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.

Oscar Combs’s picture

By: Oscar Combs

With the emergence of the coronavirus (Covid-19), many organizations are doing their part to prevent the spread of infection by practicing social distancing. Some organizations have implemented no-visitor policies, which helps prevent the spread of the disease, but is not so good when it comes to receiving services from their suppliers, which may require onsite interaction.

This is especially true for consulting, auditing, and training services, which are typically performed by onsite visits. Traditionally, organizations have been reluctant to have these services delivered remotely using web conferencing technology, but Covid-19 has thrust remote service delivery into the forefront. This article will explain the benefits of using technology, such as web conferencing, to have consulting, auditing, and training services delivered remotely to your organization.

What is remote service delivery?

Remote service delivery provides services through a web conference platform, typically conducted through the internet.

Sean Spence’s picture

By: Sean Spence

The outbreak of the Covid-19 virus in China and the railway disruptions across Canada represent two different yet similar classic case studies. They remind us that nations and global economies are becoming increasingly interconnected. Incidents thousands of kilometers away are being felt locally. This is a result of the increasing importance of critical infrastructure (CI).

In order to mitigate these negative consequences to organizations—like lost revenue, lost customers and reputational damage—they must have well-structured and defined contingency plans in place to meet operational objectives.

What’s known as critical infrastructure has many different definitions within academic literature and among different governments worldwide. But essentially, CI can be defined as infrastructure so vital that its incapacity or destruction would have a debilitating impact on the economy or the defense of the country and therefore becomes a national security issue.

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 demonstrating and establishing various subclauses of Clause 5—Leadership, to build organizational excellence and assess risk.

Clause 5—Leadership

Words have meaning. Throughout the history of ISO 9001, the terms “top management” or “senior management” have been used to describe an organization’s decision and policy makers. These individuals are ostensibly those who are accountable to themselves or to a board of directors for the company’s success. They have the power to hire and fire, and to establish the organization’s operational infrastructure.

In work with more than 700 companies, the term “management” was most often appropriate because those in charge were directors and benevolent dictators. Very few were true leaders of people who created an environment where everyone could achieve their highest level of success and excellence.

Multiple Authors
By: Sheng Lin-Gibson, Vijay Srinivasan

Biopharmaceuticals, also known as biological drugs or biologics, are manufactured from living organisms, or contain living organisms that have been genetically engineered to prevent or treat diseases. Biologics are chemically and structurally complex, and often highly heterogeneous; therefore, controlling and maintaining quality remains a challenge. The potential for new therapeutics to cure and treat previously untreatable diseases is enormous, but there is still a long way to go before they can be manufactured at the required scale, with predictive control of quality, and at a lower cost. NIST’s Vijay Srinivasan and Sheng Lin-Gibson discuss their recent paper on some of the challenges and solutions associated with manufacturing these life-saving drugs.

Tom Taormina’s picture

By: Tom Taormina

In part one of this series, I said that I want to help my colleagues use their ISO 9001 implementation as a profit center and to turn risk-based thinking into risk avoidance. To do this I will share a set of tools that help evolve quality management into business management.

These tools include:
• Evolving the requirements of ISO 9001's Section 4 from merely defining the context of the organization to working with senior management to create, implement, and make shared vision, mission, and values a cultural imperative
• Redefining Section 5 to include roles and responsibilities for everyone in the organization that are measurable and inextricably tied to the key business success goals and metrics
• Including in Section 6 the tools and culture of risk avoidance
• Evolving Section 7 from support to an outcome-based, risk-and-reward culture
• Expanding the scope of Section 8 into a holistic business management system
• Redefining Section 9 from performance evaluation to an enterprisewide culture of individual and team accountability
• Expanding Section 10 from continual improvement to business excellence

Syndicate content