This Family inherits enterprise governance from the Unified Governance Manual (SOP-QMS-GOV), including Quality Unit authority, risk management, audit governance, and Material Review Board (MRB) oversight. All Material Readiness (MR) activities operate under these L0 controls.
The Material Readiness (MR) Process Family governs the controlled preparation, exposure, verification, allocation, and segregation of materials after receipt and prior to batch manufacturing execution.
MR assumes custody of materials once containers are opened or materials are otherwise exposed, beginning with sampling and organoleptic assessment, and retains custody until materials are either dispensed for batch execution or dispositioned by Quality.
Where Material Readiness activities or equivalent preparation steps are performed by approved suppliers or contract manufacturers, oversight is governed through L0 supplier qualification, quality agreements, and Quality Unit review. This Family Pack defines internal MR controls and interfaces with outsourced activities through enterprise governance rather than duplicating supplier management requirements.
The MR Family is structured around a defined, risk-based readiness flow:
MR is a non-batch, high-risk control domain. Failures in segregation, sampling, readiness, or dispensing can directly compromise material identity, traceability, and downstream batch integrity under 21 CFR Part 111 and NSF/ANSI 455-2.
Risk Tier Classification: HIGH. MR controls protect material integrity at the point of greatest exposure risk, prior to irreversible batch manufacturing.
This section defines the WHAT-level purpose, operational scope, regulatory anchors, and Quality Control (QC) requirement anchors for each SOP within the Material Readiness (MR) Process Family. Material Readiness operates as a QC-Executing domain and serves as the primary execution layer for material-related Quality Control activities, including sampling, identity verification, coordination of outsourced testing, and generation of inputs supporting Quality Control disposition decisions.
| SOP ID | SOP Title | Purpose (Control Intent) | Scope (Operational Boundary) | QC Requirement Anchors (Executed by MR) | Regulatory Anchors |
|---|---|---|---|---|---|
| SOP-MR-SEG | Material Segregation Control | Establishes requirements for continuous status-based and physical segregation of materials to prevent mix-ups, unauthorized use, or loss of identity. | Applies to all MR activities including sampling, readiness, dispensing, staging, and transfer prior to batch execution. | QC-DI-002 (Record completeness & traceability) QC-DISP-001 (Disposition input generation) |
21 CFR: 111.105, 111.80, 111.155. NSF/ANSI 455-2: 4.6.1–4.6.3. |
| SOP-MR-SAMPLING | Material Sampling | Defines requirements for sampling as the initial readiness event, including representative sampling, organoleptic assessment, and chain-of-custody controls. | Applies to sample removal, labeling, sealing, organoleptic assessment, and custody transfer to Quality Control. | QC-SAMP-001 (Sampling plan governance) QC-DI-002 (Record completeness & traceability) |
21 CFR: 111.80, 111.95, 111.160. NSF/ANSI 455-2: 4.4.2, 4.6. |
| SOP-MR-READINESS | Material Readiness | Establishes requirements for downstream readiness activities initiated from sampling, including identity verification execution, coordination of outsourced testing, and readiness status assignment. | Applies to identity verification execution (e.g., FTIR), bench samples, outsourced laboratory testing authorization, and readiness status assignment pending Quality Control disposition. | QC-MAT-001 (Component identity verification) QC-MAT-002 (Component purity & contaminant acceptance) QC-ANL-004 (Outsourced testing governance) QC-SAMP-002 (Lot acceptance decision criteria) QC-DISP-001 (Disposition input generation) |
21 CFR: 111.70, 111.105, 111.155. NSF/ANSI 455-2: 4.6, 4.10. |
| SOP-MR-PREWEIGH | Pre-Weigh & Dispensing | Defines requirements for controlled pre-weighing and dispensing to ensure accurate quantity allocation and traceability prior to batch execution. | Applies to weighing, reconciliation, container traceability, and staging of dispensed materials. | QC-DI-002 (Record completeness & traceability) QC-DISP-001 (Disposition input generation) |
21 CFR: 111.255, 111.260. NSF/ANSI 455-2: 4.6, 4.10. |
Material Readiness (MR) operates as a QC-Executing domain. QC requirement anchors listed in this section are ordered to reflect execution logic and identify Quality Control requirements that are directly executed through MR SOPs. Ordering does not imply priority, dependency, or Quality Control decision authority. Final acceptance, rejection, and disposition authority remains with the Quality Control Organization (QCO) in accordance with the enterprise QMS.
The following WHAT-level training requirements apply to all personnel who perform, supervise, review, or support activities within the Material Readiness (MR) Process Family. Training is aligned to MR SOPs to ensure personnel competency directly supports control ownership and regulatory risk mitigation.
Training requirements define knowledge, awareness, and escalation expectations and do not include procedural instructions.
Training is role-based and risk-based. Personnel must complete initial qualification training prior to performing MR activities and receive periodic (at least annual) refresher training in accordance with L0 training governance.
This section defines WHAT-level responsibilities and high-level controls for all L0-defined roles that perform, supervise, review, escalate, or own Material Readiness (MR) activities. No procedural (HOW) content is included, and no SOP, WIN, or AA references appear in this section.
| Role | Primary Responsibilities (WHAT) | High-Level Controls (WHAT Requirements) |
|---|---|---|
| Material Readiness Operator |
• Perform sampling, readiness, dispensing, and segregation activities
under MR control. • Maintain material identity, status, and traceability once materials are opened or exposed. • Perform organoleptic assessments and readiness support activities as authorized. • Identify abnormal conditions, discrepancies, or segregation risks. • Complete contemporaneous documentation of MR activities. |
• Maintain continuous physical and status-based segregation of materials. • Prevent unauthorized commingling, movement, or use of materials. • Preserve sample and material identity and integrity. • Follow authorization boundaries for readiness and dispensing activities. • Escalate issues immediately when control integrity is in question. |
| Material Readiness Supervisor |
• Oversee execution of MR activities across sampling, readiness,
dispensing, and staging. • Ensure MR personnel are trained and qualified for assigned activities. • Review MR documentation for completeness and accuracy. • Coordinate MR handoffs with Quality Control and Production. • Escalate MR-related nonconformances or deviations. |
• Enforce segregation, custody, and non-batch boundaries. • Verify readiness and dispensing activities occur only when authorized. • Ensure abnormal conditions are documented and escalated. • Maintain oversight of MR risk controls. • Ensure MR records meet ALCOA+ expectations. |
| Warehouse Operator |
• Maintain custody of sealed materials prior to MR initiation. • Ensure correct identification, labeling, and status of materials prior to handoff. • Transfer materials to MR only when authorized. • Prevent unauthorized opening or exposure of materials. |
• Maintain segregation of sealed materials by status. • Support traceable handoff of materials to MR. • Prevent premature exposure or readiness activities. • Escalate discrepancies affecting MR handoff suitability. |
| Production Operator |
• Receive materials issued from MR under approved batch authorization. • Maintain identity and segregation of materials during batch execution. • Document material usage and returns accurately. • Identify discrepancies in issued or staged materials. |
• Do not perform MR activities within production areas. • Use only materials issued under approved batch authorization. • Maintain batch-level traceability of materials used. • Escalate material discrepancies affecting batch integrity. |
| Production Supervisor |
• Coordinate material needs with MR for batch execution. • Ensure production staging aligns with MR issuance controls. • Identify and escalate material availability or suitability concerns. • Support cross-functional alignment on material flow. |
• Prevent batch activities from bypassing MR controls. • Ensure only properly issued materials are introduced to production. • Maintain oversight of production staging areas. • Ensure escalation of material-related risks. |
| Planning / Scheduling |
• Maintain visibility into material readiness requirements for
production schedules. • Communicate timing and allocation needs to MR. • Identify supply or readiness risks requiring escalation. • Coordinate readiness and dispensing timing. |
• Ensure planned material usage aligns with MR status controls. • Prevent scheduling actions that bypass readiness or segregation requirements. • Maintain alignment between planning data and MR availability. • Escalate conflicts between schedule demands and control readiness. |
| Maintenance / Facilities |
• Maintain equipment and facility conditions supporting MR areas. • Identify environmental or infrastructure risks to exposed materials. • Support corrective actions affecting readiness areas. • Prevent maintenance activities from introducing contamination. |
• Protect exposed materials from contamination or damage. • Maintain cleanable and controlled MR environments. • Escalate facility issues impacting material suitability. • Maintain documentation supporting MR-impacting work. |
| Training & Competency |
• Maintain training requirements for MR personnel. • Ensure MR training is completed prior to task execution. • Update training assignments when MR requirements change. • Maintain training traceability for MR roles. |
• Enforce completion of MR training prior to readiness activities. • Maintain ALCOA+ integrity of training records. • Align training content with MR control requirements. • Support role-based competency verification. |
| BPO |
• Own operational governance of MR processes. • Evaluate systemic MR risks and control effectiveness. • Maintain MR process health indicators. • Oversee resolution of MR-related nonconformances. |
• Ensure MR processes align with L0 governance and QMS expectations. • Validate consistency of MR controls across dependent Families. • Maintain oversight of escalation and risk mitigation pathways. • Ensure sustained effectiveness of MR controls. |
Quality Unit roles (QA, QC, QA-SOD, QC-SOD) are intentionally excluded from this section. Their responsibilities are defined globally in the L0 Unified Governance Document and within the QA and QC Family Packs, and apply uniformly across all Process Families.
This section defines the complete and authoritative set of Auditable Artifacts (AAs) required to demonstrate effective control of the Material Readiness (MR) domain. Each AA supports a single primary SOP listed in Section 2 and is produced through execution of a corresponding WIN defined in Section 7.
The AA set is intentionally risk-based and consolidated. Each AA has one owning SOP and one primary control intent. Some SOPs are supported by multiple AAs to address distinct verification and escalation control paths. Individual executions are distinguished by operational metadata (e.g., date, lot, sample ID, dispense ID), not by AA identifier sequencing.
| # | SOP | WIN | AA Doc ID | Frequency | Description (Purpose, Scope, Control Intent & Auditor Focus) |
|---|---|---|---|---|---|
| Segregation & Status Control | |||||
| 1 | SOP-MR-SEG | WIN-MR-SEG-STATUS-CONTROL | AA-MR-SEG-LOG | Ongoing / Event-Driven |
Purpose: Maintain continuous material status and
segregation integrity during all MR activities. Control Intent: Prevent unauthorized commingling, use, or loss of material identity. |
| Sampling & Readiness | |||||
| 2 | SOP-MR-SAMPLING | WIN-MR-SAMPLING-CHAIN-OF-CUSTODY | AA-MR-SAMPLING-FRM | Per Sampling Event |
Purpose: Document sampling as the initial readiness
event with preserved chain-of-custody. Control Intent: Ensure readiness initiation is controlled, traceable, and authorized. |
| 3 | SOP-MR-READINESS | WIN-MR-READINESS-PREPARATION | AA-MR-READINESS-REC | Per Readiness Event |
Purpose: Document downstream readiness activities
initiated from sampling. Control Intent: Ensure readiness execution is traceable and clearly differentiated from Quality disposition. |
| Dispensing Controls | |||||
| 4 | SOP-MR-PREWEIGH | WIN-MR-DISPENSE-PRE-WEIGH | AA-MR-DISPENSE-REC | Per Dispense |
Purpose: Document controlled pre-weighing and
dispensing of materials prior to batch execution. Control Intent: Prevent quantity errors impacting batch integrity. |
| Exception Handling | |||||
| 5 | SOP-MR-SEG | WIN-MR-SEG-BREACH-MANAGEMENT | AA-MR-SEG-REC | As Needed |
Purpose: Document segregation breaches or status
deviations. Control Intent: Ensure prompt containment, escalation, and Quality oversight. |
All Auditable Artifacts (AAs) defined in this section leverage the Quality Assurance (QA)–owned Quality Event escalation process. Deviations, segregation breaches, or abnormal readiness conditions are escalated using WIN-QA-EXCEPTION-ESCALATION.
Domain-specific SOPs and WINs define exception identification triggers only and do not establish independent investigation or disposition authority.
This section defines the minimum required content and evidentiary intent for each Auditable Artifact (AA) listed in Section 5. These requirements establish WHAT must be captured to demonstrate effective control of Material Readiness (MR) activities.
The AA set is intentionally risk-based, consolidated, and sufficient. Each AA represents the authoritative GMP evidence for its associated MR control domain. No additional MR-specific records are required beyond those defined in Section 5.
Individual executions are distinguished through operational metadata (e.g., date, time, lot, sample ID, dispense ID, user credentials), not through creation of additional document variants.
This section defines the WHEN, WHO, and CONTROL OUTCOME expectations for execution of Material Readiness (MR) controls. Work Instructions (WINs) enforce SOP requirements and generate the Auditable Artifacts (AAs) defined in Section 5. Procedural HOW is intentionally excluded.
This Family Pack inherits all enterprise-level governance defined in the L0 Unified Governance Document (L0-QMS-UGD), which serves as the authoritative source for quality, documentation, data integrity, and system requirements. All SOPs, WINs, and FORMs within this Family must be created, maintained, and executed in alignment with L0 rules, including:
L0 requirements apply uniformly and supersede all Family-level content. This Family Pack does not replace or modify L0 governance and operates fully within the enterprise-wide QMS architecture.