“If you don’t know where you are going, you’ll end up someplace else.” – Yogi Berra
In this article, I will outline how to evaluate an individual FMEA against the FMEA Quality Objective for Scope. [Read more…]
FMEA Quality Objective 1: FMEA PLAN
Good fortune is what happens when opportunity meets with planning Thomas Edison
As summarized in the first article in this series, “New Series – The Quality of FMEAs,” each month, I will write an article focusing on one of the 14 FMEA Quality Objectives. The intent is to provide insights and application tips for evaluating how well an FMEA meets the quality objectives. By learning to apply FMEA quality objectives, you can help to ensure that product designs and manufacturing processes are safe and reliable. If you didn’t read the introductory article, now is a good time to read it, since it explains FMEA Quality Objectives, and how they are used to create high-quality FMEAs.
In this article, I will outline how to evaluate an FMEA Plan against the FMEA Quality Objective for FMEA Plans.
New Series – The Quality of FMEAs
“Quality is not act. It is a habit.” – Aristotle
This month will begin a new series of articles on the quality of FMEAs, part of the Inside FMEAs series. The series will provide insights and application tips for evaluating how well an FMEA meets quality objectives. The intent is to create FMEAs that add value by accomplishing the objectives for FMEA, not filling out a form.
What is an FMEA Quality Objective?
We’ll begin with definitions from the Oxford English Dictionary. “Quality” is defined as “the standard of something as measured against other things of a similar kind; the degree of excellence of something.” “Objective” is “a thing aimed at or sought; a goal.”
Building from the above definitions, FMEA quality objectives are specific goals or aims that measure the degree of excellence of an FMEA. [Read more…]
FMEA and Robust Design
One of the most important concepts in designing for reliability is robust design. This article is a high-level overview of robust design and its relationship to FMEA.
“For the robust, an error is information.” Nassim Nicholas Taleb
Can You Anticipate Everything?
Is it possible to anticipate everything that could go wrong?
“Prediction is very difficult, especially if it’s about the future.” Niels Bohr
In an FMEA, is it possible to think of everything that might happen in the future? What strategies can be used by FMEA teams to maximize the opportunity to anticipate what can go wrong, so risk can be reduced to an acceptable level?
Gathering Information
[Author note: This article is being published mid-month, and is part of the FMEA Preparation series. It was earlier written, but inadvertently omitted from publication, as part of this series.]
Gathering Information for FMEA Preparation
One of the most important steps in FMEA preparation is gathering all of the relevant documents and information. If this step is missed or done inadequately the FMEA meetings will be burdened with extra tasks related to missing information, the time of the subject-matter experts will be wasted, and the FMEA results potentially compromised.
“True genius resides in the capacity for evaluation of uncertain, hazardous, and conflicting information.” – Winston Churchill
Application Tip – Begin with Concerns
Stay Focused on Areas of Concern
“It is not possible for minds degraded by a host of trivial concerns to ever rise to anything great.” Jean-Jacques Rousseau
One of the most important elements of excellent FMEAs is to stay focused on areas of concern. What does this mean and how should it be applied?
Preliminary Risk Assessment
Selecting Which FMEAs to Do
FMEAs take time and cost money. They should be done when a certain level of risk can be effectively addressed by the FMEA procedure. Preliminary Risk Assessment is a procedure that uses company-determined criteria to select which FMEAs to do.
“The key is to schedule your priorities.” ― Steven Covey
[Read more…]
Discussing the Controversial Subject of FMEA Prepopulation
Should You Prepopulate an FMEA? An Overview
By prepopulating the highest priority functions, along with other selected information, the FMEA team can focus their efforts on the most important functions, and minimize in-meeting time. This is the last step in FMEA preparation. However, there are specific limitations to FMEA prepopulation that must be understood and adhered to.
“Give me six hours to chop down a tree and I will spend the first four sharpening the axe.”
Abraham Lincoln
Identifying and Prioritizing FMEA Functions
– a Key Step in FMEA Preparation
“. . . not everything that can be counted counts” Albert Einstein
A key, but often missed, step in FMEA preparation is to identify and prioritize the functions that relate to the item being analyzed. These become candidate functions to be brought into the FMEA.
Parameter Diagram and FMEA
When creating a robust design, there is probably no more important consideration than identifying the correct parameters and associated values. A robust design is insensitive to anticipated variation and P-Diagram visually shows the relationship between what the system is designed to do, the anticipated noises the system will encounter and the correct parameters to achieve the desired outcome. P-Diagram can be an essential input to FMEA.
“Concern for man and his fate must always form the chief interest of all technical endeavors. Never forget this in the midst of your diagrams and equations.” Albert Einstein
Assembling the Correct FMEA Team.
Once you have identified the scope of the FMEA project, made the scope visible, it is time identify the FMEA team members. This article discusses the composition of the FMEA team, including why each member is needed, and the underlying reason for a cross-functional team.
“Alone we can do so little; together we can do so much.” Helen Keller
Establishing FMEA Ground Rules and Assumptions
FMEA teams should agree to the ground rules that guide the analysis and the underlying assumptions that impact the entire FMEA. Failure to do so will add complexity and confusion to the resulting FMEA, and waste people’s time. Don’t miss this important step in FMEA preparation.
“Your assumptions are your windows on the world. Scrub them off every once in a while, or the light won’t come in.” Isaac Asimov
Making the FMEA Scope Visible
Adding Clarity to Your FMEA
Before commencing with the FMEA meetings, it is essential to visibly show the nature and scope of the analysis. This article discusses different ways FMEA scope can be made visible, and why this is a necessary step.
“The soul cannot think without a picture” – Aristotle
Determining the Scope of the FMEA
Why Defining FMEA Scope Is the First Step in Preparation
Every journey begins with a statement of the goal or objective. Why would it be any different for FMEA? Yet, some FMEA teams do not clearly identifying the focus of the analysis. This sounds simple, and it is; but, it is very important. This article explains why.
“Begin with the end in mind” – Stephen Covey
