Implementation of HACCP management system: Case study of a baking industry (cake) in Dhaka, Bangladesh.

: The study aims to provide technical information on the development and application of hazard analysis and critical control points (HACCP) in one of Dhaka's popular baking (cake) industries. 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 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 action as components of several HACCP principles. One critical control point (CCP) and two operational pre-requisite programs (oPRPs) were identified throughout the manufacturing process.

safety management system contributes to this goal in an open and transparent manner (Shuvo et al., 2019). 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 (FAO & WHO., 2003). 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 (FAO and WHO, 2003).
HACCP implementation is based on seven principles that are used to identify and control hazards to an acceptable level. 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 (FAO & WHO. 2003, Walker et al., 2003. 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 (Shuvo et al., 2019).
Food contamination and adulteration have recently emerged as major public health concerns in Bangladesh. As a result, an independent food safety body named BFSA was formed in 2014. According to the BABBMA, there are approximately 60 large factories registered in Bangladesh that manufacture bakery products (BAPA, 2021). Pesticide residues and postprocessing contamination with pathogenic microbes such as Salmonella and E. coli are the most prevalent food safety risks in this sector (Suman et al., 2021). 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 (Suman et al., 2021). This current study aimed to implement the HACCP system in the cake manufacturing plant in order to identify CCPs, thereby establishing an effective preventive system that will lead to safer and more efficient cake production. The application of the HACCP system can effectively ensure the quality and safety of the final product.

Company description
This study was conducted in a baking industry located in the Dhaka division of Bangladesh, which was a joint venture manufacturing. 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 industry. 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 shown below is adopted from the corresponding authors' previous work (Jubayer et al., 2020). He has conducted additional research in the same industry in 2020.

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 (CAC, 1997).
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 5: Establishing corrective actions to be executed when monitoring indicates a deviation from a predefined critical limit.
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.

Results and discussion
3.1 Implementation of HACCP plan 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 (Wallace & Williams, 2001 A team was formed to implement an efficient HACCP system. While assembling the HACCP team for the baking industry, 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 basis.
Thus the formation of the HACCP team was as follows.

Product characteristics and intended use
The HACCP team needs to start with a thorough description of the produces, defining their composition, chemical, biological, and physical properties. Table 1 shows the generic framework for the description of cake.

Construction of flow diagram
A flowchart showing the whole manufacturing process of cake was constructed ( Figure 1).
The HACCP team checked the flow diagrams on-site. Only a well-planned, informative, and well analyzed flowchart helps to facilitate overall production process, making it much easier to detect potential deviations (Pombo Marques et al., 2012).
. Figure 1. Complete flowchart of the cake manufacturing process.

Hazard analysis, identification of CCP's 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, c) chemical, and (Fernández-Segovia et al., 2014). 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 (Batista et al., 2003). 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 in the following way ( Table 2 and Table 3). Table 2. Likelihood and consequence criteria to specify potential hazard in cake manufacturing process The likelihood, i.e. probability, and consequences of a specified hazardous event occurring are combined to form risk. Thus it can be defined as,

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 (Table 3). After completing the hazard assessment, relative control measures are selected with the help of the CCP decision tree Figure 2. 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 (ISO 22000, Section 3.10).
Preprints (www.preprints.org) | NOT PEER-REVIEWED | Posted: 26 July 2021 doi:10.20944/preprints202107.0577.v1 Figure 2. CCP decision tree for HACCP implementation (adopted from Allata et al., 2017) 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) (Allata et al., 2017) and failure in the manufacturing process has no direct effect on the process (Pombo Marques et al., 2012). The hazard analysis of the cake manufacturing process is shown at Table 5.

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. Table 6 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, (2009) 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, (2015) 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 (Allata et al., 2017;Pombo Marques et al., 2012;Zhao 2003). One CCP, metal detection, and two oPRP, 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. (Smith et al., 2002;Bryan et al. 1997). 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 (Wu et al., 2017). 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 (Wu et al., 2017). As for the egg shells, they are considered as a major source of Salmonella Enteritidis (FDA, 2009b;Howard, 2012). However, cake dough is not considered a high-risk food because it has a low aw and requires baking prior to packaging and consumption (Wu et al., 2017;Clark, 2011).  (Chen et al., 2020).
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.

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 increased 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.