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Introducing the New Version of Potential Failure Mode and Effects Analysis (FMEA)

Introducing the New Version of Potential Failure Mode and Effects Analysis (FMEA)

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  • Time of issue:2021-12-10 17:37
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(Summary description)Potential Failure Mode and Effects Analysis

Introducing the New Version of Potential Failure Mode and Effects Analysis (FMEA)

(Summary description)Potential Failure Mode and Effects Analysis

  • Categories:News  center
  • Author:
  • Origin:
  • Time of issue:2021-12-10 17:37
  • Views:
Potential Failure Mode and Effects Analysis
1. Failure Mode and Effects Analysis is "Potential Failure Mode and Effects Analysis", or FMEA for short. FMEA is to analyze the subsystems and parts that constitute the product, and each process that constitutes the process one by one in the product design stage and process design stage, find out all potential failure modes, and analyze their possible consequences, so as to take necessary measures in advance. A systematic activity that measures to improve the quality and reliability of products.
The seven-step approach of the new version of the FMEA provides the structure of the technical risk record in a precise, relevant and complete way. The new structure is as follows:

1. Precise, due to the use of technical terms to describe failure modes and their potential causes;

2. Relevant because the effects of the failure describe the activities of the technical consequences of the failure;
3. Complete, because it uses the "Focused Elements - Superior Elements - Subordinate Elements" approach to comprehensively review risks.
Another notable change is the emphasis on FMEA planning and preparation as the first step in FMEA. Although defining the scope has always been part of FMEA, the new version of the FMEA Manual makes it more prominent.
Examples include determination of analytical boundaries (what to include and what not to include), application of the 5Ts (FMEA intent, time, team, tasks, tools), FMEA database preparation and lessons learned, and clear definition of roles and responsibilities (manager, technical lead) , coordinators, team members), etc.

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

1. Reduce the risk of recurrence caused by the loss of personnel and knowledge in the past;
2. Save time in the FMEA preparation process, the FMEA database is a reliable starting point for similar product and process FMEAs;
3. Make the concept of "FMEA as a dynamic document" practical;
4. Management clearly estimates and allocates resources to standardize lessons learned.
The new version of the seven-step FMEA method is more organized and has played an important role in improving the efficiency of cross-functional teams:
1. More risks can be comprehensively addressed;
2. The multidisciplinary critique of the FMEA becomes compelling, "using technology to guide thinking" rather than "unfocused brainstorming", avoiding the frustration with FMEA.
3. Enable senior managers to understand and review the necessary actions and resources to reduce technical risk.
Professional analysis of the new seven-step method of FMEA
The first step, planning and preparation
Emphasizes and clarifies the foundations needed to build a robust FMEA, such as:
1. The purpose, objectives and limitations of the FMEA Technical risk documentation specification (clear, reality-based, truthful and complete);
2. More emphasis on senior management's commitment to the FMEA development process;
3. Clarifications related to know-how protection;
4. New AIAG-VDA FMEA Manual Transition Strategy Description;
5. Use the FMEA database to preserve organizational knowledge and lessons learned;
6. Use the same failure consequences for the same characteristics analyzed in the DFMEA and PFMEA to correlate the DFMEA to the PFMEA.

7. Use the 5T method: By clarifying the purpose and scope of the work, aligning with the timing of the APQP phase, identifying the typical roles and responsibilities of the team, the use of tasks in the seven-step method, the tool FMEA example (including the use of software and traditional spreadsheets) .

The second step is structural analysis

DFMEA: Beginning with an understanding of the system structure, and after decomposing the design into systems, subsystems, and components, focus elements, superordinate elements, and subordinate elements are described in tabular form, with additional instructions for the use of tools in structural analysis (such as block diagrams, structural Tree).
PFMEA: Its structural analysis adds a more detailed breakdown of the manufacturing process:
1. Focus elements of PFMEA: step station number and name of focus process;
2. Superior element: process name (entire manufacturing process);
Subordinate element: Process element 4M type (based on characteristic factor analysis), considering categories such as man/machine/material/method, so as to obtain a more complete list of failure causes (FC).

Structural Analysis Structure Tree Example (Motor Assembly Line)

The third step, functional analysis


DFMEA: A more in-depth explanation of "how to properly describe a function", including tools to support function analysis (P diagram).
PFMEA: Added descriptions of functions and requirements related to upper-level elements and lower-level elements, and the description of failure effects (FE) and failure causes (FC) is clearer and more complete.
The fourth step, failure analysis

DFMEA: Added the concepts of failure types and failure chain models to support more comprehensive (describe more failures) and consistent (internal consistency between FE, FM, FC) failure descriptions.

1. The failure of its "Focused Element" replaces "Failure Mode (FM)";
2. Failure of "Superior Element" and/or "Vehicle End User" replaces "Failure Effects (FE)";
3. Failure of Process Element replaces Failure Cause (FC).
The fifth step, risk analysis

DFMEA: A further distinction is made between preventive controls (PC) and detection controls (DC). Confirmation of PC and DC validity needs to be considered before evaluating incidence and detection rates. After determining the severity, incidence, and detection, the DFMEA "Action Priority (AP)" replaces "RPN" and prioritizes actions based on AP high, medium, and low levels.

1. Replace "Category Column" with "Special Characteristics" and "Filter Code";
2. "Occurrence" is replaced with "FC Occurrence";
3. Occurrence is based on "predicted FC occurrence" to determine the actual effectiveness of preventive controls (PC);
4. Existing process controls, replace "Preventive Action" with "Present Preventive Control (PC) for Cause of Failure (FC)";
5. The current process control, "detection measures" will be replaced by "detection of failure causes (FC)" or "current detection controls for failure modes (FM)";
6. Replace "detection measures" with "FC or FM detection measures";
7. Detection is now based on three factors: detection method maturity, detection opportunity and detection capability;
8. "RPN" is replaced with PFMEA "Action Priority (AP)", and the action priority is determined according to the AP high, medium and low levels.
The sixth step, optimization
DFMEA: "Recommended Actions" replaced by "Precautionary Actions" and "Detective Actions". Added columns: Status (planned, decision, implementation pending, completed, abandoned) and action taken by pointing to evidence.
PFMEA: "Recommended Actions" replaced by "Preventive Actions" and "Detective Actions". Added columns: Status (Plan, Decision, Implementation Pending, Completed, Abandoned) and Actions Taken by Pointing to Evidence, Special Features, and Notes.

The seventh step is to document the results

The results document of the D/PFMEA requires internal reporting to management and the client.

Advantages and limitations of FMEA:

Advantages: It can effectively determine the failure mode and cause of failure of equipment parts, predict the types of failures that may occur in the equipment, and prevent the occurrence of equipment accidents from the source; guide the preparation of equipment operation procedures and inspection and maintenance procedures, and clarify operation safety precautions; Effective and detailed analysis can provide reference standards for equipment preventive maintenance and predictive maintenance, and can verify the correctness of equipment design, thereby guiding the selection of equipment components; the analysis results can be used as training materials, allowing operators to have a deeper understanding of the equipment structure And the operating principle, timely discovery of the unsafe state of the equipment.
Limitations: This method is mainly aimed at single equipment, and the equipment structure is relatively complex; it cannot carry out process risk analysis from the perspective of the entire process system; this method is only a supplement and improvement for the entire process risk analysis; "human factors" are not considered and the interaction between the various units of the system; do not question the design basis; in the process of adopting this method, some risk factors with low risk values ​​may be artificially reversed due to the risk value calculation relationship, resulting in greater risks. deviation.

  In the work process, we only apply FMEA to the process design, equipment and manufacturing process, which helps to objectively review the design requirements and design schemes and provide guidance for design improvement; it is helpful for the initial design of manufacturing and assembly requirements, It is possible to significantly reduce all kinds of non-conformities in the mass production stage, thereby mitigating post-event crisis modifications, as well as finding measures to avoid or reduce the occurrence of these potential failures.

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