Discussion on Operation Risk and Management of Food Inspection Organizations

Xiaolin ZHANG Jinyuan LIU Di CUI

Abstract The paper introduced the significance of risk control in food inspection organizations, expounded the risk points of food inspection organizations from the aspects of human, machine, material, law, environment and testing of laboratory operation and gave corresponding risk management measures. This will help food inspection organizationsrisk prevention and control to achieve effective management of inspection organizations.

Key words Risk; Management; Control

In recent years, food safety issues emerge constantly, from sudan red in duck eggs to melamine in milk powder, from illegal cooking oil to lean meat, from cadmium rice to poisonous bean sprouts, each of which challenges consumers and social tolerance. With the development of the national economy and the improvement of peoples living standards, food safety has become a top priority for national economy and peoples livelihood. The state and the public have paid more and more attention to the quality and health and safety of food. Correspondingly, food inspection organizations that provide technical support for food safety regulatory work often take the challenges［1］.

It is the most basic principle for each testing organization to meet the authentication requirements for inspection and testing institutions continuously, and to conduct scientific and fair inspection and testing activities following the standards of inspection and testing institutions. Testing organizations must strictly implement their own duties and ensure the food safety of the masses. However, during the food testing process, various risk factors may occur, affecting the accuracy of the food testing results. This situation is obviously unacceptable, so it is necessary to do a good job in the risk management of food inspection organizations［2］.

Because of varieties of foods, complex ingredients, different inspection items, diverse inspection standards, and complex and variable additives, in the event of any problems, it will draw high attention from the media, which determines the high risk of food inspection organizations together with many other factors. How to ensure that the inspection data and conclusions issued are objective and fair, and to clearly aware of their own risks and strive to minimize them, has become a problem that all food inspection organizations must seriously consider［1］.

Based on previous work experience, management experience and learning experience in food testing industry, the risks in the operation of food inspection agencies were analyzed, mainly from personnel, equipment, testing methods, environmental facilities and testing processes, and feasible measures were proposed.

Overview of Risk and Risk Assessment

The so-called risk refers to the possibility of a hazard or a danger. The biggest role of food inspection organizations is to produce evidence-proven data or reports for the public through professional technical testing methods to inform the public which products are reliable and which products have quality or even safety problems, which could clearly and intuitively guide the consumption of the public. If the management of the laboratory or the technical ability is at low level, or the practitioners lack the sense of responsibility and mission, the data will be inaccurate, or even cause quality or safety accidents. This kind of behavior is bound to bring bad influence and major losses to the society.

When laboratories are doing specific work, because of varieties foods, varieties of food processes and the complexity and precise requirements of food testing, various risk factors may occur, affecting the accuracy of the test results. Therefore, the manager of various organizations should do a good job in risk management to ensure the accuracy of food testing results.

Significance of Risk Management in Food Inspection Agencies

CNAS-CL01 Accreditation Criteria for the Competence of Testing and Calibration Laboratories and RB/T 214-2017 Competence Assessment for Inspection Body and Laboratory Mandatory Approval—General Requirements for Inspection Body and Laboratory have both made requirements on laboratory risks and increased the chapter of Dealing with Risks and Opportunities［3］. RB/T 214-2017 further points out that the inspection and testing organizations should establish a long-term mechanism to identify the risk of impartiality. If the impartiality risk is identified, the inspection and testing organizations should be able to prove the requirements for eliminating or reducing the risk［4］.

On the one hand, there are many fields in the inspection and testing industry, such as food, environment, pesticides, fertilizers, textiles, machinery, chemicals, electrical appliances, motor vehicles, lighting facilities, etc., covering all aspects of life, each of which is related to peoples living quality. As people regard food as their prime want, the reassurance of eating and the health of eating are the issues that everyone cares the most. On the other hand, todays living conditions have made people pay more attention to food, from eating well to eating healthily. Although the whole society has formed a certain consensus, the so-called safe and reliable food is produced, and testing is only a measure. However, because the processes and links involved in production are complicated, a paper inspection report or official report for the people is the most intuitive. Therefore, the detection of food quality and safety has become the most important way for the society to learn information, which is why the supervision of food inspection organizations has increased in recent years.

Implementing risk management can not only standardize the operation of laboratories to a maximum extent and prevent laboratories from issuing erroneous data or reports, but also can help laboratories effectively respond to changes in national policies and industry orientation or the reform of laboratories themselves and make correct decisions on protecting laboratory assets in real time. Overall, it can help to realize laboratoriesquality objectives, relatively improve laboratoriesadded value, and enhance the credibility. Therefore, whether for the labor requirements for laboratoriesemployees or the actual needs of national economy and peoples livelihood, the risk issues of food inspection organizations must be taken seriously.

Common Risk Categories for Food Inspection Organizations

There are many risks in a laboratory, and risks are everywhere. It is unrealistic to eliminate risks, so we must identify risks according to work links, work factors and work characteristics and actively avoid and correctly apply risks. According to the six main factors of laboratory operation, i.e., human, machine, material, method, environment and testing, combining with some actual laboratory cases, this paper listed some risk points that are easy to identify but not easy to attract attention or difficult to identify (Fig. 1).

Human

The outstanding problems existing in laboratory personnel are described below. Firstly, key personnel have appointment documents, and duties are also stipulated in each post, but the duties are crossed, the actual implementation process is not well-organized, and it is easy to shirk responsibility, which suggests that the work efficiency and work quality are not high. Secondly, after the change or expansion of the inspection items, no ones ability is confirmed, the employment certificate is not changed timely, and the traceability mechanism for personnel capability and authorization is not strong. Thirdly, new recruits are supervised, but the old employees, technical supervisors and other personnel are not supervised according to the quality of work or long-term separation from the post, resulting in errors in the test results; and on the other hand, supervision is in the form, unrecorded and is not  effectively improved. Fourthly, the authorized signatorys actual  ability does not meet the industrial requirements. Fifthly, the professional span of the personnel is too large, and there is no effective continuing education and assessment. At last, the flow of personnel is too fast or the employee status is unstable, and job-hopping frequently occurs, so it is impossible to form a relatively fixed and experienced team, which affects the stability of data and the judgment of abnormal work.

Specific case: ** Laboratory was qualified for the test parameter, amantadine, through expansion audit, but the authorization letter of relevant technical personnel had not been updated. After the testers had been engaged in the test for one year, problems of reports were traced back, and it was found that the personnel were unauthorized. As a result, the test qualifications were questioned, and data and reports were not effective.

Machine

According to the latest requirements in CNAS-CL01 Accreditation Criteria for the Competence of Testing and Calibration Laboratories and RB/T 214-2017 Competence Assessment for Inspection Body and Laboratory Mandatory Approval—General Requirements for Inspection Body and Laboratory, reference materials (standard strains, etc.) are classified into the scope of instruments and  equipment. The following described the equipment and laboratory standards separately.

There are mainly four kinds of risks in laboratory equipment. Firstly, the instruments and equipment are in use for a long time, lacking effective maintenance, and the period verification of instruments and equipment is in the form, resulting in a decrease in data precision. Secondly, instruments and equipment that should be calibrated are not calibrated timely, and the accuracy and precision are not guaranteed. Thirdly, instruments and equipment that are influential to each other are placed together, and thus interfere with each other, and the data are inaccurate. At last, the status of instruments is confusing, and the operation is not clearly and inaccurately recorded, so they cannot be used accurately or their use cannot be traced effectively.

Laboratory reference materials (standard strains) mainly face five kinds of risks. Firstly, standard substances, reagents and samples are stored in a mixed condition, resulting in cross-contamination. Secondly, the standard substances have no period verification record or the period verification flow is in the form, and the quality of the standard samples cannot be effectively grasped, which has an impact on the test results. Thirdly, as some standard substances are not certified and their quality is not guaranteed, or because of the purchase of cheap standard samples through the informal route, the results are affected. Fourthly, the validity period of standard samples is not monitored in time, or the quality of standard samples is not verified by quality control measures after expiration, and if the standard samples are off the validity period or used in an invalid state, the results are not accurate. At last, the storage condition required by the Reference Material Certificate is not carefully verified, and the standards are frozen or refrigerated in accordance with past experience, resulting in degradation or failure.

Xiaolin ZHANG et al. Discussion on Operation Risk and Management of Food Inspection Organizations

Benzopyrene was once detected in edible oil in a laboratory, and the test results were always far from the actual background values. The experimenters checked the state of instruments and the operation processes, and found no problems, but problems were found when checking the standard substances. According to the standard requirements, the shelf life of a 100 mg/kg standard stock solution is one year, and that of an on-site stock solution is only half a year. Then, the storage condition also met the certificate requirements, so the stored solutions should be valid standard solutions. However, the laboratory used another batch of stock solutions to prepare working solutions of the same concentrations, and compared with the original stock solution and working solutions, the peak areas and contents of the two were very different, which meant that the original standard used was problematic, and the laboratory replaced the stock solution and the working solutions in time.

Material

Material in laboratories mainly refers to detection reagents, consumables for laboratories and samples. Because of varieties of consumables, diverse usages and various samples with various properties, the daily management problems and risk problems of materials will be more. Firstly, due to the expedited reason, the materials supplied by the suppliers who are not on the qualified supplier list may be purchased, and the quality is not guaranteed as there is no technical acceptance due to expediting, resulting in a large deviation of the test results (Some organizations have purchased purification reagents for the detection of ciprofloxacin, which were found to cause too-low recovery during the verification, and were thus abandoned and replaced with newly bought purification reagents from another suppliers, which ensured the accuracy of the test results. If it had not been verified beforehand and used directly, it could have caused the background values of large quantities of samples to have no practical significance, even false positive, false negative, etc.). Secondly, there is no quota for the use of highly toxic drugs, or there is no tracking and supervision for application, and the whereabouts are unknown, resulting in a risk of leakage (such as Zhu Lingyu poisoning case of Tsinghua University). Thirdly, laboratories pay more attention to the easy-to- produce toxic reagents, but neglect the management of explosive reagents, so explosion accidents happen easily. Fourthly, in the case that a large number of reagents are purchased at one time and the storage place is limited, they cannot be classified and stored, which leads to a risk of cross-contamination. Fifthly, reagent rooms or reagent cabinets have no exhaust ventilation facilities, or the air exhausting is not up to standard, the stored reagents may harm human health. Sixthly, consumables are not purchased in accordance with standard requirements, resulting in deviations in test results (for example, the making pens purchased for sensory laboratories have an odor, causing sensory evaluation results to be invalid). Seventhly, there are too many gas cylinders in gas cylinder rooms, there are no fixed measures, and there is a risk of deflagration. Eighthly, the status of samples is not described, and special cases are not recorded when the samples are received, so abnormal results cannot be traced. Ninthly, the samples are not classified according to their categories, and the preparation order is not recorded, so there is the possibility of cross-contamination, which cannot be traced. Tenthly, the representativeness of the sample collection is not strong, or the number of samples is insufficient, resulting in unrepresentative test results (Special attention should be paid to the test items required for the amounts of sampled products in the National Food Safety Supervision and Sampling Inspection in recent years).

Method

The method of laboratory refers to standard methods, operation instructions and operation procedures. In this part, the biggest risk comes from two points. One is the wrong use of detection methods, and the other is that the methods are not operated according to the guidance methods and the operation procedures, resulting in instrument failure or accuracy decline. In recent years, the food testing standards have been updated very quickly. In the newly issued standards, the regulations, scope and specific definitions of the applicable products, and the setting of the standard solutions have changed more or less. If we still operate on experience, and dont study the standard rules carefully, there will be a series of non-conformities. For example, no stabilizer is used during the preparation of mercury standard solutions, and the testing of products (beverage, mixed liquor, hard candy, candied fruit, starch jelly, chocolate bean and colored sugar-coated products) for pigments is not in accordance with the standard. Another example is that laboratories only detected the Bing of instant noodles, while GB 17400-2015 stipulates that the detection of coliforms and total number of colonies for instant noodles is only applicable in the inspection of the mixture of the Bing and seasoning, and a report of non-conformity is issued when the detection of coliforms is positive, causing trouble for enterprises and laboratories, and wrongly guiding consumers.

Environment

The environment refers to the overall environments of laboratories. Laboratory layout, regional isolation, regional identification, setting of constant temperature and humidity zones, temperature and humidity conditions and safety for water, gas and electricity use all fall into the scope of environmental facilities. Overall, there are mainly seven risks in this link. Firstly, the temperature and humidity in areas where the temperature and humidity environment should be recorded are not recorded or recorded in the form, and problems are not discovered in time, resulting in the failure of the experimental operation or stored samples. Secondly, there are problems in laboratory ventilation facilities, the fire-fighting facilities are placed disorderly, and effective first-aid training is not taught to the personnel, which may cause harm to the personal persons of the experimental personnel. Thirdly, the “three wastes” collection devices at experimental sites are not sealed or tightened, resulting in long-term volatilization of waste liquid, which may cause potential harm to human body and experimental environment. Fourthly, environmental conditions are not recorded during detection, and the test results cannot be reproduced. Fifthly, the gas paths of instruments and equipment are crossed and cluttered, and there is a fire safety hazard. Sixthly, pathogenic microbiology laboratories do not have a biosafety device, which poses a risk of infection to operators. At last, the workspaces that affect each other are not effectively separated, affecting the accuracy of the test results and also impairing the performance of instruments used for a long time.

Testing

Testing mainly refers to the technical operation and quality control of the inspection process. The effect of this factor on the accuracy of data can be said to be decisive. Generally speaking, for the first five factors, as long as the work is strictly in accordance with the rules and regulations, and the sources are strictly controlled, the probability of occurrence of problems is not great, but the testing process adds a lot of subjective and empirical factors. There are mainly fifteen risks that may occur during this process. Firstly, insufficient understanding of standard methods, and product definitions, operating procedures and other special provisions that have not been carefully studied in standard texts, result in misuse of testing standards or testing beyond ability. Secondly, without rigorous experimentation, the reagents used in standard methods and the order of the processing procedures are arbitrarily changed, resulting in inaccurate detection results. Thirdly, for samples with data near the limit value, the re-inspection procedure is not strictly performed or the uncertainty is not applied, resulting in inaccurate results or false positive. Fourthly, the reinspection of positive samples is too simple and hastily in that the testers and test instruments are not changed and samples are not re-prepared, and as a result, the positive results are not reproducible and representative. Fifthly, the same method involves a large number of substrates, and the detection results and recovery rate of each type of substrate by the method are not verified, resulting in false positive data (for instance, in the detection of profenofos, the matrix effects of tomato and citrus are different, and there will be a large deviation in the recovery). Sixthly, the lack of in-depth interpretation of the criteria and the deviation of the judgment basis result in a wrong conclusion. Seventhly, quality control results are not properly used. For instance, the problems including low recovery, unstable comparison results and poor reproducibility are not actively and effectively analyzed and rectified, resulting in occurrence of similar situations. Eighthly, for unqualified samples, the appearance photos and label identification information are not recorded for evidence before samples are unpacked, resulting in the loss of reference basis for the re-examination results of some items. Ninthly, the detection methods of original records are inconsistent with the actual detection methods, and the deviations are not effectively recorded, resulting in the inability to obtain the data in spectra and problems in the traceback link. Tenthly, the original records are irregularly changed and there is a possibility of fraud. Eleventhly, the report data are inconsistent with the original records, and the report reviewers and approvers are not responsible. Twelfthly, the report qualifications of different fields and different natures are inaccurate and lack effective review, and the reports may be stamped incorrectly. The thirteenth risk lies in that the transmission procedure of reports is not strict, the information records are not detailed, cannot be traced effectively and risks leaking. At last, report management lacks strict management measures and is prone to risk of loss or damage.

Risk Management and Specific Measures of Food Inspection Organizations

For some risk points of food inspection organizations, we must try our best to prevent and manage them effectively. Risk management refers to the management process of how to minimize risks in a risky environment［5］. This process includes risk identification, risk analysis, risk management, effect appraisal and risk utilization.

Identification of sources of risk

Risk identification is to determine which risks may affect inspection agencies. The most important thing is to quantify the degree of uncertainty and the extent to which each risk may cause losses, which is the basic work of risk management. Only by effectively identifying the risks can we further analyze and control risk factors. However, one idea we need to establish is that some risks can be identified in actual work, while some risk factors are difficult to identify or even understood after they occur. This requires us to plan the degree and level of risk factors when identifying risks. For the risk of not being easy to identify or even insensible before occurrence, the unnecessary energy input in the early stage should be reduced.

Risk analysis

After risk identification, risk assessment should be based on the probability of occurrence of the risk, the severity of the consequences, and whether there is a realistic management mechanism. The relevant person in charge of laboratories should comprehensively analyze all the posts, links and known external influences according to the various types of laboratory operations, the type of work, the work content and the external environment, to determine the risk level and which have a direct impact on the quality of the work, which have indirect effects, which are risk-prone or manageable risks, and which are not prone to occurrence and difficult to control. Meanwhile, they should determine different disposal plans according to the level of risk, and form corresponding internal management mechanisms as necessary as the basis for later work.

Risk disposal

After identification and analysis, the disposal measures should be based on the results of risk analysis, such as the probability of occurrence, the severity of the consequences, the degree of perfection of the control mechanism, and the frequency and distribution of such events in the past.

In general, the specific disposal measures are mainly to  avoid, reduce, transfer and accept risks.

The first is to avoid risks. The risks of laboratory cannot be completely eliminated, but the staff can choose to actively avoid some unnecessary risks. For example, newly purchased reagents should be checked for quality. If a batch of products is found to have quality problems, we should stop using the product and stop purchasing the products from the supplier of the product. This is an evasive measure.

The second is to reduce risks. For example, the technical capabilities of the laboratory should be assessed, monitored and evaluated through routine capability verification, quality control, inspection process supervision, technical personnel training and technical competition, to minimize the risk probability of quality inspection. Also, through the accumulation of talents, equipment and equipment sharing, establishment of incentive systems and safety training, we can reduce operational risks, risk of key employee turnover, equipment damage risk and laboratory safety risk, to fundamentally eliminate specific risk factors.

The third is to transfer risks. Laboratories can use insurance to transfer risks to insurance companies, such as insurance for laboratory workers, insurance for laboratory property, and insurance for laboratory workers［5］.

The last is to accept risks. Some risks cannot be effectively predicted or controlled in the early stage. For example, changes in national policies and systems are often accompanied by opportunities for institutional development and change. Therefore, laboratories must be brave enough to accept risks, take advantage of the opportunities brought about by risks to innovate or reform, and win further development.

Effect evaluation

Through the analysis of work data collection and disposal measures in a certain period and a certain range or field, rigorous effect evaluation can be carried out. If each field can meet the companys goals and achieve risk aversion or reduction, it indicates that the risk control measures are applicable and effective, and the next step is to maintain and continue to observe and analyze; and if the companys goals are not met and work problems arise frequently, it is necessary to analyze the specific causes of the problems and appropriately adjust the risk control measures and prevention mechanisms.

Use of risk to identify opportunities

Risks and opportunities often coexist. In the process of risk management, there are generally opportunities for institutional development.

For example, many government laboratories have fewer social entrusted businesses because of their nature, and most of the social entrusted businesses are scattered to the inspection and testing institutions in the society, which also play an important role in government tasks now. In recent years, with the restructuring and transformation of public institutions, many government laboratories have gradually introduced to the market. From the perspective of equipment allocation and resource allocation, it will have a strong impact on the market and business volume of corporate inspection and testing institutions. This is a risk factor of the realistic environment. However, in this process, for institutions with strong risk awareness, in the social context of policy and environmental change, they can more clearly recognize their shortcomings and carry out new reforms and innovations, which is an opportunity as well.

In the final analysis, risk management must be implemented in order to become a favorable tool for laboratory development. According to the characteristics, work content and links of laboratories, the operating procedures, management methods and operation instructions are formulated step by step and in stages to provide practical guidance for the execution and operation of specific work. For risks that are unforeseen or impossible to prevent and control in advance, the risk control function should be defined, emergency plans should be prepared, and the planning of people, property and materials should be carried out. When risks occur, they can be disposed in a timely manner and properly controlled to minimize losses.

Conclusions

The quality of food is related to the health of people and the safety of life, and is the top priority of the national economy and peoples livelihood. Food inspection agencies must ensure the quality of testing and provide technical support and safety guidance for the public. This work requires strong legal awareness and a high degree of professional responsibility. It also requires a strict management system, advanced risk management awareness and management capabilities. Risks are everywhere, and we should not fear to talk about risks. We must face the objectivity and significance of risks, learn to deal with risks, avoid risks and accept risks, and seek the development path that suits ourselves, the environment and the society.

References

［1］WANG X, ZHANG HS. Risk analysis and control of food inspection organizations［J］. Sino-foreign Food Industry, 2013, 8: 68-70. (in Chinese)

［2］LIU XX. Discussion on risk management of food testing laboratories［J］. China Food Safety Magazine, 2018, 30: 57. (in Chinese)

［3］China National Accreditation. CNAS-CL01 Accreditation criteria for the competence of testing and calibration laboratories［S］. (in Chinese)

［4］Certification and Accreditation Administration of the Peoples Republic of China. RB/T 214-2017 Competence assessment for inspection body and laboratory mandatory approval—General requirements for inspection body and laboratory［S］. (in Chinese)

［5］WEN HG. Discussion on risk management of food and drug testing laboratories［J］. China Food Safety Magazine, 2015, 24: 65-66. (in Chinese)