MR – Material Readiness Business Process
The Material Readiness (MR) business process governs the controlled preparation, exposure, verification, allocation, and segregation of materials after receipt and prior to batch manufacturing execution.
Material Readiness Operating Model
The Material Readiness Operating Model below illustrates how materials are controlled from initial exposure through readiness verification, controlled allocation, and issuance for batch manufacturing execution.
Received and sealed materials
Approved sampling / readiness authorization
Inventory and status records
Representative sampling, organoleptic assessment, and chain-of-custody control
Identity verification execution support, testing coordination, and readiness status assignment
Controlled weighing, reconciliation, allocation, and staging of materials
Continuous physical and status-based segregation across all MR activities
Readiness status assignment
Dispensed and staged materials
Controlled handoff to Production or Quality disposition
Material Readiness assumes custody of materials once containers are opened or materials are otherwise exposed. MR retains custody until materials are either dispensed for authorized batch execution or dispositioned by Quality Control.
Process Interfaces & Boundaries
- Upstream: Warehousing (WH) – custody of sealed materials prior to MR initiation
- Downstream: Production (PROD) – issuance of dispensed materials under approved batch authorization
- Governance: MR executes QC requirements; Quality Control retains acceptance and disposition authority
Quality Control Requirements Executed by Material Readiness
Material Readiness is classified as a QC-Executing Domain. MR executes defined Quality Control Requirements in accordance with the Quality Control Requirements Index (QC-REQ-IDX) to generate controlled acceptance inputs supporting lot disposition decisions.
- QC-MAT-001 – Component Identity Verification: MR verifies component identity prior to release to downstream operations.
- QC-MAT-002 – Component Purity & Contaminant Acceptance: MR ensures components meet defined purity and contaminant acceptance criteria.
- QC-MAT-003 – Supplier Qualification Status Impact: MR incorporates supplier qualification status into material acceptance controls.
- QC-SAMP-001 – Sampling Plan Governance: MR executes controlled sampling in accordance with approved sampling plans.
- QC-SAMP-002 – Lot Acceptance Decision Criteria: MR generates and documents testing inputs supporting lot acceptance determinations.
- QC-ANL-004 – Outsourced Testing Governance: MR coordinates outsourced analytical activities in accordance with defined controls.
- QC-DI-002 – Record Completeness & Traceability: MR maintains complete and traceable documentation for material handling, sampling, and readiness activities.
- QC-DISP-001 – Lot Disposition Authority: MR provides controlled inputs supporting disposition decisions in accordance with defined authority boundaries.
Final lot disposition authority remains governed by the QC-DISP framework. Material Readiness executes acceptance controls but does not independently alter disposition determinations outside defined authority.
Deviations, segregation breaches, or abnormal readiness conditions identified during MR activities are documented and escalated through the Quality Event process in accordance with the enterprise Quality System.