FMEA is now in its fifth generation since the last century. So how much can people know about the new FMEA? Come and have a look ....

What is FMEA

The official definition is: FMEA, i.e. Failure Mode and Effects Analysis, is a method of analyzing the subsystems and parts that make up a product or equipment, as well as the processes that make up the process, one by one, during the product design stage and the process design stage, to find out all the potential failure modes and to analyze the possible consequences, so as to take the necessary measures beforehand to improve the quality and reliability of the product or equipment. Product or equipment quality and reliability of a systematic activity.

In 1950. the U.S. GRUMMAN company research and development of new jet fighters, in order to assess the aircraft operating system of a component of the failure analysis of the FEMA analysis method; 1957. Boeing Aircraft Company and Martin Company formally included in the FMEA engineering guidebook, the same period of time the U.S. NASA and the military also began to apply the FMEA technology; 1993. the U.S. automotive industry for a coherent approach to the failure mode, and analyze its possible consequences, so as to take the necessary measures in advance to improve the quality and reliability of products or equipment is a systematic activity. In 1993. the U.S. automotive industry for coherent design, development and manufacturing procedures, the integration of various automotive companies FMEA applications, the three major automotive companies commissioned ASOC to integrate the potential failure modes and effects of analysis of the reference manual SEA-J-1739. China in 1970 or so, the introduction of FMEA technology, used in aerospace and automotive industry.

FMEA has multiplied to the fifth generation from the last century until now. So how much can people know about the new FMEA? Come and have a look ....

The new version of the FMEA's seven-step approach provides the structure of the technical risk record in a precise, relevant and complete manner , the new structure is as follows:

1. Precise, because technical terms are used to describe failure modes and their potential causes.

2. relevant, because the failure impact describes the technical consequences of the failure; and

3. complete, because it uses the “Focused Element - Superordinate Element - Subordinate Element” approach, which allows for a comprehensive review of risks.

Another notable change is the emphasis on FMEA planning and preparation as the first step in an FMEA. While defining the scope has always been part of an FMEA, the new version of the FMEA manual makes it more prominent.

Examples include defining the boundaries of the analysis (what to include and what not to include), the application of the 5Ts (FMEA intent, time, team, task, tool), the preparation of the FMEA database and lessons learned, and the clear definition of roles and responsibilities (manager, technical supervisor, coordinator, team member).

Among the benefits of organizing lessons learned into an FMEA database are:

1. Reducing the risk of reoccurrence due to past turnover and loss of knowledge; and

2. Saving time during FMEA preparation, the FMEA database is a reliable starting point for FMEAs of similar products and processes.

3. Make the concept of “FMEA as a dynamic document” practical.

4. Management clearly anticipates and allocates resources to standardize lessons learned.

The new version of the FMEA 7-step approach is more organized and plays an important role in improving the efficiency of cross-functional teams:

1. More risks can be addressed in a comprehensive manner.

2. The multidisciplinary review of FMEA becomes compelling, with 'technical guidance for thinking' rather than 'unfocused brainstorming', avoiding a frustrated attitude towards FMEA.

3. enables senior managers to understand and review the actions and resources necessary to reduce technical risks.

FMEA

1

Step 1. Define the Scope

Emphasized and clarified the foundations needed to build a robust FMEA, such as:

1. the purpose, objectives and limiting technical risk documentation specifications of the FMEA (clear, reality-based, realistic and complete).

2. greater emphasis on senior management commitment to the FMEA development process.

3. Clarifications related to the protection of proprietary technology.

4. a description of the transition strategy for the new AIAG-VDA FMEA Handbook.

5. use of the FMEA database to preserve organizational knowledge and lessons learned; and

6. correlate DFMEA with PFMEA by using the same failure consequences for the same characteristics analyzed in both DFMEA and PFMEA.

7. use the 5T method: through defining the purpose and scope of the work, aligning with the timeline of the APQP phase, identifying typical roles and responsibilities of the team, use of tasks in the seven-step process, and tool FMEA examples (including the use of software and traditional trial balances).

2

Step 2. Structural Analysis

DFMEA: Starting with an understanding of the system structure, and then after decomposing the design into systems, subsystems, and components, the focus elements, higher-level elements, and lower-level elements will be described in tabular form, with additional instructions for using the tools used in the structural analysis (e.g., block diagrams, structural trees).

PFMEA: Its structural analysis adds a more detailed decomposition of the manufacturing process:

1. PFMEA's focus element: focus on the process of the step station number and name;.

2. Upper-level elements: process name (the entire manufacturing process);.

3. Lower-level element: process element 4M type (based on Characteristic Elementary Factor Analysis), taking into account the categories of Man/Machine/Material/Method, which results in a more complete list of Failure Causes (FC).

3

Step 3: Functional Analysis

DFMEA: Explains “how to describe a function correctly” in more depth, including tools to support functional analysis (P-diagrams).

PFMEA: Function and requirement descriptions related to higher-level and lower-level elements are added, and Failure Effects (FE) and Failure Causes (FC) descriptions are clearer and more complete.

4

Step 4: Failure Analysis

DFMEA: The concepts of failure types and failure chain modeling are added to support more comprehensive (more failures described) and consistent (internal consistency between FE, FM, FC) failure descriptions.

PFMEA :

1. the failure of its “Focus Element” replaces the “Failure Mode (FM)”; and

2. Failure substitution of “Failure Effect (FE)” for “Superordinate Element” and/or “Vehicle End-User”; and

3. Failure of the Process Element replaces the Failure Cause (FC).

5

Step 5: Risk Analysis

DFMEA: further distinguishes between preventive control (PC) and detective control (DC). Confirmation of the effectiveness of PC and DC needs to be considered before evaluating the incidence and detection rates. After determining the severity, incidence, and detection, DFMEA “Action Priority (AP)” replaces “RPN” and prioritizes actions based on high, medium, and low levels of AP.

PFMEA :

1. 「Classification Columns」replaces 「Special Characteristics」and 「Screening Codes」; and

2. Replace “Occurrence” with “Occurrence of FC”; and

3. The degree of occurrence is based on the “predicted occurrence of FC”, which is necessary to determine the actual effectiveness of preventive controls (PC).

4. For current process control, replace “preventive measures” with “existing preventive controls (PC) for the cause of failure (FC)”.

5. Existing process control, “Detection Measures” will be replaced by “Detection of Failure Causes (FC)” or “Existing Detection Controls for Failure Modes (FM)”.

6. “Detection Measures” is replaced by “FC or FM Detection Measures”.

7. Detection level is now based on three factors: detection method maturity, detection opportunity, and detection capability.

8. 'RPN' is replaced with PFMEA 'Action Priority (AP)', which prioritizes actions based on high, medium, and low AP levels.

6

Step 6. Optimization

DFMEA : 'Recommended Measures' replaced by 'Preventive Measures' and 'Detective Measures'. Added columns: “Status” (Planned, Decision, Implementation Pending, Completed, Abandoned) and Actions taken by pointing to evidence.

PFMEA: “Recommended Measures” replaced by “Preventive Measures” and “Detective Measures”. Added columns: “Status” (Planned, Decision, Implementation Pending, Completed, Abandoned) and Actions Taken by Pointing to Evidence, Special Characteristics, and Remarks.

7

Step 7. Documentation of Results

Documentation of D/PFMEA results requires internal reporting to management and customers

New version

Based on my rich experience in the automotive supply chain, I would like to share with you my suggestions to cope with the new version:

1. Start familiarizing yourself with the new AIAG-VDA FMEA manual and identify gaps in your current FMEA development process as early as possible to meet the new requirements of the new manual.

2. Train personnel who will have an impact on the development support of FMEA (cross-functional teams, FMEA coordinators, management, auditors).

3. Develop a “New FMEA Pilot Project” and define an implementation plan. Measure the financial impact of your FMEA pilot program against the cost of quality.

4. Standardize company FMEA business processes to support the application of the new FMEA manual.

AIAG-VDA FMEA