How to Map Laboratory Risks with a LIMS and Turn Challenges into Opportunities?

In recent years, risk management has become an essential, strategic part of running laboratories across every field. Although its importance is increasingly recognized, the topic still raises many questions, and a Laboratory Information Management System (LIMS) can be an important differentiator.

In the past, risk was addressed indirectly, especially under earlier versions of ISO 9001. That reality has changed, though. Today, risk is not only a clearly defined concept, it has become a formal requirement, especially after the publication of ISO/IEC 17025:2017, which introduces “risk-based thinking” into its management system requirements.

ISO/IEC 17025:2017 stresses that laboratories must plan and take actions to address risks and opportunities. The goal? To increase the effectiveness of the Quality Management System (QMS), achieve superior results, and prevent negative impacts.

Here’s the catch, though: while the standard requires laboratories to address risk, it does not define specific methods for doing so. In other words, there is no single or mandatory methodology for how laboratories should manage these risks.

To help with this process, in 2018 the International Standards Organization (ISO) updated its risk management guidelines with ISO 31000:2018. This version offers direct, practical guidance to help organizations manage risk more efficiently.

By identifying and assessing risks early, laboratories can catch problems before they escalate, enabling the implementation of preventive and corrective actions. In an ideal scenario, however, risk management is not limited to avoiding failures — it also drives continuous process improvement and excellence in results.

Risk Management in Practice

Although ISO 17025 requires the implementation of risk management in laboratories, many professionals still struggle to apply this process effectively.

This article aims to clarify the risk management process and explain how a Laboratory Information Management System (LIMS) can be an important ally.

Step 1: Risk Identification

Risk identification is the first and most important phase of risk management; identifying means finding, recognizing, and describing risks.

In the identification phase, the possible sources of risk affecting the laboratory’s entire activity must be recorded. The purpose is to find and describe the risks that could help or prevent the laboratory from achieving its objectives.

At this stage, every risk that affects the achievement of a goal must be identified, even if it is not under the laboratory’s control, since a risk that is not identified cannot be analyzed or treated.

Risk identification should be a collaborative effort, in which all potential risks and opportunities are mapped.

Some useful methods for this phase include brainstorming, SWOT analysis, scenario analysis, inspections, and audits.

A detailed study by Plebani and Carraro brought to light the main sources of error in laboratories, as shown in Table 1. This data provides valuable insights, highlighting the most vulnerable areas that demand greater attention in risk management.

Step 2: Risk Analysis

Risk analysis consists of understanding the nature of risks and their characteristics, considering, among other information, probability, consequences, time factors, and volatility.

In the risk analysis stage, the purpose is to understand the nature of the risk and its characteristics, including the risk level.

Risk classification can be descriptive (low, moderate, medium, high) or quantitative (on a scale of 1 to 10). The risk level depends on the probability and severity of the consequences occurring.

Step 3: Risk Evaluation

The risk evaluation stage compares the results of the risk analysis against the criteria established by the laboratory, supporting the decision-making process.

For each identified risk, an appropriate treatment strategy must be defined, which may be, for example: accept, mitigate, or avoid.

Step 4: Risk Treatment

In the risk treatment stage, the objective is to select and implement actions to address the identified risks.

The first step is to define a clear action plan for each identified risk. For the most critical risks, the team must establish concrete corrective measures, such as standardizing procedures, specific training, or investments in new technologies. For less concerning risks, it may be enough to simply monitor and periodically reassess them.

In addition, some situations require the implementation of preventive measures to reduce the likelihood of a risk occurring. For example, if an identified risk is related to a failure in equipment calibration, a preventive action could be creating a stricter maintenance and instrument-checking schedule.

Step 5: Risk Monitoring and Critical Review

After defining the necessary actions, it’s time to put them into practice. Laboratory management must ensure that resources are made available, that changes are properly executed, and that results are closely tracked.

After all, there is little point in planning corrective and preventive measures if they are not implemented correctly or if there is no adequate monitoring in place to assess their effectiveness.

Once actions are underway, it is essential to establish a continuous monitoring system. This means tracking the indicators related to each risk, checking whether the measures adopted are having an effect, and adjusting the action plan whenever necessary. If a risk that should be under control starts showing warning signs again, that is an indication that the strategy needs to be revisited.

In addition, monitoring should not be an isolated event, but rather a continuous process within the laboratory. Periodic reviews help identify new threats and improvement opportunities, ensuring that risk management stays aligned with the laboratory’s needs and regulatory requirements.

And what if you could centralize all of this monitoring and control on a single, secure platform? Let’s talk about how that can become a reality.

How a Laboratory Information Management System (LIMS) Can Help with Risk and Opportunity Management

A Laboratory Information Management System (LIMS) is software used in laboratories to manage and control all information related to laboratory activities. In addition, the most modern LIMS platforms also provide support for risk and opportunity management.

A LIMS becomes a major ally in risk and opportunity management by structuring data and automating calculations, providing analytical tools that help quantify the severity and probability of identified risks. It enables the precise collection of quality indicators, such as identification errors, use of incorrect containers, or insufficient samples, recording these failures and linking them to the corresponding process steps.

In addition, the system integrates with equipment and other systems to capture crucial information, such as storage temperature and reagent expiration dates, ensuring that risks are identified before they become a problem.

A LIMS can also generate risk matrices, assigning scores based on error frequency and operational impact, classifying risks according to their criticality using probability-impact matrices, as described in ISO 31000:2018.

Some important capabilities found in modern LIMS platforms include the generation of statistical reports, which help visualize trends and identify areas needing attention, while interactive dashboards allow the team to assess risks in real time and collaboratively, categorizing them by process stage or error type.

The dashboards also display risks in heat maps, charts, and reports, helping the team quickly identify which risks need immediate attention and which can simply be monitored.

A modern LIMS is able to help prioritize risks based on historical data and suggest corrective measures, in addition to ensuring continuous risk monitoring, tracking whether the implemented actions are actually delivering the expected results.

The system can issue alerts for periodic reviews and adjustments to mitigation plans, ensuring that risks that were initially under control do not become critical again. As a result, risk classification stops being a one-off activity and becomes a continuous process of laboratory improvement.

A LIMS makes executing and tracking actions far more organized and efficient, allowing each identified risk to be recorded and directly linked to its associated corrective or preventive measures. It also makes it easier to assign owners and deadlines, ensuring tighter control over the progress of these actions.

With structured, automated tracking, the laboratory can not only reduce risks efficiently but also continuously improve its processes, ensuring greater safety, quality, and regulatory compliance.

Conclusion

Risk and opportunity management is not a one-off task in the laboratory, but a continuous process that, when well executed, goes beyond regulatory compliance. It is capable of delivering better operational results, higher quality, and even greater profitability for the laboratory.

In an increasingly dynamic and competitive market, the ability to turn risks into opportunities can make all the difference. It’s not just about mitigating threats, but about finding ways to leverage challenging situations to create innovative solutions and generate added value.

This is where a Laboratory Information Management System (LIMS) comes in. By centralizing and automating data collection, monitoring, and analysis, a LIMS enables early risk identification, allowing teams to make informed, fast decisions. With it, laboratories are able not only to identify potential problems but also to spot improvement opportunities in real time, always with a clear, structured view of the data.