Quality Management : Risk Management


Dial Down

by Durivage, Mark

Traditionally, audit findings have been graded qualitatively using the generally accepted and widely used terms “minor” and “major” nonconformities....


Open Access

Clearing a Safe Path

by Taormina, Tom

The Oxford Dictionary defines risk as “a situation involving exposure to danger.” According to the Risk Management Institute, “Risk management involves understanding, analyzing and addressing risk to make sure organizations achieve their objectives.”...


Consuming the Concept of Risk

by Córdoba Galve, Vicente

One of the major changes to ISO 9001:2015 is the concept of potential nonconformity was replaced with the concept of risk. Because of this change, the primary purpose of a quality management system—prevention—must be restored....


Standard Issues: Truth or Consequences

by Aston, Bill

Most businesses and organizations recognize the importance of having established procedures that include requirements and acceptance criteria. It’s a fundamental building block for ensuring services and products meet customer needs....


Mining Matters

by Chadha, Rajeev

While switching my career from automotive to the mining sector, I realized that the mining of precious metals and commodities is inherently risky....


Open Access

Serious About Samples

by Peña-Rodríguez, Manuel E.

Sampling is one of the most-used methods in quality systems to control the output of any given process. Specifically, sampling allows organizations to distinguish between good product and defective product....


When Failure to Comply Is Not an Option

by Gooding, James L.

Managing change can demand more from an organization than the usual thoughts about migrating to new cultural values, behaviors and practices....


Open Access

Volviendo a los Fundamentos: Subir de Nivel

by Harkins, Ray

Además de cumplir con los requisitos de estándares de calidad específicos las métricas del sistema de calidad correctamente diseñadas también pueden servir como indicadores importantes sobre las fortalezas y debilidades de los diversos procesos....


Open Access

Back to Basics: Level Up

by Harkins, Ray

Developing and using metrics such as OEE that highlight an organization’s best opportunities for improvement have the potential to unlock the next level of profitability....


Impeding Progress

by Kovach, Jamison V.; Sharma, Pratibha

In general, organizational processes tend to be viewed simply as “the way we do things around here.” These routines can be a part of a formal or informal chain of process steps that are conducted to perform the work within an organization....


Open Access

Career Coach: Shades of Gray

by Wrestler, Denise

As quality assurance professionals, we spend a lot of our time making critical decisions that are black or white, yes or no. But sometimes we’re confronted with decisions that fall somewhere in the gray area between the right answer and the wrong answer....


Open Access

In Focus

by Breneman, Jim; Burrows, Dan; Durivage, Mark

Probably the most significant change to ISO 9001:2015—Quality management systems—requirements concerns integrating risk-based thinking as part of the quality management system (QMS) and decision-making processes....


Field Notes: Sorting It Out

by Laman, Scott A.

Medical device risk management is an interesting and rewarding profession because we perform critical analyses throughout a product’s life cycle to protect patients and users from harm....


New Tricks for an Old Tool

by Bukowski, Eugene R.

Failure mode and effects analysis (FMEA) is a popular risk assessment tool used to manage potential process and design risk. Not surprisingly, there may be failure modes associated with the activity of conducting an FMEA....


Entire Digital Issue: May 2017

by QP Staff

You are being directed to the May Digital Issue of QP. If your browser does not take you there click here....


Open Access

In Tandem

by Khan, Naeem

Opportunity management, a long-neglected concept in business literature, has finally been given more of the spotlight. Usually, it’s been risk management that has gotten more attention because of its negative impacts....


Expert Answers: December 2016

by Aston, Bill

Implementation of subclause 6.1 in ISO 9001:2015—actions to address risks and opportunities ......


Recognize, Rate and Resolve

by Fernandes, Christopher M.B.; Lambert, Brenda;

What do the nuclear power, airline and healthcare industries have in common? All operate in complex, high-risk environments in which accidents can be expected. How do the first two industries differ from healthcare?...


Entire Digital Issue: August 2016

by Hankel, Amanda

You are being directed to the August Digital Issue of QP. If your browser does not take you there click here....


Standards Outlook: Leaders of Change

by Aston, Bill

A case for risk-based thinking and organizational transformation....


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