Advanced Risk Assessment for Quality Risk Enables Holistic Process

By Carol Scheunemann | June 7, 2023

Move beyond compliance, drive data consistency and improve efficiency.

Product recalls are among the worst-case scenarios for quality management. Particularly for pharmaceuticals and medical devices, deficient products can endanger human health or safety. Recalling products can cost millions of dollars, often accompanied by litigation costs and fines. The company’s reputation can be severely damaged and customer trust may have to be completely rebuilt. So, it is essential to get things right the first time.

To protect buyers, quality risk management is mandatory in critical industries such as the life sciences and consumer goods, but also in food production and manufacturing. These diverse enterprises are all required to perform comprehensive risk assessments to comply with government regulations. Risk management is also essential for meeting international quality standards, such as those from the International Organization for Standardization (ISO).

Companies need to establish corporate standards and select a company-wide tool for managing quality risks. With Sphera’s Advanced Risk Assessment for Quality Risk, companies can ensure that the proper controls are in place to deliver high quality, reliable products faster and more safely and efficiently. Sphera’s solution offers a best-practices framework for various risk assessment methodologies and capabilities for risk data management.

Connecting Processes to Ensure Compliance

Without question, quality risk management is complex. Medical device manufacturers, for example, need to manage risks using the standard ISO 14971. This requires companies to define their risk management plan and conduct reporting to show that their products are safe.

Recently, the U.S. Food and Drug Administration (FDA) updated its quality risk management guidance in cooperation with the International Council for Harmonisation (ICH) guidelines. The European Union Medical Device Regulations (MDR) requires manufacturers to effectively track and control risks and.

In short, companies need a risk assessment solution that lets them connect data and documents in a holistic way. Sphera Advanced Risk Assessment for Quality Risk is a robust risk management solution that enables knowledge-sharing to break down information silos. This helps to ensure a common risk language and to promote a consistent approach to managing quality risks across the company.

Suitable for a Range of Methodologies

Meeting regulatory requirements is essential, yet it’s only one aspect of mitigating quality-related incidents. Companies can decide which risk assessment methodology works best for their products and processes. Failure Mode and Effects Analysis (FMEA), Process Hazard Analysis (PHA), Layer of Protection Analysis (LOPA), Hazard and Operability Studies (HAZOPs) and Security and Vulnerability Assessment (SVA) are among the prevalent methodologies.

Sphera’s Advanced Risk Assessment for Quality Risk offers a configurable framework for risk assessment methodologies including FMEAs, PHAs, Quality by Design (QbD), as well as specialized capabilities for risk data management. With workflow templates, your organization can standardize and record risk assessment data and ensure proper controls are in place.

Improving Efficiency and Effectiveness

Achieving compliance and standardization is followed by efforts to improve efficiency and effectiveness. Organizations often generate such a high volume of data from risk assessments that they need weeks or months to convert this raw data into meaningful metrics and performance indicators. Then quality managers need a way to make this data and communication readily accessible and sharable.

Distributing risk information and creating site risk profiles provide insights into critical quality attributes (CQAs) and critical process parameters (CPPs) to enable proactive risk management. This helps companies provide the right information to the right people at the right time. With Sphera’s Advanced Risk Assessment for Quality Risk, companies can:

Improve how critical data is structured and managed. Sphera’s Advanced Risk Assessment for Quality Risk enables audit trailing and version controls, as well as reviewer and approval functions. Users can assign roles such as risk assessment facilitators, owners, editors and readers.
Employ advanced analytics that transform data into insights. Companies can promote standardization, share a common risk language and ensure consistency. Having more accurate data enables quality managers to proactively manage operations. Users can generate reports more easily.
Gain access to intelligent, application-ready data, content and workflows. Our solution enables companies to associate new controls with different scenarios to minimize the risk of noncompliance in audits. An integrated action-tracking workflow helps companies prevent recurrence of quality issues.
Ensure continuous improvement. By using a common risk language, Advanced Risk Assessment for Quality Risk filters and disseminates lessons learned to ensure continuous improvement. With standardized capabilities and processes across the company, proactive risk management becomes a reality.

Companies report a 40% to 60% reduction in time and effort needed for risk management by leveraging standardized risk solutions such as Sphera Advanced Risk Assessment for Quality Risk. Using predefined knowledge-based repositories with historical data helps avoid duplication of risk data.

Build Stronger Processes and Improve Quality Programs

Risk management and quality management are both critical for safer, more sustainable quality processes. For example, pharmaceutical companies often use Quality by Design. In the QbD approach, manufacturers confirm they have adequate controls in place to manage their critical quality attributes and critical process parameters throughout the product’s lifecycle.

In all industries where quality risk management is critical, Sphera Advanced Risk Assessment for Quality Risk enables companies to:

Establish data libraries or repositories. Datasets that are constant across product lines and manufacturing processes can be managed in common repositories or libraries. The data can be plugged into risk assessments to minimize duplication of efforts and promote consistency.
Support incident investigation. The first step of an incident investigation is to determine whether the failure had been captured by the initial risk assessment. Was the estimated probability of occurrence reflected in the post-market surveillance? Post-market surveillance is a systematic procedure for monitoring the real-world performance of medical devices.
Reduce the cost and effort of reporting. As the number of studies increases, so do the issues with cross-study comparison. Generating an ad hoc report filtered by location, methodology, persons responsible or keywords—in minutes rather than hours—results in tremendous cost savings.

Out-of-the-Box, Industry-Specific, Fully Configurable Risk Templates and Workflows

Sphera has refined its risk assessment solution over multiple decades of interactions with environment, health and safety professionals. Our experience and expertise help companies build stronger risk assessment processes and improve their quality programs in the life sciences or in other critical industries. The benefits of Sphera’s Advanced Risk Assessment for Quality Risk include:

Time to value. With out-of-the-box templates for methodologies including FMEA, Design-FMEA, Process-FMEA and Control Plan, our solution meets the needs of any customer. You need less time to implement the solution and realize its benefits.
Productivity gains. Eighty percent of quality issues are repeated events. Sphera’s risk templates promote standardization and provide users the flexibility to easily link and share information. Companies can perform comprehensive quality risk assessments, accelerate productivity and ensure data integrity.
Risk-based decision-making. Improved visibility helps keep people safe and company assets secure. Sphera Advanced Risk Assessment for Quality Risk enables proactive risk mitigation by providing the information needed for sound risk-based decision-making and improved safety performance.