Risk Analysis Programs

The Changing Role of Risk Analysis Programs in Quality Management

In a regulated company, when a consumer is harmed as a result of a defective drug, device, or product, risk managers and quality managers immediately attempt to identify what led to the defect. Unfortunately, their parallel investigations often take them down separate paths with risk managers focused on financial loss or litigation and quality managers focused on improving the overall quality of their quality program. Today, as the shift to more proactive risk-based quality management continues, it is imperative for regulated manufacturers to ensure that their risk analysis program and quality management program are operating in sync.

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Risk Analysis Programs vs. Risk Assessment Programs vs. Risk Management Programs

While the primary goal of both risk mangers and quality managers has always been to produce safe, effective products, over the years, their parallel, yet divergent interests have contributed to a silo mentality with little or no collaboration between the two groups. Before examining the origins of the silos, as well as how to adequately address and eliminate them, it’s important to define what a risk analysis program is, and how it differs from risk assessment and risk management. These terms are sometimes used interchangeably, but in reality, they are different concepts and, as such, produce different programs.

  • Risk analysis programs identify the most probable threats or hazards to an organization, and then estimate the probabilities and expected consequences for those identified hazards. According to the Society for Risk Analysis, risk analysis (as a process) encompasses risk assessment and risk evaluation, as well as the risk management alternatives performed to understand the nature of an unwanted outcome or event.
  • Risk assessment programs seek to evaluate the risk resulting from a hazard (i.e., something with the potential to cause harm). The risk assessment process, as well as the risk assessment program produced as a result of its findings, is only one part of the risk analysis program.
  • Risk management programs outline the decisions made and policies and procedures formulated by the risk managers based on the results of the risk assessment or risk assessment program. As a process, risk management is defined as the process of weighing policy alternatives with all interested parties while taking into consideration risk assessment and other risk-related factors.

In a nutshell, risk analysis is a three part process; it starts with hazard identification, moves on to risk assessment, and concludes with risk management. Thus, an organization’s risk assessment program and risk management program are both components of its overall risk analysis program.

The Challenges of Creating Collaborative Quality Management/Risk Analysis Programs

Few would argue that successful quality management hinges upon having a consistent method for assessing and managing risk. Similarly, successfully assessing and managing risk, which is accomplished by implementing an effective risk analysis program, requires successful quality management. Why is it then that the two processes, which are so dependent upon each another, are often siloed or out of sync?

Organizational size: Often the structure of an organization’s risk management/quality management structure is driven by the size of the organization or its facilities. In a small company, the risk manager or quality manager may be the same person—someone who may or may not possess the skills or formal training required to take on the dual role. It’s also possible that the organization outsources some of its risk operations, including the creation of its risk analysis program, which makes communicating or collaborating with the quality team difficult, if not impossible. In a large company, it is not uncommon for each department or (in a multi-site organization) each office to develop and follow its own risk model (although there tends to be less variety with respect to the quality management functions in large organizations). Ultimately, silos develop when risk is apportioned among multiple departments, individuals, and outside contractors. Automated risk analysis programs like MasterControl Risk™ connect the quality and risk teams, improving improve communication and collaboration. In addition, MasterControl provides regulatory and quality departments with uniform tools and methods for conducting consistent risk analyses. Using MasterControl Risk, risk mangers and quality managers can easily document and store risk mitigation activities in product and process design, which increases efficiency and decrease the possibility of unwanted events.

Disconnected Processes: To be truly effective, an organization’s risk analysis process, as well as its risk analysis program, should be part of a holistic quality management system (QMS). Unfortunately, the silo mentality prohibits the development of a truly connected QMS, especially in companies that still rely on paper-based or hybrid quality processes. With MasterControl, risk management can be integrated with other critical quality processes such as audit management, document management, and supplier management. For companies that use other electronic systems, MasterControl can be seamlessly integrated with document repositories and enterprise applications without the need for expensive custom coding or for changing existing critical business processes. As markets continue to evolve and supply chains continue to expand, only those companies that recognize the need for a collaborative, connected risk analysis program/quality management program will remain competitive and compliant.

New Terminology, New Regulations: Risk is quickly becoming the new methodology for benchmarking compliance within a company. Regulatory agencies, such as the FDA, EMA, and others, are demanding more and more from manufactures. Patients are also demanding access to better, safer products. In the past, responsibility for compliance has fallen upon the company’s quality team. However, rules and roles are changing at a rapid pace, and assuring compliance in an ever-evolving regulatory landscape is no small feat—especially in an organization crippled by risk and quality silos and outdated manual processes. MasterControl Risk helps regulated organization’s document and demonstrate an effective risk analysis program and achieve compliance during audits and inspections.

Establishing a Enterprise Risk Analysis Program with MasterControl

Removing the obstacles that prohibit the development of a collaborative risk analysis program/quality management program is possible with MasterControl Risk. Web-based and configurable, the solution unifies all of an organization’s risk-related activities and documentation in a single, centralized repository. The solution is designed to integrate the risk analysis process with other quality processes such as document and supplier management. Centralizing data, regardless of department, role, or geographic location, promotes better visibility into all risks within the organization, which allows the quality and risk teams to make better, more informed, and more timely decisions. While the focus of the quality manager may still be different from that of the risk manager, MasterControl can serve as framework for creating a truly collaborative risk analysis program/quality management program—one that strikes a balance between financial strength and better quality. Consider the following features:

Advanced Risk Assessment Capabilities: MasterControl users are able to evaluate different categories of operational risk able and configure multiple risk types. Critical tools like risk assessments, which are essential to the creation of a risk analysis program, can be launched from anywhere within the MasterControl system to analyze hazards associated with any process or activity. Risk mitigation and reassessment tools are also available within MasterControl Risk.

Robust Reporting Tools: The ideal risk analysis program tool allows for the analysis of risk files and risk assessments. With MasterControl’s advanced analytics and reporting capabilities, the system’s scheduled reporting capability increases management awareness and assures stakeholders that corporate risk tolerance thresholds are being followed for all risk-related activities.

21 CFR Part 11-Compliant: From time-stamped audit trails and electronic signatures to robust reporting capabilities, MasterControl Risk has been designed to be Part-11 compliant. Risk files may be routed for approval and electronically authorized in accordance with 21 CFR Part 11. This offers a critical advantage to any FDA-regulated companies hoping to establish a compliant risk analysis program.

Enterprise Risk Analysis: MasterControl’s “one-stop-shop” solution automates all paper-based or hybrid risk management processes in a centralized repository, providing a complete, accurate picture of the organization’s entire risk landscape. MasterControl Risk has been specifically designed for companies that require quick access to full search capabilities and electronic workflows and signatures for the execution, review, and approval of all risk-related activities and documentation typically included in a risk analysis program.

For More Information on MasterControl

To get more detailed information on risk analysis programs, feel free to contact MasterControl representative.