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Culture of Quality Bagladesh AAPS 8 August 2015 Final

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Why we are discussing Culture of Quality?
What is Culture of Quality?
How can it help?

The American public is facing unprecedented drug shortages and recalls (erosion of confidence)

Industry and the FDA have the shared obligation to reduce quality errors …

To fulfill this responsibility, both industry and the FDA need a culture of quality.

Published in: Business
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Culture of Quality Bagladesh AAPS 8 August 2015 Final

  1. 1. Culture of Pharmaceutical Quality: What, Why, How? AABPS Convention 2015 Philadelphia Marriott Downtown, Philadelphia, Pennsylvania Saturday, August 8, 2015 ajaz@ajazhussain.com 8/9/2015 © Ajaz S. Hussain Insight Advice & Solutions LLC 1
  2. 2. Thanks for this kind invitation to share some thoughts about Culture of Quality 8/9/2015 © Ajaz S. Hussain Insight Advice & Solutions LLC 2 Environment Organizations Cultures Systems FDA AABPS NovartisGSK Merck Others Today @ Philadelphia Marriott Downtown
  3. 3. Outline What is Culture of Quality? Why we are discussing Culture of Quality? How can it help? 8/9/2015 © Ajaz S. Hussain Insight Advice & Solutions LLC 3
  4. 4. What is Pharmaceutical Quality? ‘I know is when I see it’ • FDA approval & acceptable compliance status 8/9/2015 © Ajaz S. Hussain Insight Advice & Solutions LLC 4
  5. 5. Legal enforcement 8/9/2015 © Ajaz S. Hussain Insight Advice & Solutions LLC 5 Why do we regulate? Pharmaceuticals exhibit market failures that can have devastating consequences What do we regulate? Human behavior How do we regulate? Laws, regulations, policies, review, inspections, criminal prosecutions,… Who are the regulators? All of us, not just the FDA What is the foundation for modern regulations? Scientific evidence and compliance with regulations and ‘Good Practices’
  6. 6. Medicine _ Evidence Better than Placebo Double-blind Randomized Placebo-controlled Clinical Trials - long history of being the standard • Placebo effects are genuine psychobiological events; can be robust in both laboratory and clinical settings. The Lancet, February 2010. • In clinical trials minimize the placebo effect; following approval, in clinical use, it should be maximized by harnessing patients' expectations and learning mechanisms to improve treatment outcomes. Nature Reviews Drug Discovery March 2013 Note – blinding for clinicians and other professionals involved is to minimize errors/scientific misconduct • Reminder of one thing that is sometimes forgotten. Scientists are human, too. (Misconduct in science. An array of errors. September 2011) Without integrity of evidence there is no medicine (quality, safety and efficacy) Blinding is one tool to safeguard against observer bias. We must guard against many such biases. Scientific methodology, Good Practices & [Management] Systems approach are a part of Culture of Pharmaceutical Quality. 8/9/2015 © Ajaz S. Hussain Insight Advice & Solutions LLC 6
  7. 7. Why we are now discussing Culture of Quality? Journey to improve current practices .. To reduce errors 8/9/2015 © Ajaz S. Hussain Insight Advice & Solutions LLC 7 To fulfill this responsibility, both industry and the FDA need a culture of quality. Industry and the FDA have the shared obligation to reduce quality errors … The American public is facing unprecedented drug shortages and recalls (erosion of confidence) Lawrence X. Yu, Ph.D
  8. 8. To reduce errors Irrational Behaviors 8/9/2015 © Ajaz S. Hussain Insight Advice & Solutions LLC 8 Increasing • Uncertainty • Complexity • Placebo effect Decreasing • Affordability • Availability • Confidence ? ? Purchased at http://www.jantoo.com/download/255350/web/03130525.jpg
  9. 9. For example…. Current Challenge Increasing number of manufacturers in India, China and elsewhere observed to be non-compliant. ‘Breaches in data integrity’ (BDI) is among the most serious observation. This is a global issue – not about India or China; but local norms need to be considered for effective correction and prevention.. 8/9/2015 © Ajaz S. Hussain Insight Advice & Solutions LLC 9 Data Integrity Key to GMP Compliance September 2014 FDA Bans Drugs Made by Indian Manufacturer Over GMP Problems January 2015 Data Integrity: The Whole Story
  10. 10. 8/9/2015 © Ajaz S. Hussain Insight Advice & Solutions LLC 10 Trends: Lab & Manufacturing “Deletion of Data” “Testing Into Compliance” “BMR manipulation is a slippery slope” “Suggestive of faulty manufacturing process or practices, even if this is not the case” “It is top management’s responsibility to ensure the training program is robust and effective!” Recent inspectional trends (Bangalore, Nov 13 2014 - Nov 14 2014) Growing concern @ some companies “data looks too good to be true” Ajaz S. Hussain. [‘Excipient’] Knowledge Management: 2015 & Beyond
  11. 11. Patterns suggestive of ‘intentional holes’ 8/9/2015 © Ajaz S. Hussain Insight Advice & Solutions LLC 11 “….records 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….” Each additional observation adds reasons to confirm that this is very likely a system with intentional ‘holes’ in its defenses.
  12. 12. Risk of unintended or intended normative support for ‘testing into compliance’? attitude toward performin g the behavior Process validation is done so quality is good; test prone to error “Batch failure means I made a mistake” subjective norm Documents not critical; Compendial testing sufficient Local regulators collect & test samples – no issue there! 8/9/2015 © Ajaz S. Hussain Insight Advice & Solutions LLC 12 “Testing into compliance”
  13. 13. Why a need to emphasize Culture of Quality? In an organization errors are detected reported/escalated without fear; i.e., error detection, correction and prevention is normal, easy and rewarding. We have to constantly work to ensure there is a comprehensive and consistent understanding of what pharmaceutical quality is across all functions and levels – ‘blind-spots’ and/or incomplete understanding contributes to errors, non-compliance and protracted/uncertain remediation? Although we have made progress on Quality by Design, Life Cycle Approach to Method and Process Validation, and in adopting a Systems approach to Quality Assurance – we still have more work to do to achieve an effective and integrated implementation 8/9/2015 © Ajaz S. Hussain Insight Advice & Solutions LLC 13
  14. 14. 8/9/2015 © Ajaz S. Hussain Insight Advice & Solutions LLC 14 Questions? • What are few examples of ‘blind-spots’? • Please see: http://www.slideshare.net/a2zpharmsci/product- quality-patient-safety-usp-workshop-mumbai-12-june-2015 • How does ‘blind-spots’ and incomplete understanding contributes to errors, non-compliance and protracted/uncertain remediation? • This insight and advice is not free 
  15. 15. How to describe/define a Culture of Pharmaceutical Quality? It should help us understand and inform on how people behave – specifically misbehave - in an pharmaceutical organization – specifically when making and executing decisions on quality • Culture is dynamic, emergent properties based on interactions (within and outside the organization) -it, ideally is an open system with feedback-loops • Is it a sub-system of an Organizational Culture? 8/9/2015 © Ajaz S. Hussain Insight Advice & Solutions LLC 15
  16. 16. 8/9/2015 © Ajaz S. Hussain Insight Advice & Solutions LLC 16 Being human means….. “we can be blind to the obvious, and we are also blind to our blindness.” We like to think of ourselves as rational in our decision making, the truth is we are subject to many biases. We are predictably irrational. Daniel Kahneman, Thinking, Fast and Slow http://web.mit.edu/persci/people/adelson/checkershadow_proof.html
  17. 17. Cognitive biases • The way you feel filters the way you interpret the worldAffect heuristic • People are over-reliant on the first piece of information they hearAnchoring bias • We tend to listen only to the information that confirms our preconceptionsConfirmation bias • Failing to recognize your cognitive biases is a bias in itselfBias blind spots • When you choose something, you tend to feel positive about it, even if the choice has flaws.Choice-supportive bias • Tendency to see patterns in random eventsClustering illusion • Overestimate the importance of information that is available to themAvailability heuristic • Where a word, name or thing you just learned about suddenly appears everywhereFrequency illusion • The tendency for people to want an immediate payoff rather than a larger gain later on.Hyperbolic discounting: 8/9/2015 © Ajaz S. Hussain Insight Advice & Solutions LLC 17
  18. 18. 8/9/2015 © Ajaz S. Hussain Insight Advice & Solutions LLC 18 1 Fast Practice Practice Practice Develop Good Habits Overshadow Bad Habits Awareness of Biases 2 Slow Daniel Kahneman, Thinking, Fast and Slow The largely subconscious System 1 makes intuitive snap judgments based on emotion, memory, and hard- wired rules of thumb. The conscious System 2 laboriously checks the facts and does the math, but is so "lazy" and distractible that it usually defers to System 1. Facts, Knowledge, Logic Training, Assessment, Scientific methodology Plan-do-check-act
  19. 19. Pre-conditions for malice or disregard 8/9/2015 © Ajaz S. Hussain Insight Advice & Solutions LLC 19 Rationalization & Attitude Pressure & Incentive Opportunity – ‘holes in the QMS” Most individuals, operating on their own and given the opportunity, will cheat—but just a little bit, all the while indulging in rationalization that allows them to live with themselves. The Honest Truth about Dishonesty: How We Lie to Everyone-- Especially Ourselves. Dan Ariely, (2012). HarperCollins Publishers.
  20. 20. What is Organizational Culture? • Organizational culture is a system of shared assumptions, values, and beliefs, which governs how people behave in organizations*. • These shared values (unwritten rule) have a strong influence on the people in the organization and dictate how they dress, act, and perform their jobs. 8/9/2015 © Ajaz S. Hussain Insight Advice & Solutions LLC 20 * Please note source/reference is hyperlinked. Also see a useful video available here.
  21. 21. Causal chain: From Antecedents to Culture through to Outcomes 8/9/2015 © Ajaz S. Hussain Insight Advice & Solutions LLC 21 Antecedents Structure System Technology Skills Constructive norms Passive/ Defensive norms Aggressive/ Defensive norms Individual Outcomes Role clarity Communication Quality “Fit” in organization Behavior conformity Job satisfaction Organizational Outcomes Quality of products/services Commitment- customer satisfaction Adaptability Turnover Quality of workplace Know-how management *Pierre A. Balthazard, Robert A. Cooke, Richard E. Potter, (2006) "Dysfunctional culture, dysfunctional organization: Capturing the behavioral norms that form organizational culture and drive performance", Journal of Managerial Psychology, Vol. 21 Iss: 8, pp.709 - 732 Constructive norms – ‘emphasize quality over quantity’, ‘good human relations skills’, ‘help others to grow and develop’ Defensive/Passive norms – ‘do what is expected’, ‘switch to please others’ Defensive/Aggressive: ‘look for mistakes’, ‘turn job into contest’, ‘authority of position’
  22. 22. Organizational Culture, Good or Bad? What can we learn from cases of “Organizations Gone Wild”?* Normative support for misconduct can occur in three main ways: Endorse it with varying degrees of explicitness (e.g., ADM) “Techniques of neutralization”; or a basis for rationalization (e.g., SB) Place a high value on achieving extraordinary performance (e.g., Enron) 1 2 3 *HENRICH R. GREVE, DONALD PALMER, and JO-ELLEN POZNER. Organizations Gone Wild: The Causes, Processes, and Consequences of Organizational Misconduct. The Academy of Management Annals Vol. 4, No. 1, (2010), 53–107 Also see: A Demon of Our Own Design QMS 8/9/2015 © Ajaz S. Hussain Insight Advice & Solutions LLC 22
  23. 23. QC Staff (junior) behavioral norms are ‘passive – defensive’ [e.g., approval seeking)* QC Staff person - Passive Intention –behavior Doing Good, Being Good, or Looking Good ‘Good‘ as judged within an organization 8/9/2015 © Ajaz S. Hussain Insight Advice & Solutions LLC 23 QC Supervisor – Constructive, Passive or Aggressive
  24. 24. How would you respond to this statement? 15.21 9.9 14.1 17.5 43.4 At many Pharma companies [in India] the staff would feel afraid to question a supervisor’s order even when they know for sure that the supervisor’s order is not in the interest of patients. 8/9/2015 © Ajaz S. Hussain Insight Advice & Solutions LLC 24 I disagree with this statement I completely agree with this statement N=263 Skipped = 0
  25. 25. How would you respond to this statement? I think management should urgently work towards making error/mistake reporting Normal, Easy and Rewarding. 5.8 6.6 17.4 32.8 31.54 8/9/2015 © Ajaz S. Hussain Insight Advice & Solutions LLC 25 It is already easy – so this is not urgent. It is very difficult currently so this is very urgent topic N=259 Skipped =4
  26. 26. 8/9/2015 © Ajaz S. Hussain Insight Advice & Solutions LLC 26 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 “WE CANNOT CHANGE THE HUMAN CONDITION. BUT…WE CAN CHANGE THE CONDITIONS UNDER WHICH HUMANS WORK” JAMES REASON
  27. 27. Without fear, giving a full-hearted team performance We are scientists, pharmacist, engineers, physicians and managers; trained to be good practitioners of methodologies developed within our disciplines We work in teams, to integrate our knowledge and aligning our methodologies, for developing medicines and the evidence we must provide to satisfy the needs of patients We recognize that nothing is perfect and there will be some errors in our design, systems, and procedures, and 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 our mistakes In doing so we work consciously in the interest of patients, even when no one is looking – and this describes our Culture of Quality! 8/9/2015 © Ajaz S. Hussain Insight Advice & Solutions LLC 27 What is Culture of Quality?
  28. 28. 8/9/2015 © Ajaz S. Hussain Insight Advice & Solutions LLC 28 Culture of Quality Normal Easy Rewarding QMS System Knowledge Variation Behavior Behavior - GXPs Fear Removed Mastery Awareness Environment Leadership Emphasis Message Credibility Peer Involvement Employee Empowerment Connect to CoQ Connect to GXPs A Framework and a Tool (for gap analysis)
  29. 29.  Systems thinking: System is the product of interacting parts; improving the parts taken separately will not improve the system CEO & Sr. Management Culture of Quality Managers & Leaders Effective QMS GXP Compliance All Employees Quality is Easy 8/9/2015 © Ajaz S. Hussain Insight Advice & Solutions LLC 29
  30. 30. Going beyond rules pays.. 8/9/2015 © Ajaz S. Hussain Insight Advice & Solutions LLC 30 How can it help?
  31. 31. Many companies that have a strong culture of quality and they should be recognized 8/9/2015 © Ajaz S. Hussain Insight Advice & Solutions LLC 31 • Lot Acceptance Rate • Product Quality Complaint Rate • Invalidated Out-of-Specification (OOS) Rate • Annual Product Review (APR) or Product Quality Review (PQR) On Time Rate Proposed Quality Metrics • Senior Management Engagement; Was each APR or PQR reviewed and approved by the following: (1) the head of the quality unit, (2) the head of the operations unit; (3) both; or (4) neither? • CAPA Effectiveness; What percentage of your corrective actions involved re- training of personnel (i.e., a root cause of the deviation is lack of adequate training)? • Process Capability/Performance • Establishment’s management calculated a process capability or performance index for each critical quality attribute (CQA) as part of that product’s APR or PQR? • A policy of requiring a corrective action or preventive action (CAPA) at some lower process capability or performance index. What is the process capability or performance index that triggers a CAPA? Importance of quality culture ….proposing… How can it help?
  32. 32. Our journey to improve current practices and system– to more reliably deliver medicine & evidence Process validation + testing First attempt at ‘Quality system’ Quality by design + Quality system (revisited with emphasis on process understanding) Process Validation - emphasis on process understanding & process control) Leveraging integration (CMC & CGMP), OPQ.. Culture of quality, quality metrics,… 8/9/2015 © Ajaz S. Hussain Insight Advice & Solutions LLC 32 July 2015 error detection, correction and prevention is normal, easy and rewarding. This builds confidence and facilitates risk-based oversight Journey to improve current practices ..

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