Presented by: Ken Imler Sr. Vice President RAQA Arrow International
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Transcript of Presented by: Ken Imler Sr. Vice President RAQA Arrow International
Presented by:Ken Imler
Sr. Vice President RAQAArrow International
Working with Suppliers:Forming Strategic Alliances to
Accelerate Compliance & Improve Supplier Performance
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For Medical Devices
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An Integrated Approach of
Risk Management
Project Management
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Suppliers are strategic partners in your ultimate success (or failure).
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• Suppliers must understand and meet not just your product or service requirements.– Products and processes – How their parts of services impact these
• They must understand and meet your business requirements.– How they add value– How they impact you ability to do business
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• In an FDA, ISO,CMDRAS, PAL, etc. regulated environment, you are responsible for establishing, monitoring and maintaining an adequate level of control over all suppliers and the materials and services they supply.
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QUALIFYSUPPLIERS
FEEDBACKTO SUPPLIERS
MONITORSUPPLIERS
SELECTSUPPLIERS
Supplier
Effectiv
e
SupplierIneffective
Most organizations look at Supply Chain Management in this manner.
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SELECT & QUALIFY SUPPLIERS
FEEDBACKTO SUPPLIERS MANAGE RISK
& SUPPLIERS
IDENTIFYPOTENTIAL
RISKS
Risk
acceptable
RiskUnacceptable
World-class organizations modify the process
Design Control& Specifications
ProductPerformance& Complaints
QFD & Involvement
Lean -Six SigmaRisk Management
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• You must understand and manage the risks involved and demonstrate the appropriate level of controls necessary to assure, to a high degree of confidence that the products, devices and services provided meet their predetermined specifications and requirements.
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• You must also understand and manage the process and business risks associated with the Supply Chain; to make the process effective, efficient and value added.
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• Risk Based Supply Chain Management– Starts with a cross functional team– Starts in the design and development process– Use a basic FMEA-type approach - Define:
• Process steps• Potential failure modes• Potential effects• Potential causes• Detection/Modes of control• Total Risk
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Get the potential suppliers involved in the process, up front.
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Occurrence
Sev
erit
ySafety
Qu
alit
y
Regulatory
Bu
siness
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Process Step Potential
Failure
S Potential Effect
Potential Cause
P Detection/Mode of Control
RPN
Selection
Qualification
Monitoring
Feedback
FMEA Table
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Process Step Potential
Failure
S
1-5Potential
EffectPotential
CauseP
1-5Detection/Mode of Control
RPN
Selection Select ineffective supplier
4-5 Bad components
Ineffective supplier
2 Supplier Audit
First Article Inspection
8-10
Qualification Underestimate capabilities
3-4 Inadequate quantities
Supplier capability underestimated
2-3 Supplier Audit
On site engineer
6-12
Monitoring Poor performance
3 Continued receipt of wrong/bad components
Inadequate purchasing data
2-3 Establish correct data/metrics
6-9
Feedback No link to CAPA 3 No improvement
No communication with supplier
3 Monthly feedback reports and communication
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FMEA Table
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Occurrence
Sev
erit
ySafety
Bu
siness
Highest levelof Management
& Control
Lowest levelof Management
& Control
Safety
Qu
alit
y
Regulatory
Bu
siness
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Risk Category Potential
Failure
S Potential Effect
Potential Cause
P Detection/Mode of Control
RPN
Safety Performance or functional failure
5 Harm to patient
User or mfg personnel
Faulty design
Mfg errors
1-2 Inspection and/or testing
5-10
Quality
Reliability
Out of box failure
Rework or scrap
3-4 Unable to use
Back orders
Low yields
Faulty design
Mfg errors
3 Design validations
Inspection and testing
9-12
Regulatory Lack of proper 510 k, PMA, CE certificate or PAL
2-3 Need new submission
Lack of Understanding of regulations
3 Submission Review
Supplier Audit
6-9
Business Lack of detail in contract/agreement
3 Increased cost, schedule and/or resources
Inefficient mfg, standards or documentation
4 Supplier Audit
Supplier monitoring
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FMEA Table
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• It is about strategic Management of the Supplier and the entire Supply Chain integrated with management of strategic suppliers
• It is not just monitoring the deliveries, AQLs and PPVs.
• Link strategic suppliers into your quality system
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• More traditional Risk Based methods to manage to and control the supply chain include:– Audits– Certificates of Analysis– Inspection and Testing at the supplier– Inspection and testing in-house
• First Article Inspections• Increased sampling
– Inspection and testing by a third party– Technical presence on site at the supplier
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• Think more holistically …
• Supply Chain Management starts in development and extends through the product life cycle.
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• Project Management is the other activity vital to the success of Supply Chain Management.
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• Project Management establishes a strategic plan that specifically identifies:– Activities– Deliverables– Roles and Responsibilities– Schedules and Milestones
• Remember to get the suppliers involved in the beginning.
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• Supply Chain Projects must:– Be prioritized by management– Have adequate resources allocated and
assigned to the project– Have a real project manager– Have a budget– Have goals and metrics– Have management oversight
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• Supply Chain Management as a strategic Project is most effectively managed by PURCHASING.
• Team members include:– The Supplier(s)– Quality Assurance– Product Development– Sustaining/Manufacturing Engineering– IT– Others as deemed necessary by the team
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Summary
• Integrate risk and project management.
• Together they create synergies that can be extremely effective and efficient.
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Summary• Use risk management to understand and
manage the Supply Chain.• Use project management to strategically apply
the appropriate level of control in supplier– Selection,– Qualification,– Monitoring and control.
• Provide objective evidence.
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Summary• Get the suppliers involved and engaged,• Keep the suppliers involved and engaged.• Apply state of the art quality, purchasing and
business tools to the process.
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In Conclusion
EARLY ENOUGH and GOOD ENOUGH
… NEVER ARE
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Questions