FMEA Application in Production Proc
FMEA Application in Production Proc
Abstract: The FMEA (Failure Mode and Effects Analysis) method is a systematic approach used to identify potential failure modes in pro-
duction processes, as well as the associated effects and likelihood of those failures occurring. The FMEA method helps to prioritize potential
failure modes based on their potential impact, allowing organizations to address the most critical issues first. This article presents a compre-
hensive review of the FMEA method, including its history, principles, and steps. The article also discusses the benefits of the FMEA method
for companies, including improved product quality, reduced costs, and enhanced customer satisfaction. The FMEA form is an essential com-
ponent of the FMEA process, as it helps to ensure that all relevant information is captured and organized in a structured manner. This article
will introduce the FMEA method and provide an overview of the FMEA form, including its various sections and how it is used in the FMEA
process. The aim of this article is to provide a comprehensive analysis of FMEA and the ways in which it is applied, to ensure the applicability
of FMEA to manufacturing processes for manufacturers. In this way, manufacturers will benefit in time, budget, energy and profitability. In
addition, with FMEA, problems will be prioritized according to their criticality, and errors will be intervened at the right time and in the fastest
way. In the article, an FMEA form will be created for the steel rope production process as a study case, and the benefit and profitability it will
provide to the manufacturer will be revealed. In this way, the effect of FMEA in a production process will be embodied.
Key words: FMEA, Failure Mode and Effect Analysis, FMEA Form, Steel Rope Manufacturing FMEA
1. Introduction 2. Experimental
FMEA, or Failure Modes and Effects Analysis, is a risk man- FMEA was formalized in 1949 by the US Armed Forces by the
agement tool that was developed in the late 1940s by the military to introduction of Mil-P 1629 Procedure for performing a failure mode
identify potential failures in a system and to assess the severity of effect and criticality analysis.. The objective was to classify failures
those failures. It was initially used to analyze complex systems such “according to their impact on mission success and personnel/equip-
as aircraft and missiles. FMEA has since been adapted for use in ment safety” [2].
various industries, including manufacturing, healthcare, and service In 1950s the increasing attention paid to safety and the need to
industries. It is used to identify and prioritize potential failures in a prevent predictable accidents in aerospace industry led to the devel-
process, product, or service, and to develop strategies to mitigate opment of the FMEA methodology. Later, it was introduced as key
those failures. FMEA can be used during the design phase of a prod- tool for increasing quality and efficiency in manufacturing processes
uct or process, or it can be used to analyze an existing product or [3]. In 1977, Ford Motors introduced FMEA to address the potential
process to identify opportunities for improvement. problems in the Research and Development (R&D) in the early stage
Failures are prioritized according to how serious their conse- of production and published the Potential Failure Mode and Effects
quences are, how often they occur, and how easily they can be de- Analysis Handbook in 1984 to promote the method. Later on the au-
tected. The purpose of FMEA is to take measures to eliminate or tomobile manufacturers in America also introduced the FMEA into
reduce failures, starting with those with the highest priority. FMEA the management of suppliers, and took it as a key check issue [4].
is used during design to prevent failures. It is then used for control Find out reasons behind the failure of some subjects of mechan-
before and during the ongoing operation of the process. Ideally, ical engineering course and after analyzed the system through
FMEA begins at the earliest conceptual stages of design and contin- FMEA and they suggested recommend to solve the problem [5]. Ex-
ues throughout the life of the product or service [1]. ecute FMEA to develop an effective quality system and to improve
The purpose of the FMEA is to evaluate the risk associated with the current production processfor the better quality of the products
the identified failure modes, effects and causes, and prioritize issues [6]. FMEA a It is a proven tool to reduce lifecycle warranty costs. It
for corrective action, after identifying possible failure modes and is much more economical to fix problems that occur in the early
causes and the effects of the failure on the system or end users. stages of product development than to fix these errors post-launch.
The aim of this article is to enable a company to minimize er- FMEAs can identify problems in the production process and provide
rors and losses in the manufacturing process and to help the com- an opportunity to take action before a potential disaster scenario.
pany increase its efficiency by using the FMEA method in a manu-
facturing process by helping to implement corrective actions to
address the most serious concerns in the manufacturing or in any
kind of producing processes.
27
ARCHIWUM WIEDZY INŻYNIERSKIEJ TOM 7 NR 1 (2022) 27-32
2.1 FMEA Standards stakeholders involved in the process, then possible failure modes
FMEA, or Failure Mode and Effects Analysis, is a systematic and their associated causes should be identified. After the effects of
method for identifying potential failures in a system or product and each failure mode have been identified, including the potential im-
assessing the associated risks. It is used to identify and prioritize ac- pact on the customer and the organization, the probabilities and de-
tions that can be taken to prevent or mitigate those failures. In order gree of danger of each failure mode and its effects should be deter-
to apply this method, there are several specified standards and guide- mined. Then, the measures to be taken to prevent or reduce the
lines that provide guidance on how to conduct an FMEA, including: identified risks to an acceptable level should be determined on the
ISO 9001: This international standard provides requirements basis of regulations. After the identified actions have been imple-
for a quality management system (QMS) and includes guidance on mented, the DFMEA should be reviewed periodically to be current
how to use FMEA as a tool for identifying and mitigating risks in and effective. If the risk situations again rise above the accepted
the design and development of products and processes. level, a reanalysis should be carried out.
SAE J1739: This standard, developed by the Society of Auto- Concept FMEA (CFMEA): It is a type of FMEA used to iden-
motive Engineers (SAE), provides guidance on conducting FMEA tify and evaluate potential failure types and associated risks during
for automotive systems. the conceptual design phase of a product, and to identify the neces-
MIL-STD-1629A: This military standard provides guidance on sary design requirements and features that will enable the product to
conducting FMEA for aerospace and defense systems. meet its performance and reliability objectives.
AIAG FMEA: The Automotive Industry Action Group (AIAG) Concept FMEA is often used to evaluate the feasibility and po-
has developed a set of guidelines for conducting FMEA in the auto- tential risks of different design concepts and to determine the best
motive industry. process plan for moving forward in the development of a product. It
Six Sigma: The Six Sigma methodology includes a specific is an important tool in the early stages of the design process to iden-
type of FMEA called a "DFMEA" (Design FMEA) that is used to tify and address potential problems where they can more easily and
identify and mitigate risks in the design of products and processes. cost-effectively intervene and produce solutions.
Regardless of the specific standard or guidelines being fol- The concept FMEA execution process follows the same general
lowed, the general approach to conducting an FMEA typically in- steps as traditional FMEA, with some customized considerations for
volves identifying potential failure modes, determining the effects the early stages of product development. The main aim is to identify
of those failures, evaluating the likelihood and severity of those ef- potential failure modes, identify the potential risks and effects of
fects, and implementing actions to prevent or mitigate the identified each failure mode, and ensure that appropriate corrective actions are
risks. taken to reduce or eliminate these risks.
2.2. Purposes of FMEA Process FMEA (PFMEA): It is similar to traditional Failure
The primary purpose of conducting an FMEA is to identify and Modes and Effects Analysis (FMEA), but is specifically focused on
mitigate risks in a system or product. This is typically achieved by identifying and mitigating potential issues within a process, rather
identifying potential failure modes and their associated causes, de- than in a product or system. PFMEA provides continuous improve-
termining the effects of those failures, evaluating the likelihood and ment for the process with a proactive, systematic, collaborative and
severity of those effects, and implementing actions to prevent or mit- risk-based approach.
igate the identified risks. Also, some purposes of conducting an
FMEA include:
Helping to organizations to identify and address potential is-
sues in the supply chain by involving suppliers in the FMEA process
Helping organizations to identify and prioritize areas for im-
provement in a product or process.
Improving communication and collaboration within an organi-
zation by involving a diverse group of stakeholders in the FMEA
process.
Documenting the risk assessment process through an FMEA
can be useful for demonstrating due diligence and complying with
regulatory requirements.
Helping to improve the overall reliability and safety of a sys-
tem or product by identifying and addressing potential failure
modes,
The main goal of conducting an FMEA is to proactively iden-
Fig. 1. Types and relations of FMEA
tify and address potential issues before they occur, which can help
to improve the quality, reliability, and safety of a product or system,
and reduce the cost and impact of product failures. 2.3 Procedures of FMEA
2.3 Types of FMEA After a comprehensive understanding of the FMEA process,
There are several different types of FMEA that can be used to long meetings and time losses in workplaces will be avoided, and
identify and mitigate risks in a system or product. work processes or productions will become more efficient with the
Design FMEA (DFMEA): The main aim of a DFMEA is to quality, loss reduction and savings provided by FMEA.
identify and address potential issues in the design of a product or 1. Define the scope of the FMEA by identifying the product or
process especially before it is built or implemented, which can help process being analyzed, the potential failure modes, and the po-
to improve the overall reliability and safety of the product or pro- tential effects of those failure modes on the product or process.
cess, and reduce the cost and impact of product failures. 2. Identify the potential failure modes by identifying all of the
The basic implementation process required for effective use of ways in which the product or process could fail, as well as the
DFMEA can be evaluated as follows: Scope of DFMEA should be root causes of those failure modes.
defined, including the product or process analyzed and the
28
ARCHIWUM WIEDZY INŻYNIERSKIEJ TOM 7 NR 1 (2022) 27-32
29
ARCHIWUM WIEDZY INŻYNIERSKIEJ TOM 7 NR 1 (2022) 27-32
⑥ in Figure 4 is the manner represents the root cause or particular failure mode. The RPN is calculated by multiplying the
underlying mechanism of a particular failure mode. This can be cited ratings for the likelihood of occurrence, the severity of the effect,
as any positive factor or root cause in the product or process that and the detectability of the failure mode.
may be more contributing, along with the particular conditions or 𝑅𝑃𝑁 = 𝑆𝑒𝑣𝑒𝑟𝑖𝑡𝑦 × 𝑂𝑐𝑐𝑢𝑟𝑒𝑛𝑐𝑒 × 𝐷𝑒𝑡𝑒𝑐𝑡𝑖𝑜𝑛
factors that contributed to the failure. ⑪ in Figure 5 represents the actions that can be taken and
⑦ in Figure 4 is the manner under the “Occurrence” col- the course to be followed to reduce or mitigate the detected failure
umn, represents the probability or probability of a particular failure mode and reduce the associated risk.
mode occurring. This probability is determined by a joint assessment ⑫ in Figure 5 represents the date by which recommended
of each factor that has an impact on the product or process, along actions to prevent or mitigate a particular failure mode are expected
with the particular conditions that led to the failure. To identify the to be completed. The target completion date should be realistic and
qııantitative occurrence by 1 to 10 scales. The probability of oc- achievable, taking into account the resources and constraints availa-
curence decreases from 10 to 1. ble.
⑬ in Figure 6 Represents the date recorded on the FMEA
Table 2. Occurrence guidelines for design FMEA [7]. form to monitor the progress of risk reduction efforts after recom-
mended actions have been implemented. The actual completion date
Effect Rank Criteria should be compared with the targeted completion date to determine
Almost Failure unlikely. History shows no fail- whether the proposed actions are completed on schedule. If the ac-
1
never ure tual completion date is later than the targeted completion date, it may
Remote 2 Rare number of failures likely reveal delays or obstacles that prevent the proposed actions from be-
Very ing completed on time.
3 Very few failures likely
Slight ⑭ in Figure 6 represents the actions taken to reduce the
Slight 4 Few failures likely identified risk. The actions may be modifications to the design or
Low 5 Occasional number of failures likely process, material changes, extra inspection or testing procedures, or
Medium 6 Medium number of failures likely any other measure aimed at reducing the severity of their effects.
Modre- Moderately high number of failures ⑮, ⑯, ⑰, ⑱ in Figure 6 represents current Severity
7
ately high likely value after actions taken, current Occurence value after actions
High 8 High number of failures likely taken, current Detection value after actions taken and new RPN
Very high 9 Very high number of failures likely value after necessary risk reducer actions taken, respectively. After
Almost the actions taken, the new severity, occurrence, and detection values
10 Failure almost certain
certain gives the new RPN value. If the new RPN value determined is not
at the desired level and is still at a dangerous level, it is recom-
⑧ in Figure 4 represents inputs that can be used to eval- mended to take new actions. If the RPN value is at the desired level,
uate the effectiveness of existing design controls in preventing or it is recommended to repeat the FMEA process periodically to en-
mitigating the identified failure mode and to identify additional con- sure effectiveness.
trols that may be necessary to further reduce the risk of failure. In Figure 7 below, FMEA form is created for a steel rope
⑨ in Figure 4 represents the probability of detecting a production process. Potential problems that may arise at the stages
failure mode before it causes adverse effects, on a numerical scale of the steel rope production process have been identified. Within the
of 1-10. This column is used to rate the probability that a failure framework of FMEA principles and depending on the process flow,
mode can be detected beforehand during the design, development, starting from critical problems, solutions were offered for functions
manufacture or use of a product or system. above the limit value and risks were brought to a reasonable level.
In the "heat treatment" step in the steel rope production process, po-
Table 3. Detectability guidelines for design FMEA [7]. tential failure effects were determined as ductility and durability
Effect Rank Criteria problems for the potential failure modes. Since ductility problems in
Almost Proven detection methods available in steel ropes or cables produced can cause fatigue crack of the mate-
1 rial, the "severity" value of this problem is set as 9. The "detectence"
Certain concept stage
Very Proven computer analysis available in value is set to 7, since it takes place inside the fatigue crack material
2 and has low detectability. The "occurence" value of this problem,
Slight early design stage
which has a low potential for realization as it is an important param-
Simulation and/or modeling in early
Slight 3 eter and its controls are provided in many stages, was determined as
stage
3. Accordingly, the RPN value was calculated as 189 and the need
Minor 4 Tests on early prototype system element
for a solution arose because it was above 100, which is considered a
Tests on preproduction system compo- risky value. As a solution to this problem, the action was taken to
Moderate 5
nents update the machine and give the necessary instructions to the em-
Significant 6 Tests on similar system component ployees. Thanks to that, the new RPN value has been updated to 36
Tests on product with prototypes and and the risk status has been reduced. This situation enabled the prob-
Major 7
system components installed lem to be identified and solved through FMEA without incurring an
Proving durability tests on products with extra cost for the manufacturer.
Extreme 8
system components installed Optimizing costs by maximizing the customer satisfaction
Only unproven or unreliable technique(s) constitutes the basic principle of creating quality. It is sufficient to
Serious 9
available produce faultless and complete product and offering it to the clients,
Hazardous 10 No known techniques available the expectations of customers should also be met [8]. In order to cre-
ate a quality, FMEA is a key application for quality control as it is
⑩ in Figure 5 represents the Risk Priority Number (RPN) one of the methods to be applied for cost reduction and quality cre-
is a quantitative measure of the overall risk associated with a ation.
30
ARCHIWUM WIEDZY INŻYNIERSKIEJ TOM 7 NR 1 (2022) 27-32
Fig. 7. A FMEA Form Case Study Example Prepared for the Steel Rope Manufacturing Process
3. Results and discussion method helps companies reduce the occurrence of defects and fail-
ures, resulting in increased customer satisfaction and loyalty, as
The results of the study show that the application of FMEA well as reduced costs associated with repairing and replacing defec-
method has a significant positive effect on the profitability and tive products.
productivity of the producer.
In terms of profitability, according to case example study 4. Summary and conclusions
made in the study, manufacturers saw a reduction in the number of
product defects and malfunctions. This results in fewer warranty The FMEA method helps increase the reliability and up-
claims and customer complaints. This results in increased customer time of production processes, increasing productivity and efficiency.
satisfaction and loyalty, as well as reduced costs associated with re- This is especially important in today's competitive business environ-
pairing and replacing defective products, and increasing long-term ment, where companies are under pressure to deliver high-quality
benefits. The FMEA method also helped the manufacturer identify products at lower cost and with shorter lead times.
and prioritize possible types of failures and take corrective action The study showed that one of the main benefits of the
before they happen, leading to a reduction in unplanned downtime FMEA form is that it helps to organize and document the results of
and an increase in the overall reliability of production processes. the FMEA analysis in a structured and systematic manner. This in-
This resulted in increased productivity as the company was able to cludes identifying potential failure modes, their potential effects,
produce more products with fewer interruptions in a given time and the recommended actions for addressing them. By capturing this
frame. information in a standardized form, manufacturers are able to easily
The results of our study demonstrate the value of FMEA communicate and share the results of the FMEA analysis with rele-
in increasing profitability and productivity for manufacturers. By vant stakeholders, including engineering, quality, and production
identifying and addressing potential failure modes, the FMEA teams.
31
ARCHIWUM WIEDZY INŻYNIERSKIEJ TOM 7 NR 1 (2022) 27-32
Literature
32