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Apr 23, 2015

Risk: 2015’s Most Valuable Player?

In 2015, risk may become quality's most 
valuable player and could drive quality to a 
new level of proficiency.
by Marci Crane
Marketing Communications, MasterControl



For quality professionals, and especially those in quality management, there are often quality themes that seem to emerge from year to year. In 2000, the theme of process-driven quality was certainly salient and other various themes--though not necessarily new to quality management—seem to stand out as each year passes.

Chances are high that those reading this blog entry are beginning to see the emerging patterns of quality in their own organizations. Perhaps, even this early in the year, one area of quality already stands out more than others. There are certainly many improvements that can be made and when even one aspect of quality is improved it’s likely that new successes will present themselves organization-wide.

Risk as MVP
Risk management, no matter how it’s defined, has always played an essential part in quality, but in 2015 risk may become the recognized most valuable player, and could by the end of the year, drive quality to a new level of proficiency. 

Global Changes Involving Risk
With a major revision of ISO 9001 standards currently in review and slated to be published in the last half of 2015 (ISO 9001:2015) with pertinent risk management changes highlighted as one of the main evolving quality mindsets, it is clear that the way risk is managed is changing worldwide. According to a recent video regarding the ISO 9001:2015 major revision, quality systems consultants Walt Murray and Peter Knauer explain the revision’s emphasis on risk-based thinking and the possible implications of that emphasis.  According to Murray and Knauer, these implications could include a de-emphasis on preventive action and more thought/strategy involved with risk planning on a global level.

The video also highlights that within the new revision there will be no quality manual required which may result in mixed feelings. With these changes, some quality professionals may get nervous and wonder how to proceed but many (hopefully most) will find the freedom they need to really focus on strategy and process over time in the way that his/her organization needs it most.

This article is related to the Whitepaper: Noncompliance to FDA Quality Standards: What's the Risk to Executives? To get the full details, please download your free copy.


Why Focus on Risk-Based Thinking?
There are myriad reasons to focus on risk-based thinking but avoiding product recalls is still high on that list. According to LNS Research’s recent assessment of risk-related issues in 2014, recalls are still a major concern in various high-tech industries including those related to healthcare

Describing recall rates in healthcare throughout 2014, the article states that “…it is worth pointing out that in healthcare recalls are also a regular occurrence. At the fifty week mark for 2014, the FDA has made 56 recalls in the medical devices category alone, more than one per week,” and LNS quotes Forbes in saying that “The recall rate could be an indication of a manufacturer’s risk tolerance or strategy.”

Risk-Based Thinking Affects Everything
Another reason to focus on risk-based thinking and risk strategy is that the scope of risk is valuable throughout the quality management experience and not just in procedures or processes that directly affect the product itself. Since this is the case, it is clear that quality professionals will begin to see the scope of risk-based thinking expand into the realm of the entire quality experience. According to the same LNS Research article, “Methodologies and control and mitigation strategies are required to prevent the entire system from experiencing damaging or catastrophic system failures. This explicit risk management approach extends across the entire value chain and will prove exceptionally difficult to implement and maintain without a consistent framework, interoperability, and integration found in EQMS solutions.”

Difficulties with Risk
On any road that can lead to significant improvement there may be found obstacles that present themselves. One of the difficulties with risk-planning and the overall results that come from risk-based thinking is finding ways to effectively track the outcomes (i.e, overall worth) of time spent on risk planning and activities. There are ways, however, to dig deep and ensure that an organization’s management clearly understands the difference that strategic risk-based thinking/planning is making company-wide.

A recent blog entry by Rod Farrar describes three methods for measuring the benefits of risk-management and includes information regarding compliance, risk maturity and value add.

For more information on current risk trends as presented by LNS Research please check out “2015: Will It Be The Year of Risk for EQMS?” and learn more regarding the following topics:

--Supplier Quality Management and Risk
--Driving Quality-Related Action Priorities (Risk analysis should underpin approaches to CAPA, for example.) --Supporting Risk Management with Excellent Analytics --The Future of EQMS


Marci Crane is a marketing communications specialist at MasterControl, Inc.











Watch Related Videos:

How MasterControl Makes Your Job Easier
Creating a Paperless Process Using MasterControl


Download Free Resources
White Paper: GAMP®5: A Risk-based Approach to Compliant GxP Computerized Systems
Webinar: Risk Management: FDA Regulated Industries
Webinar: GAMP 5 - A Risk-based Approach to Compliant GxP Computerized Systems
Q&A: Risk Management for Pharmaceutical Companies Under FDA's Q9 Guidance



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