Culture of Quality

1. Saturday, October the 10, 2015
Quality, a Lifestyle for Success
Full day workshopHabib University, Karachi
Dr. Iftikhar A. Jafri
Chief Operating Officer, PharmEvo

2. Thanks & References:
Mary Oates, 2012
Global Quality Operation
Pfizer
Guy Villax, 2014,
Pharmaceutical Technology

3. 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

4. Quality Drugs: A Continuous Concern
Quality Culture is the keystone

5. Product
Quality
Product
Efficacy
Patient
Safety
Claim
Promise
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6. SYSTEM
CONTROLS
Ensures every product meets quality standards
Is it enough ???

7. Your decision impacts product quality Uncounted decisions taken daily
Every decision is not supported by SOPs
Complex
manufacturing
environment
Potential
risks

8. Does compliance not guarantee?
Is compliance not enough?
Are System & Controls meaningless?
Is Experience not bullet proof?

9. An environment where every person understands Product
Quality & Patient Safety
Without quality culture, product & public safety cannot be
assured
Single most important indicator to determine the ability of
delivering the quality drugs
Q
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10. 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

11. An eagerness to solve problem
Share learning and drive to RFT
Issues are escalated and resolved
collaborately
CoQ

12. 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

13. Report mistakes fearlessly
Learn from mistakes
Quality is everyone’s responsibility
CoQ

14. Birth of Quality Culture
Does not happen by accident
It has to be created
Relevant process &
control must be in place Understood & Followed

15. Numerous
workarounds
Numerous
waivers
Lack of Control
Please close your eyes
& try to visualize the
operation floor

16. Kindly remember
Quality culture builds on the expertise & processes in
the organization and results in behaviors & decision
making that will result in quality outcome

17. Doing the right things and doing
things right
is valued above cost & speed
Continuous improvement is the
priority resulting in eagerness to
identify & address issues
Must create an environment in which
Culture driven by leadership … Must provide the fundamentals to product quality

18. 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

19. 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

20. 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

21. Particularly, on this basis the business agreement was not
pursued
The potential partner later experienced significant
quality failures
Hypothetical External Example 1

22. 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

23. When combined with existing culture, product quality was assured
The firm worked diligently to improve systems, resulting in
acceptable controls
Hypothetical External Example 2

24. Management must
proclaim the value of
escalating issues &
opening deviation
investigations
Management must help
employees recognize
deviations & implement a
process for effectively
raising them
Management must
establish a monitoring
mechanism and track and
publish metrics
What if Lack of Culture: Symptoms & Actions

25. Management must celebrate an increase in deviations and hold accountable those
who do not bring them forward
Management must ensure that deviation investigations get to true root cause and
define full scope of the issue
What if Lack of Culture: Symptoms & Actions

26. Management must ensure that holistic corrective actions are implemented to
prevent recurrence
Management must reinforce the criticality of continuous improvement
What if Lack of Culture: Symptoms & Actions

27. Its about behaviors, not SOPs
• Without a strong quality culture,
risks to product quality cannot be
fully mitigated
Criticality of Quality Culture

28. 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

29. 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 Culture

30. 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

31. 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

32. Quality Pyramid based on safety

33. Resource & System Maturity
1 • An expedited compliant 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

34. 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

35. 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

36. 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

37. 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

38. 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

39. Keep walking & talking on…
Respect values
Come out from fear to report
Celebrate mistakes
Be knowledgeable
Understand your product & process
Closing words
Thank you of your attention