Services

Root Cause Analysis

Many organizations have recurring problems that their corrective action process does not effectively address.  The cause is often inadequate depth of the analysis … fixing only the physical and not the system or organizational causes.  We teach people how to distinguish between the levels of causes, how to determine when deeper levels should be pursued, and how to use powerful tools for guiding the analysis.

We’ve conducted this course more than 500 times in the past eighteen years.  One company reduced the number of paperwork errors by more than 90% within two weeks; other projects have had a bottom line impact of $100k-$500k. The course is relevant for dealing with customer complaints, equipment or product failures, audit findings, and many other process or organizational problems.  We also have versions of the course designed specifically for the medical device industry, health care (sentinel events) and project management. 

This course is available via virtual delivery (contact us via the Contact page) and also an e-learning version of the course (go to the Resources page). Many participants have indicated this is the best course they ever attended!

 Process Performance Metrics

Organizations often have difficulty maintaining a consistent focus on strategic priorities.  One mechanism for accomplishing this is the use of process performance metrics aligned to strategic objectives deployed throughout the organization.  This workshop provides a structured approach for selecting, defining, reporting and managing metrics that allow everyone in the organization to effectively manage and improve processes for which they are responsible.  A course participant from a service organization quickly learned the value of process thinking when trying to identify metrics.

This course is available in a virtual version (Contact us) and an elearning version of the course is available on the Resources page.

Risk Based Thinking/Risk Management

Risk management has gotten much greater attention since the turn of the century.  Many quality management standards now require risk management or at least risk-based thinking (RBT), which means that organizations need to have a framework for understanding the steps involved in identifying, assessing, treating and monitoring risks to achieving business/quality objectives.

We have created a 1-day workshop focused on understanding the RBT requirements within ISO 9001, which also includes discussion of risk-focused standards such as ISO 31000 & 31010, as well as the COSO ERM framework.  The course then provides attendees with a comprehensive view of the risk management landscape, allowing them to decide what level of depth makes sense for their organizational context.

Risk-Based Quality Auditing

With the introduction of risk-based thinking in ISO 9001:2015, and more in-depth risk management requirements in other quality management system requirements (e.g., AS 9100, IATF 16949, ISO 13485), it is important for quality audit programs to take on a risk perspective.  This means both proactive and reactive risk-based audit planning and execution using both qualitative and quantitative methods to help prioritize audit activities.  This 1-day course presents multiple options for integrating risk based thinking, risk management, and risk assessment techniques into an audit program.  Adding the RBT/RM course above creates a 2-day course that provides auditors with a comprehensive understanding of both risk management and how audits can be planned, performed and reported based on a risk-based perspective.

Problem Solution Generation

Organizations and individuals are always trying to solve analytical and/or creative problems. Far too often the process of brainstorming is relied on as the primary method to help identify potential solutions. However, there are more powerful options available that are more rigorous and typically generate a greater number of possibilities that are likely to be more potent and reliable. These include: Engineering analysis, process benchmarking, biomimicry, mistake-proofing (with TRIZ principles), and TRIZ techniques (e.g., IFR, resources, SLP, 9 boxes, functional analysis, contradictions).

Process Management

The foundation of success for every organization is alignment of operations with strategy.  This calls for understanding how to identify, manage and improve business processes.  We provide training and support for organizations to help them understand the critical nature of process management, how to plan and define operational processes, how to monitor process performance and how to improve processes.

It is also critical in today’s environment to integrate process management with IT and HR, and to align processes with widely accepted and validated frameworks.  We also have a process management maturity matrix that can be used to evaluate the degree to which your organization effectively manages operational processes.

Guest Speaker/Webinar Presenter

Management retreats, professional conferences, and many other groups look for someone who can provide listeners with an understanding or new ways of acting on trends. We’ve spoken to more than 200 groups on a wide variety of topics; following is a partial list:

  • Critical Issues in Common Risk Assessment Methods
  • Risk Ranking Audit Nonconformities
  • Dealing with “Can’t Find Root Cause” Situations
  • Comparing 8D, A3 and 5Ys Problem Solving
  • Why You Should Use ISO 19011
  • Would a Bowtie Make Your Risk Assessment More Presentable?
  • Dealing with Delayed Responses to Corrective Action Requests
  • Using Analytics to Plan Internal Quality Audits
  • Risk-Based Quality Audits
  • Problem Solution Generation Options
  • Maximizing the Yield and Minimizing the Damage from Performance Metrics
  • e-QM: Quality Management in a Digital World
  • Barriers to Effective Root Cause Analysis
  • Complex Adaptive Systems and Quality Management: Are They Compatible?
  • Critical Thinking: A Fundamental Requirement for 21st Century Organizations

See our YouTube page for recorded versions of some of these topics.

    Musings: My Blog

    RCA/CA Maturity

    If you didn't happen to see my post on LinkedIn where I submitted a maturity matrix for evaluating the Root Cause Analysis & Corrective Action process you can get it here on my website. I've also added more videos to my YouTube channel, which can make for good...

    Podcast on RCA

    I was recently interviewed by Jon Taber who hosts a bi-weekly podcast on auditing.  Brief but good discussion of root cause analysis. https://podcasts.apple.com/be/podcast/episode-34-root-cause-analysis-duke-okes/id1590407172?i=1000577361463

    More RCA Videos

    I always enjoy seeing how others approach root cause analysis.  Here are links to a couple of videos that are pretty good. https://www.youtube.com/watch?v=D77iE0kSkLc   https://www.youtube.com/watch?v=zk7Hg4w1Jsg

    Long time, no see!

    Yes, it's been several months since I've posted, although that doesn't mean I've not been musing.  Just too many things on the plate. However, here's a short collection of thoughts. Webinars: 1) One of the most frustrating things I've experienced in the past couple of...

    Technology and Auditing

    The use of Zoom, etc. for auditing has certainly taken hold, albeit driven primarily by COVID rather than a desire to improve the audit process. There are several other areas where technology can help, including Analytics, Process Mining, and Text Mining. I've already...

    Some Wisdom Here

    Whether it's investing or self-development, this interview of Chamath Palihapitiya by Barry Rithholtz is worthwhile.  You can listen or read here.

    Good Article on Risk Management

    Over the past couple of years I've spoken several times on problems with many risk assessments, and also published an article on it (see here). I recently ran into an article from 2005 that discusses similar issues, but especially points out problems with...

    Should They be in Quality Profession

    It's amazing how I still see/hear complaints about risk-based thinking (RBT) being included in ISO 9001.  It always makes me wonder whether or not the individual should even be allowed to call themselves a quality professional. Consider that one of the earliest things...

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