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The 2017 version of ISO/IEC 17025 certification, which aims for closer alignment with ISO 9001, has made it necessary for laboratories to adopt risk-based thinking in regard to their operations. Preventive action was used to address this in earlier editions of the standards, but the addition of risk-based thinking necessitates that the laboratory take a thorough and strategic look at the unique risks and opportunities it faces.
Many laboratories could be unsure of the procedures to be followed in order to detect, assess, and treat risks and opportunities because it is a new need and the standard does not specify how it should be done. The goal of this article is to help laboratories manage risk in accordance with ISO 17025 certification in Dubai.
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Risk is the inability of the laboratory to achieve its goals, such as client satisfaction. Uncertainty, though, can either be a risk or an opportunity. The five steps of the risk management approach for laboratories are described below.
Management, quality employees, and technical staff should be viewed as a team in the ISO/IEC 17025 certification risk management process. All the potential issues and possibilities that can result from laboratory activities must be listed in this step. At this point, the following techniques—which can be employed singly or in combination—are helpful:
Brainstorming: It permits the gathering of viewpoints on all internal and external risk sources. The most thorough and accurate risk assessment is ensured by include employees of all ranks in brainstorming sessions. At this point in the process, all suggestions are welcomed and none are rejected.
Methodical approach: It takes into account both internal and external factors. The inputs and outputs of the process or activity, including management, methodologies, labor, materials, machines, and the environment, are examined in order to identify the sources.
Analysis of potential future possibilities: It entails the production of numerous situations, including both positive and negative ones (best and worst case scenarios), which serve as the foundation for the development of an acting style. Data that can be gathered, such as through audit reports or consumer comments and complaints, should be the foundation for predicting. As an illustration, client input demanding more tests may be used to spot a chance to expand testing.
Strengths, Weaknesses, Opportunities, and Threats analysis. It examines both internal and external elements, such as the distinctive services provided by the laboratory, together with market pressures and competitive positioning.
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You could choose to carry either a qualitative or quantitative assessment of your risks and opportunities depending on the complexity of your business. For qualitative evaluations, the team would rate each risk as low, medium, or high. The probability that the event would occur and the seriousness of its ramifications (such as whether the laboratory may suffer financial hardship or irreparable harm to its reputation) would determine the level of risk.
In order to make a quantitative assessment, give each risk and opportunity a value based on their likelihood of happening and their severity. The amount of risk can be calculated and determined using 33 or 55 risk matrices, respectively. The laboratory would use different risk and opportunity matrices. For each element, laboratories may give scores between 1 and 3, which, when multiplied, would give risk numbers between 1 and 9. Each element may be given a score between 1 and 5 for a laboratory with more complicated processes, resulting in risk ratings between 1 and 25. The value of the ensuing risk (or opportunity) is listed as low, medium, or high.
The optimal risk rating at this point should be agreed upon by all parties in order to decide which hazards need to be addressed first, then second, and so on. Rankings may take into account not just the estimated or assigned risk value but also the cost to address the risk and the resources that are available.
To handle the risks and opportunities identified, the team will have to suggest and choose the appropriate course of action. Because the likelihood of the risk occurring is so remote, actions can range from taking steps to mitigate or eliminate the hazards to doing nothing at all. Not every risk analysis must lead to risk-reduction measures.
The team may decide to address the simpler problems first in order to cross them off the list, but problems that could pose a serious risk to the laboratory should not be put on hold. It is a good idea to designate a person or people to be in charge of the tasks and a deadline for their completion.
The chosen activities must next be put into practice in the lab. The administration of the laboratory will be in charge of making sure that resources are available, that the suggested measures are carried out, and that they are having the desired impact.
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