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What are the best practices for conducting a risk assessment and mitigating potential issues?

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Risk assessment is a crucial step in computer system validation (CSV), as it helps to identify and prioritize the potential hazards and failures that may affect the quality, performance, and compliance of the system. By applying a systematic and structured approach to risk assessment, you can mitigate the issues and ensure that your validation efforts are focused on the most critical aspects of the system. In this article, we will discuss some of the best practices for conducting a risk assessment and mitigating potential issues in CSV.

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Vinaya Kumar J

Asst.General Manager Global Quality at AUROBINDO PHARMA LIMITED
Srinath Gangishetty, M.S

CSV Quality Consultant encouraging CSA
Anand Sharma ????

CSV,Compliance and Validation

1 Define the scope and objectives

Before you start the risk assessment, you need to define the scope and objectives of the validation project. This includes identifying the system boundaries, functions, requirements, specifications, and intended use. You also need to establish the validation criteria, such as the acceptance criteria, test methods, and documentation standards. By defining the scope and objectives, you can set the expectations and goals for the risk assessment and ensure that it is aligned with the regulatory and business requirements.

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Anand Sharma ????

CSV,Compliance and Validation
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Implementing ICH Q9 principles involves a structured approach to risk management. Utilizing tools like FMEA, FMECA, and RTA enhances risk assessment, identifying potential issues and their impacts. Effective risk control measures are then implemented. Clear communication ensures stakeholders are informed about identified risks and the strategies in place. Regular risk reviews, facilitated by these tools, support ongoing evaluation and improvement. This systematic process ensures the continual enhancement of pharmaceutical quality and safety throughout the product lifecycle.

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Naveen Bandi

?? Cultivating Excellence: Meet the Pharma Graduate with a Passion for Validation and Compliance! ????
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Establish Accountability: Assign risk management roles to all employees to foster a proactive risk culture. Regular Assessments: Conduct periodic risk assessments to keep the risk profile current for informed decision-making. Prioritise Risks: Rank risks by likelihood and impact to allocate resources effectively to critical threats. Document Findings: Keep detailed records of identified risks and mitigation strategies for compliance and future reference. Continuous Review: Regularly update the risk management plan to reflect changes in the environment and lessons learned.

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2 Choose a suitable risk assessment method

There are various risk assessment methods that can be applied to CSV, such as Failure Mode and Effects Analysis (FMEA), Fault Tree Analysis (FTA), Hazard Analysis and Critical Control Points (HACCP), and Risk Ranking and Filtering (RRF). Each method has its own advantages and disadvantages, depending on the complexity, size, and nature of the system. You need to choose a suitable risk assessment method that matches your system characteristics, validation objectives, and available resources. You also need to follow a consistent and transparent process for applying the method and documenting the results.

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Srinath Gangishetty, M.S

CSV Quality Consultant encouraging CSA
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While assessing the suitable Risk Assessment; it’s essential to consider the impact and risk associated with Patient safety, Product and Process. Data Integrity Risk Assessment performed in conjunction helps the Stakeholders understand process related gaps with systems and respective procedures. The outcome of these Assessments helps project and leadership teams to understand the resource allocations and clarity on further change in scope for present project or carry it forward to future scope of work.

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3 Identify and analyze the risks

The next step is to identify and analyze the risks that may affect the system quality, performance, and compliance. This involves brainstorming, researching, and consulting with relevant stakeholders to generate a list of potential hazards and failures that may occur during the system lifecycle. You also need to evaluate the likelihood and severity of each risk, as well as the existing controls and mitigation measures. You can use various tools and techniques, such as risk matrices, checklists, diagrams, and tables, to organize and visualize the risk information.

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Vinaya Kumar J

Asst.General Manager Global Quality at AUROBINDO PHARMA LIMITED
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An example, I have seen as a part of analyzing and identifying potential risks is data gathering pertaining to the scope of the risk assessment which involves the gathering all the pertinent information related to the event that is being assessed and brainstorming with all the cross functional team members to identify the potential risks based on the data gathered. All the identified potential risks must be analyzed to determine which risks needs to be mitigated and which risks can be accepted.

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4 Prioritize and classify the risks

Based on the risk analysis, you need to prioritize and classify the risks according to their level of importance and urgency. You can use different criteria and scales, such as risk score, risk rating, risk category, or risk level, to rank and group the risks. The purpose of prioritizing and classifying the risks is to determine which risks need to be addressed first and which risks can be accepted or ignored. This can help you to allocate your validation resources and efforts more efficiently and effectively.

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5 Mitigate and monitor the risks

The final step is to mitigate and monitor the risks that have been identified and prioritized. This involves developing and implementing risk reduction strategies, such as corrective actions, preventive actions, contingency plans, or design changes, to eliminate or minimize the risks. You also need to verify and validate the effectiveness of the risk mitigation measures and document the outcomes and evidence. Moreover, you need to monitor the risks throughout the system lifecycle and update the risk assessment as needed, to account for any changes or new information.

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Vinaya Kumar J

Asst.General Manager Global Quality at AUROBINDO PHARMA LIMITED
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For any high risk elements, implement mitigation actions first before proceeding with the activity, review of the risk assessment post implementation of the mitigation actions must be undertaken to make sure that the implemented actions doesn't generate new risks and /or implemented actions are as expected and successful.

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Naresh Goyal

Ex. General Manager-Audits (GSK's Global Group of Auditors) at GlaxoSmithKline
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This is where most risk management programs loose steam. You identify risks, spend hours discussing their risk rating and priortising and then days to develop action plans. But then the focus reduces. The risk mitigation actions are not monitored as well as they should be. Monitoring also means making suitable changes to the action plans if the outcome is not exactly desirable. And here managements are also part of the problem... due to their too much focus on "closure" of risks rather than mitigation

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6 Here’s what else to consider

This is a space to share examples, stories, or insights that don’t fit into any of the previous sections. What else would you like to add?

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What are the best practices for conducting a risk assessment and mitigating potential issues?

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1 Define the scope and objectives

2 Choose a suitable risk assessment method

3 Identify and analyze the risks

4 Prioritize and classify the risks

5 Mitigate and monitor the risks

6 Here’s what else to consider

Computer System Validation

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