Abstract

Background: Accreditation ensures a very high level of control of the risks that laboratories may face during their cycle regardless of a systemic situation, internal or external change or even in a state of crisis. MULTILAB, which is an Agri-Food and Environmental analysis laboratory, decided in 2018 to start the project accreditation for the microbiological analysis unit according to the new version of the ISO / CEI 17025: 2017 standard. This study evaluates 3 processes at MULTILAB to identify, evaluate, and control all the risks related to each process using a risk management process. The aim of this study is to reduce the identified risks of the 3 chosen processes in MULTILAB to ensure a complete identification of probable risks to enable then the laboratory to succeed the transition and accreditation project. Methods: This study was performed from March to May 2018 in MULTILAB. The samples chosen for the study were 3 processes of MULTILAB; Monitoring and Measurement as a management process, Request Review as realization process and Provision of Skills as a support process. The internal process sheets which include all the data relating to the processes were used to collect data. The risks are defined according to the 5M method and the risk process used comprised 3 phases; identification, assessment and action phase. To evaluate the risks, different rating benchmarks were used for each process. After the definition of the risk’s likelihood and severity, the criticality was calculated and then the priority number was defined for all risks. For the action phase, different actions were defined according to the priority level of each risk in each process to reduce or eliminate risks. Results: The total number of identified risks was 85 in MULTILAB; Skills Provisioning process had the majority of identified risks (37 risks), Monitoring and Measurement process represented 25 risks and Request Review process had the lowest number of risks (23 risks). Regarding the 5M method, in a total of 3 processes, the highest number of identified risks belongs to the Methods (30 risks) and there are no risks that belong to Machines within MULTILAB. Regarding the treatment priorities, the majority of the identified risks for the three processes were moderate risks. Conclusion: A risk management approach is necessary to succeed not just in the accreditation project according to the new version of the ISO17025: 2017 standard but also to succeed in all next projects and to ensure the credibility of the tests carried out. Most of the risks identified do not require immediate action, but permanent control and monitoring can mitigate and even eliminate them completely.

1. Introduction

In 2017 as per ISO 17025, the “laboratory is body that performs one or more of the following activities: testing, calibration and sampling, associated with subsequent testing or calibration” ¹.

Previously, laboratories were just responsible for carrying out tests in a basic and simple way within a well-defined framework, but currently a test result carried out in one country could be accepted in another country ¹.

Actually, more than 60,000 laboratories throughout the world are doing calibration, testing, and sample analysis on a regular basis. Their main purpose is to reassure clients that their results are accurate. It allows them to show that they are technically capable of producing valid and reliable results ².

The definition of accreditation for a laboratory is the process during which the laboratory’s technical competence is assessed, approved and periodically audited by an internationally recognized authority in accordance with certain standards, for the reliability of the tests and analyzes ³. At the international level, accreditation is a strong vector of trust facilitating recognition of the reliability of results, as if they had been carried out locally ⁴.

Laboratory accreditation is an activity which adjusts technical and general requirements based on ISO / IEC 17025 with related accreditation institutions ⁵. Accreditation is also an important mechanism to overcome the limited knowledge, budget, planning, policies, and staff needed to improve laboratory services ⁶.

Accreditation ensures a very high level of control of the risks that laboratories may face during their cycle regardless of a systemic situation, internal or external change or even in a state of crisis. It ensures also the improvement of the organization, the quality of the services or the product it provides, the satisfaction of these customers, a good brand image and staff involvement in a project which creates added value.

Accreditation guaranteed for competent laboratories:

i. Official national and international recognition of the reliability of the results.

ii. Loyal customers with reliable testing, measurement and calibration services that meet their needs.

iii. Become an industry sub-contractor.

iv. To be able to establish itself in a new market given the international recognition.

v. Guaranteed sustainability of laboratory activities.

vi. Receive approval from the public authorities.

vii. Continuously ensure better governance, process and risk management.

In Tunisia, the accreditation of testing and / or calibration laboratories as well as that of technical inspection bodies is based on the principle of voluntary service; it is open to all organizations which request it and which comply with the technical criteria set by the TUNAC (National Accreditation and Quality Council).

The application of ISO/IEC 17025 is a mandatory requirement for obtaining laboratory accreditation. Requirements needed in fulfilling laboratory accreditation by auditing eight elements, namely organization, observation systems, documents, quality system records, relationships with customers and colleagues, laboratory work, quality research, and laboratory personnel ^{7, 8}.

In order to obtain laboratory accreditation, MULTILAB was able, thanks to its credible risk management methodology, to retain a certain number of customers throughout the territory of the Republic of Tunisia.

MULTILAB was among the first private Agri-Food and Environmental analysis laboratories to obtain accreditation according to ISO / IEC 17025: 2005 in 2012 and it has succeeded in maintaining ISO / IEC 17025 accreditation following follow-up audits .

Internal audits are carried out each year to verify the accordance of the Quality Management System with the technical requirements of ISO / IEC 17025: 2005 to ensure the effectiveness of the laboratory's activities and management system.

ISO/IEC 17025 as well lets simplify collaboration among laboratories and different associations upon producing larger approbation of findings among nations. Experiment reports and certificates can be regarded as true from one nation to another without the requirement for additional experimenting, which successively enhances international trade ^{9, 10}.

ISO 17025: 2005 has been revised by a new version including some modifications (Table 2) ^{11, 12}.

The new version appeared in November 2017 updating some concepts. As a result, ISO 17025: 2005 accredited laboratories have to obtain the new accreditation according to the new version by developing their quality management system and integrating

There are 141 requirements of ISO / IEC 17025: 2017 (Table 1).

ISO/IEC 17025:2017 ¹³ was modernized cooperatively by ISO and the International Electrotechnical Commission (IEC) under the responsibility of the ISO Committee on conformity assessment (CASCO) ^{14, 15, 16}.

Currently, analysis and testing laboratories increasingly need to provide their customers with a credible and transparent methodology to give confidence in these results and reduce measurement error.

Accreditation under the ISO17025 standard represents official recognition of the competence of laboratories and enables their clients to find reliable services that meet their needs.

Recognized tests of products from various industries are carried out in accredited testing laboratories to ensure that they comply with legal and customer standards ¹⁷.

The issue is that due to different errors that might occur throughout the pre-analytical, analytical, and post-analytic phases, not all laboratory tests will yield conform results ¹⁸. To acquire accurate test findings, error detection must be complete. ¹⁹. The risk is associated with the unknown outcomes of a future event with the assumption that these outcomes will be undesirable ¹⁷.

“To deal with it effectively, risk-based considerations must be integrated into an analytical framework such as Risk Management” ²⁰.

According to the International Organization for Standardization (ISO) 14971, risk management is described as the systematic application of management policies, procedures and practices to the tasks of analyzing, evaluating, controlling, and monitoring risk ²¹.

Risk management, according to Nichols, is a way of determining relationships in the processes of recognizing, assessing, evaluating, handling, lowering, and continuous monitoring of risks in order to reduce losses and maximize opportunities while keeping risks at an acceptable level. ²².

The Risk Management is comprised in the HLS structure (High Level Structure) of the new versions of management standards (ISO 9001, ISO17025, ISO14001 and others) because today everywhere in the world it is no longer the technical aspect that will be evaluated in companies but the ability of the latter to know the risks in each process of the company and work on the treatment needed to reduce all of risks to ensure a successful management approach. As a result, risk management must be viewed as an integral aspect of an organization's quality management system.

Risk management is currently one of the most popular subjects among management researchers and practitioners ²³. Various risk management strategies were offered in the studies. The risk assessment phase, which includes identification, analysis, and prioritizing, and the control phase, which includes risk management planning, classification, and monitoring, are the two key phases outlined by Boehm ²⁴.

Risk management, according to Kremljak, is a four-phase process that includes planning, evaluation, handling, and monitoring. This procedure corresponds to the Deming cycle of continuous quality management improvement (PDCA - Plan, Do, Check, and Act) ²⁵.

Chapman and Ward have proposed a process consisting of nine phases ²⁶:

• Defining the project's main features

• Focusing on a strategic risk management approach

• Identifying potential risk locations

• Organization data information about risk assumptions

• Assigning accountability and ownership for a certain risk

• Calculating the degree of uncertainty

• Evaluating and determining the magnitude of the risks

• Assigning responsibility for risk planning, monitoring, and management.

Risk management includes 3 phases:

• Identification of risks

• Assessment of risks

• Mitigation of risks

First, with identifying risks, we register all the potential risks that concern all the laboratory’s activities ²⁷.

The risk can be identified using multiple techniques such as System Mapping Approaches (SMAs), 5M method, structured brainstorming, etc. ²⁸.

The risk assessment and determination of its se is necessary for selection of the appropriate measure that depends on the priority of the risk.

The risk assessment step could be carried out in a variety of ways, such as establishing rating benchmarks to define likelihood and severity levels. The assessment could be conducted also using Failure Mode and Effect Analysis (FMEA). This method of analysis is mainly used in medical, biomedical and educational laboratories, hospitals and even in industries.

For the mitigation of risks, laboratories have to establish quality indicators to apply efficient treatment actions.

Risk management approaches must be integrated into the testing process in areas requiring non-expert personnel, departmental communication, and general collaboration. The entire system must participate in enhancing the overall testing process in accordance with ISO standards ²⁷.

To be able to carry out processes in accordance with ISO norms, appropriate and effective personnel training must be ensured. ²⁹.

As a result, the entire system must be involved in improving the overall testing process, successfully carrying out risk management measures, and bringing better rewards to project performance through increased productivity and reduced threat impact ³⁰.

In a global setting, many countries have implemented risk management for laboratories but the majority of the studies were related to clinical, medical, educational and biomedical laboratories. These studies concerned utmost the safety and security. A study in Kenya presented enhanced training for laboratory staffs on bio-security and bio-safety as highly associated with compliance to bio-risk codes ³¹.

Another study on risk management in clinical laboratories in Africa found that most laboratories have undeveloped transmission control activities as a result of a lack of awareness, a lack of trained personnel in infection control, inadequate infrastructure, and procurement barriers, all of which result in poor infection control ^{32, 33}. Besides, a study at Qatar University concerned the Risk Management Assessments among students, Staffs, and in educational biomedical laboratories in hematology laboratory and microbiology laboratory. This study showed that chemical and ergonomic hazards account for almost a quarter of the identified hazards in laboratories and it recommended control measure can decrease the severity and the likelihood of identified hazards ³⁴. However, the studies carried out concerning the risk management at test / calibration laboratories and aiming at a transition or the success of an accreditation project are very rare even at global setting.

In Tunisia, the studies done at test/calibration laboratories were carried out in a global way e.g. the risk management studies related to accreditation projects in many Tunisian laboratories and other bodies were based on a single risk rating benchmark to evaluate likelihood and severity of risks of different processes.

In this study, the rating benchmarks for each process are different from each other given the risks, its levels of probability of occurrence and its levels of severity differ from process to other.

In terms of risk management, MULTILAB executives began to be concerned not only about the risks associated with work accidents, financial losses or the notion of criminal risk but also risks such as customer dissatisfaction, regulatory environment, information systems, IT security, and market competition.

The Quality Management Unit has developed the internal documents necessary for controlling risks relating to the processes, including process sheets including all the processes data (Risks, input data and output, performance indicators, etc.) to define a benchmark for rating the risks of process (identification, analyzes, evaluation and treatment) to define then control and monitoring plan relating to identified risks. The process sheets can be revised after having carried out continuous monitoring of risks and treatment actions either to reclassify the risks or to completely eliminate the risks treated.

The main objective of this study was to assess the ability of the MULTILAB laboratory to successfully complete the transition to the new version of ISO 17025:2017 standard.

To approach this objective, we identified and evaluated the risks of Monitoring and Measurement process, Request Review process and Provision of Skills process following different models of rating benchmark for monitoring and mitigating risks to decide the measure controls.

2. Methodology

The study was conducted from March to May 2018 at MULTILAB in Tunisia.

3 processes were selected and used, namely Monitoring and Measurement as management process, Request Review as realization process and Provision of Skills as support process.

The processes chosen are of different class since the assessment of the risks relating to the transition to the new version of the standard mainly concerns these 3 processes so they were included to ensure the identification and effective treatment of the identified risks.

The chosen processes are exposed to several types of risks like for example, slow treatment of complaints, no follow-up of deviations, late communication with the customer on corrective actions, customer loss...

The risks identified were defined according to the 5M method (Manpower, Machines, Materials, Methods, Management) to ensure a detailed assessment of the probable risks.

The study was evaluated and then approved by the MULTILAB’s Quality Management Unit.

A SWOT analysis was prepared to evaluate the case study method (Figure 1).

To assess risks, risk matrix and different rating benchmarks were used.

a) Risk Assessment Tools

The documents used for assessment included laboratory manual quality, process mapping, processes sheets. The process diagrams have been used to obtain the relative risks according to the 5M method.

b) The Risks Identification and Evaluation

The risk’s identification tables of each process contains a description and a classification of risks; the risk’s evaluation tables includes an estimation of likelihood, severity, criticality and a prioritization number.

For Monitoring and Measurement, the likelihood and severity had respectively 4 levels, as shown in Table 3 and Table 4.

For Request Review, the likelihood and severity had respectively 4 levels, as shown in Table 5 and Table 6.

For Provision of Skills, the likelihood and severity had respectively 4 levels, as shown in Table 7 and Table 8.

Regarding the risk evaluation, criticality levels for risks were calculated separately by multiplying the likelihoods and the severity scores of risks.

Then a risk matrix was defined as shown in Figure 2.

According to the priority level of the risks; the risks have been divided into 4 levels; critical risks (priority 1), high risk (priority 2), moderate risks (priority 3) and minor risks (priority 4) as shown in Table 9. Each level was described as shown in Table 10 and Table 11.

Afterwards, treatment actions relating to the various identified risks were defined to propose them to the managers of the different units and also to the managers of the laboratories to approve it.

c) Statiscal Analysis

The data from the processes sheets, which was utilized to evaluate risks, was transferred to the computer for analysis using Microsoft Office for Windows 10 (version 21H1).

The data in this study are descriptive of the risks and controls.

The Microsoft Word 2010 was used to draw graphs and figures.

The Radar graph was used to assess the criticality of the risks identified for each process.

The Histogram chart was used to present the distribution of risks for the three processes studied.

3. Results

a) Distribution of risks for the 3 processes

i. Identification and assessment of the risks

The different risks of each process, its frequencies, severity and levels were defined respectively.

For Monitoring and Measurement process the total defined number of risks was about 25 risks as shown in Table 12.

For Requests Review process, the total defined number of risks was about 23 risks as shown in Table 15.

For Skills Provision process, the total defined number of risks was about 37 risks as shown in Table 18.

ii. Interpretation of process risk assessment

After identifying, characterizing, defining the criticality and also prioritizing the potential risks to the processes.

We illustrated the different levels of risk criticality of the 3 processes with radar graphs as shown in Figure 6 – Figure 8.

b) The Risk Assessment of processes risks

i. The Risk Matrix

The defined risks matrix were defined for each process as shown in Figure 3 – Figure 5.

ii. The Assessment of Risks Priorities

The Risk Priority is the result of combining the likelihood and the severity of a risk.

For Monitoring and Measurement process, the assessment of risks priority of identified risks presented 2 critical risks, 5 high risks, 11 moderate risks and 7 minor risks as shown in Table 13.

For Requests Review process, the assessment of risks priority of identified risks presented 2 critical risks, 6 high risks, 9 moderate risks and 6 minor risks as shown in Table 16.

For Skills Provision process, the assessment of risks priority of identified risks presented 1 critical risk, 4 high risks, 20 moderate risks and 11 minor risks as shown in Table 19.

After identifying, characterizing, defining the criticality and prioritizing the potential risks to the process the different levels of risks criticality of each process as shown in Figure 6 - Figure 8.

c) Recommended Control Measures

According to the different risk priorities of each process, lists of actions proposed to mitigate or eliminate the risks have been defined as shown in Table 14, Table 17 and Table 20.

4. Discussion

Given the globalization of trade today, concern for the environment, health and consumer protection is still very high. As a result, standard-setting, certification, accreditation and conformity assessment bodies have set the assessment bar at a very high level to achieve compliant products and services, to improve the international competitive environment by minimizing obstacles and by application of the requirements relating to risk control and for the protection of the environment and consumer health.

The accreditation of Agri-food and environmental analysis laboratories will allow them to meet the requirements of customers concerned about the safety of the products they commonly consume and of industrialists concerned with offering the market safe products that comply with international requirements and according to customers' requirements.

The issue for these laboratories is that they are unable to accomplish and guarantee successful test findings due to a variety of risks that may arise during various process phases. Therefore, including the Including the notion of risks in any phase of the process as well as in the process sheets will make it possible to permanently and continuously identify, assess and control any probable risk to ensure its mitigation or its elimination.

A study carried out by Vasilnakova (2018) concluded that the implementation of a breast risk management process in all the activities of calibration / test laboratories is in high demand to minimize the appearance of risk as much as possible and therefore reduce its impact on activities the laboratory processes ¹⁶.

Laboratories that can successfully detect and assess risks will be better able to increase their chances of gaining accreditation by proving their technical competence and ability to produce valid and reliable results ¹⁶.

The present study aims to assess the risks encountered in three different types of MULTILAB laboratory processes; Monitoring and Measurement process as a Management process, Requests Review process as a Realization process and Skills Provision process as Support process.

The study concluded the criticality of identified risks and actions or control measures proposed to mitigate or reduce risks.

The current study's findings revealed two significant findings. First, for the 3 processes different risk number was identified; Skills Provision process had the highest number of risks (37), Requests Review process had the lowest risks number (23 risks) and Monitoring and Measurement process had 25 risks (Figure 9). Second, the majority of the identified risks were of moderate priority. In details, for Skills Provision process, there was only 1 critical risk. However, for Monitoring and Measurement process and for Requests Review process there were 2 critical risks. Thus, the laboratory has to focus first on the application of actions and constant monitoring to reduce the severity of moderate risks which presented the highest number and at the same time it needs to determine treatment actions to eliminate critical risks.

The current study’s findings demonstrated also that the total number of risks related to the methods is equal to 30, the risks related to the manpower were about 24, those related to the management, were about 20 risks and finally there were 11 risks related to materials and no risks related to machines were identified.

Thus, the laboratory’s Quality Management Unit needs to focus on creating a risk management process and to include it into the process mapping of the laboratory to facilitate the process of risk management within all activities.

Studies have highlighted the importance of risk management as a well-defined laboratory process. For example for agri-food laboratories, Tummala and Schoenherr (2011) introduced a supply chain risk management process to help laboratory managers to identify, assess and control risks in the performance of the supply Chain ³⁵.

Another study done by Leat and Revoredo-Giha (2013) conducted that it is true that the focus on risk management seems to be one of the difficult responsibilities of managers, but it is necessary to have a high perception to anticipate and identify risks in order to manage them accordingly ³⁶.

5. Limitations

This study’s main limitation is the small sample size (only 3 processes) and the data used for risk identification comprised only process's sheets so this could compromise the results.

In addition, this study did not cover a detailed statistical analysis, thus a permanent follow of risks and control measures related to a statistical analysis should be done to create an efficient risk management process.

6. Conclusion

ISO / IEC 17025 and which defines a series of general requirements relating to the competence of testing and calibration laboratories. It enables laboratories to gain international recognition and provide reliable test results, which allows it to improve its image and consolidate its competitive position in the market.

Accreditation according to the ISO17025 standard represents official recognition of the competence of conformity assessment bodies (testing or calibration laboratories, inspection or certification body, etc.) and allows their client to find reliable services that meet their needs. In order to maintain this recognition, these bodies must regularly submit to periodic re-evaluations carried out by the accreditation body, which thus checks whether they remain in compliance with the requirements in this area and ensures that they comply with their work standards.

This study is the first attempt to assess the risks encountered in agro-food analysis laboratories aiming to be accredited according to the new version of the ISO / IEC 17025/2017 standard.

The data obtained highlighted the risks relating to the various processes chosen as well as the measures adopted to manage the risks. The results are used as a basic tool to improve the quality of the activities of the MULTILAB laboratory to successfully transition the Quality Management System to the new version of the ISO 17025: 2017 standard.

This study showed that most of the risks identified are related to laboratory methods and that the highest number of risks relates to the Skills Provision process.

7. Recommendations

In the future, based on the results of this study, the quality management unit should focus on setting up a risk management process to integrate it into the risk mapping, generate a complete database on the risks relating to the various processes as well as their follow-up actions. It must also establish a plan to recruit qualified personnel in the field of risk management.

In particular, it is necessary to plan awareness-raising sessions for all laboratory units.

8. Prospective

Further additional studies should be performed in the laboratory to further emphasize the need for the integration of the risk management process. For example, research should be conducted to study the risks of other laboratory processes to create aggregate data on the likely risks, its severity and likelihood levels. So in this way, the sample size is going to be enlarged and as well the monitoring of control could be effective.

Acknowledgments

Thanks to the MULTILAB quality management unit for support of this study.

Special thanks to Mrs Dhouha KHMERI for her support and guidance.

This study was extracted from the author’s master thesis titled: “Transition from the Quality Management System from ISO 17025 v2005 to ISO 17025 v2017 within the Laboratory of Agri-Food and Environment Analysis MULTI LAB” presented on September 21, 2018, supervised by Dr Leila CHELBI GUALLOUZ.

Disclosure

The author declares that she have no competing interests.

References