Food Control 120 (2021) 107501

Contents lists available at ScienceDirect

Food Control
journal homepage: www.elsevier.com/locate/foodcont

Food quality and safety risk diagnosis in the food cold chain through failure
mode and effect analysis
Jhao-Yi Wu , Hsin-I Hsiao *
Department of Food Science, National Taiwan Ocean University, Keelung, Taiwan, ROC

A R T I C L E I N F O A B S T R A C T

Keywords: Improper handling in the food cold chain may compromise food safety and degrade quality, which can result in
Chilled economic losses and negative effects on food availability. This study evaluated risk in food cold chains using a
Frozen failure mode and effect analysis (FMEA) approach and developing improvement strategies. The research
Food safety
comprised two stages: The first stage used surveys to evaluate risk associated with cold chain logistics, and the
Diagnosis
Improvement
second used case studies to evaluate improvement strategies. We mailed 566 questionnaires to chilled or frozen
food companies including processors, wholesalers, and logistics service providers in Taiwan; the response rate
was 9.4%. Receiving, storage, dispatch, and delivery were the four major steps for food quality and safety risk
diagnosis in food cold chains. Survey results demonstrated that among the top five food quality and safety risks,
the product receiving stage involved three risks, namely long cargo handling time, temperature abuse, and
product damage; the dispatch step involved risks of temperature abuse; and delivery involved risks from poor
driving conditions. The case study suggested that food quality and safety risks of the cold chain system could be
effectively reduced after adoption of improvement plans. These findings demonstrate that the FMEA approach
could be used as a preventive tool to diagnose the food quality and safety risks in food cold chain and that risks
can be reduced through effective control strategies.

1. Introduction unsuitable temperatures (Zöller, Wachtel, Knapp, & Steinmetz, 2013).

As food trade grows and develops, ensuring safety and quality in the
food supply chain has become a major challenge. Due to the complexity
of the food supply chain, many risk factors affect the safety and quality
of products, particularly low-temperature foods (Prakash, Soni, Rathore,
& Singh, 2017). For low-temperature foods, exposure to unsuitable
temperatures can cause microbial growth, reduced quality, food
spoilage, and increased food poisoning (Carullo, Corbellini, Parvis,
Reyneri, & Vallan, 2008). According to market research,
low-temperature foods are necessitating the development of cold chain
logistics; the international market value is predicted to reach approxi­
mately US$300 billion by 2023 (Markets and markets, 2018). Therefore,
cold chain operators must provide an effective logistics system to ensure
the safety and quality of food (Kuo & Chen, 2010).
In recent years, many temperature control problems have occurred
in food cold chain around the world (E. Derens-Bertheau, Osswald,
Laguerre, & Alvarez, 2015; Lundén et al., 2014) Approximately 35% of
chilled foods are damaged during the logistics process due to exposure to
To solve this problem, many solutions have been proposed. For instance,
suggestions have been made that the government should implement
food temperature standards during loading or uploading (Chaudhuri,
Dukovska-Popovska, Subramanian, Chan, & Bai, 2018) by establishing
monitoring of temperature for food quality (Ringsberg, 2014; L.; Wang,
Kwok, & Ip, 2010). Despite the numerous studies nowadays dedicate
much effort to cold chain control and management, the cold chain
performance is not yet satisfactory (Mercier, Villeneuve, Mondor, &
Uysal, 2017a; Ndraha, Hsiao, Vlajic, Yang, & Lin, 2018). There is a
constant pressure to evaluate and improve the cold chain performance in
order to comply with stakeholder requirements (Chaudhuri et al., 2018).
Failure mode and effect analysis (FMEA) is a systematic, proactive
method for evaluating the process of identifying pressing problems
(Rana & Belokar, 2017). Through assessing the risk priority number
(RPN), causes are established and addressed one by one (Rana & Belo­
kar, 2017). FMEA improves operational performance of process cycles
and reduces overall risk level through establish corrective actions. In
addition, FMEA aid in raising awareness of risk management (Abou,

* Corresponding author.
E-mail address: hi.hsiao@ntou.edu.tw (H.-I. Hsiao).

https://doi.org/10.1016/j.foodcont.2020.107501
Received 8 April 2020; Received in revised form 19 July 2020; Accepted 21 July 2020
Available online 10 August 2020
0956-7135/© 2020 Elsevier Ltd. All rights reserved.
J.-Y. Wu and H.-I. Hsiao Food Control 120 (2021) 107501

Hassan, Elsherpieny, Kholif, & Khorshid, 2017; Trafialek & Kolanowski,
2014). FMEA has been widely used in the food industry to assess risks in
the food production process (Özilgen & Özilgen, 2017). Thus, this
research diagnoses food quality and safety risk in food cold chain pro­
cess using an FMEA approach and suggests improvement strategies.
2. Literature review
2.1. Cold chain definition
most critical step in FMEA analysis. The method involves analyzing the
failure modes. Through the establishment of the risk assessment team,
the failure mode and cause can be listed and analyzed. Furthermore,
effects may be evaluated.
Step 4. Risk indicator assessment: The severity, occurrence, and
detectability of the failures are assessed. The numerical scales for these
parameters are defined by the FMEA team according to preferences of
the team (Scipioni, Saccarola, Centazzo, & Arena, 2002). And then the
three parameters are determined to calculate the RPN.

According to the Codex, the cold chain is an uninterrupted series of Step 5. RPN: For each failure, the RPN is found by multiplying
refrigerator or freezer production, storage, and distribution activi­ together the three values for severity, the occurrence, and the
ties—along with associated equipment and logistics—that maintain the detectability.
low-temperature range and ensure quality and safety (Codex Ali­
Step 6. Improvement strategy: This step is mainly to determine the
mentarius Commission C, 2008). In the cold chain, temperature condi­
priority of improvement by sorting the RPN, to establish the main failure
tions affect shelf life and final product quality. Maintaining low
modes, discuss them, and formulate improvement strategies. After
temperatures reduces the risks of foodborne diseases, maintains product
implementing the improvement plan, the risk indicators can be reeval­
quality, and slows the growth of spoilage-causing bacteria (Montanari,
uated and the improved RPN used for verification.
2008). Government or industry standards had issued regulations or
guideline for temperature requirement of chilled or frozen foods for In recent years, FMEA has been used in the food industry (see
transportation, storage, and dispatch stages. For instance, the ware­ Table 1). Abou et al. (2017) and Özilgen and Özilgen (2017) used FMEA
housing and transportation, the United States requires refrigeration to to assess the risk involved in the milk processing and quality inspection
be colder than 4 ◦ C and freezing colder than − 18 ◦ C (U.S. FDA, 2017). process, and the RPN was significantly reduced by implementing the
Canada requires refrigeration to be colder than 4 ◦ C and freezing colder
than − 18 ◦ Canadian Food Inspection Agency (2010). In the United Table 1
Kingdom and Wales, cold storage must be colder than 4 ◦ C; the Summary of current FMEA applications in food industry.
maximum allowable temperature for freezing is − 12 ◦ C (Food Standards
Type Application Author (year)
Agency Wales, 2015). Australia has a maximum allowable temperature
milk The FMEA is used mainly to improve the Abou et al. (2017)
of 5 ◦ C for refrigeration and − 18 ◦ C for freezing (Australian Food &
quality of the preanalytical stage, to
Grocery Council, 2017). In Asia, Japan requires refrigeration to be identify potential failures, and to develop
colder than 10 ◦ C and freezing colder than − 15 ◦ C (New Supermarket and prioritize improvement strategies
Association of Japan, 2017). Taiwan requires refrigeration to be colder using milk samples in the laboratory. This
than 7 ◦ C and freezing to be colder than − 18 ◦ C (Taiwan Food and Drug method reveals the chief reasons for
failures with the highest RPNs and uses an
Administration, 2014). For dispatch (loading and unloading), only
effective improvement action plan to
Australia have suggested that the air temperature should be colder than significantly decrease the RPN (decrease
15 ◦ C (Australian Food & Grocery Council, 2017). by 71%–85%).
Milk (FMEA The author compiles a wide-ranging Özilgen and
template) literature survey on the hazards involved in Özilgen (2017)
2.2. FMEA and its applications in food industry the primary processing steps; the common
factors in a general FMEA template are
used with study of pasteurized milk
In the 1950s, attention was paid to safety for preventing foreseeable
production. In numerous stages, drastic
accidents in the aerospace industry. This led to the development of reductions in the RPNs result in
FMEA methodology, which was later introduced as a key tool for implementation of the corrective actions
increasing efficiency and quality in manufacturing processes. FMEA is a (reduced eight-fold). The FMEA can be
management technology used to analyze security, prevent problems, helpful for improving the safety of a
pasteurization process.
measure risk issues in systems, and assist managers in monitoring and
metallic This study elaborated and validated the Trafialek et al.
improvement (Rana & Belokar, 2017). FMEA can be used as a system foreign risk analysis procedure of metallic foreign (2016)
preventive program to eliminate potential failure modes, assess its bodies bodies contaminating dry foods with
causes and effects, and improve product reliability to meet customer and FMEA. The implementation of the
procedure left two production stages at risk
government requirements (Özilgen & Özilgen, 2017). FMEA evaluates
of metallic particle contamination. The
the severity, occurrence, and detectability of each failure in the system methods of risk management and risk
and quantifies it to calculate the RPN. The RPN is given by the product of communication were established. The
occurrence, severity, and detection. RPN approximates the most FMEA may be a convenient tool for
affecting parameters in the process. This method can detect how failure improved food safety assurance.
HACCP The aim of the study was to design an Trafialek and
occurs and suggest preventive action (Rana & Belokar, 2017). The FMEA
system HACCP system that precisely assesses the Kolanowski (2014)
implementation steps are organized into six steps (Giannakis & Papa­ systems functioning in two bakeries. The
dopoulos, 2016; Rana & Belokar, 2017; Özilgen & Özilgen, 2017): method was based on an audit
questionnaire, including all HACCP steps
Step 1. Determining the theme: The theme can be evaluated by and principles, associated with the analysis
reviewing the literature or by reviewing high-risk or weakness issues, of audit findings for FMEA. The method
such as customer complaints or reducing failure rates. precisely identifies high and critical risks in
HACCP areas of verification and
Step 2. Drawing a flowchart: According to the theme, the entire sys­ recordkeeping. Therefore, the
tem is graphically depicted as a flowchart. If the process is complex (if incorporation of FMEA analysis within the
HACCP system verification procedure may
the number of processes is large, for example), specific parts of the
be a convenient tool for better food safety
process can be selected for analysis. assurance and applicable to all types of
food enterprises.
Step 3. Identifying failure modes: Listing potential failure modes is the

2
J.-Y. Wu and H.-I. Hsiao
FMEA method and developing an improvement strategy. Trafialek,
Kaczmarek, and Kolanowski (2016) also used this method to assess the
risk of contamination by metal foreign bodies in food and used the re­
sults to establish risk management and risk communication methods for
ensuring food safety. Trafialek and Kolanowski (2014) combined FMEA
with hazard analysis and critical control points (HACCP) to audit the
main risks of the HACCP system. The authors also mentioned that FMEA
is a convenient tool for improving food safety assurance and is appli­
cable to all types of food enterprises. Accordingly, the implementation of
FMEA is beneficial to alleviate potential risks. It can be used to improve
the risk awareness of managers, identify the possible causes, and
formulate improvement policies to ensure food quality and safety.
2.3. Research methods
FEMA comprises six steps. The first and second steps involve deter­
mining the theme, and step 2 involves creating a flowchart. The theme
and flow were already clear in this research. To execute steps 3–6, we
designed two research stages. The first stage used a survey approach to
explore steps 3–5. The second stage used a case study approach to
explore step 6.
2.4. Stage 1: Survey
(1) Identifying failure modes (food quality and safety risks)
Failure modes in this research are defined as food quality and safety
risks. The potential food quality and safety risks were first identified
from a literature review. The data were collected from various academic
search engines and databases. The search keywords were “cold chain
risk,” “weak link cold chain,” “temperature control,” “temperature
management,” “logistic process risk,” “food supply chain risk,” “logistic
food risk,” “storage,” “transportation,” and “distribution.”
(2) Calculating RPN
- Research population and sample
Food companies were selected among vendors or distributors of
chilled or frozen foods. However, some chilled and frozen food manu­
facturers also produced food products stored at room temperatures. To
answer our research questions, we posted 566 food companies in total to
members of the Taiwanese Industry & Technology Intelligence Service
(www.itis.org.tw). The postal survey entailed two waves of mailings,
with all nonrespondents to the first wave receiving a second-wave
replacement questionnaire. According to Armstrong and Overton
(1977), nonresponse bias was examined by comparing early and late
respondents. No significant differences in firm size, sales growth rate
and food sectors between early and late respondents were detected
indicating that nonresponse bias is not a problem in this study. A total of
50 surveys were undeliverable or returned from recipients disqualifying
themselves as respondents. In total, 62 useable responses were received,
of which 10 had missing data and were judged unusable, yielding an
effective sample size of 52 for a response rate of 9.4% (52/556).
- Questionnaire development
Our procedures for designing the survey included a literature review
and interviews with food logistic quality and safety professionals. The
questionnaire was examined and improved in a pretest by two academic
experts and two business executives with experience in quality man­
agement and cold chain logistics. The survey questionnaire consisted of
four parts: The first part contained information on food companies; the
second part the frequency of occurrence of each failure mode in logistics
operation; the third part the problem of low-temperature food circula­
tion operation and processing capacity; and the fourth part the effect of
failure mode on food safety and quality. Likert-type scales were used for
3
Food Control 120 (2021) 107501
answers, numbered from 1 to 7 (Giannakis & Papadopoulos, 2016). A
definition for each risk grade was also provided to facilitate the re­
sponses and avoid confusion. Occurrence refers to the probability of
occurrence in failure mode (ranging from 1 = almost never to 7 = almost
always). Detectability is the detection capacity, when the failure mode
occurs, of the current control scheme (ranging from 1 = certainty of
detection to 7 = impossible to detect). Severity: the effect of a failure
mode (ranging from 1 = no effect to 7 = catastrophic effect).
- RPN
The RPN is calculated by multiplying together the three values for
the severity (S), occurrence (O), and detectability (D) of each risks to
obtain their product (RPN = S × O × D) (Rana & Belokar, 2017). In this
study, the data analysis involved descriptive statistics and one-way
ANOVA using SPSS version 22.0 (IBM SPSS Statistics 22.0) and Micro­
soft Office Excel 2010 (Microsoft, USA).
2.5. Stage 2: Case study
This study used in-depth interviews for the case study. Two food
companies were selected in this case study stage. In the survey stage, we
asked the respondents if they were willing to be contacted for further
case studies. Respondents of company A were quality assurance man­
agers with more than 10 years’ work experience. Respondents of com­
pany B were general managers with more than 12 years’ work
experience.
(1) RPN
The RPN calculation method was the same as the calculation method
from previous section. The case study used the same questionnaire
developed in the previous stage.
(2) Improvement strategy
After the risk priority factors were calculated and ranked, the top five
risk factors were examined for improvement strategies. The solutions
were adopted from various academic search engines and databases and
discussed with experts in this field. The improvement solutions were
then implemented in the two case study companies. After six months,
the RPN were reassessed to verify the effectiveness of the improvement
strategy.
3. Results and discussion
3.1. Survey result
- Food quality and safety risks identified in food cold chain
Based on the literature review, we designed 24 failure modes that
related temperature management with food quality and safety (Table 2).
The temperatures in the low-temperature library required regular
recording and management, and the refrigeration system had to be
regularly maintained to prevent temperature loss caused by equipment
damage (Osorio Gómez, Manotas Duque, Rivera, & García-Alcaraz,
2017). Inappropriate management of information related to the goods,
inappropriate handling methods (e.g., use of unsuitable transportation
equipment) or negligence in the receiving of goods and transportation
operations may cause product expiry, collision damage, or other prob­
lems with the goods. In addition, uncertainty regarding product
receiving times or excessively long handling times during dispatch could
also cause problems, such as dock congestion and excessively long du­
rations of product retention at inappropriate temperatures. Šolc (2012)
mentioned that product quality (e.g., expiration date or temperature),
improper storage of goods, failure to follow first-in-first-out protocol,
J.-Y. Wu and H.-I. Hsiao Food Control 120 (2021) 107501

Table 2 detected risk, followed by “R1 uncertainty of receiving time (3.71).” At

Failure mode of cold chain logistics. detection, “R1 uncertainty of product receiving time (2.81)” was the
Process Failure mode References most detected risk, followed by “R2 excessively long cargo handling
time (2.79).” Most of the industry believes that the greatest effects on
Receipt R1 Uncertainty of product Expert interview
receipt time food safety and quality (score 6 or greater) resulted from “R3 Temper­
R2 Cargo handling time is Australian Food and Grocery ature abuse (6.17),” “R6 lack of product temperature information
too long Council (2017) (6.10),” and “R4 product damage (6.02)” (Fig. 1a).
R3 Temperature abuse Xu (2011) At storage, “R11 counting errors (2.86)” and “R12 expiry or near-
R4 Product damage
R5 Receipt of an irregular Šolc (2012)
expiry (2.86)” was the most detected risk, followed by “R14 first-in,
product first-out rule not followed (2.78).” The most detected risk is “R11
R6 Lack of product Canadian Food Inspection Agency counting mistake (2.56),” the second most detected was “R13 incorrect
temperature (2010), Šolc (2012) storage data (2.48),” and the next most detected was “R8 improper
information
stacking (2.48).” For severity, “R10 cold room malfunctions (6.28),” “R9
Storage R7 Wrong storage location Šolc (2012)
R8 Improper stacking temperature abuse (6.24),” “R12 expiry or near-expiry (6.14),” and “R14
R9 Temperature abuse Osorio Gómez, Duque, Rivera, and first-in, first-out rule not followed (6.04)” greatly affected food safety
García-Alcaraz (2017), Hu (2014) and quality (Fig. 1b).
R10 Cold room breakdowns Osorio Gómez et al. (2017), Hu At dispatch, “R18 unconfirmed product temperature before loading
(2014)
R11 Counting mistake expert interview
(3.04)” occurred with the highest frequency; “R15 cargo excessively
R12 Expiry dates or near- Šolc (2012), expert interview long loading time (2.81)” had the most detected risk degree, and “R17
expiry temperature abuse (6.29)” the greatest severity (Fig. 1c).
R13 Incorrect storage data Finally, at delivery, the frequency and detection of “R22 poor driving
R14 First-in-first-out rule Šolc (2012), expert interview
conditions” were the highest (3.59 and 3.02, respectively), although
not followed
Dispatch R15 Excessive cargo loading Australian Food and Grocery most operators considered this to affect food safety and quality only
time is too long Council (2017) moderately severely (4.69); other failure modes were considered to
R16 Product damage significantly affect food safety and quality in terms of severity (Fig. 1d).
R17 Temperature abuse Xu (2011)
R18 Unconfirmed product Food Standards Australia New
- RPN: level of food quality and safety risks
temperature before Zealand (2016), Bogataj, Bogataj,
loading and Vodopivec (2005)
Delivery R19 No precooling before Xu (2011), expert interview The survey included several questions regarding the respondents and
loading their organizations (Table 3). The majority of organizations hire “more
R20 Vehicle breakdowns Hu (2014), Šolc (2012)
than 301 employees” (42.3%). In addition, for the business category, the
R21 Vehicle temperature Hu (2014), Tamimi, et al. (2010),
unconfirmed by driver expert interview majority of respondents were categorized as “logistics service providers”
R22 Poor driving conditions Šolc (2012), expert interview (51.9%), followed by food processors (28.8%), wholesalers (15.4%), and
R23 Temperature abuse Tamimi et al. (2010), expert importers (3.8%). Table 4 summarizes FMEA results from the survey.
interview Overall survey results indicate that the top five food quality and safety
R24 Products temperature SQF (2017)
risks are “R2 excessively long cargo handling time (RPN 61.40),” “R22
loss at delivery
poor driving conditions (RPN 53.37),” “R4 product damage (RPN
53.25),” “R17 dispatch temperature abuse (RPN 52.43),” and “R3
traffic congestion, or vehicle breakdowns may cause product tempera­ product receiving temperature abuse (RPN 51.81).”
ture rises, inventory, cross-contamination, or delayed delivery. Xu It is important to note that, among the top five food quality and
(2011) also indicated that exposing products to inappropriate ambient safety risks, the product-receiving step involved three risks (excessively
temperatures (due to lack of precooling or frequent switching of the long cargo handling time, temperature abuse, and product damage),
vehicle, for example) may have negative effects. followed by the dispatch step (temperature abuse), and delivery (poor
driving conditions). To a significant extent, food cold chain operators
- Occurrence, detection and severity of food quality and safety risks encountered the most food safety problems at the product receiving step.
Interestingly, prior studies have focused cold chain problems only on
Fig. 1a–d describes occurrence, detection and severity of food quality storage and delivery (Brown, Ryser, Gorman, Steinmaus, & Vorst, 2016;
and safety risks at the various stages of the cold chain. At product E Derens-Bertheau, V Osswald, O Laguerre, & G; Alvarez, 2015; Derens,
receiving, “R2 cargo handling time is too long (3.90)” was the most

Fig. 1a. Risk indicators at the product receipt stage.

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J.-Y. Wu and H.-I. Hsiao Food Control 120 (2021) 107501

Fig. 1b. Risk indicators at the storage stage.

Fig. 1c. Risk indicators at the tally or dispatch stage.

Fig. 1d. Risk indicators at the transportation and distribution stage.

Palagos, & Guilpart, 2006; Koseki & Isobe, 2005; Mai et al., 2012;
McKellar, LeBlanc, Lu, & Delaquis, 2012; Tingman, Jian, & Xiaoshuan,
2010), but the findings in this studies indicated that product receiving is
an important risk sources. This step should be controlled because it is at
the start of any food chain operators’ process, and the link between cold
chain parties. The Australian Food & Grocery Council issued Food Cold
Chain Guidelines in 2017, providing instructions for product receipt
operators when receiving chilled or frozen food. For example, the
product receipt operator should identify goods and enter details into the
product receipt operator’s system for stock management, including
batch identification and date markings. The product receipt operator
should check the vehicle for storage hygiene and, in particular, for
damaged packaging or potential contamination from other products (e.
g., household chemicals). Furthermore, the product receipt operator
should note the time that the product leaves refrigerated transport and
the temperature of the actual goods or air temperature (Australian Food
& Grocery Council, 2017). Future research is needed in this area,
particularly concerning temperature control in receiving. We also sug­
gest regulatory authorities should pay special attentions on product
receiving such as temperature recording. Thus, the establishment and
global harmonization of cold chain related laws and regulations, or
manufacturing practices is hence important for future (Mercier et al.,
2017a; Ndraha et al., 2018).
Product damage may result from inappropriate stacking methods (S.
Wang, Tao, Shi, & Wen, 2017). When goods are handled manually or by
using equipment (such as stackers), attention should be paid to the gap

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J.-Y. Wu and H.-I. Hsiao Food Control 120 (2021) 107501

Table 3 generally believes that poor driving conditions (such as traffic jams)
Profile of survey companies (N = 52). have little effect on safety and quality, but the scores in detection are the
Item Number % highest, demonstrating that this risk is more difficult to prevent. Ac­
cording to McKellar et al. (2014), the delivery time and season affect
Employee number <10 1 1.9
11–50 9 17.3 product temperature. For example, long-term retention under the sun
51–100 9 17.3 causes air and food temperatures to rise. To reduce such temperature
101–200 4 7.7 rises, low-temperature logistics operators are recommended to have
201–300 7 13.5 high cooling capacity and thermal insulation function, to regularly
22 42.3
inspect cooling machines, and to maintain the tightness of door seals
>301
Company size (million NTD) <500 1 1.9
501–1000 3 5.8 (SQFI, 2017) or emergency vehicles.
1001–3000 7 13.5
3001–5000 4 7.7
5001–10000 10 19.2 3.2. Case study
>10000 26 50.0
Business category Food processors 15 28.8 - Background of companies
Logistics service provider 27 51.9
Wholesaler 8 15.4
In this study, two food companies were interviewed. Company A was
Importer 2 3.8
a wholesaler for chilled (25%) and frozen (70%) foods such as hot pot
ingredients and barbecue products (number of employees = approxi­
between the vehicle and dock. The Canadian Food Safety Guidelines mately 200). Company B was a food processor of chilled (60%) and
mentioned that food should be stably stacked during dispatch and frozen (10%) food products such as meat and vegetables (number of
should avoid packaging damage and contamination (Canadian Food employees = approximately 50). Company B has license of HACCP and
Inspection Agency, 2010. In addition, Abou et al. (2017) considered that ISO22000.
training and management could be enhanced to improve personnel’s
understanding of transport and handling in such a manner as to reduce - RPN
risks caused by human error.
According to McKellar, LeBlanc, Rodríguez, and Delaquis (2014), Tables 5 and 6 demonstrate case study results for company A and B,
temperatures often rise during dispatch operations. Villeneuve, Bazinet, respectively. The top 5 food quality and safety risks for company A were
and Mercier (2005) also mention that the handling time for loading and “R21 vehicle temperature unconfirmed by driver (120),” “R22 poor
unloading could affect food temperature. Mercier, Villeneuve, Mondor, driving conditions (114),” “R1 uncertain time of product receipt (96),”
and Uysal (2017b) argued that effectively planning and managing times “R2 excessively long cargo handover time (80),” and “R15 excessively
and temperatures for loading and unloading operations is crucial. At long cargo loading time (80).” Company B’s top five risks are “R1 un­
present, recommendations for the loading and unloading processing certainty of receiving time (144),” “R2 excessively long cargo handling
times only specify that low-temperature foods should be loaded and time during receiving of products (126),” “R17 tally temperature abuse
unloaded rapidly (Australian Food & Grocery Council, 2017). Recom­ (72),” “R18 unconfirmed product temperature before loading (72),” and
mendations in Australia and China specify that environmental temper­ “R14 first-in-first-out principle not followed (63).”
atures during loading and unloading should be 15 ◦ C or colder to reduce
the effects on product quality caused by temperature changes (Austra­ - Improvement strategy
lian Food & Grocery Council, 2017).
Moreover, according to the results of this study, most of the industry Most risk factors of company A are related to worker errors, such as

Table 4
FMEA format of surveyed companies.
Occurrence (O) Detection (D) Severity (S) RPNa
b
R1 3.71 ± 1.76 2.81 ± 1.44 4.81 ± 1.90 48.62 ± 37.56
R2 3.90 ± 2.93 2.79 ± 1.33 5.92 ± 1.12 61.40 ± 41.86
R3 3.10 ± 1.47 2.58 ± 1.35 6.17 ± 1.10 51.81 ± 42.06
R4 3.12 ± 1.37 2.75 ± 1.30 6.02 ± 1.10 53.25 ± 40.31
R5 3.08 ± 1.36 2.35 ± 1.00 5.69 ± 1.38 41.67 ± 26.15
R6 2.50 ± 1.45 2.38 ± 1.20 6.10 ± 1.02 37.96 ± 29.42
R7 2.54 ± 1.36 2.40 ± 1.18 5.02 ± 1.69 34.80 ± 32.24
R8 2.58 ± 1.46 2.48 ± 1.33 5.20 ± 1.51 36.08 ± 30.18
R9 2.50 ± 1.62 2.22 ± 1.20 6.24 ± 1.09 38.94 ± 39.03
R10 2.24 ± 1.39 2.14 ± 1.10 6.28 ± 1.00 30.84 ± 24.81
R11 2.86 ± 1.51 2.56 ± 1.27 4.86 ± 1.62 37.82 ± 30.55
R12 2.86 ± 1.52 2.28 ± 1.10 6.14 ± 1.06 40.50 ± 28.48
R13 2.74 ± 1.45 2.48 ± 1.19 5.76 ± 1.12 39.72 ± 27.82
R14 2.78 ± 1.50 2.30 ± 1.08 6.04 ± 1.02 39.80 ± 29.97
R15 3.00 ± 1.47 2.81 ± 1.13 5.96 ± 1.05 46.02 ± 34.47
R16 2.78 ± 1.42 2.43 ± 1.12 5.94 ± 1.14 40.86 ± 28.71
R17 3.00 ± 1.50 2.59 ± 1.17 6.29 ± 0.98 52.43 ± 43.01
R18 3.04 ± 1.49 2.57 ± 1.30 6.00 ± 1.07 50.55 ± 44.16
R19 2.67 ± 1.57 2.35 ± 1.15 6.00 ± 1.16 38.35 ± 31.18
R20 2.22 ± 1.25 2.59 ± 1.14 5.82 ± 1.08 34.04 ± 23.75
R21 2.65 ± 1.39 2.49 ± 1.28 6.12 ± 1.04 44.14 ± 37.86
R22 3.59 ± 1.44 3.02 ± 1.33 4.69 ± 1.62 53.37 ± 38.79
R23 2.79 ± 1.43 2.49 ± 1.11 6.16 ± 1.06 44.45 ± 37.28
R24 2.63 ± 1.29 2.49 ± 1.20 6.00 ± 1.03 40.84 ± 30.79
a
:RPN = O*D*S, RPN = risk priority number.
b
:Mean ± SD, N = 52.

6
J.-Y. Wu and H.-I. Hsiao Food Control 120 (2021) 107501

forgetting to record temperatures and lack of knowledge or training
programs. After discussion with experts in the field, we suggested an
improvement strategy. For instance, to modify education and training, a
temperature recorder may be installed, worker numbers increased, on-
site supervision and management strengthened, and cargo handling
standard operation procedures established. After adopting the
improvement strategy, we reevaluated the scores for the top five food
quality and safety risks (Table 5). We observed that the score for “R21
vehicle temperature unconfirmed by driver” reduced from 120 to 72, for
“R22 poor driving conditions” can be reduced from 114 to 108, for “R1
uncertain product receiving time” reduced from 96 to 60, and for “R2/
R15 excessively long cargo loading and unloading handling times”
reduced from 80 to 64. Thus, the results demonstrated that the
improvement strategy can reduce overall risk level of the cold chain
system.
For company B, the major causes of food quality and safety risks
included poor driving conditions, lack of workers, lack of training pro­
grams, excessive cargo, poor design of the tally area, absence of legal or
company requirement to record product temperature, lack of inventory
management systems, and worker errors. To address the food quality
and safety risks of company B, we suggest strengthening and modifying
existing education training, measuring and recording product temper­
atures before loading, resetting the dock area, and establishing a tem­
perature alarm warning system (Table 6). Because some risk problems
require time and cost to achieve results, such as through measures
related to plant design or warning systems, these risk scores were
evaluated using expectation scores. Improvement strategies can reduce
overall risk level of the cold chain system. In addition, by the end of this
project, company B considered the respective methods simple, easy to
follow, and helpful for managers to quickly identify potential risks and
propose improvement strategies.
Some recommendations can lead to a significant risk reduction in the
studied period, for example, temperature monitoring, measuring and
recording product temperatures before loading or establish a tempera­
ture alarm warning system (Abad et al., 2009; Gogou, Katsaros, Derens,
Alvarez, & Taoukis, 2015; Raab, Petersen, & Kreyenschmidt, 2011).
Cold chain monitoring and temperature information mapping are
important because it is not only address the issue of food spoilage
(Bruckner, Albrecht, Petersen, & Kreyenschmidt, 2012) but also to
address the overarching challenges associate with global food security
(Kim, Aung, Chang, & Makatsoris, 2015). The technology related with
temperature monitoring are for examples, wireless sensing monitoring
technologies including Radio Frequency technologies and WSN or
thermal image etc. (Badia-Melis, Mc Carthy, Ruiz-Garcia, Garcia-Hierro,
& Robla Villalba, 2018). In future it could support the flow of key in­
formation between stakeholders to obtain from a safety and security
perspective (Hsiao & Huang, 2016).
Some recommendations cannot easily reduce risk in the studied
period relatively, for example, training and education, contingency plan
for driving conditions, establish standard operation procedures or
redesign working space. A Contingency Plan enables you to remove risks
to your system posed by outages and disruptions (Taylor, 2013). Not like

Table 5
RPN scores of the top five risks before and after improvement plan for company A.
Top five risk items Failure effect Cause RPN before improvement Action recommended RPN after
improvement

O D S RPNa O D S RPN

R21 Vehicle temperature ‧Temperature rises ‧Drivers’ lack of knowledge‧Drivers’ 4 5 6 120 ‧Establish real- 3 4 6 72
unconfirmed by drivers failure to record temperatures time
temperature
and alarm
system
‧Develop and
improve
training plans
R22 Poor driving conditions ‧Distribution delays ‧Unforeseeable events (car accidents, 6 4 6 140 ‧Establish 6 3 6 108
traffic jams, etc.) contingency
plan
‧Temperature rises ‧Strengthen
communication
and contact
with clients
R1 ‧Temperature rises due to ‧Poor driving conditions 6 4 4 96 ‧Establish 5 3 4 60
delays in tally areas contingency
plan
Uncertainty of product receipt ‧Lack of real-time communication ‧Strengthen
time with suppliers communication
and contact
with suppliers
R2b ‧Temperature rises ‧Lack of labor 5 4 4 80 ‧Increase 4 4 4 64
number of
workers
commensurate
with the
workload
Excessively long cargo handling ‧Distribution delays ‧Lack of knowledge and training ‧Provide
time during receipt of products suitable
supervision
R15 ‧Too much cargo during peak hours ‧Strengthen new
personnel
training and
knowledge
Excessively long cargo loading ‧Establish the
time during tally areas SOP
a
RPN = Risk priority number, RPN = O × D × S, O = Occurrence, D = Detection, S = Severity (for example, RPN of R21 before improvement is 120 = 4 × 5 × 6).
b
R2 and R15 have same RPN scores.

7
J.-Y. Wu and H.-I. Hsiao Food Control 120 (2021) 107501

Table 6
RPN scores of the top five risks before and after improvement plan for company B.
Top five risk items Failure effect Cause RPN before Action recommended RPN after
improvement improvement

O D S RPNa O D S RPN

R1 ‧Temperature rises ‧Poor driving conditions 4 6 6 144 ‧Establish contingency plan 4 3 6 72

Uncertainty of product ‧Delays in subsequent
receipt time processes and schedule
R2 ‧Temperature rises ‧Lack of workers 3 6 7 126 ‧Increase number of workers 2 4 7 56
commensurate with the
workload
Excessively long cargo ‧Delays in subsequent ‧Lack of training programs ‧Develop and improve training
handling time during processes and schedule plans
receipt of products
‧Large cargo volume or handling ‧Establish KPI forms
of differently shaped goods
R17 ‧Temperature rises ‧Poor design of the tally area 4 3 6 72 ‧Redesign space 2 4 6 48
Temperature abuse ‧Product waste ‧Improve working
environment
R18 ‧Temperature rises ‧Recording of product 4 3 6 72 ‧Measure and record product 1 2 6 12
Product temperature temperatures is not required by temperatures before loading
unconfirmed before law or by the company.
loading
R14 ‧Temperature rises ‧Lack of inventory management 3 3 7 63 ‧Control inventory profile 2 2 7 28
system (POS system)
The first-in-first-out principle ‧Product shelf life ‧Worker errors ‧Establish active alarm
for goods is not adhered to expiry
‧Increased food waste
a
RPN = Risk priority number, RPN = O × D × S, O = Occurrence, D = Detection, S = Severity.

proactive mitigation strategies, rerouting contingency plan is a reactive 4. Conclusion

strategies which are taken after disruption occurrences (Parajuli, Kuz­
gunkaya, & Vidyarthi, 2017). A major challenge for this is in having the
desired units of backup production available within a short response
time so as to improve disruption recovery speeds. Response time is
dependent on the manufacturing system structure of a backup produc­
tion facility (Ebrahim Nejad, Niroomand, & Kuzgunkaya, 2014; Tomlin,
2006). Regarding of training and education, studies have showed that
the improvement (enhancement) of the food quality and safety risk
because of training was clearly identifiable (Soares, García-Díez,
Esteves, Oliveira, & Saraiva, 2013). Although food safety related
training is an intricate part of food safety management under food law,
flexibility exists regarding the type of “training” undertaken by food
businesses (e.g. in-house training, external training, online training,
blended learning etc.) (Abdelhakim, Jones, Redmond, Hewedi, & Sea­
man, 2019). Yeung et al. (2019) found that there are some discrepancies
in knowledge increase between online and in-person workshops.
Furthermore, they suggested food business should accurately evaluate
the effectiveness for food safety education and training. This is because
the methods to measure actual behavior are sometimes invasive and
costly. Research to lower the cost for measuring actual behavior will
further allow researchers to report actual behavior instead of
self-reported behavior.
Our results demonstrated that the top five food quality and safety
risks included the product receipt step, involved three risks (long cargo
handling time, temperature abuse, and product damage), followed by
the dispatch (temperature abuse), and delivery (poor driving condi­
tions). The case study suggested that food quality and safety risks were
effectively reduced after adopting an improvement plan. Suggested
improvement plans include, for example, training workers, recording
product receipt temperatures, establishing real-time temperature and
alarm systems. Overall, by analyzing food quality and safety risks in the
food cold chain, firms can use ex ante preventive measures to reduce
expost remedies and losses.
CRediT authorship contribution statement
Jhao-Yi Wu: Conceptualization, Methodology. Hsin-I Hsiao: Su­
pervision, Writing - review & editing.
Declaration of competing interest
The authors declare that there is no conflict of interest.

Appendix A. Supplementary data

3.3. Limitations and further research

Supplementary data to this article can be found online at https://doi.

This research provides a detailed examination of the food quality and
safety risk diagnosis for the food cold chain but is limited in several
respects that might be addressed in future research. First, the number of
firms processing and distributing chilled or frozen food was low,
meaning that the overall population for mailing was low. We thus
encourage further research in other countries to examine food quality
and safety risks in the food cold chain. Second, this research tested only
major process in the food cold chain. Product receiving, storage,
dispatch, and delivery were four major steps for food quality and safety
risk diagnosis in this study. The subprocesses were neglected due to
complications and numerous details requiring consideration (Jong, Tay,
& Lim, 2014, pp. 165–176). We encourage more research considering
subprocesses for analyzing food quality and safety risks in more detail.
org/10.1016/j.foodcont.2020.107501.
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