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This Week in Quality Digest Live
FDA Compliance Features
Heather Thompson
Want to be part of FDA’s SaMD precertification program? Get your QMS up to par.
Dileep Thatte
Producing safe food doesn’t just make sense. It’s the law.
Boris Liedtke
The wine industry shows how eco-friendly production can benefit both companies and consumers
Jon Speer
We all benefit from a larger perspective
Steven Brand
A crucial method for differentiation (and profitability) in a tight market

More Features

FDA Compliance News
Creates adaptive system for managing product development and post-market quality for devices with software elements
VQIP allows for expedited review and importation for approved applicants that demonstrate safe supply chains
An invite from Alcon Laboratories
Intended to harmonize domestic and international requirements
Pharma quality teams will have performance-oriented objectives as well as regulatory compliance goals
Strategic investment positions EtQ to accelerate innovation efforts and growth strategy
The FDA’s RMAT designation goes live
Awards help states implement multiyear produce-safety systems

More News

Mike Micklewright: Creating a Leaner Quality Management System

Video Information

Micklewright suggests applying lean principles to your quality management system.

 

Downsize Documentation

• Companies tend to overdocument their QMS

• Sort your documents

• Check the revision record of documents

• Check documents from old standards

• Check contents of documents

• Create two-page quality manual

 

Using quick changeover to modify documents

• Value stream map of documentation

• Reduce wasted time in creating, modifying or approving documents

 

Integrating lean into your QMS

• Lean, ISO 9001, and other quality programs often duplicate each other

 

For more information on making a lean QMS, read Micklewright's book: Lean ISO 9001: Adding Spark to your ISO 9001 QMS and Sustainability to your Lean Efforts available at the ASQ book store.

 
 

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