1. Shawn Beddes
Senior Quality Manager
DELIVERING RESULTS IN REGULATED INDUSTRIES

4. Audits
ISO Cert
Scorecard
Testing
Inspection
Quality
Agreements
Periodic
Reviews
Status
C of A

5. »Supplier Audits
˃ Process Assessment
˃ Quality Systems Audit
˃ Desk Audit
˃ 3rd Party Report
+ ISO Audit
+ Other qualified auditor
+ Regulated Body
Audits

6. »ISO Certification
˃ ISO 9001
˃ ISO 13485
˃ ISO 17025
ISO Cert

7. »Incoming Inspections
˃ Sampling AQL
+ Supplier Level
+ Inspection History
+ Certificates of Analysis
Inspection
C of A

8. »Testing
˃ Establish Testing Frequency
+ Supplier Level
+ Testing History
Testing

9. »Supplier Quality
Agreements
˃ Detailed agreement signed by both parties
˃ Summarized agreement signed by both parties
˃ Summarized and embedded in Bard specification
˃ Summarized and embedded in Bard purchase orderQuality
Agreements

10. »Quarterly Business
Reviews
˃ Alternate hosting
˃ Attended by key parties to resolve
significant issues
˃ Many may attend via teleconference/
WebEx

11. »Supplier Scorecard
˃ Lot Acceptance Rate (LAR)
˃ Supplier Corrective Action Reports
(SCARs)
˃ On-Time Delivery
˃ Last Audit Results
Scorecard

12. »Supplier Status
1. Certified Supplier
2. Qualified Supplier
3. New Supplier/ Provisional
4. Unapproved Supplier
Status

13. »Supplier Status
1. Certified Supplier
+Qualified Supplier
+Process Assessment Audit
Status

14. »Supplier Status
2. Qualified Supplier
+>1 year or 3 shipments
+LAR ≥ 97%
Status

15. »Supplier Status
3. New Supplier / Provisional
+< 1 year or 3 shipments
+LAR < 97%, ≥ 93%
+Provisional status retained for
suppliers with < 20 lots per year
and 1 NCR
Status

16. »Supplier Status
4. Unapproved Supplier
+LAR < 93%
Status

18. But we have
the exact same
lemonade!
Only slightly
different
reputations.
Not made with
iguana spit

20. »Supplier Types/Levels
˃ Highest Risk (Level 1)
+ Sterilization
+ Contract Manufacturing
˃ High Risk (Level 2)
+ Active Pharmaceutical Ingredients
+ Direct Patient Contact
˃ Moderate Risk (Level 3)
+ Indirect Contact, includes packaging, labels, IFUs,
sacrificial parts
˃ Moderate Risk (Level 4)
+ Key Service Suppliers – Calibration, Lab Testing
˃ Lower Risk (Level 5)
+ Equipment
+ Other Service Suppliers
+ Spare Parts

21. »Supplier Types/Levels
˃ Highest Risk (Level 1)
˃ High Risk (Level 2)
˃ Moderate Risk (Level 3)
˃ Moderate Risk (Level 4)
˃ Lower Risk (Level 5)