presented by: ken imler sr. vice president raqa arrow international working with suppliers: forming...

Presented by:Ken Imler

Sr. Vice President RAQAArrow International

Working with Suppliers:Forming Strategic Alliances to

Accelerate Compliance & Improve Supplier Performance

ASQ Biomedical ConferenceManufacturing Compliance

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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

9

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

12

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

presented by: ken imler sr. vice president raqa arrow international working with suppliers: forming...

Documents

biomedical conferenceselect

biomedical conferencerisk

strategic management

supply chain managementstarts

entire supply chain

link strategic suppliers

strategic partners

strategic alliances