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The term Risk Assessment refers to an organization’s ability to assess and identify compliance risks, and then evaluate their capacity for managing these risks before working to promptly address and eliminate nonconformities. To ensure compliance, risk assessment must be conducted on a regular basis.


In the context of Life Sciences companies, the requirements of a quality risk assessment are defined in accordance with:

    • ISO13485
    • 21 CFR 820
    • ICH Q7, Q8(R2), Q9, and Q10

Life Sciences companies must comply with regulatory bodies such as the:

    • Food & Drug Administration (FDA) in the U.S.
    • European Medicines Agency (EMA) in Europe
    • Medicines and Healthcare products Regulatory Agency (MHRA) in the UK.

Warnings from these entities can produce nonconformities that cause import alerts, resulting in products and medications being pulled from the shelves. This can affect patient safety and compromise the integrity of Life Sciences companies—making risk assessment all the more imperative.



What Does a Risk Assessment Entail?

A risk assessment is a proven process for addressing risks and preventing them from occurring. To prevent bottlenecks and nonconformities, companies must conduct quality risk assessments.

Generally speaking, this process includes the:

    1. Identification of risks.
    2. Evaluation of the potential impact of each individual risk (by comparing the likelihood of threats to the consequences already faced).
    3. Assessment of current resources and the ability to mitigate risks.

Risk assessment must be continuous and ongoing. It is essential to prioritize tasks based on what is most urgent. Once risks of the highest priority are identified, Life Sciences organizations can start to build their risk management action plan.


Why Risk Assessment Matters

Risk assessment should be a top priority in every sector, and the Life Sciences Industry is no exception. Without risk assessment, it can become challenging to identify and solve quality issues. A risk assessment can help to pinpoint the underlying causes of problems and determine the actions needed to address them.

In the Life Sciences, many organizations fail to leverage their risk assessment results in the product lifecycle. This occurs because:

    • Risk assessment can be subjective.
    • Risk assessment tasks are often assigned to a single person, increasing the chance of bias.
    • Over-optimistic risk assessments can cause further problems and waste company time.

Sound documentation, a clear action plan, and cross-functional input can streamline and improve both company risk assessment processes and audit success.


Risk Assessment Tools


The most common risk assessment strategies Life Sciences companies use to address quality issues include:

    • Cause and Effect Analysis
    • The “Five Whys”
    • Fault Tree Analysis
    • Failure Mode Effect Analysis (FMEA)
    • Risk Ranking

Learn more about these tools and how they apply to risk assessment in the Life Sciences industry here.



Ensure Compliance with CAPA

Contrary to popular belief, risk management isn’t a one-time activity—and non-conformity shouldn’t be viewed as a single incident. To ensure compliance across the board, risk assessment must be viewed as a proactive, continuous process:

    • It should not only address nonconformities and quality issues, but prevent them when possible. This is known as taking Corrective and Preventative Action (CAPA).
    • From there, Change Control will help to evaluate, document, approve, and implement changes.
    • Ultimately, Continuous Reassessment of the risk must remain a top priority. 


It’s important to note that the above process should reoccur throughout the product life cycle. Many Life Sciences organizations fail to recognize that the risk assessment process—and risk management in general—should be a routine rather than an occasional task. Skipping the continuous reassessment of the risk in question simply won’t cut it, as all risks must be revisited periodically in order to assess the change. 

To summarize, Life Sciences organizations can ensure compliance by documenting clear CAPAs, implementing Change Control, and reassessing risks on a regular basis. Additionally, documents must be standardized, with clear titles, authors, and the names of any cross-functional teams and stakeholders involved in the process. The date of preparation, version and page number, and signatures of all people involved should be clearly documented as well.

With these insights in your toolkit, Life Sciences organizations like yours can elevate your risk assessment and effectively eliminate nonconformities in the product lifecycle.




Are you worried about managing your risk assessment process? Contact our experts, who will guide you through the Scilife Risk Management module. This module can help you eliminate conformities and achieve regulatory compliance. Or you can also watch this Risk Assessment Module workshop by demand.

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