Culture of Quality - Part IV (Updated & Reproduced) 03 Aug-2019
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1. The document discusses the importance of creating and maintaining a culture of quality in pharmaceutical manufacturing. It outlines several key aspects of a quality culture, including a focus on continuous improvement, willingness to identify and address issues, and an understanding that quality is everyone's responsibility. 2. Maintaining a quality culture requires leadership commitment to reinforce the right behaviors and decision making. Quality culture can deteriorate quickly if management loses focus on it or faces pressures like cost reductions. Early indicators of issues need to be addressed immediately. 3. The document provides examples of metrics that can help measure quality culture, such as the number of reported deviations, complaints, and process failures. A strong quality culture helps ensure product quality is not compromised
Culture of Quality - Part IV (Updated & Reproduced) 03 Aug-2019
- 1. Creating a Sustainable Culture of Quality Roohi B. Obaid 03 Aug 2019 (Part – IV)
- 2. 1 Quality of Product & Safety of Consumer 2Birth of Quality Culture 5 Quality Culture Indicators 6Closing Words 3 Criticality of Quality Culture 4Maintaining Quality Culture
- 3. Quality Drugs: A Continuous Concern Quality Culture is the keystone Quality of Product & Safety of Consumer1
- 4. Claim
- 9. SYSTEM CONTROLS Ensures every product meets quality standards
- 10. SYSTEM CONTROLS Ensures every product meets quality standards Is it enough ???
- 12. Uncounted decisions taken daily
- 13. Your decision impacts product quality Uncounted decisions taken daily
- 14. Your decision impacts product quality Uncounted decisions taken daily Complex manufacturing environment Potential risks
- 15. Your decision impacts product quality Uncounted decisions taken daily Complex manufacturing environment Potential risks Every decision is not supported by SOPs Remember
- 17. Is compliance not enough?
- 18. Does compliance not guarantee? Is compliance not enough?
- 19. Does compliance not guarantee? Is compliance not enough? Are System & Controls meaningless?
- 20. Does compliance not guarantee? Is compliance not enough? Are System & Controls meaningless? Is Experience not bullet proof?
- 21. An environment where every person understands Product Quality & Patient Safety Quality Culture
- 22. Without quality culture, product & public safety cannot be assured Quality Culture
- 23. Single most important indicator to determine the ability of delivering the quality drugs Quality Culture
- 24. Quality is built in from the beginning Risk to providing quality medicines are understood & mitigated Performance is monitored in real time & course corrections are made as needed CoQ
- 25. An eagerness to solve problem Share learning and drive to RFT Issues are escalated and resolved collaboratively CoQ
- 26. No pointing of finger or laying blame Difficult decisions are made to do the right things Don’t care about obstacles for right things CoQ
- 27. Report mistakes fearlessly Learn from mistakes Quality is everyone’s responsibility CoQ
- 28. Birth of Quality Culture Does not happen by accident It has to be created Relevant process & control must be in place Understood & Followed 2
- 29. Numerous workarounds Numerous waivers Lack of Control Please close your eyes & try to visualize the operation floor
- 30. Kindly remember Quality Culture builds on the expertise & processes in the organization and results in behaviors & decision making that will result in quality outcome
- 31. Doing the right things and doing things right is valued above …. Continuous improvement is the priority resulting in eagerness to …. Must create an environment in which Culture driven by leadership … Must provide the fundamentals to product quality Cost Speed Identify Address Issues
- 32. Strong management oversight Adequate resources Training of colleagues Maintenance of plant & equipment Focus on continual improvement An organization capable of making right decisions to protect product quality Provide Fundamentals
- 33. Is Quality Culture Measurable? The concept is not new • What’s your inner (gut) feeling whether it exists or not? Challenges of current environment urged to quantitatively evaluate • A semi-quantitative tool was developed that uses data gathered mainly from interviews of employees across all levels in the firm together with observations of operations and review of supporting documentation The tool can be used both internally & externally
- 34. A relationship with a third party was under evaluation Due diligence identified the acceptability of all relevant systems, controls and processes at a potential partner The quality culture assessment identified significant weaknesses Cont’d Hypothetical External Example 1
- 35. Particularly, on this basis the business agreement was not pursued The potential partner later experienced significant quality failures Hypothetical External Example 1
- 36. Open, eager to learn, committed to continuous improvement, management focused on delivery of quality product Systems & controls were inadequate but culture was strong Third party partnership under evaluation Cont’d Hypothetical External Example 2
- 37. When combined with existing culture, product quality was assured The firm worked diligently to improve systems, resulting in acceptable controls Hypothetical External Example 2
- 38. Management must proclaim the value of escalating issues & opening deviation investigations Symptoms and ActionIf lack of CultureWhat
- 39. Management must help employees recognize deviations & implement a process for effectively raising them Symptoms and ActionIf lack of CultureWhat
- 40. Management must establish a monitoring mechanism and track and publish metrics Symptoms and ActionIf lack of CultureWhat
- 41. Management must celebrate an increase in deviations and hold accountable those who do not bring them forward Symptoms and ActionIf lack of CultureWhat
- 42. Management must ensure that deviation investigations get to true root cause and define full scope of the issue Symptoms and ActionIf lack of CultureWhat
- 43. Management must ensure that holistic corrective actions are implemented to prevent recurrence Symptoms and ActionIf lack of CultureWhat
- 44. Management must reinforce the criticality of continuous improvement Symptoms and ActionIf lack of CultureWhat
- 45. Its about behaviors, not SOPs • Without a strong quality culture, risks to product quality cannot be fully mitigated Criticality of Quality Culture 3
- 46. Quality culture cannot be externally imposed and is not introduced only through changes to GMP systems • Quality culture cannot be changed in the near-term but can be lost very quickly if focus on it is lost Criticality of Quality Culture
- 47. Management must be vigilant in keeping the organization focused on the right behaviors and decisions Pressures exist and culture can change quickly if not protected • Supply demands • Supply chain complexity • Cost reduction Maintaining Quality Culture4
- 48. May result in organizational & procedural changes The risk of such changes must be understood and mitigated • Risk assessment tools can be utilized • Assessment may indicate the risk is too great to take • Can be utilized retrospectively Cost Pressures
- 49. May erode quality culture by driving decisions that can adversely affect product quality Early indicators should be in place • Quantitative (e.g. over-due items) • Decision-making at the operational level If early signals indicate potential impact, corrective actions should be implemented immediately Cost Pressures
- 50. Recordable event Near miss At risk behavior Quality Culture/leadership Quality Pyramid based on safety Regulatory body action Notification to Management/ Market Action
- 51. Resource & System Maturity 1 • An expedited complaint becomes overdue 2 • ↑ in number of operator errors/ batch 3 • ↑ in Doc. Errors corrected before lot release 4 • ↑ in # of unplanned quarantine shipments 5 • ↑ in % employee turnover 6 • Relative degree of experience with staff Quality indicators from the Pyramid characterized by key focus area
- 52. Leadership Quality 1 • Leadership drives programs that enhance quality culture, RFT. etc. 2 • % of reported near misses addressed, this means action defined & communicated & colleague rewarded for reporting Quality indicators from the Pyramid characterized by key focus area
- 53. Change Impact 1 • ↑ in number of rejected lots 2 • ↑ in % complaints per units produced 3 • # of capital projects linked to GMP or compliance being delayed 4 • ↓ in process robustness/ capability (% products that have defined capabilities that are tracked Quality indicators from the Pyramid characterized by key focus area
- 54. Regulatory Impact 1 • Self-identified risk areas (Internal Audits)-step back from tactical findings from audits & look more across the board Quality indicators from the Pyramid characterized by key focus area
- 55. Cultural Aspects 1 • ↓ in compliance to training curriculum 2 • ↓ in investigation effectiveness ratio 3 • Feedback loop Quality indicators from the Pyramid characterized by key focus area
- 56. Resource Availability 1 • ↑ in average disposition cycle time 2 • ↓ in % PM completed on time 3 • Minimum staffing requirements met 4 • Staffing per workload unit Quality indicators from the Pyramid characterized by key focus area
- 57. Keep walking & talking on .. Closing words6
- 59. Come out from fear to report Closing words
- 62. Understand your product & process Closing words
- 63. Thanks