Implementation of A Traceability System for Canned Fish Products using The FMECA Approach

PT. XYZ is a company that operating in the canned fish processing sector. In implementing the traceability system, traceback product still experiences obstacles so it cannot be implemented properly in the Company. This research was conducted to determine the traceability critical point which is a weakness of the traceability system being implemented. The method used is the FMECA (Failure Modes, Effects, and Criticality Analysis) approach, which is a development of the FMEA (Failure Mode Effect Analysis) method with the inclusion of the CA (Criticality Analysis) method to evaluate the effective level and efficiency of the traceability system being implemented. The results of the analysis showed that 43 possible failure points were identified, of which 2 points were in the unacceptable area, 3 points were in the undesirable area, 12 points were in the acceptable with revision area, and 26 points were in the acceptable without revision area. Traceability of canned fish products at fish canning companies has been going well with 5 critical points of traceability, namely the absence of information on the origin of the fish, not providing special coding for each fish received, not carrying out microbiological testing on the fish received, each fish received is not differentiated. The storage location is between each supplier, and no special records are made at the draining stage.


INTRODUCTION
Fish canning is one form of fish processing that is popular among the public.According to Arini & Sri (2019), fish processing holds the main principle, namely to protect fish from damage and extend their shelf life.The demand for canned fish products will continue to increase along with an instant and productive lifestyle, where this product is easy to serve, practical, and has a long shelf life, and contains the nutritional content needed by the human body.With the increasing market demand for canned fish products, attention to quality, safety, and production processes are of key importance to ensure that these products are safe for consumption and free from contamination that can harm consumer health (Rini & Lestari, 2020).
Every industry engaged in food processing, of course has endeavoured to be able to produce products that are in accordance with the specifications set by world food institutions.However, the Company's activities cannot be separated from uncertainties or unexpected events that can affect the smooth flow of materials and components in the process chain, as well as the success of the processed products (Febrianik et al., 2017).In this case, the possibility of failure to maintain the quality of the products produced and the potential risks that endanger consumers cannot be ignored because it can trigger product recalls from the market.To avoid product recalls, it is important to implement a traceability system to track the production history of a product unit.Traceability is the ability to track batches of products and their history as a whole, or part of the production chain from upstream to downstream that can be identified from recording documents (Olsen & Borit, 2013).Although many canned fish processing industries have implemented a traceability system in their production process chain, there are still obstacles and shortcomings in its implementation, especially in tracking the origin of the fish raw materials used.
Based on the flow, traceability is divided into three functions, namely trace forward, trace back, and a combination of both (Sudibyo, 2012).In this case, the Company implemented both traceability flows.However, the Company has not been able to carry out the trace-back system properly, especially in the local fish raw materials used, where the Company experienced a loss of information regarding the origin of the fish raw materials used, resulting in a break in the traceability chain carried out in the Company.
Basically, the traceability process must be carried out effectively and efficiently to ensure that the traceability system is able to collect comprehensive product information in a short time to reduce product safety risks and improve the canned fish industry's response to product recalls that could harm consumers.In addition, traceability also assists the industry in monitoring and tracking the movement of the product in its process flow to ensure that the product has been processed in accordance with established standards.By implementing a traceability system, food product manufacturers can ensure good documentation of the history of raw materials, additives, and product distribution.This aims to create good traceback conditions in the event of unwanted events after food products are distributed (Dwiyitno, 2017).
In order to achieve optimal traceability implementation conditions, it is important for the Company to identify the critical points in order to prevent product traceability chain breaks.Traceability critical points are locations where loss of product information occurs systematically (Karlsen & Olsen, 2011).Identification of traceability critical points can be done using various methods, namely the FMEA (Failure Mode Effect Analysis), FMECA (Failure Modes, Effects, and Criticality Analysis), and FTA (Fault Tree Analysis) methods.The FTA (Fault Tree Analysis) method is a structured approach to identifying factors that can cause failure.However, this FTA method has limitations in its scope and is subjective, and requires special expertise in the calculation process (Satriyo & Puspitasari, 2017).
The FMEA method is an analytical approach that can be used in identifying and resolving all possible failures in products and processes as a whole through process improvement by generating RPN (Risk Priority Number) values.It aims to identify problems systematically in order to prevent failures in the process and products produced (Pratama & Suhartini, 2019).However, FMEA has weaknesses in the flexibility of use, especially in terms of design improvement.In addition, statements in FMEA tend to be subjective.
The FMECA method is a development of FMEA (Failure Mode Effect Analysis) with the inclusion of the CA (Criticality Analysis) method, which aims to identify and analyse traceability critical points.FMEA is present to identify possible failures that occur in a system and analyse their impact.Meanwhile, Criticality Analysis is an analytical approach that is carried out to identify key failures that have a significant impact on the system, as a preventive measure for corrective actions that may be needed (Sultan, et al., 2023).
The FMECA method has the advantage of being able to improve maintenance functions.In addition, FMECA can also produce a reliable system to minimise failures and keep components and functions well controlled, so it can be applied to aspects that are crucial in controlling failures, especially to factors that have the highest critical risk (Rahman & Fahma, 2021).According to Ulfah (2018), states that FMECA can be used in identifying possible failures in the implementation of a system, analysing potential factors and causes or impacts resulting from system failures by giving a priority scale to each possible failure identified, so that quick and appropriate corrective action can be formulated.Based on this, the FMECA method was chosen in this study to be applied to corrective research to prevent it.This has also been proven by research conducted by Suryono et al (2023), with the result that the implementation of the FMECA (Failure Modes, Effects, and Criticality Analysis) method was successful in identifying and establishing traceability critical points.Through the FMECA approach, possible failures will be identified, the risk value will be assessed to determine the priority of failures in the implementation of traceability, and can provide recommendations to reduce or avoid traceability failures in the Company.The aim research is to determine the critical level of each failure mode, determine the critical point of the application of internal traceability, and provide solutions that can be used by the Company as a guideline in optimising the implementation of traceability, so that traceability can run well, effectively, and efficiently, and prevent the break of the traceability chain in the production process chain carried out in the Company.

Research Time and Location
The research was conducted for four months, in the period from September to December 2023 at one of the fish canning companies (PT.XYZ) in Bali Province.

Research Methods
This research was conducted using the FMECA (Failure Mode, Effect, and Critically Analysis) method approach which is a method of combining qualitative and quantitative approaches by involving experts from the industry.This analysis was conducted to identify potential risks that may arise in the production process chain, assess the priority of failure for each possible failure identified, and find improvement steps for the traceability management system implemented in the Company.FMECA analysis is conducted in two stages of analysis, namely Failure Mode and Effect Analysis (FMEA) and Criticality Analysis (CA).This research uses a single-shot study approach, which implies that data is collected only once without additional iterations to ensure proper representation of the observed phenomenon.

Failure point analysis and impact analysis (FMEA)
This analysis was conducted in two stages of analysis, there are:

Analysis of traceability failure points (failure mode analysis)
The steps that need to be taken include: a) Specify the function ID; b) Determine the process stage (function), and c) Determine the possible failure modes and cause of failures.
Identification of failure modes was done through observation or analysis of documents that record information on how often failures occur in a process stage.

Effects analysis
Impact analyses were conducted on both local and global impacts.Local impacts are specific errors that occur in a limited context within the company and arise due to system failures at critical points.Meanwhile, the global impact is a general type of error that occurs on a wider scale of problems.

Critical Analysis (CA)
This analysis was carried out in several steps, there were: 1. Determining the severity (S), occurrence (O), and detection (D) of failure by experts with a scale ranging from 1-10 with criteria referring to the US Department of Defence (1980).This standard is specifically used in applying the FMECA method, where this standard has been recognised and accepted, and has obtained accurate and precise results in identifying and reducing risks that have the highest level.
2. Determining the value of each failure point using the RPN method: [RPN = S×O×D] 3. Determining the position in the criticality matrix.The position in the criticality matrix is determined qualitatively based on severity and likelihood of occurrence, by applying the judgement of experts.
4. Determining the criticality level or critical area.This step is used to determine the critical level of each failure point obtained from reading the critical matrix, including unacceptable, undesirable, acceptable with revision, and acceptable without revision.

Failure Mode and Effect Analysis (FMEA)
The initial step in analysing FMECA is to identify potential failures at each process step through FMEA analysis.The FMEA process is divided into two stages, namely the identification of traceability failure points and evaluation of their impacts, which include local and global impacts.To determine traceability failure points, interviews with experts are required to obtain concrete and relevant information.An expert is someone who has expertise in a particular field and can give his opinion on the topic discussed (Hakim, 2018).
Failure probability analysis involves observing potential failures and their impact at each stage of the production process, where each possible failure identified is given a unique code to facilitate data analysis.FMEA is used in identifying failure modes in order to reduce or prevent failures in the system by taking the correct corrective action (Susendi, et al., 2021).The results of possible failure points in the traceability system are presented in Table 1.

Critical analysis (CA)
Critical analysis is conducted to evaluate the critical risk of failure modes, as well as assess the probability of occurrence and severity based on previously identified failure modes (Hadiwiyanti & Yuliawati, 2022).A commonly used approach in assessing each failure mode is through the use of Risk Priority Number (RPN), which is obtained from multiplying the severity, occurrence, and detection values involving experts in providing an assessment of these three aspects.The purpose of this analysis is to identify the most important failure modes, so that action can be taken to reduce or eliminate them from the system, improve or reduce their impact, and ignore or allow them to occur (Supriyadi & Nabilla, 2020).The results of the analysis of the four Experts are presented in Table 2.The higher RPN value indicates that the possibility of failure has a higher risk, so that it can be prioritised for immediate corrective action (Kartika, 2022).Based on the results of the analysis that has been carried out, it shows that the failure mode with the highest RPN value comes from failure ID 1.1, namely in the form of no information on the origin of the fish imported into the Company with an RPN value of 627 and is at the unacceptable matrix level.If this failure continues to occur, there will be a break in the product traceability chain due to the unknown identity of the fish being processed.Conversely, failure ID 15.1, which is an error in entering data on time, temperature, and retort pressure during the sterilisation period, has the lowest RPN value of 19 and is in the acceptable without revision area in the critical matrix.This shows the existence of a good work system supported by dual documentation in the form of manual data written by employees and retort recording, so that information about the condition of the retort is well documented.
The results of the critical analysis in the critical matrix show that failure IDs 4. 1; 6.1; 7.1; 7.2; 8.1; 9.1; 10.1; 10.2; 11.2; 12.3; 13.1; 14.1; 15.1; 15.2; 15.3; 16.1; 16.2; 18.1; 20.2; 21.1; 21.3; 22.1; and 23.1 fall into the acceptable without revision category.This indicates that the implementation of traceability in all functions with these failure codes has been done well without requiring revisions or corrective actions.Failure ID 1.1 and 2.2 are in the unacceptable area in the critical matrix.If at this point a failure occurs, it can result in loss of information about the identity of the processed fish raw materials and doubts about the quality and safety of the fish raw materials received and processed, thus leading to a break in the product traceability chain.Microbiological testing of fresh fish is important to ensure product quality and safety, and to prevent food poisoning due to contamination with pathogenic bacteria or diseases caused by microbes (Mailoa et al., 2019).The unacceptable area in the critical matrix indicates that the failure code, if allowed to occur, can have a serious and unacceptable impact on product traceability.Maulana et al (2021) state that the unacceptable area is the level for unacceptable failure points and must be eliminated.
In the critical matrix, it can be seen that failure IDs 2.1, 3.1, and 9.2 are in the undesirable area.In failure ID 2.1, coding each fish received is a crucial step to differentiate fish between different suppliers, where the code plays a role in efficiently identifying and tracking each processed fish, thus facilitating the product traceback process through labels.In failure ID 3.1, fish from each different supplier must be differentiated in storage.This action aims to improve the operational efficiency of the traceability system.Thus, if there is a problem with a product, traceback can be done more accurately and quickly because each product can be traced back directly to the storage area that comes Ensure that the test results are in accordance with the standards and COA provided by the supplier from a particular supplier.In failure ID 9.1, each stage of the production process requires a special record that contains information about the product being processed, which is done so that all stages of the process can be identified and traced properly based on existing recording documents.
For failure ID 5.2; 7.2; 7.3; 12.1; 12.2; 14.2; 15.3; 17.1; 19.1; 20.3; 21.2; 22.2 are in the acceptable with revision area.This shows that in the failure code, traceability has been running well but requires a little revision in the implementation.Both failure points in the unacceptable, undesirable, and acceptable with revision areas are given corrective actions as listed in Table 3.With this, there are 5 critical points of product traceability at PT XYZ that occupy the unacceptable and undesirable areas, including failure ID 1.1; 2.1; 2.2; 3.1; and 9.2.
The implementation of the traceability system in the Company is not only to improve product quality, but also indirectly to demonstrate the quality of the Company to the general public.Besides that, traceability not only aims to reduce the likelihood of a food crisis, but also to reduce the impact (Masengi et al., 2018).

CONCLUSION
The product traceability system run at the fish canning company has been well implemented by implementing a paper base system at all stages in the production process chain.In the system that runs in the company, it is divided into 23 functions with a total of 43 possible causes of system failure, where there are 2 points in the unacceptable area, 3 points in the undesirable area, 12 points in the acceptable area with revision, and 26 points in the acceptable area without revision.With this, it is determined that the traceability of canned fish products in the fish canning company has 5 critical points of traceability, namely the absence of information on the origin of the fish, no special coding is given to each fish received, no microbiological testing is carried out on the fish received, each fish received is not differentiated in storage between each supplier, and no special recording is made at the draining stage.The corrective actions that can be taken by the Company are by requiring raw material suppliers to pocket the identifying information of the fish they carry, conducting microbiological testing, distinguishing fish storage, carrying out work in accordance with the Standard Operational Procedure (SOP), checking document records regularly, and correcting them if necessary, and implementing a documentation and coding system at each stage of the process being carried out.

Table 1 .
Failure Mode and Effect Analysis (FMEA)

Table 2
Results of FMECA analysis of the four experts

Table 3
Corrective actions on the traceability system in the company