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.
What is an FMEA Plan?
The definition of “plan” is “a detailed proposal for doing or achieving something.” An FMEA plan is a detailed proposal for the set of FMEAs that will be done in support of a project, including FMEA types, when each will be done, and by whom.
Why is an FMEA Plan needed?
There are two primary reasons an FMEA Plan is needed. The first reason is few companies or organizations have the resources to do FMEAs on everything. FMEAs take time and cost money. Once the set of FMEAs are determined, they are listed in the FMEA Plan. The second reason is any plan of action needs good organization to be executed. This includes who will lead the FMEA, when it needs to be started and when it needs to be completed, and other resource information to enable efficient implementation.
What is the Quality Objective for FMEA Plan?
The FMEA Plan quality objective is:
The right set of FMEAs have been identified and prioritized, based on company policy, and organized into an executable FMEA plan.
The end result (deliverable) of an FMEA Plan is a listing of the agreed-upon FMEAs that need to be done for a given project, prioritized in sequence, including the necessary organizing information.
How do you assess how well an FMEA project meets the quality objective?
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 Plan and assess how well it meets the objective described above. See if it makes sense and can be readily implemented.
Consider these questions:
- Does the FMEA Plan include the set of FMEAs that need to be done, based on preliminary risk assessment? See article Preliminary Risk Assessment
- Does the FMEA Plan have all the necessary elements of good planning, such as who will lead the team, start and completion dates, and other planning resources?
- Does the FMEA Plan include reference to the Ground Rules and Assumptions and Operating Environment? See article Establishing FMEA Ground Rules and Assumptions
- Does the FMEA Plan reference relevant company FMEA procedures and standards?
- Does the FMEA Plan integrate into company project execution system, so it can be easily tracked and implemented?
What is an example of FMEA Plan?
Below is an example of an FMEA Plan that is evaluated for Quality Objective # 1: FMEA Plan.
Tips
The Preliminary Risk Assessment prioritizes and selects the most important FMEAs. This is key input to the FMEA Plan. When reviewing the FMEA Plan, always ask for the Preliminary Risk Assessment to see how it impacted the FMEA Plan.
Summary
All FMEA projects should develop a well-written FMEA Plan. By following the advices in this article, you can evaluate how well the FMEA Plan meets quality objectives.
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