Attaining and Sustaining Quality - PQRI– Product Life cycle management ... Manufacturing, Testing,...
Transcript of Attaining and Sustaining Quality - PQRI– Product Life cycle management ... Manufacturing, Testing,...
Quality Affordable Healthcare Products™
Attaining and Sustaining Quality
FDA/PQRI Conference on Evolving Product Quality
September 16, 2014 Louis W. Yu, Ph.D.
Quality Affordable Healthcare Products™
Two Biggest Reasons Why I Am
Passionate About Pharmaceutical Quality
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Generic & OTC Industry Perspective
on Pharmaceutical Quality
Quality is meeting customer requirements
Consumers want drug products to be: – Effective when used as directed
– Safe when used according to labelled indications
– Available when needed
– Cost effective
These requirements are the same regardless of brand, generic & OTC industry sectors:
– Our industry has achieved a high level of quality as viewed from consumers perspectives (SISPQ)
– Some opportunities for continuous improvement when viewed in the context of procedural compliance
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Sustaining Quality & Business Success at Perrigo
127-year legacy of focusing on people –
employees, customers, consumers and
neighbors
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Perrigo Is a High Volume Pharmacuetical
Manufacturer with a Diverse Product
Offering
Facilities
Total:
EU
Middle/
Far East 4 Plants
3 Plants
14 Plants North
America
Semi-Solids
(Rx, OTC)
800 Million Doses
400 Million Doses
100 Million Doses
1.3 Billion Doses
Solid Dose
(Rx, OTC)
42 Billion Tablets
1 Billion Tablets
47 Billion Tablets
4 Billion Tablets
Liquids
(Rx, OTC)
2.3 Billion Doses
500 Million Doses
2.8 Billion Doses
Infant Formula
36 Million Units
36 Million Units
50 Million Doses
23 Total Sites
12 OUS Sites
Over $3.5 Billion in Sales Over 10,000
employees
Markets over 3,000 products/18,000 SKUs 5 Quality Affordable Healthcare Products™
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Perrigo’s Impact on Customers
Globally, Perrigo saves consumers more than $7.5
billion each year
$1 Savings for
every person in
the world !
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Every second of every day,
somewhere in the world,
nearly 1,600 people will
use a Perrigo product
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Core Values & Five Pillars Form the Foundations of Our
Strategy to Attain & Sustain Quality & Business Growth
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Quality Drives Sustained Growth
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Keep Existing
Customers
Gain New Customers
Sustained Organic & Inorganic Growth
Our Customers:
users of our products, our regulators and our shareholders
Compliance: Total Quality Approach
• Quality is everyone’s responsibility
• Meeting customers requirements means doing things right the first time in everything we do
• When we do things right the first time, quality is free
• If we don’t get right the first time, we must learn and do it right the second time – this means learning to make quality certain.
Effectiveness for the Users of Our Products
Efficiency for the
Shareholders
Compliance for our
Regulators
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A Culture of Quality & Continuous Improvement
Everyone in our
organization must focus
on continuous
improvement, to enable
a robust quality culture
We must win the loyalty
of our customers and
reduce the cost of poor
quality and cost of
nonconformance
Management
understanding and
leadership is key to
model behaviors to
align, enable and help
colleagues improve
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Strategies to Attain & Sustain Quality
• Quality Risk Management
– Product & customer safety as highest priority
– Manage constantly evolving quality and compliance expectations
• Process Excellence
Meet quality and compliance expectations
Life Cycle Approach to Validation – use statistics to track & trend Ppk during PPQ/CPV stages
A continuous improvement quality culture – RFT focus
• Built in Product Quality
Full product life cycle quality-by-design
Quality into supply chain
• Innovation & Growth
Speed to market, flexibility and agility while maintaining consistent product quality and compliance
Incorporate a global, integrated manufacturing and supply chain to comply with regulatory and
corporate standards
• Human Capital Enhancement
A scalable organizational structure to support product lifecycle and organic/inorganic global growth
Processes and mechanisms to foster a learning organization & quality culture
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Quality Capability Building Blocks
To Attain and Sustain Quality
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Organizational Culture Smart & healthy; Continuous improvement learning organization
Governance
Employee Engagement
& Enablement
Quality Systems
Robustness
Fit For Purpose
(Facility, workforce, product mix, process,
equipment, technology, capacity,
complexity)
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Fit For Purpose
Organizational Culture Smart & healthy; Continuous improvement learning organization
Governance
Employee Engagement
& Enablement
Quality Systems
Robustness
Fit For Purpose
(Facility, workforce, product mix, process,
equipment, technology, capacity,
complexity)
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Fit For Purpose Components
Facility Equipment Technology Capacity Workforce Product Focus
Process Focus
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Fit For Purpose
• Facility – HVAC – BMS – Water System
• Equipment – Overall Equipment Effectiveness – SCADA – Automated equipment – Vision systems – Mistake Proofing (Poka-yoke)
• Technology – Information – Production – Enterprise Resource Management
• Capacity – Constraints
• Workforce – Selection
– Development
– Performance Management
– Enablement
– Engagement
• Product Focus – Product selection & product mix
– Complexity
– Product Life cycle management
– PpK and CpK
– Statistical process controls
• Process – Value chain processes
– Supplier chain security and integrity
– Process design & capability
– Process controls
– Process Improvement
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Fit For Purpose
Organizational Culture Smart & healthy; Continuous improvement learning organization
Governance
Employee Engagement
& Enablement
Quality Systems
Robustness
Fit For Purpose
(Facility, workforce, product mix, process,
equipment, technology, capacity,
complexity)
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Focus on Quality System
• Quality is defined as conformance to
requirements
• The system for causing quality is
prevention, not appraisal
• The performance standard must be
Zero Defects (meet AQL requirements)
• The measurement of quality is the
Price of Non-conformance, not indices
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The Headlines – Supply Chain Insecurity
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Diethylene Glycol (DEG) -Cold
Medicine contamination Over 500 deaths reported in Panama, Bangladesh,
Haiti South Africa, India, Nigeria and Argentina.
Heparin Incident (tainted blood
thinner) The API was contaminated which led to allergic
reactions and deaths in 10 countries, including the
U.S.
Melamine - Milk products & Pet
Food contamination
4 dealths and sickness in more than 54,000
children.
Cargo Theft – Lilly lost $76 mm; JNJ
Pocrit Stolen; Perrigo cargo diverted in
Texas; Teva Copaxone cargo $12 mm
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End-to-End Supply Chain Operations Quality
S I P O C
Internal Support Services & Quality, EHS, Engineering, IT, Facilities
Supplied
Materials/
Products
Manufacturing
& Testing Packaging Warehouse &
Distribution
End User /
Customer
External Contracted Services
Manufacturing, Testing, Artwork & Origination, Packaging, Warehousing & Distribution, Calibration
Products/Service
Design &
Development
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Supply Chain Security & Integrity
“ Know Unknowns, Unknown Unknowns”
– D. Rumsfeld
“…Complacency breeds failure,
only the paranoid survive” – Andy Grove
We source globally, we must be constantly vigilant
to protect the safety of our customers
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Supply Chain Quality Risk Management
Request detailed information from the supplier Increase audit frequency Active engagement on improvement initiatives Right size sampling and testing programs Business practice review – enterprise wide risk management
Risk Mitigation: Increase Visibility & Transparency
Risk: Opacity of the Supply Chain
Shadow Factories – Unscrupulous suppliers use show-and-shadow factory arrangements Sometimes, the actual manufacturer is only identified when an audit is requested Brokers, re-packagers and distributors involvement in the supply chain Prevention Knowledge
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• Collaboration with Law Enforcement & Government Agencies
Cross functional Suspected Tampering Action Team
FDA District Offices, OCI to identify tamper suspect
FDA Cincinnati Forensic Chemistry Center (FCC) to collect evidence, FBI to press charges
• Risk Surveillance & Monitoring
Internal company global network & escalation process
Rx-360
PCSC
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Teaming to Improve Supply Chain
Security & Integrity – we can’t do it alone
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OTC Product Quality Focus
Keep the Consumer in Mind
• Smart tablets and containers to augment patient compliance – apply QbD principles to design product based on user demography
• Effective and clear “How Used” label directions to reduce dosing error
• Tamper evident packaging and dosage forms (e.g. banded capsules)
• Child Resistant Closures & Geriatric Easy to Open closure system
• Flow restrictors on Pediatric liquids
• Product tampering – Effective communication with the public
– Collaboration with law enforcement agencies OCI, FBI, local police, FDA District Office
– Track and trend Call Center case logs
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Data Integrity – Trust But Verify
• Recent FDA inspections have uncovered data integrity issues in certain areas
• Opportunities for industry to improve
• Extend quality & culture to contract and supply partners
• Honed our skills to conduct forensic audits
• Perrigo is holding hands-on workshops to improve the competency of our global auditors
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Pharmacovigilance – Global Patient Safety is
Part of the Global Quality Function at Perrigo
• Pharmacovigilance (PhV) - the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem
• The aims of PhV are to enhance patient care and patient safety in relation to the use of medicine and to support public health programmes by providing reliable, balanced information for the effective assessment of the risk-benefit profile of medicines
86% of the US Rx are filled by generic drugs – we have the awesome responsibility to apply Good Vigilance Practice
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Fit For Purpose
Organizational Culture Smart & healthy; Continuous improvement learning organization
Governance
Employee Engagement
& Enablement
Quality Systems
Robustness
Fit For Purpose
(Facility, workforce, product mix, process,
equipment, technology, capacity,
complexity)
Employee Engagement and Enablement
• Quality-driven – Quality at the Source
• Right-First-Time (RFT) Culture
• Learning Organization – If not RFT, then Right-the-Second-Time!
• Innovation through diversity of culture, thought, experience
• Culture of compliance – “we do what’s right”
• Open communications through various channels
• Focus on skills development & operational excellence
• Continuous Improvement – Involve employees at all levels and in all functions
• Recognition Programs
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Sample Survey of the U.S. Workforce
Stephen Covey, in his book The 8th Habit, surveyed 23,000 employees from a number of companies and industries:
• Only 37 % have a clear understanding of their organization goals
• Only one in five was enthusiastic about their team's and their organization's goals
• Only one in five said they had a clear "line of sight" between their tasks and their team's and organization's goals
• Only 15 percent felt that their organization fully enables them to execute key goals
• Only 20 percent fully trusted the organization they work for
Perrigo’s Survey Results
• Consistently strong engagement levels from survey to survey
– Employees across Perrigo express strong commitment and effort levels, and would gladly recommend the company as a great place to work.
– Retention levels exceed benchmark comparisons, and approach high performing company comparisons.
0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100%
Perrigo Global Pharma
I am proud to work
for Perrigo
I would recommend
Perrigo as a great
place to work
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Organizational Culture Smart & healthy; Continuous improvement learning organization
Governance
Employee Engagement
& Enablement
Quality Systems
Robustness
Fit For Purpose
(Facility, workforce, product mix, process,
equipment, technology, capacity,
complexity)
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Governance - A holistic approach
Sites • Audits • Event Escalation Procedure • Floor level Quality Committees • Local Quality Council • Continuous Improvement Roadmap • Site Steering Teams • Quality Metrics • Visual boards
Quality Culture • Quality Incentives & Recognition • Employee Involvement in Continuous
Improvement • Always Quality Program • Communication Systems & Feedback
Loops
Corporate Quality • Corporate Audits • System Assessments • GxP Intel • Trend Reviews • Annual Strategy Update • Global Quality Review Team • Sustainable Quality Compliance
Committee • Executive Steering Team
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How Do We Know We Are Winning
or Losing?
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Effectiveness
Customer Service Level
Leading
Human Error Reduction
Leading
Confirmed Customer Complaints/PV Signals
Lagging
Efficiency
Total Cost of Quality
Leading
Right First Time
Leading
Monetary Amount on Quality Hold
Lagging
Compliance
Field Alerts/ Equivalent Regulatory Reporting
Lagging
Regulatory Compliance Status
Lagging
Recalls/Withdrawals
Lagging
Perrigo E2C Metrics
Metrics and Culture
“Not everything that can be counted counts, and,
Not everything that counts can be counted”
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Albert Einstein:
Culture is our collective behavior Observable, but not easy to measure
To Attain & Sustain Quality, Focus on
Organization Capability & the One True
Leading Indicator – Culture
• Effectiveness of CAPA
• Right 2nd Time
• Repeat Deviations
Quality Maturity
• Total cost of quality
• Quality Hold
• Right First time
• % Back order
Operational Excellence
• Capital Investment in quality and compliance
• % of time per employee spent on learning
Organizational Readiness
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Current Thought Leaders on Organization
Culture – P. Lencioni & G. Hamel
• Smart/Value Focus
– Quality
– Growth
– Leadership
– Service
– Strategy
– Technology
– Finance
• Healthy/Joy Focus
– Truth
– Honor
– Beauty
– Love
– Justice
– Minimum Politics
– High Productivity
– Low Turnover
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“Culture Trumps Strategy – Healthy Trumps Smart”
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• Core Values: Integrity, Respect, Responsibility
• 5 Pillars • E2C Quality • Quality Affordable Health Care • Organizational Health
Health (Key Behavior Focus)
Effectiveness (Key Performance Focus)
ORGANIZATIONAL
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Principles
1) Create Value for the Customer
2) Create Constancy of Purpose
3) Think Systemically
4) Focus on Process
5) Seek Perfection
6) Embrace Scientific Thinking
7) Flow and Pull Value
8) Assure Quality at the Source
9) Lead with Humility
10) Respect Every Individual
Slide courtesy of the Institute for Enterprise Excellence
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Culture is beliefs, Values & Behavior
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Health (Key Behavior Focus)
ORGANIZATIONAL
Effectiveness (Key Performance Focus)
ORGANIZATIONAL
Results
Behavior
KBI KPI
As a lean organization matures,
the focus will shift
from pure
performance to
behaviors
Leading Indicators
Lagging Indicators
Quality maturity
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FDA Evolving Pharmaceutical Quality
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FDA Evolving Pharmaceutical
Quality
Formation of the Office of Pharmaceutical Quality
Introducing the Office of Surveillance – Q Metrics
Enabling Alignment of ORA with CDER
Focusing on International Inspection
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• Excited about FDA shifting focus from procedural compliance quality to customer centric quality
• Impose clinically relevant specifications
• Align ORA & CDER approach to review, approve drugs; conduct risk and quality system based inspections & enforcement
• Regulatory relief to enable industry innovation in manufacturing & quality
• Continue to assure no unintended consequences when implementing global, pan industry Q metrics
• Gradually evolve adoption of Quality metrics & surveillance
FDA Evolving Pharmaceutical Quality
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Thank You FDA for Promoting &
Protecting My Family’s Health
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Thank You
Questions?
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