Risk Management Article

Chad Kymal’s picture

By: Chad Kymal

What is enterprise quality? Simply put, it is a system where there is one quality manual, and a core of common processes, work instructions, and forms and checklists for a multisite environment. Why is this a good idea? Because it saves money.

Figure 1 illustrates how enterprise quality takes many isolated management systems and transforms them into a common one.

Michael Jovanis’s picture

By: Michael Jovanis

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Particles of metal in children’s medicine. Adulterated baby formula. Spontaneously combusting smartphones. When scandal is only a tweet away, companies can’t hide from quality failures.

Ryan E. Day’s picture

By: Ryan E. Day

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Timothy Lozier’s picture

By: Timothy Lozier

Compliance is a common term that is very broad, and many companies interpret compliance as a host of different items. It can be related to quality, safety, or operations, but it encompasses a long list of areas within the organization, including financial, risk, governance, sustainability, and more. Companies try to fit this broad category of compliance into a single term, which can be a daunting feat. However, compliance is not the only component on which companies should be focusing

Greg Anderson’s picture

By: Greg Anderson

The most astute executives in health systems are rightfully concerned about compliance risks in physician contracting. Among these risks are that a transaction or an arrangement between a hospital and a physician are consistent with fair market value (FMV) and are commercially reasonable (CR) as those terms are defined in the healthcare regulatory context.

Jon Speer’s picture

By: Jon Speer

If you’re in the business of developing medical devices, then risk and risk management become terms synonymous with your daily operations. Your overall task is to bring a device to market that not only provides a needed function to a patient, but is also proven to be safe to use—maybe even used by someone who is near and dear to you.

Mark Whitworth’s picture

By: Mark Whitworth

Layered process auditing (LPA) is a quality management approach increasingly used by manufacturing and service companies alike to address a gap in traditional product-oriented approaches. When properly implemented, layered auditing is the most effective way to ensure that processes consistently follow approved standards, which reduces waste and rework, improves quality, and drives cultural change throughout an organization.

Multiple Authors
By: Daniel Blake, Caterina Moschieri

Pulling out of a country is an expensive proposition for a multinational firm, but it is sometimes required for the corporate bottom line. If the host country changes laws or even expropriates a subsidiary, it is often time to leave or divest.

Thomas R. Cutler’s picture

By: Thomas R. Cutler

Two words no manufacturing organization wants to hear: product recalls. By their very nature, product recalls are unpredictable events.

The cost to a company transcends potentially expensive litigation and settlements. Product recalls and the effects that product failures have on companies that fail to conduct proper design analysis before, during, and after the manufacturing process are often unrecoverable.

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