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 causes.  We teach people how to distinguish between the two levels of causes, how to determine when the deeper level 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 fourteen 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 a version of the course designed specifically for health care.  Analyzing sentinel/adverse events is a critical undertaking that also requires a structured investigation.  This course provides the skills to lead or participate in such analysis.

Another version of the course is titled Root Cause Analysis for Project Managers.  It communicates the importance of applying RCA within and across projects, as well as for failed projects.  It calls on project managers to look beyond the current project to consider future projects, regardless of who manages them.

And our latest version is titled Root Cause Analysis/CAPA for Medical Device Manufacturers.  Although RCA is RCA, the rigor around the entire corrective action process, including risk assessment throughout and full documentation, makes it a bit more structured.

If you’d like to attend an open-enrollment course see the Events page for upcoming courses.  If you’d like to bring the course in-house, Contact us.  If you’d like to take an online version of the course go to the Resources page.  We’ve also published several articles and a book on root cause analysis, which are listed on our Publications page.  You can download some of the articles as well as the first chapter of the book.

Many participants have indicated this is the best course they ever attended!

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.

If you’d like to attend an open-enrollment course see the Events page for upcoming courses.  If you’d like to bring the course in-house, Contact us. We also offer training in process failure mode & effects analysis (FMEA).

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.

MEASURING PROCESS & ORGANIZATIONAL PERFORMANCE

Organizations often have difficulty maintaining a consistent focus on strategic priorities.  One mechanism for accomplishing this using 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.

If you’d like to attend an open-enrollment course see the Events page for upcoming courses, and if you’d like to take an online course go here.  If you’d like to bring the course in-house, Contact us. We’ve also published articles and a book on performance metrics, which are listed on our Publications page.

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.

PROCESS FAILURE MODE & EFFECTS ANALYSIS

When you’re designing or changing a process it’s useful to think through what all could go wrong, what the impact would be, and how well the current controls in the process will be able to deal with it.  A pFMEA is a formally designed way of conducting such a review, and provides rankings that allow prioritizing what areas might be deemed most at risk, so preventive action be taken prior to releasing the process.

This course presents how to get organized for a pFMEA (such as who to involve and what information should be available beforehand), how to step through the process to identify the risks, and how to review the output for potential actions.  Other uses of the pFMEA, such as for training and process maintenance planning are also discussed, as well as how to do FMEAs in a high-product-mix environment.

Examples used during the course are processes with which anyone is familiar, and practice on your own processes is also provided in the longer versions.

FACILITATION SKILLS

It’s one thing to bring together a group in order to improve a process or implement a quality management system, but it’s another to have that group work effectively and efficiently.  This is the role of a facilitator, to bring organizational and technical skills that help the group achieve their mission.

This courses covers three major components of the facilitation role: 1) having and following a Technical Process for achieving the mission, 2) using good Meeting Process techniques so that time is well utilized, and 3) ensuring that the Group Process creates an environment where people will contribute.

OTHER EDUCATION & TRAINING

In an age where everyone has access to the same capital & equipment, knowledge is the greatest tool for competitive advantage. We help companies increase performance by providing specially developed courses targeted at not only improving the work process, but also how people think about their work. Workshops are also available to professional organizations and universities for continuing professional development. Examples of additional courses we’ve developed and delivered include:

• Project Management
• Change Agent Skills
• Statistical Process Control
• Understanding ISO 9000 (and ISO/TS 16949)
• Train-the-Trainer
• Process Analysis and Improvement Methods
• Advanced Quality Planning

If you’d like to improve the skills of your employees so they can better manage and improve your processes Contact us.

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
• Decision Quality Management
• 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
• Monte Carlo Simulation for the Uninititiated
• Using Mistake Proofing to Prevent or Detect Human Error
• Would a Bowtie Make Your Risk Assessment More Presentable?
• Clarifying the Risk-Based Thinking Requirements in ISO 9001:2015
• Making the Problem Statement Your #1 Goal in Root Cause Analysis
• Augmenting ISO 9001 with ISO 31000 for Risk Management
• Six Approaches for Finding Root Causes
• Dealing with Delayed Responses to Corrective Action Requests
• Using Analytics to Plan Internal Quality Audits
• Risk-Based Quality Audits
• Diagnosing Human Error
• Problem Solution Generation Options
• Root Cause Analysis for Project Managers
• Selecting the Optimum Problem Solving Approach
• The Role of Root Cause Analysis in Continual Quality Improvement
• Selecting the Right Tools for Root Cause Analysis
• 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

SPECIAL PROJECTS

Sometimes there simply aren’t enough resources available within an organization to carry out a specific high-need project. We’ve provided expertise as a project manager, process improvement specialist, process facilitator and/or technical writer to help organizations implement projects such as:

• Conduct an organizational assessment based on a knowledge management framework
• Write a European Quality Award application
• Design, document and implement a quality management system
• Review production processes for control adequacy, and facilitate cross-functional development of process failure mode & effects analyses (pFMEA)
• Develop the requirements and conceptual design for a computer aided process planning (CAPP) system
• Improve the strategic planning process to make it more holistic
• Facilitate a root cause analysis to confirm findings of an internal investigation