SmartSolve® – A Risk-Based Approach to Quality
Life Sciences businesses must continually plan for and manage the inherent risks associated with delivering products aimed at improving human health. Increasingly complex value chains that incorporate global suppliers, contract manufacturers, shippers and providers grow the amount of risk to your company. Today, regulatory bodies are using risk-based models to determine who to audit, how frequently, and what aspects to inspect. New and modified regulations are taking a risk-based strategy, and they are issuing mandates for you to do the same.
SmartSolve, Pilgrim’s quality management software, incorporates a risk-based approach into its solutions for managing quality. SmartSolve gives you tools for documenting and assessing risks, defining controls, managing assessments and audits, and preventing issues in a centralized and coordinated manner.
- Evaluate processes, parts, suppliers and observations
- Assign severity, frequency and detection ratings
- Calculate risk priorities
- Monitor and report on trend and variances
Risk Calculations Monitor Key Indicators
Every day across your enterprise, thousands of valuable indicators of your future results are represented by events across your value chain. Raw material deviations, process deviations, equipment malfunctions, and shipping non-conformances all contribute to variance that leads to poor quality and operational risks.
SmartSolve captures and maintains this data and uses it to monitor risk on an ongoing basis. Risk priority calculations are derived from multiple factors and are based upon potential severity, frequency of incident, detection rating and trending related to:
- Number of change orders by product, process, and supplier
- Number of internal or external audit observations
- Number of complaints, adverse events, nonconformances or CAPAs by product, process, and supplier
- Number of dispositions by product and supplier
SmartSolve lets you identify data and circumstances that represent the failure modes, root causes, and immediate actions required to discover and mitigate issues.
Risk Assessment and Analysis
By implementing closed-loop quality management software across your enterprise, you can reduce the potential inefficiencies that result from unanticipated operational disruptions and evolving regulations and restrictions. SmartSolve provides a centralized quality solution with risk management built in. Whether you are managing supplier, product or process issues, our risk assessment computations provide the data you need for a clear view into your organization’s risk profile.