Supplier Risk Management


As a life science organization's network of suppliers grows, so do the risks to supply, product and supplier quality. Choose the risk management software that can manage risk throughout the lifecycle of a supplier and the sourcing process.

Regulated organizations face increasingly complex supply chains. The result is that risks related to suppliers' processes and materials have grown in number and severity – including uncontrolled supplier changes that result in out-of-spec materials or non-conforming components that pose significant health hazards. Meanwhile, regulatory bodies are placing greater focus on upstream activities and consumers are demanding greater assurance of safe products.

For all of these reasons, life science organizations have made supplier risk management a key priority. Even so, many such efforts have had limited impact on preventing and mitigating supplier risk.

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Supplier Quality Management Process

Reduce Your Risk Using Supplier Management Software

As a company expands its network of suppliers, contract manufacturers and other third parties, managing the risks associated with the complex web of partners, goods and services becomes increasingly challenging. Preventing and mitigating supplier risk is made all the more difficult for organizations that have only a fragmented picture of their suppliers and what they deliver.

Adopting robust software solutions like MasterControl's enables organizations to manage supplier relationships and documentation in one place and, ultimately, maintain an effective supplier risk management system.

MasterControl Risk Helps Manage Supplier Management Pitfalls

MasterControl Risk unifies all risk-related activities and documentation in a single, centralized repository. The solution provides seamless integration with MasterControl Supplier, and together these tools provide a complete and accurate picture of the risk landscape across product lines, business processes and business units, as well as suppliers and their goods and services.

Here's how MasterControl Risk helps companies ensure supplier risk is properly managed, easily tracked and efficiently addressed.

Supplier Risk ChallengesMasterControl Solutions
 
Disjointed Systems:

A lack of standard risk analysis methodologies and assessments results in enterprise-wide waste of time, money and resources.

Integrated System:

MasterControl brings together all risk-related data and documentation, including those related to an organization's suppliers, in a single location. MasterControl's scheduled reporting and search capabilities provide insight into, and easy access to, risk assessment and mitigation activities. Using the solution with MasterControl Supplier provides ready access to supplier risk files and risk assessment types, scorecards and dynamic trending.

 
Inconsistent Risk Assessments:

In environments where risk assessments are performed but are not standardized, risk evaluations may vary from one assessor to the next. Whether an appropriate action is taken depends on the particular assessor, meaning similar issues may be treated differently.

Standardized Risk Analysis Process:

MasterControl ensures that a single system is used to collect and manage risk-related activities, and that corporate risk tolerance thresholds are employed and followed for risk-related activities across the enterprise. Using the solution with MasterControl Process enables implementation of standardized risk calculation tools and methodologies.

 
Disconnected Processes:

The use of manual systems often results in the creation of separate data repositories (e.g., risk analyses and corresponding CAPAs), making it difficult to track and record comprehensive documentation.

Connected Processes:

MasterControl gives personnel across departments and locations a simple and efficient method for participating in risk assessment and mitigation activities. MasterControl Risk provides electronic workflows and signatures for managing risk activities and documentation, and enables users to leverage a risk-based approach in supplier-related quality events, supplier qualification activities and other processes.

 

Features and Benefits

Companies using MasterControl in their supplier risk management efforts have a number of advantages over their peers, including:

  • Uniformity: MasterControl gives quality and regulatory departments uniform methods to perform consistent risk analyses and enables various personnel (e.g., engineering, manufacturing, procurement, etc.) to easily document and store risk mitigation activities.

  • Risk Assessment Capabilities: MasterControl enables users to configure multiple risk types for evaluating different categories of operational risk, and lets users launch risk assessments from anywhere within the system to analyze hazards associated with any process or activity.

  • Reporting Tools: MasterControl's analytics reports enable in-depth analyses of risk files and assessments, and the system's scheduled reporting capability and intelligent threshold rules also helps ensure comprehensive and transparent supervision of risk activities.

  • Risk File Management: A single repository for all risk-related activities relevant to a supplier (or product or process) consolidates all risk assessments, documentation and other supplier risk management processes. Risk files may be routed and authorized electronically in accordance with 21 CFR Part 11.

  • Integration Points: Keywords are used to launch risk assessments from any MasterControl Process form. Risk files are associated with vendors stored in MasterControl Supplier to track risk-related activities. Risk assessments launched from an item in any MasterControl solution are automatically linked to related InfoCards in MasterControl.

Learn More About Supplier Risk Management

To learn more about supplier risk management, please contact a MasterControl representative.