To compete in today's global market, regulated companies must comply with numerous requirements, directives, and standards from regional, national, and international bodies. The requirements vary, but they all emphasize risk management and require the use of risk management tools. Whether they are regulatory requirements (FDA , WHO GMP, EU GMP) or guidelines from ICH and industry organizations (ISPE, PDA, IPEC, APIC), they all share the common goal of minimizing, if not preventing, risks to patients and consumers.
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ICH Q9 Quality Risk Management, an international guidance for pharmaceutical companies, discusses some of the most common risk management tools used in the industry today. They include flowcharts, check sheets, process mapping, and cause and effect diagrams.
ICH Q9's list of risk management tools also includes risk ranking and risk filtering. Risk ranking involves breaking down a basic risk question into many components to capture possible risk factors, which are then combined into a single relative risk score that can be used for ranking risks. Risk filters refer to weighting factors or cut-offs for risk scores that can be used to scale risk ranking.
The guidance also discusses other widely used risk management tools such as Failure Mode Effects Analysis (FMEA), Failure Mode, Effects, and Criticality Analysis (FMECA), and Fault Tree Analysis.
ISO 14971 and IEC 60812 are international standards that highlight the importance of risk management tools, especially to medical device companies. ISO 14971 provides risk management guidelines for medical device manufacturers to help them establish a process for identifying risks, estimating and evaluating them, and implementing risk controls.
IEC (International Electrotechnical Commission) 60812 focuses on these risk management tools: FMEA and FMECA. While the standard is not specifically for medical device companies, using either FMEA or FMECA as a risk management tool will help medical device companies identify potential failure modes for a product or a process, assess the risks associated with those failure modes and rank those risks, as well as implement appropriate corrective actions.
In the United States, the food and beverage industry is facing new requirements under the Food Safety Modernization Act (FSMA). The law, signed in 2011, is meant to help protect the public from foodborne illnesses and to ensure food safety. Now more than ever, food and beverage companies need to incorporate the use of risk management tools in their daily operations.
Hazard Analysis and Critical Control Points (HACCP) is a food safety management system that utilizes process controls to minimize risks. HACCP serves as an effective risk management tool that helps ensure compliance with FSMA.
MasterControl software is widely used in life science, food and beverage, and other regulated industries to help ensure quality and compliance, as well as to incorporate effective risk management tools in all critical processes.
MasterControl Risk provides a single platform for all risk management tools, documentation, tasks, and activities for compliance purposes. It unifies all risk management activities within a company and brings all stakeholders together for a holistic approach to compliance. Here are some of MasterControl Risk's features and benefits:
For more information about risk management tools offered by MasterControl, contact a MasterControl representative or by calling 800-942-4000.