Glossary

Risk Based Thinking

What is Risk Based Thinking?

Risk Based Thinking is a fundamental approach to decision-making that goes beyond traditional risk management. It involves the systematic application of information, knowledge, and actions to address uncertainty and potential opportunities within an organization.

What are the key aspects of risk-based thinking?

  • Systematically identifying potential risks and opportunities that could impact the organization’s objectives.
  • Thoroughly analysing the identified risks and opportunities to understand their likelihood and potential impact.
  • Comprehensively evaluating the risks and opportunities to assess their significance and prioritize them.
  • Developing and implementing appropriate strategies to effectively manage the identified risks and capitalize on the opportunities.

The latest versions of ISO standards, such as ISO 9001:2015 and ISO 14001:2015, have incorporated Risk-Based Thinking as a key requirement. Organizations must demonstrate the application of Risk-Based Thinking across their quality management systems, and decision-making processes to maintain compliance.

Why is Risk Based Thinking important in pharma?

Risk-Based Thinking is crucial in the pharmaceutical industry because it ensures that risks are identified, considered, and controlled throughout the design and use of the quality management system. This approach helps in maintaining product safety, efficacy, and quality, while also ensuring compliance with regulatory standards, such as ISO 9001 and ICH guidelines. It facilitates a proactive stance towards risk management, enabling continuous improvement and operational efficiency. Ultimately, it builds trust and transparency among stakeholders, including regulatory authorities and consumers.

What are the benefits of Risk Based Thinking in pharma?

Risk-based thinking in pharma enhances compliance, product quality and safety in pharma. It also enables continuous improvement, accelerates decision-making, optimizes resource allocation and promotes trust and transparency.