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A modified version of a

presentation @ Patheon –
Pharmaceutical Culture of Quality, Bridgewater, NJ Seminar

Assurance of Data Integrity & Quality by Thursday, July 31, 2014

Design: Connecting the Dots Quality by Design -


Experience, Trends and
Outlook
Ajaz@ajazhussain.com

8/1/2014 © Ajaz S. Hussain | INSIGHT, ADVICE & SOLUTIONS LLC 1


These slides were used for a invited presentation @ Patheon Seminar –
Bridgewater, NJ, 31 July 2014.
• Some modification have been made to connect the dots for the audience who will review this
slide-deck on the internet.
• This presentation provides a very brief snap-shot of a day long training program conducted
recently at a company in India.

In preparing the day long training session I had asked the following
questions
Prologue • How to effectively communicate to an audience of a group of young and bright Indian
professionals in any company in India and their supervisors/management about the
importance of cGMPs and QbD?
• How do I understand their challenges, perspectives and biases?
• How do I connect with them to share the joy of Quality by Design?

The response received has been overwhelming from the audiences in India
and yesterday at the Patheon Seminar in Bridgewater, NJ
• I hope you will also the see some of the important dots and the connections
• How this content connects to regulatory requirements is not covered in this slide deck – it
connects via ‘A, B, C, D’ to 21 CFR, Quality Systems Approach to cGMP, ICH 7, 8, 9, 10, and 11.

8/1/2014 © Ajaz S. Hussain | INSIGHT, ADVICE & SOLUTIONS LLC 2


“The Gold Sheet”
March 2014 Thakur: Cahilly: Hussain: Takahashi:
• Data • Focus on • Empowering • Look out for
Integrity India masks workers is these data
Cox: Confronting requires
stronger
the real data
integrity
the key to
data integrity
integrity
Issues
Illusions of Quality local
enforcement
problems

in Indian Generics
Manufacturing
Understanding the behaviors –
it is a human issue & this is not about India.
http://www.pharmamedtechbi.com/publications/the-gold-sheet/48/3/confronting-illusions-of-quality-in-indian-generics-manufacturing

8/1/2014 © Ajaz S. Hussain | INSIGHT, ADVICE & SOLUTIONS LLC 3


 How to effectively communicate to an audience of a
Empowering group of young and bright Indian professionals in any
workers is the company in India about cGMPs and QbD?
key to data  How do I understand their challenges, perspectives and
integrity - this is my biases?
personal journey to see if I can  How do I connect with them to share the joy of Quality
help.
by Design?

8/1/2014 © Ajaz S. Hussain | INSIGHT, ADVICE & SOLUTIONS LLC 4


We must do certain things
The challenge at hand is that
consciously; and cultivate
of human reliability – it is a
some good habits -
global issue
subconsciously.

Quality by
Design
Where do corporate
Irrationality, Biases, Thinking
managers, schooled in
Fast, and Slow – connections
rational assumptions ….go
to econometrics suggested.
from here?
Deming - The journey
requires leadership with
Profound Knowledge as
a guide. Is there a culture of error
When organizations
management where there’s a
acknowledge and anticipate
genuine effort to learn from
irrational behavior, they can
mistakes, or is it one of error
learn to offset it and avoid
aversion, where errors are
damaging results.
avoided at all cost?

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Doing things consciously – stuck in my mind

FDA’s ACPS Meeting October 2005

Quality by Topic - Achieving and demonstrating “Quality by Design” with respect to


Design –What is it? drug release/dissolution performance for conventional or immediate
release solid oral dosage forms

A PhRMA Perspective – presented by C. Sinko and R. Reed.

“Features of Quality by Design: Doing things consciously”

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Doing • Scientific methodology
something Consciously • Engineering Design
Consciously or • Plan-Do-Check-Act
Subconsciously
The End of Rational Economics -
“[Allen Greenspan] made a
mistake in presuming that the
self-interest of organizations, • Habits (work to get rid of bad ones)
specifically banks and others, was • Habits (work to cultivate good one)
such that they were best capable Subconsciously
of protecting their own • Keystone habits (Safety @ Alcoa;
shareholders.” Dan Ariely
Harvard Business Review July
A.L.C.O.A. of data integrity)
2009 The Power of Habit: Why We Do What We Do in Life and Business. Charles Duhigg

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Intention to care
– duty of care

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Kahneman and Tversky, the
first researchers to identify
and rigorously study
KAHNEMAN, Daniel,
cognitive biases, proved that
and Amos TVERSKY,
a simple version of expected
1979. Prospect
utility theory did not
Theory: An Analysis of
accurately describe human
Decision under
behavior.Their response was
Risk. Econometrica, 47
to develop prospect theory, a
(2), 263–292
model of how people really
make decisions.
Daniel Kahneman, Nobel Prize 2002

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Chemometric,
Pharmacometrics
& Econometrics

Econometrics
Commercial operations,
Ajaz S. Hussain. SWISS profitability & availability
PHARMA 34 (2012) Nr. 6.

Review & Approval


Chemometrics

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Evidence of benefit and risk is collected carefully in well controlled
clinical trials to eliminate many sources of variability and biases
Two products –
Medicine and To be on the market the evidence must convincingly conclude that
Evidence. the benefit outweighs the risks, often compared to a placebo

Better than There is no evidence without adequate assurance of data integrity


Placebo

Our assurance of data integrity distinguishes our products from


adulterated and counterfeit products

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If the agency’s trust is One Quality Voice; Value
lost it will be difficult to Statements
earn it back; posing Put patients first by
challenges far beyond an balancing risk and
initial manufacturing availability

FDA’s Stern Warning On Data Integrity


(The Pink Sheets, 21 July 2014)

Pharmaceutical Quality, CDER, FDA


The new (proposed) Office of
setback.
Have one quality voice
Complete honesty after a by integrating review
FDA CDER slip up will go a long way and inspection across
Challenges & Although India and product lifecycle
China have been the
Changes current focus, FDA is
Other points; see:
FDA/CDER’s Office of
seeing data integrity Pharmaceutical Quality
breaches everywhere to http://www.fda.gov/downloads/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/UCM404568.pdf

some degree.

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 Review (CMC,…)
 Design of specifications and controls; prior knowledge and statistical
confidence
 Clinical relevance, failure-mode and risk-based
 New, Biosimilar, and Generic; differences in review approaches
Life cycle of  Question base Review – improvements on going
 Tightening specifications after development – not aligned with QbD
regulatory
communications  cGMP Compliance & Inspection
 Life-cycle approach to process validation
 Continued process verification and statistical confidence
 cGMP remediation in response to 483 or WL
 Life-cycle approach to error management
 Quality Metrics & Culture of Quality

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Persuasive What is often missed Signals that question the
demonstration of: or is unconvincing is competence, motivation,
and/or integrity of
how you will
What does it (1) Ability to face
facts
strengthen culture of
company personnel
quality.
take to come (2) Legal & regulatory
out of the requirements, “Let one who wants to
3) Systems approach move and convince
cGMP crisis? to quality, others, first be Do not defend the plainly
convinced and moved indefensible; it adds
4) Changing behavior themselves.” Thomas further serious credibility
& culture Carlyle costs

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Evidence/Data

Claims

Effective format for


communication Claim(s)
Evidence/
Data

Warrants

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Within the organization?
How do we
“Let one who communicate In response to 483’s and WL?
wants to move Culture of Quality
and convince In drug applications?
others, first be
convinced and Why is it so?
Today the phrase
moved Culture of
themselves.” Quality is a hot What is it?
Thomas Carlyle topic of
discussion
How do we strength it?

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 Not recording activities contemporaneously
Data integrity –  Backdating
deviant  Fabricating data
behaviors
 Copying existing data as new data
Alicia M. Mozzachio, RPh, MPH , July 15,  Re-running samples
2014 , FDLI, Washington, DC
 Discarding data

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A keystone

“It may take


more than a
Assurance of Data
letter to resolve Integrity ?
this issue”
Carmelo Rosa, Psy.D.; Director-DIDQ, WL in 2014
CDER/OC/OMPQ, July 15, 2014 (FDLI) (7/14/14) + 92%

WL in 2013 + 31%

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“What must be admitted, very painfully, is that this was a disaster ‘Made
Blaming failure in Japan,’ ” Dr. Kurokawa said in his introduction to the English version
of the report. “Its fundamental causes are to be found in the ingrained
on a Nation’s conventions of Japanese culture: our reflexive obedience; our reluctance
to question authority; our devotion to ‘sticking with the program’; our
culture is a cop- groupism; and our insularity.” The Japanese version contained a similar
0ut! criticism.

The chairman of the Reaction was swift. “To pin the blame on [a Nation’s] culture is the
Fukushima Nuclear ultimate cop-out,” Columbia University professor Gerald Curtis wrote in
Accident Commission the Financial Times. “If that is Japanese culture, then we are all
blamed the disaster on “the Japanese”.
ingrained conventions of “Is there a culture of error management - where there’s a genuine effort
Japanese culture”. to learn from mistakes, or is it one of error aversion, where errors are
avoided at all cost, people can expect to be metaphorically dragged out
in to the alley as a prelude to the evidence being covered up?”
http://mbs.edu/mbshub/Pages/Article/How_Fatal_is_your_firms_Error_culture.aspx

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Quality is
everyone's
responsibility. If you can't Rational
If you do not describe behavior
Whenever
Learning is not Lack of know how to what you are requires
there is fear,
knowledge... ask the right doing as a theory.
compulsory... neither is you will get
that is the question, you process, you Reactive
wrong
survival. problem. discover don't know behavior
figures.
nothing. what you're requires only
doing. reflex action.
It takes years, plus a
degree of erosion of
Selected quotes, W. Edwards Deming
confidence in our system,
to resolve cGMP issues.

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• As leaders responsible for system change, top
management is most in need of profound
knowledge
• Quality is often determined in the boardroom.
• Problems arise when management reacts to
common cause or chance variation as if it were
“Out of the The journey special cause variation
requires
Crisis” leadership with • Prediction based in theory provides a
Profound foundation for planning a course of action.
Knowledge as Plan – Do – Check – Act
W. Edward Deming, MIT • The leader serves the people with clear vision
a guide.
Press (2000) and guidance to empower them. To be
empowered is to share ownership in the
identity
• Giving people a certain degree of control over
their work fulfills the need for freedom and
provides opportunity for taking joy in work

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“We cannot change Latent अप्रकट conditions Goal conflicts & mixed messages
Production pressures
the human condition.
Fear of error
But…we can change
the conditions under
which humans work” Design flaws

James Reason
Organization
(Policies & Sr.
Mgmt.)
Team & Supervisor
(Soft Defenses)
J. Reason. Human error:
models and management. Individual
Error (Training & Certification)
BMJ. Mar 18, 2000; 320: 768– Defenses
770 Technology (Quality Management System)
(Constraints & Controls)

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Perhaps the most important distinguishing
feature of high reliability organizations is
High reliability
organizations • They expect to make errors and train their
workforce to recognize and recover them.
• They continually rehearse familiar
scenarios of failure and strive hard to
imagine novel ones.
J. Reason. Human error:
models and management. • Instead of isolating failures, they
BMJ. Mar 18, 2000; 320: 768– generalize them. Instead of making
770
local repairs, they look for system
reforms.

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“….records are not “…OOS not “…appropriate
completed investigates per XYZ controls not
contemporaneously” SOP” established….”

An increasingly
From individual to
common pattern “…observed analyst
“…over-writing
electronic raw system failure –
back-date logbooks”
in recent FDA data…..” with each
additional
483’s observation,
“…results failing confirmation of a
specifications are system with
“…trial injections…..” retested until intentional ‘holes’
acceptable results
are obtained….” in its defenses.

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Why are Serious
remediation enforcement
actions
efforts not
uniformly Past: “…results cGMP Repeat: “…results
remediation
effective? failing
specifications are
failing
specifications are
retested until retested until
acceptable results 3rd party acceptable results
are obtained….” are obtained….”
oversight

What will it take to


3rd party data
change behavior? integrity
training

3-4 years Same company different people/site

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Understanding
Attitude
the behaviors - towards the
behavior
usually found to predict
behavioral intentions with a high
degree of accuracy
intentions, in combination with
perceived behavioral control, can
account for a considerable

“testing into proportion of variance in


behavior.

compliance”.
Subjective Future
Past Intention
Behavior norm Behavior

Ajen, I. The theory of planned


behavior. ORGANIZATIONAL
BEHAVIOR AND HUMAN
DECISION PROCESSES 50, 179- Perceived
211 (1991) behavioral
control

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At the individual Reasons that are often used to rationalize deviant behavior

level, in QC documentation
Process
function– how validation is done
so quality is
not critical;

often does this good;

attitude
occur? toward test prone to subjective Compendial
performing error norm testing sufficient
the behavior
Indian regulators
In general – low empowerment “Batch failure
collect & test
is a significant challenge (low means I made a
samples – no
mistake”
perceived behavioral control); issue there

plus there are reasons to


rationalize…. “Testing into compliance”

Extension to organizational dynamics: If the root cause is product design,


would QC/QA be able to question/challenge R&D?

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US Congress called this the
THE HEPARIN DISASTER American Failures

 November 2007, Children's


 We may never know whether
Understanding - Hospital in St. Louis,
an FDA pre-approval
Missouri, began noticing
Why cGMPs are adverse reactions
inspection would have
prevented this ….
critical?  On January 17th, almost 3
 However, it is regrettable that
months later, Baxter, started
FDA did not inspect this plant
US Congress Hearing April 2008 recalling products
sooner, …
 On February 11th, FDA
 Make no mistake about it:
announced that Baxter had
…have failed the American
halted manufacture of multi-
public.
dose vials
https://house.resource.org/110/org.c-span.205093-1.raw.txt

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Testing/Pharmacovigilence Questions
What is the
FDA reports 149 deaths with allergic or likelihood, in
hypersensitivity symptoms during that period the US, of
Understanding - •Contaminated heparin from China
detecting a
•(a) Don’t know,
•(b) higher than what it was for
less toxic Heparin in 2007, or
Why cGMPs are QC Testing
contaminant
or an or
•(c) lower than what it was for
Heparin in 2007

critical? •Initial testing failed to detect the contaminant


sub‐potent
formulation?

Detection & QC limitations Pharmacovigilence


•(a) USP test for Heparin were not
Why do you designed to test this particular
•Signals in the pharmacovigilence systems responded slowly
and think testing contaminant
did not •(b) The QC labs involved did not
Eventually, the severity of reactions associated detect the know how to test the samples
made it likely that the contamination would be contaminant? •(c) QC lab was manipulating the
detected, data

•albeit too late.

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• Some of these people are already very vulnerable,
It is hard to detect harm and proving the cause of harm from impurities,
Why – the adulteration, and counterfeits can be elusive.

reminder -
FDA inspectors look for • Certainly the companies are obligated to ensure a
Heparin tragedy a culture of quality at culture of quality and maintain vigilance as well.
(2007-2008) manufacturing facilities. This reflects a systems approach to safety.

When the drug safety This system approach • FDA policies led to the failure to inspect the
system fails, people get wasn't at play here. Chinese plant.
sick. Some die…
Congressman Shimkus
(Illinois) This brings me to China • While it doesn't deny the counterfeit source, tries
and its quality culture or to say that counterfeits didn't cause the reaction,
lack thereof. as if the adulteration itself was no big deal.
https://house.resource.org/110/org.c-span.205093-1.raw.txt

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A • GENERAL PROVISIONS

B • ORGANIZATION AND PERSONNEL

21 CFR PART C • BUILDINGS AND FACILITIES

211: SUBPARTS D • EQUIPMENT

Why a combination of E • CONTROL OF COMPONENTS AND DRUG PRODUCT CONTAINERS


AND CLOSURES

deviations can signal a


serious need to strengthen F • PRODUCTION AND PROCESS CONTROLS

Culture of Quality – for


example….. G • PACKAGING AND LABELING CONTROL

H • HOLDING AND DISTRIBUTION

I • LABORATORY CONTROLS

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 An organization is a complex
Culture of system which makes many
thousands of decisions each
Quality: day – writing a SOP for each
decision is not always
practical.
Environment that
 A systems approach to
facilitates individuals quality is essential!
to guide their behavior
to work in the interest  It should recognize that the
weakest link in the system is
of patients and to often human fallibility –
continually improve variable capacity to act
this ability. consciously – when no one is
looking.

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Going beyond
rules pays..

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 Behaviors beyond GXP
 Predictors of a Culture of Quality

 Culture
 Culture of Quality creates an environment needed to facilitate every
individual to guide his/her own behavior to work in the interest of
patients and to continually improve this ability.
How to  System
Connect?  A systems approach to quality is essential! It recognizes that the
weakest link in the system is often human fallibility – variable
capacity to act consciously – when no one is looking.

 GXP, Behavior
 An organization is a complex system which makes many thousands
of decisions each day – writing a SOP for each decision by each
individual (controlling behavior) is not always practical.

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Human Behaviors Beyond GXPs

Human behavior: Predictors of Culture of Quality


Connecting the
Dots; With the Culture of Quality
Right Connectors
Why people change their behavior: 1, 2, 3

Quality Management System

What makes a QMS reliable? A, B, C, D


Why, What, and How of
Culture of Quality?
GXPs – rational behaviors

How proactive compliance is achieved? X, Y, Z

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‘Connecting the I
1
A
X
II B
Dots’ helps to Behaviors
beyond
GXPs
III
Culture of
Quality 2 QMS
C
Behavior -
GXPs Y

communicate IV
3
D
Z

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Creating a Culture of
Quality: Financial
incentives don’t reduce Leadership
Emphasis
errors. Employees Normal (1)
must be passionate Only four
Message
People will
Credibility
about eliminating attributes
actually predict
change their
behavior if they Rewarding (2)
mistakes. a culture of
quality: Peer
see the new
behavior as
Involvement
Easy (3)
Ashwin Srinivasan and Employee
Bryan Kurey. Harvard Empowerment

Business Review, April


2014.
Act consciously in the interest of patients – when no one is looking.

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Leadership Message Peer Employee
Environment Emphasis Credibility Involvement Empowerment

(1) It is Normal to Do
Culture of
Quality Act consciously in
the interest of
Consciously – by design: (2) It is Rewarding
Scientific Methodology,
patients – (satisfaction)
Engineering Design, or specially when no
Plan-Do-Check-Act one is looking.
Interest of Patients:
Regulatory commitments +
(3) It is Easy to Do

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Leadership Message Peer Employee
Environment Emphasis Credibility Involvement Empowerment

A
Quality 1. Normal

Management Culture of
B
System Quality
2. Rewarding QMS
C
3. Easy
Any Body Can Dance
D

Deming's System of Profound Knowledge + James Reason’s Swiss Cheese Model

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• Appreciation for System
A. • Organization viewed as a system; an
orchestra
A, B, C, D
• Theory of Knowledge
B. • Without theory – there is no learning; Asking
the right questions; Plan-Do-Check-Act
Deming's System of
Profound Knowledge +
James Reason’s Swiss • Knowledge of Variation
Cheese Model C. • Common cause and special cause variability;
control charts
Training to ensure Any Body
Can Dance
• Human behavior (pride/satisfaction +
conscious/subconscious biases)
D. • System support and safe guards; system for
error management

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Leadership Message Peer Employee
Environment
CoQ to Emphasis Credibility Involvement Empowerment

QMS to GXP
Behaviors
A
1 X
Facilitating error detection B
and correction. CoQ 2 QMS
GXP
Behaviors
Y
C
X
C. van Dyck. Putting errors 3
D
to good use : error
management culture in
organizations (2000).
http://dare.uva.nl/document/83803
A poor quality product is an error consequence and is not
necessarily related to error management per se. In fact, a poor
quality product may be the result of lack of error management.

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Culture of Error
गलती
Management
प्रबंधन

What words would you use


to describe how you feel
and react to mistakes?
Your own, of a co-worker, of
a subordinate.
How does your supervisor
react?
Picture purchased from www.pixtastock.com

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X. Fear of Errors (reduce)
X, Y, Z Error strain -
Y. Mastery Orientation

Covering up
Z. Awareness
Communicating
C. van Dyck. Putting errors to Analyzing errors Anticipation
good use : error management Error correction Risk-taking
culture in organizations (2000). Learning from errors to
http://dare.uva.nl/document/83803
QbD/RFT

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Error strain Covering up

 In general, people feel  Our motto is; “Why admit an


embarrassed after making a error when no one will find
mistake. out?”
Reduce Fear of
 If an error occurs, people get  It can be harmful to make
Errors upset and irritated. your errors known to others.
(C. van Dyck. 2000)
 If an error is reported it  Employees that own up to
becomes a topic of ridicule their errors are asking for
trouble.
 In this organization,
supervisors feel very  People in this organization
aggravated when mistakes prefer to keep their errors to
are made. themselves.

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Communication Analyzing error

 When someone makes an  After making a mistake,


error, (s)he shares it with people try to analyze what
others so that they won’t caused it.
make the same mistake.
Mastery  In this organization, people
think a lot about how errors
 When people are unable to
orientation correct an error, they turn to could have been avoided.
(C. van Dyck. 2000) their colleagues.  After an error people think
 If people are unable to through how to correct it.
continue their work after an  Our errors point us to what
error, they can rely on others. we can improve.
 When people do something  In mastering a task, people
wrong they can ask others for can learn a lot from their
advice on how to continue. mistakes

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Learning from errors Error correction

 Our errors point us to what


 When an error has occurred
we can improve.
we usually know how to
Mastery  In mastering a task, people rectify it.
can learn a lot from their
orientation  When an error is made, it is
mistakes.
corrected right away.
(C. van Dyck. 2000)
 An error provides important
 If an error is restorable, we
information for the
usually know how to do it.
continuation of the work
 Although we make mistakes,
 When a error occurs we use
we don’t let go of the final
the learning to improve the
goal.
work process.

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Anticipation Risk taking

 It is very likely that people


 For an organization to
will make errors in the
achieve something, it has to
process of mastering their
Awareness task.
risk the occurrence of errors.
(C. van Dyck. 2000)  To get better in what we do,
 When people start to work on
we don’t mind that
something, they are aware
something can go wrong in
that mistakes can occur.
the process.
 In this organization, we take
 It’s fine to risk an error every
into account that things will
once in a while.
go wrong from time to time.

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Good Design Technological safeguards
Expect it to fail Normal
and build Easy
Rewarding
safeguards Team member
support

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QbD/RFT

Error detection

Error strain Anticipation


Reduce
Mastery
Fear of Awareness Communication
orientation
Errors
Covering up Risk taking

Analyzing errors

Correction

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Maturity &
Responsibility

Richard L. Friedman, M.S. Management Oversight and Lifecycle Quality Assurance. FDLI Workshop, Washington DC, 14-15 July, 2014

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Connecting the Normal
System
Fear
Removed
Dots and Culture
of Rewarding QMS
Knowledge
Behavior Mastery
- GXPs
Communicating Quality
Easy
Variation
Awareness

Effectively Behavior

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Summary
Why Quality by We do our best to develop products that meet the needs of patients – we
develop our products consciously – this is our QbD.
Design is the
foundation of We recognize nothing is perfect and there will be some errors in our design,
systems and procedures, or we may make mistakes in following set
Culture of procedures.

Quality It is normal, easy and rewarding to work within our quality management
system, without fear, to detect, correct and to learn from errors.

In doing so we act consciously in the interest of patients – specially when no


one is looking, and continually improve our quality by design and aim for
right first time.

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