The document outlines Shawn Beddes' responsibilities as a Senior Quality Manager in delivering quality assurance results for regulated industries. It discusses various quality assurance processes including supplier audits, ISO certification, inspections, testing, quality agreements, periodic reviews, scorecards, certificates of analysis, and categorizing supplier types and risk levels. The quality assurance processes aim to ensure suppliers meet standards, identify issues, and maintain high quality.
5. »Supplier Audits
˃ Process Assessment
˃ Quality Systems Audit
˃ Desk Audit
˃ 3rd Party Report
+ ISO Audit
+ Other qualified auditor
+ Regulated Body
Audits
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
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