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
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
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
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