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Slide 1 of 27
Robert Packard, Consultant
www.MedicalDeviceAcademy.com
[email protected] June 13, 2013
Are your suppliers qualified?
Prove it!
Slide 2 of 27
Robert Packard, Consultant
www.MedicalDeviceAcademy.com
[email protected] June 13, 2013
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…
Slide 3 of 27
Robert Packard, Consultant
www.MedicalDeviceAcademy.com
[email protected] June 13, 2013
How do you
Qualify Suppliers?
Slide 4 of 27
Robert Packard, Consultant
www.MedicalDeviceAcademy.com
[email protected] June 13, 2013
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)
Slide 5 of 27
Robert Packard, Consultant
www.MedicalDeviceAcademy.com
[email protected] June 13, 2013
You Need to Use the Right Tool for the Job
Slide 6 of 27
Robert Packard, Consultant
www.MedicalDeviceAcademy.com
[email protected] June 13, 2013
“Antique” Tools
• ISO Certification
• Quality Manual
• Supplier Questionnaire
• Certificate of Compliance
Slide 7 of 27
Robert Packard, Consultant
www.MedicalDeviceAcademy.com
[email protected] June 13, 2013
ISO Certification
• Make Sure the Registrar is Accredited
• Track the Certificate Expiration
• Keep Most Recent Copy on File
• Request 3rd Party Audit Reports
Slide 8 of 27
Robert Packard, Consultant
www.MedicalDeviceAcademy.com
[email protected] June 13, 2013
What if they don’t have ISO Certification?
• Document Product Specifications
• Obtain “Supplier Info”
• Validate Process & Testing
• Identification & Segregation of Status
Slide 9 of 27
Robert Packard, Consultant
www.MedicalDeviceAcademy.com
[email protected] June 13, 2013
Quality Manual
• Use Manual to Plan Supplier Audits
• Look for Process Interaction Diagram
• Request Procedure List with Revisions
• If it’s Generic, Delete It
Slide 10 of 27
Robert Packard, Consultant
www.MedicalDeviceAcademy.com
[email protected] June 13, 2013
Supplier Questionnaire
• Don’t use a generic questionnaire
• Don’t ask “yes/no” questions
• Get it updated annually
• Use an Excel spreadsheet
Slide 11 of 27
Robert Packard, Consultant
www.MedicalDeviceAcademy.com
[email protected] June 13, 2013
Certificate of Compliance (CoC)
• Switch to Certificate of Analysis (CoA)
• Request First Article Inspections
• Statistically Determine Sample Size
• Verify 100% of Measurements
Slide 12 of 27
Robert Packard, Consultant
www.MedicalDeviceAcademy.com
[email protected] June 13, 2013
“Modern” Tools
• A3 Proposal Report
• Process Validation
• Statistical Process Control
• PPAP Report
Slide 13 of 27
Robert Packard, Consultant
www.MedicalDeviceAcademy.com
[email protected] June 13, 2013
A3 Proposal Report
Slide 14 of 27
Robert Packard, Consultant
www.MedicalDeviceAcademy.com
[email protected] June 13, 2013
Process Validation
Process Validation Guidance
GHTF/SG3/N99-10:2004 – January 2004
http://www.imdrf.org/documents/doc-ghtf-sg3.asp
Slide 15 of 27
Robert Packard, Consultant
www.MedicalDeviceAcademy.com
[email protected] June 13, 2013
SPC Run Chart
Slide 16 of 27
Robert Packard, Consultant
www.MedicalDeviceAcademy.com
[email protected] June 13, 2013
PPAP
• Supplier Restates Your Requirements
• Gage R&R / Process Capability
• Risk Control Plan
• Part Submission
Slide 17 of 27
Robert Packard, Consultant
www.MedicalDeviceAcademy.com
[email protected] June 13, 2013
Supplier Auditing
• Risk-based approach
• Strategically select auditors & Train auditors well
• Plan auditing goals & objectives for team in advance
• Create a formal audit agenda
Slide 18 of 27
Robert Packard, Consultant
www.MedicalDeviceAcademy.com
[email protected] June 13, 2013
Can I justify fewer supplier audits?
Slide 19 of 27
Robert Packard, Consultant
www.MedicalDeviceAcademy.com
[email protected] June 13, 2013
Can you justify more
supplier audits?
Slide 20 of 27
Robert Packard, Consultant
www.MedicalDeviceAcademy.com
[email protected] June 13, 2013
Costs of Poor Quality (COPQ)
Slide 21 of 27
Robert Packard, Consultant
www.MedicalDeviceAcademy.com
[email protected] June 13, 2013
Auditing 100% of your critical suppliers may seem impossible due to limited resources, but have you ever seen a cost/benefit analysis?
Slide 22 of 27
Robert Packard, Consultant
www.MedicalDeviceAcademy.com
[email protected] June 13, 2013
Prioritizing Supplier Audits
• FDA Approach
• Risk-based Approach
• Logistical Approach
• Strategic Approach
Slide 23 of 27
Robert Packard, Consultant
www.MedicalDeviceAcademy.com
[email protected] June 13, 2013
Allocation of Resources
Slide 24 of 27
Robert Packard, Consultant
www.MedicalDeviceAcademy.com
[email protected] June 13, 2013
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
Slide 25 of 27
Robert Packard, Consultant
www.MedicalDeviceAcademy.com
[email protected] June 13, 2013
Q & A
Slide 26 of 27
Robert Packard, Consultant
www.MedicalDeviceAcademy.com
[email protected] June 13, 2013
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
Slide 27 of 27
Robert Packard, Consultant
www.MedicalDeviceAcademy.com
[email protected] June 13, 2013
Future Course Dates
October 2013
3 Thursday
October 2013
4 Friday
Supplier Qualification CAPA
San Diego Airport
Liberty Station
http://www.sandiegoairport.homewoodsuites.com/