# Implementation of HACCP Management System in a Cake Manufacturing Company in Dhaka, Bangladesh: A Case Study

Authors: Md. Fahad Jubayer; Md. Sajjad Hossain; Md. Al-Emran; Md. Nasir Uddin
Journal: Journal of Food Quality
 (2022)

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## Abstract

The study aims to provide technical information on the development and application of hazard analysis and critical control points (HACCP) in one of the popular cake manufacturing companies in Dhaka, Bangladesh. A generic HACCP plan in accordance with legal requirements was created after a detailed analysis of data collected from the company. Every step of the production process was examined for biological, chemical, and physical hazards. The prerequisite program was designed to address some hazards prior to production, thereby simplifying the HACCP plan. The critical control points were determined by answering the questions in the decision trees. Finally, the HACCP control chart was created to include critical limits, monitoring, and corrective actions as the components of several HACCP principles. One critical control point (CCP) and two operational prerequisite programs (oPRPs) were identified throughout the manufacturing process. This is the first HACCP study aimed at a cake manufacturing company, and it is expected that it would assist process engineers and quality control specialists in designing and implementing control measures.


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## Body

## 1. Introduction

Cakes are popular sweet bakery products all over the world. Globally, the cake market is expected to grow at a rate of 3.3% per year from 2018 to 2023, reaching a value of $75 billion by 2023 [1, 2]. Cakes are available in an enormous variety of forms and recipes, making them popular among people of all ages and demographics around the world. The primary raw materials of cake include flour, sugar, egg, shortening [3], color, flavor, salt, and emulsifier, which are then processed into finished goods via various processing steps such as mixing, baking, cooling, and packaging [4]. Foodborne illnesses are usually associated with this kind of processed products. Escherichia coli O157 : H7 has been found in cheese and pizza, Listeria monocytogenes in cheese and ice cream, and Salmonella typhimurium in peanut butter [5]. Between 2004 and 2013, there were 142 cases of foodborne disease outbreaks and 2822 illnesses associated with bakery products in the United States [6]. Numerous food safety hazards associated with cake raw materials have been discovered, including aflatoxin B1 [7], mycotoxins [8], E. coli, Salmonella spp., Bacillus cereus, and several pathogenic microorganisms in flour [9]. Besides, presence of Salmonella [10], Campylobacter [11], and Listeria [12] is very common in the raw eggshell. Various types of hazards can be introduced during the cake manufacturing process through different processing steps such as food raw materials, processing equipment, processing environment, and food handlers.The food industry is responsible not only for producing safe foods, but also for demonstrating how food safety issues are designed and implemented. Developing a food safety management system contributes to this goal in an open and transparent manner [13]. The HACCP system is a powerful and efficient tool for producing safe food. In the food production system, the HACCP tool application is a systematic science-based system that specifies specific food safety hazards. It determines the food safety control measure [14]. At the moment, many countries, including the United States, Japan, the United Kingdom, and European Union member states as well as international organizations such as the WHO, FAO, and Codex Alimentarius Commission (CAC), have adopted the HACCP system and have stringent criteria regarding food imports [13]. Every HACCP system is capable of addressing and accommodating changes in technological advancement, advancement in equipment design, adjustments in processing procedures, and so on. Principles of the HACCP system have been adopted by the Codex Alimentarius Commission (CAC), and application guidelines are presented in an annex to the general principles of food hygiene [14]. HACCP implementation is based on seven principles that are used to identify and control hazards to an acceptable level [15, 16]. Before implementing a HACCP plan, a strong prerequisite program should be in place. Prerequisite programs (for example, sanitation, pest control, personnel practices, GHP, ingredient and product specifications, staff training, cleaning and disinfectant regimes, and hygienically designed facilities) are used to ensure that employees, equipment, premises, and transportation do not contribute to or become food safety hazards [14, 17]. Subsequently, HACCP is a globally recognized, effective, and preventive food safety management system for measuring hazards, estimating risks, and establishing precise control measures that emphasize prevention and control rather than reliance on end-product testing and traditional inspection methods. Implementing HACCP is more effective than traditional quality assurance methods in gaining consumer trust and establishing a good corporate image [13].Food contamination and adulteration have lately arisen as serious public health concerns in Bangladesh, and unsanitary food handling practices have become a prevalent phenomenon in the Bangladesh food industries [18]. As a result, an independent food safety body named BFSA was formed in 2015. According to the BABBMA, there are approximately 60 large factories registered in Bangladesh that manufacture bakery products [19]. Pesticide residues and postprocessing contamination with pathogenic microbes such as Salmonella and E. coli are the most prevalent food safety risks in this sector [20]. Bangladesh has a moderate level of food safety inspection, though the leading private food industries have the internal capacity to ensure food safety compliance with US and European standards [20]. Adopting HACCP is beneficial for building the trust of customers and developing a positive corporate image. The use of HACCP enables Bangladeshi food companies to break down trade barriers and participate in worldwide business, thus expanding their markets and generating revenues. Furthermore, a rational and appropriate HACCP plan can assist food companies in improving their management level and raising the safety consciousness of their employees [13]. Hence, this current study aimed to implement the HACCP system in a cake manufacturing plant in order to identify CCPs, thereby establishing an effective preventive system that will lead to safer and more efficient cake production. To the best of our knowledge, this is the first study to show HACCP implementation in a cake manufacturing company in Bangladesh. This will be helpful for the process engineers and quality control specialists to design and implement control measures in the baking industries. The method is intended for use in cake manufacture when higher control is sought for broader applicability. The implementation of the HACCP system can effectively ensure the quality and safety of the final product.


## 2. Materials and Methods

### 2.1. Company Description

This study was conducted in a cake manufacturing company located in the Dhaka division of Bangladesh, which was a joint venture manufacturing company between Denmark and Bangladesh. Dhaka, Bangladesh’s capital city, is home to a plethora of food businesses. For this study, we chose a freshly formed company that intends to fully implement food safety regulations. Moreover, it was the first specialized cake manufacturing company in Bangladesh. The research was carried out from January to August of 2019. It was classified as a medium-scale plant, with a monthly production capacity of 500 tons and a workforce of around 200 people during the study period. Muffins, plain cakes, fruit cakes, Swiss rolls, and sponge cakes were among the products produced by the company. In addition to the domestic market, the products had begun to be exported directly to international markets. The restructuring was intended to expand the company’s market. As a result, the company planned to implement an effective FSMS to ensure consumer food safety and high-quality products. This study explains the PRPs, OPRPs, and HACCP principles in accordance with the standard requirements for the cake manufacturing line. The company layout (Figure1) shown below is adopted from the corresponding authors’ previous work [21].Figure 1
Layout of the plant [21].


### 2.2. HACCP Implementation Steps

HACCP is a scientific and systematic approach to food safety that identifies and controls specific food safety hazards. Implementing HACCP is a symbol of product quality and safety that ensures consumer satisfaction. According to Codex Alimentarius, the HACCP system is based on seven scientific principles [22].Principle 1.
Perform hazard analysis (HA) for the identification of physical, chemical, and biological hazards.Principle 2.
Identification of critical control points (CCPs) according to the decision tree.Principle 3.
Establishing critical limits (CL) to ensure uniformity in the safety analyses of the processes involved.Principle 4.
Monitoring each CCP.Principle 5.
Establishing corrective actions to be executed when monitoring indicates a deviation from a predefined critical limit.Principle 6.
Establishing effective record-keeping procedures.Principle 7.
Establishing procedures for verification that the HACCP system is working correctly.
In this study, PRPs and OPRPs are applied along with HACCP plan throughout the whole production process.


## 2.1. Company Description

This study was conducted in a cake manufacturing company located in the Dhaka division of Bangladesh, which was a joint venture manufacturing company between Denmark and Bangladesh. Dhaka, Bangladesh’s capital city, is home to a plethora of food businesses. For this study, we chose a freshly formed company that intends to fully implement food safety regulations. Moreover, it was the first specialized cake manufacturing company in Bangladesh. The research was carried out from January to August of 2019. It was classified as a medium-scale plant, with a monthly production capacity of 500 tons and a workforce of around 200 people during the study period. Muffins, plain cakes, fruit cakes, Swiss rolls, and sponge cakes were among the products produced by the company. In addition to the domestic market, the products had begun to be exported directly to international markets. The restructuring was intended to expand the company’s market. As a result, the company planned to implement an effective FSMS to ensure consumer food safety and high-quality products. This study explains the PRPs, OPRPs, and HACCP principles in accordance with the standard requirements for the cake manufacturing line. The company layout (Figure1) shown below is adopted from the corresponding authors’ previous work [21].Figure 1
Layout of the plant [21].


## 2.2. HACCP Implementation Steps

HACCP is a scientific and systematic approach to food safety that identifies and controls specific food safety hazards. Implementing HACCP is a symbol of product quality and safety that ensures consumer satisfaction. According to Codex Alimentarius, the HACCP system is based on seven scientific principles [22].Principle 1.
Perform hazard analysis (HA) for the identification of physical, chemical, and biological hazards.Principle 2.
Identification of critical control points (CCPs) according to the decision tree.Principle 3.
Establishing critical limits (CL) to ensure uniformity in the safety analyses of the processes involved.Principle 4.
Monitoring each CCP.Principle 5.
Establishing corrective actions to be executed when monitoring indicates a deviation from a predefined critical limit.Principle 6.
Establishing effective record-keeping procedures.Principle 7.
Establishing procedures for verification that the HACCP system is working correctly.
In this study, PRPs and OPRPs are applied along with HACCP plan throughout the whole production process.


## 3. Results and Discussion

### 3.1. Implementation of HACCP Plan

According to an analysis of the HACCP system applied in the company, there was no reduction in end-product quality during the manufacturing process, with notably strong application of prerequisites and entire commitment and sense of responsibility on the part of all employees. However, numerous external factors can be a potential barrier in all stages of the HACCP implementation process, including (a) the illusion of control in the absence of adequate staff training; (b) company size as a potential factor due to a lack of resources, technical knowledge, and experience; (c) major industries that find it easier to implement the HACCP system than small businesses; (d) lack of HACCP program leadership; (e) lack of cooperation between industry and law enforcement authorities; (f) insufficient equipment; (g) poorly designed equipment and an incorrect plan layout; (h) employee lackness of time to accomplish HACCP; (i) lack of equivalence of different types of HACCP programs [23].


#### 3.1.1. Listing the Prerequisite (PRP)

Prior to the HACCP system, PRPs are systematically applied in the food processing sector to support and improve the system’s effectiveness and efficiency. PRP application is considered as the foundation of HACCP system. PRP represents the formalization of GMP and GHP elements [24]. The PRPs were PRP environmental hygiene, PRP establishment-design and facilities, PRP premises and rooms, PRP equipment, PRP water supply, PRP drainage and waste disposal, PRP cleaning and sanitation, PRP personnel hygiene facilities and toilets, PRP temperature and air quality control, PRP lighting, PRP handling, storage, and transportation, PRP control of operation, PRP pest control, PRP waste management, PRP traceability, and PRP training.


#### 3.1.2. Preliminary Steps to Enable Hazard Analysis

The implementation of a food safety system (HACCP) is a continuous process that is based on the management concepts of an iterative four-step management method known as the PDCA cycle (plan, do, check, and act).(1) The HACCP team. A team was formed to implement an efficient HACCP system. While assembling the HACCP team for the company, the following factors were taken into account. The team was supposed to have six members.(a)
In terms of qualifications and experience, the members must be competent in their particular fields of activity(b)
The team should be led by a team leader who will direct the activities(c)
The team coordinator will be in charge of developing, implementing, and maintaining the HACCP system(d)
All team members are expected to receive proper training(e)
The team must develop and maintain all documents in accordance with the HACCP system(f)
Furthermore, if there is a change or modification in the process, the team must examine the adequacy of the HACCP system on a yearly basisThus, the formation of the HACCP team was as follows:HACCP Team LeaderPlant ManagerHACCP Team CoordinatorManufacturing ManagerHACCP Team MembersQuality Assurance ManagerManager-HRM and ComplianceWare House ManagerMaintenance Manager (Electrical)Maintenance Manager (Mechanical)Supply Chain ManagerThe team leader, as the highest authority, maintains the smooth operation of the company and ensures that all legal criteria for its proper operation are met. It is also his obligation to supervise all phases of the plan, as well as the responsibilities and coordination of all internal and external corporate operations [25]. The team members are responsible for keeping and regulating the records related to their area of operation.(2) Product characteristics and intended use. The HACCP team needs to start with a thorough description of the produces, defining their composition and chemical, biological, and physical properties.Table1 shows the generic framework for the description of cake.Table 1
Product description and intended use.
ProductCake is a bakery productProduct compositionWheat flour, sugar, eggs, salt, vegetable fat, glycerol, starch, wheat starch, skim milk powder, raising agents (E 500), preservative (E 202), and flavorProduct characteristicsPhysicochemical characteristics:Moisture18–22% wbWater activity (aw)0.76–0.81Acid value of extracted fat, (as oleic acid), percent by mass, max.1.0Protein5–7 g/100gMicrobiological characteristics:Total viable count, cfu/g, max.20000Enterobacteriaceae spp.≤ 102 UFC/gStaphylococcus aureus≤ 102 UFC/gSalmonella spp.AbsentListeria monocytogenesAbsentColiformAbsentMold, maximum50 CFU/gSensory characteristics:Physical conditionSolidColorCharacteristicsFlavorTypicalTextureTypicalLabeling requirementsProduct’s name, composition, allergen information, origin, manufactures date, expiry date, destination, net weight, storage temperature, and destinationStorage and transport conditionsPrimary packages should be packaged further in a secondary packing procedure (gift boxes). Secondary boxed must packed in tertiary packaging (cartons). Final storage and transportation should make at ambient temperatureShelf life4 monthsIntended useDirect consumption. The product mentioned is for the general population, except for gluten-sensitive groupsApplicable lawsBDS 1574, specifications for cakes; BDS 1240, specifications for drinking water; BDS 381, specifications for maida; BDS 1567, specifications for refined oil; BDS 79, specifications for jams and jellies; BDS 1615, specifications for cocoa powder; BDS 138, specifications for refined sugar; BDS 207, specifications for milk powder and cream powder; BDS 822, code of hygienic conditions for food processing units, etc.(3) Construction of flow diagram. A flowchart showing the whole manufacturing process of cake was constructed (Figure 2). The HACCP team checked the flow diagrams on site. It is critical that the flowchart be properly prepared and thoroughly analyzed on the ground and contain as much information as feasible. Only a well-planned, informative, and well-analyzed flowchart helps to facilitate overall production process, making it much easier to detect potential deviations [25].Figure 2
Complete flowchart of the cake manufacturing process.


#### 3.1.3. Hazard Analysis and Identification of CCPs and oPRPs

The hazard analysis assists in identifying potential hazards associated with the entire process, from raw material receipt to product delivery to consumers. During the hazard analysis, hazards were further categorized into three categories: (a) biological, (b) physical, and (c) chemical [26]. Hazard analysis or identification is generally aimed to identify potential threats to human health that may be introduced into baked goods during the manufacturing process. Based on the hazard analysis, further risk assessments were accomplished. In the process of risk assessment, customer complaints, shipment returns, and laboratory test results were typically taken into account [27]. Hazards as identified for each step of the process flow diagram were entered in the format. Following the completion of the subsequent process steps, values for the likelihood of the hazard’s presence and the consequences of the hazards were entered into the assessment column. The values were determined as in Table 2 and Table 3.Table 2
Likelihood and consequence criteria to specify potential hazard in cake manufacturing process.
Likelihood (probability)Consequences (severity)4. Frequent, e.g., daily4. Very high (catastrophe), e.g., death3. Likely, e.g., weekly3. High (critical), e.g., illness2. Occasional, e.g., monthly2. Medium, e.g., injury1. Unlikely, e.g., yearly1. Minor, e.g., no injuriesTable 3
Analysis of likelihood vs. consequences.
Hazard typesLikelihood (probability)Consequences (severity)RIPhysical (stones, sand, husks, and plastic)XyXyChemical (mercury (hg), chromium (cr), aflatoxin, melamine)XyXyBiological: total plate count (TPC), coli form, molds, and pestsXyXyThe likelihood, i.e., probability, and consequences of a specified hazardous event occurring are combined to form risk. Thus, it can be defined as follows: risk index (RI) = likelihood × consequences.Significant hazards were identified using a numerical scale of one (1) to four (4) of likelihood and consequence. When rating likelihood and consequences, previous experiences, records, and data were considered (Table3).According to Table3, the IR for this current study varies between 1 and 12. The calculated risk index shows that if the RI is higher than 8, then it should be managed by the HACCP plan. HACCP plan is a document prepared in accordance with the seven principles of HACCP [25]. On the other hand, when the IR is less than 4, the results should be maintained by the oPRPs [25]. The RI for the production of cake is shown in Table 4.Table 4
Risk index and its management [25].
RIRisk typeManagement of riskRI ≤ 4Satisfactory riskShould be managed by oPRPs4 ≥ RI ≤ 8Lower risk8 ≥ RI ≤ 12Increased riskShould be managed by the HACCP plan12 ≥ RI ≤ 16Critical riskAfter completing the hazard assessment, relative control measures are selected with the help of the CCP decision tree as shown in Figure3. CCP is a step in which a specific control measure must be implemented in order to prevent or eliminate a food safety hazard or reduce the risk to an acceptable level [16] (Section 3.1).Figure 3
CCP decision tree for HACCP implementation (adopted from [15]).An oPRP’s components are the same as those of a CCP, with the exception that no critical limit is required for control measure(s) [15], and failure in the manufacturing process has no direct effect on the process [25]. The hazard analysis of the cake manufacturing process is shown in Table 5.Table 5
Hazard analysis for the production process of cake.
Processing stepHazardsRisk effectsProbable causesRisk evaluationControl measures (SOP or work instructions)Decision treeRecordPSRIQ1Q2Q3Q4Q5Receiving of raw and packaging materialsPhysical: foreign objects, such as hair, insects, broken plastics.Without consequencesPackaging, hygiene, pest control313Visual inspectionYYNYYPRPChemical: acidity, melamine, heavy metals, residual chemical, etc.Without consequencesCoA, packaging133Supplier evaluation, CoA, HACCP certificate, personal and transport hygiene status, lab test (QA)YYNYYPRPBiological: microbial contamination (pathogenic)With consequencesCoA, hygiene144Supplier evaluation, CoA, HACCP certificate, personal and transport hygiene status, lab test (QA)YYNYYPRPStorage of raw and packaging materialsPhysical: foreign objects, insectsWithout consequencesIrregular inspection and improper hygiene313Keep storage environment safe, keep containers closed. Separate areas for raw and packaging materialsYYNNPRPChemical: production of H2S (eggs)Without consequencesStorage temperature212Maintaining suitable storage condition, FIFONPRPBiological: microbial, pests and insectsWith consequencesTransport and storage temperature, pest control, hygiene144FIFO, maintaining suitable storage and transport temperature, pest controlling plan, maintain personal and environmental hygiene during storage and transportYYNYYPRPTaking RM and PM from storage to productionPhysical: foreign objectsWithout consequencesImproper handling and personal hygiene313Maintain personal hygiene, wear mask, apron, gloves, head cover and beard cover, maintain SOP, GHPYYNYYPRPChemical: unidentifiedBiological: unidentifiedBatch preparation (weighing and mixing)Physical: foreign objects, broken egg shellsWithout consequencesImproper handling and personal hygiene212Provision of filter in egg broker machine, visual inspection, maintaining personal hygiene, wear mask, apron, gloves, head cover, and beard coverYYNYYPRPChemical: excess additives, detergents, etc.Without consequencesIncorrect hygiene and cleaning, faulty recipe111Follow the recipe and recheck, timely calibration of measuring instrumentsNPRPBiological: Pathogenic microorganismWith consequencesImproper personal hygiene144Strict personal hygiene, regular hand swab tests by the QA, proper hygiene, food safety, and behavioral trainingYYNYYPRPMixingPhysical: broken piece of mixing machine, foreign objectsWith consequences, without consequencesMaintenance of mixing machine, improper personal hygiene313Checking the status of mixing machine, maintain personal hygiene, wear mask, apron, gloves, head cover, and beard coverYYNYYPRPChemical: detergents residueWithout consequencesImproper hygiene and cleaning practice111Maintain proper hygiene and cleaning practiceYYNYYPRPBiological: pathogenic microorganismWith consequencesImproper personal hygiene144Maintain strict personal hygiene, wear mask, apron, gloves, head cover and beard cover, keep the equipment properly sanitizedYYNYYPRPDosingPhysical: broken piece of dosing nozzleWith consequencesMaintenance of dosing machine111Checking the status of dosing machineYYNYYPRPChemical: unidentifiedBiological: unidentifiedBakingPhysical: unidentifiedChemical: moisture content and water activityWithout consequencesImproper baking time and temperature313Frequent lab test for MC andaw from each batch, maintenance of baking temperature and time as per SOPNPRPBiological: microbial contaminationWith consequencesImproper baking time and temperature144Maintenance of baking temperature and time as per SOPYYNYNoPRPCoolingPhysical: unidentifiedChemical: moisture content and water activityWithout consequencesImproper cooling time and temperature212Check for cooling conveyor speed and cooling temperatureNPRPBiological: unidentifiedCream fillingPhysical: broken part of cream dosing nozzleWith consequencesMaintenance of cream filling machine122Checking the status of cream filling machineYYNYYPRPChemical: unidentifiedBiological: unidentifiedMetal detectionPhysical: metal partsWith consequencesInactive sensor of the metal detection machine, machine broken3412Frequent checking of the machine statusYYYNNCCPChemical: unidentifiedBiological: unidentifiedPackagingPhysical: foreign parts from packaging machine surface, damaged pack, leakage in packingWith consequencesImproper cleaning, shortage of nitrogen gas, PLC fault313Proper cleaning of packaging machine, check for nitrogen gas level, regular checking of the PLC systemYYNYYPRPChemical: detergents residueWithout consequencesImproper hygiene and cleaning practice111Maintain proper hygiene and cleaning practiceYYNYYPRPBiological: microorganismsWith consequencesImproper personal hygiene, contamination in packing materials248Regular hand and surface swab test, ATP check before packing, strict maintaining of personal hygiene, QA online check for leak packageYYNYNoPRPFilling in box and date codingNo hazardWithout consequencesNo riskFinished goods storePhysical: tertiary package damage by rodentsWithout consequencesNo pest traps and pest control212Put glue trap in proper places, conduct timely pest control actionYYNYYPRPChemical: unidentifiedBiological: unidentifiedDelivery transport to marketNo hazardNo risk


#### 3.1.4. Establishing the oPRP and HACCP Plan

The HACCP plan was established for each oPRP and CCP by specifying the hazards, control measures, CL, corrective action, verification, and records management. The potential control points for the hazards appeared in both the raw material and the manufacturing process. Table6 and Table 7 show the oPRP and HACCP plan in the cake manufacturing process. The HACCP control chart (Table 7) showed all the potential critical hazards that can occur during the processing steps. Gandhi [28] included hazard description, critical limit, observation procedure, responsible person, monitoring procedure, and corrective action in his HACCP control chart for soy milk production, whereas Burson [29] reported processing steps, records, and verification procedures in his meat product control chart. The HACCP control chart in the current study is similar to some previous studies [15, 25, 30]. One CCP, metal detection, and two oPRPs, baking and packaging, were discovered during the cake manufacturing process. The center temperature of the bakery product crumb needs to be above 100 °C for few minutes. During baking, all vegetative pathogenic bacteria should be destroyed [31, 32]. The main ingredients of cake dough include fats and oils, eggs, flour, and sugar. Among these, sugar is comparatively safe in regard to any foodborne illness. Fats and oils can be a potential source of Listeria [9]. Flour, on the other hand, can pose both chemical and microbial risks. However, the most dangerous and common thing that can happen is mycotoxin, such as aflatoxin. Despite the fact that the physicochemical properties of flour (i.e., low aw) do not allow bacteria to grow, microorganisms can survive for extended periods of time during storage [9]. As for the egg shells, they are considered as a major source of Salmonella enteritidis [33, 34]. However, cake dough is not considered a high-risk food because it has a low aw and requires baking prior to packaging and consumption [9, 35].Table 6
oPRPs in the cake manufacturing process.
Processing stepHazardControl measure(s)Critical limitMonitoring proceduresRecordsCorrective actionVerificationWhat?How?Who?Frequency (when?)BakingBiological: microbial contaminationMaintenance of baking temperature and time as per SOPBaking temperature between 150 and 250 °C for 5–50 minutesOven temperaturePhysical inspectionQA officer, production officerEvery one hour intervalQA and production (plan oPRP)Reset the temperature and time, reject or reuse the productPhysical observation, calibrationPackagingBiological: microbial contaminationRegular hand and surface swab test, ATP check before packing, strict maintaining of personal hygiene, QA online check for leak packageSurface ATP = <50 RLU; Hand swab for coliform = nil; Hand swab for mold = <50 cfu/mlMachine surface, workers handsSwab test, microbiological test in the QA labQA executiveATP test every day, hand swab test twice in a weekQA and production (plan oPRP)Reclean the surface, observation (hygiene status) of infected hands (person) for a month, reject the leak pack and productsRecheckTable 7
HACCP control chart.
Processing stepHazardControl measure(s)Critical limitMonitoring proceduresRecordsCorrective actionVerificationWhat?How?Who?Frequency (when?)Metal detectionPhysical: metallic componentDetection of metallic component by metal detectorAbsence of metallic componentSensor of the metal detector, PLC, alarmPhysical inspection and check for alarm (by passing a metal under the metal detector)Maintenance dept., QA and production dept.Every 1 hr interval during the production timeQA, production, and maintenance register (plan CCP)Rejection of the whole lot of nonconformed productsIn-house checking by metal pieces, maintenance records, calibration of metal detector, and auditingThe physical hazard of metal in cake is the most serious, and it is harmful to the consumer. Metal detectors can now be used to detect and remove metallic components during food processing. The presence of metallic components can significantly reduce food safety, resulting in perforation of human gastrointestinal tissues and surgical resection. The presence of metallic particles can cause damage to various valuable machine parts, resulting in a sudden production line shutdown and economic loss. Metal detectors are installed by food processing industrialists for product quality and safety, equipment protection, consumer satisfaction, and regulatory body requirements, among other things. Metal detectors are extremely important and effective for metal hazard control in solid seasoning powder and liquid sauces through the implementation of a HACCP plan [36]. In the current study, there was no additional step in the manufacturing process that could detect or eliminate this problem, according to the process flowchart. According to a study conducted by [13], packaging and cartooning are the most important parts of the production process, with no other steps left out to assure process safety. The authors in [13] conducted their study on a biscuit manufacturing plant in Bangladesh. Baking and metal detection were also identified as two of the CCPs in that investigation, which is consistent with the current study.To ensure that the HACCP plan is working as intended, the food safety team developed a verification strategy that describes the goal, methods, frequency, and responsibilities for the verification activities. Records and documentation are generated to offer evidence of the system’s effective execution [37]. Different documentation formats were also employed in our research to monitor specified measure control and ensure suitable corrective actions. Documentation often included deviations, accompanying remedial activities, and veriﬁcations. The following aspects for monitoring procedure comprised of HACCP were object, such as additive quantity; method, such as requiring for inspection report; frequency, such as every batch; and persons, such as operators [38].This present study identifies a significant risk that could have an impact on public health. Nonetheless, the process was controlled by systematic monitoring from primary to final production that was a critical concern for food safety. This system is subject to regular systematic monitoring. CCP was not the only factor. The documentation and data provided by the HACCP system could easily aid in the tracing of the contamination [13]. This approach also aided in the prevention of cross contamination. Finally, it can be declared that this approach delivers greater quality and hygiene standards and ensures superior cake quality.


## 3.1. Implementation of HACCP Plan

According to an analysis of the HACCP system applied in the company, there was no reduction in end-product quality during the manufacturing process, with notably strong application of prerequisites and entire commitment and sense of responsibility on the part of all employees. However, numerous external factors can be a potential barrier in all stages of the HACCP implementation process, including (a) the illusion of control in the absence of adequate staff training; (b) company size as a potential factor due to a lack of resources, technical knowledge, and experience; (c) major industries that find it easier to implement the HACCP system than small businesses; (d) lack of HACCP program leadership; (e) lack of cooperation between industry and law enforcement authorities; (f) insufficient equipment; (g) poorly designed equipment and an incorrect plan layout; (h) employee lackness of time to accomplish HACCP; (i) lack of equivalence of different types of HACCP programs [23].


### 3.1.1. Listing the Prerequisite (PRP)

Prior to the HACCP system, PRPs are systematically applied in the food processing sector to support and improve the system’s effectiveness and efficiency. PRP application is considered as the foundation of HACCP system. PRP represents the formalization of GMP and GHP elements [24]. The PRPs were PRP environmental hygiene, PRP establishment-design and facilities, PRP premises and rooms, PRP equipment, PRP water supply, PRP drainage and waste disposal, PRP cleaning and sanitation, PRP personnel hygiene facilities and toilets, PRP temperature and air quality control, PRP lighting, PRP handling, storage, and transportation, PRP control of operation, PRP pest control, PRP waste management, PRP traceability, and PRP training.


### 3.1.2. Preliminary Steps to Enable Hazard Analysis

The implementation of a food safety system (HACCP) is a continuous process that is based on the management concepts of an iterative four-step management method known as the PDCA cycle (plan, do, check, and act).(1) The HACCP team. A team was formed to implement an efficient HACCP system. While assembling the HACCP team for the company, the following factors were taken into account. The team was supposed to have six members.(a)
In terms of qualifications and experience, the members must be competent in their particular fields of activity(b)
The team should be led by a team leader who will direct the activities(c)
The team coordinator will be in charge of developing, implementing, and maintaining the HACCP system(d)
All team members are expected to receive proper training(e)
The team must develop and maintain all documents in accordance with the HACCP system(f)
Furthermore, if there is a change or modification in the process, the team must examine the adequacy of the HACCP system on a yearly basisThus, the formation of the HACCP team was as follows:HACCP Team LeaderPlant ManagerHACCP Team CoordinatorManufacturing ManagerHACCP Team MembersQuality Assurance ManagerManager-HRM and ComplianceWare House ManagerMaintenance Manager (Electrical)Maintenance Manager (Mechanical)Supply Chain ManagerThe team leader, as the highest authority, maintains the smooth operation of the company and ensures that all legal criteria for its proper operation are met. It is also his obligation to supervise all phases of the plan, as well as the responsibilities and coordination of all internal and external corporate operations [25]. The team members are responsible for keeping and regulating the records related to their area of operation.(2) Product characteristics and intended use. The HACCP team needs to start with a thorough description of the produces, defining their composition and chemical, biological, and physical properties.Table1 shows the generic framework for the description of cake.Table 1
Product description and intended use.
ProductCake is a bakery productProduct compositionWheat flour, sugar, eggs, salt, vegetable fat, glycerol, starch, wheat starch, skim milk powder, raising agents (E 500), preservative (E 202), and flavorProduct characteristicsPhysicochemical characteristics:Moisture18–22% wbWater activity (aw)0.76–0.81Acid value of extracted fat, (as oleic acid), percent by mass, max.1.0Protein5–7 g/100gMicrobiological characteristics:Total viable count, cfu/g, max.20000Enterobacteriaceae spp.≤ 102 UFC/gStaphylococcus aureus≤ 102 UFC/gSalmonella spp.AbsentListeria monocytogenesAbsentColiformAbsentMold, maximum50 CFU/gSensory characteristics:Physical conditionSolidColorCharacteristicsFlavorTypicalTextureTypicalLabeling requirementsProduct’s name, composition, allergen information, origin, manufactures date, expiry date, destination, net weight, storage temperature, and destinationStorage and transport conditionsPrimary packages should be packaged further in a secondary packing procedure (gift boxes). Secondary boxed must packed in tertiary packaging (cartons). Final storage and transportation should make at ambient temperatureShelf life4 monthsIntended useDirect consumption. The product mentioned is for the general population, except for gluten-sensitive groupsApplicable lawsBDS 1574, specifications for cakes; BDS 1240, specifications for drinking water; BDS 381, specifications for maida; BDS 1567, specifications for refined oil; BDS 79, specifications for jams and jellies; BDS 1615, specifications for cocoa powder; BDS 138, specifications for refined sugar; BDS 207, specifications for milk powder and cream powder; BDS 822, code of hygienic conditions for food processing units, etc.(3) Construction of flow diagram. A flowchart showing the whole manufacturing process of cake was constructed (Figure 2). The HACCP team checked the flow diagrams on site. It is critical that the flowchart be properly prepared and thoroughly analyzed on the ground and contain as much information as feasible. Only a well-planned, informative, and well-analyzed flowchart helps to facilitate overall production process, making it much easier to detect potential deviations [25].Figure 2
Complete flowchart of the cake manufacturing process.


### 3.1.3. Hazard Analysis and Identification of CCPs and oPRPs

The hazard analysis assists in identifying potential hazards associated with the entire process, from raw material receipt to product delivery to consumers. During the hazard analysis, hazards were further categorized into three categories: (a) biological, (b) physical, and (c) chemical [26]. Hazard analysis or identification is generally aimed to identify potential threats to human health that may be introduced into baked goods during the manufacturing process. Based on the hazard analysis, further risk assessments were accomplished. In the process of risk assessment, customer complaints, shipment returns, and laboratory test results were typically taken into account [27]. Hazards as identified for each step of the process flow diagram were entered in the format. Following the completion of the subsequent process steps, values for the likelihood of the hazard’s presence and the consequences of the hazards were entered into the assessment column. The values were determined as in Table 2 and Table 3.Table 2
Likelihood and consequence criteria to specify potential hazard in cake manufacturing process.
Likelihood (probability)Consequences (severity)4. Frequent, e.g., daily4. Very high (catastrophe), e.g., death3. Likely, e.g., weekly3. High (critical), e.g., illness2. Occasional, e.g., monthly2. Medium, e.g., injury1. Unlikely, e.g., yearly1. Minor, e.g., no injuriesTable 3
Analysis of likelihood vs. consequences.
Hazard typesLikelihood (probability)Consequences (severity)RIPhysical (stones, sand, husks, and plastic)XyXyChemical (mercury (hg), chromium (cr), aflatoxin, melamine)XyXyBiological: total plate count (TPC), coli form, molds, and pestsXyXyThe likelihood, i.e., probability, and consequences of a specified hazardous event occurring are combined to form risk. Thus, it can be defined as follows: risk index (RI) = likelihood × consequences.Significant hazards were identified using a numerical scale of one (1) to four (4) of likelihood and consequence. When rating likelihood and consequences, previous experiences, records, and data were considered (Table3).According to Table3, the IR for this current study varies between 1 and 12. The calculated risk index shows that if the RI is higher than 8, then it should be managed by the HACCP plan. HACCP plan is a document prepared in accordance with the seven principles of HACCP [25]. On the other hand, when the IR is less than 4, the results should be maintained by the oPRPs [25]. The RI for the production of cake is shown in Table 4.Table 4
Risk index and its management [25].
RIRisk typeManagement of riskRI ≤ 4Satisfactory riskShould be managed by oPRPs4 ≥ RI ≤ 8Lower risk8 ≥ RI ≤ 12Increased riskShould be managed by the HACCP plan12 ≥ RI ≤ 16Critical riskAfter completing the hazard assessment, relative control measures are selected with the help of the CCP decision tree as shown in Figure3. CCP is a step in which a specific control measure must be implemented in order to prevent or eliminate a food safety hazard or reduce the risk to an acceptable level [16] (Section 3.1).Figure 3
CCP decision tree for HACCP implementation (adopted from [15]).An oPRP’s components are the same as those of a CCP, with the exception that no critical limit is required for control measure(s) [15], and failure in the manufacturing process has no direct effect on the process [25]. The hazard analysis of the cake manufacturing process is shown in Table 5.Table 5
Hazard analysis for the production process of cake.
Processing stepHazardsRisk effectsProbable causesRisk evaluationControl measures (SOP or work instructions)Decision treeRecordPSRIQ1Q2Q3Q4Q5Receiving of raw and packaging materialsPhysical: foreign objects, such as hair, insects, broken plastics.Without consequencesPackaging, hygiene, pest control313Visual inspectionYYNYYPRPChemical: acidity, melamine, heavy metals, residual chemical, etc.Without consequencesCoA, packaging133Supplier evaluation, CoA, HACCP certificate, personal and transport hygiene status, lab test (QA)YYNYYPRPBiological: microbial contamination (pathogenic)With consequencesCoA, hygiene144Supplier evaluation, CoA, HACCP certificate, personal and transport hygiene status, lab test (QA)YYNYYPRPStorage of raw and packaging materialsPhysical: foreign objects, insectsWithout consequencesIrregular inspection and improper hygiene313Keep storage environment safe, keep containers closed. Separate areas for raw and packaging materialsYYNNPRPChemical: production of H2S (eggs)Without consequencesStorage temperature212Maintaining suitable storage condition, FIFONPRPBiological: microbial, pests and insectsWith consequencesTransport and storage temperature, pest control, hygiene144FIFO, maintaining suitable storage and transport temperature, pest controlling plan, maintain personal and environmental hygiene during storage and transportYYNYYPRPTaking RM and PM from storage to productionPhysical: foreign objectsWithout consequencesImproper handling and personal hygiene313Maintain personal hygiene, wear mask, apron, gloves, head cover and beard cover, maintain SOP, GHPYYNYYPRPChemical: unidentifiedBiological: unidentifiedBatch preparation (weighing and mixing)Physical: foreign objects, broken egg shellsWithout consequencesImproper handling and personal hygiene212Provision of filter in egg broker machine, visual inspection, maintaining personal hygiene, wear mask, apron, gloves, head cover, and beard coverYYNYYPRPChemical: excess additives, detergents, etc.Without consequencesIncorrect hygiene and cleaning, faulty recipe111Follow the recipe and recheck, timely calibration of measuring instrumentsNPRPBiological: Pathogenic microorganismWith consequencesImproper personal hygiene144Strict personal hygiene, regular hand swab tests by the QA, proper hygiene, food safety, and behavioral trainingYYNYYPRPMixingPhysical: broken piece of mixing machine, foreign objectsWith consequences, without consequencesMaintenance of mixing machine, improper personal hygiene313Checking the status of mixing machine, maintain personal hygiene, wear mask, apron, gloves, head cover, and beard coverYYNYYPRPChemical: detergents residueWithout consequencesImproper hygiene and cleaning practice111Maintain proper hygiene and cleaning practiceYYNYYPRPBiological: pathogenic microorganismWith consequencesImproper personal hygiene144Maintain strict personal hygiene, wear mask, apron, gloves, head cover and beard cover, keep the equipment properly sanitizedYYNYYPRPDosingPhysical: broken piece of dosing nozzleWith consequencesMaintenance of dosing machine111Checking the status of dosing machineYYNYYPRPChemical: unidentifiedBiological: unidentifiedBakingPhysical: unidentifiedChemical: moisture content and water activityWithout consequencesImproper baking time and temperature313Frequent lab test for MC andaw from each batch, maintenance of baking temperature and time as per SOPNPRPBiological: microbial contaminationWith consequencesImproper baking time and temperature144Maintenance of baking temperature and time as per SOPYYNYNoPRPCoolingPhysical: unidentifiedChemical: moisture content and water activityWithout consequencesImproper cooling time and temperature212Check for cooling conveyor speed and cooling temperatureNPRPBiological: unidentifiedCream fillingPhysical: broken part of cream dosing nozzleWith consequencesMaintenance of cream filling machine122Checking the status of cream filling machineYYNYYPRPChemical: unidentifiedBiological: unidentifiedMetal detectionPhysical: metal partsWith consequencesInactive sensor of the metal detection machine, machine broken3412Frequent checking of the machine statusYYYNNCCPChemical: unidentifiedBiological: unidentifiedPackagingPhysical: foreign parts from packaging machine surface, damaged pack, leakage in packingWith consequencesImproper cleaning, shortage of nitrogen gas, PLC fault313Proper cleaning of packaging machine, check for nitrogen gas level, regular checking of the PLC systemYYNYYPRPChemical: detergents residueWithout consequencesImproper hygiene and cleaning practice111Maintain proper hygiene and cleaning practiceYYNYYPRPBiological: microorganismsWith consequencesImproper personal hygiene, contamination in packing materials248Regular hand and surface swab test, ATP check before packing, strict maintaining of personal hygiene, QA online check for leak packageYYNYNoPRPFilling in box and date codingNo hazardWithout consequencesNo riskFinished goods storePhysical: tertiary package damage by rodentsWithout consequencesNo pest traps and pest control212Put glue trap in proper places, conduct timely pest control actionYYNYYPRPChemical: unidentifiedBiological: unidentifiedDelivery transport to marketNo hazardNo risk


### 3.1.4. Establishing the oPRP and HACCP Plan

The HACCP plan was established for each oPRP and CCP by specifying the hazards, control measures, CL, corrective action, verification, and records management. The potential control points for the hazards appeared in both the raw material and the manufacturing process. Table6 and Table 7 show the oPRP and HACCP plan in the cake manufacturing process. The HACCP control chart (Table 7) showed all the potential critical hazards that can occur during the processing steps. Gandhi [28] included hazard description, critical limit, observation procedure, responsible person, monitoring procedure, and corrective action in his HACCP control chart for soy milk production, whereas Burson [29] reported processing steps, records, and verification procedures in his meat product control chart. The HACCP control chart in the current study is similar to some previous studies [15, 25, 30]. One CCP, metal detection, and two oPRPs, baking and packaging, were discovered during the cake manufacturing process. The center temperature of the bakery product crumb needs to be above 100 °C for few minutes. During baking, all vegetative pathogenic bacteria should be destroyed [31, 32]. The main ingredients of cake dough include fats and oils, eggs, flour, and sugar. Among these, sugar is comparatively safe in regard to any foodborne illness. Fats and oils can be a potential source of Listeria [9]. Flour, on the other hand, can pose both chemical and microbial risks. However, the most dangerous and common thing that can happen is mycotoxin, such as aflatoxin. Despite the fact that the physicochemical properties of flour (i.e., low aw) do not allow bacteria to grow, microorganisms can survive for extended periods of time during storage [9]. As for the egg shells, they are considered as a major source of Salmonella enteritidis [33, 34]. However, cake dough is not considered a high-risk food because it has a low aw and requires baking prior to packaging and consumption [9, 35].Table 6
oPRPs in the cake manufacturing process.
Processing stepHazardControl measure(s)Critical limitMonitoring proceduresRecordsCorrective actionVerificationWhat?How?Who?Frequency (when?)BakingBiological: microbial contaminationMaintenance of baking temperature and time as per SOPBaking temperature between 150 and 250 °C for 5–50 minutesOven temperaturePhysical inspectionQA officer, production officerEvery one hour intervalQA and production (plan oPRP)Reset the temperature and time, reject or reuse the productPhysical observation, calibrationPackagingBiological: microbial contaminationRegular hand and surface swab test, ATP check before packing, strict maintaining of personal hygiene, QA online check for leak packageSurface ATP = <50 RLU; Hand swab for coliform = nil; Hand swab for mold = <50 cfu/mlMachine surface, workers handsSwab test, microbiological test in the QA labQA executiveATP test every day, hand swab test twice in a weekQA and production (plan oPRP)Reclean the surface, observation (hygiene status) of infected hands (person) for a month, reject the leak pack and productsRecheckTable 7
HACCP control chart.
Processing stepHazardControl measure(s)Critical limitMonitoring proceduresRecordsCorrective actionVerificationWhat?How?Who?Frequency (when?)Metal detectionPhysical: metallic componentDetection of metallic component by metal detectorAbsence of metallic componentSensor of the metal detector, PLC, alarmPhysical inspection and check for alarm (by passing a metal under the metal detector)Maintenance dept., QA and production dept.Every 1 hr interval during the production timeQA, production, and maintenance register (plan CCP)Rejection of the whole lot of nonconformed productsIn-house checking by metal pieces, maintenance records, calibration of metal detector, and auditingThe physical hazard of metal in cake is the most serious, and it is harmful to the consumer. Metal detectors can now be used to detect and remove metallic components during food processing. The presence of metallic components can significantly reduce food safety, resulting in perforation of human gastrointestinal tissues and surgical resection. The presence of metallic particles can cause damage to various valuable machine parts, resulting in a sudden production line shutdown and economic loss. Metal detectors are installed by food processing industrialists for product quality and safety, equipment protection, consumer satisfaction, and regulatory body requirements, among other things. Metal detectors are extremely important and effective for metal hazard control in solid seasoning powder and liquid sauces through the implementation of a HACCP plan [36]. In the current study, there was no additional step in the manufacturing process that could detect or eliminate this problem, according to the process flowchart. According to a study conducted by [13], packaging and cartooning are the most important parts of the production process, with no other steps left out to assure process safety. The authors in [13] conducted their study on a biscuit manufacturing plant in Bangladesh. Baking and metal detection were also identified as two of the CCPs in that investigation, which is consistent with the current study.To ensure that the HACCP plan is working as intended, the food safety team developed a verification strategy that describes the goal, methods, frequency, and responsibilities for the verification activities. Records and documentation are generated to offer evidence of the system’s effective execution [37]. Different documentation formats were also employed in our research to monitor specified measure control and ensure suitable corrective actions. Documentation often included deviations, accompanying remedial activities, and veriﬁcations. The following aspects for monitoring procedure comprised of HACCP were object, such as additive quantity; method, such as requiring for inspection report; frequency, such as every batch; and persons, such as operators [38].This present study identifies a significant risk that could have an impact on public health. Nonetheless, the process was controlled by systematic monitoring from primary to final production that was a critical concern for food safety. This system is subject to regular systematic monitoring. CCP was not the only factor. The documentation and data provided by the HACCP system could easily aid in the tracing of the contamination [13]. This approach also aided in the prevention of cross contamination. Finally, it can be declared that this approach delivers greater quality and hygiene standards and ensures superior cake quality.


## 3.1.1. Listing the Prerequisite (PRP)

Prior to the HACCP system, PRPs are systematically applied in the food processing sector to support and improve the system’s effectiveness and efficiency. PRP application is considered as the foundation of HACCP system. PRP represents the formalization of GMP and GHP elements [24]. The PRPs were PRP environmental hygiene, PRP establishment-design and facilities, PRP premises and rooms, PRP equipment, PRP water supply, PRP drainage and waste disposal, PRP cleaning and sanitation, PRP personnel hygiene facilities and toilets, PRP temperature and air quality control, PRP lighting, PRP handling, storage, and transportation, PRP control of operation, PRP pest control, PRP waste management, PRP traceability, and PRP training.


## 3.1.2. Preliminary Steps to Enable Hazard Analysis

The implementation of a food safety system (HACCP) is a continuous process that is based on the management concepts of an iterative four-step management method known as the PDCA cycle (plan, do, check, and act).(1) The HACCP team. A team was formed to implement an efficient HACCP system. While assembling the HACCP team for the company, the following factors were taken into account. The team was supposed to have six members.(a)
In terms of qualifications and experience, the members must be competent in their particular fields of activity(b)
The team should be led by a team leader who will direct the activities(c)
The team coordinator will be in charge of developing, implementing, and maintaining the HACCP system(d)
All team members are expected to receive proper training(e)
The team must develop and maintain all documents in accordance with the HACCP system(f)
Furthermore, if there is a change or modification in the process, the team must examine the adequacy of the HACCP system on a yearly basisThus, the formation of the HACCP team was as follows:HACCP Team LeaderPlant ManagerHACCP Team CoordinatorManufacturing ManagerHACCP Team MembersQuality Assurance ManagerManager-HRM and ComplianceWare House ManagerMaintenance Manager (Electrical)Maintenance Manager (Mechanical)Supply Chain ManagerThe team leader, as the highest authority, maintains the smooth operation of the company and ensures that all legal criteria for its proper operation are met. It is also his obligation to supervise all phases of the plan, as well as the responsibilities and coordination of all internal and external corporate operations [25]. The team members are responsible for keeping and regulating the records related to their area of operation.(2) Product characteristics and intended use. The HACCP team needs to start with a thorough description of the produces, defining their composition and chemical, biological, and physical properties.Table1 shows the generic framework for the description of cake.Table 1
Product description and intended use.
ProductCake is a bakery productProduct compositionWheat flour, sugar, eggs, salt, vegetable fat, glycerol, starch, wheat starch, skim milk powder, raising agents (E 500), preservative (E 202), and flavorProduct characteristicsPhysicochemical characteristics:Moisture18–22% wbWater activity (aw)0.76–0.81Acid value of extracted fat, (as oleic acid), percent by mass, max.1.0Protein5–7 g/100gMicrobiological characteristics:Total viable count, cfu/g, max.20000Enterobacteriaceae spp.≤ 102 UFC/gStaphylococcus aureus≤ 102 UFC/gSalmonella spp.AbsentListeria monocytogenesAbsentColiformAbsentMold, maximum50 CFU/gSensory characteristics:Physical conditionSolidColorCharacteristicsFlavorTypicalTextureTypicalLabeling requirementsProduct’s name, composition, allergen information, origin, manufactures date, expiry date, destination, net weight, storage temperature, and destinationStorage and transport conditionsPrimary packages should be packaged further in a secondary packing procedure (gift boxes). Secondary boxed must packed in tertiary packaging (cartons). Final storage and transportation should make at ambient temperatureShelf life4 monthsIntended useDirect consumption. The product mentioned is for the general population, except for gluten-sensitive groupsApplicable lawsBDS 1574, specifications for cakes; BDS 1240, specifications for drinking water; BDS 381, specifications for maida; BDS 1567, specifications for refined oil; BDS 79, specifications for jams and jellies; BDS 1615, specifications for cocoa powder; BDS 138, specifications for refined sugar; BDS 207, specifications for milk powder and cream powder; BDS 822, code of hygienic conditions for food processing units, etc.(3) Construction of flow diagram. A flowchart showing the whole manufacturing process of cake was constructed (Figure 2). The HACCP team checked the flow diagrams on site. It is critical that the flowchart be properly prepared and thoroughly analyzed on the ground and contain as much information as feasible. Only a well-planned, informative, and well-analyzed flowchart helps to facilitate overall production process, making it much easier to detect potential deviations [25].Figure 2
Complete flowchart of the cake manufacturing process.


## 3.1.3. Hazard Analysis and Identification of CCPs and oPRPs

The hazard analysis assists in identifying potential hazards associated with the entire process, from raw material receipt to product delivery to consumers. During the hazard analysis, hazards were further categorized into three categories: (a) biological, (b) physical, and (c) chemical [26]. Hazard analysis or identification is generally aimed to identify potential threats to human health that may be introduced into baked goods during the manufacturing process. Based on the hazard analysis, further risk assessments were accomplished. In the process of risk assessment, customer complaints, shipment returns, and laboratory test results were typically taken into account [27]. Hazards as identified for each step of the process flow diagram were entered in the format. Following the completion of the subsequent process steps, values for the likelihood of the hazard’s presence and the consequences of the hazards were entered into the assessment column. The values were determined as in Table 2 and Table 3.Table 2
Likelihood and consequence criteria to specify potential hazard in cake manufacturing process.
Likelihood (probability)Consequences (severity)4. Frequent, e.g., daily4. Very high (catastrophe), e.g., death3. Likely, e.g., weekly3. High (critical), e.g., illness2. Occasional, e.g., monthly2. Medium, e.g., injury1. Unlikely, e.g., yearly1. Minor, e.g., no injuriesTable 3
Analysis of likelihood vs. consequences.
Hazard typesLikelihood (probability)Consequences (severity)RIPhysical (stones, sand, husks, and plastic)XyXyChemical (mercury (hg), chromium (cr), aflatoxin, melamine)XyXyBiological: total plate count (TPC), coli form, molds, and pestsXyXyThe likelihood, i.e., probability, and consequences of a specified hazardous event occurring are combined to form risk. Thus, it can be defined as follows: risk index (RI) = likelihood × consequences.Significant hazards were identified using a numerical scale of one (1) to four (4) of likelihood and consequence. When rating likelihood and consequences, previous experiences, records, and data were considered (Table3).According to Table3, the IR for this current study varies between 1 and 12. The calculated risk index shows that if the RI is higher than 8, then it should be managed by the HACCP plan. HACCP plan is a document prepared in accordance with the seven principles of HACCP [25]. On the other hand, when the IR is less than 4, the results should be maintained by the oPRPs [25]. The RI for the production of cake is shown in Table 4.Table 4
Risk index and its management [25].
RIRisk typeManagement of riskRI ≤ 4Satisfactory riskShould be managed by oPRPs4 ≥ RI ≤ 8Lower risk8 ≥ RI ≤ 12Increased riskShould be managed by the HACCP plan12 ≥ RI ≤ 16Critical riskAfter completing the hazard assessment, relative control measures are selected with the help of the CCP decision tree as shown in Figure3. CCP is a step in which a specific control measure must be implemented in order to prevent or eliminate a food safety hazard or reduce the risk to an acceptable level [16] (Section 3.1).Figure 3
CCP decision tree for HACCP implementation (adopted from [15]).An oPRP’s components are the same as those of a CCP, with the exception that no critical limit is required for control measure(s) [15], and failure in the manufacturing process has no direct effect on the process [25]. The hazard analysis of the cake manufacturing process is shown in Table 5.Table 5
Hazard analysis for the production process of cake.
Processing stepHazardsRisk effectsProbable causesRisk evaluationControl measures (SOP or work instructions)Decision treeRecordPSRIQ1Q2Q3Q4Q5Receiving of raw and packaging materialsPhysical: foreign objects, such as hair, insects, broken plastics.Without consequencesPackaging, hygiene, pest control313Visual inspectionYYNYYPRPChemical: acidity, melamine, heavy metals, residual chemical, etc.Without consequencesCoA, packaging133Supplier evaluation, CoA, HACCP certificate, personal and transport hygiene status, lab test (QA)YYNYYPRPBiological: microbial contamination (pathogenic)With consequencesCoA, hygiene144Supplier evaluation, CoA, HACCP certificate, personal and transport hygiene status, lab test (QA)YYNYYPRPStorage of raw and packaging materialsPhysical: foreign objects, insectsWithout consequencesIrregular inspection and improper hygiene313Keep storage environment safe, keep containers closed. Separate areas for raw and packaging materialsYYNNPRPChemical: production of H2S (eggs)Without consequencesStorage temperature212Maintaining suitable storage condition, FIFONPRPBiological: microbial, pests and insectsWith consequencesTransport and storage temperature, pest control, hygiene144FIFO, maintaining suitable storage and transport temperature, pest controlling plan, maintain personal and environmental hygiene during storage and transportYYNYYPRPTaking RM and PM from storage to productionPhysical: foreign objectsWithout consequencesImproper handling and personal hygiene313Maintain personal hygiene, wear mask, apron, gloves, head cover and beard cover, maintain SOP, GHPYYNYYPRPChemical: unidentifiedBiological: unidentifiedBatch preparation (weighing and mixing)Physical: foreign objects, broken egg shellsWithout consequencesImproper handling and personal hygiene212Provision of filter in egg broker machine, visual inspection, maintaining personal hygiene, wear mask, apron, gloves, head cover, and beard coverYYNYYPRPChemical: excess additives, detergents, etc.Without consequencesIncorrect hygiene and cleaning, faulty recipe111Follow the recipe and recheck, timely calibration of measuring instrumentsNPRPBiological: Pathogenic microorganismWith consequencesImproper personal hygiene144Strict personal hygiene, regular hand swab tests by the QA, proper hygiene, food safety, and behavioral trainingYYNYYPRPMixingPhysical: broken piece of mixing machine, foreign objectsWith consequences, without consequencesMaintenance of mixing machine, improper personal hygiene313Checking the status of mixing machine, maintain personal hygiene, wear mask, apron, gloves, head cover, and beard coverYYNYYPRPChemical: detergents residueWithout consequencesImproper hygiene and cleaning practice111Maintain proper hygiene and cleaning practiceYYNYYPRPBiological: pathogenic microorganismWith consequencesImproper personal hygiene144Maintain strict personal hygiene, wear mask, apron, gloves, head cover and beard cover, keep the equipment properly sanitizedYYNYYPRPDosingPhysical: broken piece of dosing nozzleWith consequencesMaintenance of dosing machine111Checking the status of dosing machineYYNYYPRPChemical: unidentifiedBiological: unidentifiedBakingPhysical: unidentifiedChemical: moisture content and water activityWithout consequencesImproper baking time and temperature313Frequent lab test for MC andaw from each batch, maintenance of baking temperature and time as per SOPNPRPBiological: microbial contaminationWith consequencesImproper baking time and temperature144Maintenance of baking temperature and time as per SOPYYNYNoPRPCoolingPhysical: unidentifiedChemical: moisture content and water activityWithout consequencesImproper cooling time and temperature212Check for cooling conveyor speed and cooling temperatureNPRPBiological: unidentifiedCream fillingPhysical: broken part of cream dosing nozzleWith consequencesMaintenance of cream filling machine122Checking the status of cream filling machineYYNYYPRPChemical: unidentifiedBiological: unidentifiedMetal detectionPhysical: metal partsWith consequencesInactive sensor of the metal detection machine, machine broken3412Frequent checking of the machine statusYYYNNCCPChemical: unidentifiedBiological: unidentifiedPackagingPhysical: foreign parts from packaging machine surface, damaged pack, leakage in packingWith consequencesImproper cleaning, shortage of nitrogen gas, PLC fault313Proper cleaning of packaging machine, check for nitrogen gas level, regular checking of the PLC systemYYNYYPRPChemical: detergents residueWithout consequencesImproper hygiene and cleaning practice111Maintain proper hygiene and cleaning practiceYYNYYPRPBiological: microorganismsWith consequencesImproper personal hygiene, contamination in packing materials248Regular hand and surface swab test, ATP check before packing, strict maintaining of personal hygiene, QA online check for leak packageYYNYNoPRPFilling in box and date codingNo hazardWithout consequencesNo riskFinished goods storePhysical: tertiary package damage by rodentsWithout consequencesNo pest traps and pest control212Put glue trap in proper places, conduct timely pest control actionYYNYYPRPChemical: unidentifiedBiological: unidentifiedDelivery transport to marketNo hazardNo risk


## 3.1.4. Establishing the oPRP and HACCP Plan

The HACCP plan was established for each oPRP and CCP by specifying the hazards, control measures, CL, corrective action, verification, and records management. The potential control points for the hazards appeared in both the raw material and the manufacturing process. Table6 and Table 7 show the oPRP and HACCP plan in the cake manufacturing process. The HACCP control chart (Table 7) showed all the potential critical hazards that can occur during the processing steps. Gandhi [28] included hazard description, critical limit, observation procedure, responsible person, monitoring procedure, and corrective action in his HACCP control chart for soy milk production, whereas Burson [29] reported processing steps, records, and verification procedures in his meat product control chart. The HACCP control chart in the current study is similar to some previous studies [15, 25, 30]. One CCP, metal detection, and two oPRPs, baking and packaging, were discovered during the cake manufacturing process. The center temperature of the bakery product crumb needs to be above 100 °C for few minutes. During baking, all vegetative pathogenic bacteria should be destroyed [31, 32]. The main ingredients of cake dough include fats and oils, eggs, flour, and sugar. Among these, sugar is comparatively safe in regard to any foodborne illness. Fats and oils can be a potential source of Listeria [9]. Flour, on the other hand, can pose both chemical and microbial risks. However, the most dangerous and common thing that can happen is mycotoxin, such as aflatoxin. Despite the fact that the physicochemical properties of flour (i.e., low aw) do not allow bacteria to grow, microorganisms can survive for extended periods of time during storage [9]. As for the egg shells, they are considered as a major source of Salmonella enteritidis [33, 34]. However, cake dough is not considered a high-risk food because it has a low aw and requires baking prior to packaging and consumption [9, 35].Table 6
oPRPs in the cake manufacturing process.
Processing stepHazardControl measure(s)Critical limitMonitoring proceduresRecordsCorrective actionVerificationWhat?How?Who?Frequency (when?)BakingBiological: microbial contaminationMaintenance of baking temperature and time as per SOPBaking temperature between 150 and 250 °C for 5–50 minutesOven temperaturePhysical inspectionQA officer, production officerEvery one hour intervalQA and production (plan oPRP)Reset the temperature and time, reject or reuse the productPhysical observation, calibrationPackagingBiological: microbial contaminationRegular hand and surface swab test, ATP check before packing, strict maintaining of personal hygiene, QA online check for leak packageSurface ATP = <50 RLU; Hand swab for coliform = nil; Hand swab for mold = <50 cfu/mlMachine surface, workers handsSwab test, microbiological test in the QA labQA executiveATP test every day, hand swab test twice in a weekQA and production (plan oPRP)Reclean the surface, observation (hygiene status) of infected hands (person) for a month, reject the leak pack and productsRecheckTable 7
HACCP control chart.
Processing stepHazardControl measure(s)Critical limitMonitoring proceduresRecordsCorrective actionVerificationWhat?How?Who?Frequency (when?)Metal detectionPhysical: metallic componentDetection of metallic component by metal detectorAbsence of metallic componentSensor of the metal detector, PLC, alarmPhysical inspection and check for alarm (by passing a metal under the metal detector)Maintenance dept., QA and production dept.Every 1 hr interval during the production timeQA, production, and maintenance register (plan CCP)Rejection of the whole lot of nonconformed productsIn-house checking by metal pieces, maintenance records, calibration of metal detector, and auditingThe physical hazard of metal in cake is the most serious, and it is harmful to the consumer. Metal detectors can now be used to detect and remove metallic components during food processing. The presence of metallic components can significantly reduce food safety, resulting in perforation of human gastrointestinal tissues and surgical resection. The presence of metallic particles can cause damage to various valuable machine parts, resulting in a sudden production line shutdown and economic loss. Metal detectors are installed by food processing industrialists for product quality and safety, equipment protection, consumer satisfaction, and regulatory body requirements, among other things. Metal detectors are extremely important and effective for metal hazard control in solid seasoning powder and liquid sauces through the implementation of a HACCP plan [36]. In the current study, there was no additional step in the manufacturing process that could detect or eliminate this problem, according to the process flowchart. According to a study conducted by [13], packaging and cartooning are the most important parts of the production process, with no other steps left out to assure process safety. The authors in [13] conducted their study on a biscuit manufacturing plant in Bangladesh. Baking and metal detection were also identified as two of the CCPs in that investigation, which is consistent with the current study.To ensure that the HACCP plan is working as intended, the food safety team developed a verification strategy that describes the goal, methods, frequency, and responsibilities for the verification activities. Records and documentation are generated to offer evidence of the system’s effective execution [37]. Different documentation formats were also employed in our research to monitor specified measure control and ensure suitable corrective actions. Documentation often included deviations, accompanying remedial activities, and veriﬁcations. The following aspects for monitoring procedure comprised of HACCP were object, such as additive quantity; method, such as requiring for inspection report; frequency, such as every batch; and persons, such as operators [38].This present study identifies a significant risk that could have an impact on public health. Nonetheless, the process was controlled by systematic monitoring from primary to final production that was a critical concern for food safety. This system is subject to regular systematic monitoring. CCP was not the only factor. The documentation and data provided by the HACCP system could easily aid in the tracing of the contamination [13]. This approach also aided in the prevention of cross contamination. Finally, it can be declared that this approach delivers greater quality and hygiene standards and ensures superior cake quality.


## 4. Conclusion

The HACCP system provides food manufacturers with effective preventive methods for ensuring food safety and improving the quality. Furthermore, the documentation and records generated by the HACCP system can easily assist in tracing the source of contamination, preventing further production of substandard products and reducing the consumption of manpower, material, and financial resources. The current study developed a HACCP plan for a cake manufacturing plant in Bangladesh in order to improve product safety and quality. The hazards in cake manufacturing are primarily due to the use of improper processing conditions, an unsanitary manufacturing environment, and a lack of legislative implementation. We found a CCP and two oPRPs in the entire cake manufacturing process. Further linking of the HACCP system introduced in the factory for quality management systems, such as International Organization for Standardization regulation, can potentially provide higher quality/hygiene standards, as well as increasing customer awareness. However, rather than establishing the HACCP system, management teams of food corporations should ensure the application of the HACCP system in their entire production system.



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*Source: 5321333-2022-03-09.xml*