|
Regulators are watching your supplier management practices closely. The FDA’s Quality System Regulation (QSR), ISO 13485 and the international Medical Device Single Audit Program (MDSAP) all have specific requirements for purchasing controls and acceptance activities. They expect your suppliers to function as an extension of your quality system. So how do you choose the ones most likely to meet your standards? |
An effective supplier evaluation system includes determining your expectations, converting them into measurable characteristics/metrics, defining the measurement method and setting the target you expect suppliers to hit.
In the Supplier Quality Metrics for Devicemakers management report you’ll learn how to use predictive analysis of such metrics as delivery time, management efficiency and lot acceptance rate to identify suppliers you can count on and spot potential problems in the future. You’ll learn:
- Requirements for receiving acceptance
- The difference between a contract manufacturer and a specifications developer and why it matters
- What aspects of your purchasing controls will be evaluated in an MDSAP audit
- How to create a supplier scorecard
- How to evaluate what you receive from suppliers
- Issues to look for in a supplier’s complaint records
- How to analyze performance metrics to predict if a supplier is likely to create a problem.
Order your copy of Supplier Quality Metrics for Devicemakers: Predicting and Selecting the Best and gain a system for predicting and managing supplier conformance with FDA and international standards.
Order Your Copy Today
PDF Edition
|
|
Available Format |
|
PDF Edition — $397
Table of Contents
- Introduction
- Purchasing Controls and Supplier Evaluation
- QSR and Purchasing Controls
- International Purchasing Control Standards
- And More …
View the entire TOC
Who Will Benefit
- Purchasing managers/agents
- Supplier management staff
- Quality managers
- Data analysts
- Regulatory affairs staff
Multi-user Access
Save money with a license agreement allowing significant numbers of users access to an electronic version of this book. For multi-user access to multiple titles, FDAnews offers the FDAnews Online Library — a personalized collection of FDAnews publications that is fully searchable. Contact Customer Service for a quote or more information.
Our Guarantee
Not satisfied with your publication? For the PDF version, you must notify FDAnews within 24 hours of receipt of purchase and we will refund 100 percent of your purchase price.
|
|
|
