Assessing Food Safety Compliance in a Small-Scale Indian Food Manufacturer: Before and after Certification of the Food Safety Management System and Foreign Supplier Verification Program

Abstract

The implementation of food safety management systems has a great influence on global food safety and security, especially for developing nations. The principles of the Hazard Analysis and Critical Control Points are crucial for food safety and are the basis of food safety management systems. The purpose of this study was to assess the food safety management systems of a selected small-sized food company in India, both before and after certification of the International Organization for Standardization (ISO) 22000 and the Foreign Supplier Verification Program (FSVP). This company manufactured traditional fried vegetable snacks using manual processing. The effectiveness of these certifications was assessed through direct audit. The integrated FSVP and ISO 22000 audit checklist were elaborated and applied in this study. It was shown that the certification significantly improved (97.14%) food safety system conformity in the company in question. Before certification, many non-compliances were found, especially for HACCP implementation. After certification, the only non-conformity concerned pest control. The integrated FSVP and ISO 22000 audit checklist used for the assessment enabled an evaluation of several factors: the food quality and safety compliance level, the effectiveness of certification, and the readiness of the small-sized Indian snack producer to develop the export of their products to the U.S. and other developed countries. It was shown that certification enabled a small-sized Indian food producer to meet the requirements of ISO 22000 and FSVP, which are the prerequisites for exporting to the U.S. and other developed countries.

1. Introduction

India is the most populous country in the world and has become one of the World’s largest food producers and exporters. This is of particular importance in the context of world population growth—now at over 8 billion—and increasing global food shortages, which are exacerbated by climate changes. Also, wars, such as in Ukraine, disrupt existing food supply channels. However, Indian food exports are often constrained by unverified food safety and the absence of certifications, which restricts the supply of Indian food to other countries [1,2]. Also, Indian food exporters regularly face challenges, such as foodborne illnesses and numerous recalls, bans, and rejections, which are mostly related to non-compliance with the stringent food safety and health standards and regulations set by developed importing countries. However, implementing and following these international food safety standards can result in certain difficulties, especially for small-scale food companies in developing countries [3].

Food safety incidents, such as the 2015 withdrawal of Maggie Noodles and government surveillance of foodborne diseases, have helped raise awareness of food safety in India [4]. The implementation of food safety requirements in India has become a significant task in recent years. Also, the Indian government is implementing policies and many schemes to promote sustainable agricultural practices [3]. However, in comparison to other countries, such as the United States (U.S.), the United Kingdom (U.K.), the European Union (E.U.), and Japan, food safety requirements and inspections in the Indian food chain are still not rigorous enough. In 2006, the Government of India consolidated food regulations into a single act known as the Food Safety and Standards Act (FSSA, 2006). The FSSA covered the concept of food safety across the entire supply chain—from manufacturing and storage to distribution. The FSSA consolidated the laws relating to food and established the Food Safety and Standards Authority of India (FSSAI) to lay down science-based standards for regulating food manufacturing, storage, distribution, and sale to increase food safety [5]. Under the FSSAI, in 2011, six regulations were implemented, covering the interests of food business operators and consumers, e.g., Food Safety Standards (FSS) (licensing and registration) and FSS (packaging and labelling) [6,7]. The FSSA laid down rules and regulations for running a food business and is also responsible for the registering and licensing of food business operators. Small operators, like street food vendors and local shops, are required to obtain registration with minimum Good Hygiene Practices (GHP) and Good Manufacturing Practices (GMP) requirements. However, medium and large operators are required to obtain a license under the Food Safety Regulations (2011) and need to be able to demonstrate the implementation of hazard control using the HACCP-based approach [8]. Consequently, India’s presence in the global food market for both raw and processed foods is growing. Although the Indian food industry is attempting to meet food hygiene requirements, there is a level of uncertainty due to a lack of harmonisation of food standard regulations between India and other countries [9].

Currently, a triangulation of various methods is used all over the world to assess and analyse food safety culture [10,11]. However, in India, only the audit method seems feasible due to the different cultures of operation, data collection, and food safety. The audit covers an assessment of all processes in the plant and concerns both process documentation, their practical implementation, and the skills and qualifications of staff. In addition, in a small Indian plant that manufactures traditional snacks using manual processing and that has never used advanced assessment methods before, an audit is the only solution to assess the implemented system [12]. Therefore, the implementation and certification of a food safety management system would seem to be a reliable method to improve the level of food safety culture.

The successful implementation of food safety standards in food businesses is proved during the certification process. There are several internationally accepted private, voluntary standards, including the British Retail Consortium (BRC), International Featured Standards (IFS), Food Safety Management Systems 22000 (ISO 22000), and Quality management systems (ISO 9001) [13,14,15,16,17,18]. Private standards have stimulated exports from suppliers in developing countries [19]. Some local organizations, e.g., the Cashew Export Promotion Council of India (CEPCI), have supported the adoption of private food safety standards such as ISO and HACCP. Apart from offering training on quality certification, CEPCI covers up to a third of the costs stemming from food safety certification, including consultancies, audits, and the equipment required for quality control [20]. The certifications ensure that food businesses comply with the appropriate standards. Another example of voluntary standards is the U.S. Foreign Supplier Verification Program (FSVP), mandated by the Food and Drug Administration (FDA). FSVP mandates importers to verify that their foreign suppliers of food for both human and animal use comply with the applicable FDA safety requirements [21]. ISO 22000, also called Food Safety Management Systems 22000 is a globally recognised auditable standard. Developed countries have strong Food Safety Management Systems (FSMS) and well-established statutory frameworks, thereby effectively managing food safety hazards and reducing foodborne infections. In contrast, developing nations, especially small-scale producers, face challenges when implementing FSMS because of limited financial resources, limited access to international markets, huge costs, weak regulations, and a lack of awareness about food safety and the benefits of FSMS [3,22]. But these challenges seem minor when compared to the costs associated with non-compliance [23].

International certification is necessary for food exporters who wish to enter the markets of developed countries [24]. However, there is a significant gap in the literature discussing the implementation of FSVP within the Indian food sector and its influence on the approval of quality management system standards in small food companies. While some research has been conducted on the impact of ISO 22000 certification on food quality, it is important to note that these studies were not performed in the Indian food sector [25,26,27,28,29,30]. There are only a few papers including authors from India discussing the role of food safety management systems in safe food production or ISO 22000 implementation methodology [31,32,33], and there is a lack of ready-to-implement tools, i.e., an integrated audit checklist, making it possible to check the requirements of both FSVP and ISO 22000 standards.

The Indian food processing industry is primarily export-oriented and also an exporter of processed vegetables to many countries. The research gap concerns the lack of knowledge about the readiness of small Indian food enterprises to meet the requirements of FSVP and ISO 22000 and their readiness to export to the U.S. or other developed countries. There are also no reports showing that FSVP and ISO 22000 certification are possible for small food producers in India. The next research gap concerns the impact of certification on the functioning of the quality and safety systems in small-sized Indian food companies. Furthermore, though India exports food products to many countries, including the U.S., the exporters are big companies. For these reasons, our hypothesis is that optimisation of food safety management in a small factory that manufactures traditional fried vegetable snacks using manual processing in India is possible by implementing non-mandatory food safety standards. Therefore, the aim of this study was to assess the food safety management system before and after certification of ISO 22000 and the Foreign Supplier Verification Program in a selected small-sized food producer in India using direct audit.

2. Materials and Methods

2.1. Materials

The company selected for this study was a small-sized company [34], Malayalam Exports. The company employed 25 workers and was located in Kerala State in India. The company manufactured a variety of South Indian fried vegetable snack products. Production was carried out six days a week and consisted of one eight-hour production shift, followed by half an hour for sanitation. The company was selected because of its small size and its production of traditional fried vegetable snacks using manual processing. A sanitary facility program was in place, with dry-cleaning procedures enforced in most production areas of the facility to minimise the establishment of environmental pathogens. A separate wet-washing room was used for washing, drying, and sanitising small equipment. The reason for the selection of this company for this study was because the enterprise was an exporting company, intending to expand exports to developed countries. The selected company achieved two certifications: ISO 22000:2018 and the Foreign Supplier Verification Program (FSVP) certification to fulfil their importing countries’ standard requirements. Both certifications were conducted by third-party audits (SGS India Pvt. Ltd., Gurugram, India) (Figure 1). Prior to the implementation, no staff members had received specialised instruction in the fundamentals of food safety. The factory hired and trained an expert for this job in order to prepare for the implementation. The hiring and training of such a worker was one of the crucial responsibilities involved in the implementation process.

2.2. Assessment

The assessment was done in two periods: stage 1 in 2019, i.e., before the FSVP and ISO 22000 certification, and stage 2 in 2021, i.e., after FSVP and ISO 22000 certification. The assessment was carried out by an internal audit method. The audit methodology was based on the guidelines given in ISO 19011 [12] and the plant’s own internal audit procedure. The assessment checklist was prepared based on the requirements of the Foreign Supplier Verification Program for Importers of Food for Humans and Animals (FDA, 2014), ISO 22000 (2018) and previous research on this subject [14,21,31,35]. An integrated audit checklist was developed to encompass the standard requirements of both the FSVP and ISO 22000. Before implementation, this comprehensive checklist was piloted by a quality manager and two independent experts. All shortcomings were improved. The checklist contained 70 questions grouped into 10 food safety sections: regulatory compliance, food safety plan, process and product control, sanitation, workers’ hygiene practices, plant and grounds, food allergens, pest control, packaging and labelling, and employees and visitors (Figure 2 and

Table 1. The integrated audit checklist is according to the Foreign Supplier Verification Program (FSVP) and ISO 22000 requirements [17,21,36,37].

>No	Assessment Questions		Stage 1		Audit Evidence	Stage 2		Audit Evidence
			C *	NC **		C	NC
1.	Regulatory Compliance
	1.1	Does the company have a written Food Safety Policy? Is it readily available to relevant employees?
	1.2.	Does the company have a documented training program on food safety and quality for all associates including upper management?
	1.3.	Does the company have a current organizational chart that shows all individuals responsible for food safety and quality?
	1.4.	Does the company have a responsible, designated Quality Assurance or Food Safety Manager?
	1.5.	Does the company have a preventive control qualified individual (PCQI)?
	1.6.	Does the company have a written and documented customer complaint program?
	1.7.	Does the company have documentation to track the effectiveness of policies?
	1.8	Does the company operate in accordance with the Quality and Safety policy?
	1.9	Does the company have a system in place to correct all violations noted in regulatory, in-house and third-party inspections?
	1.10	Are all required licenses present and current?
2.	Food Safety Plan
	2.1	Has the company developed a food safety plan as per FSMA regulations?
	2.2	Does the food safety plan cover the HACCP plan for the company?
	2.3.	Does the company conduct hazard analyses based on experience, illness data, scientific reports, etc.?
	2.4	Does the food safety plan cover a written preventive inspection as required?
	2.5	Does the company document and implement food allergen preventive controls?
	2.6	Does the company maintain food safety plan-based records?
	2.7	Are the food safety plan-based records overseen by the PCQI in place?
	2.8	Does the food safety plan cover a recall plan as required?
	2.9	Does the company have a risk-based environmental monitoring plan?
	2.10	Have all critical control points (CCP), critical limits, monitoring procedures and corrective actions been correctly identified, documented and implemented?
3.	Process and Product Control
	3.1	Does the company maintain product specifications for all raw materials, ingredients and packaging which is available to all relevant personnel?
	3.2	Is there a written and documented program in place to verify raw materials for compliance with specifications?
	3.3	Does the company require and maintain letters of guarantee on a yearly basis or certificates of analysis for incoming raw materials, ingredients and packaging?
	3.4	Has the company developed, documented and monitored a pre-requisite program?
	3.5	Does the company have procedures and systems in place to prevent cross-contamination between raw materials, packaging and finished products?
	3.6	Does the company conduct routine calibration of operational equipment and measuring devices?
	3.7	Does the company have a product traceability plan?
	3.8	Does the company have a metal detector or magnets in the packaging areas?
	3.9	Does the company conduct mock withdrawal?
	3.10	Does the company use proper identification labels for all stored ingredients?
4.	Sanitation
	4.1	Does the company have a master cleaning schedule (MCS)?
	4.2	Do records and inspections indicate that the MCS is being properly executed?
	4.3	Are all food contact equipment and utensils clean and properly stored in a sanitary manner and re-sanitised prior to use?
	4.4	Are all non-food contact areas such as floors, walls, ceilings, fans, blowers, racks, etc. maintained and cleaned in an orderly manner?
	4.5	Are all garbage, trash and other waste materials disposed of in identifiable, covered containers?
	4.6	Are all pallets spaced at an adequate distance from walls to facilitate cleaning and monitoring for pests?
	4.7	Are waste containers clearly identified as to their intended purpose?
	4.8	Is waste removed from processing areas on a regular basis?
	4.9	Are all chemicals used in the company properly stored and secured?
	4.10	Does the company maintain a Material Safety Data Sheet (MSDS) for all the chemicals used?
5.	Workers’ Hygiene Practices
	5.1	Do plant employees wear clean uniforms, smocks or other protective clothing that is free of buttons and outer pockets above the waist?
	5.2	Are smocks, uniforms or other protective clothing removed prior to breaks or entering restrooms and stored in a sanitary manner?
	5.3	Are hand washing signs posted above all hand sinks in the company and in a language appropriate for employees?
	5.4	Do employees have hairnets and/or beard nets correctly in place when working around exposed products, packaging and ingredients?
	5.5	Are employee-support facilities physically separated from food processing areas and maintained in a sanitary condition?
6.	Plant and Grounds
	6.1	Does company management perform a monthly audit of GMP and company conditions?
	6.2	Are there an adequate number of accessible hand sinks at the entrances of and in food-handling and food-processing areas?
	6.3	Are the walls properly designed, constructed, finished and maintained?
	6.4	Does the company have a documented metal detection or foreign material program?
	6.5	Does the company keep yards and parking areas free from external sources of contamination?
	6.6	Does the company implement an environmental monitoring plan?
	6.7	Is the design of the plant developed to facilitate maintenance and sanitary operations for food production purposes?
7.	Food Allergens
	7.1	Are the food allergen and sensitising ingredients used in the company clearly identified?
	7.2	Is the production line tested for specific allergens during a changeover and post sanitation?
	7.3	Does the company have written allergen control procedures in place to prevent the cross-contamination of non-allergic ingredients with allergens?
	7.4	Is the potential for allergen cross-contamination adequately and properly controlled in the company?
8	Pest Control
	8.1	Does the company maintain a documented pest control program that is either performed by in-house employees or contracted by an outside provider?
	8.2	Does the company have the current material safety data sheet (MSDS) and pest control operator (PCO) applicator license on file?
	8.3	Are flying insect traps properly located near exterior doors?
	8.4	Is there an adequate number of properly placed and adequately maintained rodent control devices in the company?
	8.5	Is the company provided with self-closing doors and proper ceilings to prevent the entry of pests?
9.	Packaging and Labelling
	9.1	Are there label accuracy procedures in place that meet regulatory requirements?
	9.2	Is there a documented policy to ensure compliance with net-weight requirements?
	9.3	Is there a program in place to ensure package integrity?
	9.4	Is there a plan in place to prevent the use of unauthorised or incorrect labels?
10.	Employees and Visitors
	10.1	Do employee applications contain full personal, employment, and legal history?
	10.2	Does the company check that personal items and/or containers are not brought into the operating areas by employees?
	10.3	Is there a designated plant employee to accompany visitors?
	10.4	Is there a documented process for managing all visitors which includes verification of ID and a sign-in process?
	10.5	Is there any documented evidence to verify that visitors have signed out?

* C—conformity, ** NC—non-conformity.

). The questions applied to both stages (before and after certification) and were assessed according to conformity, i.e., whether the requirements of the evaluating criteria were fulfilled or not. The level of compliance with the audit criteria was assessed on a point scale. In the case of conformity, the item was marked with 1, and in the case of non-conformity—0. To determine conformity, audit evidence, such as records, statements of fact, or other verifiable information relevant to the audit criteria, were used [12].

2.3. The Auditor

The assessment was conducted by the first author of this paper. She had experience in the food industry as a Quality Assurance in Charge/Food Safety Team Leader person. She is qualified as a Preventive Control Qualified Individual. She had worked for many years in the food industry as an auditor of quality management systems. Throughout this period, she continued to develop and improve her competence and skills through a professional development program and periodic evaluations according to the criteria set out in ISO 19011 (2011). Additionally, she is an expert in the development and implementation of HACCP and the food safety plan for ISO 22000: 2018 and FSMA FSVP certification. She also has experience in the chemical and microbiological analysis of food products.

2.4. Statistics

In order to determine the most common assessments from the audit, the sections included in the checklist were calculated using mean, mode, and standard deviation (SD). To assess the effectiveness of food safety certification, the total of the items in conformity (i.e., fulfilment of requirements) was taken for Stage 1 and Stage 2. To compare the level of fulfilment of the audit criteria, the Student’s t-test was used. The null hypothesis (H0) and the alternative hypothesis (H1) were formulated as follows:

Hypothesis 0 (H0). 

Certification has no impact on the number of items in the checklist that were compliant.

Hypothesis 1 (H1). 

Certification has a significant impact on the number ofcompliant items.

McNemar’s test was performed in order to verify the hypotheses [38,39]. It was examined whether the certification had a significant impact on the number of compliant items in the evaluated sections. McNemar’s test was as follows:

$$x_1^2=\frac{{\left(B-C\right)}^2}{B+C}$$

(1)

$$x_2^2=\frac{{\left(D-A\right)}^2}{A+D}$$

(2)

where:

A—the number of compliant observations before and after certification;

B—the number of compliant observations before certification, which after certification were not compliant;

C—the number of not compliant observations before certification, which after certification were not compliant;

D—the number of non-compliant items before and after certification.

McNemar’s test is used to compare two dependent samples when the results of individual measurements are defined by only two categories, that is, when the variable is a dichotomous variable taking only two values labelled 1 and 0 (for example, “yes” and “no”; “improvement”, “no improvement”). Cochran’s Q test is an extension of McNemar’s test. Thus, these statistics fit perfectly with the research objective set, that is, to evaluate the food safety management system before and after ISO 22000 certification and the Foreign Supplier Verification Program.

In calculating McNemar’s Chi-square statistic, the values of the chi-square statistic and the p were used to check if the numbers of A and D as well as B and C were the same. The B/C ($x_1^2$) corresponded to the Chi-square and p values, which were used to verify the hypothesis that the numbers of B and C were the same, whereas A/D ($x_2^2$) corresponded to the Chi-square and p values, which were used to verify the hypothesis that the numbers of A and D were the same [38,39]. The H0 hypothesis was rejected at p < 0.05.

In order to deepen the calculations of McNemar’s test, Cochran’s Q test was performed [40]. This tests two or more dependent groups (k ≥ 2). Cochran’s Q test was used to verify the hypothesis of symmetry between the results of multiple measurements. The tested feature could have only two values, to which (for the purposes of the analysis) numbers 0 and 1 were assigned. Cochran’s Q test statistic calculation equation was as follows:

$$Q=\frac{\left(k-1\right){\left(k.C-S\right)}^2}{k.S-K}$$

(3)

where:

Q—Cochran’s Q test;

k—the number of measurements;

C, K, S—theoretical values.

McNemar’s test was used for the calculations because it is a non-parametric statistical test for comparing two related samples where the variables are nominal or dichotomous. The test was used to search for differences between groups in the conditions of the experiment before and after the certification. It was convenient for meeting food safety requirements before and after certification. Parametric statistical tests were not used because the sample was small and did not meet the condition of normal distribution. The Cochran Q test, on the other hand, is a non-parametric statistical test and an extension of the McNemar test. It was used to determine if numbers or paired items were significantly different from each other [40,41]. Cronbach’s alpha test was used to measure the internal consistency and reliability of the audit checklist used. In the case of this study, it was the internal consistency of the checklist, overall and divided into ten sections. The results of Cronbach’s alpha test showed that the reliability coefficient for the overall audit checklist was 0.75, and for each of the ten sections was above 0.72, which indicated acceptable internal consistency. All calculations were performed using Statistica 13.3 software (StatSoft, Inc., Krakow, Poland). Significance was identified when p ˂ 0.05.

3. Results

3.1. Overall Assessments

The results obtained showed that the implementation of the FSVP and ISO 22000 standards and the resulting certification significantly improved the degree of compliance with the requirements (

Table 2. Level of compliance with food safety requirements before and after certification—McNemar’s test.

Stage of Assessment	After Certification: Compliant		After Certification: Not-Compliant		Totally Before Certification
	Given from the Equations (1) and (2)	Number of Requirements	Given from the Equations (1) and (2)	Number of Requirements
Before certification: compliant	A	35	B	0	35
Before certification: not compliant	C	33	D	2	35
Totally after certification	-	68		2	70

Equation (1): McNemar’s Chi-square B/C = 31.03; p < 0.0001; Equation (2): McNemar’s Chi-square A/D = 27.68; p < 0.0001.

, Figure 3). There was 50% compliance in Stage 1 (before certification) and 97.14% in Stage 2 (after certification) (Student’s t-test p = 0.0011). The analysis of individual sections showed a significant improvement in 6 out of 10 sections. Significant improvement was achieved in the case of the following sections: food safety plan (Student’s t-test p = 0.0000), process and product control (Student’s t-test p = 0.0017), sanitation (Student’s t-test, p = 0.0247), food allergens (Student’s t-test, p = 0.0240), pest control (Student’s t-test, p = 0.0241), and packaging and labelling (Student’s t-test, p = 0.0240). The biggest differences before and after certification were found in the food safety plan and the packaging and labelling sections. These sections were not implemented at all before certification. In both sections, full compliance (conformity) was established after certification. Conformity before certification was found only in the workers’ hygiene practices section. Only small differences before and after certification were found in the regulatory compliance section, where there was only a 10% improvement, and in Employee and Visitors, where there was a 20% improvement. In other sections, the levels of improvement were more significant.

3.2. Analysis of Non-Compliances

Before certification, 35 of the 70 assessed parameters were compliant with requirements. However, after certification, 68 parameters were compliant, and only 2 remained not compliant, which were two requirements in the pest control section (Q 8.3 and 8.4).

The differences were significant, which is confirmed by McNemar’s Chi-square statistic A/D = 27.68, with p < 0.001. This indicated that the certification had a significant impact on meeting the food safety requirements. After certification, considerably more food safety parameters were compliant than before certification. The differences were significant, which is confirmed by McNemar’s Chi-square statistic A/D = 31.03, with p < 0.001. The null hypothesis was rejected in favour of an alternative hypothesis, which indicated that before certification there were significantly more not compliant parameters than after certification.

Cochran’s Q test showed that the overall level of compliance before certification was 50%, and after certification—97.14% (Figure 4). The p < 0.0001 was lower than α, which indicated that the certification had a positive and significant impact on the level of compliance.

Non-conformities before and after certification (Stages 1 and 2) are shown in

Table 3. Identified non-conformities before and after certification.

Section	Assessment Questions as per Table 1	Non-Conformities
		Before Certification	After Certification
Regulatory Compliance	1.5	+	-
	1.10	+	-
Food Safety Plan	2.1	+	-
	2.2	+	-
	2.3	+	-
	2.4	+	-
	2.5	+	-
	2.6	+	-
	2.7	+	-
	2.8	+	-
	2.9	+	-
	2.10	+	-
Process and Product Controls	3.1	+	-
	3.3	+	-
	3.5	+	-
	3.6	+	-
	3.9	+	-
	3.10	+	-
Sanitation	4.5	+	-
	4.6	+	-
	4.8	+	-
	4.10	+	-
Workers’ Hygiene Practices	all	-	-
Plant and Grounds	6.5	+	-
	6.6	+	-
Food Allergens	7.2	+	-
	7.3	+	-
	7.4	+	-
Pest Control	8.1	+	-
	8.3	+	+
	8.4	+	+
Packaging and Labelling	9.1	+	-
	9.2	+	-
	9.3	+	-
	9.4	+	-
Employees and Visitors	10.5	+	-

(-) shows conformities; (+) shows non-conformities.

. Before certification, non-conformities were observed in all sections except one—workers’ hygiene practices. Whereas after certification, non-conformity was found only in the pest control section. All individual non-conformities in each section were improved after certification except for two parameters in the pest control section. The flying insect traps were not properly located near exterior doors (Q. 8.3) and rodent control devices were not properly placed and maintained in the facility (Q. 8.4).

The differences in compliance with the food safety section are presented in Figure 5. The largest differences resulting from certification were observed in the food safety plan and packaging and labelling sections, where none of the parameterisation conditions were met before certification but all improved afterwards. In second place was the food allergens section, where there was an improvement from 0.3 to 1. There was also a large improvement in the process and product control section, where the post-certification score improved from 0.4 to 1. No differences were observed in the workers’ hygiene practices section, and slight differences were observed in the regulatory compliance section, where there was only a 0.1 improvement, and in the employees and visitors section, where there was a 0.2 improvement.

4. Discussion

Rarely does a comparative assessment of the results of food safety audits in developing countries appear in the literature. The results presented in this study showed two stages of the implementation of ISO 22000 and FSVP requirements, both for the documentation and the food safety system in place at the company. An innovative ready-to-implement checklist was elaborated and used, which was a combination of the requirements of FSVP and ISO 22000: 2018 (Table 1). Such a combination has yet to be presented in the literature. Usually, the audit criteria or checklists of a single audited system are presented [42,43,44].

This approach helped us to provide an analysis of the company’s readiness to export to developed countries. We assessed ten sections of the FSVP and ISO 22000: 2018 standards, beginning with regulatory compliances followed by requirements of the food safety plan, process and product control, sanitation, workers’ hygiene practices, plant and grounds, food allergens, pest control, packaging and labelling, and employees and visitors. The initial assessment before certification of the company showed that the organization’s functioning was far from the ISO 22000 and FSVP requirements. This was due to a lack of experts, trained employees, and proactive measures by senior management. Implementing food safety management reforms led to changes in management practices, staff education, and increased employee consciousness [3]. A high level of non-compliance was found in the food safety plan, including the HACCP plan. The lack of a food safety plan or a labelling and packaging system was not in line with mandatory Indian regulations [6,45]. Many Indian food companies have implemented HACCP principles incorrectly, which was the main non-conformity reported by the official inspectorate in India [46]. This decreases food safety and makes exports very difficult or impossible. However, there are some food business operators in India that cover all HACCP principles like the extended dissemination of private standards in the Indian cashew industry where, previously, safety-related problems were noticed and overcome [20].

Food handling personnel are crucial for maintaining FSMS but may be hesitant to implement basic sanitary procedures due to time constraints. In this study, it was found that only personnel hygiene procedures of employees were found to be satisfactory both before and after the certification. All employees in the company were found to comply with good protective clothing (Q 5.1), its management (Q 5.2), hand washing signages (Q 5.3), proper usage of hairnets and/or beard nets (Q 5.4), and employee support facilities (Q 5.5). Non-compliance with personnel hygiene was noted in the works of Al-Shabib et al., Reboucas et al. and Trafiałek et al. [44,47,48]. In contrast, Jakubowska et al. and Tomašević et al. reported only a few discrepancies in this area [42,49].

Deviations from specific requirements are referred to as non-conformities. Many studies have pointed out the huge number of non-conformities in Indian food companies, e.g., lack of sufficient infrastructure and modern equipment [3], and detectable antimicrobial residues in the milk with most samples positive for neomycin and streptomycin [50]. For example, a major problem with the plant infrastructure was also reported in plants in Serbia [49]. In this study, the non-conformity concerned pests. Even though there were chances that pests and rodents could enter into the company’s premises, adequate pest control activities based on risk assessment were not managed by the company, even after certification. Pests are a common problem among Indian food producers [51], and an in-place effective pest control system is required by ISO 22000: 2018, FSVP, and the FSSAI [5]. This problem has been pointed out by other authors in European countries [42], not only in food plants but in agriculture as well. Goyal et al. reported that Indian agricultural exporters faced rejections and bans in key markets due to non-compliance with food safety and health standards, including pest infestations [52].

Reddy et al. indicated poor hygiene practices in India, in particular, process control [53]. Poor plant hygiene was identified in previous studies [35,54]. There were also some studies that did not record such non-compliance, e.g., in meat plants [49]. Goyal et al. and Jakubowska et al. reported poor storage and transportation conditions and a lack of general cleanliness [42,52]. Those non-conformities were observed partly at the snack producer’s plant before certification. After certification, the plant was totally clean—the waste and waste removal process as well as product control were managed correctly. The same observation concerned the packaging and managing allergens. There are results presenting non-compliance with the safety of food packaging [43], or managing allergens [49,55,56] which was observed before but not after the certification in the industry under study.

In the works of Jakubowska et al., Djekic et al., and Trafiałek et al., many non-conformities in food safety plans were found [14,42,57]. The same problems were identified by the snack producer before the certification. A higher degree of non-compliance in the food safety system and documentation of the company before the certification could have been caused by many factors, such as key personnel having insufficient knowledge, lack of monitoring, poor awareness of employees, costs, etc. [8]. Reddy et al. reported that approx. 60% of food industry employees in India were not aware of FSSA food safety requirements [53]. This was the reason that the high level of non-conformity decreased. However, certification and the necessary training of the workers due to the requirements of ISO 22000 and FSVP increases food safety awareness [58]. Schuster et al. and Goyal et al. found problems with the traceability of food raw materials and products in India [24,52]. However, this non-compliance was not found in the company in question, neither before nor after certification as in other studies performed in Europe [42].

The results of this study show a continuous improvement in the functioning of the food safety system and the proper documentation in place at the company under review. The active management of non-compliance at this company was connected to having the license required by Indian food law. However, not all companies running food businesses have the license [53]. All food business operators in India are required to be registered or licensed [45,59]. In 2020, 58,538 licenses were issued by the Central Licensing Authorities, with an increased percentage compared to the previous year. Between 2019 and 2020 an increase of 25% in issued Central licenses and 24% and 28% in State licenses and registrations, respectively, were reported in comparison to the previous year [46].

During recent decades in India, many changes in lifestyle and eating patterns have been observed [60]. However, despite robust economic growth, in India, there are still cases of malnutrition [61,62]. Despite this, food companies that have implemented voluntary food safety standards like ISO 22000 and FSVP are prepared to deliver safe food and be good food suppliers for other countries. At this point, it is worth relying on proven methods of assessing the level of food safety, such as the audit method [42,63,64] when planning the use of currently supported triangulation methods [65,66]. The use of other methods in the audited company to compare the level of implementation of a food safety management system before and after certification would not be possible because the company did not collect any data on food safety before certification. Only after certification is it possible to include the audit method in the modern trend of assessing food safety culture by triangulation, as proposed by De Boeck et al. [67].

This study showed the effective implementation of international food safety standards, confirmed by certification in the evaluated small-size food company. However, certification is more often beneficial to large companies rather than small ones [68]. Our results showed that the standards associated with certification beneficially affect the food safety management system in small companies as well. Implementing international food safety standards and certification often necessitates significant effort and expense for the company. However, the benefits usually compensate for implementation costs [69]. Periodic inspections of compliance with food safety requirements are necessary, especially in the case of a food export company [52,56]. Because the assessment checklist we prepared was based on the ISO 22000 and FSVP requirements, it could be useful for food producers exporting their products to developed countries like the U.S. and the E.U. Lee et al. reported that the International FSMS application and certification increased significantly in Indian companies, greater than in African or Latin American companies and close to levels in developed countries [3].

This study has some limitations. It only included one small-sized fried snack producer from India, representing the low-risk food sector. Conclusions from this work may not be applicable to producers of higher food safety risks, such as dairy and meat companies, nor to plants located in other countries where food safety is not mandatory. However, despite these limitations, our results showed the need to check the readiness of Indian food companies to export their products to other countries. The results obtained also have certain implications for research and practice. The results after certification can be used for a comparative assessment of the results from developed countries. Through this study, it is clear that even small-scale enterprises can meet international food safety standards. A small-size producer of traditional fried vegetable snacks, after implementation of the requirements of ISO 22000 and FSVP and after certification of these standards, became ready to export to the U.S. and other developed countries.

5. Conclusions

Some food manufacturers in India are improving their food safety management system. The certification of the food safety management system can allow food export to countries, where food safety expectations are high, like in the U.S. and the E.U.

The results of this study showed that the certification of ISO 22000 and the Foreign Supplier Verification Program in a selected small-size food company in India significantly improved the level of food safety management system implementation in the company in question. Before certification, many non-compliances were found, especially for HACCP implementation. The most satisfactory result, both before and after certification, was full compliance with the requirements in the workers’ hygiene practices section. After certification, both the food safety system in place at the company and the documentation met the requirements. The highest increase in compliance was found in the food safety plan section as well as packaging and labelling section. The only non-conformity concerned pest control. Certification significantly improved food safety system conformity in the evaluated company. Certification gives credibility to the safety of traditional Indian fried vegetable snack products. The developed integrated audit checklist can be used by other food companies in India or other developing countries to check whether they meet the adequate level of fulfilment of food safety management requirements. However, more work is needed to confirm its reliability and validity, as well as its usefulness for other food sector companies. Further studies concerning the possibility of implementing ISO 22000 and FSVP requirements in other food companies using manual production as well as in other food sectors, especially with higher food safety risks, are needed.