Content By Quality Digest

David Stevens’s picture

By: David Stevens

The United States has more than 6,000 hospitals, and each one has thousands, if not tens of thousands, of clinical assets, such as imaging machines, ventilators, and IV pumps. Managing this equipment becomes a mighty task when hospital staff must handle the monitoring, repair, and maintenance of each.

Even a minor mistake could prove problematic. Missteps can bring on unnecessary expenditures, compromise patient care, and exhaust both the time and spirits of hospital staff. According to TRIMEDX’s health provider surveys, nurses spend up to an hour each shift just locating equipment or verifying its cleanliness.

Avoiding such troubles begins with determining your vulnerabilities within your asset management system. Healthcare facilities struggle with clinical asset management in four fundamental ways.

Richard Harpster’s picture

By: Richard Harpster

On Dec. 7, 2021, Ford Motor Co. updated its IATF 16949—“Customer specific requirements” (CSR), which require the use of reverse FMEAs (RFMEA) on new equipment (“tooling”). The first sentence of the reverse FMEA requirement reads: “Organizations are required to have a process in place that ensures all new launches complete an RFMEA event once the equipment is installed and running.”

As one might expect, multiple webinars are offered by RFMEA training providers, as well as two-day RFMEA classes ranging in price from $795 to $995. My guess is that it won’t be long before RFMEA software is available for purchase.

Having spent six years as a Ford plant and equipment design engineer, and an additional 32 years afterward helping companies manage new tooling risk, I see significant problems with the RFMEA processes being proposed by RFMEA training providers. Ford’s objective in requiring companies to use the RFMEA is to ensure that their suppliers effectively manage tooling risk.

Quality Digest’s picture

By: Quality Digest

(Brightpearl: Bristol, U.K.) -- Small merchants in the US are struggling to get to grips with spiralling delays and costs of major Enterprise Resource Planning (ERP) projects, according to a new study by Brightpearl, a world-leading retail operating system.

Leaders from more than 500 small-to-medium sized retailers took part in a study, which found that major ERP projects take six months longer than they were told to get live.

Jeremy L. Boerger’s picture

By: Jeremy L. Boerger

You may not be familiar with the term “information technology asset management” (ITAM), but most businesses deal with it on a regular basis (for better or worse). ITAM is what helps control the costs of computers, servers, software, and services used to create the computing environment modern businesses need to function.

Ideally, the ITAM team (you do have one, right?) should be able to tell their business leadership the exact number of laptops in use by a remote sales force, or if more software licenses are needed to avoid a monstrous audit penalty at year’s end, or the costs of limping along on Windows 7 because that one CAD/CAM tool can’t handle the latest operating system.

Quality Digest’s picture

By: Quality Digest

(ASTM: West Conshohocken, PA) -- A new ASTM International standard will provide guidance to medical device manufacturers on powder reuse in powder bed fusion manufacturing processes.

Kari Miller’s picture

By: Kari Miller

Quality management is essential to the growth and performance of any organization. It’s a valuable resource in the effort to ensure that products and services satisfy the highest quality requirements and deliver positive customer results.

Pharmaceutical manufacturers must ensure that the ingredients and packaging materials they use comply with regulatory requirements and meet the standards their markets expect. Risk-based, incoming supplier-product inspections help optimize supplier compliance, improve quality, and boost company profitability.

How risk-based supplier inspections work

Conducting a risk-based inspection (RBI) program requires companies to implement a system that includes three primary components: a sampling plan, a skip lot schedule, and inspection state switching rules.

Quality Digest’s picture

By: Quality Digest

(Qualio: San Francisco) -- Qualio, a trusted cloud quality management system for the entire life sciences ecosystem, announced significant growth during the first half of 2022, including expanded business and technology integration capabilities, and an enhanced consulting partner program.

“As the emerging life sciences ecosystem evolves post-pandemic, companies and the organizations that support them run up against silos of data and broken processes that impede their ability to get critical products to market,” says Robert Fenton, Qualio’s CEO and founder. “We take our mission to enable life sciences companies to launch and scale lifesaving products faster very seriously, and that’s why we’ve doubled down on product, people, and partner growth over the last few months.”

Gleb Tsipursky’s picture

By: Gleb Tsipursky

Elon Musk recently demanded that all Tesla staff return to the office full-time, according to an email sent to executive staff and leaked on social media. Musk said those who don’t want to come to office should “pretend to work somewhere else,” insinuating that those who work from home aren’t actually working.

This authoritarian, top-down approach rooted in mistrust and false assumptions goes against best practices. It speaks to an illusion of control that will undermine employee productivity, engagement, innovation, retention, and recruitment at Tesla.

Quality Digest’s picture

By: Quality Digest

(L.S. Starrett Co.: Athol, MA) -- L.S. Starrett Co., a leading global manufacturer of precision measuring tools and gauges, metrology systems and more, will be demonstrating the latest in quality control inspection technology at International Manufacturing Technology Show booth 135044 in the Quality Pavilion, East Hall in McCormick Place in Chicago from Sept 12- 17, 2022.

For the first time at a live major event, attendees can see demonstrations of automated wireless measurement data capture and transmission from handheld wireless/electronic gauges via the new DataSure 4.0 Wireless Data Collection System, or from vision systems and optical comparators via integrated software supporting Industry 4.0, IoT, and the Digital Factory.

William A. Levinson’s picture

By: William A. Levinson

Quality-related data collection is useful, but statistics can also deliver misleading and even dysfunctional results when incomplete. This is often the case when information is collected only from surviving people or products, extremely satisfied or dissatisfied customers, or propagators of bad news about relatively rare incidents. This is simply an extension of the basic principle that a sample should reflect the entire population rather than just a portion—especially a portion that might self-select for the indicated reasons.

Survivor bias

Survivor bias occurs when samples include only people or items that survive harmful conditions. When World War I started in 1914, the soldiers of most armies wore cloth or leather caps that provided almost no protection against shrapnel and small arms fire. The French, for example, replaced their world-famous kepi with the equally recognizable Adrian helmet only in 1915. The British followed suit and introduced the Brodie, later called “Tin Kelly,” helmet. Even the famous German spiked helmet was made of leather and not steel, to be replaced by the Stahlhelm a year into the war.