How can you use other industries' lessons learned in GMP risk management?

1 Learn from aviation

Aviation is an industry with a long history and experience in risk management, as it is a complex, dynamic, and high-stakes field. It has developed a proactive risk management system that integrates safety culture, human performance, data analysis, and continuous improvement. This system can be applied to GMP risk management. For example, adopting a just culture that encourages reporting and learning from errors and near-misses without blaming or punishing individuals for honest mistakes. Additionally, using a bow-tie model to visualize and analyze the causes and consequences of potential hazards, as well as the preventive and mitigating barriers and controls that can reduce the likelihood and severity of undesired events. Furthermore, implementing a safety management system (SMS) that provides a structured and systematic framework for managing safety risks throughout the organization. And conducting regular audits, inspections, and assessments to monitor and evaluate the effectiveness of your risk management processes and controls, in order to identify any gaps or weaknesses that need improvement.

2 Learn from healthcare

Healthcare is a diverse, complex, and rapidly evolving industry that deals with human lives, health, and well-being. As a result, healthcare faces many challenges and uncertainties in delivering safe, effective, and efficient care to patients. To address these issues, healthcare has adopted various risk management strategies and tools. For example, a failure mode and effects analysis (FMEA) can be used to identify and prioritize potential failure modes of a product or process. Additionally, a root cause analysis (RCA) can be used to investigate the underlying factors that contributed to an incident or problem. Moreover, a risk matrix can be employed to classify and rank the risks according to their probability and impact. Ultimately, these strategies and tools help to communicate and visualize the risks to stakeholders and decision-makers.

3 Learn from automotive

Automotive is a highly competitive, dynamic, and global industry that produces complex and sophisticated products that have to meet high standards of quality, performance, reliability, and safety. As a result, automotive faces many risks and uncertainties in its product development and manufacturing processes. To manage these risks and ensure customer satisfaction, automotive has implemented various risk management techniques and tools. For example, they use a design for six sigma (DFSS) methodology to design and optimize their products or processes based on customer needs and expectations. Additionally, they rely on a statistical process control (SPC) technique to monitor and control their production processes using statistical data. Lastly, they adopt an advanced product quality planning (APQP) process to plan and execute their product development and manufacturing activities in a structured way. This helps them guarantee that their products meet the specifications of their customers and regulators.

4 Learn from finance

Finance is a complex, volatile, and highly regulated industry with various risks and challenges. As such, finance has developed risk management models and methods to measure, monitor, and mitigate these risks and ensure financial stability. For example, finance can use a value at risk (VaR) model to estimate the maximum potential loss that a portfolio or position could incur over a given period of time. Stress testing techniques can also be used to evaluate the resilience and robustness of a portfolio or position under various scenarios and conditions. Additionally, a risk-based internal audit function can provide independent and objective assurance and advice on the adequacy and effectiveness of risk management processes and controls. This helps identify and report any risks or issues that need attention or improvement.

5 Learn from construction

Construction is an industry with a lot of insight and best practices in risk management due to its large size, diversity, and project-based nature. Construction projects involve multiple stakeholders, phases, and activities, and they face many risks and uncertainties such as delays, cost overruns, accidents, disputes, and quality problems. To manage these risks and ensure project success, construction has adopted various risk management approaches and tools. For example, a risk register documents and tracks the risks that could affect project objectives, scope, schedule, budget, and quality. A Monte Carlo simulation estimates the possible outcomes and uncertainties of project variables based on random sampling and probability distributions. Lastly, a risk breakdown structure (RBS) organizes and categorizes project risks into hierarchical levels and groups. All of these tools help to identify interrelationships among the risks and allocate resources for risk management.

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?