GxP Lifeline Medical Device Publication Click to visit GxP Lifeline Home Click to visit mastercontrol.com

Featured Articles

October 2012

Richard Vincins

Why You Need to Go Beyond Risk Analysis and Apply Total Risk Management

by Richard Vincins
Vice President of Quality Assurance, Emergo Group

Traditionally companies have been performing risk analysis to identify hazards, categorize the risk, and find methods for mitigating those risks. This approach has only been focused on the finished product with a limited view during design controls, not on how product is actually used. The risk analysis has been done as part of design and development with the development team itself identifying the risks and hazards. What we are seeing over the last few years is that risk analysis or risk assessment is just a part of the entire picture. Organizations are realizing that a total risk management system must be implemented for their quality system to gain the full advantage. This article will discuss how companies can integrate risk management philosophies and techniques into their quality system processes.

In this article, the term "risk management" will be used to encompass traditional risk analysis methods and risk assessment. The definition of risk management can be found in a couple of standards, notably ISO 31000 and ISO 14971. The causes for conducting risk management encompass a myriad of reasons, mainly the identification of hazards and control of those hazards to an acceptable level. Conducting only risk analysis through Failure Modes and Effect Analysis (FMEA) or Fault Tree Analysis (FTA) typically does not include the entire lifecycle of the product. By performing only FMEA/FTA there are aspects of risk management that are lost, including the product lifecycle, processes within the quality system affecting the product, and understanding the application of the product once launched. Implementing total risk management for the quality system allows the organization not only to identify hazards related specifically to the product, but other processes that may impact the company's product.

Read more.

Seth Mailhot

Five CAPA Tips that Help Ensure Compliance

by Seth A. Mailhot
Special Counsel, Sheppard Mullin Richter & Hampton LLP

Having been intimately involved in how the U.S. Food and Drug Administration ("FDA") inspects current Good Manufacturing Practice ("cGMP") requirements for nearly two decades, I find myself repeating certain things to companies. Most often, the issues I repeat relate to Corrective and Preventive Action ("CAPA") systems. CAPA systems are a focal point in FDA inspections precisely because they are the process that manufacturers follow in case something goes wrong. In the same way that a person's character may be understood by trial through adversity, quality system auditors and FDA investigators understand a company's operations through its CAPA system.

Read more.

Jason Clegg

Quality Audit: A Tool for Continuous Improvement and Compliance

by Jason Clegg
Marketing Director, MasterControl, Inc.

The word "audit," in the broadest sense, refers to a variety of activities. It may refer to an accounting firm examining the financial statements of a public corporation, or a consultant checking the process of lid sealant dispensing in a semiconductor package assembly line. It may even refer to a mystery shopper testing the patience of sales clerks in an upscale department store.

Read more.


Featured Brochure:

Featured Service/Solution:

Previous Newsletters:

Watch Customer Videos

View Upcoming Events

Did You Know?

November 7-9, 2012, Manchester, UK

November 14-16, 2012, Düsseldorf, Germany

View More Events

Did you know that the FDA is proposing a series of steps to strengthen and modernize its postmarket surveillance of medical devices? The Association for the Advancement of Medical Instrumentation recently issued a news release about the FDA's 25-page report on postmarket surveillance.
Read More