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A method for analyzing the types and consequences of potential defects. Initial data for FMEA analysis. Scope of application of FMEA analysis

All risk analysis methods can be divided into expert and calculation methods.

Expert methods- these are methods for determining relative risk characteristics (low, medium or high risk) by a group of specialists.

Calculation methods- these are methods for calculating risk in the characteristics of the probability of causing harm of a certain type (for example, the risk of a fatal outcome, the risk of food poisoning).

Expert methods are most widely used. This is explained by their greater simplicity, which makes it possible to involve in security analysis practitioners who do not have special training in the field of probability theory and mathematical statistics. In addition, the use of a number expert methods dictated international standards in the field of management systems created in relation to automotive products, food products, and medical equipment. Calculation methods are used mainly in the design of industrial products.

For this reason, this tutorial covers only expert methods.

Method for analyzing the types and consequences of potential defects

In the literature, this method is known as the FMEA method (in English transcription) and is set out in the GOST 51184.2-2001 standard (2.14). The basic idea of determining risk is to take into account three characteristics:

1) the significance of the potential defect;
2) the probability of a defect occurring;
3) probability of detecting a defect.

Based on three characteristics it is calculated complex indicator risk of defect - priority risk number (PRN)). Based on the magnitude of the PPR, a decision is made on the need to refine the design and (or) production process.

For each characteristic of the analyzed technical object (structural unit, production process operation), experts assign points (penalty) ranging from 1 to 10 on the corresponding scale recommended by the standard.

Let us give examples of assessing each of the three characteristics using the example of analyzing the structural components of a car.

Potential defect significance score (S) is set to 10 for a consequence called a “hazard warning.” If there are no consequences, 1 point is given.

Defect Probability Score(O) is set to 10 for a very high probability (the defect is almost inevitable): with a frequency of 1 in 2. For a low probability (less than 1 in 1,500,000) a score of 1 is given.

Defect Detection Score (D) is set to 10 for absolute uncertainty. In this case, the designed control does not detect potential cause and subsequent defect. If the category is given the definition of “almost certainly”, a score of 1 is given, the designed control almost certainly detects the potential cause and subsequent type of defect.

After receiving three groups of expert assessments - S, O, D- calculate the priority number of the PCR using the formula:

PFR = S × O × D.

The PPR value ranges from 0 to 1000.

For PHR, a critical limit is set in advance - PHRgr ranging from 100 to 125. At the discretion of the marketing service and other services of the enterprise, the value of PHRgr can be set to less than 100. A decrease in PHRgr corresponds to the creation of higher quality and more reliable objects and processes.

The responsibility of the relevant services of the enterprise is to compile a list of defects/causes for which the PPR value exceeds PPRgr. It is for them that the design and (or) production process should be refined.

In table 7.1 shows a fragment of the protocol for analyzing the design of the mechanism for adjusting the position of the steering column of a light car. Initially, the proposed design involved applying notches to the mating planes (bracket and column holders) to securely fix the column. But a significant excess of the permissible PPR value (200, 700) indicated the need to take more effective measures to improve the design of the unit.

Table 7.1

Fragment of the protocol for analyzing the types, causes and consequences of potential defects

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Ministry of Education and Science

Russian Federation

FEDERAL STATE BUDGET

EDUCATIONAL INSTITUTION OF HIGHER

PROFESSIONAL EDUCATION

"SAMARA STATE AEROSPACE

UNIVERSITY NAMED AFTER ACADEMICIAN S.P. QUEEN

(NATIONAL RESEARCH UNIVERSITY)"

Faculty aircraft

Department of aircraft production and

quality management in mechanical engineering

Coursework

in the discipline “Means and methods of quality management”

on the topic: “Method for analyzing the types and consequences of potential defects

(FMEA designs)"

Completed by student gr. 1511 Smirnova M.A.

Checked by Vashukov Yu.A.

Samara 2012

FMEA ANALYSIS, APE-120-I ABSORPTION APPARATUS, TEAM OF EXPERTS, PRIORITY NUMBER OF RISKS, SIGNIFICANCE RANK (S), OCCURENCE RANK (O), DETECTION RANK (D)

Object of study - draft gear APE - 120 - I

The purpose of this work is to highlight FMEA methods for analyzing the types and consequences of potential design nonconformities.

In the process of work, the FMEA design analysis method was used.

As a result of the work, an analysis of the design of the draft gear was carried out, possible defects were identified and recommended actions were developed to eliminate the defect.

INTRODUCTION

1. Description of the open joint-stock company "Kuznetsov"

2. Basic concepts and principles of FMEA analysis

2.1 Goals, objectives and types of FMEA analysis

2.2 Principles of FMEA analysis

2.3 Technology for conducting FMEA analysis

2.3.2 Initial data for FMEA analysis

3. Carrying out FMEA analysis of the draft gear APE-120-I

CONCLUSION

APPLICATION

INTRODUCTION

One of the main objectives of the quality management system is to ensure the identification of potential non-conformities (defects) and the prevention of their occurrence at all stages life cycle products. The most important method for solving this problem is the analysis of the types and consequences of potential nonconformities (FMEA). Currently, at least 80% of developments technical products and technologies is carried out using analysis of the types and consequences of potential nonconformities (FMEA methodology).

Analysis of the types and consequences of potential nonconformities is widely used by many global companies both for the development of new designs and technologies, and for quality analysis and planning. production processes and products. The FMEA methodology allows you to assess the risks and possible damage caused by potential design inconsistencies and technological processes at the earliest stage of design and creation of the finished product or its components.

The scope of application of the method covers all stages of the product life cycle and any technological or business processes. The greatest effect is obtained from the use of FMEA at the stages of design and process development, however, in existing production, the method can be effectively used to eliminate inconsistencies and their causes that were not identified during development or were caused by factors of variability of production processes.

1. Description of the open joint stock company"Kuznetsov"

quality expert management

1.1 Production activities

OJSC Kuznetsov is a Russian engineering company and an aviation and space engine manufacturing enterprise of the same name. The company is located in Samara.

The company was founded in 1912 in Moscow French company"Gnome" was the first specialized plant in Russia for the production of Gnome aircraft engines.

In May 1977, the plant was transformed into Kuibyshevskoye production association(“KMPO”) named after. M.V. Frunze". In October 1991, KMPO named after. M.V. Frunze" was renamed "SMPO im. M.V. Frunze".

Based on the decision of the Samara State Property Management Committee, Motorostroitel OJSC was established through transformation state enterprise"Samara Engine-Building Production Association named after. M.V. Frunze" and registered by the Administration of the Industrial District of Samara by Resolution No. 1222 of May 23, 1994.

From April 21, 2010, Motorostroitel OJSC, by an extraordinary decision general meeting shareholders was renamed OJSC KUZNETSOV.

OJSC "KUZNETSOV" is the only enterprise of the Russian military-industrial complex, where two key technologies strategic importance:

Production of Soyuz launch vehicle engines for all manned space programs of the Russian Federation.

Development, modernization, serial production, technical support in service and all types of repairs of the entire family of engines for long-range strategic aviation aircraft of the Air Force and Navy aircraft such as Tu-95MS, Tu-142, Tu-22M3, Tu-160.

OJSC "KUZNETSOV" in these competencies, as well as in the production of engines for space launch vehicles in the interests of the Ministry of Defense of the Russian Federation, is the main executor of the state defense order.

To implement these areas, the enterprise has production capacity, trained specialist personnel, uses a previously created unique experimental and development base, a testing complex, which has no analogues in Russia and the CIS.

The engines produced by JSC KUZNETSOV are distinguished by high operational reliability, high efficiency, and excellent technical characteristics.

Main types of products:

gas turbine engines for aviation;

liquid rocket engines for launch vehicles;

gas turbine engines for gas pumping units main gas pipelines, block-modular power plants.

JSC KUZNETSOV has been producing various modifications of rocket engines for decades. Manned launches have been carried out using these engines. spaceships such as "Vostok", "Voskhod", "Soyuz", cargo transport spacecraft "Progress" and automatic stations to Mars, the Moon, Venus.

For more than 30 years, JSC KUZNETSOV has been producing gas turbine engines for the gas pumping industry. JSC "KUZNETSOV" is the first to use aircraft engines for ground use. The company produces a wide range of engines with power from 6.3 to 25 MW. During this time, the products have found application and received high recognition not only in Russia, but also abroad. The engines produced by the company operate successfully in Argentina, Bulgaria, Poland, Turkmenistan, Uzbekistan and other countries.

Along with the use of gas turbine engines as part of gas pumping units, the direction of their use as drives for power plants is intensively developing. The production of block-modular power plants of various capacities has been mastered.

Main types of production and commercial activities:

Production of rocket engines for Soyuz and Soyuz-2 launch vehicles

In this industry, OJSC Kuznetsov occupies a monopoly position. The demand for products in this industry depends entirely on government orders, in particular on state program space exploration.

The engines produced by the plant were serially installed on Soyuz launch vehicles, including the one that launched the Vostok spacecraft into orbit with the world's first cosmonaut Yuri Gagarin.

Repair of engines for strategic aviation of the Russian Air Force (Tu-95, Tu-22M3, Tu-160) Motorostroitel OJSC is also a monopolist in this segment. This type of activity is one of the most important for the enterprise due to the high growth rate of government orders for these services.

Production and maintenance gas pumping engines This market is characterized by fairly strong and increasing competition. In addition to OJSC Kuznetsov, NPO Saturn, OJSC Perm Motors, and OJSC Kazan Engine Production Association operate in this segment. Although the range of engines produced varies (in terms of power), in general the companies are direct competitors. This market is completely focused on the needs of the only customer - RAO Gazprom. One of the advantages of OJSC Kuznetsov is its long history of cooperation with the gas industry -- piping system countries have been equipped with engines from OJSC Kuznetsov since 1976.

Production and repair of block-modular power plants (BME) for the production of electricity and heat with a capacity of 10 and 25 MW.

1.2 Quality management system

A quality management system is a set of organizational structure, procedures, processes and resources necessary for the implementation of quality management and is a tool for ensuring the competitiveness of an enterprise. Figure 1 shows the organizational structure of the Quality Service (Quality Directorate) management.

Figure 1 - Organizational structure Quality services of OJSC "KUZNETSOV"

The main goal of creating a quality system is to satisfy the internal needs of management in achieving successful performance results. Efficient system Quality management must be designed and operated in such a way that the needs and expectations of both consumers and the organization itself are met. Satisfaction of consumer demands and expectations is ensured by constant maintenance of the established level of quality.

Enterprise QMS applies to:

Creation necessary conditions to ensure the fulfillment of consumer requirements for product quality;

Creating the necessary conditions for effective use financial and other resources;

Increasing the efficiency of ensuring product quality at stages of its life cycle to prevent deviations from specified requirements;

Reducing the risk for consumers when placing and fulfilling an order;

Ensuring the company's reputation as a reliable order fulfiller.

The main objectives of the enterprise's QMS are:

Annual increase or maintenance at a high level (at least 97%) of the degree of consumer satisfaction with the performance indicators of the enterprise in the design, development, production, repair and maintenance of products;

Annual increase or maintenance at a high level (at least 0.95) of the efficiency coefficient of the quality management system processes (the efficiency coefficient of QMS processes is calculated according to STP 7512619.01.022).

Continuous improvement of the enterprise's performance as a whole is seen as a permanent goal. The Policy sets out following rules, the implementation of which leads to continuous improvement:

Updating and development of enterprise standards;

Assessing the effectiveness of quality management system processes;

Monitoring compliance with customer requirements and regulatory and technical documentation in force at the enterprise;

Assessment of labor and product quality;

Development and implementation of measures to prevent and eliminate quality inconsistencies;

Customer satisfaction assessment;

Optimization of quality management system processes;

Implementation advanced technologies, equipment and quality standards;

Continuous improvement of the qualifications of performers, engineers and professional competence of management.

The Company's quality policy corresponds to the goals and objectives of the Company, includes a commitment to meet requirements and constantly improve the effectiveness of the QMS, and creates the basis for setting and analyzing quality goals.

All employees of the Company are familiar with the quality policy. Upon joining, each employee studies the Policy and signs the Policy Commitment Form. The quality policy is updated annually. Each employee gets acquainted with the updated Quality Policy upon signature.

To improve services and achieve success in its activities, OJSC KUZNETSOV is guided by the following principles:

meet the requirements and expectations of consumers by providing them with safe, timely consulting services and constantly monitoring and analyzing the quality of services provided;

senior management, being a leader in the development of the QMS, makes decisions based on facts, ensures its functioning with all types of resources and uses the capabilities of the system to reduce costs and reduce losses when performing services;

achieve your goals by creating conditions for professional development their employees and providing them with a high level of motivation. Employees of the company, being both customers and suppliers for their colleagues, responsibly fulfill their duties and contribute to the achievement of common success;

meet the requirements of stakeholders, implementing the principles of openness and long-term cooperation;

apply a process approach to continuously manage QMS processes in order to increase efficiency and continuously improve the company’s performance;

work with proven suppliers, build partnerships with them and involve them in the process of continuous improvement of service quality.

The quality management system is an integral part common system management of the company's activities.

2. Basic concepts and principles of FMEA analysis

A method for analyzing the types and consequences of potential defects is a method effective tool improving the quality of developed technical objects, aimed at preventing defects or reducing the negative consequences of them. This is achieved through the anticipation of defects and/or failures and their analysis carried out at the design stage of the structure and production processes.

The FMEA method allows you to analyze potential defects, their causes and consequences, assess the risks of their occurrence and non-detection at the enterprise and take measures to eliminate or reduce the likelihood of damage from their occurrence. This is one of the most effective methods refining the design of technical objects and their manufacturing processes at such critical stages of the product life cycle as its development and preparation for production.

The introduction of the FMEA design method will improve the technical level of quality of draft gears.

2.1 Goals, objectives and types of analysis of FMEA analysis

The Nonconformity Effects Analysis (FMEA) method is a systematic set of activities carried out in order to:

Identify nonconformities of products and processes, as well as the consequences of these nonconformities, and quantify them;

Create a ranked list of types and causes of nonconformities for planning corrective and preventive actions;

Identify corrective and preventive actions that could eliminate or reduce the likelihood of nonconformities;

Document the data from the analysis results for accumulation in the knowledge base.

The use of FMEA is a mandatory requirement of the ISO/TU 16949 standard (subsections 7.3, 8.5) and other standards of the automotive, aerospace and aviation industries.

The purpose of applying the method is to study the causes and mechanisms of nonconformities and prevent nonconformities (or minimize their negative consequences), and therefore improve product quality and reduce costs for eliminating nonconformities at subsequent stages of the product life cycle.

Timeliness is the most important condition for the effectiveness of the method for analyzing the types and consequences of nonconformities. FMEA should be carried out either before the occurrence of a nonconformity, or immediately after identifying the nonconformity or the reasons leading to its occurrence, in order to prevent consequences or minimize their risk. The costs of analysis and implementation of corrective/preventive actions during process development and production preparation are significantly lower than the costs of similar actions in mass production carried out upon detection of inconsistencies.

There are two main types of analysis: FMEA - design analysis (FMEA - structures) and FMEA - process analysis (FMEA - process (technology)). FMEA - design considers the risks that arise for the external consumer, and FMEA - process - for the internal consumer.

FMEA - design is carried out both for the developed and for the existing structure. The purpose of the analysis is to identify potential product defects that cause the greatest risk to the consumer and make changes to the product design that would reduce such risk.

FMEA is also carried out - analysis of the process of using the product by the consumer. The purpose of such an analysis is to formulate requirements for the design of a product that ensure safety and customer satisfaction, that is, to prepare initial data both for the design development process and for the subsequent FMEA design.

2.2 Principles of FMEA analysis

The application of the method for analyzing the types and consequences of potential nonconformities is based on the following principles: Teamwork. FMEA is carried out by a specially selected multifunctional team of experts. The effectiveness of the analysis directly depends on the professional level, practical experience and consistency of the actions of specialists.

Hierarchy. For complex products, processes and processes for manufacturing complex technical objects, both the product/process as a whole and its components (parts/operations) are analyzed.

Iterativeness. The analysis is carried out repeatedly; it is resumed when new factors are identified and any changes entail a change in the consequences and their risks.

Data logging. An analysis of the types and consequences of potential nonconformities and its results should be documented.

2.3 Technology for conducting FMEA analysis

2.3.1 Formation of a team of experts

The basic (minimum required) composition of a team of specialists should consist of six people: manager working group, process engineer responsible for the development of a technological process, process engineer responsible for the development of a similar technological process, design engineer; representative of the customer relations department, representative of the production / control service.

FMEA - the team is formed from specialists with high professional qualifications who have significant practical experience with similar products and technologies in the past. In each team, depending on the analysis, a leader is selected. Any member of the FMEA team who is recognized by others as a leader and professional in solving the task of improving the proposed design and (or) technology can be selected as the leader.

Figure 2 shows possible compositions of teams for testing the design and technology, respectively. Such teams begin to work in the early stages of developing the design and technology. The commands work using the “ brainstorming” 3-6 hours a day in rooms and conditions that are most favorable for creative activity.

The essence of the FMEA team’s work is to analyze and refine the proposed draft design or technology. In this case, for each element of the structural model of the object, a list of potential defects is compiled. Such defects are usually associated either with the failure of a functional element (its destruction, breakage, etc.), or with the element’s incorrect performance of its useful functions (failure of accuracy, performance, etc.), or with an incorrect sequence of the component formation process ( skipping an operation, performing it incorrectly, etc.). As a first step, it is recommended to review the results of the previous FMEA - analysis or analysis of problems that arose during the warranty period. It is also necessary to consider potential defects that may arise during transportation, storage, and also when external conditions change.

2.3.2 Initial data for FMEA analysis

Before conducting FMEA, a team of experts collects and studies source data. The initial data for analyzing the FMEA of a process must contain information about the process and product, requirements for the system as a whole and its individual components, factors environment, influencing the results. Materials and data for further analysis may include drawings, technological and other documents.

The study of technological processes should include not only the study of documentation, but also the analysis of technological processes in the workplace.

Technological processes (operations, transitions) for subsequent analysis of the types, consequences and causes of potential inconsistencies are selected according to certain criteria. When choosing technological processes (operations, transitions), it is necessary to take into account not only the requirements for the product, but also the features of the technological process.

When selecting technological processes for FMEA, the following criteria can be used:

The technological process is new (more than 50% of new operations);

During the technical process, parameters are formed that affect product safety;

The technical process uses new or modernized equipment/tools/tools;

There have been changes in technology, incl. changing control methods in the technical process;

There was a change in the schedules for repair and maintenance of equipment used in the technical process, and for verification, calibration, certification and repair of measuring instruments used in the technical process.

Any defect in the product (or assembly) in question can be fairly fully characterized by just three indicators (criteria):

significance, measured in terms of the severity of the consequences of a given

refusal (S);

relative frequency (probability) of occurrence (O);

the relative frequency (probability) of detecting a given defect or its cause (D).

The significance parameter (severity of consequences for the consumer) S is an expert assessment given on a 10-point scale; the highest score is given for cases where the consequences of a defect entail legal liability. An example of evaluation criteria for parameter S is given in Table 1 based on the FMEA design.

Table 1 - Criterion for assessing the significance of a defect - parameter S

Evaluation criteria (impact on consumer)	Evaluation points
It is unlikely that the defect would have any appreciable effect on the operation of the system. The consumer will probably not notice the defect
The defect is insignificant and will hardly bother the consumer
Defect of moderate severity, causes dissatisfaction among the consumer
Severe defect, makes the consumer angry
A defect of extreme severity, or when it comes to safety and/or violations in compliance with legal requirements

The defect frequency parameter O is an expert assessment given on a 10-point scale; the highest score is given when the estimated incidence is? and higher. An example of evaluation criteria for parameter O is given in Table 2 based on the FMEA design.

D defect detection parameter is also a 10-point expert assessment; the highest score is given for “hidden” defects that cannot be identified before the consequences occur.

An example of evaluation criteria for parameter D is given in Table 3 based on the FMEA design.

Table 2 - Criteria for assessing the probability of a defect occurring - parameter O

Evaluation criteria	Evaluation points	Possible probability of defect
The probability is very low. It is unlikely that a defect will occur		Less than 1/20000
The probability is low. In general, the design is consistent with previous designs for which relatively few defects were identified
The probability is low. In general, the design corresponds to previous projects in which defects were accidentally discovered, but not in large numbers
The probability is high. In general, the design is consistent with projects that have always presented difficulties in the past
The probability is very high. It is almost certain that defects will occur in large quantities

Table 3 - Criteria for assessing the probability of detecting a defect - parameter D

For each defect from the compiled list, a “step to the right” and a “step to the left” are taken. A step to the right is half a consequence this refusal(assessed on the appropriate scale), there may be several of them, but it is enough to take only the most “severe”, that is, the most significant consequence in terms of significance score. Step to the left - these are the reasons leading (or potentially leading) to this defect. All reasons must be considered separately and for each the frequency of occurrence must be assessed on the appropriate scale (table) for expert assessments. When considering the manufacturing technology of a product, an expert assessment is given based on the criterion for detecting a given defect or its cause along the entire technological chain.

After this, for each defect a generalized assessment is given in the form of a product of three separate parameters according to the corresponding criteria. The generalized assessment is usually called the priority risk number - PPR.

The priority risk number is a generalized quantitative characteristic of the object of analysis. PPR is determined after receiving expert assessments of the components - ranks of significance, occurrence and detection, by multiplying them. Objects of analysis are ordered in descending order of PPR values.

For each application area, a limit value of PChR must be set - PChRgr. If the actual value of the PPR exceeds the PPRgr, based on the results of the analysis, corrective/preventive actions should be developed and implemented to reduce or eliminate the risk of consequences. If the actual value does not exceed PHRgr, then it is considered that the object of analysis is not a source of significant risk and corrective/preventive actions are not required

The results of the analysis are recorded in Table 4.

Table 4 - FMEA analysis protocol form

All defects for which the PPR value has exceeded the critical limit are subject to further consideration. At the beginning of work on FMEA analysis, the recommended level of PChRgr can be 100-120 points.

For defects with PPR>PChRgr, work is underway to improve the proposed design and (or) technology.

eliminate the cause of the defect. By changing the design or process, reduce the possibility of a defect occurring (parameter O decreases);

prevent the occurrence of a defect. Using statistical control, prevent the occurrence of a defect (parameter O decreases);

reduce the impact of the defect. Reduce the impact of a defect on the consumer or the subsequent process, taking into account changes in timing and costs (parameter S decreases);

facilitate and increase the reliability of defect detection. Make it easier to identify a defect and subsequent repairs (parameter D decreases).

According to the degree of influence on improving the quality of a process or product, corrective measures are arranged as follows:

changing the structure of an object (design, diagram, etc.);

changing the process of functioning of an object (sequence of operations and transitions, their content, etc.);

improvement of the quality system.

The developed activities are entered in the last column (Table 12) of the FMEA analysis table. Then the potential risk of PFR is recalculated after corrective measures are taken. If it was not possible to reduce it to acceptable limits (low risk of PFR<40 или среднего риска ПЧР<100), разрабатываются дополнительные корректировочные мероприятия и повторяются предыдущие шаги. На рисунке 3 приведена схема цикла FMEA - конструкции.

Based on the results of the analysis, a plan for their implementation is drawn up for the developed corrective measures. Defined by:

in what time sequence these measures should be implemented and how long each activity will require, how long after the start of its implementation the planned effect will appear;

who will be responsible for carrying out each of these activities, and who will be the specific performer;

where (in what structural unit of the enterprise) they should be carried out;

from what source will the event be financed (enterprise budget item, other sources).

3. Carrying out FMEA analysis of the draft gear APE - 120 - I

A draft gear is a draft device with a design stroke of no more than 120 mm, which is part of the automatic coupling device of cars and locomotives and is designed to absorb the longitudinal forces acting on them. In accordance with the technical specifications of the Ministry of Railways of the Russian Federation for modern draft gears, the need arose to apply new approaches to design and complex technical solutions.

It is proposed to use a set of design documentation and technical specifications for product components (ADK or ASC, bushings, seals), as well as technical specifications for the draft gear as fundamental documents.

An important point in the design of the draft gear was the use of FMEA analysis.

Defects can occur at all stages of the product life cycle. To adequately understand the work when conducting FMEA analysis, it is necessary to consider all the factors affecting the draft gear at each stage of the life cycle. The two main basic stages of the draft gear life cycle are the production and operation stages. It is at these stages that the object manifests itself as a single whole. The stages of operation and assembly give an idea of the level of the product: its operational properties, ensuring the declared parameters, ease of assembly, and its manufacturability.

The use of FMEA - design analysis, involves a diagram of connections and stages. The main difference of this scheme is that the design development stage receives a larger amount of input data, which facilitates a detailed consideration of design requirements. Further FMEA analysis ensures that the design is refined through the comprehensive experience of highly qualified specialists. The subsequent stage of consolidating the final design scheme ensures the coordination of the proposals of the previous stage and design developments into a single design.

For each of the three evaluation criteria, a rating scale is drawn up, shown in Tables 5 - 7. The significance of the defect was considered not only in terms of the operation of the draft gear, but also in the overall system with the car. This is explained by the fact that the operation of the device is aimed at protecting the structure of the car, and the significance of the defect for the structure, and therefore the transported cargo, can be different. Understanding the possible consequences as a result of the failure of the draft gear leads to the need to consider the significance in this particular way. In Table 5, the highest score is given to the most “dangerous” defect, which can lead to a critical situation. A decrease in points means a decrease in significance towards the loss of basic functions, losses, costs, etc.

Table 5 - Criteria for assessing the significance of a defect - parameter S

Evaluation criteria	Description of influence	Evaluation points
It is unlikely that a defect (failure) could have any noticeable impact on the operation of the product and the car as a whole	No influence or very weak influence
The defect (failure) is insignificant and causes a slight disruption to the operation of the product. The effect of the defect on the car is detected only during long-term operation	Weak influence
Defect (failure) of moderate severity. The product is operational and safe, but operates with reduced output parameters, which can lead to a decrease in the service life of the car	Significant influence
Severe defect (failure). Loss of basic functions, which may lead to the need to take the car out of service (uncoupling repair)	Maximum permissible influence
A defect (failure) causes a gradual or sudden loss of performance and safety, and can lead to premature failure of the car	Catastrophic Impact

The probability of a defect occurring is assessed in accordance with the orientation towards the last column of Table 6

Table 6 - Criteria for assessing the probability of a defect occurring - parameter O

When determining the probability of detection, the possibility of detecting a defect by enterprise control methods and means was considered. The determination of this parameter is based on the experience of members of the FMEA team in identifying similar causes of defects using appropriate detection methods (Table 7).

Table 7 - Criteria for assessing the probability of detecting a defect - parameter D

Evaluation criteria	Detection Probability Characteristics	Evaluation points
It is not realistic that a defect (failure) will not be detected during inspection, testing or assembly	Almost always found
A defect (failure) is almost always detected during planned activities	Probability of detection is high
Moderate probability that planned activities will reveal the presence of a defect (failure)	Moderate detection probability
Very low chances of detecting a defect (failure)	Rarely found
Planned activities do not allow or cannot identify a defect (failure)	Very rarely or practically undetectable

In the process of conducting FMEA analysis, a team of specialists generates all kinds of defects that arise at various stages of the product life cycle. In this case, it is necessary to highlight at what stage or stages a particular defect is possible. Failure to differentiate between stages will result in many defects not being fully disclosed, which will reduce the efficiency of the team.

Determining the stage at which a defect occurs allows you to create a chain of possible deficiencies leading to the occurrence of a defect. By tracing the entire sequence of causes and mechanisms of the defect, it will be possible to eliminate the source of the defect, or identify weak points of the design, the shortcomings of which are the causes of their occurrence.

When working with the FMEA team, the appropriate form of the protocol of the event is used. The protocol must ensure the traceability of the document, the ability to record it, and also contain all the necessary information to ensure reliable identification of each working day of the FMEA team. Appendix A shows the form of the FMEA protocol - design.

It is recommended to set the priority limit risk number in the range from 100 to 125. Taking into account the high requirements for the reliability of the draft gear and the increased requirements for the quality of the apparatus, the priority limit risk number is set to 40, that is, PPRgr = 40.

The composition of the FMEA team should presumably include the following specialists:

constructor;

production cycle technologist;

technical control bureau specialist;

quality management specialist;

operation specialist.

Working as a team makes it possible to take into account all the “cons,” while mutual training and advanced training of team members in related areas occurs. When a team works, design time is reduced, while the total costs, taking into account the necessary changes and losses, are sharply reduced.

As a result of the developed procedures, a trial work of the FMEA team was carried out. The results of the event are presented in Appendix B.

In the work carried out, which indicates the stage of the life cycle where a potential defect is supposed to occur, it was proposed that when assessing a defect using expert scales, we consider the connection between two elements: “potential defect - potential cause.” Due to the fact that the cause or potential mechanism for the occurrence of a defect cannot be identified explicitly, which is explained by many influencing factors, when assessing the probability of a defect occurring, various chains of “potential defect - potential cause” were analyzed.

At the same time, the probability of occurrence of a given defect with a given mechanism was assessed separately.

As a result of the existence of the probability that a defect could manifest itself in each of them, regardless of other chains, estimates of the occurrence of a potential defect were added up.

The calculation of the PPR value was carried out as the product of the parameter S, D and the total parameter O.

CONCLUSION

Quality management is one of the key functions of the enterprise policy, the main means of achieving and maintaining product competitiveness.

Quality is created at all stages of the product life cycle: from design to disposal. The course work examined a method for analyzing the types and consequences of potential inconsistencies in the design of the draft gear APE - 120 - I.

Scales of expert assessments have been developed in relation to the production specifics and requirements for the draft gear. An algorithm for carrying out the analysis, the composition of the team of performers and a method for calculating the priority risk number are given.

LIST OF REFERENCES USED

1. Methods for assessing and managing the quality of industrial products. Textbook. Edition 2nd revised. and additional - M.: Information and Publishing House “Filin”, Rilant, 2009. - 328 p.

2. A.N. Chekmarev, V.A. Barvinok, V.V. Shalavin. Statistical methods of quality management. - M.: Mechanical Engineering, 1999. - 320 p.

3. Rozno M.I. How to learn to look forward? Introduction of FMEA methodology. // Quality management methods. - 2010-№6. p.25-28.

4. Total quality management: Textbook for universities / O.P. Gludkin, N.M. Gorbunov, Yu.V. Zorin; Ed. O.P. Gludkina. - M.: Radio and Communications, 2008. - 600 p.

5. Quality management: Textbook / I.I. Mazur, V.D. Shapiro. Under. ed. I.I. Mazura. - M.: Higher School, 2009. - 334 p.

APPLICATION

Drawing of the draft gear APE-120-I

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Transcript

1 STATE STANDARD OF THE REPUBLIC OF BELARUS STB Quality Management METHOD OF ANALYSIS OF TYPES AND CONSEQUENCES OF POTENTIAL DEFECTS Kiravanne yakassu METAD OF ANALYSIS OF TYPES OF PATENTIAL DEFECTS Official publication BZ Gosstandart Minsk

2 UDC: (083.74)(476) MKS (KGS T59) Key words: technical object, production process, defect, failure, method of analyzing the types and consequences of potential defects, cross-functional team, quality systems in the automotive industry Preface 1 DEVELOPED by the research and production republican unitary by the enterprise "Belarusian State Institute of Standardization and Certification (BelGISS)" INTRODUCED by the standardization department of the State Standard of the Republic of Belarus 2 APPROVED AND ENTERED INTO EFFECT by the resolution of the State Standard of the Republic of Belarus dated October 29, 2004 INTRODUCED FOR THE FIRST TIME This standard cannot be replicated and distributed without the permission of the State Standard of the Republic of Belarus Published on Russian language II

3 Contents Introduction... IV 1 Scope Regulatory references Definitions Basic provisions Composition of FMEA teams and requirements for their members Methodology of FMEA teams (main stages of FMEA) Criteria for assessing complex risk...8 Appendix A Type analysis protocol form , causes and consequences of potential defects...13 Appendix B Examples of refinement of initial design and technological solutions by FMEA teams...14 Appendix B Bibliography...17 III

4 Introduction The method for analyzing the types and consequences of potential failures (hereinafter referred to as FMEA) 1 is an effective tool for improving the quality of developed technical objects, aimed at preventing failures, defects or reducing the negative consequences of them. This is achieved through the assumption of possible defects and/or failures and their analysis carried out during the design stages of the structure and production processes. The method can also be used to refine and improve designs and processes put into production. The FMEA method allows you to analyze potential defects, their causes and consequences, assess the risks of their occurrence and non-detection at the enterprise and take measures to eliminate or reduce the likelihood and damage from their occurrence. This is one of the most effective methods for refining the design of technical objects and their manufacturing processes at such important stages of the product life cycle as its development and preparation for production. At the stage of finalizing the design of a technical object before approving the design or when improving an existing design using the FMEA method, the following tasks are solved: identifying the “weak” points of the design and taking measures to eliminate them; obtaining information about the risk of failure of the proposed and alternative design options; refinement of the design to the most acceptable from various points of view: manufacturability, ease of maintenance, reliability, etc.; reduction of expensive experiments. At the stage of finalizing the production process before its launch or when improving it using the FMEA method, the following tasks are solved: identifying “weak” points of technological processes and taking measures to eliminate them when planning production processes; making decisions about the suitability of proposed and alternative processes and equipment for process development; refinement of the technological process to the most acceptable from various points of view, namely: reliability, safety for personnel, detection of potentially defective technological operations, etc.; preparation of serial production. The FMEA method is recommended to be used when operating conditions of a technical facility change, customer requirements, when modernizing structures or technological processes, etc. The FMEA method can also be used when making decisions regarding non-conforming products (materials, parts, components) in economically justified cases. The FMEA method can also be used in the development and analysis of any other processes, such as sales, service, marketing, etc. The standard is intended for technical specialists and business managers. The basis of this standard is the guide “Analysis of the types and consequences of potential failures”, which is part of the system of documents for the standard “QS Requirements for Quality Systems”. The application of this standard is not limited to the automotive industry. The methods established in the standard are applicable to enterprises in other industries interested in improving the quality of developments, development and continuous improvement of designs and technological processes. 1 Potential Failure Mode and Effects Analysis (FMEA) analysis of the modes and consequences of potential failures is a method set out in the manual with the same name to the QS-9000 standard “Requirements for Quality Systems”; in this standard, the method covers both an analysis of the consequences and an analysis of the causes of potential defects in technical objects and their manufacturing processes, as well as the necessary modification of technical objects based on the analysis data. IV

5 STATE STANDARD OF THE REPUBLIC OF BELARUS STB Quality Management METHOD FOR ANALYSIS OF TYPES AND CONSEQUENCES OF POTENTIAL DEFECTS Kiravanne yakassu METHOD FOR ANALYSIS OF THE TYPES OF PATENTIAL DEFECTS Quality management METHOD FOR POTENTIAL FAILURE DE AND EFFECTS ANALYSIS 1 Scope Date of introduction This standard applies to technical objects of the automotive industry. The standard establishes the methodology and procedure for analyzing the types, consequences and causes of potential defects (failures) of technical objects and their production processes, as well as the modification of these objects and processes based on the results of the analysis. The standard is used at the stages of development and production of technical objects, as well as for improving and finalizing existing designs and production processes of technical objects, as well as for making decisions on product components that have inconsistencies in certain quality indicators. The standard is applied in cases where for technical objects the relevant documents (standard, technical specifications, contract, quality and reliability assurance program, etc.) recognize the need for analysis by the FMEA method. The standard can be applied proactively if the FMEA method is considered appropriate to prevent or eliminate errors and defects in design and/or technological processes. The standard is recommended for use in the development of organizational standards, guidelines, methods and other documents within the framework of the quality system operating at the enterprise. 2 Normative references This standard uses references to the following regulatory documents: STB ISO Quality Management Systems. Basic provisions and vocabulary of STB Quality Management. Methods of statistical process control GOST Reliability in technology. Basic concepts. Terms and definitions GOST Reliability in technology. Analysis of types, consequences and criticality of failures. Basic provisions 3 Definitions This standard uses terms with the corresponding definitions in STB ISO 9000, GOST and GOST, as well as the following terms: 3.1 Non-compliance - failure to comply with requirements (STB ISO 9000). 3.2 Defect - failure to fulfill a requirement related to intended or specified use (STB ISO 9000). 3.3 Failure is a phenomenon not intended for the normal functioning of a technical object, leading to negative consequences during the operation or manufacture of this technical object. Note Further in the standard, the term “defect” is used in a meaning that generalizes the given terms “nonconformity”, “defect” and “failure”. 3.4 Significance is a qualitative or quantitative assessment of the expected damage from a given. Official edition 1

6 3.5 (rank) of significance (S) 1 expert assessment, corresponding to the significance of the given in terms of its possible consequences. 3.6 Probability of occurrence is a quantitative assessment of the share of products (of its total output) with a defect of a given type; this share depends on the proposed design of the technical object and the process of its production. 3.7 (rank) of occurrence (O) 2 expert assessment, corresponding to the probability of occurrence of a given. 3.8 Probability of detection is a quantitative assessment of the proportion of products with a potential defect of a given type, for which the monitoring and diagnostic methods provided in the technological cycle will make it possible to identify this potential defect or its cause if it occurs. 3.9 (rank) detection (D) 3 expertly assigned assessment corresponding to the probability of detection Complex risk comprehensive assessment in terms of its significance in terms of consequences, probability of occurrence and probability of detection Priority number of risk (PNR) 4 quantitative assessment of complex risk, which is the product of significance points, occurrence and detection for a given Analysis of the types and consequences of potential defects (FMEA) is a formalized procedure for the analysis and refinement of a designed technical object, the manufacturing process, operating and storage rules, the maintenance and repair system of a given technical object, based on the identification of possible (observable) defects of various types with their consequences and cause-and-effect relationships that determine their occurrence, and assessments of the criticality of these defects. Technical object (object) is any product (element, device, subsystem, functional unit or system) that can be considered separately. Note An object may consist of hardware, software, or a combination thereof, and may, in particular cases, include personnel who operate, maintain, and/or repair it. 4 Basic provisions 4.1 Objectives of the FMEA method The FMEA method is carried out to analyze and refine the design of a technical object, production process, operating rules, system of maintenance and repair of a technical object to prevent the occurrence and/or reduce the severity of the possible consequences of its defects and to achieve the required characteristics safety, environmental friendliness, efficiency and reliability. 4.2 Principles of applying the FMEA method Teamwork. The implementation of the FMEA method is carried out by a specially selected cross-functional team of experts. Hierarchy. For complex technical objects or processes for their manufacture, both the object or process as a whole and their components are analyzed; defects of components are considered according to their impact on the object (or process) in which they are included. Iterativity. The analysis is repeated for any changes in the object or requirements for it, which may lead to a change in the complex risk. Registration of the results of the FMEA method. The relevant reporting documents should record the results of the analysis and decisions on necessary changes and actions. The necessary changes and actions specified in the reporting documents must be reflected in the relevant documents within the framework of the quality system in force at the enterprise. 1 Solemnity significance. 2 Origin origin. 3 Disclosure detection. 4 Priority number of risk priority number of risk. 2

7 4.3 Tasks solved when carrying out the FMEA method STB In the process of carrying out the FMEA method, the following tasks are solved: they compile a list of all potentially possible types of defects of a technical object or its production process, taking into account both the experience of manufacturing and testing of similar objects, and the experience of real actions and possible personnel errors during production, operation, maintenance and repair of similar technical objects; determine possible adverse consequences from each, conduct a qualitative analysis of the severity of the consequences and quantitative assessment of their significance; determine the causes of each and evaluate the frequency of occurrence of each cause in accordance with the proposed design and manufacturing process, as well as in accordance with the expected operating, maintenance, and repair conditions; assess the sufficiency of the operations provided for in the technological cycle aimed at preventing defects in operation, and the sufficiency of methods for preventing defects during maintenance and repair; quantitatively assess the possibility of prevention through the provided operations to detect the causes of defects at the stage of manufacturing of the object and signs of defects at the stage of operation of the object; quantify the criticality of each (with its cause) by priority risk number (PNR); at high PNR values and the significance of the consequences, the design and production process, as well as the requirements and operating rules, are refined in order to reduce the criticality of this. 4.4 When carrying out the FMEA method, along with the proposed design or manufacturing process, it is recommended to also analyze alternative technical solutions. These options are considered in order to reduce the complex risk of PNR, reduce the cost and increase the efficiency of the technical object or its manufacturing technology. 4.5 The methodology for analyzing the types, causes and consequences of defects involves the organization of a cross-functional team (FMEA team), consisting of different specialists, whose knowledge is necessary when analyzing and finalizing the design of an object and/or production process (see). Requirements for the composition of FMEA teams in accordance with the section Various types of FMEA In cases where, when developing a technical object, it is impractical to separate the design and production process, the development of the design and production process is carried out jointly using a common FMEA. Industry examples of the appropriate use of general FMEA are: rubber production, tire industry, etc. In this case, a generalized methodology for analyzing the types and consequences of design and technology defects is used according to this standard, as well as according to GOST In cases where a technical object being developed involves first developing the design of this object , and then the development of processes for its production, the FMEA method can be divided into two stages: the design development stage (DFMEA 1 or FMEA design) and the production process development stage (PFMEA 2 or FMEA process) Analysis of the types and consequences of design defects (DFMEA, FMEA design) is a procedure for analyzing the initially proposed design of a technical object and refining this design during the work of the corresponding FMEA team. FMEA designs are carried out at the stage of developing the design of a technical object. This method allows you to prevent the launch of an insufficiently developed design into production, helps to improve the design of a technical object and provide in advance the necessary measures in the manufacturing technology, preventing the occurrence and/or reducing complex risk due to: the collective work of diverse specialists included in the DFMEA team; 1 DFMEA Potential failure mode and effects analysis in design (Design FMEA) analysis of the types and consequences of potential design failures. 2 PFMEA Potential failure mode and effects analysis in manufacturing and assembly processes (Process FMEA) analysis of the types and consequences of potential process failures. 3

8 initial and complete consideration of requirements for component manufacturing, assembly requirements, manufacturing control, serviceability, etc.; increasing the likelihood that all types of potential defects and their consequences will be considered during the DFMEA team's work; analysis of complete and comprehensive information when planning effective testing of a structure; analysis of a list of all types of potential defects, ranked by their impact on the consumer, in which a system of priorities is established when carrying out design improvements and a testing program; creating an open form for recommendations and tracking actions that reduce the risk of defects; development of recommendations that help in further activities to analyze the set of requirements, evaluate design changes, as well as in the development of subsequent promising designs Analysis of the types and consequences of process defects (PFMEA, FMEA-process) is a procedure for analyzing the initially developed and proposed production process and refining this process during the work of the corresponding PFMEA command. RFMEA is carried out at the development stage of the production process, which helps prevent the introduction of insufficiently mature processes into production. RFMEA allows you to: identify types of potential defects in the manufacturing process of a given technical object, leading to damage to this technical object; assess potential consumer reactions to relevant defects; identify potential manufacturing and assembly process factors and process variations that require enhanced action to reduce the frequency (likelihood) of defects or to detect process defect conditions; create a ranked list of potential process defects, thereby establishing a system of priorities for consideration of corrective actions; document the results of the manufacturing or assembly process. The FMEA method can be used to make decisions regarding batches of components that have deviations in certain quality indicators. At the same time, the criticality of potential defects that may occur in a technical object that includes these components is assessed. In this case, the expertly assigned points S, O, D (see sections 6 and 7) must relate to the technical object that includes these components. 4.7 The FMEA methodology is recommended both when designing new technical objects and when developing modified versions of the design and/or production process of technical objects (in accordance with 4. 2.3). The FMEA methodology is also useful when considering new operating conditions of a technical object or new customer (consumer) requirements for this object. 5 Composition of FMEA teams and requirements for their members 5.1 FMEA team (cross-functional team) is a temporary team of different specialists created specifically for the purpose of analyzing and refining the design and/or manufacturing process of a given technical object. If necessary, experienced specialists from other organizations can be invited to join the FMEA team. 5.2 In their work, FMEA teams use the brainstorming method; Recommended operating time is 3 to 6 hours per day. To work effectively, all members of the FMEA team must have practical experience and a high professional level. This experience assumes that each team member has significant past experience with similar technical assets. 5.3 The recommended number of FMEA team members is from 4 to 8 people. The full composition of the FMEA team members for working with this technical object must remain unchanged, however, on some days, an incomplete composition of the FMEA team may take part in the work of the FMEA team, which is determined by the expediency of the presence of certain specialists when considering the current issue. 5.4 It is recommended that the members of the DFMEA team collectively have practical experience in: developing similar technical objects, various design solutions; 4

9 component production and assembly processes; control technologies during the manufacturing process; maintenance and repair; tests; analysis of the behavior of similar technical objects in operation. 5.5 It is recommended that the members of the PFMEA team collectively have practical experience in: the design of similar technical objects; component manufacturing and assembly processes; control technologies during the manufacturing process; analysis of the operation of relevant technological processes, possible alternative technological processes; analyzing the frequency of defects and monitoring the operation of relevant equipment and personnel. Note If necessary, specialists with practical experience in other areas of activity are also involved in the FMEA teams. 5.6 In the case when it is inappropriate to separate the design stages of the structure and production processes of a given technical object (see), a common FMEA team is formed. The members of this team must collectively have practical experience in all areas of activity listed in 5.4 and In the case when a DFMEA team and a PFMEA team are separately formed for a given technical object, it is recommended that they include the same individuals of the following specialties: designer , technologist, assembler, tester, controller. 5.8 The team must have a leader, who can be any of the team members recognized by the others as a leader in the issues under consideration. 5.9 The professionally responsible person in the DFMEA team is the designer, and the technologist in the PFMEA team. 6 Methodology of work of FMEA teams (main stages of FMEA) 6.1 FMEA planning is carried out in accordance with GOST (clause 5.3). It is necessary to decide on the modifications and stages of work according to the FMEA method: first DFMEA, then PFMEA or general FMEA. 6.2 The formation of cross-functional FMEA teams is carried out in accordance with the requirements of the section Familiarization with the proposed design and/or technological process projects. The leader of the FMEA team presents a set of documents on the proposed design project and/or technological process project for review by members of his team. It is recommended at this stage to draw up a block diagram of the interaction of the FMEA object with other components of the system, determine operating conditions and limit values of environmental factors. 6.4 Determination of types of potential defects, their consequences and causes For a specific technical object and/or production process with its specific function, all possible types of defects are determined (using available information, previous experience, brainstorming). The list of types of defects should include not only defects that may occur, but also those that may not occur. In addition, it is necessary to take into account defects that occur only under certain operating conditions (i.e., under the influence of factors such as temperature, humidity, pollution, etc.) or under certain conditions of use (for example, in mountainous areas or on urban roads and etc.). Potential defect types may be caused by a higher level subsystem or system or be a consequence of a lower level component. A description of each type is entered into a protocol for analyzing the types, causes and consequences of potential defects, compiled, for example, in the form of a table. The form of the protocol must be pre-selected and approved. The recommended form of the protocol is given in Appendix A. Examples of types of defects in a technical object: cracking, delamination, deformation, play, leakage, puncture, short circuit, oxidation, rupture, destruction, unstable signal, incorrect signal, lack of signal, electromagnetic compatibility (EMC) and radio interference. 5

10 Examples of types of process defects: bending, breakage, contamination, deformation, insufficient coating thickness, omission of a cotter pin installation operation, broken chain, use of a different material, omission of marking. Note Types of potential defects should be described in physical or technical terms, and not in the form of external signs (symptoms) noticeable to the consumer. For all types of potential defects described, their consequences are determined based on the experience and knowledge of the FMEA team. Examples of the consequences of defects: noise, improper operation, poor appearance, instability, intermittent operation, roughness, inoperability, bad odor, control damage, non-compliance with standards, customer dissatisfaction, roughness, damaged equipment, long transfer times, danger to the operator when work. Notes 1 For each type of defect there may be several potential consequences, all of which must be described. 2 The consequences of defects should be described by signs that can be noticed and felt by the consumer, meaning that the consumer can be both internal (in subsequent operations of creating the object) and external. 3 The consequences of defects should be expressed in specific terms of the system, subsystem or component being analyzed. For each consequence, a significance score S is determined by an expert using a table of significance scores. significance varies from 1 (for the least significant defects in terms of damage) to 10 (for the most significant defects in terms of damage). For a specific plant, this table should be revised in accordance with the specifics of the plant and the specific consequences of defects. significance is a relative value and depends on the scope of a particular FMEA. Therefore, the FMEA team must agree on evaluation criteria and their classification, which must be constant for the analysis performed. Typical values of significance points are given in Tables 1 and 2. When setting PNR (according to 6.4.8), one maximum significance score S is used from all the consequences of a given one (examples of using the maximum score S when calculating PNR are given in Appendix B). Notes 1 For types of defects with a significance score of 1, further analysis is not recommended. 2 A high significance score may be reduced by design changes that offset or reduce the resulting significance. For example, lowering tires can reduce the significance of a sudden tire puncture, or seat belts can reduce the significance of a car accident. For each, potential causes and/or mechanisms of its occurrence are identified. For one, several potential causes and/or mechanisms of its occurrence may be identified; all of them should be described as fully as possible and considered separately. Examples of causes of defects: different material used, inadequate assumption of design viability, overloading, insufficient lubrication capabilities, incomplete maintenance instructions, incorrectly set tolerances, incorrect algorithm, inappropriate software requirements, improper transportation, poor protection from adverse environmental conditions. The causes (mechanisms) of defects can be, for example: fluidity, creep, material instability, fatigue, wear, corrosion, chemical oxidation, electromigration. For each potential cause, an O occurrence score is expertly determined. At the same time, the proposed manufacturing process is considered and the frequency of this cause is expertly assessed, leading to the defect in question. occurrence varies from 1 (for the most rarely occurring defects) to 10 (for defects that occur almost always). Typical occurrence score values are given in Tables 3 and For each and/or cause, identify the proposed detection or prevention measures that have been or are being used in similar designs or processes, or other actions (for example, design validation/verification, bench testing, mathematical analysis ), providing detection capabilities. 6

11 Two types of controls should be distinguished: preventive controls prevent the occurrence of the cause and/or mechanism or reduce the frequency of occurrence; controls determine the cause and/or mechanism or species by analytical or physical methods after the product is manufactured. The use of preventative control measures is preferred. Note It is recommended to divide this column into two columns in the protocol or to identify with the help of labels the proposed measures to detect and prevent defects. For example, “P” and “K” are for preventive and control measures, respectively. This will help the FMEA team clearly differentiate between the types of control measures and clearly illustrate their use in each specific case. For and each individual cause, determine a detection score D for that or its cause, taking into account the proposed control measures. detection ranges from 10 (for virtually undetectable defects and/or causes) to 1 (for almost reliably detected defects and/or causes). Typical detection score values are given in Tables 5 and After receiving expert estimates S, O, D, the priority risk number PNR is calculated using the formula PNR = S O D. (1) For defects that have several causes, several PNRs are determined accordingly. Each PNR can have values from 1 to A list of defects/causes is compiled for which the PNR and significance S values are the greatest. It is for them that the design and/or production process should be further refined through recommended actions. The goal of the recommended actions is to reduce any of the indicators: the significance of the consequence, the frequency of occurrence and the probability of undetected. In general, regardless of the resulting PNR, special attention should be paid to those that have the greatest significance. Examples of recommended actions include reviewing geometric dimensions and/or tolerances, reviewing the characteristics of materials used, designing an experiment (especially when multiple or interrelated causes are present), reviewing the test plan. It should be noted that only design revision can reduce the consequence significance score. Strengthening or applying preventive controls affects the occurrence score, and control controls affect the detection score. Note If there are no recommended actions for a specific reason, this should be noted. Once the recommended actions have been identified, the S significance, O occurrence, and D detection scores for the new proposed design and/or manufacturing process should be assessed and recorded. The new proposed option should be analyzed and the new PNR value calculated and recorded. All new PNR values should be reviewed and, if further reduction is necessary, the previous steps should be repeated. The engineer responsible for the design and/or production process should confirm that all suggestions from the team members for revision have been considered. At the end of the FMEA team's work, a protocol should be drawn up and signed. , which reflects the main results of the team’s work, including: the composition of the FMEA team; description of the technical object and its functions; list of defects and/or causes for the originally proposed design and/or manufacturing process: expert scores S, O, D and PNR for each and the reasons for the originally proposed design and/or manufacturing process; corrective actions proposed during the work of the FMEA team to refine the initially proposed design option and/or production process; expert scores S, O, D and PNR for each and the reasons for the revised design and/or manufacturing process. The recommended form of the protocol is given in Appendix A. 7

12 If necessary, the corresponding drawings, tables, calculation results, etc. are attached to the work protocol of the FMEA team. 7 Criteria for assessing complex risk 7.1 In accordance with the methodology outlined in Section 6, each defect and cause are assessed by experts according to three criteria: significance ; probability of occurrence; probability of detection. Note Members of the FMEA team must have a common opinion on the system and criteria for expert assessments. These criteria and rating scales must remain constant as the design and manufacturing process are modified. 7.2 When members of the FMEA team assign a significance score S, Tables 1 and 2 for DFMEA and РFMEA, respectively, can be taken as a basis. Before FMEA teams begin working, these tables should be reviewed and presented taking into account the specifics of the enterprise. It is possible to develop several tables for different types of structures and production processes. When compiling such tables, it should be taken into account that as the significance of defects decreases, when describing the consequences, one should move from safety and environmental indicators to indicators of the functioning of the facility, then to efficiency indicators (taking into account losses for elimination, etc.), then to indicators of consumer dissatisfaction, including including consumers and personnel involved in the manufacturing process, as well as personnel servicing the technical object in operation. Note It is recommended that economic losses be weighed against the cost of the technical object itself. Table 1 Recommended significance score scale S for FMEA design Consequence Dangerous without warning Consequence significance criterion S Very high significance rank when the species impairs the safety of the vehicle and/or causes non-compliance with mandatory safety and environmental requirements without warning 10 Dangerous with warning Very high rank significance when the type impairs the safety of the vehicle or causes non-compliance with mandatory safety and environmental requirements with a warning 9 Very important The vehicle/component is inoperable with loss of its main function 8 Important The vehicle/component is operable, but the level of efficiency is reduced. Customer is extremely dissatisfied 7 Moderate The vehicle/unit is functional, but the comfort/convenience systems are ineffective. Customer dissatisfied 6 Weak The vehicle/unit is operational, but the comfort/convenience systems are not operational. The consumer experiences discomfort 5 Very low The finish and noise level of the product do not meet consumer expectations. The defect is noticed by the majority of consumers (more than 75%) 4 Minor The finish/noise of the product does not meet consumer expectations. The defect is noticed by the average consumer (about 50%) 3 Very minor The finish/noise of the product does not meet consumer expectations. The defect is noticed by picky consumers (less than 25%) 2 Absent No discernible/visible consequence 1 Note “Dangerous with warning” is a consequence, the possibility of which the consumer (user, operator) is warned in advance by a light, sound or other indicator. In some cases, it is impossible or technically impractical to prevent an occurrence with its consequences, but it is easy to prevent such an occurrence in the near future (for example, wear of brake pads, a drop in the level of brake fluid, etc.). 8

13 Table 2 Recommended significance score scale S for the FMEA production process Consequence Criterion for the significance of the consequence S Dangerous without warning Dangerous with warning Very important Important Moderate Weak Very weak Insignificant Very insignificant Very high level of significance when the type impairs the safety of the vehicle and/or causes non-compliance with mandatory safety and environmental requirements without warning or may endanger personnel at the machine or in the assembly without warning 10 Very high level of significance when the type impairs the safe operation of the vehicle and/or causes non-compliance with mandatory safety and environmental requirements with warning or may endanger personnel at the machine or on the assembly with warning 9 The vehicle/assembly is inoperable with loss of the main function. Major disruption to the production line. Up to 100% of products may be rejected. The time required for correction is more than one hour 8 The vehicle is operational, but with reduced efficiency. The consumer is extremely dissatisfied. Minor disruption to the production line. It may be necessary to sort products when some of them are rejected (less than 100%). The time required for correction is min 7 The vehicle/unit is operational, but some comfort and convenience systems do not work. The consumer is dissatisfied. Minor disruption to the production line. Some products (less than 100%) may be rejected (without sorting). Time required for correction is less than 30 minutes 6 The vehicle/component is operational, but some comfort and convenience systems are operating at reduced efficiency. The consumer experiences some dissatisfaction. Minor disruption to the production line. 100% of the product may require rework, but does not need to be corrected by the repair department 5 The finish and noise level of the product do not meet customer expectations. This defect is noticed by the majority of consumers (more than 75%). Minor disruption to the production line. Product may need to be sorted and partially reworked (less than 100%) 4 Finish and noise levels do not meet consumer expectations. The defect is noticed by the average consumer (about 50%). Minor disruption to the production line. Some of the product may need to be reworked (less than 100%) during production (online), but not at position 3 Finish and noise levels do not meet consumer expectations. The defect is noticed by a discerning consumer (less than 25%). Minor disruption to the production line. It may be necessary to refine part of the product (less than 100%) during the production process (online) at position 2 Absent No consequence When expertly scoring the occurrence of O, tables 3 and 4 for DFMEA and РFMEA, respectively, can be taken as a basis. 9

14 In the case of PFMEA, if the cause of occurrence is a violation of the established tolerance for a given quality indicator and if there is a statistical analysis for a similar process, then the recommended guideline for assigning a score O is the P pk index given in Table 4. Note The statistical process suitability index P pk takes into account the alignment of the process to the center of the tolerance field and determines the practical capabilities of the technological process to ensure compliance with the requirements of the established tolerance for a given quality indicator X. The P pk index is calculated using the formula P pk ((USL X); (X LSL) ) min =, (2) 3σˆ where USL, LSL are the upper and lower limit values of the tolerance field of the quality indicator X; T X sample average or estimate of the position of the process adjustment center; σˆ T estimate of the standard deviation (total variability) of the process. The calculation of this indicator is described in more detail in the STB. In any case, when assigning points for the occurrence of O, members of the FMEA team should consider the following questions: What is the experience in operating and maintaining a similar technical facility/production process? Is the technical object/production process borrowed (similar) from those used previously? How significant are the design and/or manufacturing process changes from previous ones? Are the components radically different from previous ones? Is the component completely new? Could there be changes in the environment? Are preventive controls carried out at the right time and in the right place? Table 3 Recommended scale for scoring O occurrence (FMEA constructs) Probability Possible frequency O Very high: defect almost inevitable More than 1 in 10" 1 in 20 High: repeated defects More than 1 in 50" 1 in 100 Moderate: random defects More than 1 out of 200" 1 out of 500" 1 out Low: relatively few defects More than 1 out of 2,000" 1 out Low: defect unlikely Less than 1 out Table 4 Recommended scale for scoring the occurrence of O (FMEA process) Probability Possible frequency Very high: defect almost inevitable More than 1 in 10" 1 in 20 High: associated with similar processes More than 1 in 50 that frequently fail" 1 in 100 Moderate: associated with previous processes that had occasional defects, but not in large proportion More than 1 in 200 "1 out of 500" 1 out Index Less than 0.55 More than 0.55 More than 0.78" 0.86 More than 0.94" 1.00" 1.10 P pk O

15 End of table 4 Probability Possible frequency Index P pk O Low: individual defects associated with similar processes More than 1 of More than 1.20 3 Very low: individual defects associated with almost identical processes More than 1 of More than 1.30 2 Low: defect unlikely. Defects are never associated with the same identical processes More than 1 of More than 1, When assigning a detection score D, tables 5 and 6 for DFMEA and PFMEA, respectively, can be taken as a basis. When conducting RFMEA and using Table 6, defects in the production process and the possibility of their detection by the intended methods and means of control are taken into account. Detection D ratings are based on the previous experience of the FMEA team members in the detection capabilities of similar causes of defects with the appropriate detection methods embedded in the manufacturing process. Table 5 Recommended scale for scoring detection D (FMEA constructs) Detection Criterion: Likelihood of detection under designed control D Absolute uncertainty Very poor Poor Very weak Weak Moderate Moderately good The intended control will not and/or cannot detect the potential cause/mechanism and subsequent no species or control at all 10 Very poor chance of detecting a potential cause/mechanism and subsequent species under putative control 9 Poor chance of finding a potential cause/mechanism and subsequent species under putative control 8 Very limited chance of finding a potential cause/mechanism and downstream species under putative control Good /mechanism and subsequent species under suspected control 3 Very good Very high chance of detecting a potential cause/mechanism and subsequent species under suspected control 2 Very High Suspected actions (controls) almost always detect a potential cause and subsequent species 1 11

16 Table 6 Recommended scale for assigning a detection score D (FMEA process) Detection Almost impossible Very poor Poor Very weak Weak Moderate Moderately good Good Very good Very high Criterion Absolute confidence in the impossibility of detection Most likely controls will not provide detection Controls have weaknesses chances of detection Controls have a weak chance of detection Controls can provide detection Controls can provide detection Controls have a good chance of detection Controls have a good chance of detection Controls are almost always capable of detection Controls are capable of detection Types control A B C Description of control measures D X Impossibility of detection or verification was not carried out 10 X Control is carried out only using indirect (no direct measurements) or random (no frequency requirements) checks 9 X Control is carried out only through visual control 8 X Control is carried out only through double visual inspection 7 X X Inspection is carried out using diagrammatic methods such as statistical process control (SPC) 6 X Inspection is carried out by measuring various dimensions or by 100% pass/fail inspection of products after the products have left the position 5 X X Identification of defects in subsequent operations or taking measurements during setup and testing of the first product 4 X X Identification of defects in position or in subsequent operations using several levels of acceptance: delivery, selection, installation, verification. Impossibility of accepting non-conforming products 3 Х Х Detection of defects at the position (automatic control with a protective measure such as automatic stop). Passage of non-conforming products is impossible 2 X Manufacturing of non-conforming products is impossible due to the fact that the product is protected from incorrect actions of the performer when designing the product/process 1 Note Types of control: A protection from incorrect actions; B size control; In visual control, control without measuring instruments. 7.5 Tables 1 to 6 use discrete point estimates S, O, D. For specific technical objects and processes, it is possible to use continuous scales, for example in the form of graphs or formulas. The scoring values should not differ noticeably from those given in the tables

17 Appendix A (recommended) Form of protocol for analyzing the types, causes and consequences of potential defects Object of analysis Service responsible for conducting FMEA: FMEA protocol code/number Type of product, year of manufacture Planned timing of FMEA: Page. from End Product Manufacturer start end Team Leader Scope: Valid FMEA Application Dates: Team Members Structural Design Start End Process Improvement Nonconforming Product Management Item/function Type Consequence S Potential Cause(s) or Mechanism(s) O Detection and Prevention Measures D PNR Recommended actions Responsibility and target date Actions taken (changes) Work results New point values S O D PNR 13

18 Appendix B (for reference) Examples of refinement of initial design and technological solutions by FMEA teams Example 1 The FMEA team is working to improve the design of a pressure hose connecting the pump to the power steering for a car. The initially proposed design of the hose involved connecting it to the pump using a tube with a double conical flare and a union nut. A fragment of the protocol for analyzing the types, causes and consequences of potential defects (see Appendix A) is given in Table B.1 (in this case, preventive control measures were not used). Table B.1 Type Leak in the connection Consequence S 1 Pollution 10 of the environment 2 Reduced efficiency 8 of the steering 3 Reduced ease of control 7 Potential cause 1 Destruction of the connection seat 2 Deviation of the geometry of the hose tube or seat 3 Difficulty in accessing the union nut in the car O Measures detection Visual Special meters D PNR Torque wrench As a result of consideration of alternative designs, a mechanical seal with copper washers was selected to connect the hose to the pump and the location of this connection in the pump was changed to facilitate access to the connection during factory assembly and repair. The new point values are shown in Table B.2. Table B.2 View Leakage in connection Consequence 1 Environmental contamination S Potential cause 1 Deviation of end connector geometry or connection plane on pump 2 Insufficient tightening torque 3 Insufficient annealing of copper washers O Originally suggested detection measures Visual plus fixtures 2 Reduced steering efficiency 3 Reduced ease of operation Torque wrench Selectively on fixture D PNR Result: the connection has become more reliable; easier access for installation and repair; the cost of the new connection is not higher than the cost of the originally proposed connection. Formally: the maximum PNR value for this has become equal to

19 Example 2 The FMEA team is working to improve the design of the mechanism for adjusting the position of the steering column of a passenger car. The initially proposed design involved fixing the column using a transverse tie on a double-sided bracket with an eccentric with a handle; for reliable fixation on the mating planes (bracket and steering column holder), a notch was proposed. A fragment of the protocol for analyzing the types, causes and consequences of potential defects (see Appendix A) is given in Table B.3. Table B.3 View Poor fixation of the column Consequence 1 Possibility of fixation not in any position 2 Sudden change in the position of the column when turning the steering wheel sharply S 7 10 Potential cause O 1 Reduced hardness of the notch 5 2 Wear of the notch due to frequent adjustments 7 Initially proposed detection measures Selective inspection hardness Torque Wrench D PNR A simple and effective alternative design is the use of friction washers between mating flat surfaces, but this design solution is patented by Ford Motor Company. When considering other alternative solutions, a design with friction linings glued to the column cage plates was chosen. The new point values are shown in Table B.4. Table B.4 View Poor fixation of the column Consequence 1 Sudden change in the position of the column during a sharp turn of the steering wheel 2 Difficulty adjusting the position of the column when the friction lining peels off S 10 7 Potential cause 1 Reduced coefficient of friction of the friction linings 2 Peeling of the linings due to a violation of the sticker technology O 4 5 Initially proposed detection measures Control during vehicle assembly for the shear force of the column with a specially incomplete clamping Selective control for separation D PNR It was decided to reduce the importance of the newly appeared consequence of difficult adjustment of the column when the lining is peeled off (see Table B.4) by introducing two semi-recessed pins and corresponding holes on the glued pads. The new score for this consequence is S = 3, and the new value PNR = 75 (this is not shown in Table B.4). Result: the clamp has become more reliable; The estimated cost of the new clamp design is 4% higher than the cost of the original design. Formally: the maximum PNR value for this has become equal to

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During the development and production of various equipment, defects periodically occur. What is the result? The manufacturer incurs significant losses associated with additional tests, inspections and design changes. However, this is not an uncontrolled process. You can assess possible threats and vulnerabilities, as well as analyze potential defects that could interfere with the operation of equipment, using FMEA analysis.

This analysis method was first used in the USA in 1949. Then it was used exclusively in the military industry when designing new weapons. However, already in the 70s, FMEA ideas found their way into large corporations. Ford (the largest car manufacturer at that time) was one of the first to introduce this technology.

Nowadays, the FMEA analysis method is used by almost all machine-building enterprises. The basic principles of risk management and analysis of the causes of failures are described in GOST R 51901.12-2007.

Definition and essence of the method

FMEA is an acronym for Failure Mode and Effect Analysis. This is a technology for analyzing the types and consequences of possible failures (defects due to which an object loses the ability to perform its functions). What is good about this method? It gives the company the opportunity to anticipate possible problems and malfunctions even at an early stage. During the analysis, the manufacturer receives the following information:

list of potential defects and malfunctions;
analysis of the causes of their occurrence, severity and consequences;
recommendations for reducing risks in order of priority;
general assessment of the safety and reliability of the product and system as a whole.

The data obtained as a result of the analysis is documented. All detected and studied failures are classified according to their degree of criticality, ease of detection, maintainability and frequency of occurrence. The main task is to identify problems before they arise and begin to affect the company's customers.

Scope of application of FMEA analysis

This research method is actively used in almost all technical industries, such as:

automobile and shipbuilding;
aviation and space industry;
chemical and oil refining;
construction;
manufacturing of industrial equipment and mechanisms.

In recent years, this risk assessment method has been increasingly used in non-production areas, for example in management and marketing.

FMEA can be carried out at all stages of the product life cycle. However, analysis is most often performed during product development and modification, and when existing designs are used in a new environment.

Species

Using FMEA technology, they study not only various mechanisms and devices, but also the processes of company management, production and operation of products. In each case, the method has its own specific features. The object of analysis can be:

technical systems;
designs and products;
processes of production, packaging, installation and maintenance of products.

When inspecting mechanisms, the risk of non-compliance with standards, malfunctions during operation, as well as breakdowns and reduced service life are determined. This takes into account the properties of materials, the geometry of the structure, its characteristics, and interfaces with other systems.

FMEA process analysis allows you to detect inconsistencies that affect product quality and safety. Customer satisfaction and environmental risks are also taken into account. Here, problems can arise from humans (in particular, enterprise employees), production technology, raw materials and equipment used, measuring systems, and the impact on the environment.

When conducting research, different approaches are used:

"top to bottom" (from large systems to small parts and elements);
"bottom up" (from individual products and their parts to

The choice depends on the purpose of the analysis. It can be part of a comprehensive study in addition to other methods or used as a stand-alone tool.

Stages of implementation

Regardless of the specific tasks, FMEA analysis of the causes and consequences of failures is carried out using a universal algorithm. Let's take a closer look at this process.

Preparation of the expert group

First of all, you need to decide who will conduct the research. Teamwork is one of the key principles of FMEA. Only this format ensures the quality and objectivity of the examination, and also creates space for non-standard ideas. As a rule, a team consists of 5-9 people. It includes:

project Manager;
process engineer who develops the technological process;
design engineer;
production representative or;
employee of the consumer relations department.

If necessary, qualified specialists from third parties may be involved to analyze structures and processes. Discussion of possible problems and ways to solve them takes place in a series of meetings lasting up to 1.5 hours. They can be carried out either in full or in part (if the presence of certain experts is not necessary to resolve current issues).

Project Study

To conduct an FMEA analysis, you need to clearly define the object of study and its boundaries. If we are talking about a technological process, we should identify the initial and final events. For equipment and structures, everything is simpler - you can consider them as complex systems or focus on specific mechanisms and elements. Inconsistencies can be considered taking into account the needs of the consumer, the stage of the product life cycle, the geography of use, etc.

At this stage, members of the expert group should receive a detailed description of the object, its functions and operating principles. Explanations must be accessible and understandable to all team members. Usually, at the first session, presentations are made; experts study instructions for the manufacture and operation of structures, planning parameters, regulatory documentation, and drawings.

#3: Listing Potential Defects

After the theoretical part, the team begins to assess possible failures. A complete list of all possible inconsistencies and defects that may occur at the facility is compiled. They may be associated with the breakdown of individual elements or their improper functioning (insufficient power, inaccuracy, low performance). When analyzing processes, you need to list specific technological operations that carry a risk of errors - for example, non-execution or incorrect execution.

Description of causes and consequences

The next step is an in-depth analysis of such situations. The main task is to understand what can lead to certain errors, as well as how the detected defects can affect employees, consumers and the company as a whole.

To determine the likely causes of defects, the team reviews operation descriptions, approved performance requirements, and statistical reports. The FMEA analysis protocol can also indicate risk factors that the enterprise can adjust.

At the same time, the team considers what can be done to eliminate the chance of defects occurring, suggests control methods and the optimal frequency of inspections.

Expert assessments

S - Severity/Significance. Determines how severe the consequences of a given defect will be for the consumer. Rated on a 10-point scale (1 - practically no effect, 10 - catastrophic, in which the manufacturer or supplier may face criminal penalties).
O - Occurrence/Probability. Shows how often a certain violation occurs and whether the situation can be repeated (1 - extremely unlikely, 10 - failure occurs in more than 10% of cases).
D - Detection. Parameter for assessing control methods: will they help to identify nonconformities in a timely manner (1 - almost guaranteed to be detected, 10 - a hidden defect that cannot be identified before the consequences occur).

Based on these assessments, a priority number of risks (PRN) is determined for each failure mode. This is a generalized indicator that allows you to find out which breakdowns and violations pose the greatest threat to the company and its clients. Calculated using the formula:

PFR = S × O × D

The higher the PPR, the more dangerous the violation and the more destructive its consequences. First of all, it is necessary to eliminate or reduce the risk of defects and malfunctions for which this value exceeds 100-125. Violations with an average threat level score from 40 to 100 points, and a PPR of less than 40 indicates that the failure is minor, occurs rarely and can be detected without problems.

After assessing deviations and their consequences, the FMEA working group determines priority areas for work. The first priority is to develop a corrective action plan for the bottlenecks—the items and activities with the highest PFRs. To reduce the threat level, you need to influence one or more parameters:

eliminate the original cause of failure by changing the design or process (O score);
prevent the occurrence of a defect using statistical control methods (grade O);
mitigate negative consequences for buyers and customers - for example, reduce prices for defective products (S rating);
introduce new tools for timely detection of faults and subsequent repairs (grade D).

So that the enterprise can immediately begin to implement the recommendations, the FMEA team simultaneously develops a plan for their implementation, indicating the sequence and timing of each type of work. The same document contains information about the performers and those responsible for carrying out corrective measures, and sources of financing.

Summing up

The final stage is preparing a report for company managers. What sections should it contain?

Overview and detailed notes on the study.
Potential causes of defects during production/operation of equipment and performance of technological operations.
A list of likely consequences for employees and consumers - separately for each violation.
Assessing the level of risk (how dangerous possible violations are, which of them can lead to serious consequences).
List of recommendations for maintenance services, designers and planners.
Schedule and reports on the implementation of corrective actions based on the results of the analysis.
A list of potential threats and consequences that were eliminated by changing the design.

The report is accompanied by all tables, graphs and diagrams that serve to visualize information about the main problems. Also, the working group must provide the schemes used to assess nonconformities by significance, frequency and probability of detection with a detailed explanation of the scale (which means a particular number of points).

How to fill out the FMEA protocol?

During the study, all data must be recorded in a special document. This is the “FMEA Cause and Effect Analysis Protocol”. It is a universal table where all information about possible defects is entered. This form is suitable for studying any systems, objects and processes in any industry.

The first part is completed based on personal observations of team members, study of enterprise statistics, work instructions and other documentation. The main task is to understand what can interfere with the operation of the mechanism or the completion of any task. At its meetings, the working group must assess the consequences of these violations, answer how dangerous they are for workers and consumers, and what is the likelihood that the defect will be discovered at the production stage.

The second part of the protocol describes options for preventing and eliminating inconsistencies, a list of measures developed by the FMEA team. A separate column is provided for assigning those responsible for the implementation of certain tasks, and after making adjustments to the design or organization of the business process, the manager indicates in the protocol a list of completed work. The final stage is re-grading, taking into account all changes. By comparing the initial and final indicators, we can draw a conclusion about the effectiveness of the chosen strategy.

A separate protocol is created for each object. At the very top is the title of the document - “Analysis of the types and consequences of potential defects.” Below are the equipment model or process name, the dates of the previous and next (according to schedule) inspections, the current date, as well as the signatures of all members of the working group and its leader.

Example of FMEA analysis (Tulinovsky Instrument-Making Plant)

Let's look at how the process of assessing potential risks occurs based on the experience of a large Russian industrial company. At one time, the management of the Tulinovsky Instrument-Making Plant (JSC TVES) was faced with the problem of calibrating electronic scales. The company produced a large percentage of incorrectly functioning equipment, which the technical control department was forced to send back.

After reviewing the workflow and requirements for the calibration procedure, the FMEA team identified four subprocesses that had the greatest impact on calibration quality and accuracy.

moving and installing the device on the table;
checking the position by level (the scales must be 100% horizontal);
placing cargo on platforms;
registration of frequency signals.

What types of failures and malfunctions were recorded during these operations? The working group identified the main risks, analyzed the causes of their occurrence and possible consequences. Based on expert assessments, PHR indicators were calculated, which made it possible to identify the main problems - the lack of clear control over the execution of work and the condition of the equipment (stand, weights).

Stage	Failure Scenario	Reasons	Consequences	S	O	D	PCHR
Moving and installing scales on the stand.	Risk of the scale falling due to the heavy weight of the structure.	There is no specialized transport.	Damage or failure of the device.	8	2	1	16
Check the horizontal position by level (the device must be absolutely level).	Incorrect calibration.	The table top of the stand was not level.		6	3	1	18
	Incorrect calibration.	Employees do not follow work instructions.		6	4	3	72
Arrangement of loads at reference points of the platform.	Using weights of the wrong size.	Operation of old, worn-out weights.	The quality control department returns the defect due to metrological discrepancy.	9	2	3	54
	Using weights of the wrong size.	Lack of control over the placement process.		6	7	7	252
	The mechanism or sensors of the stand have failed.	The combs of the moving frame are skewed.	Constant friction wears out weights quickly.	6	2	8	96
		The cable broke.	Suspension of production.	10	1	1	10
		The gear motor has failed.		2	1	1	2
		The schedule of scheduled inspections and repairs is not followed.		6	1	2	12
Registration of frequency signals of the sensor. Programming.	Loss of data that was entered into the storage device.	Power outages.	It is necessary to carry out the calibration again.	4	2	3	24

To eliminate risk factors, recommendations were developed for additional training of employees, modification of the stand table top and purchase of a special roller container for transporting scales. Purchasing an uninterruptible power supply solved the problem with data loss. And in order to prevent problems with calibration in the future, the working group proposed new schedules for maintenance and routine calibration of weights - checks began to be carried out more often, due to which damage and failures can be detected much earlier.

Before conducting FMEA, a team of experts collects and studies source data. The initial data for analyzing a FMEA process must contain information about the process and product, the requirements for the system as a whole and its individual components, and environmental factors influencing the results. Materials and data for further analysis may include drawings, technological and other documents.