Best Practices for Quality Leaders to Manage and Mitigate Risks in the Life Sciences Industry

Companies in the life sciences sector are required to implement a risk-based approach to quality management as per ISO13485 and 21 CFR 820. However, several companies continue to receive warning letters from regulatory bodies in their regions for non-compliance. Sometimes, they have to recall products, causing their brand reputation to be eroded. Poor quality of products in the life sciences industry can also endanger the life of the patients, which makes it critical for the manufacturers of drugs and therapies to improve compliance by identifying and mitigating risks proactively. It adds to cost and time delays due to scrapping and rework.

Benefits of Proactive Risk Management and Mitigation

A risk-based approach to quality management is recommended as it helps life sciences companies with the following:

• Resource Optimization: A proactive approach to risks enables businesses to plan their strategy keeping the threats and potential failures in mind and use resources better.
• Continuous Improvement: It helps implement controls to mitigate and minimize impact. This helps with constant fine-tuning of the quality processes
• Improved Customer Satisfaction: It helps to ensure the products meet the expectations of customers and are fit for purpose.
• Greater Compliance: It helps to keep pace with regulatory changes, uncover areas of nonconformance and noncompliance, and draw insights from customer feedback to improve upstream processes and meet regulatory requirements.

5 Best Practices to Manage and Mitigate Risks to Improve Quality

To constantly improve quality management systems and identify and mitigate risks, some of the best practices life sciences companies can implement include:

5 Key Pillars of a proactive risk management strategy to improve quality performance

Best Practice #1 - Be Data Driven - Manual risk management can be very restrictive due to the lack of visibility into processes across functions, and geographies. This can leave the companies vulnerable to potential dangers that can affect product and process quality. Data-driven risk management enables businesses to identify deviations and address them immediately. A cloud-based quality management system can help identify and respond to risks faster. An AI-based solution can also improve risk mitigation.

Best Practice #2 - Rank and Manage Risks Based on Priority - A business will face many risks, managing all of which can be a challenge and also a waste of time and resources. Therefore, they must be ranked based on impact and frequency of occurrence to optimize resource utilization and address critical risks first. A risk matrix will help businesses prioritize risk mitigation strategies for greater efficiency and effectiveness.

Best Practice #3 - Use Tools for Risk Assessment - Use risk assessment tools to assess and rank risks. Some of the common tools used include

• Five Whys
• Cause and Effect Analysis
• Fault Tree Analysis
• Failure Mode Effect Analysis (FMEA)

This will help assess the risk potential accurately for effective mitigation. More importantly, if you want to be proactive in terms of building an enterprise-wide quality culture, a robust risk assessment strategy is crucial.

Best Practice #4 - Create a Risk Response Strategy - Timely and apt response to risks is crucial. This requires determining the correct mitigation strategies and assigning responsibilities to ensure they are implemented correctly and effectively. To ensure that the risk does not increase, it must be monitored and any increase in level reported. Corrective and preventive action must be taken to rectify the problem in the present and prevent future recurrence.

The mitigation strategy can be to

• Accept risk
• Transfer risk to a partner
• Reduce risk by implementing controls
• Avoid risk by triggering it

Best Practice #5 - Review Strategies and Risks Periodically - Risk management is an ongoing process and must be reviewed periodically. New risks may have emerged or existing risks may have increased or decreased in criticality, necessitating appropriate changes to the response strategies. Management review of data to constantly improve risk management should be part of the corporate strategy.

A Risk-based Approach to Quality Management in the Life Sciences Industry

ComplianceQuest Risk Management solution is cloud-based and built on Salesforce. It provides a clear, consolidated view of the organization’s risk, enabling the identification, evaluation, mitigation, and continuous monitoring of risks proactively. The solution is aligned with the latest standards (ISO 31000, ISO 14971, ICH Q9, and risk principles in ISO 9001:2015, ISO 13485:2016, ISO 45001, and ISO 14001), improving compliance.

• Centralized Repository of Risks: All identified risks are maintained in a centralized repository at the project, department, or company level. This helps drive strategic decisions on potential threats, assess, identify, and analyze risk trends, and drive risk mitigation activities. The right approaches for mitigation can be determined, thereby improving process efficiency, risk management, and internal controls.
• AI-based Analytics: The AI and analytics capabilities of the solution help to spot potential risks based on history and trending data along with key metrics. With embedded intelligence, quality, and risk management leaders can proactively start their risk mitigation efforts before it becomes a major challenge.
• Facilitate Proactive Risk Mitigation: Quality leaders can get a complete and accurate view of the risk landscape, prioritize and collaborate on risk mitigation efforts, and make the best strategic decisions to offset new risks and improve operations. Risk assessments can be launched from anywhere within the ComplianceQuest platform to analyze hazards associated with any process or activity such as Audits, CAPAs, Change, Customer Complaints, Deviations, Nonconformances, Safety analysis, and Environmental impact.
• Identify Risk Trends: CQ Risk Management helps define risk tolerance thresholds and policies and automatically initiates risk assessment when required. Leaders can capture patterns and gather insights from quality data across the enterprise using Einstein Analytics to identify risks related to business, quality, and operations in a unified manner. Access to historical data on past risk factors using the risk register enables identifying and capturing trends. Prioritizing risk trends and addressing the highest risks is made possible to prevent future events by leveraging the assessment and evaluation capabilities of CQ Risk Management.

To know more about how you can implement the risk management best practices in your organization using CQ Risk Management Software, visit: https://www.compliancequest.com/risk-management/risk-management-software/