# Risk Analysis in Manufacturing Processes: An Integrated Approach Using the FMEA Method

Luís Basto, Isabel Lopes, Cláudia Pires

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Luís Basto, Isabel Lopes, Cláudia Pires. Risk Analysis in Manufacturing Processes: An Integrated Approach Using the FMEA Method. IFIP International Conference on Advances in Production Management Systems (APMS), Sep 2022, Gyeongju, South Korea. pp.260-266, 10.1007/978-3-031-16407-1_31. hal-05386073

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# Risk Analysis in Manufacturing Processes: An Integrated Approach Using the FMEA Method

Luís Basto<fnref n="1" />(✉), Isabel Lopes<fnref n="1" />✉, and Cláudia Pires<fnref n="2" />

**Abstract.** Risk management is a requirement of today's management system standards. FMEA is one of the most commonly used tools to perform risk assessment. However, neither FMEA nor other risk assessment tools were originally developed to assess risk jointly by several management areas to analyze failure events that can originate failure modes of different types. This paper aims to present an integrated approach for risk analysis, in manufacturing processes, using the FMEA method. The proposed approach considers the involvement of the quality, environment, health and safety, and maintenance management areas. A linkage between Machinery FMEA (operation failures) and Process FMEA is proposed, which allows to better prioritize maintenance actions. This integrated approach is intended to be implemented in a network aimed at collaboration among areas, an important aspect in the context of Industry 4.0.

**Keywords:** Collaborative tool · Machinery FMEA · Process FMEA · Risk management

## 1 Introduction

According to ISO 31000:2018, which provides the guidelines for risk management, *risk* is defined as the “effect of uncertainty on objectives”, while *risk management* is defined as the “coordinated activities to direct and control an organization with regard to risk” [1].

The importance of risk management has grown in manufacturing industries with the last revision of ISO 9001, the international quality management standard, in 2015. ISO 9001:2015 highlights risk-based thinking as an essential approach for an effective quality management system [2]. Besides this, ISO 14001, for environmental management [3], ISO 45001, for safety and health management [4], and IATF 16949, for quality management in the automotive industry [5], also require companies to carry out risk analysis.

FMEA, HAZOP, HACCP, APR, and FTA are qualitative and/or quantitative methods to support risk management [6–8]. According to Badreddine *et al.*, these techniques were

<footnote n="1">¹ ALGORITMI Research Centre, University of Minho, Guimarães, Portugal
luis.basto@dps.uminho.pt</footnote>

<footnote n="2">² CATIM – Centro de Apoio Tecnológico à Indústria Metalomecânica, Porto, Portugal</footnote>
not designed to cope with multiple management areas at once, although the same source of hazard can affect targets in many areas, such as the environment, health and safety, and quality [8]. FMEA is a methodology that identifies failure modes and associated causes and effects. Each failure mode criticality is assessed by quantifying its occurrence, severity, and detection (using usually values between 1 and 10). FMEA can be used to address product reliability [9], environmental aspects, such as toxic emissions and land contamination [10], as well as health and safety incidents, such as falls and electric shocks [11]. Process FMEA is a type of FMEA concerned with product quality in manufacturing processes [9].

In an industrial context, the risk management approach is departmentalized, which means that each company sector performs risk analysis and management in its unique perspective (e.g., quality, safety, environment).

Risk management integration in the context of standardized management systems – mainly of quality, environment, and safety – is addressed in the literature [7, 8, 12, 13]. However, these works do not propose a specific integrative approach for risk analysis for this issue or, when they do, it only addresses the effects integration level. Romdhane et al. proposed an extension of the FMEA method to take into account different management areas, integrating at the effect level, by determining severity levels for the following targets: people, equipment, environment, production, and management [12]. Zeng et al. used FMEA in the construction sector to jointly analyze risks associated with occupational health and safety, environment, and/or quality [13]. The authors consider, as failure modes, failures related to product quality, hazardous events to the environment, and accidents and dangerous events on occupational health and safety. Each failure mode can affect more than one area (for example, high noise can affect workers’ safety, as well as the environment). The authors state that an integrated risk analysis could reduce effort and resource inputs.

FMEA can also be used to enhance maintenance planning, an important aspect that is addressed by Filz et al. [14] and Lolli et al. [15]. In production processes, equipment failures frequently cause problems of different natures, such as defects. However, maintenance records are not linked to quality records and no connection between equipment failures and defects is established.

This paper presents an integrated approach for risk analysis, in manufacturing processes, using the FMEA method. This approach addresses the areas of quality, environment, health and safety, and maintenance. A linkage between Machinery FMEA (which is concerned with machinery operation failures) and Process FMEA is proposed. This allows for maintenance actions to be prioritized considering the effects of equipment failures in the process. This integrated approach is intended to be achieved through the collaboration of different departments, which is in line with the concept of Industry 4.0, and is being developed with the support of a Portuguese metalworking company, to test and validate the proposed solutions.

This work mainly focuses on the risk identification and evaluation functions presented in a previous work [16], which defines the specifications and functions of the dynamic and collaborative risk assessment tool under development. For this tool, the FMEA method was chosen since, nowadays, many organizations have been using it in the development of their processes [17]. It is, however, important to highlight that, despite
published manuals and ongoing training describing the method, few organizations can take full advantage of FMEA [17]. This method is developed differently from team to team with a significant degree of subjectivity, creating inconsistencies, such as in the failure modes definition [17, 18]. Therefore, in this paper, a clear structure is presented for different individuals to elaborate FMEA more objectively.

This paper is organized as follows: Sect. 2 presents the proposed approach for integrated risk assessment of manufacturing processes, both conceptually and through practical examples; Sect. 3 includes the conclusions and future work.

# 2 Integrated Risk Analysis Using the FMEA Method

## 2.1 The Concept

Impacts related to different departments can have a common cause. For instance, a specific equipment failure can cause a gas leakage, affecting personnel and the environment, and also affecting product quality. Departmental risk analysis does not take into consideration that a specific event can originate failure modes of different types, which gives rise to an incomplete view and evaluation of risks, besides increasing the time of execution. To avoid these issues, an integrated risk analysis is needed.

The conceptual model for the integrated risk analysis of manufacturing processes is presented in Fig. 1. This approach is centered on the Process FMEA, where failure modes – the way the failure is observed in the process, whether by quality, safety, or environmental perspective – are registered. These failure modes can be due to the same event or cause. In this Process FMEA, the causes of failure modes can be grouped into Ishikawa's Ms – Machine, Man, Method, Measure, Milieu (Environment), and Material – as it is presented in AIAG & VDA FMEA Handbook [11] under the name of Work Elements. Concerning the Machine group, a Machinery FMEA can be developed to assess the machine reliability and to support maintenance planning. Therefore, the root cause of a failure mode registered in the Process FMEA is defined. In the Machinery FMEA, failure modes are concerned with functional failures during equipment operation and are registered at the component level (although they could also be registered at the module or machine level). A manufacturing process can involve more than one machine, each with its Machinery FMEA, which will be associated with the analyzed process and linked to the Process FMEA.

In the Process FMEA, failure modes are divided into three categories – Quality, Safety, and Environment – and the respective failure modes are expressed as follows:

- *Quality*: concerning product defects, such as a certain dimension above or below the specified limits, burrs, and marks;

- *Safety*: concerning hazardous events or exposures that can cause injury or ill health to workers, such as falls, gas leakages, and fires;

- *Environment*: concerning hazardous events that can damage the environment.

These failure modes in the process lead to undesired effects, such as injury and ill health to workers, environmental damage, and internal or external failure costs (i.e., non-quality costs associated with scrap, rework, returned parts, etc.). These undesired
effects impact stakeholders – whether they are internal or external clients, administra-
tion, society (mainly due to environmental issues), or company collaborators – and can,
therefore, be grouped by the stakeholders they impact on.

According to Ford's FMEA Handbook, a failure mode can be an effect of a previ-
ous operation or a cause of a subsequent operation [19]. This statement allows linking
Process FMEAs of interrelated processes (i.e., when one process output is another one's
input), fomenting the implementation of a process-based approach, as prescribed in ISO
9001:2015 [2].

<figure><img src="image_3.png" /><figcaption>Fig. 1. The conceptual model for the integrated risk analysis of manufacturing processes.</figcaption></figure>

## 2.2 Practical Examples

To illustrate the proposed approach with practical examples, two interrelated processes from the metalworking industry were considered, as shown in Fig. 2. In this figure, the stamping process transforms the metal sheet into stamped parts, which are then transformed into finished parts by the coating process.
<figure><img src="image_4.png" /><figcaption>Fig. 2. Interrelated processes.</figcaption></figure>

A defective output of the stamping process can affect the subsequent process (in this case, the coating process). In this way, a linkage between the respective Process FMEAs is applied, as exemplified in Fig. 3. In this figure, an excessive gap in the stamped parts can cause parts to stick together in the coating process.

<figure><img src="image_5.png" /></figure>

USL: Upper Specification Limit

<caption>Fig. 3. An example of the linkage between process FMEAs.</caption>

The same logic is applied to establish the linkage between Machinery and Process FMEA, exemplified in Fig. 4. In this figure, two failure modes of the Process FMEA have a common cause, related to the Machinery FMEA: machinery speed above recommendation results in serious machinery vibration, which affects stamping quality and exposes workers to excessive noise.

The risk assessment of a specific event, involving failure modes in the Machinery FMEA and in the Process FMEA, should be done collaboratively between areas or departments. In the process planning phase, the level of the occurrence factor (O) and the respective preventive controls for the Machinery FMEA should mainly be defined by the maintenance department and used on the Process FMEA, since the occurrence factor is related to the failure cause. The level of the detection factor (D) should be defined by the maintenance department and other departments involved in the process, taking into account the respective detection controls. In the example presented in Fig. 4, the failure event could be detected at the machine level – by identifying the excessive SPM (Strokes Per Minute) or the damaged component – or in the process – by the failure modes occurrence, i.e., identification of the defective parts or the excessive noise. The level of the severity factor (S), related to the end effects, is intended to be defined in the Process FMEA, considering all the effects on different areas, and used on the Machinery FMEA (nevertheless, a corrective cost and time of the machinery failure could also be used to better assess the severity level).
## Process FMEA

<table><thead><tr><th>Item</th><th>Failure Mode</th><th>Effects</th><th>S</th><th>Causes</th><th>O</th><th>D</th></tr></thead><tbody><tr><td rowspan="2">Stamping</td><td>Defective parts</td><td>Quality: Scrap</td><td>3</td><td rowspan="2">Machine:<br>Excessive SPM</td><td rowspan="2">2</td><td rowspan="2">3</td></tr><tr><td>Excessive noise</td><td>Safety: Hear damage</td><td>7</td></tr></tbody></table>

## Machinery FMEA at component level

<table><tr><td rowspan="2">Comp. X</td><td rowspan="2">Damaged</td><td>Machine: Excessive SPM</td><td>3</td><td rowspan="2">Wear</td><td rowspan="2">2</td><td rowspan="2">3</td></tr><tr><td>Process: Defective parts,<br>Excessive noise</td><td>7</td></tr></table>

SPM: Strokes Per Minute

<caption>Fig. 4. An example of the proposed linkage between machinery and process FMEA.</caption>

## 3 Conclusions and Future Work

This paper presents an integrated approach for risk analysis, in manufacturing processes, using the FMEA method. It was shown how risk identification and evaluation can be integrated, considering the areas of quality, environment, health and safety, and maintenance. To illustrate the proposed approach, practical examples from the metalworking industry are presented.

For future work, this approach is intended to be operationalized through a computer application. The collaborative network has to be defined to facilitate communication among the different departments. It should also be noted that the proposed approach can be extended to non-manufacturing processes.

**Acknowledgment.** The authors would like to express appreciation for the companies involved. This work has been supported by Norte 010247 FEDER 046930 - CORIM I&DT.

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