Introducing MatRisk-S ™ for Material & Supplier Management

During the BoM-Lock™ exercise, all Raw Materials (containers, reagents, buffers, single-use components etc.) on the Bill of Materials (BoMs) of your most important products are ranked by criticality to

• prioritize all  material-related activities such as testing etc.
• identify critical materials that may need to be substituted
• start Material and Supplier risk mitigation planning 

The BoM-Lock™ tool lets you easily prioritize your critical raw material activities to do the right thing at the right time

The Raw Material assessment form of the MatRisk-S ™ toolbox documents the internal risk assessment for each of your most critical raw materials used in your own production,  considering among others:

• Potential impact on the own products' SISPQ (Safety, Integrity, Strength, Purity, Quality)
• Material qualification status and vendor data
• Supplier risk/status
• Material sterility assessment
• Adventitious / viral agents and TSE risk assessment
• Material particulates assessment
• Material stability assessment 
• Material E & L and adsorptivity assessment
• Other additivity assessments (residual solvents, elemental impurities etc.)
• Manufacturer's specification appropriateness

Following Quality by Design (QbD) principles, potential Critical Material Attributes are determined for your Material Qualification and own testing plan as well as other attributes where you may rely on manufacturer data.

The easy-to-follow Product assessment form of the MatRisk-S ™ toolbox documents the risk assessment for each of your important products:

• Potential impact on your customers' products' SISPQ (Safety, Integrity, Strength, Purity, Quality)
• Material sterility assessment
• Adventitious / viral agents and TSE risk assessment
• Material particulates assessment
• Material stability assessment 
• Material E & L and adsorptivity assessment
• Other additivity assessments (residual solvents, elemental impurities etc.)
• Manufacturer's specification appropriateness

This tool enables critical decisions on testing and raw materials choices and helps establish your product library.

SupRisk™, the Supply Continuity tool of MatRisk-S ™, covers all critical raw materials across your important products. It assesses the available capacity, regulatory/quality maturity, and financial health of your suppliers and for each critical raw material:

• the strategic fit (i.e., relative importance of your business based to the supplier based on their profile analysis)
• the ease of sourcing (i.e., difficulty of sourcing and qualifying an additional supplier)
• the sourcing diversification (i.e., how many supplier sites are available and/or qualified)
• the quality audit & compliance status
• the supplier quality history score and on-time performance score

This lets you easily prioritize your critical materials and suppliers in order to take appropriate actions such as SRM (Supplier Relationship Management), Inventory management, second sourcing, alternative sourcing etc.

The MatPIL™ tool is a comprehensive Product Information Library for each your products, intended to be shared with customers to enable them to qualify your products for their manufacturing process.

It contains all critical information for customers’ material onboarding and qualification.

QTM-Risk™, our additional Supply Continuity tool for all your quality testing and in-process control testing materials, will assess for each raw material used in Quality Control:

• Ease of Sourcing
• Supplier on-time supply history
• Supplier quality history
• Service history

It helps you prioritize your critical quality testing materials and suppliers in order to take appropriate actions such as SRM (Supplier Relationship Management), Inventory management, second sourcing, alternative sourcing etc.