# The Development of a Cold-Chain-Packaging Risk Management Model Based on Fuzzy Bayesian Network
###### Abstract  
Cold chain packaging faces high levels of uncertainty due to its complex nature and dynamic environments during transportation, and the importance of safety and risk management. This study aims to propose a risk assessment model for cold chain packaging based on a fuzzy Bayesian Network. A case study on vaccine cold chain shipping containers is conducted for the illustration of the risk management model, and risk factors like container risk, packaging risk, monitoring risk and handling risk, occupational and product safety risk have been identified and assessed. This paper will add new knowledge to the field of cold chain packaging, which still lacks research attention, and will be useful for industry managers to gain a better understand of the dynamics and risks of cold chain packaging. risk management; fuzzy Bayesian Network; cold chain; packaging; shipping container; temperature-sensitive products +
Footnote †: journal: Medical  
temperature, therefore maintaining the quality of the cold chain food. Vaccines are also very sensitive to temperatures, as well, and insufficient temperature control can lead to the loss of vaccine efficacy and have the potential cause to health hazards. Some vaccines are very freezing-sensitive, and temperature disruptions can lead to the over-thawing of vaccines, harming their potency and effectiveness [5]. Also, cold chain workers face potential safety hazards due to the extraordinarily cold working environment [2]. Temperature control and safety management are critical for vaccine cold chains. Chemical and biological products such as temperature-sensitive reagents (e.g., enzymes, antibodies, growth media), DNA, RNA, proteins, etc., need to be stored in certain required temperature ranges to keep from degradation. Cold chains are very necessary to store and transport temperature-sensitive products. There are many ways to preserve the temperature during storage and transportation, e.g., fridges, freezers, cold rooms, ice, cold storage boxes, etc. Packaging is an important part of the whole cold chain design since it is involved almost along the whole cold chain. And it has also been identified as one of the main risks of cold chain disruptions [1]. However, packaging is often overlooked in cold chain systems and safety management. The cold chain packaging market is expected to reach USD 40 billion by 2026, with an annual growth rate of 12.92% [6]. It is vital to study the role of packaging on cold chains and its impact on the overall safety and efficiency of cold chains. Packaging has many functionalities, consisting of containment, protection, transportation, storage, etc., and the main goals of packaging are different depending on the perspective. For example, from an economic point of view, the goal of packaging is to maximize profits while minimizing costs of delivery [7]. From the perspectives of efficiency and personnel safety, packaging should maximize ergonomic design and ensure safety. Packaging used in cold chains plays an important role in regulating and monitoring the temperatures during transportation and storage. Comprehensive cold chain shipping solutions are often offered by cold chain providers. A cold chain shipping solution often includes the provision of suitable pallets, containers, monitoring devices and accessories, as well as training and recycling programs if needed [8]. It is highly demand-driven, and customized shipping containers are often provided to meet specific end needs. For instance, due to the COVID-19 pandemic and the expansion of global immunization programs, the demand for vaccine cold chain shipping containers has increased dramatically in the past few years [9; 10]. However, vaccine cold chains are not risk free. The rate of COVID-19 vaccine failure due to poor storage, scheduling and preparation is reported to be about 50% [11]. Maintaining and monitoring the temperature along cold chains is of great importance since insufficient temperature control during can lead to serious quality and safety deteriorations.