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Determination of the Type and Extent of Controls for Suppliers
Shawn BeddesSenior Quality Manager
DELIVERING RESULTS IN REGULATED INDUSTRIES
Audits are not the only tool
Supplier
Controls
AuditsISO Cert
Scorecard
Testing
Inspection
QualityAgreements
PeriodicReviews
Status
C of A
Supplier Controls
»Supplier Audits˃ Process Assessment ˃ Quality Systems Audit ˃ Desk Audit ˃ 3rd Party Report
+ ISO Audit + Other qualified auditor+ Regulated Body
Audits
Supplier Controls
»ISO Certification˃ ISO 9001˃ ISO 13485˃ ISO 17025
ISO Cert
Supplier Controls
»Incoming Inspections˃ Sampling AQL
+ Supplier Level + Inspection History+ Certificates of Analysis
Inspection
C of A
Supplier Controls
»Testing˃ Establish Testing Frequency
+ Supplier Level + Testing History
Testing
Supplier Controls
»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
Supplier Controls
»Quarterly Business Reviews˃ Alternate hosting ˃ Attended by key parties to resolve
significant issues˃Many may attend via teleconference/
WebEx
»Supplier Scorecard˃ Lot Acceptance Rate (LAR)
˃ Supplier Corrective Action Reports (SCARs)
˃ On-Time Delivery
˃ Last Audit Results
Supplier Controls
Scorecard
»Supplier Status1. Certified Supplier
2. Qualified Supplier
3. New Supplier/ Provisional
4. Unapproved Supplier
Supplier Controls
Status
»Supplier Status1. Certified Supplier
+ Qualified Supplier+ Process Assessment Audit
Supplier Controls
Status
»Supplier Status2. Qualified Supplier
+ >1 year or 3 shipments+ LAR ≥ 97%
Supplier Controls
Status
»Supplier Status3. New Supplier / Provisional
+ < 1 year or 3 shipments+ LAR < 97%, ≥ 93%+ Provisional status retained for
suppliers with < 20 lots per year and 1 NCR
Supplier Controls
Status
»Supplier Status4. Unapproved Supplier
+ LAR < 93%
Supplier Controls
Status
WE MUST STAY TRUE TO OUR CORE VALUES:
QUALITY * INTEGRITY SERVICE * INNOVATION
But we have the exact
same lemonade!
Only slightly
different reputation
s.
Not made with iguana
spit
Determination Based on RISK
Levels Based on RISK
»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
Levels Based on RISK
»Supplier Types/Levels˃ Highest Risk (Level 1)
˃ High Risk (Level 2)
˃ Moderate Risk (Level 3)
˃ Moderate Risk (Level 4)
˃ Lower Risk (Level 5)
“It is not necessary to change. Survival is not mandatory.”
– W. Edwards Deming
Thank you! Questions?
I look forward to working with you and our suppliers.
