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.

What will be covered in the new series?

The new series will focus on 14 FMEA quality objectives. These quality objectives cover both Design FMEA and Process FMEA, and can be adjusted to apply to other types of FMEAs. Each quality objective helps to assure that the FMEA is high-value and accomplishes the purpose of FMEA.

What is the purpose of FMEA?

The purpose of Design FMEA is to analyze the product design, focusing on potential design-related deficiencies, with emphasis on improving the product design and the effectiveness of tests, helping to ensure product operation is safe and reliable during useful life.

The purpose of Process FMEA is to analyze the manufacturing or assembly process, focusing on potential process-related deficiencies, with emphasis on improving the manufacturing or assembly processes.

What are the high-level steps for FMEA procedure?

The listing of FMEA quality objectives will align with the general FMEA procedural steps, which are:

1. 1. Project Planning
   2. Preparation
   3. Technical Risk Analysis
   4. Risk Assessment and Prioritization
   5. Action Plan to Reduce Risk
   6. Document Results

How can FMEA Quality Objectives be used?

From an application viewpoint, FMEA Quality Objectives can be used as follows:

1. 1. Become part of FMEA training
   2. Reviewed at FMEA meetings
   3. Incorporated as a part of FMEA quality audits
   4. Consider leaving the FMEA open until quality objectives are met

Note: 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.

What are the FMEA Quality Objectives?

FMEA Procedure Step 1: Project Planning

Quality Objective 1: FMEA PLAN

The right set of FMEAs have been identified and prioritized, based on company policy, and organized into an executable FMEA plan.

FMEA Procedure Step 2: FMEA Preparation

Quality Objective 2: 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).

Quality Objective 3: INTERFACES

For Design FMEAs, the FMEA scope includes integration and interface failure modes in both Block Diagram and analysis.

Quality Objective 4: LESSONS LEARNED

The Design FMEA considers all major “lessons learned” (such as high warranty or field failures, for Design FMEAs, or manufacturing history for Process FMEAs) as input to failure mode identification.

Quality Objective 5: TEAM

The right people are identified and participate as part of the cross functional FMEA team throughout the analysis and are adequately trained in FMEA methods.

FMEA Procedure Step 3: Technical Risk Analysis

Quality Objective 6: TECHNICAL RISK ANALYSIS

Each portion of the FMEA technical risk analysis has been properly performed, based on correct FMEA fundamentals and procedure.

FMEA Procedure Step 4: Risk Assessment and Prioritization

Quality Objective 7: HIGH-RISK FAILURES IDENTIFIED

All potential high-risk failure modes and associated causes are properly identified and prioritized, including past field issues (for similar items) and potential new issues.

Quality Objective 8: SPECIAL CHARACTERISTICS

The FMEA identifies appropriate special characteristics candidates, based on company policy.

FMEA Procedure Step 5: Reduce and Communicate Risks

Quality Objective 9: DESIGN IMPROVEMENTS

The FMEA drives actions to improve product or process designs as the primary objective.

Quality Objective 10: TEST IMPROVEMENTS

The FMEA drives actions to improve Test Plan (for Design FMEAs) or Process Control Plan (for Process FMEAs) as a secondary objective.

Quality Objective 11: HIGH-RISK FAILURES ADDRESSED

The FMEA addresses all high-risk Failure Modes, as identified by the FMEA team, with executable Action Plans. The result is risk reduced to an acceptable level.

Quality Objective 12: TIMING

The FMEA is completed during the “Window of Opportunity” where it could most efficiently impact the product design and the Test Plan (for Design FMEAs) or the manufacturing process (for Process FMEAs).

FMEA Procedure Step 6: Summarize and Document Results

Quality Objective 13: DOCUMENTATION

Each portion of the FMEA document is properly completed, summarized, and linked, using correct FMEA definitions and principles.

Quality Objective 14: TIME USAGE

Time spent by the FMEA team, as early as possible and focused on areas of concern, is an effective and efficient use of time, with a value-added result.

Summary

Each month, I will write an article focusing on one of the 14 quality objectives for FMEA. 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.

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