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ROI CalculatorQuality risk management (QRM) is an approach to managing quality risk based on systematic quality control. Once a risk has been identified, the next step is to evaluate the possible consequences of that risk and the probability that the hazard identified may occur and then determine what actions must be taken to mitigate that specific risk. Lastly, there should be ongoing monitoring of the effectiveness of the controls put in place to mitigate risks to product and customer safety.
All manufacturing and processing industries need QRM to some degree. However, QRM becomes increasingly important to organizations within a regulated industry, such as biotechnology, pharmaceuticals, and healthcare. Utilizing the principles associated with QRM provides a framework to enhance informed decision making, prevent errors and product defects, and ultimately build trust with stakeholders and customers.
QRM is a systematic and well-structured process with multiple key steps. Each part helps ascertain, evaluate, and alleviate possible risks.
The first step in the QRM process is identifying all the potential risks that could affect product quality or patient health. These risks can arise from hazards associated with materials, design, process, failure modes, etc.
An organization can analyze its manufacturing processes to identify the risks to product quality or patient safety. There are various analytical tools such as FMEA – Failure Modes and Effects Analysis that may be utilized to help identify potential risks.
After you’ve recognized and defined the hazards that are present in your organization, it’s important to then analyze the risks associated with those hazards to determine how severe a risk is, the probability of an actual occurrence and the potential consequence due to the risk. There are three key factors to consider when analyzing the risk associated with a hazard, frequency of occurrence, the ability of users to be able to detect the risk before it results in an incident, and how the risk can affect customer safety, product quality, and compliance with applicable regulations.
Using QRM tools and techniques, you can evaluate and prioritize the identified risks. Risk matrices are commonly used to get a visual representation of the likelihood and severity of foreseeable risks. You can also use risk matrices to classify the severity and likelihood of the identified risks.
Quantifying risks can also assign a numerical value to a risk, allowing for a more objective method of determining the severity and likelihood of an identified risk.
After evaluating the risks, you can narrow down the options of what to do about the identified risks. The first option is to mitigate or reduce risks. Some examples of how to mitigate or reduce risks include closing design or process gaps, implementing additional control measures, increasing employee training, and changing the way a process works. Employing these types of corrective actions reduces the potential consequence or occurrence of the identified risk. In some situations, certain risks may be acceptable and thus may not require any action.
QRM is an ongoing activity that needs constant surveillance and enhancement. Organizations should routinely evaluate their processes and designs, while continuing to evaluate the QRM techniques that they use, based on newly available information, as their processes and products are continuously changing and expanding. All findings associated with QRM, including activities and decisions made during the QRM process should be documented and communicated to both regulatory agencies and relevant stakeholders.
