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 Marie Bailey’s picture

By: Dawn Marie 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.

Julius DeSilva’s picture

By: Julius DeSilva

ISO 9001 certifications have seen a decline during the past two years, per data from ISO. Some say the standard has gotten too complicated with the introduction of organizational context, risk-based thinking, and the removal of mandatory documented procedures. Even a few of QMII’s clients have considered letting their certification lapse because conformity to the new standard was perceived as too complex.

To certify or not

Let’s begin by looking at the purpose of ISO 9001. The standard provides a framework for organizations looking to put in place a system that will enable them to consistently deliver products or services that meet their customers’ requirements and enhance their satisfaction. ISO 9001 certification is external validation that the system meets the requirements of ISO 9001. However, ISO 9001 allows organizations to use the standard and self-declare conformity without incurring the cost of certification. Many argue that there is no value in doing this. This is probably correct if you are implementing a system to meet a contractual or customer requirement. In these cases, certification is a requirement.

Multiple Authors
By: Donald J. Wheeler, Al Pfadt

Each day we receive data that seek to quantify the Covid-19 pandemic. These daily values tell us how things have changed from yesterday, and give us the current totals, but they are difficult to understand simply because they are only a small piece of the puzzle. And like pieces of a puzzle, data only begin to make sense when they are placed in context. And the best way to place data in context is with an appropriate graph.

When using epidemiological models to evaluate different scenarios it is common to see graphs that portray the number of new cases, or the demand for services, each day.1 Typically, these graphs look something like the curves in figure 1.


Figure 1: Epidemiological models produce curves of new cases under different scenarios in order to compare peak demands over time. (Click image for larger view.)

Mark Rosenthal’s picture

By: Mark Rosenthal

Sometimes I see people chasing their tails when trying to troubleshoot a process. This usually (though not always) follows a complaint or rejection of some kind.

A few years ago I posted “Organize, Standardize, Stabilize, Optimize” and talked in general terms about the sequence of thinking that gives reliable outcomes. This is a series of questions that, if asked and addressed in sequence, can help you troubleshoot a process. The idea is that you must have a very clear yes to every question before proceeding to the next.

Question 1: Is there a clear standard for the outcome?

Why is this important? Because if you don’t have a clear expectation of what “good” looks like, then your definition of “not good” is subjective and varies depending on who, what, and when things are being looked at.

Eric Stoop’s picture

By: Eric Stoop

According to the National Safety Council, the rate of preventable workplace fatalities per 100,000 workers has flattened or risen slightly since 2009 after decades of steady improvement in occupational safety.

Companies conducting layered process audits (LPAs) can help get the United States get back on track reducing the workplace fatality rate by conducting daily checks to help identify safety nonconformances and fix them before they cause safety incidents.

With daily checks of high-risk processes, layered process audits lead to more conversations about safety, also demonstrating that leadership prioritizes safe work—both critical to creating a culture of safety.

Achieving this level of reliability, however, doesn’t happen overnight. Organizations must first make a key mindset shift, and take a strategic approach to uncovering and resolving instances where people don’t follow standards.

The quality-safety link

Quality and safety may occupy two different departments in the average manufacturing organization, but the reality is that safety is itself an aspect of quality.

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