are your suppliers qualified?

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Robert Packard, Consultant

www.MedicalDeviceAcademy.com

[email protected] June 13, 2013

Are your suppliers qualified?

Prove it!

http://www.medicaldeviceacademy.com/

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Raise Your hand

How to get what you want…

• If there is a , pay attention.

• If there is a hyperlink, check it out.

• If you have a question…


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How do you

Qualify Suppliers?


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Supplier Evaluation • Less is More (http://bit.ly/Less-is-more)

– On-Time Delivery

– % of Nonconforming Lots

• Take 5 (http://bit.ly/SupplierEval-take5)

– Prioritize by Risk

– Pick 5 Suppliers Each Year (Per SQE)

– 5 Audits Per Year (Per SQE)


http://bit.ly/Less-is-more





http://bit.ly/SupplierEval-take5



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You Need to Use the Right Tool for the Job


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“Antique” Tools

• ISO Certification

• Quality Manual

• Supplier Questionnaire

• Certificate of Compliance


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ISO Certification

• Make Sure the Registrar is Accredited

• Track the Certificate Expiration

• Keep Most Recent Copy on File

• Request 3rd Party Audit Reports


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What if they don’t have ISO Certification?

• Document Product Specifications

• Obtain “Supplier Info”

• Validate Process & Testing

• Identification & Segregation of Status


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Quality Manual

• Use Manual to Plan Supplier Audits

• Look for Process Interaction Diagram

• Request Procedure List with Revisions

• If it’s Generic, Delete It


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Supplier Questionnaire

• Don’t use a generic questionnaire

• Don’t ask “yes/no” questions

• Get it updated annually

• Use an Excel spreadsheet


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Certificate of Compliance (CoC)

• Switch to Certificate of Analysis (CoA)

• Request First Article Inspections

• Statistically Determine Sample Size

• Verify 100% of Measurements


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“Modern” Tools

• A3 Proposal Report

• Process Validation

• Statistical Process Control

• PPAP Report


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A3 Proposal Report


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Process Validation

Process Validation Guidance

GHTF/SG3/N99-10:2004 – January 2004

http://www.imdrf.org/documents/doc-ghtf-sg3.asp







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SPC Run Chart


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PPAP

• Supplier Restates Your Requirements

• Gage R&R / Process Capability

• Risk Control Plan

• Part Submission


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Supplier Auditing

• Risk-based approach

• Strategically select auditors & Train auditors well

• Plan auditing goals & objectives for team in advance

• Create a formal audit agenda


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Can I justify fewer supplier audits?


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Can you justify more

supplier audits?


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Costs of Poor Quality (COPQ)


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Auditing 100% of your critical suppliers may seem impossible due to limited resources, but have you ever seen a cost/benefit analysis?


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Prioritizing Supplier Audits

• FDA Approach

• Risk-based Approach

• Logistical Approach

• Strategic Approach


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Allocation of Resources


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Related Blog Postings 3 Tools for Qualifying Suppliers (http://bit.ly/3SupplierTools) – 1/2/13 The Supplier Audit Agenda (http://bit.ly/SupplierAuditAgenda) – 4/21/12 Supplier Survey with a Twist (http://bit.ly/SupplierSurvey) – 3/29/12 Which Suppliers Should You Audit? (http://bit.ly/WhichSuppliers) – 3/26/12 Why did you Qualify that Supplier? (http://bit.ly/WhythatSupplier) – 3/20/12 How do you qualify a supplier that doesn’t have a Quality Management System? (http://bit.ly/NoQMSupplier) – 3/9/12 Who Does Supplier Audits in Your Company? (http://bit.ly/Whodoesaudits) – 3/2/12 Supplier Evaluation – Take 5 (http://bit.ly/SupplierEval-take5) – 1/3/11 Supplier Evaluation – Less is more (http://bit.ly/Less-is-more) – 1/2/11 Supplier Qualification: How To Get The Best Results (http://bit.ly/HowQualifyaSupplier) – 11/17/10


http://bit.ly/3SupplierTools

http://bit.ly/SupplierAuditAgenda

http://bit.ly/SupplierSurvey

http://bit.ly/WhichSuppliers

http://bit.ly/WhythatSupplier

http://bit.ly/NoQMSupplier

http://bit.ly/Whodoesaudits









http://bit.ly/HowQualifyaSupplier

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Q & A


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Future Course Dates

September 2013

9 Monday

September 2013

10 Tuesday

Supplier Qualification CAPA

http://embassysuites3.hilton.com/en/hotels/florida/embassy-suites-orlando-airport-MCOATES/about/index.html

Orlando Airport












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Future Course Dates

October 2013

3 Thursday

October 2013

4 Friday

Supplier Qualification CAPA

San Diego Airport

Liberty Station

http://www.sandiegoairport.homewoodsuites.com/


http://www.sandiegoairport.homewoodsuites.com/

are your suppliers qualified?

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