Tag Archives: Risk-Based Thinking

Why Risk-Based Thinking Should Be Part of Your Quality Management System

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While the concept of risk is easy enough to understand, figuring out how to apply it to your organization can be somewhat more complicated. Learning how to manage the effect of uncertainty in such a way as to determine the impact on how value is created and sustained requires a deep understanding of your organization’s processes. Many organizations are tempted to avoid these difficulties by ignoring risk management altogether, which can lead to cost overruns, time delays, waste, rework, or even to more serious problems that have an impact on health and safety or the environment.

Fortunately, ISO 9001:2015 for quality management systems (QMS) can provide some much-needed guidance on how to make risk-based thinking the cornerstone of your QMS. ISO 9001:2015 incorporates risk-based thinking throughout to help your organization make better quality decisions that anticipate and prevent process problems. It also incorporates the high-level structure of Annex SL to … Read more...

Demonstrate Risk-Based Thinking to Auditors

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The auditor is coming, or will be coming, to evaluate your organization. While continuous improvement and compliance helps, there are things that you can do to make the auditing process go much more smoothly (this applies to internal audits as well). Preparation doesn’t start the week before, it starts the minute you implement a quality management system or prepare for ISO 9001 certification. You need a systematic approach to audit reporting that begins with core management principles, training, traceability, and credibility.

Because risk-based thinking is more prominent in ISO 9001:2015 than in previous versions of the standard, many organizations are wondering how to demonstrate how they do it to auditors. Fortunately, most activities in the domain of quality management, if successful, serve to reduce risks. The key is to keep track of how your efforts relate to risk.

Here are five actionable recommendations to demonstrate risk-based thinking to auditors :… Read more...

How and Why to Adopt Risk-Based Thinking

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Why implement risk-based thinking?

Are  you looking for certification? Undergoing an audit? Just trying to achieve compliance? There are many reasons, but put simply organizations adopt risk-based thinking with the objective of making better decisions — especially when they are operating in a challenging, fast-paced or otherwise uncertain environment. Although the return on investment (ROI) for risk-based thinking is difficult to characterize, most organizations have anecdotes about the (sometimes spectacular) failures and inefficiencies that have come from pretending that nothing unexpected will happen – or by not investing the time or resources required to plan for the unanticipated.

According to Willumsen et al. (2017), this improved decision making can yield many benefits, including:

  • Reducing frequency of losses
  • Reducing likelihood of losses
  • Reducing costs of losses
  • Improving response time to unexpected events
  • Reducing stress
  • Improving communication
  • Enhancing organizational learning
  • Capturing new opportunities for growth and improvement

Risk assessment and risk management … Read more...

How Risk-Based Thinking Can Have a Significant Impact on Brand Equity

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By Nicole Radziwill & Sonduren Fanarredha

For an organization to deliver high-quality products and services consistently, it must be able to create and sustain long-term value. An organization’s brand therefore consists not only of its name, but also its logo, its overall image and how it is perceived. “Brand equity” is the additional value a brand acquires because of its reputation or prestige in the marketplace. Brand equity takes time to build and, since it can have an impact on buying decisions over time, it is a significant part of an organization’s brand recognition and value. Losing this equity because of brand damage can also have far-reaching negative consequences.

As powerful as it can be, brand equity is also fragile. There are many forces that can threaten it, including:

  • Industry environments that are more uncertain and competitive.
  • Consumers that are increasingly empowered and have a stronger idea of what they
… Read more...

Uncovering Opportunities with a Risk-Based Mindset in Quality

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Quality management is more than it appears to be. While many see it as being about meeting specifications and creating processes that don’t fail, it’s also about enhancing performance by helping people and machines work together more easily and efficiently. Sometimes this means putting controls in place to prevent losses and waste. At other times it means identifying opportunities for improvement and growth. Knowing how to act on those opportunities comes from managing risk.

Risk is not simply the potential for negative outcomes. It’s really the effect of uncertainty on outcomes. Organizations are exploring risk every time they engage with the idea of uncertainty or try to anticipate anything that could prevent them from achieving their objectives. When organizations make decisions that put them closer to their goals, they are successfully engaging with, and addressing, risk.

Risk therefore considers the uncertainty in both threats and opportunities. Risk-based thinking can be … Read more...

Are you Ready for ISO 9001:2015?

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Three years in the making, the latest and greatest revision to the Quality Management Systems standard was published on September 23, 2015 as ISO 9001:2015.  It felt like Christmas morning waiting to get the new standard – well almost.  I’ve already purchased my copy from ASQ  for $173 USD and it was immediately available for download as a PDF once the payment processed.  I’m excited to learn more about how ISO 9001:2015 can help organizations improve and deliver value to customers in a variety of industries and markets.  For anyone that is currently certified to ISO 9001:2008, you have a 3 year grace period to become certified to the new standard’s requirements.  This means you have until September 2018 in order to adopt and demonstrate compliance to the new requirements of ISO 9001:2015.  According to a recent webinar with Quality expert Peter Merrill hosted by the ISO 9001 club… Read more...