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

Tom Taormina’s picture

By: Tom Taormina

In 1989, I was handed a copy of ISO 9001:1987 by my employer with the direction to find out what it was all about. Our company was headquartered in Europe, and we would be compelled to implement the standard straightaway.

My first reaction was that I wished it had been published 20 years earlier when I was operating under the burdensome military specification MIL-Q-9858A. ISO 9001 was very straightforward and written so that virtually any organization could use is as the foundation for an effective quality management system.

The local ASQ section was abuzz about the new standard and eager to “interpret” the requirements. Those who were in quality management were excited to present the standard to senior management as the new solution for lowering defects and scrap rates.

Early adopters were classically trained quality professionals. ISO 9001:1987 was titled “Quality systems—Model for quality assurance in design/development, production, installation, and servicing.” This standard had the potential, we hoped, to inculcate the tenets of quality management into an entire organization. And the quality managers saw it was good.

Calin Moldovean’s picture

By: Calin Moldovean

As today’s industries and operations become increasingly more global, an effective management system is rapidly becoming an essential part of a sustainable business strategy. A management system defines how work is done, the desired results, and the controls imposed to ensure those outcomes.

Your management system certification is more than a manual and more than the certificate on the wall. It’s a critical tool that will help you meet requirements (customer, regulatory, and legal), minimize risks, strengthen your market position, protect your brand, focus on the customer, improve organizational efficiency, and reduce costs. If your certifying body is not helping you continually improve your management system performance, then you should consider transferring your certifications.

Your certified management system should bring continual improvement throughout your organization, including:

1. Stronger leadership

William A. Levinson’s picture

By: William A. Levinson

The Automotive Industry Action Group’s (AIAG’s) and German Association of the Automotive Industry’s (VDA’s) new Failure Mode and Effects Analysis Handbook (AIAG, 2019) offers significant advances over FMEA as practiced 15 or 20 years ago.The publication is definitely worth buying because the new approach includes valuable methodology; this article will cover the most important points and highlights.

New features

The new process is qualitative rather than quantitative, which overcomes a major drawback of the previous approach. The older occurrence ratings were based on the probability of a failure, and the older AIAG manuals even tabulated recommended nonconforming fraction ranges. If, for example, the failure was 50 percent or more likely, the occurrence rating was 10 (worst possible on a 1 to 10 scale), while one or fewer per 1.5 million opportunities earned a rating of 1. These probabilities can be estimated from a process capability study, assuming that one is available; otherwise, one might easily have to guess.

Michael Lueck’s picture

By: Michael Lueck

After the first crash, of Lion Air in Indonesia in October 2018, people blamed poor maintenance and insufficient pilot training. When a second airliner, an Ethiopian Air aircraft, crashed in March 2019, similarities quickly transpired. There was no apparent external influence such as poor weather. Neither was there any interference with the flight decks, as in a hijacking.

In both cases the pilots could not keep the aircraft from nose-diving. Airlines and regulators around the world started grounding the MAX indefinitely. Australia’s Civil Aviation Authority prohibited any B737 MAX aircraft in its airspace, followed by New Zealand’s Civil Aviation Authority.

Surprisingly, the last authority to clamp down was the U.S. Federal Aviation Administration, the governmental body in charge of certifying aircraft.

Miriam Boudreaux’s picture

By: Miriam Boudreaux

If you are wondering whether your organization could benefit from formal root cause analysis (RCA) and corrective action training, read on to see if any of these issues are present in your day-to-day operations. RCA and corrective actions are some of the most useful tools for continual improvement.

Here’s why you should include them among your company’s (and all employees’) tool set.

1. High number of NCRs in your company

It’s true that the number of nonconformance reports (NCRs) will depend on the volume of operations a specific company has. Therefore, the “number” of NCRs is a relative figure. However, if you know you have a high number of NCRs, the issue may be that you are not performing effective RCA and corrective action.

Quality Digest’s default image

By: Quality Digest

As usual with Quality Digest’s diverse audience, this year’s top stories covered a wide range of topics applicable to quality professionals. From hardware to software, from standards to risk management, from China trade to FDA regulations. It’s always fun to see what readers gravitate to, and this year was no different.

Below are five articles that garnered a lot of interest from our readers. As you can see, the topics are quite diverse.

Improve Risk Management and Quality Across the Value Chain by Increasing Visibility
by Kelly Kuchinski

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