Quality Management : Risk Management


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....


Open Access

Standards Outlook: Prove It

by Guzik, John J.

How to demonstrate risk-based thinking for auditors....


Open Access

Quality in the First Person: Worth the Investment

by Vaidya, Jigish

Reliability professionals are often overlooked in the quality field, but their data analysis can save money and greatly improve the overall performance and outlook of your organization....


Open Access

One Good Idea: Risky Business

by Barsalou, Matthew

Evaluate the potential risk of a project decision by including risk factors in your prioritization matrix....


Open Access

Beyond Tried and True

by Coleman Sr., Lance B.

Risk elimination. Risk management. Risk mitigation. These phrases are an increasingly important part of the lexicon of management as organizations strive to succeed in a business environment with global competition, diverse suppliers and new technology....


Running a Risk

by James J. Rooney

A process for seeing decisions’ potential risks and adverse effects....


Adjust, Adapt and Advance

by Snee, Ronald D.

Quality is on the radar of many organizations, including the U.S. Food and Drug Administration (FDA) and pharmaceutical and biotech companies. Quality pioneer Joseph M. Juran predicted that the 21st century would be the “century of quality.”...


Entire Digital Issue: May 2016

by Hankel, Amanda

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


Innovation Imperative: Never Miss an Opportunity

by Merrill, Peter

Many organizations have approached ISO 9001:2015 implementation by mindlessly mitigating risk. Instead, they should go on the attack and think about opportunity first....


Open Access

Volviendo a los Fundamentos: Mitigación de Riesgos

by Wells, Greg

LAS ORGANIZACIONES DE VEZ EN CUANDO producen piezas no conformes y por lo tanto deben garantizar que dichas piezas no sean enviadas a los clientes....


Open Access

Back to Basics: Mitigate Risk

by Wells, Greg

Organizations occasionally produce nonconforming parts and must ensure defects are not shipped to customers. To prevent these defects from reaching customers, we need a foolproof process to manage products that are potentially nonconforming....


Open Access

Best of Back to Basics: Calculated Risk

by Sherman, Peter J.

A formula for balancing the cost of risk and uncertainty....


Open Access

Best of Back to Basics: Sufficient Evidence

by Suedbeck, John

A U.S. Federal Drug Administration standard on quality risk management provides guidance for applying quality risk management to supplier evaluation systems....



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