Section 1 - Family Summary

This Family operates under the governance requirements defined in the Unified Governance Manual (QMS-GOV), including the Quality Manual, Risk Management Program (RMP), Internal Audit Program (IAP), and Material Review Board (MRB) governance administered by QA. All QA responsibilities and Work Instructions must align with these enterprise governance authorities.

The Quality Assurance (QA) Process Family executes and administers enterprise Quality Management System processes across all GMP activities under the governance of the QMS and the authority of the Quality Unit. QA ensures that systems, processes, and products are controlled, compliant, validated, traceable, and continuously improving.

The Quality Unit retains ownership of the Quality Management System (QMS). Quality Assurance administers defined QMS processes under delegated authority but does not hold ultimate system ownership or non-delegable quality authority.

QA administers quality oversight of outsourced manufacturers and critical suppliers under the governance of the Quality Unit. This includes qualification, audit oversight, performance monitoring, material disposition controls, and risk-based surveillance to ensure compliance with applicable GMP and regulatory requirements.

Authority Delegation & Escalation Framework

The Quality Unit holds non-delegable quality authority as required under 21 CFR Part 111 Subpart F. This authority protects product safety, regulatory compliance, and independence from operational influence.

Quality Assurance executes Quality Management System processes under formally delegated authority from the Quality Unit. QA may finalize routine quality system determinations when outcomes are fully defined by approved specifications, established acceptance criteria, and controlled procedures.

QA may execute and finalize decisions that are objectively determined by predefined, documented criteria.
QA may not independently authorize determinations requiring discretionary judgment outside established criteria.
Matters requiring interpretation, deviation from approved limits, risk evaluation, or regulatory impact assessment must be escalated to the Quality Unit.
Escalation triggers are defined within applicable SOPs and are mandatory when met.

Non-Delegable Quality Unit Authority

The following authorities are retained exclusively by the Quality Unit and may not be delegated:

Approval of product release outside predefined acceptance criteria.
Authorization of rework, reprocessing, or salvage not previously defined in approved procedures.
Acceptance of product or data outside specification without documented risk assessment.
Determination of regulatory reporting obligations.
Final resolution of confirmed data integrity violations.
Override of established specifications, validated parameters, or QC limits.
Authority to halt manufacturing, packaging, distribution, or release due to quality risk.

Delegation of execution does not transfer final Quality Unit authority. The Quality Unit retains the right to review, intervene, or assume direct authority in any quality-impacting matter.

QA maintains independence from Production, Packaging, Warehouse, and other operational Process Families to ensure unbiased execution of quality system controls and oversight activities.

QA administers WHAT-level enterprise quality system controls, including:

Release and disposition of components, work-in-process, and finished goods
Deviation, investigation, and CAPA management
Change control and validation/qualification oversight
Document control and record lifecycle management
Complaint handling and recall management
Internal audits and audit readiness
Management Review facilitation and system administration
Specification and master data oversight
Nonconformance management and MRB participation
Reserve sample and stability program oversight
Sampling program governance

Regulatory frameworks including 21 CFR Part 111, 21 CFR Part 11, and NSF/ANSI 455-2 require manufacturers to maintain independent quality oversight functions that ensure:

Validated systems and processes
Controlled and compliant documentation
Reliable data integrity and electronic records
Traceable and complete GMP records
Consistent and controlled product quality

Key QA risk themes include:

Incomplete or inadequate investigations
Ineffective or missing CAPAs
Uncontrolled changes or validation gaps
Outdated or uncontrolled documentation
Incorrect or unsupported release decisions
Insufficient management oversight

QA interfaces with all Process Families—including QCL, QCP, TAL, IT, WH, PROD, PKG, SAN, MNT, PROC, and others—by providing:

Independent oversight
Approval and control enforcement
Verification of compliance
Escalation of quality risks

Risk Tier Classification: VERY HIGH. QA system controls form the foundation of GMP compliance. Failure in QA execution or oversight can compromise the entire Quality Management System, expose the organization to regulatory enforcement, and jeopardize product safety.

Section 2 - Purpose, Scope & Regulatory Anchors

Product Disposition & Nonconformance

SOP ID	SOP Title	Purpose (Control Intent)	Scope (Operational Boundary)	Regulatory Anchors
SOP-QA-RELEASE	Product Release & Disposition	Establishes WHAT-level controls for batch release, material disposition, and QA authorization prior to use or distribution.	Applies to finished goods, components, labels, packaging materials, and intermediates requiring QA approval.	21 CFR 111.123, 111.165; NSF/ANSI 455-2 §4.1.1.
SOP-QA-NCMR	Nonconforming Material Review	Defines controls for identifying, segregating, evaluating, and dispositioning nonconforming materials.	Applies to materials or product deemed unsuitable or out of specification.	21 CFR 111.113, 111.165; NSF/ANSI 455-2 §4.4.1.
SOP-QA-RETURNS	Returned Product, Salvage & Reprocessing	Establishes controls for evaluation and disposition of returned product, including salvage and reprocessing pathways.	Applies to all returned product and associated investigations.	21 CFR 111.525, 111.530; NSF/ANSI 455-2 §4.2.3.

Deviations, CAPA & Change Control

SOP ID	SOP Title	Purpose	Scope	Regulatory Anchors
SOP-QA-DEVIATION	Deviation Management	Defines documentation, investigation, evaluation, and closure controls for deviations and abnormal events.	Applies to all unplanned events impacting GMP operations.	21 CFR 111.113, 111.503.
SOP-QA-CAPA	Corrective & Preventive Action	Establishes controls for root cause analysis, corrective actions, and effectiveness verification.	Applies to systemic issues arising from deviations, audits, complaints, or trend analysis.	21 CFR 111.75, 111.503; NSF §4.4.2.
SOP-QA-CHANGE	Change Control	Defines evaluation, approval, implementation, and verification of quality-impacting changes.	Applies to changes affecting product, systems, documents, equipment, or facilities.	21 CFR 111.103; NSF §4.4.3.

Document & Specification Control

Specifications and acceptance criteria are established under Quality Unit authority within the Quality Control (QC) Control Framework. QA administers the controlled lifecycle management of approved specifications but does not independently establish acceptance criteria.

SOP ID	SOP Title	Purpose	Scope	Regulatory Anchors
SOP-QA-DOCCTRL	Document Control	Establishes lifecycle controls for creation, revision, approval, distribution, archival, and retirement.	Applies to all controlled QMS documents.	21 CFR 111.605, 111.610; NSF §4.7.1.
SOP-QA-SPEC	Specification Management	Establishes controls for authoring, approving, issuing, and revising product and material specifications.	Applies to specifications for raw materials, packaging, intermediates, and finished goods.	21 CFR 111.70, 111.75; NSF §4.2.1.

Complaints & Market Actions

SOP ID	SOP Title	Purpose	Scope	Regulatory Anchors
SOP-QA-COMPLAINT	Complaint Handling	Establishes controls for receiving, evaluating, investigating, and trending complaints.	Applies to all consumer, customer, and regulatory complaints.	21 CFR 111.560, 111.570; NSF §4.2.4.
SOP-QA-RECALL	Recall Management	Defines requirements for recall initiation, coordination, execution, and closure.	Applies to voluntary and mandatory recalls.	21 CFR 111.535; NSF §4.2.5.

Audit, Management Review & Oversight

SOP ID	SOP Title	Purpose	Scope	Regulatory Anchors
SOP-QA-AUDIT	Internal Audit Program	Establishes planning, execution, documentation, and follow-up of internal audits.	Applies to all GMP process audits.	21 CFR 111.503; NSF §4.6.1.
SOP-QA-MGMTREV	Management Review	Defines formal review of QMS performance, risks, metrics, and corrective actions.	Applies to executive leadership oversight.	NSF §4.1.1, 4.6.1.

Sampling, Stability & Retention

SOP ID	SOP Title	Purpose	Scope	Regulatory Anchors
SOP-QA-SAMPLING	Sampling Program	Establishes controls for defining and maintaining sampling plans and methodologies.	Applies to all GMP sampling activities.	21 CFR 111.80, 111.160.
SOP-QA-STABILITY	Stability Program	Defines stability study design, monitoring, and evaluation controls.	Applies to finished goods stability programs.	21 CFR 111.75, 111.85.
SOP-QA-RESERVE	Reserve Sample Program	Establishes controls for collection, storage, and management of reserve samples.	Applies to all finished goods requiring retains.	21 CFR 111.83.

Citations above support WHAT requirements; compliance traceability is maintained at the L0 level.

Section 3 - General Training Requirements

The following WHAT-level training requirements apply to all personnel who work within or support the Quality Assurance (QA) Process Family. Training expectations are grouped by governing SOP and aligned to the domain structure defined in Section 2 to improve traceability, audit clarity, and architectural consistency.

Personnel must complete initial qualification training prior to independent execution of QA-controlled activities and must complete annual refresher training thereafter. Retraining is required upon significant procedural revision, regulatory update, or identified performance gap.

Product Disposition & Nonconformance

SOP-QA-RELEASE — Product Release & Disposition

Personnel must understand that QA performs independent batch record review and prepares disposition decisions under delegated Quality Unit authority.
Personnel must understand that final quality authority resides with the Quality Unit.
Personnel must understand records reviewed as part of release (manufacturing, packaging, QC, deviations, changes).
Personnel must understand that incomplete, inaccurate, or missing records prevent release.

SOP-QA-NCMR — Nonconforming Material Review

Personnel must understand what constitutes nonconforming material.
Personnel must understand segregation and status-control requirements.
Personnel must understand approved disposition pathways.
Personnel must understand escalation requirements to QA and the Quality Unit.

SOP-QA-RETURNS — Returned Product, Salvage & Reprocessing

Personnel must understand returned product risk controls.
Personnel must understand evaluation and disposition criteria.
Personnel must understand that redistribution requires QA authorization under delegated authority.

Deviations, CAPA & Change Control

SOP-QA-DEVIATION — Deviation Management

Personnel must understand deviation definitions and identification triggers.
Personnel must understand documentation and timeliness requirements.
Personnel must understand escalation thresholds.

SOP-QA-CAPA — Corrective & Preventive Action

Personnel must understand systemic risk identification and CAPA initiation triggers.
Personnel must understand effectiveness verification requirements.

SOP-QA-CHANGE — Change Control

Personnel must understand quality-impacting change definitions.
Personnel must understand impact and risk assessment principles.
Personnel must understand approval and verification requirements.

Document & Specification Control

SOP-QA-DOCCTRL — Document Control

Personnel must understand document lifecycle controls including creation, revision, approval, issuance, and retirement.
Personnel must understand version control and effective date governance.
Personnel must understand restrictions on use of obsolete documents.

SOP-QA-SPEC — Specification Management

Personnel must understand that specifications define acceptance criteria under Quality Unit authority.
Personnel must understand the approval and revision process for specifications.
Personnel must understand linkage between specifications, testing, and release decisions.

Complaints & Market Actions

SOP-QA-COMPLAINT — Complaint Handling

Personnel must understand complaint intake and classification requirements.
Personnel must understand investigation expectations and timeliness standards.
Personnel must understand escalation requirements for safety-related complaints.

SOP-QA-RECALL — Recall Management

Personnel must understand recall initiation triggers and scope definition.
Personnel must understand traceability and reconciliation expectations.
Personnel must understand regulatory notification requirements.

Audit, Management Review & Oversight

SOP-QA-AUDIT — Internal Audit Program

Personnel must understand audit planning and execution principles.
Personnel must understand documentation and corrective action follow-up expectations.
Personnel must understand auditor independence requirements.

SOP-QA-MGMTREV — Management Review

Personnel must understand required inputs to management review.
Personnel must understand leadership oversight responsibilities.
Personnel must understand action tracking and follow-up expectations.

Sampling, Stability & Retention

SOP-QA-SAMPLING — Sampling Program

Personnel must understand approved sampling plans and statistical rationale.
Personnel must understand documentation and traceability requirements.

SOP-QA-STABILITY — Stability Program

Personnel must understand stability study design and monitoring requirements.
Personnel must understand escalation requirements for stability excursions.

SOP-QA-RESERVE — Reserve Sample Program

Personnel must understand reserve sample retention requirements.
Personnel must understand controlled retrieval and documentation expectations.

Section 4 – Roles & Governance Responsibilities

This section defines organizational roles within the Sawgrass Nutra Labs Quality Management System (QMS) and the governance responsibilities assigned to each role.

A Role represents a defined structural position within the quality governance architecture (Authority, System Administration, Technical Execution, Operational Execution, or Cross-Functional Governance).

Responsibilities define the outcome-based accountabilities assigned to that role. Responsibilities do not confer authority beyond that defined by the Quality Unit.

Architectural Tier	Role	Primary Responsibilities (WHAT)	Authority & Escalation Boundaries
Authority	Quality Unit (QU)	• Holds final, non-delegable authority for quality-related decisions. • Approves or rejects materials, components, and finished products. • Authorizes rework, reprocessing, or destruction activities. • Determines regulatory reporting and stop-work decisions.	• Authority cannot be overridden by operational, financial, or commercial interests. • Retains right to assume direct authority in any quality-impacting matter.
System Administration	Quality Assurance (QA)	• Executes and administers the Quality Management System under delegated authority of the Quality Unit. • Performs batch record review and prepares disposition determinations within predefined acceptance criteria. • Administers deviations, CAPA, change control, document control, audits, complaints, stability, and specification programs. • Maintains system effectiveness, traceability, and regulatory compliance.	• May finalize decisions only when outcomes are fully defined by approved specifications and procedures. • Must escalate discretionary decisions, deviations from limits, or regulatory-impacting matters to the Quality Unit. • Maintains independence from operational execution.
Technical Data Generation	Laboratory & Analytical Function	• Generate laboratory data, analytical results, and sampling evidence in accordance with approved methods and specifications. • Coordinate third-party laboratory testing as required. • Provide scientific input to investigations and CAPA.	• Execute strictly within validated methods and approved specifications. • Escalate out-of-specification, out-of-trend, or atypical results immediately to QA. • Do not determine final material or product disposition.
Operational Execution	Operations (Production, Packaging, Warehouse, Sanitation, Maintenance)	• Execute GMP activities in accordance with approved batch records, SOPs, and specifications. • Maintain accurate, complete, and contemporaneous documentation. • Support investigations and implement approved corrective actions.	• Escalate deviations, abnormal conditions, or quality risks immediately to QA. • Do not independently authorize release, rework, or disposition decisions. • Operate strictly within predefined acceptance criteria.
Cross-Functional Governance	Business Risk Manager (BRM)	• Identify and evaluate systemic and cross-process risks affecting quality and compliance. • Support enterprise risk integration and management review processes.	• Escalate systemic quality risks to QA and the Quality Unit. • Does not hold product release or disposition authority.
Cross-Functional Governance	System Operations Manager (SOM)	• Ensure consistent operational adoption of QA-controlled processes. • Monitor execution alignment across Process Families. • Support implementation of approved system changes.	• Escalate execution gaps impacting quality system effectiveness. • Does not override Quality Unit authority or QC requirements.
Support Functions	IT, Document Control, Training & Competency	• Maintain validated electronic systems, controlled documents, and training records. • Provide infrastructure supporting QA-controlled activities.	• Ensure compliance with Part 11, ALCOA+, and document lifecycle controls. • Escalate system or data integrity risks to QA.

Architectural Clarification: Quality Control (QC) represents the Control Framework — acceptance criteria, specifications, and release rules — established under Quality Unit authority. QC is not an organizational role.

Section 5 — Required Auditable Artifacts (AAs) & Traceability Matrix

This section defines the complete and authoritative set of Auditable Artifacts (AAs) required to demonstrate effective control of the Quality Assurance (QA) Process Family.

Each AA supports one governing SOP listed in Section 2 and is generated through execution of the corresponding WIN listed in Section 7. SOPs define WHAT-level controls. WINs define HOW-level execution.

QA executes review, verification, and documentation activities under delegated authority of the Quality Unit (Quality Control Operations – QCO). Final regulatory authority and non-delegable quality decisions remain with the Quality Unit in accordance with enterprise governance.

The AA structure is risk-based and consolidated. Each AA has one primary owning SOP and one defined control intent. Individual executions are distinguished through operational metadata (e.g., batch number, event ID, date, system reference), not by AA numbering variations.

#	SOP	WIN	AA Doc ID	Frequency	Description (Purpose, Control Intent & Auditor Focus)
Product Disposition & Nonconformance
1	SOP-QA-RELEASE	WIN-QA-RELEASE	AA-REC-QA-RELEASE-REL	Per Batch	Purpose: Document independent QA batch record review and disposition decision executed under delegated Quality Unit authority. Control Intent: Ensure only product meeting predefined specifications and acceptance criteria is released. Auditor Focus: Independence, completeness of review, specification alignment, and documented authority.
2	SOP-QA-NCMR	WIN-QA-NCMR	AA-REC-QA-NCMR-EVT	Per Event	Purpose: Document evaluation and disposition of nonconforming material under QA-controlled workflow. Control Intent: Prevent use or distribution of material not meeting acceptance criteria. Auditor Focus: Disposition rationale, authority traceability, segregation controls, and linkage to specifications.
3	SOP-QA-RETURNS	WIN-QA-RETURNS	AA-REC-QA-RETURNS-EVT	Per Return	Purpose: Document QA evaluation and final disposition of returned product. Control Intent: Prevent reintroduction of potentially compromised product into distribution. Auditor Focus: Traceability, investigation linkage, and documented disposition authority.
Deviations, CAPA & Change Control
4	SOP-QA-DEVIATION	WIN-QA-DEVIATION	AA-REC-QA-DEVIATION-EVT	Per Event	Purpose: Document identification, investigation, assessment, and closure of deviations. Control Intent: Detect, assess, and correct quality failures or compliance gaps. Auditor Focus: Timeliness, root cause analysis, risk assessment, and escalation documentation.
5	SOP-QA-CAPA	WIN-QA-CAPA	AA-REC-QA-CAPA-EVT	As Required	Purpose: Document corrective and preventive actions, including effectiveness verification. Control Intent: Prevent recurrence of systemic or repeated quality failures. Auditor Focus: Root cause linkage, effectiveness checks, and documented QA approval.
6	SOP-QA-CHANGE	WIN-QA-CHANGE	AA-REC-QA-CHANGE-EVT	Per Change	Purpose: Document evaluation and approval of quality-impacting changes. Control Intent: Prevent uncontrolled or unassessed changes affecting validated state or regulatory compliance. Auditor Focus: Risk assessment, impact analysis, and documented approval authority.
Document & Specification Control
7	SOP-QA-DOCCTRL	WIN-QA-DOCCTRL	AA-LOG-QA-DOCCTRL-APR	Per Action	Purpose: Document approval, revision, issuance, and retirement of controlled documents. Control Intent: Ensure only current, approved documents are available for GMP execution. Auditor Focus: Version control, approval traceability, and lifecycle governance.
8	SOP-QA-SPEC	WIN-QA-SPEC	AA-REC-QA-SPEC-APR	Change-Driven	Purpose: Approve and maintain quality specifications defining acceptance criteria. Control Intent: Ensure specifications support product safety, identity, purity, strength, and composition. Auditor Focus: Approval authority and linkage to testing and release criteria.
Complaints, Recalls & Market Actions
9	SOP-QA-COMPLAINT	WIN-QA-COMPLAINT	AA-REC-QA-COMPLAINT-EVT	Per Complaint	Purpose: Document complaint intake, investigation, evaluation, and closure. Control Intent: Detect and address post-market quality risks. Auditor Focus: Timeliness, classification, escalation, and CAPA linkage.
10	SOP-QA-RECALL	WIN-QA-RECALL	AA-CHK-QA-RECALL-EVT	As Required	Purpose: Verify execution and effectiveness of recall or mock recall activities. Control Intent: Ensure rapid and traceable market removal capability. Auditor Focus: Traceability, reconciliation accuracy, and documented oversight.
Audit, Management Review & Oversight
11	SOP-QA-AUDIT	WIN-QA-AUDIT	AA-REC-QA-AUDIT-APR	Planned	Purpose: Document internal audit execution, findings, and follow-up actions. Control Intent: Verify QMS conformance and effectiveness. Auditor Focus: Independence, coverage, and corrective action tracking.
12	SOP-QA-MGMTREV	WIN-QA-MGMTREV	AA-REC-QA-MGMTREV-APR	Periodic	Purpose: Capture management review inputs, decisions, and actions. Control Intent: Ensure leadership oversight of QMS performance and risk management. Auditor Focus: Inputs, outputs, decision traceability, and action follow-up.
Sampling, Stability & Retention
13	SOP-QA-SAMPLING	WIN-QA-SAMPLING	AA-TMP-QA-SAMPLING-APR	Change-Driven	Purpose: Define and approve sampling plans. Control Intent: Ensure representative and statistically appropriate sampling aligned to specifications. Auditor Focus: Plan approval and execution linkage.
14	SOP-QA-STABILITY	WIN-QA-STABILITY	AA-LOG-QA-STABILITY-APR	Ongoing	Purpose: Monitor stability study execution and trend results. Control Intent: Detect quality changes over declared shelf life. Auditor Focus: Trend review, excursion handling, and escalation.
15	SOP-QA-RESERVE	WIN-QA-RESERVE	AA-LOG-QA-RESERVE-APR	Per Batch	Purpose: Track reserve sample retention and controlled retrieval. Control Intent: Maintain evidence for investigation and regulatory support. Auditor Focus: Retention compliance and traceability.

Quality Event Escalation (Cross-Domain Governance)

All Auditable Artifacts leverage the centralized QA Quality Event escalation process. Deviations, complaints, excursions, specification failures, or risk indicators are escalated through WIN-QA-DEVIATION or the applicable QA event pathway.

Domain-specific SOPs and WINs define event identification triggers only. They do not establish independent investigation, escalation, or final disposition authority. Final regulatory authority remains under the Quality Unit governance framework.

Section 6 — AA Content & Completeness Requirements

This section defines the minimum required content elements for each Auditable Artifact (AA) identified in Section 5. These requirements establish documentation completeness, traceability, authority verification, and regulatory defensibility.

All AAs must comply with ALCOA+, Good Documentation Practices (GDP), and 21 CFR Part 11 (where electronic). Approval authority must align with delegated Quality Unit governance.

All risk assessments performed within Deviations, CAPA, Change Control, Specification evaluation, and Complaint investigations must follow the enterprise Risk Management Program (RMP) methodology to ensure consistent, documented, and risk-based decision-making.

6.1 AA-REC-QA-RELEASE-REL (Batch Release Record)

Batch/Lot identification and product description
Reference to governing specifications
Verification of completed manufacturing, packaging, and QC records
Deviation and CAPA status confirmation
Explicit disposition decision (Release / Reject / Hold)
QA approval signature with date and authority traceability

6.2 AA-REC-QA-NCMR-EVT (Nonconforming Material Record)

Material identification and status
Description of nonconformance
Specification reference
Risk assessment summary
Disposition decision and justification
Segregation and traceability confirmation
QA approval

6.3 AA-REC-QA-RETURNS-EVT (Returned Product Record)

Return source and lot traceability
Reason for return
Investigation reference (if required)
Disposition decision
QA approval

6.4 AA-REC-QA-DEVIATION-EVT (Deviation Record)

Event identification and date
Description of deviation
Immediate containment actions
Root cause analysis summary
Impact/risk assessment
CAPA linkage (if initiated)
Closure approval

6.5 AA-REC-QA-CAPA-EVT (CAPA Record)

CAPA trigger/source
Root cause reference
Defined corrective and preventive actions
Responsible party and due dates
Effectiveness verification criteria
QA approval and closure documentation

6.6 AA-REC-QA-CHANGE-EVT (Change Control Record)

Description of proposed change
Risk and impact assessment
Validation/qualification requirements
Approval signatures
Implementation verification
Closure confirmation

6.7 AA-LOG-QA-DOCCTRL-APR (Document Control Log)

Document identification and version
Revision description
Approval authority
Effective date
Obsolescence traceability (if applicable)

6.8 AA-REC-QA-SPEC-APR (Specification Approval Record)

Specification identification
Defined acceptance criteria
Regulatory or compendial reference (if applicable)
Approval signatures
Effective date

6.9 AA-REC-QA-COMPLAINT-EVT (Complaint Record)

Complaint source and date
Product and lot traceability
Classification (quality, safety, labeling, etc.)
Investigation summary
CAPA linkage (if applicable)
Disposition and closure approval

6.10 AA-CHK-QA-RECALL-EVT (Recall / Mock Recall Verification)

Recall scope definition
Notification documentation
Traceability reconciliation data
Effectiveness check results
Closure approval

6.11 AA-REC-QA-AUDIT-APR (Audit Record)

Audit scope and criteria
Audit findings
Risk classification
Corrective action linkage
Closure verification

6.12 AA-REC-QA-MGMTREV-APR (Management Review Record)

Review inputs (KPIs, audits, CAPA status, complaints, trends)
Risk assessment summary
Management decisions
Assigned actions and timelines

6.13 AA-TMP-QA-SAMPLING-APR (Sampling Plan Template)

Sampling rationale and statistical basis
Defined sample size and frequency
Specification reference
Approval authority

6.14 AA-LOG-QA-STABILITY-APR (Stability Monitoring Log)

Lot identification
Storage condition reference
Testing intervals
Result summary and trend notation
Escalation reference (if required)

6.15 AA-LOG-QA-RESERVE-APR (Reserve Sample Log)

Lot identification
Storage location
Retention period
Retrieval or destruction record (if applicable)

Section 7 — Work Instruction (WIN) Layer

This section identifies the operational Work Instructions (WINs) that execute the WHAT-level controls defined in Section 2 (SOP Layer).

WINs define controlled execution steps, sequencing, system interaction, and documentation workflows. They do not establish regulatory authority. Final quality authority and non-delegable decisions remain under the Quality Unit governance framework.

Each WIN produces one primary Auditable Artifact (AA) defined in Section 5 and governed by the completeness requirements of Section 6.

WIN-QA-RELEASE — Product Release & Disposition

Defines structured batch record review workflow.
Verifies completeness of production, packaging, QC, and deviation records.
Confirms specification alignment and resolution of exceptions.
Executes documented disposition under delegated Quality Unit authority.

Associated AA: AA-REC-QA-RELEASE-REL

WIN-QA-NCMR — Nonconforming Material Review

Defines workflow for identification and documentation of nonconforming material.
Guides risk evaluation and specification comparison.
Controls disposition routing and segregation verification.

Associated AA: AA-REC-QA-NCMR-EVT

WIN-QA-RETURNS — Returned Product Handling

Defines intake, traceability verification, and evaluation process.
Links investigation and CAPA workflows where required.
Controls documented disposition decision pathway.

Associated AA: AA-REC-QA-RETURNS-EVT

WIN-QA-DEVIATION — Deviation Management

Defines deviation intake and classification workflow.
Guides investigation sequencing and risk assessment steps.
Controls escalation and closure routing.

Associated AA: AA-REC-QA-DEVIATION-EVT

WIN-QA-CAPA — Corrective & Preventive Action

Defines CAPA initiation and root cause documentation workflow.
Controls assignment, tracking, and effectiveness verification.
Establishes structured closure pathway.

Associated AA: AA-REC-QA-CAPA-EVT

WIN-QA-CHANGE — Change Control

Defines structured change proposal submission process.
Guides impact assessment and review routing.
Controls implementation verification and documented closure.

Associated AA: AA-REC-QA-CHANGE-EVT

WIN-QA-DOCCTRL — Document Control

Defines controlled document lifecycle workflow.
Guides revision, approval, issuance, and retirement sequencing.
Maintains document status integrity.

Associated AA: AA-LOG-QA-DOCCTRL-APR

WIN-QA-SPEC — Specification Management

Defines creation and revision workflow for specifications.
Guides cross-functional review and approval routing.
Controls issuance of approved acceptance criteria.

Associated AA: AA-REC-QA-SPEC-APR

WIN-QA-COMPLAINT — Complaint Handling

Defines intake, logging, and classification workflow.
Guides investigation sequencing and risk evaluation.
Controls closure and escalation routing.

Associated AA: AA-REC-QA-COMPLAINT-EVT

WIN-QA-RECALL — Recall Management

Defines recall initiation and scope determination workflow.
Guides notification, reconciliation, and traceability verification.
Controls effectiveness verification and documented closure.

Associated AA: AA-CHK-QA-RECALL-EVT

WIN-QA-AUDIT — Internal Audit

Defines audit planning, execution, and documentation workflow.
Guides finding classification and corrective action linkage.
Controls finalization and closure documentation.

Associated AA: AA-REC-QA-AUDIT-APR

WIN-QA-MGMTREV — Management Review

Defines structured collection of QMS performance inputs.
Guides formal leadership review process.
Controls documentation of decisions and assigned actions.

Associated AA: AA-REC-QA-MGMTREV-APR

WIN-QA-SAMPLING — Sampling Program

Defines sampling plan development and approval workflow.
Guides statistical justification documentation.
Controls issuance of approved sampling plans.

Associated AA: AA-TMP-QA-SAMPLING-APR

WIN-QA-STABILITY — Stability Program

Defines stability monitoring schedule management.
Guides review of test results and trend assessment.
Controls escalation of stability excursions.

Associated AA: AA-LOG-QA-STABILITY-APR

WIN-QA-RESERVE — Reserve Sample Program

Defines reserve sample identification and retention workflow.
Guides controlled retrieval and documentation.
Maintains traceability through retention lifecycle.

Associated AA: AA-LOG-QA-RESERVE-APR

1.0 Purpose

This Work Instruction defines the standardized process for microbiological data review, risk evaluation, and disposition of finished dietary supplement products manufactured or packaged at Sawgrass Nutra Labs (SNL). It ensures that all results from microbiological testing are scientifically valid, accurately interpreted, and dispositioned according to validated limits and regulatory expectations.

The purpose of this WI is to operationalize the requirements of SOP-QC-2 (Finished Goods Testing) and SOP-QA-9 (Product Release Authorization), ensuring compliance with 21 CFR 111.70 – 111.95, 21 CFR Part 11, and NSF/ANSI 455-2 §§ 4.6.8 – 4.6.10.

This instruction provides QA personnel with a decision framework for classifying microbiological findings as acceptable, alert, action, or escalation events and defines the criteria for release, conditional release, rejection, or third-party review.

2.0 Scope

This Work Instruction applies to all finished-goods lots produced or packaged under SNL control, including:

The scope includes sampling verification, analytical data review, trend evaluation, microbiological risk assessment (MRA), and escalation (QA → QA Director → 3rd Party Expert → QASC).

It does not describe test execution; testing procedures are defined in SOP-QC-2 §§ 5.1–5.2 and associated laboratory work instructions.

This WI also covers QA review of non-objectionable organism classifications, Microbiological Deviation Reports (MDRs), and Microbiological Risk Assessments (MRAs) prior to release authorization.

Department / Role	Primary Responsibilities	Records Generated	Linked SOPs
Quality Assurance (QA)	Owns this Work Instruction and ensures compliance with regulatory and internal QA system requirements. Performs Microbiological Data Review and Microbiological Risk Assessments (MRA) for all results exceeding alert or action levels. Approves all conditional release or rejection decisions. Escalates cases to third-party experts or QASC as defined in this WI. Ensures all data reviews are traceable per 21 CFR 111.95 and Part 11.	MRA Report, QA-RA-001, MDR Form	SOP-QA-9, SOP-QA-8, SOP-CAPA-1
Quality Control (QC)	Coordinates sample submission, chain-of-custody, and testing with approved laboratories. Ensures laboratory data packages include all method, media, and control verifications. Performs preliminary verification of outlier results or deviations before QA review.	QA-SSF-001, QA-COC-001	SOP-QC-1, SOP-QC-2, SOP-QC-5
Warehouse / Production	Collects representative finished-good samples (begin/mid/end) per WI-020-01. Maintains sealed retains and supports re-sampling if required.	Sampling Log, COC	SOP-QC-1, WI-020-01
Third-Party Laboratories	Conduct testing per USP <61>/<62>/<1111> using validated methods. Provide traceable COAs with control documentation. Maintain ISO/IEC 17025 accreditation or equivalent GMP qualification.	COA / Lab Report Package	SOP-QC-2
QASC (Quality & Science Council)	Reviews escalated cases involving high-risk, regulatory, or brand impact (≥ $10,000 risk or potential recall). Ensures management review and consensus decision per SOP-QA-5.	QASC Minutes, MRA Summary	SOP-QA-5, SOP-QA-9

Term	Definition / Basis
Alert Level	Early-warning threshold (≤ 50% above specification) requiring trending or monitoring, but not automatic hold.
Action Level	Defined microbial limit exceedance that triggers a formal Microbiological Risk Assessment (MRA) but may still be scientifically justified for release.
Absolute Limit	Maximum permissible microbiological result. Values above require external expert review or rejection.
Non-Objectionable Organism	Environmental or benign species consistent with product type (e.g., B. subtilis, S. cerevisiae), not pathogenic or toxigenic per USP <1111>.
Objectionable Organism	Any microorganism that may cause illness, spoilage, or stability risk, including Salmonella spp., E. coli, S. aureus, P. aeruginosa.
Conditional Release	QA-approved release of a lot that marginally exceeds limits but is scientifically justified safe following MRA and QA Director sign-off.
Microbiological Risk Assessment (MRA)	Structured QA review of microbiological data to determine if exceedance is objectionable or acceptable based on organism ID, product type, and risk.
Microbiological Deviation Report (MDR)	Record documenting deviations, investigation, corrective actions, and final QA disposition.
3rd-Party Escalation Limit	Threshold requiring escalation to an external qualified microbiologist (e.g., ≥ 10⁵ CFU/g or unusual flora) even when pathogens are absent.
QASC	Executive Quality & Science Council – multi-disciplinary group that reviews high-impact or uncertain microbial disposition cases.

5.0 Procedures

The following stepwise procedures outline the review, assessment, and disposition of microbiological data for finished goods. Each process ensures that microbiological limits are validated, test data are verified, and disposition decisions are justified, documented, and compliant with 21 CFR 111.70–111.95 and NSF/ANSI 455-2 §§ 4.6.8–4.6.10.

5.1 Sampling Plan & Chain of Custody

Representative finished-goods samples shall be collected under controlled conditions to ensure validity, traceability, and prevention of contamination during transfer to approved third-party laboratories. This procedure satisfies 21 CFR 111.80(c), 111.95, and NSF/ANSI 455-2 § 4.7.

A – Sampling Requirements

Representative Sampling: Collect three (3) finished-goods containers per lot – beginning, middle, and end – to capture process variability.
Composite Test Sample: Request on COC that the 3rd-party laboratory combine equal aliquots aseptically into one composite unit for submission to the external laboratory (USP <61>/<62> valid).
Labeling: Each sample container shall be labeled with product name, lot #, date/time of collection, sampler ID, and unique seal ID.
Cold-Chain Control: Maintain 2 – 8 °C for liquids or probiotics as applicable.

B – Sample Submission to External Laboratory

All samples are shipped directly to the contracted ISO/IEC 17025-accredited laboratory identified on the QA-SSF-001 Sample Submission Form.
Samples shipped externally are not part of or drawn from the QA sealed retains. The sealed retains are completely separate finished-product units held under QA control as reference material only and are never used for testing. All microbiological testing occurs solely on the dedicated composite test sample submitted to the external ISO/IEC 17025-accredited laboratory.
The external laboratory assumes custody upon receipt and acknowledges transfer by signed or electronic QA-COC-001 Chain-of-Custody Record.

C – Chain-of-Custody Controls

QA or QC completes the QA-COC-001 documenting date/time of hand-off, courier, tracking #, and receiver signature.
Any broken seals, temperature excursions, or transit deviations must trigger a deviation investigation per SOP-CAPA-1.
QA reviews all COC and lab receipts prior to data acceptance.

No internal retesting of retained bottles is performed at SNL unless specifically authorized under a Microbiological Risk Assessment (MRA) and documented in a CAPA.

D – Executive QA Override (Rare Use Authorization)

In exceptional circumstances where a confirmatory investigation or regulatory inquiry requires retention testing at SNL, the QA Director may authorize the selection of one (1) retained finished-goods unit to be released for third-party laboratory analysis. This override shall be documented in writing and recorded in the QMS as follows:

Authorization: Only the QA Director (or designee approved under SOP-QA-1 § 5.3) may approve an override.
Justification: Must cite a specific MRA, MDR, CAPA, or regulatory request as the cause for deviation.
Documentation: A completed Executive Override Log Entry is created and linked to the corresponding lot record in the QMS.
Chain-of-Custody: The unit released is assigned a new QA-COC-001 record labeled “Executive Override Sample.”
Disposition: After testing, the third-party laboratory disposes of all materials per the Quality Technical Agreement (QTA).
Reporting: Results are reviewed by QA and trended in the Annual Product Quality Review (APQR) under SOP-QA-8.

All Executive Override events must be reviewed during Management Review per SOP-QA-5. Unauthorized or undocumented removal of retains for testing is strictly prohibited.

5.2 Pathogen Triage Process

Purpose: Define the standardized process for evaluating presumptive or confirmed pathogen detections (e.g., Salmonella spp., E. coli O157:H7, Staphylococcus aureus, Pseudomonas aeruginosa) in finished goods per USP <62>, 21 CFR 111.70 (b), and NSF/ANSI 455-2 § 4.6.10.

A – Pathogen Specification Limits

Target Organism	Specification (Scientific)	Numeric Limit	Basis
Salmonella spp.	Absence in 1 g	0 CFU / 1 g	USP <62>; 21 CFR 111.70(b)
Escherichia coli O157:H7	Absence in 1 g	0 CFU / 1 g	USP <62>; FDA BAM
Staphylococcus aureus	Absence in 1 g	0 CFU / 1 g	USP <62>

B – Action and Escalation Levels

Level	Status / Type	Condition / Result	QA Action	Default Disposition
1	Presumptive Positive (Lot-Specific)	Initial screen indicates potential pathogen detection.	Quarantine lot; verify method, media, analyst, and COC documentation.	Hold pending confirmation
2	Confirmed Negative (Lot-Specific)	Confirmatory USP <62> testing shows pathogen absent.	Document as false positive; issue CAPA if cause identified; release lot.	Release
3	Confirmed Positive (Lot-Specific)	Compendial confirmation identifies pathogen in finished lot.	Initiate MDR + MRA; reject or reprocess using validated kill step; retest before release.	Reject / Reprocess & Retest
4	Absolute Escalation (Systemic / Adverse Trend)	Repeated positives, unidentified flora ≥ 10⁵ CFU/g, or any event suggesting process or supplier contamination.	Escalate to external microbiology expert and QASC; open CAPA and include in APQR review.	QASC Review / CAPA

C – Decision Tree (Pathogen)


Pathogen screen →
   Presumptive positive?  YES →
      Hold lot → Confirm via USP <62>
         Confirmed?
            YES → Initiate MDR + MRA → Reject / Reprocess
            NO  → False positive → CAPA → Release
   NO → Within spec → Release

D – Rapid Verification Checks

Verify media and control performance and expiration.
Confirm sample labeling, integrity, and traceability (see QA-COC-001).
Cross-check environmental and sanitation logs for potential correlation.
Assess matrix interference (e.g., botanicals or preservatives).

QA Documentation: All pathogen triage events must be documented in MDR, MRA, and APQR trending records.

5.3 Total Plate Count (TPC) Triage Process

Purpose: Define the review process for quantitative microbial count results (CFU/g) in finished goods to distinguish quality indicator trends from microbiological risks.

A – Category-Based TPC Specification Limits

Category	Typical Matrix	Specification (Scientific)	Numeric Limit
Cat 1	Vitamins, minerals, tablets	≤ 1 × 10³ CFU/g	≤ 1,000 CFU/g
Cat 2	Botanical or herbal blends	≤ 1 × 10⁴ CFU/g	≤ 10,000 CFU/g
Cat 3	Fermented or probiotic formulations	≤ 1 × 10⁶ CFU/g	≤ 1,000,000 CFU/g

B – Action and Escalation Limits

Category	Action Level (Trigger MRA)	Absolute Escalation Limit	Disposition Path
Cat 1	> 1 × 10³ (1,000) CFU/g	> 1 × 10⁴ (10,000) CFU/g	MRA → Escalate if confirmed
Cat 2	> 1 × 10⁴ (10,000) CFU/g	> 1 × 10⁵ (100,000) CFU/g	MRA → Escalate if confirmed
Cat 3	> 1 × 10⁶ (1,000,000) CFU/g	> 1 × 10⁸ (100,000,000) CFU/g	MRA → Escalate to external expert

C – Decision Tree (TPC)


TPC result received →
   Verify test validity (COA, controls, lab method)
   Within spec? → YES → QA review → Release
   NO →
      Exceeds Action Level? → YES → Initiate MRA
         Organism objectionable? YES → Reject
                                 NO  → Conditional Release (QA Director)
      Exceeds Absolute Limit? → Escalate to Expert / Reject

D – Documentation & Trending

All exceedances logged in QA-TRI-003 (Microbiological Trending Register).
MRAs archived with MDR and APQR records.
QA to trend TPC deviations by product family and matrix type semi-annually.

5.4 Yeast & Mold (Y/M) Triage Process

Purpose: Establish risk-based thresholds for evaluating yeast and mold counts in finished goods and define actions for trending, MRAs, and rejections. These limits align with USP <61>/<1111>, 21 CFR 111.70 (b), and NSF/ANSI 455-2 §§ 4.6.8 – 4.6.10.

A – Category-Based Y/M Specification Limits

Category	Typical Matrix	Scientific Limit (CFU/g)	Numeric Limit (CFU/g)
Cat 1	Vitamins / Minerals / Tablets	≤ 1 × 10²	≤ 100
Cat 2	Botanical / Herbal Blends	≤ 1 × 10³	≤ 1,000
Cat 3	Fermented / Probiotic Formulations	≤ 1 × 10⁴	≤ 10,000

B – Action and Escalation Limits

Category	Action Level (Trigger MRA)	Absolute Escalation Limit	Default Disposition Path
Cat 1	> 1 × 10² (100)	> 1 × 10³ (1,000)	MRA → Conditional Release / Escalate if confirmed
Cat 2	> 1 × 10³ (1,000)	> 1 × 10⁴ (10,000)	MRA → Conditional Release / Escalate if confirmed
Cat 3	> 1 × 10⁴ (10,000)	> 1 × 10⁵ (100,000)	MRA → External Expert / Escalate to QA Director

Action / Escalation Guidance: Results ≤ Action Level → Trend only. Results > Action Level → Initiate MRA. Results ≥ Absolute Limit or toxigenic species → Escalate to QA Director / External Expert per SOP-CAPA-1.

C – Decision Tree (Y/M)


Y/M result received →
   Within spec? → Release
   ≤ Action Level? → Verify → Trend → Conditional Release (if safe)
   > Action Level? → Identify species → MRA
      Objectionable / toxigenic? YES → Reject / Escalate
                                 NO → Conditional Release
   ≥ Absolute Limit → Escalate to QA Director / External Expert
   Persistent trend → CAPA → APQR review

D – Additional Checks

Request species ID for filamentous molds or elevated Y/M trends.
Perform mycotoxin screen (aflatoxin / ochratoxin) if Aspergillus or Penicillium detected.
Retain isolates for 10 days for confirmatory testing.

5.5 Microbiological Risk Assessment (MRA)

Purpose: Define the structured QA evaluation to determine whether microbial exceedances are objectionable, non-objectionable, or acceptable for conditional release.

A – Objectionable Organisms

Pathogenic or toxigenic species (Salmonella spp., E. coli O157:H7, S. aureus).
Microbes capable of proliferation under normal storage (e.g., in liquids or high a_w products).
Species known to produce spoilage indicators (odor, gas, turbidity, color).

B – Non-Objectionable Organisms

Environmental flora or benign species common to dietary matrices (e.g., B. subtilis, M. luteus, S. cerevisiae).

C – MRA Process


Exceedance detected →
   Verify lab data integrity →
   Identify organism (MALDI-TOF / sequencing) →
      Objectionable? YES → Reject / CAPA
                      NO  → Justify via literature → Conditional Release
   QA Director approval → Record in MRA file

D – Documentation

MRA form completed and filed with QA-RA-001 (Release Authorization).
Cross-referenced in MDR if deviation occurred.

5.6 Product Release, Label Verification & Escalation Workflow

Purpose: Define QA decision-making, verification, and escalation structure for finished goods lot release. This workflow integrates microbiological review, label verification, and QA disposition authorization per 21 CFR 111.12(a), 111.70(b), 111.123(a)(3), and NSF/ANSI 455-2 §§ 4.6.8–4.6.10.

A – Disposition Categories & Criteria

Disposition	Criteria	Authority	Required Documentation
Release	All microbial, label, and specification results within limits; no open deviations or CAPA.	QA Supervisor / QA Manager	QA-RA-001 (Release Authorization Form)
Conditional Release	Quality indicator exceeded but non-objectionable flora per approved MRA and label verified accurate.	QA Director	MRA + QA-RA-001
Reject	Confirmed pathogen, objectionable organism, or labeling deviation affecting compliance.	QA Director	MDR + QA-RA-001
Escalate	≥ 3rd-Party Escalation Limit, unresolved MRA, or significant labeling/regulatory risk.	QA Director → QASC (Quality Assurance Steering Committee)	MRA + QASC Meeting Minutes

B – Decision Tree (Integrated Release Workflow)

Microbiological review complete →
   All results within specification?
      YES → Verify Label Accuracy → QA Release → Record on QA-RA-001
      NO →
         Action Level Exceeded → Perform MRA → Conditional Release (if justified)
         Pathogen / Objectionable → Reject (MDR)
         ≥ 3rd-Party Escalation Limit → External Expert Review → QASC Escalation

Label Verification → Completed? YES → Final QA Sign-off → Release
                                       NO → Hold until compliant

Note: Final release approval remains solely under QA authority per 21 CFR 111.12(a). Electronic approvals are Part 11 compliant within the QMS.

6.0 Records & Retention

All records generated under this Work Instruction must be maintained within the controlled Quality Management System (QMS) and retained according to 21 CFR 111.605 and NSF/ANSI 455-2 §§ 4.4.41–4.4.42. Electronic records must comply with 21 CFR Part 11 and SOP-IT-2 (Electronic Record Management).

Finished-goods test samples submitted to third-party laboratories are not retained by SNL. Custody and disposal of test materials are managed by the contracted laboratory per the Quality Technical Agreement (QTA). SNL maintains only digital and signed copies of QA-SSF-001, QA-COC-001, and all associated COAs within the QMS.

QA-SSF-001 Sample Submission FormQC / QAProduct Life + 2 Years21 CFR 111.95 QA-COC-001 Chain-of-Custody LogQC / QAProduct Life + 2 Years21 CFR 111.95 Laboratory COAs / ReportsQAProduct Life + 2 Years21 CFR 111.75, 111.605 Microbiological Risk Assessment (MRA)QA3 YearsNSF § 4.6.10; 21 CFR 111.90(b) Microbiological Deviation Report (MDR)QA3 Years21 CFR 111.90(b) QA-RA-001 Product Release AuthorizationQAProduct Life + 2 Years21 CFR 111.140 QASC Minutes / Escalation RecordsQAProduct Life + 2 YearsNSF §§ 4.4.41–42 External Expert Reports / QTAQAProduct Life + 2 Years21 CFR 111.75(c) Electronic Sign-offs / Audit TrailsQA & ITSystem Life + 2 Years21 CFR Part 11

QA shall ensure that all MRA and MDR records are linked to the relevant batch record and that microbial data are trended semi-annually within the Annual Product Quality Review (APQR) per SOP-QA-8.

Appendix A – Non-Objectionable Organisms Reference (QA-APP-002)

This appendix provides representative examples of non-objectionable microorganisms that may be considered acceptable in finished dietary supplement products when supported by a validated Microbiological Risk Assessment (MRA).

Organism	Classification	Basis for Acceptance	Reference
Bacillus subtilis	Environmental / Commensal	Common soil organism, non-toxigenic strains acceptable under USP <1111>	USP <1111>, NSF 173
Micrococcus luteus	Environmental / Commensal	Non-pathogenic, common in air and dust, acceptable as incidental flora	USP <1111>
Saccharomyces cerevisiae	Yeast / Process Flora	Benign fermentative yeast frequently present in natural ingredients	USP <1111>, NNHPD
Lactobacillus plantarum	Probiotic / Functional	Recognized beneficial microbe; expected in probiotic formulations	USP <2022>, NNHPD
Bacillus coagulans	Probiotic / Spore-former	GRAS and acceptable for probiotic blends under validated control	USP <2022>, NSF 173

The complete, controlled list of acceptable non-objectionable organisms is maintained in QA-APP-002 (Microbiology Reference List) and reviewed annually by QA Microbiology. Any organism classification change must undergo formal review and approval under SOP-QA-6 (Management of Change).

End of WI-QA-2A – Finished Goods Microbiological Data Review & Disposition

QUALITY ASSURANCE QMS FAMILY PACK

Table of Contents

Work Instructions

Section 1 - Family Summary

Authority Delegation & Escalation Framework

Non-Delegable Quality Unit Authority

Section 2 - Purpose, Scope & Regulatory Anchors

Product Disposition & Nonconformance

Deviations, CAPA & Change Control

Document & Specification Control

Complaints & Market Actions

Audit, Management Review & Oversight

Sampling, Stability & Retention

Section 3 - General Training Requirements

Product Disposition & Nonconformance

SOP-QA-RELEASE — Product Release & Disposition

SOP-QA-NCMR — Nonconforming Material Review

SOP-QA-RETURNS — Returned Product, Salvage & Reprocessing

Deviations, CAPA & Change Control

SOP-QA-DEVIATION — Deviation Management

SOP-QA-CAPA — Corrective & Preventive Action

SOP-QA-CHANGE — Change Control

Document & Specification Control

SOP-QA-DOCCTRL — Document Control

SOP-QA-SPEC — Specification Management

Complaints & Market Actions

SOP-QA-COMPLAINT — Complaint Handling

SOP-QA-RECALL — Recall Management

Audit, Management Review & Oversight

SOP-QA-AUDIT — Internal Audit Program

SOP-QA-MGMTREV — Management Review

Sampling, Stability & Retention

SOP-QA-SAMPLING — Sampling Program

SOP-QA-STABILITY — Stability Program

SOP-QA-RESERVE — Reserve Sample Program

Section 4 – Roles & Governance Responsibilities

Section 5 — Required Auditable Artifacts (AAs) & Traceability Matrix

Quality Event Escalation (Cross-Domain Governance)

Section 6 — AA Content & Completeness Requirements

6.1 AA-REC-QA-RELEASE-REL (Batch Release Record)

6.2 AA-REC-QA-NCMR-EVT (Nonconforming Material Record)

6.3 AA-REC-QA-RETURNS-EVT (Returned Product Record)

6.4 AA-REC-QA-DEVIATION-EVT (Deviation Record)

6.5 AA-REC-QA-CAPA-EVT (CAPA Record)

6.6 AA-REC-QA-CHANGE-EVT (Change Control Record)

6.7 AA-LOG-QA-DOCCTRL-APR (Document Control Log)

6.8 AA-REC-QA-SPEC-APR (Specification Approval Record)

6.9 AA-REC-QA-COMPLAINT-EVT (Complaint Record)

6.10 AA-CHK-QA-RECALL-EVT (Recall / Mock Recall Verification)

6.11 AA-REC-QA-AUDIT-APR (Audit Record)

6.12 AA-REC-QA-MGMTREV-APR (Management Review Record)

6.13 AA-TMP-QA-SAMPLING-APR (Sampling Plan Template)

6.14 AA-LOG-QA-STABILITY-APR (Stability Monitoring Log)

6.15 AA-LOG-QA-RESERVE-APR (Reserve Sample Log)

Section 7 — Work Instruction (WIN) Layer

WIN-QA-RELEASE — Product Release & Disposition

WIN-QA-NCMR — Nonconforming Material Review

WIN-QA-RETURNS — Returned Product Handling

WIN-QA-DEVIATION — Deviation Management

WIN-QA-CAPA — Corrective & Preventive Action

WIN-QA-CHANGE — Change Control

WIN-QA-DOCCTRL — Document Control

WIN-QA-SPEC — Specification Management

WIN-QA-COMPLAINT — Complaint Handling

WIN-QA-RECALL — Recall Management

WIN-QA-AUDIT — Internal Audit

WIN-QA-MGMTREV — Management Review

WIN-QA-SAMPLING — Sampling Program

WIN-QA-STABILITY — Stability Program

WIN-QA-RESERVE — Reserve Sample Program

Governance Inheritance

WI-QA-2A – Finished Goods Microbiological Data Review & Disposition

1.0 Purpose

2.0 Scope

3.0 Responsibilities

4.0 Definitions

5.0 Procedures

5.1 Sampling Plan & Chain of Custody

A – Sampling Requirements

B – Sample Submission to External Laboratory