FMEA and consideration of real work situations for safer design of production systems

Abstract

Production equipment designers must ensure the health and safety of future users; in this regard, they augment requirements for standardizing and controlling operator work. This contrasts with the ergonomic view of the activity, which recommends leaving operators leeway (margins for manoeuvre) in performing their task, while safeguarding their health. Following a brief analysis of design practices in the car industry, we detail how the Failure Modes and Effects Analysis (FMEA) approach is implemented in this sector. We then suggest an adaptation that enables designers to consider real work situations. This new protocol, namely, work situation FMEA, allows experience feedback to be used to defend the health standpoint during designer project reviews, which usually only address quality and performance issues. We subsequently illustrate the advantage of this approach using two examples of work situations at car parts manufacturers: the first from the literature and the second from an in-company industrial project.

A fuzzy-QFD approach for the enhancement of work equipment safety: a case study in the agriculture sector

“…In particular, the framework proposed by Bas (2014) can allow engineers to carry out risk assessment in a thorough manner suggesting them the preventive/protective interventions that have effect on multiple events. Nevertheless, such an approach lacks in addressing the analysis on specific work situations, considering that to properly enhance the safety level of a work task designers need to focus on what will be performed by the operators (the activities), which is often very different from what the they have imagined and stipulated (the task), as stressed by Lux et al (2016). This is particularly true when considering the use of a work equipment (Hasan et al, 2003;Khanzode et al, 2012;De Galvez et al, 2016).…”

Design for human safety in manufacturing systems: applications of design theories, methodologies, tools and techniques

“…However, the starting point of this analysis is always a quality failure; certain potentially hazardous work situations, which would generate no quality risk, could be exempted from the analysis. Lux et al (2015) also proposed an FMEA model based on formalism called 'Work situation FMEA'. It prompts designer discussion around data relevant to real work situations and encourages discussion and decision-making around real work situations, by focusing special attention on health and safety issues affecting future operators (Lux et al 2015).…”

“…Lux et al (2015) also proposed an FMEA model based on formalism called 'Work situation FMEA'. It prompts designer discussion around data relevant to real work situations and encourages discussion and decision-making around real work situations, by focusing special attention on health and safety issues affecting future operators (Lux et al 2015). Shahrokhi and Bernard (2010) developed a mathematical model based on the hypothesis used in ETA, FTA and energy flow/barrier analysis for modelling accidents.…”

About ATMPs, SOPs and GMP: The Hurdles to Produce Novel Skin Grafts for Clinical Use

“…A commonly used tool is the risk assessment based on the method of failure modes and effects analysis (FMEA). It is a systematic technique for assessing the risk of each component of a system, originally designed by the American army [27]. A complex process such as the manufacturing of an ATMP is divided into small manageable production steps (e.g., starting materials, consumables, handling techniques, and equipment used).…”

“…According to a previously defined threshold for the risk priority number, actions to reduce the risk have to be taken. [27,28,29]…”