{domain:"www.qualitydigest.com",server:"169.47.211.87"} Skip to main content

User account menu
Main navigation
  • Topics
    • Customer Care
    • FDA Compliance
    • Healthcare
    • Innovation
    • Lean
    • Management
    • Metrology
    • Operations
    • Risk Management
    • Six Sigma
    • Standards
    • Statistics
    • Supply Chain
    • Sustainability
    • Training
  • Videos/Webinars
    • All videos
    • Product Demos
    • Webinars
  • Advertise
    • Advertise
    • Submit B2B Press Release
    • Write for us
  • Metrology Hub
  • Training
  • Subscribe
  • Log in
Mobile Menu
  • Home
  • Topics
    • 3D Metrology-CMSC
    • Customer Care
    • FDA Compliance
    • Healthcare
    • Innovation
    • Lean
    • Management
    • Metrology
    • Operations
    • Risk Management
    • Six Sigma
    • Standards
    • Statistics
    • Supply Chain
    • Sustainability
    • Training
  • Login / Subscribe
  • More...
    • All Features
    • All News
    • All Videos
    • Contact
    • Training

All Features

The Perils of Outsourcing: A Case Study
Tom Taormina
Outsourcing is historically one of the most misunderstood concepts in quality management system (QMS) implementation and operation. Prior to ISO 9001:2015, the requirement for outsourced processes was limited to a few sentences in the standard’s clause 4.1. This article will present, through a case…
Information Security: To Hack, or Not to Be Hacked
Chad Kymal
When we think about IT security, we typically think about the large hacks that were reported in the press. When viewed as a whole, we can understand the magnitude of lost data. It’s no surprise that these hacks are what come to mind when we think about information security. The table below shows…
What to Expect During an FDA QSIT Inspection
Jon Speer
You arrive at work one morning, and there are FDA inspectors sitting in your waiting area. If you are lucky, you may be notified ahead of time that they’re coming, but otherwise, the US. Food and Drug Administration (FDA) is fully within its rights to show up unannounced at any time. Because of…
ANSI’s Role in the Wide World of Standards
Ryan E. Day
I love standards, and whether you know it, you love standards, too. For example, let’s say a bulb in your lamp goes bad. You drive down to the local hardware store, buy a bulb, come back home, change out the bulb, plug the lamp back in, and... it lights up. You just benefited from at least seven U.…
The Keys to Quality Assurance
Donald J. Wheeler
Managers the world over want to know if things are “in control.” This usually is taken to mean that the process is producing 100-percent conforming product, and to this end an emphasis is placed upon having a good capability or performance index. But a good index by itself does not tell the whole…
Design Robust Processes to Avoid ISO 9001:2015 Nonconformances
William A. Levinson
The Pareto principle calls for focus on the vital few rather than the trivial many. While none of ISO 9001’s clauses are trivial—a nonconformance for any of them requires corrective action—ISO 9001 users can avoid most nonconformances by focusing on the clauses that are the most frequent trouble…
FDA Milestones
Laurel Thoennes @ QD
Compliance to U.S. Food and Drug Administration (FDA) regulations has come a long way in the past 30 years. Here are the main changes. Have they affected your business? 1988: Food and Drug Administration ActOfficially establishes the FDA as an agency of the Department of Health and Human Services…
Taking a Risk-Based Approach to Drug Inspections
Dirk Dusharme @ Quality Digest
As the United States struggles with rising healthcare costs, reducing the amount of money pharmaceutical companies spend dealing with regulation, while at the same time meeting drug safety requirements, would seem to be competing interests. The goal of any honest pharmaceutical company is to make…
Proactive Processes in High-Reliability Organizations
Graham Freeman
Many industries have no clear boundary between safety and quality culture. In fact, they are often closely integrated. Quality failures and nonconformances that require rework have been correlated with increased accidents and recordable injury rates in manufacturing organizations. These injuries…
The Do’s and Don’ts of Preparing a New Facility for the First Audit
Wendy White
Starting a new facility in the food-processing industry is an enormous undertaking. There are thousands of things that must be accomplished, from hiring and training new staff to ordering and installing equipment. This scenario is a perfect example of “too much to do and not enough time to do it…
Opinion: Should the AIAG Be in the FMEA Software Business?
Richard Harpster
On Oct. 13, 2018, the Automotive Industry Action Group (AIAG) sponsored a webinar on the status of the AIAG Core Tools Software (AIAG CTS). John Cachat, AIAG project manager for the AIAG CTS project, was the presenter for the webinar. The presentation provided information on why the AIAG was…
Inside Quality Digest Live for December 21, 2018
Dirk Dusharme @ Quality Digest
We tied up last year in a neat little bow, talking about how stories define ourselves and our work; waste is waste, no matter your political leanings; and putting numbers from the news in context. “The Gift of Being Small” This article by Quality Digest’s Taran March wonderfully illustrates how we…
ISO 9001: It’s About the Records, Not the Documents
Bretta Kelly
Back in January 2009, I wrote an article for Quality Digest titled “ISO 9001 Documentation Is Like a Box of Chocolates.” Here we are, almost 10 years later, all of the ISO 9001 and related standards have been updated, yet companies still misunderstand what to document, how to document, or why to…
ISO 14001, ISO 50001 Benefit the Environment and the Bottom Line
William A. Levinson
The U.S. government’s Fourth National Climate Assessment warns that climate change “creates new risks and exacerbates existing vulnerabilities in communities across the United States, presenting growing challenges to human health and safety, quality of life, and the rate of economic growth.” The…
Historic Vote Ties Kilogram and Other Units to Natural Constants
NIST
A convocation of delegates representing 60 countries voted last month in Versailles, France, to implement the most significant change to the International System of Units (SI) in more than 130 years. For the first time, all measurement units will be defined by natural phenomena rather than by…
Five Role-Model Organizations Win 2018 Baldrige National Quality Award
NIST
The U.S. Department of Commerce announced that the 2018 Malcolm Baldrige National Quality Award will be given to two educational institutions, an organ donor group, a hospital, and a project management firm. A presidential-level honor, the award recognizes exemplary U.S. organizations and…
Inside Quality Digest Live for Nov. 16, 2018
Dirk Dusharme @ Quality Digest
In this episode we look at lessons learned (or not) from GE, the difference between ISO and FDA “requirements,” and this year's Baldridge recipients. “GE’s Lessons Won’t Determine Whether You Succeed or Fail” Does the success or failure of GE’s CEO really matter that much when it comes to how most…
The Benefits of a Connected Quality Platform
Ryan E. Day
BioBridge Global (BBG) is a parent organization for four subsidiary organizations, three of which are involved in production activities, and they’re all around regenerative medicine, including blood components, clinical laboratory testing, and cell and tissue therapies. Organizations in the life…
FDA: Innovation Spoken Here
Taran March @ Quality Digest
These days, even regulatory agencies must innovate if they expect to keep pace with the speed of doing business. The U.S. Food and Drug Administration is no exception, and this year especially it has challenged itself to find ways to enhance efficiency and update old regulations. Quality Digest has…
Canada's MDSAP Mandate Could Be Bad for Canadian Healthcare
Dirk Dusharme @ Quality Digest
The Dec. 31, 2018 deadline looms for medical device companies that sell their devices in Canada. On that day, any company that sells medical devices to Canada will either need to hold an MDSAP certificate or show proof that they are on track to be MDSAP certified, or they won’t be able to sell…
Quality’s Role in Biomedical Morals and Ethics
Mike Richman
The future is the ultimate abstraction; anyone who has ever attempted to discern the nature of tomorrow by looking at the yesterdays leading up to today knows that prediction is a fool’s errand. That’s the unfortunate reality for weather forecasters, stockbrokers, sports bookmakers, political…
Life Science Pioneer Takes Cues From 21 CFR and ISO 13485
Ryan E. Day
One of the unique aspects of Finch Therapeutics is that although its product does not fall easily into any regulated category and thus is not FDA-approved, the company has been working closely with the agency for at least five years. The FDA has broad jurisdiction to regulate all health products,…
Top Five Things Life Science Companies Need to Know about ISO and FDA Requirements
Matthew M. Lowe
Life science companies play a major role in the global economy, with revenues expected to reach a staggering $1.5 trillion by 2020.1 Such a rosy forecast is likely to attract innovators and encourage current industry players to blaze new trails. Whether new or established, life science companies…
Use ISO 45001 to Support OSHA VPP Star Status
William A. Levinson
Chad Kymal1 gave an excellent overview of the ISO 45001 occupational health and safety (OHS) standard that was released in March 2018. I purchased a copy of the standard, and it provides an excellent framework, modeled on Annex SL, which defines the structure of all the new ISO standards, for an…
Occupational Health and Safety: A Standard Approach
Andreas Engelhardt
An international standard that specifies requirements for an occupational health and safety (OH&S) management system, ISO 45001:2018—“Occupational health and safety management systems–requirements” replaces OHSAS 18001 as the primary OH&S standard used internationally. It follows other…

Pagination

  • First page « First
  • Previous page ‹ Previous
  • …
  • Page 7
  • Page 8
  • Page 9
  • Page 10
  • Current page 11
  • Page 12
  • Page 13
  • Page 14
  • Page 15
  • …
  • Next page Next ›
  • Last page Last »
      

© 2025 Quality Digest. Copyright on content held by Quality Digest or by individual authors. Contact Quality Digest for reprint information.
“Quality Digest" is a trademark owned by Quality Circle Institute Inc.

footer
  • Home
  • Print QD: 1995-2008
  • Print QD: 2008-2009
  • Videos
  • Privacy Policy
  • Write for us
footer second menu
  • Subscribe to Quality Digest
  • About Us
  • Contact Us