SmartSolve® – Risk-Based Quality Management
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, distributors, and service providers elevate the degree of risk to which your company is exposed. 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 increasingly focused on leveraging risk-based strategies, and regulatory agencies worldwide are issuing mandates for you to do the same.
Risk management is an integral part of SmartSolve, Pilgrim’s enterprise quality management software platform. SmartSolve features built-in risk-based quality management processes within its solutions as opposed to requiring a separate, disparate system. SmartSolve provides effective tools to define risk policies and thresholds, to document and assess risk while evaluating quality events, and to monitor and report on risk trends and variances.
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 tools provide enhanced rigor to your quality process and a clear view into your organization’s risk profile. SmartSolve allows you to:
- Maintain and assign Failure Modes and related severity, frequency, and detection ratings
- Generate automated alerts based on Failure Mode tolerance policies
- Establish Heat Map and Risk Priority Thresholds at the system level
- Objectively determine when to escalate events to a CAPA with built-in Risk Assessments
Supplier Risk Ratings
Suppliers are an important part of your overall value chain and managing their performance is key to protecting the quality of your products. SmartSolve Supplier Risk Management drives efficiencies across your organization by allowing you to manage your supplier activities with the same quality processes that you use for your internal quality events. When quality events are categorized as relating to a supplier, SmartSolve has built-in capabilities that automate the aggregation of this data to provide detailed supplier scorecards.
SmartSolve allows you to:
- Automatically calculate supplier ratings based on quality event results such as incoming Inspections, Nonconformances, CAPAs, and Audit findings
- Drive Inspection Sampling plans and determine the frequency of Supplier Audits based on Supplier Risk Level
- Reduce overall risk by extending quality processes to your suppliers via the SmartSolve Quality Portal
Key Risk Indicator Monitoring
Every day throughout your enterprise, thousands of valuable indicators of your organizational quality are represented by events across your value chain. Raw material deviations, process deviations, equipment malfunctions, and shipping nonconformances all contribute to variance that leads to poor quality and operational risks. SmartSolve allows you to capture and maintain this data and use it to monitor risk on an ongoing basis. Risk priority calculations, based upon potential severity, frequency of incident, detection rating and trending, can be tracked by:
- 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.
Pilgrim’s SmartSolve is built to integrate risk considerations within your standard existing processes, so you can circumvent potentially adverse situations before they can become realities. Minimizing organizational risk will maximize your compliance and quality improvements, thereby growing customer trust and brand loyalty, and ultimately increasing your organization’s bottom line.