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

The QA Pharm’s picture

By: The QA Pharm

Weekly CGMP Quiz 1: Part 210 & 211 Subpart A General Provisions. Use with your team for training credit!

This is the first of eleven quizzes on CGMPs that will appear weekly on QA Pharm. Try it yourself, and use it as a discussion tool for your staff groups.

Also, each quiz will have one letter tile at the bottom. Collect all eleven tiles and unscramble the letters for an important message.

When you have completed all 11 quizzes, you will have satisfied the requirement in 21CFR211.25(a) for continuing CGMP training. Be sure to document this training according to your established procedures.

An answer key will be provided after the eleventh quiz to use for further discussion.

 

Heather Thompson’s picture

By: Heather Thompson

Software as a medical device (SaMD) is a growing sector in medical device technology. Through the use of artificial intelligence and machine learning, SaMD has the power to influence health on a global scale as well as allow for personalization in medicine and life-saving therapies.

Medical device companies developing these products can take advantage of the FDA’s new programs designed to advance trusted companies so they can get products to market efficiently and effectively.

Equally important, if you want to be part of the SaMD trend and its accompanying regulatory pathway, the FDA is clear: Make sure your quality management system (QMS) is exemplary.

ISO’s picture

By: ISO

As artificial intelligence (AI) becomes increasingly ubiquitous in various industry sectors, establishing a common terminology for AI and examining its various applications is more important than ever. In the international standardization arena, much work is being undertaken by ISO/IEC’s joint technical committee JTC 1—Information technology—Subcommittee SC 42—Artificial intelligence, to establish a precise and workable definition of AI. Through its working group WG 4, SC 42 is looking at various use cases and applications. The convener of SC 42/WG 4 is Fumihiro Maruyama, senior expert on AI at Fujitsu Laboratories.

Currently, there are a total of 70 use cases that the working group is examining. Health, for example, is a fascinating area to explore. Maruyama himself describes one use case in which a program undertakes a “knowledge graph” of 10 billion pieces of information from existing research papers and databases in the medical field. The application then attempts to form a path representing the likely development from a given gene mutation to the disease that deep learning has predicted from the mutation.

Chad Kymal’s picture

By: Chad Kymal

With the advent of the internet, cloud, and electronic workflows, what is the future of documented management systems? Do we continue with a structure of quality manual, processes, work instructions, and forms and checklists? How do we imagine the future of documented management systems?

For enterprise and site documentation, there’s a need for all entities, from site to department to individuals, to have their own documented management system structure. The documented management system should be a repository of organizational knowledge, in the form of documentation, records, projects, audits, dashboards, customer and/or interested party needs and expectations, calibration data, and much more. How is this possible?

Furthermore, documented flows should give way to virtual electronic workflows that help implement and sustain an integrated management system.

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