Leaning towards action rev a

www.sqaservices.com - "Global Quality on Demand"
Leaning Towards Action:
The Who, What, Why, When and How of
Improving Quality in Your Supply Chain
Gerard J. Pearce
Executive Vice President
SQA Services, Inc.

www.sqaservices.com - "Global Quality on Demand"www.sqaservices.com - "Global Quality on Demand"
Understand Supplier
Quality Drivers
WHY
WHO
Review Supplier
Quality Techniques
WHEN
WHAT
HOW
TODAY
Objective Focus

WHY do it?
• FDA: to help ensure “products consistently
meet applicable requirements and
specifications”
• Best patient and business outcome
• Cost savings and risk mitigation
• Supply chain disruption – first and second tier
• Growth in outsourcing and complex supply
chains

WHY do it?

WHY do we have to?
21 CFR 820 dictates:
•Supplier evaluation and selection “on the basis
of their ability to meet specified requirements”
•…which determines “the type and extent of
control to be exercised”
RISKRISK

WHY is it challenging?
• Supply chain is a moving target
• Distance, language, culture and local
knowledge
• Information under- or over-load
• CAR Sickness
• ‘Standard’ Tools
• Quality-Supply Management disconnect

WHO
• Focus based on status and risk
• Strategic Partners
• Strategic Stinkers
• Regional Coverage
low medium high
high
medium
low
Risk
Ranking

WHEN
Spend/Leverage
Criticality
Low High
Quality Performance
Environment
Good Poor
Little Much
Stable Unstable
Strategic Alignment
Well Poorly
lessfrequent
morefrequent

WHAT
High-level look to low-level look:
1.‘D&B-style’ check
2.Self- or desk-audit
3.ISO-style audit
4.Specialized audit
5.Assessment

Typical Audit Strategy
Coverage
Additional Elements Needed For
Full Plan-Do-Check-Act Closure
 GMP Planning and Compliance
 Testing and Containment
 Personnel Training
 Resources
 Validation of Process in First Batches
 Risk Assessment
 Process Controls & Capability Analysis
towards High Risk Elements
 Investigation System Design towards
Plan, Do, Check , Act
 KPI True Analysis and Trends towards
Remediation
 Validation taking in consideration full
variability of the process
moving towards broader scope
WHAT
Supplier Evaluation Evolution:

Qualification
& Validation
Policy and
Strategy for
GMPs
Resources
GMP
Compliance
Personnel
Orientation
Current Auditing
Coverage
Supplier Evaluation Evolution:
moving towards broader scope
WHAT
Investigation System & Improvement
Enablers Results
General
System
Inputs
and
Outputs
Elements needed
for full PDCA
Closure
Total Quality Management

WHAT
Supplier
Impact
Evaluation
Investment
Supplier Impact-Investment Map

HOW
Requires a:
•well-managed
•well-defined
•automated
•targeted
•measured
•shared
•global
…program aimed at ACTION

HOW
Quality-Supply Integration:
strategic
sourcing
supplier
quality
supplier
development

HOW
Three-tier structure:
Corporate level
Business Unit /
Regional level
Plant
level
Business Unit /
Regional level
Plant
level
Plant
level
• Clear vision and strategy
• Center-led
• Standardized objectives,
policies, processes and
procedures

HOW
Balance between:
Inspections
Non-conforming product
Supplier Corrective Action
Material returns
Quality Agreements
Supplier Scorecards
Supplier Consolidation
Supplier Qualification
Supplier Audits & Assessments
Supplier Remediation
Quality
Control and
Quality
Development

HOW
Process: ‘Manufactured’ Supplier Evaluation
– Consistency Vs Redundancy
– Consider all the moving parts and control them
– Map all activity and share with stakeholders
– Free up high-value resources for high-value tasks
– Invite self-serve visibility rather than reports
– Exploit ‘Administrative Intelligence’

HOW
Tools
– Consensus on the tools and how to use them
– More than a checklist (templates, notifications,
completed samples, lessons learned)
– More than one size
– Feedback loop through review
– Share with pride

HOW

HOW
Automation
– Support the process, not just the results
– Align with IT strategy and existing infrastructure
– Eliminate manual steps
– Monitoring and alerts
– Facilitate exchanges (beyond Outlook)
– Don’t forget controls
alert!

HOW
Aim to create “Supply Chain Intelligence”

HOW
Quality / Performance
Are they succeeding?
External
factors
- Are they
impacted by the
environment?
Compliance
- Are they set up to
succeed?
Criticality
- how important are they?
Overall Risk
Supplier Scorecard
Supplier Dashboard
Supplier Quality Profile
…others?
Integrating supplier data:

HOW
Share Responsibility
– Obtain commitment up front
– Data: do it once, do it fast, do it right
– Develop two-way visibility
– Buy-in eliminates redundancy, errors
– Establish ‘Controlled Connection’ through
organizational boundaries
– Opportunities beyond simple transactions
– Promote a collaborative, time-saving environment

HOW
Set up for streamlined CAPA:
– Establish or reinforce the process
– Identify the stakeholders
– Opportunity presented by corrective action
– Different levels of corrective action
– Avoid ‘CAR sickness’

HOW
Close the CAPA loop
– Explain the process
– Follow-up
– Help the supplier
– Act on results

HOW
Take the lead
– Identify resources
– Agree minimum acceptance criteria
– Use closure date guidelines for milestones
– Have a library of improvement tools
– Monitor in line with streamlined Corrective
Action
– Adjust accordingly

RECOMMENDED READING
• The Signal and the Noise – Nate Silver
• Single Point of Failure – Gary Lynch
• Everything is Obvious – Duncan Watts
• Reinventing Discovery – Michael Nielsen
• Crazy From the Heat – David Lee Roth

Questions and further information:
Gerard Pearce
310-802-4448
gpearce@sqaservices.com
THANKYOU!

Leaning towards action rev a

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