing
Leverages process knowledge
and understanding
No formal risk program Addresses risks leading to
fewer issues
lsquoToo slowrsquo lsquoRisk Aversersquo
lsquoNot Risk Averse Enoughrsquo Satisfied customers
Reduced Errors
What to Expect When You Succeed
The Power of Error Reduction Improved Quality and Lower Cost
Cu
mu
lati
ve S
avin
gs (
M)
Sin
ce 2
006
Err
ors
per
Lo
t
00
05
10
15
20
2006 2007 2008 2009 2010 2011 2012
$0
$50
$100
$150
Year
Cum Savings Error Rate
95
Faster Cycle Times
Reduced Errors
What to Expect When You Succeed
Disposition Cycle Time Days
0
20
40
60
80
2006 2012
Da
ys
Drug Substance Drug Product
64
64
What to Expect When You Succeed
Less Scrap Rework
and Rejects
Faster Cycle Times
Scrap Reduction
0
50
100
150
200
250
300
350
2006 2012
Do
llars
Year
92
Reduced Errors
This All Happened While
What to Expect When You Succeed
Less Scrap Rework
and Rejects
Lower Cost
Robust Reliable Supply
Faster Cycle Times
Reduced Errors
Sales Increased
Headcount Decreased
Cost Decreased
And we supplied every patient every time
Serving Patients Is a Privilegehellip
We must be there for every patient every time
Quality System
Define
customer
requirements
Plan
activities to
consistently
produce
desired result
Measure
performance
make
corrections and
improvements
Identify
monitor and
control
characteristics
important to
quality
Motivate and
engage staff
A Well Designed QMS Promotes Accountability
Transparency and Continuous Improvement
A Simple Example of Simple Robust and Sustainable
Stacks Of Paper
Standard Operating Procedures
OR
What Does SOP Mean
Uses Proven Tools such as Information
Mapping
Uses Pictures and Symbols
Clear Concise and Accurate
Written for the Userrsquos Benefit
A Simple Example of Simple Robust and Sustainable
OR
A Good Standard Operating Procedure
Stacks Of Paper
Standard Operating Procedures
Consequences of Poor Quality Can Be Significant
These ramifications are not insignificant and must
not be viewed as a ldquocost of doing businessrdquo
Harms patients
Incurs regulatory sanctions
Loss of business
Incurs Liability
Decreases Productivity
Increases cost
Why Have Others Implemented an Effective Modern QMS
A common thread was to satisfy the customer
and achieve a competitive advantage
Semi-
Conductor
Industry Survival
Consumer
Electronics Reduce defects
Automotive
Industry Competitive advantage
The US Nuclear Navy Also Implemented an Ideal QMS
Clear concise
and accurate
procedures
Train on what
to do what can
go wrong and how
to respond
Qualifications
required
Repeat back
process
Immediate
irreversible with
significant
consequences
Not fully automated
Victims of
success
High barriers to
entry and change
Isolation from
economic
downturns
Accept
variability
Blind compliance If it isnrsquot broke
donrsquot fix it
Fear of gaining
regulatory approval
Inspect and test in
quality approach
What Keeps the Pharma Industry From Changing There Has Not Been Sufficient
Pain Creating Pressure to Force Us to Change
Is the Perfect Storm Brewing Successful companies will batten down
the hatches today to weather the storm tomorrow
Cost pressures Easy to copy High capital Raw material
variability
Health
care cost Look-a-likes High capital
Raw material
variability
Reliable
Safe
ELECTRONICS INDUSTRY
BIO-PHARMA INDUSTRY
How to Develop an Ideal Quality Management System
Rome was not built in a day and building an
effective QMS is a journey that never ends
Create a culture of quality
Promote the benefits of quality
Tailor the message for the audience
Gain executive support
Work cross-functionally
Drive operational excellence
Implement new techniques and technologies
Implement
Management
Review
Focus
on CAPA (Corrective Action
Preventive Action)
Identify track
and control
variation
Obtain process
product
knowledge and
understanding
Conduct risk
assessments to
focus effort
Where to Start
Management Needs to Know When Stuff Happens
Remember serving patients is a privilege
The outcome of management reviewhellip
a Improvements
b Resources
c Revisions to quality policy and objectives
d Timely and effective communication of the results of the management review
A Simple CAPA System That Is Commonly Used Today
However this is not enough for an
effective and efficient CAPA system
Utilizes a risk based approach
Determines root cause
CAPA
Requires an Exception
Happens in manufacturing
Initiates an Investigation
Implements a corrective action
CAPA
Must look for and address weak signals
An Advanced CAPA System Will
CAPA
Respond to data trending and holistic data reviews
Document continuous improvement projects
Provide feedback throughout the
lifecycle of a project
Implement CAPA earlier in the
development process
Address industry and regulatory surveillance
Utilizes a risk based approach
Determines root cause
Requires an Exception
Happens in manufacturing
Initiates an Investigation
Implements a corrective action
Identify track and control variation
Obtain process product knowledge and understanding
Conduct risk assessments to focus effort
Three Other Important Things to do
Current Quality Management System Ideal Quality Management System
Multiple internal reviews and ldquore-dosrdquo Get it right the first time
Unpredictable inconsistent output Consistency in quality
Continuous fixes to product
and processes Build in Quality from the start
Confusing SOPs and
inefficient processes
Clear SOPs and more simple
and robust process
People dependent quality Overall culture of quality
Relies on extensive inspection
and testing
Leverages process knowledge
and understanding
No formal risk program Addresses risks leading to
fewer issues
lsquoToo slowrsquo lsquoRisk Aversersquo
lsquoNot Risk Averse Enoughrsquo Satisfied customers
Reduced Errors
What to Expect When You Succeed
The Power of Error Reduction Improved Quality and Lower Cost
Cu
mu
lati
ve S
avin
gs (
M)
Sin
ce 2
006
Err
ors
per
Lo
t
00
05
10
15
20
2006 2007 2008 2009 2010 2011 2012
$0
$50
$100
$150
Year
Cum Savings Error Rate
95
Faster Cycle Times
Reduced Errors
What to Expect When You Succeed
Disposition Cycle Time Days
0
20
40
60
80
2006 2012
Da
ys
Drug Substance Drug Product
64
64
What to Expect When You Succeed
Less Scrap Rework
and Rejects
Faster Cycle Times
Scrap Reduction
0
50
100
150
200
250
300
350
2006 2012
Do
llars
Year
92
Reduced Errors
This All Happened While
What to Expect When You Succeed
Less Scrap Rework
and Rejects
Lower Cost
Robust Reliable Supply
Faster Cycle Times
Reduced Errors
Sales Increased
Headcount Decreased
Cost Decreased
And we supplied every patient every time
Serving Patients Is a Privilegehellip
We must be there for every patient every time
A Simple Example of Simple Robust and Sustainable
Stacks Of Paper
Standard Operating Procedures
OR
What Does SOP Mean
Uses Proven Tools such as Information
Mapping
Uses Pictures and Symbols
Clear Concise and Accurate
Written for the Userrsquos Benefit
A Simple Example of Simple Robust and Sustainable
OR
A Good Standard Operating Procedure
Stacks Of Paper
Standard Operating Procedures
Consequences of Poor Quality Can Be Significant
These ramifications are not insignificant and must
not be viewed as a ldquocost of doing businessrdquo
Harms patients
Incurs regulatory sanctions
Loss of business
Incurs Liability
Decreases Productivity
Increases cost
Why Have Others Implemented an Effective Modern QMS
A common thread was to satisfy the customer
and achieve a competitive advantage
Semi-
Conductor
Industry Survival
Consumer
Electronics Reduce defects
Automotive
Industry Competitive advantage
The US Nuclear Navy Also Implemented an Ideal QMS
Clear concise
and accurate
procedures
Train on what
to do what can
go wrong and how
to respond
Qualifications
required
Repeat back
process
Immediate
irreversible with
significant
consequences
Not fully automated
Victims of
success
High barriers to
entry and change
Isolation from
economic
downturns
Accept
variability
Blind compliance If it isnrsquot broke
donrsquot fix it
Fear of gaining
regulatory approval
Inspect and test in
quality approach
What Keeps the Pharma Industry From Changing There Has Not Been Sufficient
Pain Creating Pressure to Force Us to Change
Is the Perfect Storm Brewing Successful companies will batten down
the hatches today to weather the storm tomorrow
Cost pressures Easy to copy High capital Raw material
variability
Health
care cost Look-a-likes High capital
Raw material
variability
Reliable
Safe
ELECTRONICS INDUSTRY
BIO-PHARMA INDUSTRY
How to Develop an Ideal Quality Management System
Rome was not built in a day and building an
effective QMS is a journey that never ends
Create a culture of quality
Promote the benefits of quality
Tailor the message for the audience
Gain executive support
Work cross-functionally
Drive operational excellence
Implement new techniques and technologies
Implement
Management
Review
Focus
on CAPA (Corrective Action
Preventive Action)
Identify track
and control
variation
Obtain process
product
knowledge and
understanding
Conduct risk
assessments to
focus effort
Where to Start
Management Needs to Know When Stuff Happens
Remember serving patients is a privilege
The outcome of management reviewhellip
a Improvements
b Resources
c Revisions to quality policy and objectives
d Timely and effective communication of the results of the management review
A Simple CAPA System That Is Commonly Used Today
However this is not enough for an
effective and efficient CAPA system
Utilizes a risk based approach
Determines root cause
CAPA
Requires an Exception
Happens in manufacturing
Initiates an Investigation
Implements a corrective action
CAPA
Must look for and address weak signals
An Advanced CAPA System Will
CAPA
Respond to data trending and holistic data reviews
Document continuous improvement projects
Provide feedback throughout the
lifecycle of a project
Implement CAPA earlier in the
development process
Address industry and regulatory surveillance
Utilizes a risk based approach
Determines root cause
Requires an Exception
Happens in manufacturing
Initiates an Investigation
Implements a corrective action
Identify track and control variation
Obtain process product knowledge and understanding
Conduct risk assessments to focus effort
Three Other Important Things to do
Current Quality Management System Ideal Quality Management System
Multiple internal reviews and ldquore-dosrdquo Get it right the first time
Unpredictable inconsistent output Consistency in quality
Continuous fixes to product
and processes Build in Quality from the start
Confusing SOPs and
inefficient processes
Clear SOPs and more simple
and robust process
People dependent quality Overall culture of quality
Relies on extensive inspection
and testing
Leverages process knowledge
and understanding
No formal risk program Addresses risks leading to
fewer issues
lsquoToo slowrsquo lsquoRisk Aversersquo
lsquoNot Risk Averse Enoughrsquo Satisfied customers
Reduced Errors
What to Expect When You Succeed
The Power of Error Reduction Improved Quality and Lower Cost
Cu
mu
lati
ve S
avin
gs (
M)
Sin
ce 2
006
Err
ors
per
Lo
t
00
05
10
15
20
2006 2007 2008 2009 2010 2011 2012
$0
$50
$100
$150
Year
Cum Savings Error Rate
95
Faster Cycle Times
Reduced Errors
What to Expect When You Succeed
Disposition Cycle Time Days
0
20
40
60
80
2006 2012
Da
ys
Drug Substance Drug Product
64
64
What to Expect When You Succeed
Less Scrap Rework
and Rejects
Faster Cycle Times
Scrap Reduction
0
50
100
150
200
250
300
350
2006 2012
Do
llars
Year
92
Reduced Errors
This All Happened While
What to Expect When You Succeed
Less Scrap Rework
and Rejects
Lower Cost
Robust Reliable Supply
Faster Cycle Times
Reduced Errors
Sales Increased
Headcount Decreased
Cost Decreased
And we supplied every patient every time
Serving Patients Is a Privilegehellip
We must be there for every patient every time
Uses Proven Tools such as Information
Mapping
Uses Pictures and Symbols
Clear Concise and Accurate
Written for the Userrsquos Benefit
A Simple Example of Simple Robust and Sustainable
OR
A Good Standard Operating Procedure
Stacks Of Paper
Standard Operating Procedures
Consequences of Poor Quality Can Be Significant
These ramifications are not insignificant and must
not be viewed as a ldquocost of doing businessrdquo
Harms patients
Incurs regulatory sanctions
Loss of business
Incurs Liability
Decreases Productivity
Increases cost
Why Have Others Implemented an Effective Modern QMS
A common thread was to satisfy the customer
and achieve a competitive advantage
Semi-
Conductor
Industry Survival
Consumer
Electronics Reduce defects
Automotive
Industry Competitive advantage
The US Nuclear Navy Also Implemented an Ideal QMS
Clear concise
and accurate
procedures
Train on what
to do what can
go wrong and how
to respond
Qualifications
required
Repeat back
process
Immediate
irreversible with
significant
consequences
Not fully automated
Victims of
success
High barriers to
entry and change
Isolation from
economic
downturns
Accept
variability
Blind compliance If it isnrsquot broke
donrsquot fix it
Fear of gaining
regulatory approval
Inspect and test in
quality approach
What Keeps the Pharma Industry From Changing There Has Not Been Sufficient
Pain Creating Pressure to Force Us to Change
Is the Perfect Storm Brewing Successful companies will batten down
the hatches today to weather the storm tomorrow
Cost pressures Easy to copy High capital Raw material
variability
Health
care cost Look-a-likes High capital
Raw material
variability
Reliable
Safe
ELECTRONICS INDUSTRY
BIO-PHARMA INDUSTRY
How to Develop an Ideal Quality Management System
Rome was not built in a day and building an
effective QMS is a journey that never ends
Create a culture of quality
Promote the benefits of quality
Tailor the message for the audience
Gain executive support
Work cross-functionally
Drive operational excellence
Implement new techniques and technologies
Implement
Management
Review
Focus
on CAPA (Corrective Action
Preventive Action)
Identify track
and control
variation
Obtain process
product
knowledge and
understanding
Conduct risk
assessments to
focus effort
Where to Start
Management Needs to Know When Stuff Happens
Remember serving patients is a privilege
The outcome of management reviewhellip
a Improvements
b Resources
c Revisions to quality policy and objectives
d Timely and effective communication of the results of the management review
A Simple CAPA System That Is Commonly Used Today
However this is not enough for an
effective and efficient CAPA system
Utilizes a risk based approach
Determines root cause
CAPA
Requires an Exception
Happens in manufacturing
Initiates an Investigation
Implements a corrective action
CAPA
Must look for and address weak signals
An Advanced CAPA System Will
CAPA
Respond to data trending and holistic data reviews
Document continuous improvement projects
Provide feedback throughout the
lifecycle of a project
Implement CAPA earlier in the
development process
Address industry and regulatory surveillance
Utilizes a risk based approach
Determines root cause
Requires an Exception
Happens in manufacturing
Initiates an Investigation
Implements a corrective action
Identify track and control variation
Obtain process product knowledge and understanding
Conduct risk assessments to focus effort
Three Other Important Things to do
Current Quality Management System Ideal Quality Management System
Multiple internal reviews and ldquore-dosrdquo Get it right the first time
Unpredictable inconsistent output Consistency in quality
Continuous fixes to product
and processes Build in Quality from the start
Confusing SOPs and
inefficient processes
Clear SOPs and more simple
and robust process
People dependent quality Overall culture of quality
Relies on extensive inspection
and testing
Leverages process knowledge
and understanding
No formal risk program Addresses risks leading to
fewer issues
lsquoToo slowrsquo lsquoRisk Aversersquo
lsquoNot Risk Averse Enoughrsquo Satisfied customers
Reduced Errors
What to Expect When You Succeed
The Power of Error Reduction Improved Quality and Lower Cost
Cu
mu
lati
ve S
avin
gs (
M)
Sin
ce 2
006
Err
ors
per
Lo
t
00
05
10
15
20
2006 2007 2008 2009 2010 2011 2012
$0
$50
$100
$150
Year
Cum Savings Error Rate
95
Faster Cycle Times
Reduced Errors
What to Expect When You Succeed
Disposition Cycle Time Days
0
20
40
60
80
2006 2012
Da
ys
Drug Substance Drug Product
64
64
What to Expect When You Succeed
Less Scrap Rework
and Rejects
Faster Cycle Times
Scrap Reduction
0
50
100
150
200
250
300
350
2006 2012
Do
llars
Year
92
Reduced Errors
This All Happened While
What to Expect When You Succeed
Less Scrap Rework
and Rejects
Lower Cost
Robust Reliable Supply
Faster Cycle Times
Reduced Errors
Sales Increased
Headcount Decreased
Cost Decreased
And we supplied every patient every time
Serving Patients Is a Privilegehellip
We must be there for every patient every time
Consequences of Poor Quality Can Be Significant
These ramifications are not insignificant and must
not be viewed as a ldquocost of doing businessrdquo
Harms patients
Incurs regulatory sanctions
Loss of business
Incurs Liability
Decreases Productivity
Increases cost
Why Have Others Implemented an Effective Modern QMS
A common thread was to satisfy the customer
and achieve a competitive advantage
Semi-
Conductor
Industry Survival
Consumer
Electronics Reduce defects
Automotive
Industry Competitive advantage
The US Nuclear Navy Also Implemented an Ideal QMS
Clear concise
and accurate
procedures
Train on what
to do what can
go wrong and how
to respond
Qualifications
required
Repeat back
process
Immediate
irreversible with
significant
consequences
Not fully automated
Victims of
success
High barriers to
entry and change
Isolation from
economic
downturns
Accept
variability
Blind compliance If it isnrsquot broke
donrsquot fix it
Fear of gaining
regulatory approval
Inspect and test in
quality approach
What Keeps the Pharma Industry From Changing There Has Not Been Sufficient
Pain Creating Pressure to Force Us to Change
Is the Perfect Storm Brewing Successful companies will batten down
the hatches today to weather the storm tomorrow
Cost pressures Easy to copy High capital Raw material
variability
Health
care cost Look-a-likes High capital
Raw material
variability
Reliable
Safe
ELECTRONICS INDUSTRY
BIO-PHARMA INDUSTRY
How to Develop an Ideal Quality Management System
Rome was not built in a day and building an
effective QMS is a journey that never ends
Create a culture of quality
Promote the benefits of quality
Tailor the message for the audience
Gain executive support
Work cross-functionally
Drive operational excellence
Implement new techniques and technologies
Implement
Management
Review
Focus
on CAPA (Corrective Action
Preventive Action)
Identify track
and control
variation
Obtain process
product
knowledge and
understanding
Conduct risk
assessments to
focus effort
Where to Start
Management Needs to Know When Stuff Happens
Remember serving patients is a privilege
The outcome of management reviewhellip
a Improvements
b Resources
c Revisions to quality policy and objectives
d Timely and effective communication of the results of the management review
A Simple CAPA System That Is Commonly Used Today
However this is not enough for an
effective and efficient CAPA system
Utilizes a risk based approach
Determines root cause
CAPA
Requires an Exception
Happens in manufacturing
Initiates an Investigation
Implements a corrective action
CAPA
Must look for and address weak signals
An Advanced CAPA System Will
CAPA
Respond to data trending and holistic data reviews
Document continuous improvement projects
Provide feedback throughout the
lifecycle of a project
Implement CAPA earlier in the
development process
Address industry and regulatory surveillance
Utilizes a risk based approach
Determines root cause
Requires an Exception
Happens in manufacturing
Initiates an Investigation
Implements a corrective action
Identify track and control variation
Obtain process product knowledge and understanding
Conduct risk assessments to focus effort
Three Other Important Things to do
Current Quality Management System Ideal Quality Management System
Multiple internal reviews and ldquore-dosrdquo Get it right the first time
Unpredictable inconsistent output Consistency in quality
Continuous fixes to product
and processes Build in Quality from the start
Confusing SOPs and
inefficient processes
Clear SOPs and more simple
and robust process
People dependent quality Overall culture of quality
Relies on extensive inspection
and testing
Leverages process knowledge
and understanding
No formal risk program Addresses risks leading to
fewer issues
lsquoToo slowrsquo lsquoRisk Aversersquo
lsquoNot Risk Averse Enoughrsquo Satisfied customers
Reduced Errors
What to Expect When You Succeed
The Power of Error Reduction Improved Quality and Lower Cost
Cu
mu
lati
ve S
avin
gs (
M)
Sin
ce 2
006
Err
ors
per
Lo
t
00
05
10
15
20
2006 2007 2008 2009 2010 2011 2012
$0
$50
$100
$150
Year
Cum Savings Error Rate
95
Faster Cycle Times
Reduced Errors
What to Expect When You Succeed
Disposition Cycle Time Days
0
20
40
60
80
2006 2012
Da
ys
Drug Substance Drug Product
64
64
What to Expect When You Succeed
Less Scrap Rework
and Rejects
Faster Cycle Times
Scrap Reduction
0
50
100
150
200
250
300
350
2006 2012
Do
llars
Year
92
Reduced Errors
This All Happened While
What to Expect When You Succeed
Less Scrap Rework
and Rejects
Lower Cost
Robust Reliable Supply
Faster Cycle Times
Reduced Errors
Sales Increased
Headcount Decreased
Cost Decreased
And we supplied every patient every time
Serving Patients Is a Privilegehellip
We must be there for every patient every time
Why Have Others Implemented an Effective Modern QMS
A common thread was to satisfy the customer
and achieve a competitive advantage
Semi-
Conductor
Industry Survival
Consumer
Electronics Reduce defects
Automotive
Industry Competitive advantage
The US Nuclear Navy Also Implemented an Ideal QMS
Clear concise
and accurate
procedures
Train on what
to do what can
go wrong and how
to respond
Qualifications
required
Repeat back
process
Immediate
irreversible with
significant
consequences
Not fully automated
Victims of
success
High barriers to
entry and change
Isolation from
economic
downturns
Accept
variability
Blind compliance If it isnrsquot broke
donrsquot fix it
Fear of gaining
regulatory approval
Inspect and test in
quality approach
What Keeps the Pharma Industry From Changing There Has Not Been Sufficient
Pain Creating Pressure to Force Us to Change
Is the Perfect Storm Brewing Successful companies will batten down
the hatches today to weather the storm tomorrow
Cost pressures Easy to copy High capital Raw material
variability
Health
care cost Look-a-likes High capital
Raw material
variability
Reliable
Safe
ELECTRONICS INDUSTRY
BIO-PHARMA INDUSTRY
How to Develop an Ideal Quality Management System
Rome was not built in a day and building an
effective QMS is a journey that never ends
Create a culture of quality
Promote the benefits of quality
Tailor the message for the audience
Gain executive support
Work cross-functionally
Drive operational excellence
Implement new techniques and technologies
Implement
Management
Review
Focus
on CAPA (Corrective Action
Preventive Action)
Identify track
and control
variation
Obtain process
product
knowledge and
understanding
Conduct risk
assessments to
focus effort
Where to Start
Management Needs to Know When Stuff Happens
Remember serving patients is a privilege
The outcome of management reviewhellip
a Improvements
b Resources
c Revisions to quality policy and objectives
d Timely and effective communication of the results of the management review
A Simple CAPA System That Is Commonly Used Today
However this is not enough for an
effective and efficient CAPA system
Utilizes a risk based approach
Determines root cause
CAPA
Requires an Exception
Happens in manufacturing
Initiates an Investigation
Implements a corrective action
CAPA
Must look for and address weak signals
An Advanced CAPA System Will
CAPA
Respond to data trending and holistic data reviews
Document continuous improvement projects
Provide feedback throughout the
lifecycle of a project
Implement CAPA earlier in the
development process
Address industry and regulatory surveillance
Utilizes a risk based approach
Determines root cause
Requires an Exception
Happens in manufacturing
Initiates an Investigation
Implements a corrective action
Identify track and control variation
Obtain process product knowledge and understanding
Conduct risk assessments to focus effort
Three Other Important Things to do
Current Quality Management System Ideal Quality Management System
Multiple internal reviews and ldquore-dosrdquo Get it right the first time
Unpredictable inconsistent output Consistency in quality
Continuous fixes to product
and processes Build in Quality from the start
Confusing SOPs and
inefficient processes
Clear SOPs and more simple
and robust process
People dependent quality Overall culture of quality
Relies on extensive inspection
and testing
Leverages process knowledge
and understanding
No formal risk program Addresses risks leading to
fewer issues
lsquoToo slowrsquo lsquoRisk Aversersquo
lsquoNot Risk Averse Enoughrsquo Satisfied customers
Reduced Errors
What to Expect When You Succeed
The Power of Error Reduction Improved Quality and Lower Cost
Cu
mu
lati
ve S
avin
gs (
M)
Sin
ce 2
006
Err
ors
per
Lo
t
00
05
10
15
20
2006 2007 2008 2009 2010 2011 2012
$0
$50
$100
$150
Year
Cum Savings Error Rate
95
Faster Cycle Times
Reduced Errors
What to Expect When You Succeed
Disposition Cycle Time Days
0
20
40
60
80
2006 2012
Da
ys
Drug Substance Drug Product
64
64
What to Expect When You Succeed
Less Scrap Rework
and Rejects
Faster Cycle Times
Scrap Reduction
0
50
100
150
200
250
300
350
2006 2012
Do
llars
Year
92
Reduced Errors
This All Happened While
What to Expect When You Succeed
Less Scrap Rework
and Rejects
Lower Cost
Robust Reliable Supply
Faster Cycle Times
Reduced Errors
Sales Increased
Headcount Decreased
Cost Decreased
And we supplied every patient every time
Serving Patients Is a Privilegehellip
We must be there for every patient every time
The US Nuclear Navy Also Implemented an Ideal QMS
Clear concise
and accurate
procedures
Train on what
to do what can
go wrong and how
to respond
Qualifications
required
Repeat back
process
Immediate
irreversible with
significant
consequences
Not fully automated
Victims of
success
High barriers to
entry and change
Isolation from
economic
downturns
Accept
variability
Blind compliance If it isnrsquot broke
donrsquot fix it
Fear of gaining
regulatory approval
Inspect and test in
quality approach
What Keeps the Pharma Industry From Changing There Has Not Been Sufficient
Pain Creating Pressure to Force Us to Change
Is the Perfect Storm Brewing Successful companies will batten down
the hatches today to weather the storm tomorrow
Cost pressures Easy to copy High capital Raw material
variability
Health
care cost Look-a-likes High capital
Raw material
variability
Reliable
Safe
ELECTRONICS INDUSTRY
BIO-PHARMA INDUSTRY
How to Develop an Ideal Quality Management System
Rome was not built in a day and building an
effective QMS is a journey that never ends
Create a culture of quality
Promote the benefits of quality
Tailor the message for the audience
Gain executive support
Work cross-functionally
Drive operational excellence
Implement new techniques and technologies
Implement
Management
Review
Focus
on CAPA (Corrective Action
Preventive Action)
Identify track
and control
variation
Obtain process
product
knowledge and
understanding
Conduct risk
assessments to
focus effort
Where to Start
Management Needs to Know When Stuff Happens
Remember serving patients is a privilege
The outcome of management reviewhellip
a Improvements
b Resources
c Revisions to quality policy and objectives
d Timely and effective communication of the results of the management review
A Simple CAPA System That Is Commonly Used Today
However this is not enough for an
effective and efficient CAPA system
Utilizes a risk based approach
Determines root cause
CAPA
Requires an Exception
Happens in manufacturing
Initiates an Investigation
Implements a corrective action
CAPA
Must look for and address weak signals
An Advanced CAPA System Will
CAPA
Respond to data trending and holistic data reviews
Document continuous improvement projects
Provide feedback throughout the
lifecycle of a project
Implement CAPA earlier in the
development process
Address industry and regulatory surveillance
Utilizes a risk based approach
Determines root cause
Requires an Exception
Happens in manufacturing
Initiates an Investigation
Implements a corrective action
Identify track and control variation
Obtain process product knowledge and understanding
Conduct risk assessments to focus effort
Three Other Important Things to do
Current Quality Management System Ideal Quality Management System
Multiple internal reviews and ldquore-dosrdquo Get it right the first time
Unpredictable inconsistent output Consistency in quality
Continuous fixes to product
and processes Build in Quality from the start
Confusing SOPs and
inefficient processes
Clear SOPs and more simple
and robust process
People dependent quality Overall culture of quality
Relies on extensive inspection
and testing
Leverages process knowledge
and understanding
No formal risk program Addresses risks leading to
fewer issues
lsquoToo slowrsquo lsquoRisk Aversersquo
lsquoNot Risk Averse Enoughrsquo Satisfied customers
Reduced Errors
What to Expect When You Succeed
The Power of Error Reduction Improved Quality and Lower Cost
Cu
mu
lati
ve S
avin
gs (
M)
Sin
ce 2
006
Err
ors
per
Lo
t
00
05
10
15
20
2006 2007 2008 2009 2010 2011 2012
$0
$50
$100
$150
Year
Cum Savings Error Rate
95
Faster Cycle Times
Reduced Errors
What to Expect When You Succeed
Disposition Cycle Time Days
0
20
40
60
80
2006 2012
Da
ys
Drug Substance Drug Product
64
64
What to Expect When You Succeed
Less Scrap Rework
and Rejects
Faster Cycle Times
Scrap Reduction
0
50
100
150
200
250
300
350
2006 2012
Do
llars
Year
92
Reduced Errors
This All Happened While
What to Expect When You Succeed
Less Scrap Rework
and Rejects
Lower Cost
Robust Reliable Supply
Faster Cycle Times
Reduced Errors
Sales Increased
Headcount Decreased
Cost Decreased
And we supplied every patient every time
Serving Patients Is a Privilegehellip
We must be there for every patient every time
Victims of
success
High barriers to
entry and change
Isolation from
economic
downturns
Accept
variability
Blind compliance If it isnrsquot broke
donrsquot fix it
Fear of gaining
regulatory approval
Inspect and test in
quality approach
What Keeps the Pharma Industry From Changing There Has Not Been Sufficient
Pain Creating Pressure to Force Us to Change
Is the Perfect Storm Brewing Successful companies will batten down
the hatches today to weather the storm tomorrow
Cost pressures Easy to copy High capital Raw material
variability
Health
care cost Look-a-likes High capital
Raw material
variability
Reliable
Safe
ELECTRONICS INDUSTRY
BIO-PHARMA INDUSTRY
How to Develop an Ideal Quality Management System
Rome was not built in a day and building an
effective QMS is a journey that never ends
Create a culture of quality
Promote the benefits of quality
Tailor the message for the audience
Gain executive support
Work cross-functionally
Drive operational excellence
Implement new techniques and technologies
Implement
Management
Review
Focus
on CAPA (Corrective Action
Preventive Action)
Identify track
and control
variation
Obtain process
product
knowledge and
understanding
Conduct risk
assessments to
focus effort
Where to Start
Management Needs to Know When Stuff Happens
Remember serving patients is a privilege
The outcome of management reviewhellip
a Improvements
b Resources
c Revisions to quality policy and objectives
d Timely and effective communication of the results of the management review
A Simple CAPA System That Is Commonly Used Today
However this is not enough for an
effective and efficient CAPA system
Utilizes a risk based approach
Determines root cause
CAPA
Requires an Exception
Happens in manufacturing
Initiates an Investigation
Implements a corrective action
CAPA
Must look for and address weak signals
An Advanced CAPA System Will
CAPA
Respond to data trending and holistic data reviews
Document continuous improvement projects
Provide feedback throughout the
lifecycle of a project
Implement CAPA earlier in the
development process
Address industry and regulatory surveillance
Utilizes a risk based approach
Determines root cause
Requires an Exception
Happens in manufacturing
Initiates an Investigation
Implements a corrective action
Identify track and control variation
Obtain process product knowledge and understanding
Conduct risk assessments to focus effort
Three Other Important Things to do
Current Quality Management System Ideal Quality Management System
Multiple internal reviews and ldquore-dosrdquo Get it right the first time
Unpredictable inconsistent output Consistency in quality
Continuous fixes to product
and processes Build in Quality from the start
Confusing SOPs and
inefficient processes
Clear SOPs and more simple
and robust process
People dependent quality Overall culture of quality
Relies on extensive inspection
and testing
Leverages process knowledge
and understanding
No formal risk program Addresses risks leading to
fewer issues
lsquoToo slowrsquo lsquoRisk Aversersquo
lsquoNot Risk Averse Enoughrsquo Satisfied customers
Reduced Errors
What to Expect When You Succeed
The Power of Error Reduction Improved Quality and Lower Cost
Cu
mu
lati
ve S
avin
gs (
M)
Sin
ce 2
006
Err
ors
per
Lo
t
00
05
10
15
20
2006 2007 2008 2009 2010 2011 2012
$0
$50
$100
$150
Year
Cum Savings Error Rate
95
Faster Cycle Times
Reduced Errors
What to Expect When You Succeed
Disposition Cycle Time Days
0
20
40
60
80
2006 2012
Da
ys
Drug Substance Drug Product
64
64
What to Expect When You Succeed
Less Scrap Rework
and Rejects
Faster Cycle Times
Scrap Reduction
0
50
100
150
200
250
300
350
2006 2012
Do
llars
Year
92
Reduced Errors
This All Happened While
What to Expect When You Succeed
Less Scrap Rework
and Rejects
Lower Cost
Robust Reliable Supply
Faster Cycle Times
Reduced Errors
Sales Increased
Headcount Decreased
Cost Decreased
And we supplied every patient every time
Serving Patients Is a Privilegehellip
We must be there for every patient every time
Is the Perfect Storm Brewing Successful companies will batten down
the hatches today to weather the storm tomorrow
Cost pressures Easy to copy High capital Raw material
variability
Health
care cost Look-a-likes High capital
Raw material
variability
Reliable
Safe
ELECTRONICS INDUSTRY
BIO-PHARMA INDUSTRY
How to Develop an Ideal Quality Management System
Rome was not built in a day and building an
effective QMS is a journey that never ends
Create a culture of quality
Promote the benefits of quality
Tailor the message for the audience
Gain executive support
Work cross-functionally
Drive operational excellence
Implement new techniques and technologies
Implement
Management
Review
Focus
on CAPA (Corrective Action
Preventive Action)
Identify track
and control
variation
Obtain process
product
knowledge and
understanding
Conduct risk
assessments to
focus effort
Where to Start
Management Needs to Know When Stuff Happens
Remember serving patients is a privilege
The outcome of management reviewhellip
a Improvements
b Resources
c Revisions to quality policy and objectives
d Timely and effective communication of the results of the management review
A Simple CAPA System That Is Commonly Used Today
However this is not enough for an
effective and efficient CAPA system
Utilizes a risk based approach
Determines root cause
CAPA
Requires an Exception
Happens in manufacturing
Initiates an Investigation
Implements a corrective action
CAPA
Must look for and address weak signals
An Advanced CAPA System Will
CAPA
Respond to data trending and holistic data reviews
Document continuous improvement projects
Provide feedback throughout the
lifecycle of a project
Implement CAPA earlier in the
development process
Address industry and regulatory surveillance
Utilizes a risk based approach
Determines root cause
Requires an Exception
Happens in manufacturing
Initiates an Investigation
Implements a corrective action
Identify track and control variation
Obtain process product knowledge and understanding
Conduct risk assessments to focus effort
Three Other Important Things to do
Current Quality Management System Ideal Quality Management System
Multiple internal reviews and ldquore-dosrdquo Get it right the first time
Unpredictable inconsistent output Consistency in quality
Continuous fixes to product
and processes Build in Quality from the start
Confusing SOPs and
inefficient processes
Clear SOPs and more simple
and robust process
People dependent quality Overall culture of quality
Relies on extensive inspection
and testing
Leverages process knowledge
and understanding
No formal risk program Addresses risks leading to
fewer issues
lsquoToo slowrsquo lsquoRisk Aversersquo
lsquoNot Risk Averse Enoughrsquo Satisfied customers
Reduced Errors
What to Expect When You Succeed
The Power of Error Reduction Improved Quality and Lower Cost
Cu
mu
lati
ve S
avin
gs (
M)
Sin
ce 2
006
Err
ors
per
Lo
t
00
05
10
15
20
2006 2007 2008 2009 2010 2011 2012
$0
$50
$100
$150
Year
Cum Savings Error Rate
95
Faster Cycle Times
Reduced Errors
What to Expect When You Succeed
Disposition Cycle Time Days
0
20
40
60
80
2006 2012
Da
ys
Drug Substance Drug Product
64
64
What to Expect When You Succeed
Less Scrap Rework
and Rejects
Faster Cycle Times
Scrap Reduction
0
50
100
150
200
250
300
350
2006 2012
Do
llars
Year
92
Reduced Errors
This All Happened While
What to Expect When You Succeed
Less Scrap Rework
and Rejects
Lower Cost
Robust Reliable Supply
Faster Cycle Times
Reduced Errors
Sales Increased
Headcount Decreased
Cost Decreased
And we supplied every patient every time
Serving Patients Is a Privilegehellip
We must be there for every patient every time
How to Develop an Ideal Quality Management System
Rome was not built in a day and building an
effective QMS is a journey that never ends
Create a culture of quality
Promote the benefits of quality
Tailor the message for the audience
Gain executive support
Work cross-functionally
Drive operational excellence
Implement new techniques and technologies
Implement
Management
Review
Focus
on CAPA (Corrective Action
Preventive Action)
Identify track
and control
variation
Obtain process
product
knowledge and
understanding
Conduct risk
assessments to
focus effort
Where to Start
Management Needs to Know When Stuff Happens
Remember serving patients is a privilege
The outcome of management reviewhellip
a Improvements
b Resources
c Revisions to quality policy and objectives
d Timely and effective communication of the results of the management review
A Simple CAPA System That Is Commonly Used Today
However this is not enough for an
effective and efficient CAPA system
Utilizes a risk based approach
Determines root cause
CAPA
Requires an Exception
Happens in manufacturing
Initiates an Investigation
Implements a corrective action
CAPA
Must look for and address weak signals
An Advanced CAPA System Will
CAPA
Respond to data trending and holistic data reviews
Document continuous improvement projects
Provide feedback throughout the
lifecycle of a project
Implement CAPA earlier in the
development process
Address industry and regulatory surveillance
Utilizes a risk based approach
Determines root cause
Requires an Exception
Happens in manufacturing
Initiates an Investigation
Implements a corrective action
Identify track and control variation
Obtain process product knowledge and understanding
Conduct risk assessments to focus effort
Three Other Important Things to do
Current Quality Management System Ideal Quality Management System
Multiple internal reviews and ldquore-dosrdquo Get it right the first time
Unpredictable inconsistent output Consistency in quality
Continuous fixes to product
and processes Build in Quality from the start
Confusing SOPs and
inefficient processes
Clear SOPs and more simple
and robust process
People dependent quality Overall culture of quality
Relies on extensive inspection
and testing
Leverages process knowledge
and understanding
No formal risk program Addresses risks leading to
fewer issues
lsquoToo slowrsquo lsquoRisk Aversersquo
lsquoNot Risk Averse Enoughrsquo Satisfied customers
Reduced Errors
What to Expect When You Succeed
The Power of Error Reduction Improved Quality and Lower Cost
Cu
mu
lati
ve S
avin
gs (
M)
Sin
ce 2
006
Err
ors
per
Lo
t
00
05
10
15
20
2006 2007 2008 2009 2010 2011 2012
$0
$50
$100
$150
Year
Cum Savings Error Rate
95
Faster Cycle Times
Reduced Errors
What to Expect When You Succeed
Disposition Cycle Time Days
0
20
40
60
80
2006 2012
Da
ys
Drug Substance Drug Product
64
64
What to Expect When You Succeed
Less Scrap Rework
and Rejects
Faster Cycle Times
Scrap Reduction
0
50
100
150
200
250
300
350
2006 2012
Do
llars
Year
92
Reduced Errors
This All Happened While
What to Expect When You Succeed
Less Scrap Rework
and Rejects
Lower Cost
Robust Reliable Supply
Faster Cycle Times
Reduced Errors
Sales Increased
Headcount Decreased
Cost Decreased
And we supplied every patient every time
Serving Patients Is a Privilegehellip
We must be there for every patient every time
Implement
Management
Review
Focus
on CAPA (Corrective Action
Preventive Action)
Identify track
and control
variation
Obtain process
product
knowledge and
understanding
Conduct risk
assessments to
focus effort
Where to Start
Management Needs to Know When Stuff Happens
Remember serving patients is a privilege
The outcome of management reviewhellip
a Improvements
b Resources
c Revisions to quality policy and objectives
d Timely and effective communication of the results of the management review
A Simple CAPA System That Is Commonly Used Today
However this is not enough for an
effective and efficient CAPA system
Utilizes a risk based approach
Determines root cause
CAPA
Requires an Exception
Happens in manufacturing
Initiates an Investigation
Implements a corrective action
CAPA
Must look for and address weak signals
An Advanced CAPA System Will
CAPA
Respond to data trending and holistic data reviews
Document continuous improvement projects
Provide feedback throughout the
lifecycle of a project
Implement CAPA earlier in the
development process
Address industry and regulatory surveillance
Utilizes a risk based approach
Determines root cause
Requires an Exception
Happens in manufacturing
Initiates an Investigation
Implements a corrective action
Identify track and control variation
Obtain process product knowledge and understanding
Conduct risk assessments to focus effort
Three Other Important Things to do
Current Quality Management System Ideal Quality Management System
Multiple internal reviews and ldquore-dosrdquo Get it right the first time
Unpredictable inconsistent output Consistency in quality
Continuous fixes to product
and processes Build in Quality from the start
Confusing SOPs and
inefficient processes
Clear SOPs and more simple
and robust process
People dependent quality Overall culture of quality
Relies on extensive inspection
and testing
Leverages process knowledge
and understanding
No formal risk program Addresses risks leading to
fewer issues
lsquoToo slowrsquo lsquoRisk Aversersquo
lsquoNot Risk Averse Enoughrsquo Satisfied customers
Reduced Errors
What to Expect When You Succeed
The Power of Error Reduction Improved Quality and Lower Cost
Cu
mu
lati
ve S
avin
gs (
M)
Sin
ce 2
006
Err
ors
per
Lo
t
00
05
10
15
20
2006 2007 2008 2009 2010 2011 2012
$0
$50
$100
$150
Year
Cum Savings Error Rate
95
Faster Cycle Times
Reduced Errors
What to Expect When You Succeed
Disposition Cycle Time Days
0
20
40
60
80
2006 2012
Da
ys
Drug Substance Drug Product
64
64
What to Expect When You Succeed
Less Scrap Rework
and Rejects
Faster Cycle Times
Scrap Reduction
0
50
100
150
200
250
300
350
2006 2012
Do
llars
Year
92
Reduced Errors
This All Happened While
What to Expect When You Succeed
Less Scrap Rework
and Rejects
Lower Cost
Robust Reliable Supply
Faster Cycle Times
Reduced Errors
Sales Increased
Headcount Decreased
Cost Decreased
And we supplied every patient every time
Serving Patients Is a Privilegehellip
We must be there for every patient every time
Management Needs to Know When Stuff Happens
Remember serving patients is a privilege
The outcome of management reviewhellip
a Improvements
b Resources
c Revisions to quality policy and objectives
d Timely and effective communication of the results of the management review
A Simple CAPA System That Is Commonly Used Today
However this is not enough for an
effective and efficient CAPA system
Utilizes a risk based approach
Determines root cause
CAPA
Requires an Exception
Happens in manufacturing
Initiates an Investigation
Implements a corrective action
CAPA
Must look for and address weak signals
An Advanced CAPA System Will
CAPA
Respond to data trending and holistic data reviews
Document continuous improvement projects
Provide feedback throughout the
lifecycle of a project
Implement CAPA earlier in the
development process
Address industry and regulatory surveillance
Utilizes a risk based approach
Determines root cause
Requires an Exception
Happens in manufacturing
Initiates an Investigation
Implements a corrective action
Identify track and control variation
Obtain process product knowledge and understanding
Conduct risk assessments to focus effort
Three Other Important Things to do
Current Quality Management System Ideal Quality Management System
Multiple internal reviews and ldquore-dosrdquo Get it right the first time
Unpredictable inconsistent output Consistency in quality
Continuous fixes to product
and processes Build in Quality from the start
Confusing SOPs and
inefficient processes
Clear SOPs and more simple
and robust process
People dependent quality Overall culture of quality
Relies on extensive inspection
and testing
Leverages process knowledge
and understanding
No formal risk program Addresses risks leading to
fewer issues
lsquoToo slowrsquo lsquoRisk Aversersquo
lsquoNot Risk Averse Enoughrsquo Satisfied customers
Reduced Errors
What to Expect When You Succeed
The Power of Error Reduction Improved Quality and Lower Cost
Cu
mu
lati
ve S
avin
gs (
M)
Sin
ce 2
006
Err
ors
per
Lo
t
00
05
10
15
20
2006 2007 2008 2009 2010 2011 2012
$0
$50
$100
$150
Year
Cum Savings Error Rate
95
Faster Cycle Times
Reduced Errors
What to Expect When You Succeed
Disposition Cycle Time Days
0
20
40
60
80
2006 2012
Da
ys
Drug Substance Drug Product
64
64
What to Expect When You Succeed
Less Scrap Rework
and Rejects
Faster Cycle Times
Scrap Reduction
0
50
100
150
200
250
300
350
2006 2012
Do
llars
Year
92
Reduced Errors
This All Happened While
What to Expect When You Succeed
Less Scrap Rework
and Rejects
Lower Cost
Robust Reliable Supply
Faster Cycle Times
Reduced Errors
Sales Increased
Headcount Decreased
Cost Decreased
And we supplied every patient every time
Serving Patients Is a Privilegehellip
We must be there for every patient every time
A Simple CAPA System That Is Commonly Used Today
However this is not enough for an
effective and efficient CAPA system
Utilizes a risk based approach
Determines root cause
CAPA
Requires an Exception
Happens in manufacturing
Initiates an Investigation
Implements a corrective action
CAPA
Must look for and address weak signals
An Advanced CAPA System Will
CAPA
Respond to data trending and holistic data reviews
Document continuous improvement projects
Provide feedback throughout the
lifecycle of a project
Implement CAPA earlier in the
development process
Address industry and regulatory surveillance
Utilizes a risk based approach
Determines root cause
Requires an Exception
Happens in manufacturing
Initiates an Investigation
Implements a corrective action
Identify track and control variation
Obtain process product knowledge and understanding
Conduct risk assessments to focus effort
Three Other Important Things to do
Current Quality Management System Ideal Quality Management System
Multiple internal reviews and ldquore-dosrdquo Get it right the first time
Unpredictable inconsistent output Consistency in quality
Continuous fixes to product
and processes Build in Quality from the start
Confusing SOPs and
inefficient processes
Clear SOPs and more simple
and robust process
People dependent quality Overall culture of quality
Relies on extensive inspection
and testing
Leverages process knowledge
and understanding
No formal risk program Addresses risks leading to
fewer issues
lsquoToo slowrsquo lsquoRisk Aversersquo
lsquoNot Risk Averse Enoughrsquo Satisfied customers
Reduced Errors
What to Expect When You Succeed
The Power of Error Reduction Improved Quality and Lower Cost
Cu
mu
lati
ve S
avin
gs (
M)
Sin
ce 2
006
Err
ors
per
Lo
t
00
05
10
15
20
2006 2007 2008 2009 2010 2011 2012
$0
$50
$100
$150
Year
Cum Savings Error Rate
95
Faster Cycle Times
Reduced Errors
What to Expect When You Succeed
Disposition Cycle Time Days
0
20
40
60
80
2006 2012
Da
ys
Drug Substance Drug Product
64
64
What to Expect When You Succeed
Less Scrap Rework
and Rejects
Faster Cycle Times
Scrap Reduction
0
50
100
150
200
250
300
350
2006 2012
Do
llars
Year
92
Reduced Errors
This All Happened While
What to Expect When You Succeed
Less Scrap Rework
and Rejects
Lower Cost
Robust Reliable Supply
Faster Cycle Times
Reduced Errors
Sales Increased
Headcount Decreased
Cost Decreased
And we supplied every patient every time
Serving Patients Is a Privilegehellip
We must be there for every patient every time
Must look for and address weak signals
An Advanced CAPA System Will
CAPA
Respond to data trending and holistic data reviews
Document continuous improvement projects
Provide feedback throughout the
lifecycle of a project
Implement CAPA earlier in the
development process
Address industry and regulatory surveillance
Utilizes a risk based approach
Determines root cause
Requires an Exception
Happens in manufacturing
Initiates an Investigation
Implements a corrective action
Identify track and control variation
Obtain process product knowledge and understanding
Conduct risk assessments to focus effort
Three Other Important Things to do
Current Quality Management System Ideal Quality Management System
Multiple internal reviews and ldquore-dosrdquo Get it right the first time
Unpredictable inconsistent output Consistency in quality
Continuous fixes to product
and processes Build in Quality from the start
Confusing SOPs and
inefficient processes
Clear SOPs and more simple
and robust process
People dependent quality Overall culture of quality
Relies on extensive inspection
and testing
Leverages process knowledge
and understanding
No formal risk program Addresses risks leading to
fewer issues
lsquoToo slowrsquo lsquoRisk Aversersquo
lsquoNot Risk Averse Enoughrsquo Satisfied customers
Reduced Errors
What to Expect When You Succeed
The Power of Error Reduction Improved Quality and Lower Cost
Cu
mu
lati
ve S
avin
gs (
M)
Sin
ce 2
006
Err
ors
per
Lo
t
00
05
10
15
20
2006 2007 2008 2009 2010 2011 2012
$0
$50
$100
$150
Year
Cum Savings Error Rate
95
Faster Cycle Times
Reduced Errors
What to Expect When You Succeed
Disposition Cycle Time Days
0
20
40
60
80
2006 2012
Da
ys
Drug Substance Drug Product
64
64
What to Expect When You Succeed
Less Scrap Rework
and Rejects
Faster Cycle Times
Scrap Reduction
0
50
100
150
200
250
300
350
2006 2012
Do
llars
Year
92
Reduced Errors
This All Happened While
What to Expect When You Succeed
Less Scrap Rework
and Rejects
Lower Cost
Robust Reliable Supply
Faster Cycle Times
Reduced Errors
Sales Increased
Headcount Decreased
Cost Decreased
And we supplied every patient every time
Serving Patients Is a Privilegehellip
We must be there for every patient every time
Identify track and control variation
Obtain process product knowledge and understanding
Conduct risk assessments to focus effort
Three Other Important Things to do
Current Quality Management System Ideal Quality Management System
Multiple internal reviews and ldquore-dosrdquo Get it right the first time
Unpredictable inconsistent output Consistency in quality
Continuous fixes to product
and processes Build in Quality from the start
Confusing SOPs and
inefficient processes
Clear SOPs and more simple
and robust process
People dependent quality Overall culture of quality
Relies on extensive inspection
and testing
Leverages process knowledge
and understanding
No formal risk program Addresses risks leading to
fewer issues
lsquoToo slowrsquo lsquoRisk Aversersquo
lsquoNot Risk Averse Enoughrsquo Satisfied customers
Reduced Errors
What to Expect When You Succeed
The Power of Error Reduction Improved Quality and Lower Cost
Cu
mu
lati
ve S
avin
gs (
M)
Sin
ce 2
006
Err
ors
per
Lo
t
00
05
10
15
20
2006 2007 2008 2009 2010 2011 2012
$0
$50
$100
$150
Year
Cum Savings Error Rate
95
Faster Cycle Times
Reduced Errors
What to Expect When You Succeed
Disposition Cycle Time Days
0
20
40
60
80
2006 2012
Da
ys
Drug Substance Drug Product
64
64
What to Expect When You Succeed
Less Scrap Rework
and Rejects
Faster Cycle Times
Scrap Reduction
0
50
100
150
200
250
300
350
2006 2012
Do
llars
Year
92
Reduced Errors
This All Happened While
What to Expect When You Succeed
Less Scrap Rework
and Rejects
Lower Cost
Robust Reliable Supply
Faster Cycle Times
Reduced Errors
Sales Increased
Headcount Decreased
Cost Decreased
And we supplied every patient every time
Serving Patients Is a Privilegehellip
We must be there for every patient every time
Current Quality Management System Ideal Quality Management System
Multiple internal reviews and ldquore-dosrdquo Get it right the first time
Unpredictable inconsistent output Consistency in quality
Continuous fixes to product
and processes Build in Quality from the start
Confusing SOPs and
inefficient processes
Clear SOPs and more simple
and robust process
People dependent quality Overall culture of quality
Relies on extensive inspection
and testing
Leverages process knowledge
and understanding
No formal risk program Addresses risks leading to
fewer issues
lsquoToo slowrsquo lsquoRisk Aversersquo
lsquoNot Risk Averse Enoughrsquo Satisfied customers
Reduced Errors
What to Expect When You Succeed
The Power of Error Reduction Improved Quality and Lower Cost
Cu
mu
lati
ve S
avin
gs (
M)
Sin
ce 2
006
Err
ors
per
Lo
t
00
05
10
15
20
2006 2007 2008 2009 2010 2011 2012
$0
$50
$100
$150
Year
Cum Savings Error Rate
95
Faster Cycle Times
Reduced Errors
What to Expect When You Succeed
Disposition Cycle Time Days
0
20
40
60
80
2006 2012
Da
ys
Drug Substance Drug Product
64
64
What to Expect When You Succeed
Less Scrap Rework
and Rejects
Faster Cycle Times
Scrap Reduction
0
50
100
150
200
250
300
350
2006 2012
Do
llars
Year
92
Reduced Errors
This All Happened While
What to Expect When You Succeed
Less Scrap Rework
and Rejects
Lower Cost
Robust Reliable Supply
Faster Cycle Times
Reduced Errors
Sales Increased
Headcount Decreased
Cost Decreased
And we supplied every patient every time
Serving Patients Is a Privilegehellip
We must be there for every patient every time
Reduced Errors
What to Expect When You Succeed
The Power of Error Reduction Improved Quality and Lower Cost
Cu
mu
lati
ve S
avin
gs (
M)
Sin
ce 2
006
Err
ors
per
Lo
t
00
05
10
15
20
2006 2007 2008 2009 2010 2011 2012
$0
$50
$100
$150
Year
Cum Savings Error Rate
95
Faster Cycle Times
Reduced Errors
What to Expect When You Succeed
Disposition Cycle Time Days
0
20
40
60
80
2006 2012
Da
ys
Drug Substance Drug Product
64
64
What to Expect When You Succeed
Less Scrap Rework
and Rejects
Faster Cycle Times
Scrap Reduction
0
50
100
150
200
250
300
350
2006 2012
Do
llars
Year
92
Reduced Errors
This All Happened While
What to Expect When You Succeed
Less Scrap Rework
and Rejects
Lower Cost
Robust Reliable Supply
Faster Cycle Times
Reduced Errors
Sales Increased
Headcount Decreased
Cost Decreased
And we supplied every patient every time
Serving Patients Is a Privilegehellip
We must be there for every patient every time
Faster Cycle Times
Reduced Errors
What to Expect When You Succeed
Disposition Cycle Time Days
0
20
40
60
80
2006 2012
Da
ys
Drug Substance Drug Product
64
64
What to Expect When You Succeed
Less Scrap Rework
and Rejects
Faster Cycle Times
Scrap Reduction
0
50
100
150
200
250
300
350
2006 2012
Do
llars
Year
92
Reduced Errors
This All Happened While
What to Expect When You Succeed
Less Scrap Rework
and Rejects
Lower Cost
Robust Reliable Supply
Faster Cycle Times
Reduced Errors
Sales Increased
Headcount Decreased
Cost Decreased
And we supplied every patient every time
Serving Patients Is a Privilegehellip
We must be there for every patient every time
What to Expect When You Succeed
Less Scrap Rework
and Rejects
Faster Cycle Times
Scrap Reduction
0
50
100
150
200
250
300
350
2006 2012
Do
llars
Year
92
Reduced Errors
This All Happened While
What to Expect When You Succeed
Less Scrap Rework
and Rejects
Lower Cost
Robust Reliable Supply
Faster Cycle Times
Reduced Errors
Sales Increased
Headcount Decreased
Cost Decreased
And we supplied every patient every time
Serving Patients Is a Privilegehellip
We must be there for every patient every time
This All Happened While
What to Expect When You Succeed
Less Scrap Rework
and Rejects
Lower Cost
Robust Reliable Supply
Faster Cycle Times
Reduced Errors
Sales Increased
Headcount Decreased
Cost Decreased
And we supplied every patient every time
Serving Patients Is a Privilegehellip
We must be there for every patient every time
Serving Patients Is a Privilegehellip
We must be there for every patient every time
