Mar 31, 2016

Six Signs of Potential FSMA Fakes

Beware of companies offering a 
quick-fix for FSMA compliance systems.

by Nye Joell Hardy 

Food Safety Technical and Regulatory Writer

Since companies that grow or process fresh produce are now required to follow the Food Safety Modernization Act of 2011, it should be no surprise that there are people out there trying to make a buck off of all that confusion and desperation.  Some of these companies are honestly putting their best food forward in trying to meet your needs, but there are others you should worry about, especially if they say any of these six things: 

Mar 29, 2016

ISO 9001:2015 - A Powerful Addition to Your Professional Tool Kit

Anyone considering a career in 
management should consider becoming 
familiar with ISO 9001:2015 to improve 
business performance and make you a 
smarter, more effective professional.

by Greg Peckford

Founder, Quality Career Advancement

There are over one million organizations in over 170 countries registered to ISO 9001. That alone is a pretty impressive statistic claimed by www.iso.org. But what this stat is missing are the countless other companies worldwide that have adopted the ISO 9001 standard as a blueprint for the development and implementation of their quality management systems without becoming formally certified.

So with so many companies and organizations following this diverse management standard, wouldn't it seem beneficial to incorporate it into your career development strategy?

Quality management gets a bad rap. The fundamental concepts of process improvement and ensuring customer satisfaction can, many times, turn into a game of "gotcha," with misguided audits turning up endless infractions against procedures that often do not accurately reflect the day-to-day activities of the people performing the work, and is essentially worth no more than the paper on which they are printed. We begin to see quality as a necessary evil that is forced upon us, but really serves no purpose to the organization's bottom line.

This is a flawed interpretation of a very powerful business management tool, and in this post I am going to show you how quality management, and the new ISO 9001:2015 standard in particular, can help to improve business performance, make you a smarter, more effective professional, and help to elevate your career regardless of the industry in which you work.

Mar 24, 2016

Quality Management has Moved On!

ISO certification gets you noticed 
and in the contracting crowd.

by Andrew Foy

Owner, Foy Certification Ltd.

Quality assurance was originally conceived to document a set of procedures aimed at ensuring that quality standards and processes were adhered to by a business; but has now moved beyond the tick box concept and can play an integral part in improving business performance.

Specialist contractors are increasingly expected to demonstrate independent certification to the ISO standards of Quality Management (ISO 9001), Environmental Management (ISO 14001) and Health & Safety Management (OHSAS 18001), especially if they want to work for the better customers at the higher levels of the industry.

Mar 22, 2016

Stop Asking Why

Sometimes the "why" question should
be broken into smaller parts.

by Harish Jose 

Senior Quality Engineer


We have been trained to ask “why” a lot in lean. Today’s post is about asking “why.”

My friend was doing data analysis of ERP transactions, and he noticed that the material handler was creating transactions in two different programs for dock-to-stock components. This process created double entries and did not seem to add value. He asked the question “why” and the material handler reported that she was doing it because it was the way she was trained, and because it was the way they had always done it.

I was always curious about the “5 Why” method. English is my second language, and in my native language (Malayalam), I cannot ask the “why” question because it means more than one thing.

Mar 17, 2016

The SCIO Concept: How to Conduct Cost-Effective Clinical Trials

For the past 20 years, the cost of new drug 
development has risen at a rate that was 7.4% 
higher than inflation, and clinical trials bear 
responsibility for most of that increase. 

Don’t Make Common Mistakes in Clinical Strategy

by Dr. Candida Fratazzi M.D.

Founder/CEOBBCR Consulting 

(Boston Biotech Clinical Research)

The average cost of developing a new drug is notoriously high. In a study conducted through the Tufts Center for the Study of Drug Development in 2014, Dr. Henry G. Grabowski and Dr. Ronald W. Hansen concluded, “The estimated average pre-tax industry cost per new prescription drug approval (inclusive of failures and capital costs) is 2,558 billion.” The story does not end here. For the past 20 years, the cost of new drug development has risen at a rate that was 7.4% higher than inflation, and clinical trials bear responsibility for most of that increase. However, the increasing cost of biomedical research is not reflected in an increase in the success rate of clinical development. Instead, it presents a major hindrance to innovation in the biotech industry, while the public must bear the brunt of the problems, absorbing the steep rise in the prices of drugs and medical devices. In order to boost the efficiency of the biotechnology industry, remove the burden of expensive drugs, and create life science products in line with the future of healthcare, we should be asking how best to modify the development process to make it cost-effective.  

Mar 15, 2016

Study Sites: Too Many Vendors, Too Little Time

Clinical site employees are dealing with 
more tech vendors than ever before, 
consuming time that should be spent 
running the study, working with study 
volunteers and keeping them safe.

by Laurie Meehan

Social Media Manager

Polaris Compliance Consultants, Inc.

“I can’t get the IWRS to assign a kit number.”
“My ECG reports take forever to come back from the Core Lab.”
“The eCRF won’t let me create a new subject.”
“This stupid machine is blinking an error code again.”

Sound familiar?  Sprinkle in some colorful adjectives and it probably does -- these problems are common enough at clinical research sites.  Equipment and systems have become increasingly technical and specialized, and study site staff has had to contend with more technology than ever before.  And because of the proliferation of niche vendors who provide the new tech, sites have had to deal with more vendors than ever before, too.  

Mar 14, 2016

Why We Trek to Trade Shows

by Jill Bumgardner

Global Events Manager


Most people generally support the notion that trade shows are still relevant, but sometimes a little pep talk is in order.

Now that our feet might have finally recovered from attending MD&M West, and we look to our schedule for the rest of the year, here are a few quotes demonstrating some of the top reasons we attend shows. Think of this as motivation for INTERPHEX and Medtec Euro!

The Trade Show News Network (TSNN), the world's leading news and online resource for the trade show, exhibition and event industry since 1996, provides some powerful data to support trade show attendance: 81% of trade show attendees have buying authority.  Which means more than 4 out of 5 people walking the aisles are potential customers for exhibitors.  Source:  CEIR: The Spend Decision: Analyzing How Exhibits Fit into the Overall Marketing Budget .

Mar 11, 2016

Leveraging Quality Management Systems to Visualize and Mitigate Risk at a Cross-Enterprise Level

Learn to use a quality management system at a 
cross-enterprise level during the Proactive 
GCP Compliance Conference

MasterControl Expert Addressing Proactive GCP Compliance Conference Audience Next Week

by Robyn Barnes
Marketing Communications

You may be familiar with what a quality management system (QMS) is, but do you know how to use one at a cross-enterprise level?

Mar 10, 2016

How to Explain Your Quality Job to Young Kids in 4 Steps

First-graders learn the concept of quality 
through a paper airplane building exercise.

by Lillian Erickson

Global Quality Manager, MasterControl Inc.

When it was time to celebrate Career Day at my daughter’s school, she begged me to come talk to her first-grade class. I dreaded it. How do you explain to 6- and 7-year-olds what a quality manager does?

In my eight years in the quality field, I’ve hosted over 200 client audits and faced some of the strictest auditors. I’ve spearheaded six ISO audits, the most recent of which was held last November, when MasterControl became one of the first companies in the world to successfully complete an audit under the new ISO 9001:2015 standard.

Yet, the idea of talking about quality to elementary-school kids intimidated me. If you’re a fellow quality professional facing the same situation, here’s how I overcame my fear and completed the formidable task successfully.

Mar 8, 2016

The #1 Cause of Medical Device Recalls—and How to Avoid It

FDA report lists faulty software 
design as top recall cause.

by Lisa Weeks,MasterControl Communications

Would it surprise you to learn that the most common cause of medical device recall, according to the FDA, is software design failure? It shouldn’t. These days, it’s hard to find a device that doesn’t rely on the use of sophisticated software to operate. What’s more, a defective software component is often harder to detect than, let’s say, a defective electrical component. It really is the perfect recipe for design disaster, but it doesn’t have to be—if you know how to use risk.

Mar 3, 2016

ISO 13485:2016 What are the Changes About?

The 2016 version of ISO 13485 was published 
in February 2016. Become familiar with 
the standard's changes so your 
products stay on target.

by Linda Chatwin, Esq, RAC

Manager Medical Regulatory Advisory Services

North America UL LLC

Current Status

ISO had published the final draft of the latest ISO 13485 quality management standard for medical devices, and placed it out for voting on October 29, 2015. After a two-month approval voting period, the standard was approved for official publication.  For background, once a standard has reached the Final Draft International Standard (FDIS) stage, comments and objections have been addressed, and only negative comments with well-reasoned, technical justification would be considered. Each technical reason is addressed in a comments resolution meeting, so that the parties resolve issues before the standard is published. 

Mar 1, 2016

Quality by Design Part 1: You Can't Design Something You Don't Understand

If the cost of poor quality is like an iceberg,
the obvious penalties are a lot less scary
than what lies below the surface.

by Beth Pedersen,

Marketing Communications


Just like every other aspect of a product, quality is determined by the decisions you make in the design stages. While spending less time on planning upfront might seem to save you money, the costs associated with poor quality resulting from early design decisions can ultimately equate to 40 percent of your company’s total revenue. Correctly understanding the true nature of quality and addressing it in the design stages rather than trying to bring it in as an afterthought is the central premise of Quality by Design (QbD), and adhering to this principle could be the most cost-saving measure your company will ever take.