Tom Taormina’s picture

By: Tom Taormina

Each article in this series presents new tools for increasing return on investment (ROI), enhancing customer satisfaction, creating process excellence, and driving risk from an ISO 9001:2015-based quality management system (QMS). They will help implementers evolve quality management to overall business management. In this article we look at the clauses and subclauses of Section 10 of the standard.

10 Improvement

Define “improvement.” In quality parlance it typically means reducing defects and making processes more efficient and mistake-proof. For the CFO it might be improving the return on investment numbers on the financials. For the marketing director it might be expanding market share. For the CEO it might be exceeding the expectations of the board of directors.

The theme of this series includes “presents new tools for increasing return on investment (ROI), enhancing customer satisfaction, creating process excellence, and driving risk from an ISO 9001:2015-based quality management system (QMS).” To conclude the theme, we will look at Clause 10 from a more holistic perspective.

10.1 General

10.1 and excellence

Del Williams’s picture

By: Del Williams

Approximately 48 million people in the United States (one in six) get sick, 128,000 are hospitalized, and 3,000 die each year from foodborne diseases, according to the Centers for Disease Control and Prevention. Consequently, the FDA Food Safety Modernization Act (FSMA) is transforming the nation’s food safety system by shifting the focus from responding to foodborne illness to preventing it.

As part of the focus on preventing foodborne illness, 3-A Sanitary Standards, an independent, not-for-profit corporation for advancing hygienic equipment design for the food, beverage, and pharmaceutical industries, has recently updated its standards. The company, which maintains a large inventory of design criteria for equipment and processing systems developed to promote acceptance by USDA, FDA, and state regulatory authorities, no longer accepts “3-A compliant” as a legitimate claim.

Carson MacPherson-Krutsky’s picture

By: Carson MacPherson-Krutsky

Since the days of painting on cave walls, people have been representing information through figures and images. Nowadays, data visualization experts know that presenting information visually helps people better understand complicated data. The problem is that data visualizations can also leave you with the wrong idea—whether the images are sloppily made or intentionally misleading.

Take, for example, the bar graph presented during an April 6, 2020, press briefing by members of the White House Coronavirus Task Force. It’s titled “COVID-19 testing in the U.S.” and illustrates almost 2 million coronavirus tests completed up to that point. President Trump used the graph to support his assertion that testing was “going up at a rapid rate.” Based on this graphic, many viewers likely took away the same conclusion—but it is incorrect.

Tom Taormina’s picture

By: Tom Taormina

Each article in this series presents new tools for increasing return on investment (ROI), enhancing customer satisfaction, creating process excellence, and driving risk from an ISO 9001:2015-based quality management system (QMS). They will help implementers evolve quality management to overall business management. In this article we look at the clauses and subclauses of Section 9 of the standard.

Clause 9—Performance evaluation

Clause 9 is the part of the standard that we can use to truly quantify business excellence and risk avoidance. I will propose paradigm shifts that will make the outputs of this clause more informative for senior management and will include actionable recommendations that can contribute to the success factors that are immediately palatable and implementable for the leadership.

9.1.1 Monitoring, measurement, analysis, and evaluation—General

9.1.1 and excellence
This subclause requires that the organization must establish what needs to be monitored, measured, analyzed, and evaluated.

William A. Levinson’s picture

By: William A. Levinson

The U.S. House of Representatives has passed the HEROES Act (Health and Economic Recovery Omnibus Emergency Solutions Act)1 which will, if approved by the Senate and president, require OSHA to develop a standard for workplace protection against Covid-19.

Under section 120302 the legislation says specifically (emphasis is mine):

“(a) EMERGENCY TEMPORARY STANDARD

(1) In general—in consideration of the grave danger presented by COVID-19 and the need to strengthen protections for employees, notwithstanding the provisions of law and the Executive orders listed in paragraph (7), not later than 7 days after the date of enactment of this Act, the Secretary of Labor shall promulgate an emergency temporary standard to protect from occupational exposure to SARS-CoV-2

(A) employees of health care sector employers;
(B) employees of employers in the paramedic and emergency medical services, including such services provided by firefighters and other emergency responders; and
(C) other employees at occupational risk of such exposure. ...

Tom Taormina’s picture

By: Tom Taormina

Each article in this series presents new tools for increasing return on investment (ROI), enhancing customer satisfaction, creating process excellence, and driving risk from an ISO 9001:2015-based quality management system (QMS). They will help implementers evolve quality management to overall business management. In this article we look at the clauses and subclauses of section 8 of the standard.

Clause 8: Operation

Clause 8 contains the requirements for planning, designing, and bringing to fruition your products or services. The processes within this clause must be robustly implemented to achieve business excellence. They must also be continually scrutinized for foreseeable risk.

8.1 Operational planning and control

8.1 and excellence
The “plan” is a series of interrelated process, each with acceptance criteria, and each with metrics that tie to the organization’s key objectives and key process indicators. Or, at least that has been my interpretation while leading scores of implementations.

Mary Rowzee’s picture

By: Mary Rowzee

During the first six months after the publication of its first edition in June 2019, the AIAG & VDA FMEA Handbook gained popularity in the global automotive industry. Both U.S. and European OEMs have started to require the AIAG VDA approach to failure mode and effects analysis (FMEA) in their programs. Like the AIAG Guidebook, fourth edition, the handbook provides guidance, instruction, and illustrative examples of the requisite analytical techniques. The activities and analyses historically involved in FMEA have been formalized as discrete steps in the handbook.

 The seven-step approach described in the handbook and outlined here guides the development of design, process, and supplemental monitoring and system response of FMEA through the sequencing (and the iteration) of described activities.

Dawn Bailey’s picture

By: Dawn Bailey

In this article series, we explain some of the successful strategies and programs shared by Baldrige Award recipients to highlight categories of the Baldrige Criteria and how your organization might consider using them as inspiration. 

Quality Digest’s picture

By: Quality Digest

It’s easy to assume that something as simple as a mask wouldn’t pose much of a risk. Essentially, it’s just a covering that goes over your nose and mouth.

But masks are more than just stitched-together cloth. Medical-grade masks use multiple layers of nonwoven material, usually polypropylene, designed to meet specific standards for how big and how many particles they can block. And they are tested and certified to determine how well they do that job.

Healthcare and other frontline workers usually use either a surgical mask or an N95 mask. Both protect the patient from the wearer’s respiratory emissions. But where surgical masks provide the wearer protection against large droplets, splashes, or sprays of bodily or other hazardous fluids, an N95 mask is designed to achieve a very close facial fit and very efficient filtration of submicron airborne particles.

The “N95” (or “KN95”) designation means that the respirator blocks at least 95 percent of very small (0.3 micron) test particles. If properly fitted, the filtration capabilities of N95 respirators exceed those of face masks.

Gleb Tsipursky’s picture

By: Gleb Tsipursky

So many companies are shifting their employees to working from home to address the Covid-19 coronavirus pandemic. Yet they’re not considering the potential quality disasters that can occur as a result of this transition.

An example of this is what one of my coaching clients experienced more than a year before the pandemic hit. Myron is the risk and quality management executive in a medical services company with about 600 employees. He was one of the leaders tasked by his company’s senior management team with shifting the company’s employees to a work-from-home setup, due to rising rents on their office building.

Specifically, Myron led the team that managed risk and quality issues associated with the transition for all 600 employees to telework, due to his previous experience in helping small teams of three to six people in the company transition to working from home in the past. The much larger number of people who had many more diverse roles they had to assist now was proving to be a challenge. So was the short amount of time available to this project, which was only four weeks, and resulted from a failure in negotiation with the landlord of the office building.

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