Quality Control Authority & Governance Inheritance

This Family Pack operates under the authority and governance of the Sawgrass Nutra Labs Quality Management System (QMS) and the Quality Unit (QCO).

In accordance with 21 CFR Part 111, Quality Control (QC) retains non-delegable responsibility and authority for all quality-impacting decisions, including but not limited to:

Approval or rejection of components, in-process materials, and finished products
Review and approval of batch production and control records
Approval of deviations, investigations, and corrective and preventive actions (CAPA)
Authorization of reprocessing, rework, or disposition activities
Final release decisions and quality-impacting escalations

Quality Assurance (QA) executes defined Quality Control requirements through approved procedures, work instructions, and records under QMS governance. Execution of activities by QA personnel does not transfer Quality Control responsibility or decision authority.

All SOPs, WINs, and supporting documents contained within this Family Pack:

Inherit Quality Control authority as defined by the QMS
Shall not redefine, override, or dilute Quality Control decision rights
Shall preserve Quality Control approval points where required

For regulatory purposes, personnel executing Quality Control–governed activities under this Family Pack act as agents of the Quality Unit within the boundaries of approved procedures and do not function as independent Quality Control decision-makers unless explicitly designated.

In the event of any conflict between execution instructions and Quality Control authority, Quality Control authority prevails in accordance with QMS governance rules.

Section 1 - Family Summary

This Family inherits the governance requirements defined in the Unified Governance Manual (SOP-QMS-GOV), including the Quality Manual, Risk Management Program (RMP), Internal Audit Program (IAP), and Material Review Board (MRB) governance (SOP-QA-MRB). All WH responsibilities and WINs must align with these L2 authorities.

The Warehouse (WH) Process Family governs the controlled receipt, storage, handling, movement, staging, transport, and shipping of components, packaging materials, labels, work-in-process goods, and finished products. WH establishes the WHAT-level requirements needed to ensure that all materials are:

Received from approved suppliers
Properly identified and traceable
Protected from contamination
Stored under appropriate environmental conditions
Maintained in accurate inventory systems

WH governance defines the framework for:

Location control and rack mapping
FIFO/FEFO discipline
Status segregation (quarantine, approved, rejected)
Prevention of material mix-ups
Accurate material movement and traceability

Warehouse operations are critical because 21 CFR 111 requires manufacturers to control:

Material receipt (§111.70)
Verification and quarantine (§111.75)
Approval status and release for use (§111.80)
Storage conditions, labeling, and handling (§111.155–§111.165)

NSF/ANSI 455-2 adds further expectations for:

Material handling controls
Storage and environmental conditions
Pest- and contamination-prevention practices
Labeling accuracy and segregation
Controlled distribution and transport

Major WH risk themes include:

Incorrect or missing material identification
Receipt of materials from unapproved suppliers
Incomplete or inaccurate receiving documentation
Uncontrolled temperature or storage conditions
Incorrect rack or bin assignments
Mix-ups between quarantined and approved materials
Cross-contamination during movement or staging
Inventory inaccuracy or untraceable lot movements
Shipping, transport, or distribution errors

WH requires strong cross-functional interaction with:

Procurement (PROC): ASL alignment and supplier approval
Quality Assurance (QA): Receiving inspection, release, deviations
Quality Control (QCL): Sampling and testing at receipt
Production (PROD): Material staging and availability
Planning: Material allocation, rotation, and readiness
Shipping/Logistics: Distribution and fulfillment controls

Risk Tier Classification: HIGH. Warehouse controls directly influence material identity, traceability, contamination prevention, and batch disposition. Failures in WH operations create systemic GMP exposure and can compromise multiple batches simultaneously. For these reasons, the Warehouse Process Family is classified as a HIGH-RISK governance domain.

Exception Governance

Exception Governance Statement:
Exception conditions including returned product, nonconforming material, deviations, and corrective and preventive actions (CAPA) are governed under the Quality Assurance (QA) Process Family. The Warehouse (WH) Process Family supports these activities by performing controlled receipt, segregation, quarantine, traceability, and physical custody of affected materials. All disposition, release, salvage, reprocessing, destruction, and corrective action decisions are authorized and executed in accordance with QA Family Pack SOPs.

Section 2 - Purpose, Scope & Regulatory and QC Anchors

This section defines the WHAT-level purpose, scope, regulatory anchors, and Quality Control (QC) requirement anchors for each Warehouse (WH) SOP in the frozen hierarchy. The WH SOP set consists of core material-flow SOPs and inventory control SOPs that govern receipt, storage, status control, movement, transport, distribution, and inventory integrity. Exception conditions that intersect with Warehouse operations (e.g., returned or nonconforming materials) are governed under the Quality Assurance (QA) Process Family and are supported through Warehouse-controlled execution and evidence.

SOP ID	SOP Title	Purpose (Control Intent)	Scope (Operational Boundary)	QC Requirement Anchors (Executed by WH)	Regulatory Anchors
SOP-WH-RECV	Receiving	Defines the requirements for receiving materials, verifying accompanying documentation, assessing transport and packaging integrity, assigning initial material status, and ensuring materials remain traceable and contamination-free upon entry into GMP control.	Applies to unloading activities, visual assessment of transport suitability, inspection of unopened material packaging, verification of shipping and supplier documentation, initial quarantine assignment, and transfer of materials for Quality sampling, review, or disposition. Includes receipt of returned or rejected materials for quarantine and QA evaluation; excludes material disposition, release, salvage, or reprocessing decisions.	QC-MAT-004 (Material storage & handling condition) QC-DISP-003 (Rejection & quarantine governance)	21 CFR: 111.70, 111.75, 111.80, 111.165. NSF/ANSI 455-2: 4.3.4.2, 4.6.2, 4.6.6, 4.10.
SOP-WH-STATUS	Material Status & Quarantine	Defines requirements for assigning, maintaining, and controlling material status to prevent unauthorized use or distribution.	Applies to all materials held within Warehouse-controlled areas, including quarantined, approved, rejected, returned, and sampled materials.	QC-DISP-003 (Rejection & quarantine governance) QC-ENV-005 (Retained sample storage)	21 CFR: 111.80, 111.155–111.165, 111.475. NSF/ANSI 455-2: 4.6.2, 4.6.4, 4.10.
SOP-WH-RACKMAP	Rack Mapping	Establishes the controlled structure for assigning, maintaining, and updating warehouse rack locations to ensure traceable and accurate material storage.	Applies to creation, modification, auditing, and maintenance of rack maps including location identifiers, restricted zones, quarantine areas, and approved storage sections.	QC-ENV-001 (Warehouse environmental conditions)	21 CFR: 111.80, 111.155–111.165, 111.30. NSF/ANSI 455-2: 4.6.1–4.6.4, 4.4.2, 4.5.1.
SOP-WH-STOR	Storage	Establishes controlled requirements for storing components, labels, packaging materials, intermediates, and finished goods under conditions that maintain identity and suitability.	Applies to environmental conditions, segregation of quarantine/approved/rejected materials, FEFO/FIFO expectations, cleanliness of storage areas, and protection from contamination or mix-ups. Includes segregation and holding of nonconforming or returned materials pending Quality Assurance disposition.	QC-ENV-001 (Warehouse environmental conditions) QC-ENV-004 (Temperature-controlled storage) QC-ENV-005 (Retained sample storage) QC-MAT-004 (Material storage & handling condition)	21 CFR: 111.155–111.165, 111.30, 111.80. NSF/ANSI 455-2: 4.6.1–4.6.4, 4.7, 4.4.2.
SOP-WH-TRANS	Transfer / Transport	Defines requirements for transporting or transferring materials internally or externally in a manner that prevents contamination, damage, mix-ups, or loss of identity.	Applies to movement of materials between storage, production, staging, sampling areas, and loading docks.	QC-MAT-004 (Material storage & handling condition)	21 CFR: 111.155, 111.30, 111.475. NSF/ANSI 455-2: 4.6.6, 4.7, 4.4.2.
SOP-WH-SHIP	Shipping	Establishes requirements to ensure finished goods are picked, verified, packaged, and released under controls that maintain identity, condition, and traceability through shipment.	Applies to order verification, picking, staging, release checks, packaging, labeling, and load inspection.	QC-MAT-004 (Material storage & handling condition)	21 CFR: 111.155–111.165, 111.475, 111.30. NSF/ANSI 455-2: 4.6.5, 4.10, 4.4.2.
QA-GOVERNED	Returned Product Handling (WH Support)	Establishes Warehouse-controlled receipt, identification, segregation, quarantine, and traceability of returned finished goods in support of Quality Assurance–governed evaluation and disposition processes.	Applies to all returned finished goods physically received by Warehouse pending Quality Assurance review and disposition.	QC-DISP-003 (Rejection & quarantine governance)	21 CFR: 111.503, 111.160, 111.475. NSF/ANSI 455-2: 4.10, 4.6.5, 4.4.2.
SOP-WH-INVT	Inventory Control	Defines requirements for maintaining accurate and traceable inventory, including movement tracking, verification, and reconciliation.	Applies to issuing, returning, staging, relocating, counting, and reconciling all warehouse inventory. Includes inventory status control for quarantined, rejected, or returned materials; excludes disposition authorization.	QC-DISP-003 (Rejection & quarantine governance)	21 CFR: 111.165, 111.475, 111.255. NSF/ANSI 455-2: 4.6.4, 4.4.2, 4.10.

Quality Control (QC) requirements listed in Section 2 represent control expectations executed through Warehouse SOPs. Quality Assurance retains authority for QC requirement definition, interpretation, disposition decisions, and compliance oversight. Warehouse execution generates auditable GMP evidence through standardized artifacts.

WHAT: Section 2 — SOPs define required controls.
HOW: Section 7 — WINs define execution.
EVIDENCE: Sections 5–6 — Auditable Artifacts represent retained GMP evidence.

Section 3 - General Training Requirements

The following WHAT-level training requirements apply to all personnel who work within or support the Warehouse (WH) Process Family. Training expectations are grouped by governing SOP to improve clarity, traceability, and audit alignment. These requirements establish foundational GMP behaviors and do not include HOW-level task instructions or Work Instructions.

SOP-WH-RECV — Receiving

Personnel must understand that all received materials must be verified against accompanying documentation upon receipt.
Personnel must understand that received materials must be placed into quarantine until released by authorized Quality functions.
Personnel must be trained to recognize damaged, contaminated, or improperly labeled incoming materials and escalate appropriately.
Personnel must understand the importance of accurate lot identification and receipt documentation to support traceability.

SOP-WH-STATUS — Material Status & Quarantine

Personnel must understand material status designations (e.g., quarantined, approved, rejected, returned) and their meaning.
Personnel must understand physical and system-based segregation requirements by material status.
Personnel must understand that non-approved materials may not be used, transferred, or shipped.
Personnel must understand how to identify and escalate unauthorized status changes or segregation failures.

SOP-WH-RACKMAP — Rack Mapping & Location Control

Personnel must understand how storage locations are defined, labeled, and controlled.
Personnel must understand how incorrect placement or location mislabeling can result in material mix-ups.
Personnel must understand the role of rack mapping in supporting traceability and inventory integrity.

SOP-WH-STOR — Storage

Personnel must understand physical segregation requirements for approved, quarantined, rejected, returned, and sampled materials.
Personnel must understand storage condition expectations, including temperature, humidity, cleanliness, and pest-prevention controls.
Personnel must understand how improper storage conditions can impact material integrity and suitability.
Personnel must understand restrictions on access to controlled storage areas.

SOP-WH-TRANS — Transport

Personnel must understand proper handling techniques during internal and external transport to prevent damage or contamination.
Personnel must understand controls that prevent mix-ups or loss of material identity during transport.
Personnel must understand documentation requirements associated with transport activities.

SOP-WH-SHIP — Shipping

Personnel must understand that only approved materials may be issued or shipped.
Personnel must understand verification requirements prior to shipment to prevent incorrect material release.
Personnel must understand contamination-prevention expectations during staging and loading activities.

Returned Product Handling (QA-Governed — WH Support)

Personnel must understand that returned finished goods are treated as high-risk materials.
Personnel must understand segregation, identification, and status-control requirements for returned goods.
Personnel must understand that returned goods may not be redistributed without Quality authorization.
Personnel must understand documentation and escalation requirements associated with returned materials.

SOP-WH-INVT — Inventory Control

Personnel must understand the importance of maintaining accurate inventory records to ensure full material traceability.
Personnel must understand FIFO and FEFO principles and how inventory rotation supports GMP compliance.
Personnel must know how to identify and report inventory discrepancies, count variances, or documentation conflicts.
Personnel must understand how inventory accuracy impacts production readiness and material release decisions.

Cross-SOP Foundational GMP Expectations

Personnel must understand ALCOA+ principles and apply them to all warehouse documentation and records.
Personnel must understand that only approved documentation, forms, or electronic systems may be used.
Personnel must understand how Warehouse activities interact with QA, QC, Production, and Procurement.
Personnel must understand that warehouse access and material handling are restricted to trained and authorized individuals.
Personnel must understand how to escalate deviations, discrepancies, or abnormal conditions.

Section 4 - Unified Responsibility & High-Level Control Mapping

This section defines WHAT-level responsibilities and high-level controls for all L0-defined roles that perform, supervise, review, escalate, or own Warehouse (WH) operations. No procedural (HOW) content is included, and no SOP/WIN/FORM references appear in this section.

Role	Primary Responsibilities (WHAT)	High-Level Controls (WHAT Requirements)
Warehouse Operator	• Maintain accurate identification and segregation of all materials handled. • Perform receiving, storage, picking, staging, and movement activities according to status requirements. • Identify material issues, labeling discrepancies, or damage requiring escalation. • Maintain clean and organized storage areas to prevent contamination or mix-ups. • Execute material handling activities that support traceability and inventory accuracy.	• Follow location controls, rack assignments, and environmental expectations. • Ensure accurate documentation of all material movements. • Maintain segregation between approved, quarantined, rejected, and sampled materials. • Follow controls preventing contamination, cross-contact, or unauthorized movement. • Apply traceability controls supporting full material lifecycle visibility.
Warehouse Supervisor	• Oversee warehouse operations to ensure compliance with storage, handling, and movement expectations. • Ensure operators follow identification, segregation, and documentation requirements. • Monitor environmental, cleanliness, and organization of warehouse spaces. • Escalate mismatches, shortages, or warehouse-related nonconformances. • Ensure materials are available and in compliant status for operational needs.	• Enforce adherence to rack mapping, location control, and inventory control requirements. • Validate that receiving and shipping activities follow defined quality boundaries. • Ensure warehouse operations align with QMS expectations for traceability. • Maintain oversight of material status changes and inventory adjustments. • Ensure warehouse documentation is complete, accurate, and ALCOA+ compliant.
Production Operator	• Receive and return materials according to defined material flow expectations. • Identify issues with staged materials or labeling discrepancies. • Prevent cross-contact or contamination during material interaction. • Maintain production-area staging conditions aligned with warehouse requirements. • Support material traceability by documenting usage and returns accurately.	• Follow defined material paths and staging controls to prevent mix-ups. • Use only appropriately identified and approved materials. • Maintain accurate batch- and lot-level traceability of used materials. • Ensure returned materials maintain correct identity and segregation. • Escalate issues that may impact material suitability or movement.
Production Supervisor	• Ensure production areas receive the correct materials from Warehouse. • Maintain alignment between production requirements and warehouse staging. • Identify and escalate material discrepancies, shortages, or mix-ups. • Coordinate material flow to support production schedules. • Support cross-functional alignment on material movement and availability.	• Confirm compliance with material identification and segregation expectations. • Oversee traceability of materials entering and exiting production areas. • Ensure proper escalation of nonconforming or questionable materials. • Maintain oversight of production staging locations. • Ensure documentation of movements maintains ALCOA+ standards.
Procurement Lead	• Ensure purchased materials originate from approved suppliers with aligned specifications. • Communicate supplier changes or risks that may impact material receipt or storage. • Maintain visibility into ordering status affecting warehouse operations. • Support resolution of supplier-related receipt discrepancies. • Coordinate with Warehouse for material availability and timing needs.	• Validate supplier approval status prior to purchase initiation. • Maintain controlled communication pathways regarding supply-chain conditions. • Support receiving controls by providing accurate purchase documentation. • Ensure purchasing actions uphold traceability requirements. • Apply risk-based controls to supplier-driven issues that affect Warehouse.
Planning / Scheduling	• Maintain visibility into required material availability for production and shipping. • Communicate demand, timing, and allocation requirements to Warehouse. • Support alignment of inventory levels with operational needs. • Identify supply risks requiring cross-functional escalation. • Coordinate material movements supporting schedules.	• Ensure planned material usage aligns with status and traceability controls. • Maintain documentation supporting allocation and staging requirements. • Apply controls ensuring material readiness aligns with production needs. • Prevent scheduling actions that bypass warehouse segregation requirements. • Ensure alignment of planning data with actual warehouse inventory.
Maintenance Technician	• Maintain equipment and infrastructure supporting warehouse operations. • Identify facility conditions that pose contamination or material-damage risks. • Support corrective actions impacting storage conditions and material movement areas. • Prevent maintenance activities from introducing contamination or debris. • Escalate facility deficiencies that threaten material suitability.	• Ensure work practices protect warehouse materials from contamination. • Maintain cleanable and safe equipment used in WH operations. • Support preventive maintenance aligned with storage and movement requirements. • Maintain proper sanitation and debris control in maintenance areas. • Ensure maintenance records support traceability of WH-impacting work.
Facilities / Utilities Technician	• Maintain facility conditions including temperature, humidity, airflow, and structural integrity. • Identify facility-related risks to material storage or contamination prevention. • Support environmental controls across all warehouse zones. • Address infrastructure issues that impact material protection. • Maintain pest-prevention infrastructure relevant to storage areas.	• Maintain environmental controls within required limits. • Ensure storage areas meet structural and cleanliness expectations. • Support controls preventing pest harborage or contamination risks. • Maintain traceable documentation of facility conditions and repairs. • Escalate facility deviations affecting material suitability.
Document Control	• Maintain controlled lifecycle of Warehouse documents and forms. • Ensure controlled templates are used for receiving, storage, inventory, and shipping records. • Maintain accurate version control for WH documentation. • Support secure storage and retrieval of warehouse-related records. • Ensure cross-functional access to current WH documents.	• Enforce document-control rules across all Warehouse forms and logs. • Prevent use of outdated versions of WH documents. • Maintain metadata and approval integrity per L0 requirements. • Ensure consistent archival of WH evidence. • Maintain accessibility of controlled documents to authorized personnel.
Training & Competency	• Maintain training requirements for personnel performing warehouse activities. • Ensure WH-related training is completed before tasks are performed. • Update training assignments when WH requirements change. • Maintain training traceability supporting warehouse compliance. • Align training content with controlled WH documentation.	• Enforce training completion prior to warehouse task execution. • Maintain ALCOA+ integrity of warehouse training records. • Align training with WH SOP/WIN updates. • Support cross-functional training dependencies affecting WH. • Validate competency for equipment used in WH operations.
BRM	• Maintain cross-functional integration of Warehouse processes with the enterprise workflow. • Identify systemic risks linked to WH-related material flows. • Ensure horizontal alignment of WH controls with Procurement, Production, and QA expectations. • Support WH-related deviations, CAPA, and change evaluation. • Maintain transparency across Families for WH impacts.	• Apply enterprise-wide risk controls to WH process interactions. • Validate consistency of WH controls across dependent Families. • Maintain documentation showing alignment of WH operations with QMS architecture. • Ensure WH changes do not create cross-functional misalignment. • Support systemic review of WH-impacting changes.
BPO	• Own operational governance of WH processes. • Ensure WH controls meet enterprise expectations for traceability, segregation, and contamination prevention. • Evaluate systemic WH risks and control weaknesses. • Maintain process health indicators related to WH operations. • Oversee resolution of WH-related nonconformances.	• Ensure WH processes align with L0 governance and enterprise QMS requirements. • Ensure WH workflows maintain compliance with regulatory expectations. • Validate that WH documentation and data flows meet record lifecycle requirements. • Maintain oversight of risk mitigation and escalation pathways. • Ensure consistent application of WH controls across the organization.

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 detailed within the QA and QC Family Packs, and therefore apply uniformly to all Process Families.

Section 5 — Required AAs & Traceability Matrix

This section defines the complete and authoritative set of Auditable Artifacts (AAs) required to demonstrate effective control of this 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 correction control paths. Individual executions are distinguished by operational metadata (e.g., date, lot, transaction ID), not by AA identifier sequencing.

#	SOP	WIN	AA Doc ID	Frequency	Description (Purpose, Scope, Control Intent & Auditor Focus)
Material Flow
1	SOP-WH-RECV	WIN-WH-RECV-VERIFY	AA-WH-RECV-VERIFY	Per Receipt	Purpose: Verify identity, packaging integrity, quantity, delivery vehicle condition, and accompanying documentation of inbound materials. Control Intent: Prevent unverified or compromised materials from entering GMP control.
2	SOP-WH-STATUS	WIN-WH-STATUS-MAINTAIN	AA-WH-STATUS-MAINTAIN	Ongoing	Purpose: Maintain traceable history of material status changes. Control Intent: Prevent unauthorized use or release.
3	SOP-WH-RACKMAP	WIN-WH-RACKMAP-CONTROL	AA-WH-RACKMAP-CONTROL	Change-Driven	Purpose: Define approved rack locations by material status. Control Intent: Prevent mix-ups and enforce segregation.
4	SOP-WH-STORAGE	WIN-WH-STORAGE-ENV-MONITOR	AA-WH-STORAGE-ENV-MONITOR	Routine / Continuous	Purpose: Monitor warehouse environmental conditions applicable to material storage. Control Intent: Detect excursions that may impact material quality and trigger QA escalation. Governance: QA-defined limits; Warehouse-executed monitoring.
5	SOP-WH-STORAGE	WIN-WH-STORAGE-ENFORCE	AA-WH-STORAGE-ENFORCE	Continuous	Purpose: Enforce physical and system-based segregation of materials by status. Control Intent: Prevent mix-ups and unauthorized use.
6	SOP-WH-TRANSFERS	WIN-WH-TRANSFERS-RECORD	AA-WH-TRANSFERS-RECORD	Per Transfer	Purpose: Document controlled movement between locations. Control Intent: Prevent unauthorized status changes.
7	SOP-WH-SHIP	WIN-WH-SHIP-RELEASE	AA-WH-SHIP-RELEASE	Per Shipment	Purpose: Verify shipment accuracy and release authorization. Control Intent: Prevent incorrect distribution.
Inventory Controls
8	SOP-WH-INVT	WIN-WH-INVT-VERIFY	AA-WH-INVT-VERIFY	Cycle / Physical	Purpose: Verify inventory accuracy and reconciliation.
9	SOP-WH-INVT	WIN-WH-INVT-ADJUST	AA-WH-INVT-ADJUST	As Needed	Purpose: Document authorized inventory adjustments.

Quality Event Escalation (Cross-Domain Governance)

All Auditable Artifacts (AAs) defined in this section leverage a common, Quality Assurance (QA)–owned Quality Event escalation process. Deviations, excursions, or failures to meet defined acceptance criteria are identified within the executing domain and escalated using WIN-QA-EXCEPTION-ESCALATION.

This standardized escalation mechanism is applied consistently across Warehouse, Quality Control (QC), Manufacturing, and other GMP domains to ensure independent QA oversight, uniform investigation, and controlled disposition in accordance with Quality Assurance procedures.

Domain-specific SOPs and Work Instructions (WINs) define exception identification triggers only and do not establish independent escalation, investigation, or disposition pathways.

Domain Governance Clarifications

QC-owned In-Process Control (IPC) receiving checks may be executed by qualified Warehouse personnel under delegated authority as part of the Receiving process. Acceptance criteria, training, and oversight remain governed by Quality-owned procedures.

Warehouse storage controls include environmental monitoring, material segregation, and exception escalation activities executed by Warehouse. Environmental limits, acceptance criteria, investigation, and disposition authority are governed exclusively by Quality Assurance (QA) procedures.

Returned Product Handling (Clarification):
Returned materials do not generate a standalone Warehouse-owned Auditable Artifact. Warehouse activities related to returned product—including receipt, quarantine, segregation, status control, and traceability—are evidenced through existing Warehouse Auditable Artifacts listed in this Family Pack, primarily material status, inventory, location, and movement records. Authoritative evaluation, investigation, disposition, salvage, or destruction records for returned product are governed and retained under the Quality Assurance (QA) Process Family.

Section 6 — AA Deliverable Requirements

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 Warehouse (WH) activities.

The AA set is intentionally risk-based, consolidated, and sufficient. Each AA represents the authoritative GMP evidence for its associated warehouse control domain. No additional WH-specific records are required beyond those defined in Section 5.

Individual executions are distinguished through operational metadata (e.g., date, time, lot, location, transaction ID, user credentials), not through creation of additional forms or document variants.

Auditable Artifacts defined in this section represent the minimum sufficient GMP evidence required to demonstrate effective control of Warehouse operations. This section defines evidentiary expectations only and does not establish independent control intent, acceptance criteria, or procedural requirements, which are governed by this Family Pack SOP and applicable QA-governed procedures.

AA-WH-RECEIVING-VERIFY — Receiving Verification

Material identification and lot traceability
Quantity, condition, and documentation verification
Quarantine assignment pending Quality release
Exceptions or discrepancies identified at receipt
Date/time and personnel performing receipt verification

AA-WH-STATUS-MAINTAIN — Material Status Maintenance

Material identity and lot reference
Status designation (approved, quarantined, rejected, returned)
Authorized storage location or zone
Date/time and personnel responsible for status changes
Ongoing verification of status integrity

AA-WH-RACKMAP-CONTROL — Rack Mapping & Location Control

Approved rack maps and location identifiers
Designation of zones supporting material segregation
Verification of physical layout accuracy
Authorization and change control for layout modifications

AA-WH-STORAGE-ENV-MONITOR — Environmental Monitoring

Recorded environmental monitoring results (e.g., temperature, humidity)
Identification of applicable storage zones
Documentation of excursions or abnormal conditions
Evidence of escalation when limits are exceeded
Date/time and responsible personnel

AA-WH-STORAGE-ENFORCE — Material Segregation

Verification of physical segregation by material status
Confirmation of correct storage location assignment
Evidence preventing unauthorized access or use
Documentation of segregation checks or verifications

AA-WH-EXCEPTION-ESCALATION — Exception Escalation

Identification of warehouse-observed quality concerns
Date/time of escalation to Quality
Reference to associated Quality event, deviation, or investigation
Personnel initiating escalation

AA-WH-INVT-VERIFY — Inventory Verification

Inventory counts and reconciliation results
FIFO / FEFO verification where applicable
Identification of discrepancies or variances
Authorization of verified inventory status

AA-WH-INVT-ADJUST — Inventory Adjustment

Description and justification for adjustment
Affected material and lot identification
Authorization and approval of adjustment
Date/time and responsible personnel

AA-WH-TRANSFERS-RECORD — Material Transfer Record

Material identity, lot, and quantity transferred
Release authorization prior to transfer
Destination and receiving function
Traceability to downstream use

AA-WH-SHIP-RELEASE — Shipment Release

Material identity and shipment details
Confirmation of approved status prior to shipment
Shipping documentation and release authorization
Date/time and responsible personnel

Section 7 — WIN Layer (High-Level Execution & Control Enforcement)

This section defines the WHEN, WHO, and CONTROL OUTCOME expectations for execution of Warehouse (WH) controls. Work Instructions (WINs) enforce SOP requirements and generate the Auditable Artifacts (AAs) defined in Section 5. Procedural step-by-step HOW is intentionally excluded.

WIN-WH-RECEIVING-VERIFY

Receive inbound materials with required documentation.
Verify material identity, condition, quantity, and documentation.
Document verification results and observed exceptions.
Assign initial material status pending Quality disposition.

WIN-WH-STATUS-MAINTAIN

Assign or confirm material status.
Maintain segregation by approved status zones.
Document authorized status changes.

WIN-WH-RACKMAP-CONTROL

Maintain approved rack maps and storage zones.
Verify alignment between documented and physical layout.
Document changes or verification activities.

WIN-WH-STORAGE-ENV-MONITOR

Monitor defined warehouse environmental conditions.
Record monitoring results.
Identify and escalate excursions or abnormal conditions.

WIN-WH-STORAGE-ENFORCE

Verify physical segregation of materials by status.
Ensure materials are stored only in approved locations.
Prevent unauthorized access or movement.

WIN-WH-INVT-VERIFY

Perform cycle or physical inventory counts.
Verify FIFO / FEFO alignment.
Document results and obtain approvals.

WIN-WH-INVT-ADJUST

Identify inventory discrepancies.
Document justification for adjustment.
Obtain authorization and record adjustment.

WIN-WH-TRANSFERS-RECORD

Verify approved status prior to transfer.
Pick and issue correct materials.
Document transfer and destination.

WIN-WH-SHIP-RELEASE

Verify shipment accuracy and material identity.
Confirm required documentation.
Authorize and release shipment.

WIN-QA-EXCEPTION-ESCALATION

Identify warehouse-observed quality issues or abnormal conditions.
Initiate timely escalation to Quality.
Document escalation and reference associated Quality records.

Section 8 - Governance Inheritance

This document is an authoritative Family Pack SOP. It establishes the governing SOP requirements, minimum WIN control framework, and required Auditable Artifacts for the Warehouse (WH) Process Family. Individual SOPs or WINs do not exist outside this Family Pack unless explicitly authorized herein.

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:

Enterprise documentation control, change control, and record-lifecycle governance
ALCOA+ data integrity principles governing all GMP data
Part 11 electronic records and signature requirements
Training, qualification, and annual refresher requirements
System-of-Record expectations for creation, retention, and retrieval of evidence
Unified expectations for traceability, role accountability, and cross-functional escalation

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.

Exception Governance Inheritance

Exception conditions that intersect with Warehouse operations are governed under the Quality Assurance (QA) Process Family. Warehouse-controlled activities related to returned product, nonconforming material, deviations, and corrective and preventive actions (CAPA) inherit authority, evaluation, and disposition requirements from QA-governed SOPs.

SOP-QA-RETURNS — Returned Product, Salvage & Reprocessing
SOP-QA-NCMR — Nonconforming Material Review
SOP-QA-DEV — Deviations
SOP-QA-CAPA — Corrective & Preventive Actions

Warehouse does not authorize disposition, release, salvage, reprocessing, or destruction of materials subject to exception handling.

WAREHOUSE QMS FAMILY PACK

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