Section 1 - Family Summary

The Talent Management (TAL) Process Family governs all WHAT-level requirements for ensuring that personnel performing GMP-impacting activities are trained, competent, and formally qualified prior to performing work independently. TAL establishes the foundational human-performance controls required for compliant dietary supplement manufacturing under 21 CFR Part 111.

TAL defines and controls the framework for:

Training program governance, including onboarding, role-based SOP training, and refresher requirements
Competency assessment for hands-on, technical, analytical, and decision-based GMP roles
Personnel qualification and authorization prior to independent GMP work
Ongoing qualification maintenance and requalification where required
Documentation and control of training, competency, and qualification records

Talent Management is critical to GMP compliance because procedures, controls, and systems are only effective when executed by qualified individuals. Deficiencies in training or qualification cannot be corrected downstream through batch review or testing and therefore represent a high-impact compliance risk.

TAL directly supports and enables compliance with:

21 CFR 111 Subpart B — Personnel qualifications, education, and training
21 CFR 111.12–111.14 — Personnel responsibilities and training requirements
NSF/ANSI 455-2 — Training systems, competency, and documented authorization

Key risk themes governed by TAL include:

Untrained or underqualified personnel performing GMP tasks
Incomplete or missing training documentation
Unauthorized performance of independent GMP activities
Inadequate competency verification for technical or judgment-based roles
Lapsed or expired qualifications without timely requalification

TAL operates cross-functionally with all GMP Process Families, including:

Quality Assurance (QA): Oversight, approval, and audit of training and qualification controls
Quality Control (QCL/QCP): Analyst and reviewer qualification
Production, Packaging, Warehouse, Sanitation, Maintenance: Role-based training and competency
IT: Training system access and electronic record integrity
HR: Role changes, onboarding, and personnel status alignment

Risk Tier Classification: HIGH. Talent Management is designated as HIGH risk because failures in training, competency, or qualification directly enable GMP noncompliance at the point of execution and cannot be mitigated through later quality controls alone.

Section 2 - Purpose, Scope & Regulatory Anchors

SOP ID	SOP Title	Purpose (Control Intent)	Scope (Operational Boundary)	Regulatory Anchors
SOP-TAL-TRAIN	Training Management	Establishes WHAT-level controls for assigning, completing, documenting, and maintaining training required for GMP activities. Ensures personnel complete training prior to performing tasks and receive required refresher and role-based updates.	Applies to all GMP personnel, contractors, temporary staff, and any individual performing tasks that impact quality, safety, or compliance. Includes initial onboarding, job role training, SOP updates, annual GMP refresher training, and system-based training management requirements.	21 CFR: 111.12(c), 111.14(b), 111.70, 111.113. NSF/ANSI 455-2: 4.1.1, 4.3.1, 4.4.1 (training system requirements & competency).
SOP-TAL-COMP	Competency Management	Defines WHAT-level controls for assessing and documenting personnel competency for GMP duties. Ensures individuals demonstrate the capability to perform assigned tasks according to established methods, specifications, and quality expectations.	Applies to all GMP roles requiring demonstration of hands-on skills, technical ability, procedural understanding, or ongoing performance verification. Includes competency checks for QC, QA, production, packaging, sanitation, maintenance, warehouse, and other GMP-impacting functions.	21 CFR: 111.12(c), 111.13, 111.70, 111.105. NSF/ANSI 455-2: 4.3.1, 4.4.1 (ongoing competency requirements).
SOP-TAL-QUAL	Personnel Qualification	Establishes WHAT-level controls for qualifying personnel prior to performing unsupervised GMP work. Ensures individuals meet prerequisites, complete required training, pass competency assessments, and receive documented qualification approval.	Applies to all new hires, newly promoted individuals, individuals receiving new role assignments, and personnel transitioning into GMP functions. Includes qualification for independent roles such as QC-SOD, QA-SOD, line clearance, batch review, and laboratory functions.	21 CFR: 111.12(b)(1)-(3), 111.14, 111.70. NSF/ANSI 455-2: 4.1.1, 4.3.1 (qualification & documented authorization requirements).

AA Type–Specific Execution Requirements

Check (CHK) Requirements

Checks (CHK) are verification activities used to confirm that required, GMP-critical actions, reviews, or prerequisites have been completed in accordance with the governing SOP or WIN. Checks do not instruct how to perform tasks; they verify that required conditions or outcomes have been met.

Verify completion of discrete, GMP-critical requirements or conditions.
Use objective, binary responses (Yes/No, Pass/Fail, Accept/Reject).
Require completion of all verification points unless “N/A” is explicitly defined by procedure.
Be completed contemporaneously at the point of verification.
Trigger immediate escalation and QA notification if any verification point is not met.
Include clear operator verification and independent review or approval where required.

Log (LG) Requirements

Logs provide chronological documentation of repeated or ongoing monitoring activities. Logs in this Process Family must:

Capture each entry with date, time, and operator initials.
Be completed in real time at the point the activity occurs.
Maintain continuous entries without overwriting or removal.
Support auditability, trending, and long-term traceability.

Template (TMP) Requirements

Templates provide standardized data fields for recording measurements, quantities, equipment settings, sampling results, or other structured GMP data. Templates in this Process Family must:

Include all required fields with no blanks unless marked “N/A.”
Capture data exactly as performed or measured.
Be embedded in Batch Records, sampling sheets, or standalone as required.

Record / Form (FRM) Requirements

Records (FRMs) capture the finalized GMP evidence for this Process Family. All Records must comply with ALCOA+, GDP, Part 11 requirements for electronic records, and the metadata and retention standards defined in L0 Section 16 — AA Governance. Records may incorporate Checks, Logs, and Templates as embedded evidence.

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

Section 3 - General Training Requirements

Personnel must understand that all GMP activities require training, qualification, and documented competency before performing tasks independently.
Personnel must understand role-based training requirements, including initial onboarding, SOP-specific training, system training, and periodic refresher training.
Personnel must understand how to identify their required training assignments and the expectations for completing them within assigned due dates.
Personnel must understand that training must be completed prior to performing the associated GMP task and that unauthorized performance of tasks is prohibited.
Personnel must understand ALCOA+ documentation expectations, including accurate, legible, attributable, contemporaneous, and complete recording of training evidence.
Personnel must understand the purpose of competency assessments and how competency is demonstrated for hands-on, technical, or decision-based tasks.
Personnel must understand that qualification is required for all GMP-impacting functions and that qualification must be formally documented and approved.
Personnel must understand the requirement to escalate situations in which they feel unqualified, inadequately trained, or uncertain about GMP requirements.
Personnel must understand independence requirements for roles such as QC-SOD, QA-SOD, batch record reviewers, and laboratory verifiers.
Personnel must understand how training changes occur when SOPs, systems, or job requirements are updated, and how retraining or requalification may be required.
Personnel must understand how to access controlled training materials and the importance of using current, approved versions.
Personnel must understand expectations for training records, including how to complete electronic or paper training evidence correctly.
Personnel must understand the consequences of incomplete, inaccurate, or missing training documentation and how such gaps affect GMP compliance.
Personnel must understand the connection between TAL controls and operational Families (QCP, QCL, PRO, PKG, WH, ENG, SAN, IT) and how qualification influences authorization to perform tasks.
Personnel must understand expectations for maintaining continued qualification, including refresher evaluations, recurring certifications, and competency checks.

Section 4 - Unified Responsibility & High-Level Control Mapping

Role	Primary Responsibilities (WHAT)	High-Level Controls (WHAT Requirements)
QA	• Owns TAL governance for GMP training, competency, and qualification. • Approves job role matrices, training plans, qualification requirements, and competency criteria. • Reviews and approves training records, qualification packages, and competency assessments. • Ensures training compliance across all GMP functions and escalates training gaps or overdue items.	• Apply ALCOA+ controls to training, competency, and qualification documentation. • Ensure personnel are qualified before performing independent GMP activities. • Maintain oversight of TAL records for audits, investigations, and regulatory inspections. • Enforce training-to-role mapping accuracy and documented authorization.
QC	• Participate in role-based training, competency demonstrations, and qualification requirements. • Perform only tasks for which training has been completed and qualification approved. • Support competency assessments for analyst-specific or equipment-based tasks.	• Maintain accurate, complete training records for QC responsibilities. • Ensure training is completed prior to performing sampling, testing, verification, or CoC duties. • Support QA review by providing evidence of competency or qualification when requested.
QA-SOD / QC-SOD	• Maintain independence requirements and ensure qualification aligns with SOD role expectations. • Complete specialized training related to independent review and verification tasks. • Demonstrate competency to perform SOD activities without conflict-of-interest.	• Apply independent verification controls to training and qualification records when required. • Ensure independence and authorization are maintained for all SOD assignments. • Provide evidence of qualification for verification activities.
Functional Supervisors (PRO, PKG, WH, ENG, SAN, IT)	• Define job responsibilities and identify necessary training and competency requirements. • Ensure personnel receive required training prior to assignment of GMP tasks. • Support qualification and requalification processes in collaboration with QA. • Monitor performance for signs of insufficient training or competency.	• Ensure training plans align with job responsibilities and applicable SOPs. • Maintain oversight of functional area training compliance. • Ensure competency evaluations are completed and documented. • Support escalation of training or qualification gaps.
HR	• Support onboarding and job assignment processes requiring training alignment. • Provide personnel status changes (transfer, promotion, separation) to QA for training updates. • Maintain controlled employee records relevant to TAL requirements.	• Ensure role changes trigger TAL training and qualification workflows. • Maintain linkage between HR job data and TAL training assignments. • Support verification of employment status during audits.
Document Control	• Ensure controlled training materials remain aligned with approved SOPs, WINs, and forms. • Maintain version control and lifecycle status for training documents. • Support retrieval of TAL documentation for audits or investigations.	• Prevent use of outdated training documents or obsolete content. • Ensure training materials reflect current procedural requirements. • Maintain traceability and archival of training-related records.
Training & Competency	• Maintain training assignments, job role matrices, and qualification records. • Support competency evaluations and ensure evidence is recorded and controlled. • Manage training system data integrity and record completeness.	• Ensure training and competency evidence meets ALCOA+ requirements. • Maintain role-based training requirements consistent with TAL-controlled SOPs. • Support periodic review of training compliance and status.
BRM	• Maintain cross-functional alignment of TAL controls across the enterprise. • Identify systemic training and competency risks impacting multiple Families. • Support harmonization of TAL requirements with process-level governance.	• Validate consistency of training and qualification requirements across Families. • Ensure TAL integration in process mapping and system design. • Support escalation of TAL-related cross-functional risks.
BPO	• Own governance of TAL processes and ensure alignment with corporate training models. • Maintain oversight of training program effectiveness and qualification outcomes. • Escalate systemic TAL failures affecting quality or compliance.	• Ensure TAL SOPs comply with L0 governance and regulatory expectations. • Maintain enterprise-level visibility of TAL controls and training systems. • Validate performance of TAL controls during internal audits and assessments.

Section 5 — Required AAs & Traceability Matrix (Talent Management)

This section defines the complete and exclusive set of Auditable Artifacts (AAs) required to demonstrate execution of the Talent Management (TAL) Process Family. All AAs map directly to the SOPs defined in Section 2 and represent the authoritative L5 evidence set for training, competency, and qualification controls.

1. Training Program — SOP-TAL-TRAIN

SOP	WIN	AA ID	AA Name	Type	Purpose
SOP-TAL-TRAIN	WIN-TAL-TRAIN-ASSIGN	AA-REC-TAL-TRAIN-ASSIGN-EVT	Training Assignment Record	REC	Evidence that required training is assigned based on role and SOP applicability.
SOP-TAL-TRAIN	WIN-TAL-TRAIN-COMPLETE	AA-REC-TAL-TRAIN-COMPLETE-EVT	Training Completion Record	REC	Evidence that assigned training was completed and acknowledged.

2. Competency Program — SOP-TAL-COMP

SOP	WIN	AA ID	AA Name	Type	Purpose
SOP-TAL-COMP	WIN-TAL-COMP-EVAL	AA-FRM-TAL-COMP-EVAL-EVT	Competency Evaluation Form	FRM	Documents assessment of personnel competency for assigned GMP roles.
SOP-TAL-COMP	WIN-TAL-COMP-APPROVE	AA-REC-TAL-COMP-APPROVAL-EVT	Competency Approval Record	REC	Confirms formal approval of competency determination.

3. Qualification Program — SOP-TAL-QUAL

SOP	WIN	AA ID	AA Name	Type	Purpose
SOP-TAL-QUAL	WIN-TAL-QUAL-INITIAL	AA-CHK-TAL-QUAL-INITIAL-EVT	Initial Qualification Checklist	CHK	Verifies readiness for independent GMP role authorization.
SOP-TAL-QUAL	WIN-TAL-QUAL-MAINTAIN	AA-LOG-TAL-QUAL-STATUS-APR	Qualification Status Log	LOG	Tracks ongoing qualification and requalification status.

No additional AAs are authorized outside this table. All records are governed under L0 AA Governance requirements.

Section 6 — AA Deliverable Requirements (Talent Management)

6.1 Authorized AA Set

AA-REC-TAL-TRAIN-ASSIGN-EVT — Training assignment evidence
AA-REC-TAL-TRAIN-COMPLETE-EVT — Training completion evidence
AA-FRM-TAL-COMP-EVAL-EVT — Competency assessment documentation
AA-REC-TAL-COMP-APPROVAL-EVT — Competency approval record
AA-CHK-TAL-QUAL-INITIAL-EVT — Initial qualification verification
AA-LOG-TAL-QUAL-STATUS-APR — Qualification status tracking

6.2 Emergency Use Only — Checklist Mockup

AA-CHK-TAL-QUAL-INITIAL-EVT
Initial Qualification Checklist

[ ] Required training completed
[ ] Competency approved
[ ] Role authorization approved

Operator: __________  Date: ________
QA Review: _________  Date: ________

6.3 AA Execution Rules

CHK: Binary completion; failures require escalation.
FRM: Complete, attributable, contemporaneous.
REC: Finalized evidence meeting ALCOA+.
LOG: Chronological, traceable, non-editable entries.

Section 7 — WIN Layer (High-Level Operational HOW)

This section defines the HOW-level execution logic for the Talent Management Process Family. WINs describe operational flow only and generate the AAs defined in Section 5. No additional scope or authority is introduced.

WIN-TAL-TRAIN-ASSIGN — Training Assignment

Identify personnel role and applicable SOP requirements.
Assign required training.
Notify individual of assignment.
Record assignment.
Generate Training Assignment Record.

WIN-TAL-TRAIN-COMPLETE — Training Completion

Complete assigned training.
Capture acknowledgment.
Review completion.
Approve where required.
Finalize Training Completion Record.

WIN-TAL-COMP-EVAL — Competency Evaluation

Identify competency requirements.
Evaluate performance.
Document results.
Identify gaps.
Submit for approval.

WIN-TAL-COMP-APPROVE — Competency Approval

Review competency evidence.
Confirm requirements met.
Approve or reject.
Document decision.
Generate approval record.

WIN-TAL-QUAL-INITIAL — Initial Qualification

Verify training completion.
Verify competency approval.
Complete qualification checklist.
Obtain approvals.
Authorize GMP role.

WIN-TAL-QUAL-MAINTAIN — Qualification Maintenance

Review qualification status.
Identify expirations.
Initiate requalification.
Update status log.
Escalate gaps.

Section 8 - Governance Inheritance

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.

TALENT MANAGEMENT QMS FAMILY PACK

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