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

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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

  • PharmaceuticalCultureofQuality, AssuranceofDataIntegrity&Qualityby Design:ConnectingtheDots [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
  • 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 SystemsApproach to cGMP, ICH 7, 8, 9, 10, and 11. 8/1/2014 Ajaz S. Hussain | INSIGHT, ADVICE & SOLUTIONS LLC 2
  • TheGoldSheet March 2014 Cox:Confronting Illusions ofQuality in IndianGenerics 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 8/1/2014 Ajaz S. Hussain | INSIGHT, ADVICE & SOLUTIONS LLC 3 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 -thisismy personaljourneytoseeifIcan 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 theres 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 FDAs 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 8/1/2014 Ajaz S. Hussain | INSIGHT, ADVICE & SOLUTIONS LLC 6
  • 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 8/1/2014 Ajaz S. Hussain | INSIGHT, ADVICE & SOLUTIONS LLC 7 Scientific methodology Engineering Design Plan-Do-Check-Act Consciously 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 8/1/2014 Ajaz S. Hussain | INSIGHT, ADVICE & SOLUTIONS LLC 8
  • KahnemanandTversky,the firstresearcherstoidentify andrigorouslystudy cognitivebiases,provedthat asimpleversionofexpected utilitytheorydidnot accuratelydescribehuman behavior.Theirresponsewas todevelopprospecttheory,a modelofhowpeoplereally makedecisions. 8/1/2014 Ajaz S. Hussain | INSIGHT, ADVICE & SOLUTIONS LLC 9 Daniel Kahneman, Nobel Prize 2002 KAHNEMAN, Daniel, and AmosTVERSKY, 1979. Prospect Theory: An Analysis of Decision under Risk. Econometrica, 47 (2), 263292
  • Chemometric, Pharmacometrics & Econometrics AjazS.Hussain.SWISS PHARMA34(2012)Nr.6. 8/1/2014 Ajaz S. Hussain | INSIGHT, ADVICE & SOLUTIONS LLC 10 Chemometrics Econometrics Review & Approval Commercial operations, profitability & availability
  • Two products Medicineand 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 8/1/2014 Ajaz S. Hussain | INSIGHT, ADVICE & SOLUTIONS LLC 11
  • FDACDER Challenges & Changes FDAsSternWarningOnDataIntegrity (ThePinkSheets,21July2014) If the agencys 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. Thenew(proposed)Officeof PharmaceuticalQuality,CDER,FDA One QualityVoice;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/CDERsOffice of PharmaceuticalQualityhttp://www.fda.gov/downloads/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/UCM404568.pdf 8/1/2014 Ajaz S. Hussain | INSIGHT, ADVICE & SOLUTIONS LLC 12
  • 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 cGMPCompliance & Inspection Life-cycle approach to process validation Continued process verification and statistical confidence cGMP remediation in response to 483 orWL Life-cycle approach to error management Quality Metrics & Culture of Quality 8/1/2014 Ajaz S. Hussain | INSIGHT, ADVICE & SOLUTIONS LLC 13
  • What does it take to come out of the cGMP crisis? 8/1/2014 Ajaz S. Hussain | INSIGHT, ADVICE & SOLUTIONS LLC 14 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 8/1/2014 Ajaz S. Hussain | INSIGHT, ADVICE & SOLUTIONS LLC 15 Evidence/ Data Claim(s) Warrants Evidence/Data Claims
  • Let one who wants to move and convince others, first be convinced and moved themselves. ThomasCarlyle How do we communicate Culture of Quality Within the organization? In response to 483s andWL? 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? 8/1/2014 Ajaz S. Hussain | INSIGHT, ADVICE & SOLUTIONS LLC 16
  • Data integrity deviant behaviors AliciaM.Mozzachio,RPh,MPH ,July15, 2014,FDLI,Washington,DC Not recording activities contemporaneously Backdating Fabricating data Copying existing data as new data Re-running samples Discarding data 8/1/2014 Ajaz S. Hussain | INSIGHT, ADVICE & SOLUTIONS LLC 17
  • It may take more than a letter to resolve this issue CarmeloRosa,Psy.D.; Director-DIDQ, CDER/OC/OMPQ,July15,2014(FDLI) WL in 2013 + 31% WL in 2014 (7/14/14) + 92% Assurance of Data Integrity ? 8/1/2014 Ajaz S. Hussain | INSIGHT, ADVICE & SOLUTIONS LLC 18 A keystone
  • Blaming failure on a Nations 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 Nations] culture is the ultimate cop-out, Columbia University professor Gerald Curtis wrote in the FinancialTimes. If that is Japanese culture, then we are all Japanese. Is there a culture of error management - where theres 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. 8/1/2014 Ajaz S. Hussain | INSIGHT, ADVICE & SOLUTIONS LLC 19 http://mbs.edu/mbshub/Pages/Article/How_Fatal_is_your_firms_Error_culture.aspx
  • Quality is everyone's responsibility. Learning isnot compulsory...neither is survival. Ittakesyears,plusa degree oferosion of confidence in oursystem, toresolve cGMP issues. 8/1/2014 Ajaz S. Hussain | INSIGHT, ADVICE & SOLUTIONS LLC 20 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.EdwardDeming,MIT Press(2000) 8/1/2014 Ajaz S. Hussain | INSIGHT, ADVICE & SOLUTIONS LLC 21 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
  • Wecannotchange thehumancondition. Butwecan change theconditionsunder whichhumanswork JamesReason J. Reason. Human error: models and management. BMJ. Mar 18, 2000; 320: 768 770 8/1/2014 Ajaz S. Hussain | INSIGHT, ADVICE & SOLUTIONS LLC 22 Organization (Policies & Sr. Mgmt.) Technology (Constraints & Controls) Individual (Training & Certification) Team & Supervisor (Soft Defenses) Defenses (Quality Management System) Error Latent 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 8/1/2014 Ajaz S. Hussain | INSIGHT, ADVICE & SOLUTIONS LLC 23 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 483s .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. 8/1/2014 Ajaz S. Hussain | INSIGHT, ADVICE & SOLUTIONS LLC 24 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? 8/1/2014 Ajaz S. Hussain | INSIGHT, ADVICE & SOLUTIONS LLC 25 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) 8/1/2014 Ajaz S. Hussain | INSIGHT, ADVICE & SOLUTIONS LLC 26 Attitude towards the behavior Subjective norm Perceived behavioral control Intention Future 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. Past Behavior
  • At the individual level, inQC function how often does this occur? Ingenerallowempowerment isasignificantchallenge (low perceivedbehavioral control); plustherearereasonsto rationalize. 8/1/2014 Ajaz S. Hussain | INSIGHT, ADVICE & SOLUTIONS LLC 27 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? USCongressHearingApril2008 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. 8/1/2014 Ajaz S. Hussain | INSIGHT, ADVICE & SOLUTIONS LLC 28 https://house.resource.org/110/org.c-span.205093-1.raw.txt
  • Understanding - Why cGMPs are critical? Detection&QClimitations Testing/Pharmacovigilence FDA reports 149 deaths with allergic or hypersensitivity symptoms during that period Contaminated heparin from China QCTesting 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) Dont 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 subpotent 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? 8/1/2014 Ajaz S. Hussain | INSIGHT, ADVICE & SOLUTIONS LLC 29
  • Why the reminder - Heparin tragedy (2007-2008) Whenthe drugsafety system fails,people get sick.Some die CongressmanShimkus (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. 8/1/2014 Ajaz S. Hussain | INSIGHT, ADVICE & SOLUTIONS LLC 30 https://house.resource.org/110/org.c-span.205093-1.raw.txt
  • 21CFR PART 211:SUBPARTS Whyacombinationof deviationscansignala seriousneedtostrengthen CultureofQualityfor example.. GENERAL PROVISIONSA ORGANIZATIONAND PERSONNELB BUILDINGSAND FACILITIESC EQUIPMENTD CONTROLOF COMPONENTSAND DRUG PRODUCT CONTAINERS ANDCLOSURESE PRODUCTION AND PROCESS CONTROLSF PACKAGINGAND LABELING CONTROLG HOLDINGAND DISTRIBUTIONH LABORATORYCONTROLSI 8/1/2014 Ajaz S. Hussain | INSIGHT, ADVICE & SOLUTIONS LLC 31
  • Culture of Quality: Environment that facilitates individuals to guide their behavior to workinthe interest ofpatients andto 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. 8/1/2014 Ajaz S. Hussain | INSIGHT, ADVICE & SOLUTIONS LLC 32
  • Going beyond rules pays.. 8/1/2014 Ajaz S. Hussain | INSIGHT, ADVICE & SOLUTIONS LLC 33
  • 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. 8/1/2014 Ajaz S. Hussain | INSIGHT, ADVICE & SOLUTIONS LLC 34
  • Humanbehavior: Connectingthe Dots;With the RightConnectors 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? 8/1/2014 Ajaz S. Hussain | INSIGHT, ADVICE & SOLUTIONS LLC 35
  • Connecting the Dots helps to communicate 8/1/2014 Ajaz S. Hussain | INSIGHT, ADVICE & SOLUTIONS LLC 36 Behaviors beyond GXPs I II III IV Culture of Quality 1 2 3 QMS A B C D Behavior - GXPs X Y Z
  • Creating aCultureof Quality: Financial incentives dontreduce errors.Employees mustbe passionate abouteliminating mistakes. AshwinSrinivasanand BryanKurey. 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) 8/1/2014 Ajaz S. Hussain | INSIGHT, ADVICE & SOLUTIONS LLC 37 Act consciously in the interest of patients when no one is looking.
  • Culture of Quality Consciouslybydesign: ScientificMethodology, EngineeringDesign,or Plan-Do-Check-Act InterestofPatients: Regulatorycommitments+ 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 8/1/2014 Ajaz S. Hussain | INSIGHT, ADVICE & SOLUTIONS LLC 38 Leadership Emphasis Message Credibility Peer Involvement Employee EmpowermentEnvironment
  • Quality Management System AnyBodyCanDance Culture of Quality 1. Normal 2. Rewarding 3. Easy QMS A B C D 8/1/2014 Ajaz S. Hussain | INSIGHT, ADVICE & SOLUTIONS LLC 39 Leadership Emphasis Message Credibility Peer Involvement Employee EmpowermentEnvironment Deming's System of Profound Knowledge + James Reasons Swiss Cheese Model
  • A, B,C, D Deming'sSystemof ProfoundKnowledge+ JamesReasonsSwiss CheeseModel TrainingtoensureAnyBody CanDance 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 ofVariation 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. 8/1/2014 Ajaz S. Hussain | INSIGHT, ADVICE & SOLUTIONS LLC 40
  • CoQ to QMS toGXP Behaviors Facilitatingerrordetection andcorrection. C.vanDyck.Puttingerrors togooduse:error managementculturein organizations(2000). http://dare.uva.nl/document/83803 CoQ 1 2 3 QMS A B C D GXP Behaviors X Y X 8/1/2014 Ajaz S. Hussain | INSIGHT, ADVICE & SOLUTIONS LLC 41 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 Management 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? 8/1/2014 Ajaz S. Hussain | INSIGHT, ADVICE & SOLUTIONS LLC 42 Picture purchased from www.pixtastock.com
  • X,Y,Z C.vanDyck.Puttingerrorsto gooduse:errormanagement cultureinorganizations(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 8/1/2014 Ajaz S. Hussain | INSIGHT, ADVICE & SOLUTIONS LLC 43
  • Reduce Fear of Errors (C.vanDyck.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. 8/1/2014 Ajaz S. Hussain | INSIGHT, ADVICE & SOLUTIONS LLC 44
  • Mastery orientation (C.vanDyck.2000) Communication When someone makes an error, (s)he shares it with others so that they wont 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 8/1/2014 Ajaz S. Hussain | INSIGHT, ADVICE & SOLUTIONS LLC 45
  • Mastery orientation (C.vanDyck.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 dont let go of the final goal. 8/1/2014 Ajaz S. Hussain | INSIGHT, ADVICE & SOLUTIONS LLC 46
  • Awareness (C.vanDyck.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 dont mind that something can go wrong in the process. Its fine to risk an error every once in a while. 8/1/2014 Ajaz S. Hussain | INSIGHT, ADVICE & SOLUTIONS LLC 47
  • Expect it to fail and build safeguards 8/1/2014 Ajaz S. Hussain | INSIGHT, ADVICE & SOLUTIONS LLC 48 Team member support Technological safeguardsGood Design Normal Easy Rewarding
  • 8/1/2014 Ajaz S. Hussain | INSIGHT, ADVICE & SOLUTIONS LLC 49 Reduce Fear of Errors Error strain Covering up Awareness Anticipation Risk taking Mastery orientation QbD/RFT Error detection Communication Analyzing errors Correction
  • Maturity & Responsibility 8/1/2014 Ajaz S. Hussain | INSIGHT, ADVICE & SOLUTIONS LLC 50 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 8/1/2014 Ajaz S. Hussain | INSIGHT, ADVICE & SOLUTIONS LLC 51 Culture of Quality Normal Rewarding Easy QMS System Knowledge Variation Behavior Behavior - GXPs Fear Removed Mastery Awareness
  • WhyQuality 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. 8/1/2014 Ajaz S. Hussain | INSIGHT, ADVICE & SOLUTIONS LLC 52