“If you don’t know where you are going, you’ll end up someplace else.” – Yogi Berra
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 individual FMEA against the FMEA Quality Objective for Scope.
What is Scope in an FMEA?
Excerpting from the article “Determining the Scope of the FMEA.”
The first step in FMEA 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 identify the focus of the analysis. This sounds simple, and it is. But, it is very important.
Definition of “scope”
The Oxford English dictionary defines “scope” as “the extent of the area or subject matter that something deals with or to which it is relevant.”
Why is it important to determine the scope of an FMEA project?
Determining the scope of the analysis is an important step because clearly defined boundaries establish the issues that are to be considered and the approach that the team will take during the analysis. The scope needs to define the major elements of the FMEA project, such as the subsystems or components that will be analyzed, interfaces between lower level subsystems or components, interfaces with environment and/or humans, and other elements.
What is the FMEA Quality Objective related to Scope?
The scope for the selected FMEA is correctly defined, focused on areas of highest concern/value, and properly reflected in the FMEA Block Diagram (for Design FMEAs) or Process Flow Diagram (for Process FMEAs).
How can you assess how well an FMEA meets the Quality Objective for Scope?
There are two ways to assess Scope, when reviewing or auditing an FMEA. This assessment is best done by interviewing the FMEA team, in addition to reviewing the FMEA documents.
The first way to assess FMEA Scope is to determine if the FMEA focus areas and boundaries are clearly defined:
- Is the FMEA scope written and agreed on?
- Does the scope include clear boundaries for what is within scope and what is outside of scope?
- What level of the system hierarchy (for Design FMEA) or Process Flow Diagram (for Process FMEA) is being analyzed?
- Are the major elements of the FMEA project defined?
- Does the scope include relevant interfaces, both between the subsystems or components that will be analyzed, as well as with environment and/or humans?
The second way to assess FMEA Scope is to review the visual depiction of the scope of the FMEA.
For Design FMEAs, this is called FMEA Block Diagram. For Process FMEAs, this is called Process Flow Diagram. Reference article titled “Making the FMEA Scope Visible,” which covers the essential elements of an FMEA Block Diagram, including an example.
Does the FMEA Block Diagram include . . .
- Primary subsystems or components within the FMEA scope?
- Related subsystems or components outside the scope?
- Interfaces between the lower level items?
- Interfaces between the item being analyzed and adjacent items?
- Type of interface, such as physical connection, material exchange, energy transfer or data exchange?
- Clear depiction of boundaries of the analysis?
As covered in the first article in this series, each FMEA Quality Objective can be assessed for how well it is in place, and can be rated on a 1 to 3 or 1 to 5 scale. It is up to your company or organization what scale to use. Review the FMEA Scope and assess how well it meets the objectives described above. See if it makes sense, and can be readily implemented.
Once you have assessed these aspects of scope, you can determine how well the FMEA preparation meets the quality Objective for Scope.
What is an example of assessing Scope in an FMEA?
Below is an example of an FMEA Scope and FMEA Block Diagram that is evaluated for FMEA Quality Objective # 2: FMEA Scope.
Tip
Many FMEA projects suffer the effects of “scope creep,” in which the project begins without agreed-upon boundaries, and then expands as the meetings go on. If this happens, the team must go back and redo the early work to take into account the larger scope and the project becomes “endless.”
Summary
One of the most important steps in FMEA preparation is to clearly define the scope of the FMEA project and make the scope visible. This step is one of the FMEA Quality Objectives and can be assessed by following the advises in this article.
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