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DETERMINATION OF RISK MINIMIZATION STRATEGY FOR HERBAL DRINK PRODUCTION WITH GMP APPROACH
USING SCORING AND AHP
Ratining Indah Wardani, Imam Santoso*, Riska Septifani
Department of Agroindustrial Technology – Faculty of Agricultural Technology – Universitas Brawijaya
Jalan Veteran – Malang 65145
Corresponding Author, email: [email protected]
ABSTRACT
Herbal drinks such as herbs have become part of the culture in Indonesia. The herbal plants processed into herbal drinks include bilimbi fruit (Averrhoa bilimbi L.) and secang (Caesalpinia sappan L.). This study aims to determine the risk minimization strategy in producing herbal drinks in CV XYZ by analyzing 14 aspects of Good Manufacturing Practices (GMP) using a scoring form and the Analytical Hierarchy Process (AHP) method. The scope of GMP in this study orients to how to produce good processed food. Determination of risk minimization strategy using the Analytical Hierarchy Process (AHP) method. The assessment results in applying GMP in CV XYZ using scoring calculation gotten three aspects with the highest deviation, “the sufficient qualify category", i. e. the building aspect (78.39%), storing (78.47%), and controlling (78.65%). These results as the base for arranging the risk minimization strategy with some criteria and alternatives using AHP calculation. The priority criteria for risk minimization strategies are the effectiveness level (0.608), the easiness of applying (0.313), and cost (0.079). Then, three priorities of alternative risk minimization for CV XYZ based on the global weight are the repairing of ventilation design (0.323) by adding ventilation in the production room, screens for dust filters that can be easily removed, final product storage separation (0.228) by placing materials or products that have a strong odor and have the potential to affect the final product in a separate room, making SOPs for the production process (0.209)
Keywords: AHP, GMP, Herbal Drink, Risk Minimization, Scoring
INTRODUCTION
Indonesia is rich in various kinds of plants, especially herbal plants. Using herbal plants as the primary material of traditional herbal medicine has been part of the culture in Indonesia. Balitbangkes (2019) shows that the consumption rate percentage of herbal medicine is 44.3% among Indonesian people.
The plants used as herbal medicine, such as herbal drinks, are bilimbi fruit (Averrhoa bilimbi L.) and secang (Caesalpinia sappan L.). Based on BPS data from Taslia et al. (2022), bilimbi fruit has a production percentage level of 0.51%, with a total production of 101,553 tons in 2018.
CV XYZ is one of the herbal drinks producers that process herbal drinks by utilizing secang and bilimbi fruit in Kedungkandang, Malang,
East Java. CV XYZ commits to producing health products using natural ingredients that benefit health, society, and the environment. However, in the production process of herbal drinks, there are problems in optimizing product quality due to the risks experienced.
Production activities in the company are not free from various kinds of risks.
Risks in production activities cannot be avoided but can be minimized. Minimizing production risk is an effort to reduce and prevent the occurrence of production risk in a company (Hasan et al., 2021). The production risks that occur from the production of herbal drinks in CV XYZ include color changes in the product, color difference in the final product, consistency
64 of taste, and sediment in the final product. These may be caused by the lack of optimal implementation of Good Manufacturing Practices (GMP) aspects. GMP is a guideline for constantly producing food products following predetermined requirements to produce quality and safe products (Bimantara and Triastuti, 2018).
GMP conformity parameters based on the Regulation of the Minister of Industry of the Republic of Indonesia No. 75/M- ENG/PER/7/2010. The assessment of GMP implementation using scoring for each aspect of the scope under GMP guidelines. Audit scoring is a quantitative method of assigning values to predetermined parameters based on the number of values so that the ranking can be determined (Hasibuan, 2021). It determines the priority of the risk minimization strategy using the Analytical Hierarchy Process (AHP) method.
AHP is a method that uses multiple criteria to determine the weight of the criteria from various options so it can determine structure priority (Liu et al., 2020). This study aims to define a risk minimization strategy for herbal drinks production in CV XYZ by analyzing 14 aspects of GMP.
METHOD
The methods used in this research are scoring of GMP and AHP. Sources of data in this study consist of primary data and secondary data. Primary data is obtained directly from the object of research, namely CV XYZ several ways, including interviews by asking several questions directly to the director
of CV XYZ, deputy directors, and production managers related to aspects to be identified related to GMP; observation by direct observation related to 14 aspects; and a scoring questionnaire containing GMP conformity parameters based on the Regulation of the Minister of Industry of the Republic of Indonesia No. 75/M-IND/PER/7/2010. The AHP questionnaire is filled out, and data is processed and analyzed to obtain AHP data and documentation.
Audit Scoring of Good Manufacturing Practices (GMP) Implementation
The assessment of GMP implementation using a scale of 0-4 with a description of the assessment is shown in Table 1. Formula (1) is used for calculating the conformity value of the implementation of 14 aspects of GMP with the specified conformity (Indriani et al., 2021).
Y=(n0×0)+(n1×1)+(n2×2)+(n3×3)+(n4×4) ...(1) Where:
Y = Total value of the calculated aspect score n0 = Number of aspects that have a score of 0
in the audit scoring form
n1 = Number of aspects that have a score of 1 in the audit scoring form
n2 = Number of aspects that have a score of 2 in the audit scoring form
n3 = Number of aspects that have a score of 3 in the audit scoring form
n4 = Number of aspects that have a score of 4 in the audit scoring form
Table 1. Description scale of GMP implementation Scale Description
0 Deviations that occur by 0% (qualify implementation)
1 Deviations that occur 1-25% (implementation is sufficient to qualify) 2 Deviations that occur by 26-50% (implementation is less qualify) 3 Deviations that occur by 51-75% (implementation is very less qualify) 4 Deviations that occur by >75% (implementation does not qualify) Source: Indriani et al. (2021)
Table 2. Percentage of GMP implementation Percentage Description
80-100% The conformity aspect value of GMP implementation aspect is qualify 60-79% The conformity aspect value of GMP implementation is sufficiently qualify 40-59% The conformity aspect value of GMP implementation is less qualify
0-19% The conformity aspect value of GMP implementation does not qualify Source: Indriani et al. (2021)
65 Then calculate the number of points and percent deviation using formulas (2) and (3), respectively.
N = n × Smax ………..(2) Where:
N = Number of points
n = Number of aspects parameters to be calculated
Smax = Total value of the calculated aspect score
%Deviation=Y
N× 100% …..……….(3) The percentage of GMP compliance calculate using formula (4). The value obtained is then adjusted to the percentage scale of GMP implementation determined based on the classification shown in Table 2 (Indriani et al., 2021).
%GMP = 100% – %Deviation …………..(4) The percent deviation results with the highest percentage deviation value "enough to meet"
will be analyzed further using the Analytical Hierarchy Process (AHP) to determine the priority strategy for risk minimization.
Analytical Hierarchy Process for Risk Minimization Strategy Formulation
The stages of data analysis using the AHP method are as follows:
1. Identify the problem and determine the right solution
2. Hierarchical structure
3. Create a pairwise comparison matrix 4. Calculating consistency ratio (CR)
5. The average of the priority weight values is calculated, and the results are denoted by max.
max = Priority Weight
n ………(5)
Where n = number of criteria
6. Calculate the Consistency Index (CI) with the formula (6).
CI = (max – n)
(n – 1) ………(6)
Where:
CI = Consistency index max = Maximum eigenvalue
7. Calculating consistency ratio using formula (7).
CR = CI
RI………(7) Where, RI = Random Index
If the CR value is 0.1, the assessment is declared consistent and can be accounted for. On the contrary, if the value is > 0.1, then there is an expert respondent's assessment that must be corrected.
RESULT AND DISCUSSION CV XYZ has implemented 14 aspects of GMP well. The assessment of 14 aspects of GMP in CV XYZ can be seen in Table 4.
This assessment is carried out based on the Regulation of the Minister of Industry of the Republic of Indonesia No. 75 of 2010 regarding Guidelines for Good Manufacturing Practices (GMP).
Based on the assessment results of implementing 14 aspects of GMP at CV XYZ, Figure 1 shows three aspects of the
“Sufficient Qualify” category, i. e. building, storage, and process control 78.7. And 11 aspects with the "Qualify" category of GMP implementation, including production equipment; documentation and record;
product recall; location and environment production; employees; packaging; product label and description; materials;
maintenance and hygiene sanitation program; sanitation facilities; and final product. There are explanations regarding the 14 aspects of GMP implementation at CV XYZ:
a. Building
The building aspect gets a score of 78.2 with the "Sufficient Qualify" category.
Several parameters in building aspects of CV XYZ did not meet the requirements, such as the angle between the wall and floor did not form a curve; ventilation did not provide
66 good air circulation; the walls surface in some production rooms being easy to peel off; and the window design still allows dust accumulation. According to Ali et al.
(2021), requirements of the production room based on CPPOB are that the angle between the wall and the floor must be curved, and the ventilation design in the production room is equipped with screens for ease of cleaning and removal.
b. Storage
The storage aspect gets a score of 78.5 with the "Sufficient Qualify" category. The storage at CV XYZ for products and non- food materials is in the same place. Some final products are placed without a base on the floor and attached to the wall.
According to Prihanto (2020), storage areas must consider the factors of cleanliness, safety, suitability of room temperature, and ease of control. Raw materials and non-food materials are in good condition and separated.
c. Process Control
The process control aspect gets a score of 78.7 with the "Sufficient Qualify"
category. Process control of CV XYZ did not have an SOP (Standard Operating Procedure) regarding instructions and steps. Instructions for the production process and the number of materials used have yet to be implemented. During production, strict process control is not carried out. According to Jaya (2019), process control is carried out to minimize errors during the production process and reduce products that do not meet requirements. Process control includes controlling processes, materials, and production to anticipate contamination.
d. Production Equipment
The production equipment aspect scores 80 with the "Qualify" category. The parameters that have not met the requirements include machines used in the production process that have contact directly with non-rusting materials and are easy to maintain and clean. The equipment needs to be equipped with a
timer and temperature controller, so the accuracy of the machine cannot be ascertained. According to Devi et al.
(2018), some specifications must be considered in processing food so that the ingredients in the raw materials used are preserved and can protect the contents. Processing and monitoring processes, such as processing time and appropriate temperature, are also considered to ensure product quality.
e. Documentation and Record
The documentation and record aspect scored 83.62 with the "Qualify"
category. Parameters that still need to be met the requirements include documentation and recording of inspection and testing processes that have not been implemented optimally.
According to Prihanto (2020), companies should have records and documentation from receiving raw materials, food additives, and records related to the final product.
f. Product Recall
The product recall aspect scores 86.72 with the "Qualify" category. The parameters that did not meet the requirements, such as there are no procedures for product recall from the market and products recalled by the production manager. Still, the production manager carried out the product recall due to an expired date, and the product has yet to be sold.
According to Prihanto (2020), a product recall is carried out if the product is suspected as the cause of disease or because it does not meet food requirements so that action is taken to stop distribution.
g. Location and Environment Production The location and environment production aspect scored 89.59 with the
"Qualify" category. The location production of CV XYZ is close to residential areas, and some bushes are close to the building. According to Surono et al. (2018), the location and environment production are important
67 parts, so it needs to be considered because it is related to product safety factors. The location and environment must be clean, hygienic, and away from landfills and human settlements.
h. Employees
The employee aspect scored 92.5 with the
"Qualify" category. Parameters that have
not been implemented optimally by CV XYZ employees are the use of personal protective equipment during the production process. Personal Protective Equipment (PPE) is used to protect when at work. PPE is used to avoid accidents or reduce risks that arise in the work environment (Exposto et al., 2022; Syam et al., 2020).
Figure 1. The Assessment Result of 14 Aspects GMP Implementation in CV XYZ i. Packaging
The packaging aspect scored 93.75 with the "Qualify" category. The herbal drink packaging consists of a 250 ml bottle and a 120 ml cup. The primary packaging material is polyethylene. The packaging is safe during the treatment of transportation and circulation of the product. According to Pulungan et al.
(2018), the packaging or container used to package the final product must protect the product inside and be able to maintain product quality from the outside.
j. Product Label and Description
The product label and description aspect get a score of 93.75 with the "Qualify"
category. The parameters follow GMP guidelines and BPOM requirements. The CV XYZ product label contains the
product name, net content, materials used, production code, BPOM RI, halal information, expired date, and production address. According to Herudiansyah et al. (2019) and Sucihati et al. (2021), the label contains information related to the product and the branding of a product so easily recognized by consumers.
k. Materials
The materials aspect scored 97.5 with the "Qualify" category. Based on the GMP implementation assessment results, the parameters that still need to be met are the required materials that do not have specific criteria for being thrown away or used during sorting.
According to Hariyadi (2019), the raw materials must be sorted first. The raw
68 materials used are according to standards to guarantee product quality. The processing of raw materials must be safe and follow the physical, chemical, and organoleptic testing standards.
l. Maintenance and Hygiene Sanitation Program
The aspect of maintenance and hygiene sanitation program scored 97.5 with the
"Qualify" category. Maintenance and hygiene sanitation programs at CV XYZ are not scheduled, but maintenance and cleaning of the production environment are still done. The cleaning process is carried out physically using water and soap if needed. According to Prihanto (2020), the environment, buildings, and equipment used in production must be maintained and cleaned regularly to avoid product contamination.
m. Sanitation Facilities
The aspect of sanitation facilities gets a score of 97.79 in the "Qualify" category.
Sanitation facilities contained in CV XYZ include water supply facilities, waste disposal facilities, cleaning/washing facilities, toilet facilities, and employee hygiene facilities. The water used for production has met the quality requirements for clean water and laboratory tests. Waste from the production process is liquid waste and solid waste. Parameters that still need to
be completed the requirements include the condition of the toilet with the crust but not slippery, toilet lighting, insufficient ventilation to ensure good air circulation, and hand washing facilities in front of the entrance to the processing room. According to Prihanto (2020), sanitation facilities must exist in the food processing industry. Hand washing facilities located before entering the production process room, rubbish bin, toilets adjusted to the number of employees, and water that used comply with clean water standards.
n. Final Product
The final product aspect scored 97.91 with the "Qualify" category. The final product of CV XYZ has received halal certification from BPOM. Testing of the final product still needs to be implemented optimally, only by checking through the physical and taking samples that have been stored for six months for organoleptic testing.
The parameters of the final product implemented by CV XYZ are under GMP guidelines. Before entering the storage room and out for distribution, the final product is subjected to quality checks and specifications to ensure that the final product has the same quality and meets the standards (Sari et al., 2020).
Table 3. Results of risk identification of herbal drinks production
Risk Aspect Cause/ Parameter Deviation Impact
Building a. Ventilation does not provide good air circulation
b. The angle between the wall and the floor do not form a curve
a. The room temperature is not suitable, so it becomes stuffy and hot b. That causes the accumulation of dust and dirt, which so difficult to clean Process
control
a. There is no SOP for monitoring the raw materials level maturity of bilimbi fruit
b. There is no SOP for controlling the production process
a. The color and taste of herbal drinks are different
b. Product quality is not the same because there is no standardization of product processing
Storage a. The final product is placed without base
b. The final product is stored with other products and materials
a. Causes damage to product packaging that has the potential to affect product safety
b. Causes cross contamination
69 Production Risk Identification
Based on the scoring calculation, the aspects with the highest deviation values in a row are building, process control, and storage.
Based on the scoring results from the three aspects, risk identification is carried out by identifying the causes and impacts with the highest deviation intensity, which can be seen in Table 3. The risks identified of herbal drinks production are as follows:
a. Risk Identification of Building Aspect The building aspect gets the highest score because it did not implement requirements such as the angle between the wall and the floor did not form a curve, so it caused the accumulation of dust and dirt that was difficult to clean.
The surface of the walls in some production rooms is easy to peel off, which may affect production. The ventilation design needs better air circulation, so the room temperature needs to be more suitable and becomes stuffy. The average storage temperature ranges from 25-30 °C, so the room temperature for the production process is unsuitable for ensuring product quality. The vitamin C content in bilimbi fruit is susceptible to high temperatures that risk losing vitamin C. According to Damayanti and Prasetia (2021), the average storage room temperature is 29 °C of vitamin C content so as not to lose vitamin C. In addition, too high temperatures can also cause damage to the materials while it is being processed. The longer the heating time, the more vitamin C is oxidized, so that
vitamin C content will decrease due to decomposition (Murti, 2017).
b. Risk Identification of Process Control Aspect
The parameters that are not following the GMP guidelines of CV XYZ such as there are no written instructions regarding the stages of the production process, control, and criteria for raw materials. The standards criteria for the primary raw materials must be carried out optimally. The supply of raw materials is directly used and cleaned without paying attention to the criteria for size, color, taste, and texture.
According to Bate’e and Gea (2018), process control is needed to minimize the risks during the production process. Hence, it conforms to the standard but can take corrective action if there are deviations.
c. Risk Identification of Storage Aspect The parameters of the storage aspect are not following the GMP guidelines of CV XYZ, as the final product is not stored using a base. Still, directly to the floor, several products are attached to the wall, and other product materials are stored too close to the final product.
Raw materials and final products are stored without direct contact with floors and walls. To avoid damaging product packaging, it will affect product safety. Final product storage should be kept separate from other materials that may cause cross- contamination (Prasetiyo et al., 2017).
Table 4. Formulation of risk minimization strategy for the herbal drink production process Description
Purpose Risk Minimization Strategy for Herbal Drink Production Criteria 1. Effectiveness level
2. Cost
3. The easiness of applying
Alternative Strategy 1. Improvement of wall infrastructure design 2. Ventilation design improvement
3. Making SOPs for the production process 4. Adding a base to the final product storage 5. Final product storage separation
70 Determination of Risk Minimization Strategy
Determination of the risk minimization strategy for producing herbal drinks is carried out using the AHP method. The formulation of the risk minimization strategy for the herbal drink production process can be seen in Table 4.
To get a single value from three respondents using the geometric mean. Assessment is done by combining into one value to represent all the assessment results into one paired comparison value. The AHP output is in the form of the weight of each alternative strategy which will be ranked later, and the CR value obtained to see the consistency of the results of the respondents' answers.
The assessment of the criteria for the risk minimization strategy for the production of herbal drinks is carried out to determine the priority criteria so that the weight value of each criterion is obtained. The weight value of the criteria can be seen in Table 5. The value of the consistency ratio in the calculation of the criteria obtained a value of 0.039. It can be concluded that the criteria have met the requirements, namely the CR value 0.1, so that it can be declared consistent and the data obtained is considered valid without the need to repeat filling out the questionnaire.
Table 5. The weight value result of criteria risk minimization strategy
Criteria Weight Rank
Effectiveness level 0.6078 1
Cost 0.0790 3
The easiness of
applying 0.3131 2
The AHP calculation is carried out to determine alternative strategic priorities in assessing the minimization of production risk in herbal drinks at CV XYZ. The priority of the strategy is seen from the highest weight value obtained. The value of the alternative strategy weights obtained can be seen in Table 6.
The hierarchical structure of the AHP can be seen in Figure 2. Recommendations for alternative priority improvement strategies for CV XYZ are as follows:
a. Improve ventilation design by adding ventilation in the production room and screens for dust filters that can be easily
removed. So, it can create an environment where the production process is not stuffy, not hot, and has good airflow. It can add a fan to make the room temperature cool. Besides, affecting the product, it also causes employee discomfort. The production process of herbal drinks at CV XYZ should have paid attention to the active components of bilimbi fruit, especially the vitamin C component. There is temperature measurement in the production process. A hot and stuffy production room will affect the quality of products, such as taste, color, and shelf life. The content of vitamin C is a sensitive substance, and it will decrease high temperatures. During the cooking process, the heating temperature must be maintained at 70 °C and in the production room with average temperature ranges from 25-30 °C to maintain good product quality (Khalisa et al., 2021).
b. CV XYZ can add a base, such as a pallet or a table, to the final product storage.
Use the table as a base with a minimum height of 15 cm from the floor.
Recommendations pallets used for storage are those made of plastic to minimize termites when using wood.
Raw materials and final products are stored without direct contact with floors and walls. This is to avoid damaging product packaging, and it will potentially affect product safety. The minimum distance between the final product storage base and the floor is 15 cm to prevent cross-contamination (Salsabila, 2019).
c. SOPs that can be applied by CV XYZ can include cooking SOPs, process control SOPs, and final product storage SOPs.
SOP is printed so it can be applied and obeyed by employees. SOP can explain in detail the sequence of processes related to how to process to minimize the occurrence of procedural errors (Jakaria and Isfianadewi, 2022; Stiyawan et al., 2018). The arrangement of SOPs must always be evaluated to reduce the risk of product defects.
71
Table 6. The result of global weight minimization strategy for herbal drink production
Alternative strategy
Weight criteria
Total global weight Effectiveness
level (0.6078)
The easiness of applying
(0.0790)
Cost (0.3131) Wall infrastructure design
improvement
0.042 0.019 0.004 0.064
Ventilation design
improvement 0.302 0.018 0.003 0.323
Making SOPs for the
production process 0.077 0.105 0.026 0.209
Addition of a base to final product storage
0.116 0.049 0.011 0.176
Final product storage separation
0.071 0.123 0.034 0.228
Total 1.000
Figure 2. The Hierarchical Structure Of The AHP
d. Separate storage of the final product is carried out by placing materials or products that have a strong odor and have the potential to affect the final product in a separate room. Unnecessary items are stored tidily and put away from the final product. The final product storage room is in a clean and well-maintained condition.
According to Latief and Trimo (2019) and Rini et al. (2015), food storage areas are stored separately from the final product and always ensured to be clean to minimize contamination.
e. The wall infrastructure design can be improved by forming a curved shape. The peeling walls are immediately repaired,
clean, and well-maintained. According to Rini et al. (2015) and Salsabila (2019), the floor and the wall should form a different angle to be easy to clean and ensure no accumulation of dirt that will affect the product.
CONCLUSION
The assessment results of implementing Good Manufacturing Practices at CV XYZ Malang with scoring calculations obtained three aspects that get the “sufficient qualify” category, i.e.
building, storing, and controlling aspects.
These aspects can affect risk in herbal drink
72 products of Secang and Belimbing Wuluh if it is not considered further. The risk minimization strategy used to minimize risk in the production process of secang and bilimbi fruit herbal drinks consists of three criteria and five alternatives. The priority risk minimization for the effectiveness level criteria is ventilation design improvement. CV XYZ can apply by adding ventilation in the production room and screens for dust filters that can be easily removed. Final product storage separation is the priority risk minimization for the easiness of application and cost. CV XYZ can add a base, such as a pallet or a table, to the final product storage.
Use the table as a base with a minimum height of 15 cm from the floor. Recommendations pallets used for storage are those made of plastic to minimize termites when using wood.
CV XYZ is expected to be able to apply alternative priority strategies from the three criteria to reduce the risk of herbal drink production.
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