Practical Guideline About FMEA And Its Application In IATF 16949

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Failure Mode and Effect Analysis (FMEA) is one of the core tools of IATF 16949 which is used to design and execute risk reduction and risk elimination plans, performance analysis, crafting design improvement approaches and integration with other risk management methodologies. The core purpose of FMEA is to assist teams in foreseeing risks and hazards well before time and enabling them to take actions to prevent such risks.

FMEA is a step-by-step approach based on systematic techniques that can be utilized to identify all possible potential failures that can occur in a design process and production process or the assembly process for any product or service.

The Benefits of Using FMEA for Management Systems

FMEA, when appropriately used, can provide numerous benefits to the management systems. FMEA comes with the following mentioned benefits:

  1. Easy to Use
  2. Control Data Integrity
  3. In-Built Microsoft Access
  4. Trust-Building and Confidence: Being FMEA methodology successfully implemented in your organization will result in the boost in confidence and trust of your employees, stakeholders, and end consumers too. Such an act will give rise to the brand image of your organization and further enhance employee branding.
  5. Global Risk Management Application: FMEA enables organizations by providing them effective and efficient documentation system that is fully capable of satisfying the comprehensive needs of risk management that are required for the quality, safety, manufacturing, and environmental standards.
  6. Enhanced Visibility: FMEA tracking should be part of the weekly management meeting so that monitoring can be done effectively. You can tailor the visibility and tracking frequency as per the system running in your organization.
  7. Easy Tracking of Status: Actions taken to mitigate risks (priority wise) can be easily tracked by making it visible how many threats have been reduced and substituted and how many dangers are still pending to get mitigated and by when they can be mitigated.

How to Implement FMEA

It is preferred to implement FMEA following a stepwise approach while fulfilling activities given in each step. The implementation methodology has been made to simplify the implementation process and to save the business from wasting human resources’ time and energy.

Step 1: Identify Failure Modes

The initial step of FMEA implementation is to start with F of FMEA, which is Failure. In this step, one needs to identify all possible potential failure modes that exist in the management system. Before stepping in this process, you need to gather and grasp all the information about all primary and secondary system elements. The information that will be collected can be in the form of flow charts or may be in the form of engineering diagrams like P&ID. It is recommended to compile historical data as well for more clarity. Along with the identification of potential failure modes, it is necessary to identify the level of detection (How easy it is to detect failure) also.

Step 2: Detect Severity of Consequences

The next step is to diagnose how much the consequences are severity that is caused by failure modes. Before stepping to the second step, it is mandatory to absorb a complete understanding of the system before you step into the world of failure modes identification. If you don’t grasp the system knowledge properly, then you cannot in any way identify possible failure modes and can no longer be able to prevent them.

Step 3: Determine the Cause of Each Failure Mode

Upon successful completion of the first two steps, you need to explore the cause of each failure mode. For every identified activity, you need to dig deep down to explore the root cause. One can make use of why-why analysis for satisfactory outcomes after studying the mechanisms that might be the reason for producing failure modes. Try not to be generic and determine the root cause of every failure mode correctly. While finding the root cause, one needs to study the frequency of the occurrence of the failure mode.

Step 4: Plot Each Failure Mode Against Severity and Occurrence Level

Upon identification of every possible potential failure mode, you need to plot it against severity and occurrence level. After multiplying the figure, you will get RPN (Risk Priority Number) which is a semi-quantitative measure and used by QA team more often. The risk will take the form of acceptable and non-acceptable levels. Those risks that fall into the unacceptable level, need to be eliminated, substituted, or reduced on priority. Risk mitigation should be done based on teamwork taking process owners, safety team, and Quality assurance team on board. Failure mode analysis will be in the form of a document. In short, the product of detection, severity, and occurrence provides us RPN which can be categorized into High, Medium, and Low followed by friendly follow up periodically. High risks should be mitigated first, then medium risks and in the last low risks.

Limitations and Disadvantages of Using FMEA

With numerous advantages, FMEA brings along a few flaws and pitfalls, too, which are discussed below:

  1. FMEA is not a Risk Elimination Tool: Although FMEA is an improvement as compared to the traditional tool, FMEA is still an assessment tool and not a risk elimination tool. It can perform at its best when combined with a robust control plan.
  2. FMEA cannot Develop Innovation: FMEA is a tool only to identify risk before any danger does some harm by revealing improvement areas, but it cannot drive innovation in process chains which have to come from process owners themselves.
  3. Static Model: FMEA is not a static model, and it has to be regularly updated to introduce new failure modes whenever an update is done in process chains. Similarly, control plans need to be also updated accordingly.
  4. Subjective: FMEA is considered more of a personal approach as it depends on the experience of the engineer. That’s why it is advised to conduct FMEA always in teams so that FMEA can be done correctly, making the use of different people exposure and experience.
  5. Time Consuming and Exhausting: FMEA is a time taking practice and executing it is also a tedious and time taking task, which sometimes demotivates teams.

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