Pharmaceutical Culture of Quality, Assurance of Data Integrity & Quality by Design: Connecting the Dots
8/1/2014 © Ajaz S. Hussain | INSIGHT, ADVICE & SOLUTIONS LLC 1
A modified version of a presentation @ Patheon –
Bridgewater, NJ Seminar
Thursday, July 31, 2014
Quality by Design -Experience, Trends and
Outlook
Prologue
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
• 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
Cox: Confronting Illusions of Quality in Indian Generics Manufacturing
Thakur:
• Data Integrity requires stronger local enforcement
Cahilly:
• Focus on India masks the real data integrity problems
Hussain:
• Empowering workers is the key to data integrity
Takahashi:
• Look out for these data integrity Issues
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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
Empowering workers is the key to data integrity - this is my
personal journey to see if I can help.
How to effectively communicate to an audience of a group of young and bright Indian professionals in any company in India about 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?
8/1/2014 © Ajaz S. Hussain | INSIGHT, ADVICE & SOLUTIONS LLC 4
Quality by Design
Deming - The journey requires leadership with Profound Knowledge as a guide.
8/1/2014 © Ajaz S. Hussain | INSIGHT, ADVICE & SOLUTIONS LLC 5
The challenge at hand is that of human reliability – it is a
global issue
We must do certain things consciously; and cultivate
some good habits -subconsciously.
Irrationality, Biases, Thinking Fast, and Slow – connections to econometrics suggested.
Where do corporate managers, schooled in
rational assumptions ….go from here?
When organizations acknowledge and anticipate irrational behavior, they can learn to offset it and avoid
damaging results.
Is there a culture of error management where there’s a genuine effort to learn from mistakes, or is it one of error
aversion, where errors are avoided at all cost?
Quality by Design –What is it?
Doing things consciously – stuck in my mind
FDA’s ACPS Meeting October 2005
Topic - Achieving and demonstrating “Quality by Design” with respect to 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 something Consciously or Subconsciously
The End of Rational Economics -“[Allen Greenspan] made a mistake in presuming that the self-interest of organizations, specifically banks and others, was such that they were best capable of protecting their own shareholders.” Dan Ariely Harvard Business Review July 2009
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• Scientific methodology
• Engineering Design
• Plan-Do-Check-ActConsciously
• Habits (work to get rid of bad ones)
• Habits (work to cultivate good one)
• Keystone habits (Safety @ Alcoa; A.L.C.O.A. of data integrity)
Subconsciously
The Power of Habit: Why We Do What We Do in Life and Business. Charles Duhigg
Intention to care – duty of care
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Kahneman and Tversky, the first researchers to identify and rigorously study cognitive biases, proved that a simple version of expected utility theory did not accurately describe human behavior. Their response was to develop prospect theory, a model of how people really make decisions.
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Daniel Kahneman, Nobel Prize 2002
KAHNEMAN, Daniel, and Amos TVERSKY, 1979. Prospect Theory: An Analysis of Decision under Risk. Econometrica, 47(2), 263–292
Chemometric, Pharmacometrics & Econometrics
Ajaz S. Hussain. SWISS PHARMA 34 (2012) Nr. 6.
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Chemometrics
Eco
no
met
rics
Review & Approval
Commercial operations, profitability & availability
Two products –Medicine and Evidence.
Better than Placebo
Evidence of benefit and risk is collected carefully in well controlled clinical trials to eliminate many sources of variability and biases
To be on the market the evidence must convincingly conclude that the benefit outweighs the risks, often compared to a placebo
There is no evidence without adequate assurance of data integrity
Our assurance of data integrity distinguishes our products from adulterated and counterfeit products
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FDA CDER Challenges & Changes
FDA
’s S
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Wa
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g O
n D
ata
Inte
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k S
hee
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1 Ju
ly 2
014
)
If the agency’s trust is lost it will be difficult to earn it back; posing challenges far beyond an initial manufacturing setback.
Complete honesty after a slip up will go a long way
Although India and China have been the current focus, FDA is seeing data integrity breaches everywhere to some degree. T
he
new
(pro
pose
d) O
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P
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One Quality Voice; Value Statements
Put patients first by balancing risk and availability
Have one quality voice by integrating review and inspection across product lifecycle
Other points; see: FDA/CDER’s Office of Pharmaceutical Quality http://www.fda.gov/downloads/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/UCM404568.pdf
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Life cycle of regulatory communications
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
Question base Review – improvements on going
Tightening specifications after development – not aligned with QbD
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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What does it take to come out of the cGMP crisis?
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Persuasive demonstration of:
(1) Ability to face facts
(2) Legal & regulatory requirements,
3) Systems approach to quality,
4) Changing behavior & culture
What is often missed or is unconvincing is how you will strengthen culture of quality.
“Let one who wants to move and convince others, first be convinced and moved themselves.” Thomas
Carlyle
Signals that question the competence, motivation, and/or integrity of company personnel
Do not defend the plainly indefensible; it adds further serious credibility costs
Effective format for communication
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Evidence/Data
Claim(s)
Warrants
Evidence/Data
Claims
“Let one who wants to move and convince others, first be convinced and moved themselves.” Thomas Carlyle
How do we communicate Culture of Quality
Within the organization?
In response to 483’s and WL?
In drug applications?
Today the phrase Culture of Quality is a hot topic of discussion
Why is it so?
What is it?
How do we strength it?
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Data integrity –deviant behaviors
Alicia M. Mozzachio, RPh, MPH , July 15, 2014 , FDLI, Washington, DC
Not recording activities contemporaneously
Backdating
Fabricating data
Copying existing data as new data
Re-running samples
Discarding data
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“It may take more than a letter to resolve this issue”
Carmelo Rosa, Psy.D.; Director-DIDQ, CDER/OC/OMPQ, July 15, 2014 (FDLI)
WL in 2013 + 31%
WL in 2014 (7/14/14) + 92%
Assurance of Data Integrity ?
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A keystone
Blaming failure on a Nation’s culture is a cop-0ut!
“What must be admitted, very painfully, is that this was a disaster ‘Made 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 conventions of Japanese culture: our reflexive obedience; our reluctance to question authority; our devotion to ‘sticking with the program’; our groupism; and our insularity.” The Japanese version contained a similar criticism.
Reaction was swift. “To pin the blame on [a Nation’s] culture is the ultimate cop-out,” Columbia University professor Gerald Curtis wrote in the Financial Times. “If that is Japanese culture, then we are all Japanese”.
“Is there a culture of error management - where there’s a genuine effort 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?”
The chairman of the Fukushima Nuclear Accident Commission blamed the disaster on “the ingrained conventions of Japanese culture”.
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http://mbs.edu/mbshub/Pages/Article/How_Fatal_is_your_firms_Error_culture.aspx
Quality is everyone's responsibility.
Learning is not compulsory... neither is survival.
It takes years, plus a degree of erosion of confidence in our system, to resolve cGMP issues.
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Lack of knowledge...
that is the problem.
If you do not know how to ask the right
question, you discover nothing.
If you can't describe
what you are doing as a
process, you don't know what you're
doing.
Rational behavior requires theory.
Reactive behavior
requires only reflex action.
Whenever there is fear, you will get
wrong figures.
Selected quotes, W. Edwards Deming
“Out of the Crisis”
W. Edward Deming, MIT Press (2000)
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The journey requires
leadership with Profound
Knowledge as a guide.
• 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 special cause variation
• Prediction based in theory provides a foundation for planning a course of action. Plan – Do – Check – Act
• The leader serves the people with clear vision 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
“We cannot change the human condition. But…we can change the conditions under which humans work” James Reason
J. Reason. Human error: models and management. BMJ. Mar 18, 2000; 320: 768–770
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Organization (Policies & Sr. Mgmt.)
Technology(Constraints & Controls)
Individual (Training & Certification)
Team & Supervisor (Soft Defenses)
Defenses(Quality Management System)
Error
Latent अप्रकट conditions Goal conflicts & mixed messages
Design flaws
Production pressures
Fear of error
High reliability organizations
J. Reason. Human error: models and management. BMJ. Mar 18, 2000; 320: 768–770
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Perhaps the most important distinguishing feature of high reliability organizations is
• 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.
• Instead of isolating failures, they generalize them. Instead of making local repairs, they look for system reforms.
An increasingly common pattern in recent FDA 483’s
“….records are not completed
contemporaneously”
“…observed analyst back-date logbooks”
“…trial injections…..”
“…results failing specifications are
retested until acceptable results are obtained….”
“…over-writing electronic raw
data…..”
“…OOS not investigates per XYZ
SOP”
“…appropriate controls not
established….”
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From individual to system failure –with each additional observation, confirmation of a system with intentional ‘holes’ in its defenses.
Why are remediation efforts not uniformly effective?
Past: “…results failing
specifications are retested until
acceptable results are obtained….”
Serious enforcement
actions
cGMP remediation
3rd party oversight
3rd party data integrity training
Repeat: “…results failing
specifications are retested until
acceptable results are obtained….”
What will it take to change behavior?
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3-4 years Same company different people/site
Understanding the behaviors -“testing into compliance”.
Ajen, I. The theory of planned behavior. ORGANIZATIONAL BEHAVIOR AND HUMAN DECISION PROCESSES 50, 179-211 (1991)
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Attitude towards the
behavior
Subjective norm
Perceived behavioral
control
IntentionFuture
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 proportion of variance in behavior.
PastBehavior
At the individual level, in QC function– how often does this occur?
In general – low empowerment is a significant challenge (low perceived behavioral control); plus there are reasons to rationalize….
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attitude toward
performing the behavior
Process validation is done
so quality is good;
test prone to error
“Batch failure means I made a
mistake”
subjective norm
documentation not critical;
Compendial testing sufficient
Indian regulators collect & test samples – no
issue there
“Testing into compliance”
Reasons that are often used to rationalize deviant behavior
Extension to organizational dynamics: If the root cause is product design, would QC/QA be able to question/challenge R&D?
Understanding -Why cGMPs are critical?
US Congress Hearing April 2008
THE HEPARIN DISASTER
November 2007, Children's Hospital in St. Louis, Missouri, began noticing adverse reactions
On January 17th, almost 3 months later, Baxter, started recalling products
On February 11th, FDA announced that Baxter had halted manufacture of multi-dose vials
US Congress called this the American Failures
We may never know whether an FDA pre-approval inspection would have prevented this ….
However, it is regrettable that FDA did not inspect this plant sooner, …
Make no mistake about it: …have failed the American public.
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https://house.resource.org/110/org.c-span.205093-1.raw.txt
Understanding -Why cGMPs are critical?
Detection & QC limitations
Testing/Pharmacovigilence
FDA reports 149 deaths with allergic or hypersensitivity symptoms during that period
•Contaminated heparin from China
QC Testing
•Initial testing failed to detect the contaminant
Pharmacovigilence
•Signals in the pharmacovigilence systems responded slowly and
Eventually, the severity of reactions associated made it likely that the contamination would be detected,
•albeit too late.
Questions
•(a) Don’t know,
•(b) higher than what it was for Heparin in 2007, or
•(c) lower than what it was for Heparin in 2007
What is the likelihood, in
the US, of detecting a
less toxic contaminant
or an or sub‐potent
formulation?
•(a) USP test for Heparin were not designed to test this particular contaminant
•(b) The QC labs involved did not know how to test the samples
•(c) QC lab was manipulating the data
Why do you think testing
did not detect the
contaminant?
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Why – the reminder -Heparin tragedy (2007-2008)
When the drug safety system fails, people get sick. Some die… Congressman Shimkus (Illinois)
• Some of these people are already very vulnerable, and proving the cause of harm from impurities, adulteration, and counterfeits can be elusive.
It is hard to detect harm
• Certainly the companies are obligated to ensure a culture of quality and maintain vigilance as well. This reflects a systems approach to safety.
FDA inspectors look for a culture of quality at
manufacturing facilities.
• FDA policies led to the failure to inspect the Chinese plant.
This system approach wasn't at play here.
• While it doesn't deny the counterfeit source, tries to say that counterfeits didn't cause the reaction, as if the adulteration itself was no big deal.
This brings me to China and its quality culture or
lack thereof.
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https://house.resource.org/110/org.c-span.205093-1.raw.txt
21 CFR PART 211: SUBPARTS
Why a combination of deviations can signal a serious need to strengthen Culture of Quality – for example…..
• GENERAL PROVISIONSA
• ORGANIZATION AND PERSONNELB
• BUILDINGS AND FACILITIESC
• EQUIPMENTD
• CONTROL OF COMPONENTS AND DRUG PRODUCT CONTAINERS AND CLOSURESE
• PRODUCTION AND PROCESS CONTROLSF
• PACKAGING AND LABELING CONTROLG
• HOLDING AND DISTRIBUTIONH
• LABORATORY CONTROLSI
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Culture of Quality:
Environment that facilitates individuals to guide their behavior to work in the interest of patients and to continually improve this ability.
An organization is a complex system which makes many thousands of decisions each day – writing a SOP for each decision is not always practical.
A systems approach to quality is essential!
It should recognize that the weakest link in the system is often human fallibility –variable capacity to act consciously – when no one is looking.
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Going beyond rules pays..
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How to Connect?
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.
System 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 behavior: Connecting the Dots; With the Right Connectors
GXPs – rational behaviors
How proactive compliance is achieved? X, Y, Z
Quality Management System
What makes a QMS reliable? A, B, C, D
Culture of Quality
Why people change their behavior: 1, 2, 3
Human Behaviors Beyond GXPs
Predictors of Culture of Quality
Why, What, and How of Culture of Quality?
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‘Connecting the Dots’ helps to communicate
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Behaviors beyond
GXPs
I
II
III
IV
Culture of Quality
1
2
3
QMS
A
B
C
D
Behavior -GXPs
X
Y
Z
Creating a Culture of Quality: Financial incentives don’t reduce errors. Employees must be passionate about eliminating mistakes.
Ashwin Srinivasan and Bryan Kurey. Harvard Business Review, April 2014.
Only four attributes
actually predict a culture of
quality:
Leadership Emphasis
Message Credibility
Peer Involvement
Employee Empowerment
People will change their
behavior if they see the new behavior as
Normal (1)
Rewarding (2)
Easy (3)
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Act consciously in the interest of patients – when no one is looking.
Culture of Quality
Consciously – by design:Scientific Methodology,Engineering Design, orPlan-Do-Check-Act
Interest of Patients: Regulatory commitments +
Act consciously in the interest of
patients –specially when no
one is looking.
(1) It is Normal to Do
(2) It is Rewarding (satisfaction)
(3) It is Easy to Do
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Leadership Emphasis
Message Credibility
Peer Involvement
Employee EmpowermentEnvironment
Quality Management System
Any Body Can Dance
Culture of Quality
1. Normal
2. Rewarding
3. Easy
QMS
A
B
C
D
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Leadership Emphasis
Message Credibility
Peer Involvement
Employee EmpowermentEnvironment
Deming's System of Profound Knowledge + James Reason’s Swiss Cheese Model
A, B, C, D
Deming's System of Profound Knowledge + James Reason’s Swiss Cheese Model
Training to ensure Any Body Can Dance
• Appreciation for System
• Organization viewed as a system; an orchestra
A.
• Theory of Knowledge
• Without theory – there is no learning; Asking the right questions; Plan-Do-Check-Act
B.
• Knowledge of Variation
• Common cause and special cause variability; control charts
C.
• Human behavior (pride/satisfaction + conscious/subconscious biases)
• System support and safe guards; system for error management
D.
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CoQ to QMS to GXP Behaviors
Facilitating error detection and correction.
C. van Dyck. Putting errors to good use : error management culture in organizations (2000). http://dare.uva.nl/document/83803
CoQ
1
2
3
QMS
A
B
C
D
GXP Behaviors
X
Y
X
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Message Credibility
Peer Involvement
Employee EmpowermentEnvironment Leadership
Emphasis
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.
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?
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Picture purchased from www.pixtastock.com
X, Y, Z
C. van Dyck. Putting errors to good use : error management culture in organizations (2000). http://dare.uva.nl/document/83803
X. Fear of Errors (reduce)
Error strain -
Covering up
Y. Mastery Orientation
Communicating
Analyzing errors
Error correction
Learning from errors to QbD/RFT
Z. Awareness
Anticipation
Risk-taking
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Reduce Fear of Errors (C. van Dyck. 2000)
Error strain
In general, people feel embarrassed after making a mistake.
If an error occurs, people get upset and irritated.
If an error is reported it becomes a topic of ridicule
In this organization, supervisors feel very aggravated when mistakes are made.
Covering up
Our motto is; “Why admit an error when no one will find out?”
It can be harmful to make your errors known to others.
Employees that own up to their errors are asking for trouble.
People in this organization prefer to keep their errors to themselves.
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Mastery orientation(C. van Dyck. 2000)
Communication
When someone makes an error, (s)he shares it with others so that they won’t make the same mistake.
When people are unable to correct an error, they turn to their colleagues.
If people are unable to continue their work after an error, they can rely on others.
When people do something wrong they can ask others for advice on how to continue.
Analyzing error
After making a mistake, people try to analyze what caused it.
In this organization, people think a lot about how errors could have been avoided.
After an error people think through how to correct it.
Our errors point us to what we can improve.
In mastering a task, people can learn a lot from their mistakes
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Mastery orientation(C. van Dyck. 2000)
Learning from errors
Our errors point us to what we can improve.
In mastering a task, people can learn a lot from their mistakes.
An error provides important information for the continuation of the work
When a error occurs we use the learning to improve the work process.
Error correction
When an error has occurred we usually know how to rectify it.
When an error is made, it is corrected right away.
If an error is restorable, we usually know how to do it.
Although we make mistakes, we don’t let go of the final goal.
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Awareness (C. van Dyck. 2000)
Anticipation
It is very likely that people will make errors in the process of mastering their task.
When people start to work on something, they are aware that mistakes can occur.
In this organization, we take into account that things will go wrong from time to time.
Risk taking
For an organization to achieve something, it has to risk the occurrence of errors.
To get better in what we do, we don’t mind that something can go wrong in the process.
It’s fine to risk an error every once in a while.
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Expect it to fail and build safeguards
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Team member support
Technological safeguardsGood DesignNormal
EasyRewarding
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Reduce Fear of Errors
Error strain
Covering up
Awareness
Anticipation
Risk taking
Mastery orientation
QbD/RFT
Error detection
Communication
Analyzing errors
Correction
Maturity & Responsibility
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Richard L. Friedman, M.S. Management Oversight and Lifecycle Quality Assurance. FDLI Workshop, Washington DC, 14-15 July, 2014
Connecting the Dots and Communicating Effectively
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Culture of
Quality
Normal
Rewarding
Easy
QMS
System
Knowledge
Variation
Behavior
Behavior - GXPs
Fear Removed
Mastery
Awareness
Why Quality by Design is the foundation of Culture of Quality
Summary
We do our best to develop products that meet the needs of patients – we develop our products consciously – this is our QbD.
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
procedures.
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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