GMP Risk Assessment at an Organic and Natural Food Production Plant with Emphasis on Infrastructure by PHA and FMEA Methods

Mehrzad Zandieh

Department of Chemical Engineering, Faculty of Engineering, Razi University, Kermanshah, Iran.

In this new and applied study, the risks related to the possible states of pollution in GMP (Good Manufacturing Practices) in an organic and natural food production plant were investigated along with their risk factors and consequences and effects. Also, preventive and control measures were suggested to decrease the effects of risks. Also, the risk numbers prior and post preventive measures were calculated. To do so, the two FMEA and PHA methods were used. It was revealed that after the controlling measures, the risk numbers were decreased (in both methods) which is due to a decrease in the probability of occurrence. It is indicative of the effectiveness and fitness of all the suggested control measures.

Corresponding author: Mehrzad Zandieh

e-mail *  Mehrzad.zandieh @ yahoo.com

Received: 17 August 2019

Accepted: 22 December 2019

1. Introduction

The risk assessment is the process of identification of the risks, a procedure, or a job and then, calculation of its risk index and finally, the provision of proper corrective solutions to control them (Total, 2004). The risk is the ability of a factor to produce a specific type of damage (ACDP, 1996). The probability of actuality of danger is called the risk. The description of risk is highly related to the probability of it (Dupont and Theodore, 2012). The risk is the probability of occurrence of danger and its severity, which leads to damage. In this regard, the risk does not have a fixed quantity and it is constantly changing (Muhlbauer, 1999).

There are different ways to assess the risk such as FMEA (Failure Modes and Effects Analysis) and PHA.

FMEA is a quite subjective systematic and preventive method which is used in definition, identification, assessment, prevention, omission, or controlling of the modes, causes, and effects of the potential errors in a system, process, plan, or service, and its condition is the prediction of the failures and the ways to prevent them (Krouwer, 2004; Gressel and Gideon, 1991; Cody, 2006).

The PHA method is used to identify the potential dangers in the preconstruction phases of industrial projects whose prerequisite is the preparation of a list of different dangers (Mohammad Fam, 2008).

To conduct the study in the PHA method, it is required to fully recognize the process production objectives, the environment in which the product is going to be produced, the equipment and hardware which are used along with the product and the operational criteria for the final consumer (Halvani and Zare, 2009).

The natural and organic food production plant is among the factories in which the GMP risk management related to different modes of pollution in its GMP process, based on the infrastructures, has not been investigated so far. This new and applied study deals with the risk assessment of the probable pollution modes in the GMP process in an organic food production plant through FMEA and PHA methods as well as the investigation of the risk factors and effects and consequences along with the preventive and control measures to reduce the risks.

2. Methods:

FMEA:

The intensity of each of the risks is expressed based on Table 1 (defect intensity). The criterion for selection of the intensity index is determined based on the highest frequency. The obtained results in the intensity column (S) would be added to the risks analysis record sheet. Then, the occurrence of this incident would be determined based on Table 2, accordingly. These data also would be recorded in the risk analysis form.

Table 1: risk intensity (defect)

Table 2: risk occurrence probability

The risk index which is abbreviated as RIN is obtained from the multiplication of defect effect intensity (S) by the defect occurrence probability (O) which should be compared to the allowed rate of risk as shown in Table 3 (5).

RIN = S x O                                                                           (1)

Table 3: risk matrix

The acceptable risks have a value of lower than 5. The reason behind this choice is the sensitivity of the organic food products to pollution. In case the calculated risk index is lower than the acceptable index, the risk would be acceptable and in case it is above this value, the risk is not acceptable and corrective or preventive and control measures must be taken to eliminate or reduce the risks, and afterward, the controlling measures must continue until the risk analysis group consider the risk rate to be acceptable.

PHA Method:

Table 4: risk analysis matrix for PHA method

Table 5: the concepts of risk criteria for different levels of risk by PHA method

3. Results and Discussions:

The risk assessment by the FMEA method is shown in Table 6.

Table 6: Risk assessment by the FMEA method

Determination of risk levels prior and post controlling measures are also shown in table 7 (based on the PHA Method).

Table 7: determination of risk levels prior and post control measures based on the PHA Method

Based on Table (6), 26 different risks were identified and their causes along with their consequences and effects were determined. Also, through the calculation of the risk indices, it was revealed that all 26 items needed preventive and controlling measures (risk indices above 5). The risk indices calculated by the use of FMEA Method had values of 6 and 8 (before control measures). The cases in which the risk index was 8 were those related to risks that lead to direct pollution of the final products and semi-processed materials. And the cases in which the risk index was 6 were those related to risks of pollution of the halls, especially the production hall. Also, this table shows that through controlling measures in designing the intended factory and its infrastructure (GMP), the risk indices can be lowered to 3 and 4.

The circular diagram (figure 1) of the FMEA table has been drawn. This diagram shows that 80.77% of the risks are those with critical intensity and unlikely occurrence probability (risks that lead to the direct pollution of the product) and 19.23% of the risks are those with serious intensity and unlikely occurrence probability (the risks that merely lead to pollution of the halls, especially the production halls).

Figure 1: the circular diagram of the risks division for different modes of pollution

Table 7 shows the risk levels obtained by PHA Method. This table shows that from among a total of 26 identified risks that lead to the pollution of the product, 21 have 2D risk levels before the controlling and designing measures, which is reduced to 2E level post controlling measures. Also, the remaining 5 items have a risk level of 3D before controlling and designing measures, which is reduced to 3E after appropriate controlling measures. The comparison between the FMEA and PHA methods shows that FMEA is a quantitative and numerical method of risk assessment. Also, the PHA method is semi-quantitative. The FMEA method is much more suitable and better than the PHA method for the control and design phase.

4.      Conclusions:

This study showed that Pay attention to the discussion of infrastructure in plant design is very necessary and important for preventing hazards. Also, it was showed that adhering to the GMP (good manufacturing practices) rules in design and construction to achieve optimal hygiene and cleanliness in the production environment and ultimately to achieve a high-quality product can help to a successful risk assessment. Also, FMEA is better that the PHA method for risk assessment in the design and preventive phase.

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