**Figure 9.**

*Validation of FMEA analysis.*

The FMEA must be performed before the product is prototyped as it is a living, dynamic organism that must be updated throughout the life of the product or process.

This is the reason why the approach and implementation of the FMEA must be part of the organizational development of the product manufacturing, starting before prototyping and ending before the launch of series production.

In carrying out the FMEA method, the main "5 steps" must be completed.

These important "5 steps" in the development and implementation of the FMEA are, **Figure 10**:

Step 1—The elaboration of the structure of the system consists in the description of the system, with the definition of its component elements and the structural determination of the whole.

Step 2—The introduction of functions in the system structure involves the functional description, the structural determination of the system with functions, the correlation of functions, which will lead to obtaining a network of functions, respectively, the formation of a functional structure.

Step 3—Defects and faults analysis consists of the introduction of the "failure" functions in the system structure and correlating these functions, obtaining a "network of failures," respectively, the functional structure of the faults.

**Figure 10.** *Stages of FMEA application.*

Step 4—The risk assessment lies in the FMEA form through avoidance and detection measures, with the assessment form being completed. Step 5—Optimization is the stage in which changes are processed in the FMEA form, the risks of errors and defects are reduced by new measures, the persons responsible and the deadlines in which the recommended measures must be organized and carried out are designated, and the optimization form is made.

#### **1.6 The FMEA team**

The FMEA research is carried out in interdisciplinary groups in which the departments involved in the realization of the product participate under the leadership of a moderator.

The FMEA moderator is usually a person from outside the company or from the Quality Assurance department.

Tasks of the FMEA moderator:


Employees of the design-development, manufacturing process planning, manufacturing, control, customer service, and quality assurance departments generally participate in the implementation of the FMEA, and their number will not exceed 6–8 people.

This ensures that all departments involved in the manufacturing of their products bring their experience in the analysis. The success of the FMEA largely depends on the creativity of the team.

The product is systematically broken down by a "top-down" process into components or functions and subsequently researched to meet the constructive requirements and to maintain these requirements during manufacture. The systematic analysis procedure is supported by using an appropriate form.

In order to perform an FMEA analysis, the operation of the analyzed system must be very well known, or the appropriate means must be available to obtain the necessary information from the owners.

The FMEA team consists of, **Figure 11**:

• The project coordinator (decision-maker) is the person with responsibility in the company who has the power to exercise a final choice. They will make the final decisions regarding cost, quality, and deadlines:


Team members should, as required, provide the following:


The moderator (animator) is the guarantor of the method, the organizer of the group activity. He specifies the agenda of the meetings, conducts the meetings, provides the secretariat, and monitors the progress of the study.

Often, it is a person outside the company, or at least outside the department, to animate the members of the group.

These first three people generally do not have precise technical skills.

Experts (analysis group) in number of 2–5 people will be people responsible and competent, with good knowledge of the studied system and who could bring the necessary information for the analysis (one can only discuss what is well known).

Depending on the study, the following will be:



Their tasks are:


The FMEA designated design team consists of 5–8 people.

**Figure 12** shows the phases necessary for the preparation and planning stage of the FMEA analysis session.

#### **1.7 Stages of FMEA application**

The necessary steps for the development and implementation of the FMEA method are presented in **Figure 13** [13].

Identification of the functions of the product/process subject to FMEA analysis

When applying the FMEA to the product, identify the functions of the product, part, or component considered for the study.

In relation to these functions, potential failures are determined, assessing their severity (criticality).

The causes of errors and malfunctions are then determined, and measures are taken to prevent them from occurring. The Ishikawa Diagram or the "5 Why" technique is usually used to identify the causes of errors or malfunctions.

The application of the FMEA process involves, in a first stage, the description of the process functions. Starting from these functions, the potential faults are identified, and the critical stages of the process are highlighted. The necessary corrective measures shall be taken to prevent damage.

*The necessary steps for the preparation and planning phase of the FMEA analysis session.*

**Figure 13.**

*Steps required to develop and implement the FMEA method.*

Identifying fault modes consists of inventorying all possible faults of the product, part, component (DFMEA), or process (PFMEA) and establishing fault modes. This is usually done by specialists, but in some cases it is possible to use working groups, capitalizing on the experience gained in the field by the group members (company workers, workers serving the equipment used during the technological process). The modes of failure can be multiple: wear, deformation, corrosion, rupture, buckling, crushing, etc.
