Culture of Quality, Data Integrity, Quality by Design: Connecting the Dots

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Pharmaceutical Culture of Quality, Assurance of Data Integrity & Quality by Design: Connecting the Dots [email protected] 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

description

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. The 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: (1) 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? (2) How do I understand their challenges, perspectives and biases? and (3) 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. .....

Transcript of Culture of Quality, Data Integrity, Quality by Design: Connecting the Dots

Page 1: Culture of Quality, Data Integrity, Quality by Design: Connecting the Dots

Pharmaceutical Culture of Quality, Assurance of Data Integrity & Quality by Design: Connecting the Dots

[email protected]

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

Page 2: Culture of Quality, Data Integrity, Quality by Design: Connecting the Dots

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

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“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

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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?

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Quality by Design

Deming - The journey requires leadership with Profound Knowledge as a guide.

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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?

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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

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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 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

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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

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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

tern

Wa

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g O

n D

ata

Inte

grit

y (T

he

Pin

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

ffic

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P

ha

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l Qua

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CD

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, FD

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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

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Effective format for communication

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Evidence/Data

Claim(s)

Warrants

Evidence/Data

Claims

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“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

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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

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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

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“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

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“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

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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.

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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.

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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

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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

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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?

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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

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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

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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

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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.

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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

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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

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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.

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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?

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Picture purchased from www.pixtastock.com

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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

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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

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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

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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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