Food Control 111 (2020) 107071

Contents lists available at ScienceDirect

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

Study on the risks of metal detection in food solid seasoning powder and T
liquid sauce to meet the core concepts of ISO 22000:2018 based on the
Taiwanese experience
Hsinjung Chena,b, Bo-Kang Lioua, Fan-Jhen Daib, Pei-Ting Chuangc,∗, Chin-Shuh Chenb,∗∗
a
Department of Food Science and Technology, Central Taiwan University of Sciences and Technology, Taichung City, 40601, Taiwan, ROC
b
Department of Food Science and Biotechnology, National Chung Hsing University, Taichung City, 40227, Taiwan, ROC
c
Institute of Food Safety and Risk Management, National Taiwan Ocean University, Keelung City, 20224, Taiwan, ROC

ARTICLE INFO ABSTRACT

Keywords: Foreign objects in food threaten food safety. For the food industry, incidents involving these objects can tarnish a
Hazard analysis and critical control point company's reputation, reduce sales, and may even lead to customer distrust towards the company. There have
(HACCP) been no studies to correctly establish an operational prerequisite program (OPRP) and hazard analysis and
Acceptance critical control points (HACCP) plan in the premixed powder and liquid sauces of the small and medium-sized
ISO 22000
food enterprises (SMFEs) industry according to the ISO 22000: 2018 standard. Our research aims to propose an
Operational prerequisite program (OPRP)
ISO 22000: 2018 method for risk assessment and control of hazard assessments, and to establish and implement
HACCP and traceability systems. In this study, the solid premixed powder (Italian panna cotta powder) and
liquid sauce (white sauce) products were taken as an example. The food safety standard management system
(FSMS) ISO 22000: 2018 was introduced to investigate the influence of the metal detector on the process. The
proposed methodology combines risk analysis to identify physical significant hazards and then combines deci-
sion trees to determine hazard analysis control points (CCPs). It can be found from the research that the metal
detector is extremely important and effective for the control damage of the solid premix powder, and the metal
detector has a supplementary effect on the liquid sauce because of its complicated composition. These significant
hazards can be managed through the HACCP program and OPRP. After the implementation of the ISO 22000:
2018 standard, the number of abnormal processes has been significantly reduced, and the number of complaints
has been significantly reduced.

1. Introduction death (European commission, 2015). In all foreign materials with

The hazards in food are classified into biological, chemical and
physical. Among them, the problem of residue in food has always been
a project of the food industry (European commission, 2015; Zhao,
Jiang, Basir, & Mittal, 2004). In many food safety cases, the range of
foreign objects is very diverse, such as hair, insects, glass, metal, etc.,
often the largest source of customer complaints received by many food
manufacturers, retailers or law enforcement agencies (Edwards &
Stringer, 2007; Ok, Kim, Chun, & Choi, 2014). Depending on the type,
size and structure, foreign materials can cause damage to the throat and
mouth, damage to the digestive tissue, suffocation, swallowing pain,
tooth damage, internal bleeding, throat discomfort and reflux, and
physical hazards, the hazard of metal is serious, which will greatly re-
duce the safety of food (Trafialek, Kaczmarek, & Kolanowski, 2016).
Metal objects pose a great risk of perforation of gastrointestinal tissues
and require surgical resection. In addition, these metal fragments can
damage valuable machines and cause the production line to shut down,
causing significant economic losses. Some reasons why food manu-
facturers consider metal detectors are: product safety, equipment pro-
tection, contract (customer) requirements, regulatory compliance etc.
Among these reasons, the Federal Register (Vol. 51, No. 118) also
mentioned: “Effective measures should be taken to prevent the in-
corporation of metals or other foreign substances into food. This re-
quirement can be met by using screens, traps, electronic metal detectors

∗
Corresponding author. Institute of Food Safety and Risk Management, National Taiwan Ocean University, No. 2, Beining Rd., Zhongzheng Dist., Keelung City,
20224, Taiwan, ROC.
∗∗
Corresponding author. Department of Food Science and Biotechnology, National Chung Hsing University, No. 145, Xingda Rd., South Dist., Taichung City,
40227, Taiwan, ROC.
E-mail addresses: tpsf103@gmail.com (H. Chen), ptchuang@mail.ntou.edu.tw (P.-T. Chuang), cschen@mail.nchu.edu.tw (C.-S. Chen).

https://doi.org/10.1016/j.foodcont.2019.107071
Received 20 September 2019; Received in revised form 18 December 2019; Accepted 18 December 2019
Available online 19 December 2019
0956-7135/ © 2019 Published by Elsevier Ltd.
H. Chen, et al. Food Control 111 (2020) 107071

Table 1
Possible physical (metal) significant hazard scores for each process step.
Hazard Severity Probability Weighted Score Limits

m IDL

Physical Hazards FE ≤ 1.8 mm CU ≤ 1.8 mm SS ≤ 1.8 mm

Foreign bodies (metal)

*: Instrument detection limit, IDL.

or suitable methods. Metal detectors cannot guarantee that the food
must be free of metal, but the design is reasonable, the equipment for
installation and maintenance, and the metal pollution control program
can be effectively controlled”.
At present, the inspection of metallic foreign matter in food can be
performed by using a metal detector to detect metal foreign materials.
The metal detector is of great help to the food industry. It can screen out
metal foreign objects and avoid metal residue in food which would
cause harm to human body (Graves, Smith, & Batchelor, 1998; He &
Yoshizawa, 2002). Most metal detectors use a balanced three-coil
system to detect small and non-ferrous metals in stainless steel. When a
metal particle is passed through the coil of a metal detector, the high
frequency field is disturbed under one coil, and the voltage is changed
by a few microvolts. The detection of this change is the principle
(Bowser, 2003). Other very complex detection methods can be pulsed
terahertz spectroscopy or more sophisticated X-ray inspection instru-
ments. The advantage is that in addition to metal, glass, high-density
plastics and calcified bones can be detected, and the application is more
extensive, but there are still difficulties in detecting foreign objects,
such as paper, hair, etc. when buried.
However, mainly because of the high price of its precision instru-
ments, it is still difficult to use in the production line of the Small and
Medium Enterprises (SMEs), which accounts for a very high proportion
in the world. Currently, metal detectors commonly used can be divided
into two types: magnetic and electromagnetic waves. The magnetic
method is mainly for iron, and the electromagnetic wave method is
applied to all metals (such as iron, non-ferrous metals etc.), and its
detection. Sensitivity is affected by foreign metal objects and sur-
rounding media (Choi, 2018). The principle of the electromagnetic
metal detector is that when the product contains metal foreign matter
enters the sensing channel of the metal detector, it will affect the
electromagnetic field. The center coil is connected to the high fre-
quency radio transmitter, and the coils on both sides of the transmitter
coil are receivers. Since the two coils are identical and the same dis-
tance from the transmitter, they receive the same signal and produce
the same output voltage. When the coils are connected in opposite di-
rections, the output is cancelled, resulting in a zero value. When the
metal particles pass through the coil of the metal detector, the high
frequency field is disturbed under one coil, the voltage is changed by a
few microvolt, the equilibrium state is lost, and the coil output is no
longer zero. This phenomenon is used to detect the metal. Further
warning of the discovery of metallic foreign bodies, but in the mixture
of foods more or less contain conductive metal elements, such as so-
dium ions, iron ions, electrolytes, moisture content and product thick-
ness, etc., will interfere with electromagnetic metal detectors accuracy.
In addition, the size of the detector sensing channel, the shape and

Table 2
Organizational risk assessment judgment scale.
(a) Risk impact severity rating scale

Grade Impact severity Organizational image People Civil resistance

5 Critical
4 High
3 Medium
2 Low
1 Negligible
International news media reports negative Death of personnel Massive march
news
Taiwan news media reported negative news Serious injury To the central authorities
Regional news media reports negative news Minor injuries To the local authorities
none Rarely causes serious illness and usually has prevention Many people or groups
and treatment
none Does not cause illness in healthy adults Individual or single group
complaints

(b) Risk probability scale

Grade Possibility (frequency) Influence level

5 Frequent (daily) Serious (death)

4 Possible (weekly) High (hospital/disease)
3 Occasionally (monthly) Medium (absence)
2 Unlikely (annual) Low (complaint/economic loss)
1 Very unlikely (not yet observed) Negligible (almost no effect)

(c) The impact and severity of hazard

Hazard Impact/Severity Critical 5 5 10 15 20 25

High 4 4 8 12 16 20
Medium 3 3 6 9 12 15
Low 2 2 4 6 8 10
Negligible 1 1 2 3 4 5

1 2 3 4 5
Very Unlikely Unlikely Occasional Likely Frequent
Hazard Occurrence/Probability

2
H. Chen, et al. Food Control 111 (2020) 107071

1.1 main raw 1.2 Secondary raw material 1.3. Package

materials: acceptance: acceptance
Onion, garlic Seasoning (Acetylated distarch (printing,
adipate, carrageenan, vanilla appearance)
powder, spices, sugar)

2.1 Storage at room temperature (warehouse 2.2. Packaging material

management 25 ° C, 65% RH or less) storage (warehouse
management 25 ° C, 65%
RH or less)

3. Mixing (magnet bar *2)

4. Filling package *
CCP2-B

5. Metal detection *
(Within Fe-1.8 Cu-1.8 SUS-1.8mm)
CCP3-P

6. Finished product storage

(Warehouse management
25 ° C, 65% RH below
normal temperature) OPRP
CCP*

7. Transportation
(normal temperature)

Fig. 1. Flow chart of solid premixed powder (Italian cheese powder).

material of the metal foreign object, the temperature of the product, the
angle and position of the product entering the channel, etc., also affect
the accuracy of the metal detector. Based on our experience, the sen-
sitivity of a metal detector is influenced by the following factors: pro-
duct composition (the presence of salt and iron in the product may
cause the detector to produce false responses), product characteristics
(the product's viscosity may influence the detection results), product
temperature (a product temperature that is higher than room tem-
perature may cause detection errors), and packaging material (metal
packaging may lead to abnormal detections).
On June 19, 2018, International Organization for Standardization
(ISO) announced the requirements of the revised version of ISO 22000.
Pay more attention to risk-oriented thinking, integrate the concept of
risk assessment into the original ISO 22000 system, and enhance the
participation and commitment of the highest management in for-
mulating, implementing and communicating food safety policies. And
more emphasis on the plan do check act (PDCA) cycle, and a clearer
definition of critical control points (CCPs), operational prerequisite
programs (OPRPs) and prerequisite programs (PRPs). Risk managers
should understand the public's focus on food safety, as this must be the
basis of a risk management strategy (Frewer, 2004). Risk management
and risk communication are good tools for food safety and can be used

3
H. Chen, et al. Food Control 111 (2020) 107071

1.2 raw materials acceptance:

1.3. Packaging inspection
1.1 main raw materials: Seasoning (Ethyl adipic acid
(printing, appearance)
diamyl starch, caramel color (first
Onion, garlic acceptance*
type caramel), soy sauce, soybean
oil, rock salt, beef powder, black
pepper powder, bacon)

2.1 Refrigerated storage

(Warehouse management
2.2 Storage at room 2.3 Packaging material
below 7 °C)
temperature (Warehouse
management 25 ° C, 65% RH storage (warehouse
or less) management 25 ° C,
3. Cleaning 65% RH or less)

4.Cutting

5. Cooking (central temperature 95 ° C, 10 minutes) *

CCP2-B

6. Filling package *
CCP3-B

7. Metal detection *
(Within Fe-1.8 Cu-1.8 SUS-1.8mm)

8. Finished product storage

CCP* OPRP
°C)

9. Shipping (freezing below

-18 ° C)

Fig. 2. Flow chart of liquid sauce (white sauce) manufacturing.

in many food processing companies (Trafialek et al., 2016). Process
prevention controls play an important role in the facility's food safety
program because they are considered critical to food safety (Kottapalli
& Ledenbach, 2018). Article 8.2 of ISO 22000: 2018 emphasizes that
after the hazard analysis, the prerequisite program (PRP) should be
designed and established, and the new PRP design and establishment
should be made because Global Food Safety Initiative (GFSI) does not
currently recognize ISO 22000 as a reference standard for food manu-
facturers because there is not enough detailed information about the
PRP, and the new version has been reinforced (Pop, Dracea, &
Vlădulescu, 2018). Contains compliance with the Codex Committee's
Hazard Analysis and Critical Control Points (Codex HACCP), this is a
food safety management system (Al-Kandari and Jukes, 2011), a global
guideline for controlling food safety hazards in the international food
safety community (Kafetzopoulos, Psomas, & Kafetzopoulos, 2013). The
HACCP/Food Safety Program is the basic document for each structured
food safety management system (FSMS) (Dzwolak, 2019). Emphasis on
process control rather than final product control, it centralizes the
systematic approach to hazard identification, assessment and control in
the steps that are critical to consumer health in the processing system
(Arvanitoyannis and Tzouros, 2006; Ropkins and Beck, 2000). While
HACCP is a key element of modern food safety management practices,
designing, implementing, controlling and managing HACCP systems is
critical to the production of food safety (Wallace, Holyoak, Powell, &
Dykes, 2014). Some studies have also pointed out that enterprises
which have been verified by ISO 22000 have better HACCP than those
that hasn't been verified. (Psomas & Kafetzopoulos, 2015).
Food companies have made large-scale investments in processing
machinery and inspection equipment, so as to ensure the high quality of
their products. Despite the utilization of advanced technologies and
processes, food contamination still occurs from time to time (Ginesu,
Giusto, Margner, & Meinlschmidt, 2004). Therefore, the implementa-
tion of ISO 22000 is crucial for reducing food safety hazards (Chen, Liu,
Chen, Chen, Yang, & Chen, 2019). In different cultural contexts, the

4
 H. Chen, et al.

Table 3
Metallic hazard analysis worksheet for solid premix (Greek cheese powder).
Processing/steps Potential safety Risk assessment and risk This potential hazard Reason for determining the left column Significant hazard prevention measures CCP/
hazard (P:Physical) control SxP + W significantly affects product OPRP//CP/
weighting (points) safety (YES/NO) NO

1.1 Acceptance of main raw materials - Code S1 15 (5x4-5) YES Not covered properly, causing foreign 1. Use a vendor that has been verified by a third party. OPRP
creamer Physical (Metal matter to enter. 2. Subsequent screening and metal detection steps can
foreign matter) be removed.
1.2 raw materials acceptance - sugar, Code S2 Physical 15 (5x4-5) YES When the raw materials are stored, the 1. Purchase raw materials and food additives that meet CP
carrageenan, vanilla powder, (Metal foreign foreign matter is mixed because the hygienic practices from qualified suppliers.
acetylated adipic acid di starch, matter) package is damaged or not covered 2. The supporting documents are provided by the
spices. properly. supplier, and the validity of the quality assurance
certificate and the proportion of each batch of
ingredients are in compliance with the specifications.
1.3. Manage and partition storage according to the
procurement acceptance criteria.
2.4. If any of the unqualified persons are found, they
will be rejected or returned immediately
3. Screening can be removed.
1.3 Package acceptance Code S8 Physical 5 (5x2-5) NO If there is a metal foreign object in it, it 1. Use qualified suppliers. CP
(Metal foreign is impossible to do the subsequent 2. The original material acceptance standard
matter) packaging action. procedure is set and accepted according to the
standard.

5
3. Visually remove when using.
2.1 Storage at room temperature Code S3 Physical 5 (5x2-5) NO When the raw materials are stored, the According to the “Warehouse Control Standard CP
(Metal foreign foreign matter is mixed due to the Operating Procedures”, the items in the library must
matter) damaged or uncoated package. be properly covered.
2.2 Packaging material storage Code L9 Physical NO No related hazard introduction NO
(無)
3 Mixing Code S4 (Metal 15 (5x4-5) YES 1. Foreign matter is mixed in the work. 1. Confirm the integrity of the mechanical equipment OPRP
foreign matter)ign 2 The tool or part of the mechanical before and after use.
matter equipment is broken and mixed. 2. Regular maintenance of mechanical equipment in
accordance with standard operating procedures and
avoiding foreign matter ingress.
3. Subsequent magnetic rod and metal detection steps
can eliminate metal foreign objects.
4. Filling package Code S6 Physical 20 (5 × 3+5) NO Metal foreign matter 1. Filling operations are performed according to YES(CCP2)
(Metal foreign standard operating procedures.
matter) 2. The personnel can be operated after the dress is
completely inspected by the supervisor.
5. Metal detection Code S5 Physical 25 (5 × 4+5) YES Inadvertent ingestion of metal foreign 1. The products are all passed through metal detectors. YES(CCP3)
(Metal foreign objects can cause harm to the human 2. Metal detector testing before daily operation and
matter) body. during operation (hourly), (FE 1.8 mm、CU 1.8 mm、
SS304 1.8 mm)。
3. Metal detectors are regularly maintained.
6. Final product storage (normal Code S9 Physical No related hazard introduction NO
temperature) (NO)
7. Shipping (normal temperature) Code S10 Physical No related hazard introduction NO
(NO)
Food Control 111 (2020) 107071
 Table 4
Metallic hazard analysis worksheet for liquid sauce (white sauce).
Processing/steps Potential safety Risk assessment and This potential hazard Reason for determining the left column Significant hazard prevention measures CCP/
H. Chen, et al.

hazard (P:Physical) risk control SxP + W significantly affects OPRP//CP/

weighting (points) product safety (YES/NO) NO

1.1 Main raw material: onion, garlic acceptance
1.2 By-products: water, soybean oil, beef powder,
bacon, soy sauce, black pepper, rock salt.
Food Additives: Acetyldipic acid diamyl
starch, caramel color (first caramel color)
acceptance
1.3 Package acceptance
1.3 Refrigerated storage
Code L1 10 (5x3-5) NO Insufficient metal materials in the supplier's 1. Use qualified suppliers. CP
Physical (Metal raw materials and packaging 2. Visual inspection is performed in accordance
foreign matter) with standard operating procedures, and
subsequent cleaning and cutting steps can be
eliminated.
Code L5 Physical 15 (5x4-5) YES In the production process of the manufacturer, 1. Purchase quality-compliant raw materials OPRP
(Metal foreign the supplier is improperly stored or the package and food additives from qualified suppliers.
matter) is damaged, causing foreign matter to enter, 1. The supporting documents are provided by
which may cause harm to consumers. the supplier, and the validity of the quality
assurance certificate and the proportion of each
batch of ingredients are in compliance with the
specifications.
2. Managed and partitioned according to the
procurement acceptance criteria.
3. If it is found to be unqualified, it will be
rejected immediately or returned.
4. Screening can be removed.
Code S8 Physical 5 (5x2-5) NO If there is a metal foreign object in it, it is 1. Use qualified suppliers. CP
(Metal foreign impossible to do the subsequent packaging 2. The original material acceptance standard
matter) action. procedure is set and accepted according to the
standard.
3. Visually remove when using.
Code L2 Physical 5 (5x2-5) NO When the raw materials are stored, the foreign According to the “Warehouse Regulation CP

6
(Metal foreign matter is mixed due to the damaged or Standard Operating Procedures”, the contents
matter) uncoated package. of the library should be properly covered.
2.2 Storage at room temperature Code L6 Physical 5 (5x2-5) NO When the raw materials are stored, the foreign Managed according to the “Warehouse Control CP
(Metal foreign matter is mixed due to the damaged or Standard Operating Procedures”.
matter) uncoated package.
3. Cleaning Code L3 Physical 5 (5x2-5) NO Fruit and vegetable cleaning is not complete, Wash vegetables to remove foreign matter CP
(Metal foreign causing metal foreign matter to remain, which according to standard operating procedures.
matter) will cause harm to consumers.
1. Cut Code L4 Physical 10 (5x3-5) NO 1. Foreign matter is mixed in the work. 1. Confirm the integrity of the mechanical CP
(Metal foreign 2. The tool or part of the mechanical equipment equipment before and after use.
matter) is broken and mixed. 2. Regular maintenance of mechanical
equipment in accordance with standard
operating procedures and avoiding foreign
matter ingress.
1. Visually inspect and eliminate it.
5. Cooking Code L7 Physical 15 (5x4-5) YES Foreign matter is mixed in due to improper 1. Visual exclusion. CP
(Metal foreign operation. 2. The staff is dressed completely.
matter)
6. Filling package Code L10 Physical 10 (5x3-5) NO Metal foreign matter is mixed in the work. 1. Confirm the integrity of the mechanical CP
(Metal foreign equipment before and after use.
matter) 2. Regular maintenance of mechanical
equipment in accordance with standard
operating procedures and avoiding foreign
matter ingress.
3. Visually inspect and eliminate it.
(continued on next page)
Food Control 111 (2020) 107071
H. Chen, et al. Food Control 111 (2020) 107071

consumption of condiments and seasonings happens frequently and on

OPRP//CP/

YES (CCP4)
a large scale (de Mejia, Aguilera-Gutí errez, Martin-Cabrejas, & Mejia,
2015). Certain ingredients of condiments and seasonings may be
CCP/

NO

NO

NO
sourced from plants. The traditional processing of these plant-based
ingredients may pose hygiene and safety problems. Condiments and
2. Metal detector test (control Fe: 1.8 mm, Cu: seasonings that contain such plant-based ingredients pose a safety risk

3. Metal detectors are regularly maintained.

1.8 mm, SS304: 1.8 mm) before and during
1. Metal foreign matter mixing process can

to customers (Engle-Stone, Ndjebayi, Nankap, & Brown, 2012;

Significant hazard prevention measures

Schweiggert, Carle, & Schieber, 2007). Thus, this study focuses on the
metal hazards that may be present in condiments and seasonings. There
cause harm to the human body.

is currently very little information on how to implement the ISO 22000,

2018 food safety management system in this industry. This study pro-
poses methodologies to conduct identify significant hazards, risk as-
daily work (hourly).

sessment and control measures in order to properly establish ISO22000:

2018 HACCP plans in this industry, and explore the application of metal
detectors for solid premixed powder and liquid sauce in the manu-
facturing process. This case follows Chapter 8 of ISO 22000: 2018 and
develops a HACCP plan based on the seven principles of the Codex
Alimentarius Commission. Although ISO 22000: 2018 does not man-
date that the decision tree should be used to determine the CCP, the
Metal foreign matter mixing process can cause

decision tree method is still well-organized, with contexts and a visual

and easy-to-understand method for determining the CCP's hazard ana-
Reason for determining the left column

lysis. Therefore, this study proposes a procedure for significant hazard

analysis related to the prerequisite program and a new methodology for
No related hazard introduction

No related hazard introduction

using the CCP decision tree.

harm to the human body.

2. Research and methods

2.1. Company description and scope

The study is about a small and medium-sized enterprises in central

Taiwan that serves restaurants from a large chain food group in the
world and in Taiwan (with more than 20 brands). The company was
product safety (YES/NO)

founded in 2007. The main products are divided into two categories:
This potential hazard

solid ready-mixed powder and liquid sauce, more than 20 kinds of

significantly affects

products. The ISO 22000: 2005 standard has been fully implemented on
all production lines in 2016. In 2018, a new metal detector was pur-
chased. This study introduced the ISO 22000: 2018 standard into op-
eration. The metal detector was designed and manufactured by
YES

Compunic Electronics Co., Ltd. (a Taiwanese company with research

and development capabilities) in accordance with the products' char-
risk control SxP + W
Risk assessment and

acteristics and on-site application needs. The detector meets the com-
weighting (points)

pany's needs with respect to its use of solid seasoning powder and liquid
25 (5 × 4+5)

sauce.

2.2. Methodology
hazard (P:Physical)

2.2.1. Study stages

Code L11 Physical

Code L13 Physical

Code L14 Physical

This research product which each step in the process of solid premix
Potential safety

(Metal foreign

(S) and liquid sauce (L). The solid premix (S) of this research product
was code S1 (acceptance of the main raw material), code S2 (accep-
matter)

(NO)

(NO)

tance of by-products), code S3 (raw material storage), code S4 (mixed),

code S6 (package acceptance), code S7 (package storage), code S8 (fill
the package), code S5 (metal detection), code S9 (final product storage
(normal temperature)), code S10 (shipping (normal temperature)). The
liquid sauce (L) of this research product was code L1 (accept the main
raw material), code L2 (store (refrigerated)), code L3 (cleaning), code
L4 (cut), code L5 (auxiliary material acceptance), code L6 (storage),
code L7 (cooking), code L8 (package acceptance), code L9 package
storage), code L10 (fill the package), code L11 (cooled), code L13 (final
product storage (frozen)), code L14 (shipping (frozen)). The physical
Table 4 (continued)

(metal) significant hazard level table in each process step is shown in

7. Metal detection

9. Frozen delivery
8. Frozen storage
Processing/steps

Table 1.

2.2.2. Establish a food safety team

The company consists of a multidisciplinary team of five people to
implement the requirements of the system. Members of the team have

7
 H. Chen, et al.

Table 5
HACCP plan for solid seasoning powder (Italian cheese powder) and liquid sauce (Italian pasta sauce).
Processing/steps Safety hazard Control limits monitor Corrective action Record Verification
(CCPx-B、-C、- Specificization
P/) Project Method Frequency Operator Responsible Method Frequency
person

CCP3–P. (metal Metal substance The metal detector is set to a Metal Metal Before Quality 1. Check if the utensils Metal inspection Quality Control View the metal Every time
detection) Incorporation standard of FE ≦ 1.8 mm, foreign detector starting and control are clean and complete machine test record, Officer, Product inspection test record (days)
CU ≦ 1.8 mm, body every hour personnel, before packaging defect tracking Research form and record it in the
SS304 ≦ 1.8 mm, cannot be field operators 2. Check if the utensils improvement or Supervisor manufacturing process
detected when the final are clean and complete exception handling quality control record
product passes before packaging (1) record form
Field operators need to
manage exceptions.
(2) The quality control
must identify the cause
of metal foreign matter
mixing and prevent
recurrence.

8
3. Metal detector
abnormality: (1)
Immediately stop
production line
production and notify
maintenance
personnel.
(2) The quality control
shall isolate all
products produced
during the failure of the
detector.
(3) The maintenance
personnel restore the
detector to normal
function.
(4) Fill in the abnormal
record.
(5) The operator re-
examines the products
produced by the
inspection machine at
the time of failure.
Food Control 111 (2020) 107071
H. Chen, et al. Food Control 111 (2020) 107071

process anomalies

customer complaints

June 2017 May 2018

Fig. 3. Comparison of the customer complaints and process anomalies from June 2017 to May 2018 in the process before and after ISO22000: 2018.

2.2.3. Methodology for risk analysis and hazard assessment

Fig. 4. Comparison of the sources of abnormalities detected by the gold in-
spection machine in the process before and after ISO22000: 2018.
the expertise of the HACCP system, the ISO 22000: 2018 standard lead
auditor and the Prevention Control Qualified Individual (PCQI). The
food safety team consists of the legal representative of the food business
or the staff designated by him, and the professional with vocational
certification, quality assurance personnel, production personnel, sani-
tation control department personnel.
The new methodology of this study identifies significant hazards
using the probability and severity of occurrence and weighted scoring.
The hazard shall be subjected to risk analysis and hazard assessment
according to the probability and severity of occurrence and the classi-
fication system shall be adopted. The principles are shown in Table 2.
Identify significant hazards.
This study uses the five-point system (5 × 5) of Table 2, and then
weighted evaluation items: the hazardous events that have occurred in
the company (plus 5 points), and the items that should be monitored by
the supervisory authority (plus 5 points). And minus 5 points is that
there are still other steps after the processing step to exclude or reduce
the damage to an acceptable level. This is combined with the fourth Q1-
Q4 in the CCP decision tree. If it is due to negligence or limited orga-
nization equipment or cost considerations, the hazard to an acceptable
level can be eliminated or reduced by subsequent processing steps (Q4),
without causing harm to the final product. Significant hazards are de-
termined by a member of the competent food safety control team (who
hires an expert if necessary – citing ISO 22000, 2018) to determine the
score and combine the CCP decision tree.
According to the risk assessment after the score value ≥ 15 is de-
termined as a significant hazard, the score value < 15 is a non-sig-
nificant hazard, of which 1–5 is almost impossible to occur, so just deal
with customer complaints or emergency response. In addition, it should
be noted that when the severity determination level is the fifth level, it

Table 6
Analysis of the number of defective metals (rates) for all solid powder products and liquid sauce products in ISO 22000:2018.
lot number Solid powder product metal test sampling record Liquid test product metal test sampling record

1 2 3 1 2 3

Number of samples (n) 150 151 145 80 100 88

Adverse number (d) 1 0 0 2 1 0
NPL ratio (p) 0.0070 0.0000 0.0000 0.0025 0.0010 0.0000

9
H. Chen, et al.
is also determined to be a significant hazard. After being determined as
a significant hazard, the CCP decision tree is combined with CCP or
OPRP. The principle of judging the CCP point is as follows:
1. This step eliminates or reduces the hazard to an acceptable level.
2. The subsequent steps should not reduce the hazard to an acceptable
level.
3. In the risk assessment project, the severity is five.
As long as the above three points are met, it is decided to control the
CCP point, and the rest are monitored as OPRP and CP.
3. Results and discussion
3.1. Production and process control flow chart
This study confirmed the production and process control flow chart
in Fig. 1 and Fig. 2 for the preparation of solid premixed powder (italian
cheese powder) and liquid sauce (white sauce).
3.2. Identify significant hazards and establish CCP and operational
prerequisite programs (OPRPs)
The metal significant hazards of each processing step in the two
process cases were identified and graded, and CCP and OPRPs were
distinguished. PRP is officially known as the Support Program, pro-
viding the basis for HACCP's overall food safety management program
(da Cruz, Cenci, & Maia, 2006). Prerequisite programs are written,
implemented procedures, to address operational prerequisites, and to
provide documentation to help operate more smoothly and maintain a
comprehensive food safety program. The core of any prerequisite pro-
gram is SOP, and SOP is a written for describing the sequence of specific
events necessary to perform a task. They represent the conditions and
basic activities for providing a hygienic environment for the produc-
tion, processing and provision of safe final products in the food pro-
cessing process (Gaaloul, Riabi, & Ghorbel, 2011; ISO 22000: 2005).
The organization's prerequisite programs usually are transportation and
storage, supplier management and product handling, equipment
maintenance, cleaning, cleaning and disinfection, and personnel hy-
giene management. These programs are validated against a well-de-
fined frequency.
The score given by the metal hazard is described. During the pro-
duction process, the appliance may be damaged or the personnel may
accidently drop the metal foreign matter into the pot. The way to
control the hazard is to continuously monitor by the metal detector
after packaging to ensure no metal foreign matter remains. For the flow
chart Figs. 1 and 2, establish the hazard analysis Worksheet Table 3 and
Table 4, Hazard Analysis Worksheet - ISO 22000:2018 Sections 8.5.1.5,
8.5.2 and 8.5.3 and comply with CODEX HACCP Application step 4–6,
each process step in the two process cases is a hazard analysis and as-
sessment of crop rationality, listing all potential hazards and their
scores, and then determining whether it is a significant hazard, and
determining the cause of the significant hazard and the preventive
control measures. Each processing step is judged to be CCP or OPRP or
CP or NO, as a follow-up control measure with different monitoring
intensity (Table 5).
3.3. Establishing a HACCP plan
The HACCP plan contains the following information: Identify
Critical Control Points (CCPs), control measures, identify critical limits,
monitoring procedures, corrective actions, responsibilities, and mon-
itoring records. After the control measures are evaluated according to
the above, the “metal detection” step is determined by the important
control point CCP3–P, as shown in Figs. 1 and 2.
10
Food Control 111 (2020) 107071
- Control measures: continuous monitoring with metal detectors.
- Critical limitation: The metal detector setting standard is FE 1.8 mm,
CU 1.8 mm, SS304 1.8 mm, and the final product must not be de-
tected.
- Monitoring procedures: before starting and every hour during the
process, do recording in the metal inspection test record form, and
corrected and confirmed by quality control personnel.
- Corrective measures: Field operators need to manage abnormal
products, and quality control personnel must find out the cause of
metal foreign matter mixing and prevent recurrence.
- Responsibilities: The production department is responsible for the
production of packaging and records. The quality control depart-
ment is responsible for handling the problematic product.
- Monitoring records: production process records and non-con-
formance reports.
3.4. Verification
3.4.1. Analysis of solid seasoning powder and liquid seasoning products for
the whole organization
This study is the implementation of ISO 22000:2005 customer
complaints and process anomalies from June 2017 to May 2018.
Compared with ISO 22000:2018 from June 2018 to May 2019, the
results are shown in Fig. 3. During the period before the implementa-
tion of the company, there were 6 customer complaint cases, and the
process abnormality occurred 12 times (raw materials, production ab-
normalities, packaging abnormalities). The comparison of the sources
of abnormalities detected by the metal detector in the process is shown
in Fig. 4. However, during the period after the implementation of the
ISO 22000:2018 standard, the customer complaint handling has been
improved to one piece and the process abnormality is 4 pieces, and the
source of the abnormality detected by the metal detector in the process
has been reduced from 4 pieces to 1 piece, which are obviously effec-
tive. Reduce the number of occurrences. And as can be seen from Fig. 3,
there is a significant improvement in the abnormal analysis of the
process, the raw materials, the abnormal production process and the
abnormal packaging.
The results of this study are consistent with the results of Psomas
and Kafetzopoulos (2015), which is an effective use of HACCP princi-
ples. Kottapalli and Ledenbach (2018) also noted that CCP/OPRP must
be monitored periodically to determine if the process is operating
within critical/operating limits. At the same time, the company
changed the annual management review meeting to semi-annual in
order to implement the PDCA cycle at the management level. This
change corresponds to the internal management of the company and
the regular management review meeting, as well as the prior risk
management evaluation process, to accelerate the resolution of ab-
normal situations encountered in production. Corresponding to the
management outside the company, it can be seen from Fig. 4 that the
proportion of customer complaints has also decreased. This is because,
in addition to supplier management, more emphasis is placed on cus-
tomer opinions. Monthly customer satisfaction surveys are used to
conduct product satisfaction surveys to confirm that product quality
can be accepted by customers and reduce risks other than company
expectations.
3.4.2. Analysis of the number of defective detection (rate) of metal detectors
for solid whole seasoning powder and liquid seasoning products
After the implementation of ISO22000: 2018 for various products,
the solid powder metal test and the liquid sauce metal test as shown in
Table 6 all found that the defect rate has a significant downward trend.
Among the solid powder products, it is unexpectedly found and worth
mentioning the quality (including metal) of the plastic baskets used. In
addition, because the packaging materials are not in direct contact with
food, there is no doubt about food safety. Therefore, small and medium-
sized food enterprises often use price as the main purchasing basis for
H. Chen, et al.
cost-saving procurement. In order to avoid the misjudgment or the
cause of the abnormality cannot be solved, the constant abnormal
warning in the process caused the staff to often close the metal detector,
and finally lost the product to detect the metal crisis. With this study,
the outer packaging material can be changed to a metal basket that
meets the standard metal composition. The metal detector can be set
after packaging the inner package and before the plastic basket is
packaged. In the preparation of sauces, the metal detectors used are the
same as the powders, and they are also electromagnetic metal detectors.
The test records are as described in Table 6. For example, white
sauce used in Italian noodles contains milk, whipped cream, salt, garlic,
onion, sucrose, and salt-free cream. During the actual test, no metal
foreign matter can be observed. However, white sauce is also prone to
misjudgment of metal detectors as metal foreign matter. The size of the
metal particles are detectable, it depends mainly on the type of metal
and the type of food being inspected. Some products (such as ice cream,
cheese) are more difficult to check because of their electrical con-
ductivity, which is called product effect, and the instrument often
compensates for this, known as product effect compensation. Compared
with other types of sauces in the organization, it can be judged that the
sauce contains high salt, electrolyte and solid matter, which makes the
metal detector falsely judged because the radiation background level is
too high. Among them, liquid sauces have high salt content, sodium ion,
iron ions in high-sweet products, electrolytes in fresh products, an
electrolyte in high-moisture products all easily affect the quality of
detection. The size of the sensing channel, the material/size of the
metal foreign object, the material/size of the object to be tested, and the
position of the metal foreign object passing through the sensing channel
are also one of the factors that affect the misjudgment of the metal
detector. Through the calibration of the three standards of FE, CU and
SS304 before the process, it is found that the metal detector should not
be misjudged. It is necessary to adjust the FE 1.8, CU 1.8 and SS 1.8 to
use the loose FE 2.8, CU2.8 and SS 2.8. The standard can prevent the
metal detector from setting too high sensitivity or causing misjudgment
of the instrument due to excessive salt. In order to minimize the risk,
precautions must be taken in connection with the operation of the metal
detector to monitor the effectiveness of the metal detector in order to
repair the metal detector in accordance with the technical guidelines.
Internal and external training for production personnel in accordance
with approved schedules if required (Trafialek et al., 2016). This result
also shows that the calibration of the metal detector needs to be
maintained by professionally trained personnel to avoid the problem of
misjudgment caused by lack of experience (Wallace et al., 2014).
Choi (2018) also pointed out that the electromagnetic metal de-
tector used a standard metal test piece for identification test before
starting production every day, so as to ensure that the metal detector is
free from abnormalities. Therefore, the implementation of the
ISO22000: 2018 inspection and measurement standard operating pro-
cedures are relatively important (Chen, Chen, Liu, Yang, Chen, & Chen,
2019).
4. Conclusion
The methodology of the significant hazard analysis proposed in this
study found that code 9 and 8 steps in the solid-form Italian panna cotta
powder and liquid sauce respectively may cause physical hazards. After
evaluating the control measures, the “Metal Detection” step is de-
termined as CCPs and HACCP plan control measures or combinations
are provided, and the remaining hazards are managed by establishing
an OPRP. The test results show that the powder products have good
detection ability, and the sauces will have more variables due to the
complexity of the components, and the parameter adjustment is needed
to provide effective detection and analysis. In addition, the outer
packaging material of the solid powder can be changed to a metal
basket that meets the standard metal composition, or the metal detector
can be set after packaging the inner package and before the plastic
11
Food Control 111 (2020) 107071
basket is packaged. The study pointed out that after the implementation
of the ISO 22000: 2018 standard, the organization reduced the number
of process anomalies and the number of customer complaints, thereby
reducing the risk of metal hazards in food safety, helping to increase its
sales channels and market expansion, and providing small and medium-
sized enterprise reference.
Author contribution section
Hsinjung Chen: Conceptualization, Writing - original draft, Study
conception and design, Acquisition of data, Drafting of manuscript. Pei-
Ting Chuang: Conceptualization, Writing - original draft, Study con-
ception and design, Drafting of manuscript, Critical revision. Chin-Shuh
Chen: Conceptualization, Study conception and design, Critical revi-
sion. Bo-Kang Liou: Formal analysis, Writing - original draft,
Acquisition of data, Analysis and interpretation of data, Drafting of
manuscript. Fan-Jhen Dai: Formal analysis, Writing - original draft,
Acquisition of data, Analysis and interpretation of data, Drafting of
manuscript.
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