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Understanding the Customer Journey Map
I’ve written previously about 11 myths and mistakes about journey mapping, but I should add one more myth, which is really the umbrella myth that likely encompasses all the others: Journey mapping is just a tool. Nope, it’s not just a tool; it’s not just a workshop: It’s a process. Journey mapping…
Inside Quality Digest Live for Nov. 16, 2018
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…
Let’s Measure Effort, But...
I recently had eye surgery that required me to sleep on my back for two weeks following the operation. I have always slept on my side, ever since I was a kid. My back-sleeping attempts are so challenging, I am never able to nap on those United States to Europe flights. I usually end up burning a…
The Benefits of a Connected Quality Platform
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
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
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
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
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
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…
A Survival Guide for the Era of ‘Alternate Facts’
Last year I was invited to give a lecture on critical thinking to the U.S. Navy. I opened my presentation with a story I’d read in Reader’s Digest magazine as a child. It’s an old story you may have heard before, but it’s a perfect introduction to the importance of critical thinking. Here’s how it…
Work That Matters Starts With Matters That Work
To most of us, the phrase “work that matters” infers job satisfaction. The outcome is lower stress, lower turnover, and higher productivity—in business, a win-win for employees, customers, and shareholders. The logic is infallible. So, I ask you, why is there such a gap between the theory and the…
Inside Quality Digest Live for Oct. 26, 2018
In this episode we look at a history of quality, how you serve your customer in the housing industry, and what makes a good review. “Young couples ‘trapped in car dependency’” Building entry-level housing along highways may give couples the chance to buy a home, but at what cost to them and the…
Perfect Information: Customer Reviews That Influence Purchasing Decisions
Whether you are booking a hotel room, choosing a restaurant, deciding on what movie to see, or buying any number of things, it is likely you have read online reviews before making your decision. What makes a consumer review persuasive, though? No matter how short, it tells a story in much the same…
Continuous Feedback Is the New Way Forward for Employee Reviews
Traditionally, managers have relied on the annual performance review to provide employees with feedback. However, surveys indicate employees don’t find the process valuable. Simply meeting once a year to discuss their progress doesn’t give employees a thorough sense of their own performance. It…
Inside Quality Digest Live for Oct. 12, 2018
In this episode we look at data, data, more data, and then... engineering the perfect human? “Your Data Are Your Most Valuable Assets” Just what the heck is Quality 4.0? Remember this acronym: CIA. No, not that CIA. Nicole Radziwill explains. “Applying Smart Manufacturing Technology to Conduct…
Occupational Health and Safety: A Standard Approach
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…
Inside <em>Quality Digest Live</em> for Sept. 21, 2018
IMTS was a blast, but it was great to be back home in lovely Northern California this week. On this episode of QDL, we covered the skills that workers need and the innovations that organizations want. Plus, we brought you a live interview with author Mark Graban, and one on tape from Burt Mason of…
Book Review: <em>Data Sanity</em>
I must admit, right up front, that this is not a totally unbiased review. I first became aware of Davis Balestracci in 1998, when I received the American Society for Quality (ASQ) Statistics Division Special Publication, Data “Sanity”: Statistical Thinking Applied to Everyday Data. At the time, I…
It’s 2018. Do You Know Where Your Medical Records Are?
Can you imagine a future where the question, “Did you bring a copy of your test results?” becomes entirely unnecessary? That could happen, but the methods that most healthcare providers use to exchange healthcare information are little different than they were 5,000 years ago, when physicians…
It’s 2018. Do You Know Where Your Medical Records Are?
Can you imagine a future where the question, “Did you bring a copy of your test results?” becomes entirely unnecessary? That could happen, but the methods that most healthcare providers use to exchange healthcare information are little different than they were 5,000 years ago, when physicians…
How the Mayo Clinic Built Its Reputation As a Top Hospital
‘How is it that in the middle of a relatively small town of about 125,000 people in Minnesota, you’ve got the No. 1-rated healthcare system probably in the world?” The question was put to Jeffrey Bolton—the Mayo Clinic’s chief administrative officer—by Larry Jameson, executive vice president of…
MDSAP: When Is a Certificate Not a Certificate?
The Dental Trade Alliance learned from its members in February 2018 that the Canadian Health Ministry (“Health Canada”) had contacted the Standards Council of Canada (SCC) and the British Standards Institution (BSI). Health Canada had ordered these certification bodies to stop issuing ISO 13485…
Inside Quality Digest Live for September 12, 2018
With more than 110,000 expected attendees, IMTS is Chicago’s hottest suburb this week. (I like to refer to it as “Manufactureville.”) Here’s what we covered during our second show of the week, from the booth of today’s sponsor, Q-Mark Manufacturing: “Tapping Your Employee’s Knowledge” It’s no…
What Business Are You Really In?
Mary Parker Follett, a pioneering business consultant, was asked to help a troubled window shade company. The company’s thinking was narrow and limited. When asked to define their business, they said, “We produce window shades.” She asked them “What business are you really in from your customer’s…
Change and the Single-Title Media Company
If you want to keep stretching and improving, you’d better get comfortable with the discomfort of change. People have been saying that for decades, yet each time we successfully adjust to new business developments—or personal developments, for that matter—what’s the first thing we tend to want to…

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