MethodsX 12 (2024) 102760

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MethodsX
journal homepage: www.elsevier.com/locate/methodsx

A comprehensive protocol for evaluating health, safety, and

environmental risks of hospital solid waste through FMEA
technique ✩
Towhid Dadashi a, Saeed Hosseinpoor a, Amir Mohammadi a,b,∗
a
Department of Environmental Health Engineering, School of Public Health, Urmia University of Medical Sciences, Urmia, Iran
b
Social Determinants of Health Research Center, Clinical Research Institute, Urmia University of Medical Sciences, Urmia, Iran

a r t i c l e i n f o a b s t r a c t

Method name: This protocol outlines a comprehensive approach to evaluating hospital solid waste levels and
Hospital Solid Waste HSE Risk Assessment assessing associated health, safety, and environmental (HSE) risks using the Failure Mode and
protocol using FMEA technique Effects Analysis (FMEA) methodology. The study focuses on Imam Khomeini Hospital (RA) and
employs both quantitative and qualitative methods. Over a 3-month period, waste production and
Keywords:
Hazardous waste
potential risks are assessed, with specific attention to household, infectious, medicinal, and sharps
HSE risk assessment waste. Through FMEA, potential failure modes and associated risks in waste management sectors
FMEA technique are identified, enabling targeted interventions for risk mitigation. The protocol emphasizes the
importance of aligning waste management practices with international standards and highlights
the need for comprehensive training, awareness campaigns, and effective waste management
methods to ensure the safety and environmental responsibility of hospital waste management
practices

Specifications table
Subject area: Environmental Health Engineering
More specific subject area: Hazardous waste management
Name of your protocol: Hospital Solid Waste HSE Risk Assessment protocol using FMEA technique
Reagents/tools: Observation, Interview templates, Excel program, FMEA checklists
Experimental design: The experimental design involves a comprehensive approach to assess hospital waste management HSE risks.
It begins with a preliminary investigation, identifying stakeholders and departments. Observation and
interviews identify risks. FMEA is applied for systematic risk assessment, determining severity, occurrence,
and detection levels. Risk priority numbers (RPN) categorize risks. Disposal methods are implemented per
waste category. Data analysis involves extracting parameters and calculating RPN. Quality assurance and
control ensure accuracy. Documentation includes findings and recommendations. Continuous improvement
integrates insights for risk mitigation and process enhancement
(continued on next page)

✩
Related research article: Hosseinpoor S, Dadashi T, Mohammadi A. Comprehensive analysis of hospital solid waste levels and HSE risks
using FMEA technique: A case study in northwest Iran. Case Studies in Chemical and Environmental Engineering. 2024 Jun 1;9:100646.
https://doi.org/10.1016/j.cscee.2024.100646
∗
Corresponding author at: Department of Environmental Health Engineering, School of Public Health, Urmia University of Medical Sciences,
Urmia, Iran.
E-mail addresses: [email protected], [email protected] (A. Mohammadi).

https://doi.org/10.1016/j.mex.2024.102760
Received 22 March 2024; Accepted 13 May 2024
Available online 14 May 2024
2215-0161/© 2024 The Author(s). Published by Elsevier B.V. This is an open access article under the CC BY license
(http://creativecommons.org/licenses/by/4.0/)
T. Dadashi, S. Hosseinpoor and A. Mohammadi MethodsX 12 (2024) 102760

Trial registration: Not applicable

Ethics: The current research was funded by Urmia University of Medical Sciences, West Azerbaijan, Iran (grant no:
3199), and adhered to ethical standards outlined in ethics code IR.UMSU.REC.1402.008. All participating
workers and additional staff provided informed consent during the study. The authors express appreciation to
Urmia University of Medical Sciences and all contributors to the research.
Value of the Protocol: • Comprehensive assessment of hospital solid waste and associated health, safety, and environmental risks.
• Utilization of Failure Mode and Effects Analysis (FMEA) methodology for systematic risk identification
and mitigation.
• Emphasis on aligning waste management practices with international standards and promoting safety and
environmental responsibility.

Background

The protocol provided here stems from a pressing global challenge surrounding the management of hospital solid waste, amidst
rapid urbanization and industrialization. It is well-documented that ineffective waste management practices pose substantial risks to
both public health and the environment. Against this backdrop, the Failure Mode and Effects Analysis (FMEA) methodology emerges
as a robust approach for identifying and mitigating potential failure modes and associated risks within complex operational frame-
works. This protocol is motivated by a synthesis of recent research that has underscored shortcomings in hospital waste management
practices, ranging from inadequate staff training to challenges in hazardous waste handling. Moreover, the protocol addresses the crit-
ical need for comprehensive waste management frameworks to ensure environmental sustainability and public health safety within
healthcare settings [1].
By employing the FMEA technique, this study aims to proactively identify critical failure modes and potential risks within the
medical waste management process, thereby illuminating the intricate network of hazards and failure points inherent within the
system. Through systematic risk assessment and prioritization, the protocol facilitates the formulation of robust risk management
strategies and proactive mitigation measures. The integration of FMEA enables the identification and prioritization of potential
failure modes and risks, offering insights crucial for the development of enhanced operational protocols, advanced safety measures,
and comprehensive contingency plans [2].
The novelty of this research protocol lies in its response to the urgent global challenge of hospital solid waste management amidst
rapid urbanization and industrialization. It recognizes the documented risks ineffective waste management poses to both public
health and the environment. Through the application of the Failure Mode and Effects Analysis (FMEA) methodology, the protocol
aims to identify and mitigate potential failure modes and associated risks within complex operational frameworks. Unlike previous
studies, this protocol synthesizes recent research to address shortcomings in hospital waste management practices, such as inadequate
staff training and challenges in hazardous waste handling. Furthermore, it emphasizes the critical necessity for comprehensive waste
management frameworks to ensure environmental sustainability and public health safety within healthcare settings. By conducting
systematic risk assessment and prioritization, this protocol provides essential insights for developing improved operational protocols,
advanced safety measures, and comprehensive contingency plans. In doing so, it fills a significant gap in the existing literature and
makes a substantial contribution to the field.

Description of protocol

Hospital waste management is a critical aspect of healthcare operations, with potential implications for both public health and
environmental safety. However, there is a lack of standardized protocols for assessing and mitigating health, safety, and environmental
(HSE) risks associated with hospital waste management practices. The Failure Mode and Effects Analysis (FMEA) methodology has
emerged as a robust tool for systematically identifying and prioritizing potential failure modes and associated risks within complex
operational frameworks. By developing a comprehensive protocol using FMEA, this study aims to fill this gap by providing researchers
and practitioners with a replicable framework for assessing and managing HSE risks in hospital waste management. This protocol
will contribute to enhancing the safety and sustainability of hospital waste management practices, ultimately improving public health
outcomes and environmental protection [3,4].

Step-by-step description of the protocol

In the initial stage, as depicted in Fig. 1, a flow diagram illustrates the process undertaken to identify significant Health, Safety,
and Environment (HSE) risks in hospital solid waste management using FMEA methodology.

Preliminary investigation

Conduct a thorough assessment of the hospital waste management system to understand its organizational structure and processes.
Identify key stakeholders and personnel involved in waste management.

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T. Dadashi, S. Hosseinpoor and A. Mohammadi MethodsX 12 (2024) 102760

Fig. 1. Flow diagram of FMEA steps for determination of HSE risks.

Recognition of hospital waste management departments

Map out the different departments responsible for managing hospital waste, including collection, segregation, transportation, and
disposal.

Identification of HSE risks

To identify health, safety, and environmental (HSE) risks related to hospital waste management, a multifaceted approach was
employed. This involved direct observation of waste management processes, conducting structured interviews with key personnel
involved, and employing comprehensive checklists to systematically assess potential hazards and risks.

Risk assessment using FMEA

For systematic evaluation of HSE risks in hospital waste management, the Failure Mode and Effects Analysis (FMEA) methodology
was adopted. FMEA worksheets were utilized to identify and analyze failure modes, their potential impacts, and the likelihood of
their occurrence within the waste management framework.
Determine severity, occurrence, and detection levels for each identified failure mode.

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T. Dadashi, S. Hosseinpoor and A. Mohammadi MethodsX 12 (2024) 102760

Table 1
Ranking the likelihood (O - Occurrence) index of failure [6].

Order (O) Criterion: the proportion of potential failure / Likelihood of failure

total number of working days.

10 O ≤ 1: 2 Extremely high
9 O ≤ 1: 10 Extremely high
8 O ≤1: 20 High
7 O ≤ 1: 100 High
6 O ≤ 1:200 Moderate
5 O ≤ 1: 1000 Moderate
4 O ≤ 1: 2000 Somewhat minimal
3 O ≤ 1: 10000 Low Extremely
2 O ≤ 1: 20000 low
1 O ≤ 1: 50000 Infrequent

Table 2
Assigning a rank to the S (severity) index of failure [6].

Order (S) Criterion severity Impact

9 ≤ S ≤ 10 Causing fatalities or complete system breakdown Lethal

8 ≤ S ≤7 Inflicts severe harm to individuals or has a substantial impact on the system. More detrimental
6 ≤ S ≤5 Results in lesser harm or a reduced impact on the system. Less Less detrimental
4≤S≤3 Signifies a significant impact on individuals or the system with complete recovery. Moderate
S=2 Causes minimal disruption to the system or individuals Low
S=1 no effect on people or the system No effects

Table 3
Rating for the capability to detect failures (Detection) [6].

Order (D) Identifiable percentage ID

10 Completely unknown 0≤D≤5

9 Very detailed 6 ≤ D ≤ 15
8 Partial 16 ≤ D ≤ 25
7 Very little 26 ≤ D ≤ 35
6 Low 36 ≤ D ≤ 45
5 Moderate 46 ≤ D ≤ 55
4 Moderately high 56 ≤ D ≤ 65
3 high 66 ≤ D ≤ 75
2 too high 76 ≤ D ≤ 85
1 Almost known 86 ≤ D ≤ 100

Determination of HSE risk levels

The determination of HSE risk levels involved calculating the Risk Priority Number (RPN) for each identified failure mode. This
computation integrated multiple factors, including the probability of occurrence, severity of potential effects, and detectability of
failures, thus providing a comprehensive assessment of risk levels.
Categorize RPN levels into four classes: low risk, moderate risk, high risk, and extremely high risk.

Final disposal methods

Implement specific disposal methods for rendered wastes based on waste categories, ensuring compliance with recommended
procedures and regulations.
The FMEA technique, a powerful risk assessment tool, employed a risk priority number based on occurrence, severity, and detection
parameters [3,5]. For data analysis, which was calculated by Eq. (1):

𝑅𝑃 𝑁 = 𝑂 × 𝑆 × 𝐷 (1)

RPN: risk priority number, O: probability of occurrence, S: severity of effect, D: detectability

The occurrence, severity, and detection parameters were determined based on data extracted from Tables 1–3. In fact, each
parameter “occurrence, severity, and detection” was allocated an associated quality factor determined by the activity nature, as
outlined in Tables 1–3. The numeric result derived from Eq. (1) indicates the RPN level. The RPN number is categorized into four
classes as follows: RPN < 70 is considered low risk, 70 ≤ RPN < 200 is categorized as moderate risk, 200 ≤ RPN < 400 indicates high
risk, and RPN > 400 signifies extremely high risk.

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T. Dadashi, S. Hosseinpoor and A. Mohammadi MethodsX 12 (2024) 102760

Fig. 2. The outcomes of the health and safety risk assessment in different waste wards using the FMEA method [6].

Result of case study in one of Urmia hospital in northwest Iran

In the HSE risk assessment conducted at Urmia Hospital utilizing the FMEA technique, each of the four stages of waste manage-
ment (generation and segregation, collection, transfer, storage, and decontamination) revealed specific health and safety risks. The
assessment identified a total of 10 risk items associated with various activities in each stage. The highest risk scores were observed in
the transfer stage, categorized as high risk, while the lowest risk scores were found in the storage stage, classified as low or accept-
able. No activity was classified as very high risk, but several activities were deemed high or moderate risk. The analysis pinpointed
issues such as inadequate personnel training, low awareness levels, staff shortages, and lack of diligence as significant contributors
to identified risks. Overall, the transfer stage emerged as the most critical phase with high-risk levels, while other stages exhibited
acceptable, low, and moderate risks as Fig. 2. More detail given in our previous study [6].

Conclusion

This protocol addresses the pressing challenge of hospital solid waste management by employing the Failure Mode and Effects
Analysis (FMEA) methodology. In response to documented deficiencies in waste management practices, particularly in staff train-
ing and hazardous waste handling, the protocol emphasizes the necessity for comprehensive frameworks to ensure environmental
sustainability and public health safety in healthcare settings. Through systematic risk assessment and prioritization using FMEA,
critical failure modes within medical waste management are proactively identified, enabling the formulation of robust risk man-
agement strategies and mitigation measures. The protocol’s step-by-step description includes preliminary investigation, department
recognition, HSE risk identification, FMEA-based risk assessment, risk level determination, and final disposal methods. A case study
conducted at Urmia Hospital in northwest Iran revealed specific health and safety risks associated with various waste management
stages, highlighting the transfer stage as particularly critical. Inadequate training, low awareness levels, and staff shortages were
identified as significant contributors to these risks. Overall, this protocol serves as a valuable resource for researchers and practition-
ers, facilitating the development of enhanced operational protocols and advanced safety measures in hospital waste management,
ultimately improving public health outcomes and environmental protection.

Protocol validation

Standardized data collection protocols were employed to minimize errors and ensure uniformity. Quality control (QC) measures
were introduced to independently verify the accuracy of RPN calculations. Regular QC audits were conducted to ensure the proper
application of the RPN formula.
By categorizing QA and QC into separate sections, the study ensures a comprehensive approach to both ensuring quality and
controlling it throughout the materials and methods utilized in the evaluation of hospital waste management.

Limitations

Subjective risk assessments may introduce bias, while resource constraints could hinder protocol implementation. Additionally,
reliance on historical data may overlook emerging risks, warranting adaptations for regional regulations.

Declaration of Competing Interest

The authors declare that they have no known competing financial interests or personal relationships that could have appeared to
influence the work reported in this paper.

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T. Dadashi, S. Hosseinpoor and A. Mohammadi MethodsX 12 (2024) 102760

CRediT authorship contribution statement

Towhid Dadashi: Writing – original draft. Saeed Hosseinpoor: Formal analysis. Amir Mohammadi: Project administration.

Data availability

The data that has been used is confidential.

Acknowledgments

The current study benefited from the financial support of Urmia University of Medical Sciences, West Azerbaijan, Iran (grant no:
3199) with the ethics code of IR.UMSU.REC.1402.008. The authors would like to thank Urmia University of Medical Sciences, and
all those who helped during the study period.

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