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 FAMILY responsibilities and WINs must align with these L2 authorities.
The Sales (SALES) Process Family governs all WHAT-level requirements for managing customer communication, commercial agreements, specifications, quotes, and quality-impacting customer requirements. SALES defines how customer information is captured, validated, approved, controlled, and communicated across the organization to ensure commitments remain traceable, feasible, and compliant with GMP and internal capability.
SALES governs the WHAT-level framework for:
This Process Family is critical because SALES serves as the customer's primary interface, and therefore directly impacts GMP compliance through the accuracy, completeness, and control of specifications, label claims, and manufacturing expectations. SALES interacts with multiple requirements of 21 CFR 111, including:
NSF/ANSI 455-2 further reinforces the need for:
Key risk themes governed by SALES include:
SALES requires strong cross-functional interaction with:
Risk Tier Classification: HIGH. SALES is designated as HIGH risk because it establishes the initial customer requirements that define product formulation, labeling, testing expectations, and release criteria. Errors or gaps at this stage propagate downstream and cannot be corrected through operational controls alone, creating significant quality, regulatory, and commercial exposure.
The following table includes all SALES SOPs from the frozen L2 hierarchy. Each row defines the WHAT-level purpose, operational scope, and required regulatory anchors from 21 CFR 111 and NSF/ANSI 455-2. All citations represent mandatory control domains for the {Process} segment of each SOP.
| SOP ID | SOP Title | Purpose (Control Intent) |
Scope (Operational Boundary) |
Regulatory Reference (Non-Authoritative) |
|---|---|---|---|---|
| SOP-SALES-COMM | Sales Communications | Establishes requirements for accurate, controlled, and traceable communication with customers regarding quality, specifications, testing, and production capabilities. Ensures that all customer-facing statements align with approved internal information and do not exceed validated GMP capabilities. | Applies to all written, verbal, and electronic communications made to customers that may influence product specifications, testing expectations, labeling, regulatory claims, or manufacturing commitments. Excludes marketing copy and promotional materials. |
21 CFR: 111.103–111.105 (QC responsibilities), 111.70 (specification control),
111.60 (production system design verification), 111.123(a2) (review of production records). NSF/ANSI 455-2: 4.1.1 (separation of quality responsibilities), 4.2.1–4.2.4 (quality control authority & documentation), 4.3.1 (supplier & ingredient accuracy), 4.2.12 (visitor/customer control). |
| SOP-SALES-SPEC | Sales Specifications | Defines the controlled process for collecting, validating, approving, and maintaining customer product specifications to ensure that all manufacturing, testing, labeling, and packaging expectations are fully documented and compliant with regulatory requirements. | Applies to creation, review, approval, and change control of specifications covering formulations, test methods, allergen status, packaging, labeling claims, shipping requirements, and critical customer inputs. |
21 CFR: 111.70 (specification establishment), 111.73 (specification verification), 111.75 (criteria for specification testing), 111.103–111.105 (QC review authority). NSF/ANSI 455-2: 4.3.4 (specifications for components, labels, packaging, finished goods), 4.1.2 (QC operations), 4.2.4 (MMR/BPR controls), 4.3.2 (manufacturing process design). |
| SOP-SALES-RFQ | Request for Quote | Establishes the requirements for evaluating customer requests, assessing feasibility, determining risks, validating capabilities, and generating accurate and compliant pricing quotations that align with GMP expectations and internal capacity. | Applies to evaluation of customer RFQs, technical requirement review, specification completeness checks, risk assessments, and cross-functional feasibility validation before issuing quotes. |
21 CFR: 111.60 (production system design), 111.103 (QC review), 111.355 (manufacturing operations design to meet specs). NSF/ANSI 455-2: 4.3.2 (manufacturing processes must ensure spec compliance), 4.1.2 (QC operations), 4.3.1 (risk-based supplier/manufacturer qualification), 4.2.3 (laboratory test method suitability). |
| SOP-SALES-PMA | Product Manufacturing Agreement | Establishes the requirements for creating, approving, and maintaining Product Manufacturing Agreements (PMAs) that define customer–manufacturer obligations, quality responsibilities, testing expectations, and commercial terms aligned with GMP and internal capabilities. | Applies to PMA creation, customer approval, internal QA approval, version control, scope changes, and updates required to maintain alignment with specifications and QMS rules. |
21 CFR: 111.70 (specifications), 111.103–111.105 (QC responsibilities),
111.123 (review of manufacturing operations), 111.255 (BPR expectations). NSF/ANSI 455-2: 4.2.1–4.2.4 (QC authority), 4.1.1 (quality responsibilities distinct from operations), 4.3.4 (finished-product specifications). |
| SOP-SALES-SOW | Statement of Work | Defines the controlled structure by which the operational relationship between the customer and facility is documented, ensuring all expectations, responsibilities, and deliverables are clearly defined and consistent with GMP capabilities. | Applies to the creation, maintenance, and approval of SOWs covering scope of work, production processes, packaging expectations, testing plans, shipping requirements, and communication rules. |
21 CFR: 111.60 (process design), 111.70 (spec requirements),
111.103 (QC responsibilities), 111.355 (manufacturing design). NSF/ANSI 455-2: 4.1.1 (quality separation), 4.2.1–4.2.4 (QC operations), 4.3.2 (process design requirements), 4.3.4 (specification alignment). |
| SOP-SALES-ROE | Rules of Engagement | Establishes the rules governing customer interactions, required cross-functional reviews, limits of authority, escalation expectations, and internal alignment requirements necessary to ensure all customer actions are controlled and compliant with the QMS. | Applies to interactions involving requests, changes, commitments, specification updates, claim approvals, and any customer-driven action requiring internal review and control. |
21 CFR: 111.103–111.105 (QC responsibilities), 111.70 (specifications),
111.255 (record requirements), 111.375 (recordkeeping). NSF/ANSI 455-2: 4.1.1, 4.2.1–4.2.4, 4.2.12 (visitor/customer procedures), 4.3.1–4.3.4 (requirements planning & control). |
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.
Logs provide chronological documentation of repeated or ongoing monitoring activities. Logs in this Process Family must:
Templates provide standardized data fields for recording measurements, quantities, equipment settings, sampling results, or other structured GMP data. Templates in this Process Family must:
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.
The following WHAT-level training requirements apply to all personnel who participate in, support, or influence the SALES Process Family. These requirements ensure personnel understand the quality, regulatory, communication, and documentation responsibilities necessary to prevent specification errors, misstatements, and noncompliant customer commitments. These expectations do not require Work Instructions and reflect fundamental GMP-aligned competencies.
This section defines WHAT-level responsibilities and high-level controls for all L0-defined roles that perform, supervise, review, trend, escalate, or own any controlled element within the SALES Process Family. No HOW steps, no SOP/WIN references, and no parameters are included.
| Role | Primary Responsibilities (WHAT) | High-Level Controls (WHAT Requirements) |
|---|---|---|
| SOL |
• Maintain controlled oversight of all customer-facing inputs affecting specifications, PMAs, SOWs, and commercial expectations. • Ensure customer requirements are complete, clear, validated, and aligned with internal capabilities before acceptance. • Identify customer-driven risks requiring cross-functional review or escalation. • Maintain traceability of customer commitments and required internal follow-up actions. • Ensure customer interactions follow defined rules of engagement and authority limits. |
• Enforce accuracy, completeness, and consistency of customer requirements across all SALES processes. • Ensure customer-driven changes undergo appropriate internal review and alignment. • Maintain controlled communication pathways to prevent unapproved or conflicting statements. • Apply risk-based controls to evaluate customer specifications and commitments. • Maintain documentation integrity for customer inputs, decisions, and escalations. |
| BPO |
• Own operational execution of SALES processes requiring defined internal alignment. • Approve internally controlled requirements before they are communicated externally. • Identify potential feasibility, capability, or resourcing gaps based on customer requests. • Coordinate cross-functional evaluation of customer specifications and commitments. • Maintain responsibility for internal operational readiness to support customer expectations. |
• Ensure that all customer-related requirements meet internal capability and compliance thresholds. • Maintain consistent application of internal review pathways across SALES activities. • Ensure transparency of operational impacts to BRM, SOL, and supporting functions. • Maintain controlled documentation of operational impacts, constraints, and required actions. • Uphold enterprise-level documentation standards for customer-driven requirements. |
| BRM |
• Maintain cross-functional alignment of customer requirements across the enterprise. • Identify systemic impacts from customer specifications, PMAs, SOWs, or commercial changes. • Validate that horizontal integration of customer-facing content is accurate and complete. • Ensure customer-driven changes do not cause process drift or misalignment across Families. • Support evaluation of customer requirements during deviations, CAPA, and change control. |
• Apply enterprise-level risk controls to customer-driven requirements and changes. • Ensure cross-functional consistency of specification, PMA, and SOW elements. • Confirm that workflow changes maintain alignment with the unified governance structure. • Ensure customer requirement changes follow proper review and do not create conflicting obligations. • Maintain documented alignment evidence supporting QMS integration. |
| Document Control |
• Maintain controlled lifecycle of all SALES-related documents including versions, approvals, and archival. • Ensure controlled templates are used for customer-facing agreements and specifications. • Maintain traceability of controlled document revisions impacting customer commitments. • Ensure distribution of current versions across all required functions. • Maintain integrity of controlled records related to SALES commitments. |
• Enforce document-control rules for all SALES documents including PMAs, SOWs, and Specifications. • Maintain authoritative version control to prevent outdated or unauthorized use. • Ensure all releases meet metadata, approval, and formatting requirements defined at L0. • Maintain secure archival and retrieval of controlled customer-related documents. • Ensure cross-functional access to current documents is consistent and traceable. |
| Training & Competency |
• Maintain competency frameworks for personnel interacting with customer requirements. • Ensure required training is assigned and completed for SALES-related processes. • Maintain qualification status for personnel providing customer-impacting information. • Ensure training updates are triggered following changes to SALES-controlled documents. • Maintain traceability of training records supporting compliance with customer requirements. |
• Enforce completion of training prior to personnel performing SALES-related activities. • Maintain alignment of training content with controlled SALES requirements. • Ensure training records remain complete, accurate, and ALCOA+ compliant. • Ensure cross-functional training is current following customer-driven changes. • Support governance requirements linking training to document revisions. |
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 across all Process Families.
This section defines the authoritative inventory of Auditable Artifacts (AAs) that provide objective evidence of SALES SOP execution. Scope is strictly limited to SOPs listed in Section 2.
| SOP | WIN | Auditable Artifact (AA) | Evidence Intent |
|---|---|---|---|
| SOP-SALES-COMM | WIN-SALES-CUSTCOMM | AA-CHK-SALES-CUSTCOMM-REL | Verification of QA-reviewed customer communications |
| SOP-SALES-COMM | WIN-SALES-CUSTCOMM | AA-REC-SALES-CUSTCOMM-REL | Approved customer communication record |
| SOP-SALES-SPEC | WIN-SALES-SPEC-CTRL | AA-CHK-SALES-SPEC-APR | Specification completeness and approval verification |
| SOP-SALES-SPEC | WIN-SALES-SPEC-CTRL | AA-REC-SALES-SPEC-APR | Approved customer specification record |
| SOP-SALES-RFQ | WIN-SALES-RFQ-REL | AA-CHK-SALES-RFQ-REL | RFQ feasibility and QA review verification |
| SOP-SALES-RFQ | WIN-SALES-RFQ-REL | AA-REC-SALES-RFQ-REL | Approved RFQ decision record |
| SOP-SALES-PMA | WIN-SALES-PMA-APR | AA-CHK-SALES-PMA-APR | PMA completeness and QA approval verification |
| SOP-SALES-PMA | WIN-SALES-PMA-APR | AA-REC-SALES-PMA-APR | Executed Product Manufacturing Agreement |
| SOP-SALES-SOW | WIN-SALES-SOW-APR | AA-CHK-SALES-SOW-APR | SOW scope and approval verification |
| SOP-SALES-SOW | WIN-SALES-SOW-APR | AA-REC-SALES-SOW-APR | Approved Statement of Work |
| SOP-SALES-ROE | WIN-SALES-ROE-CTRL | AA-CHK-SALES-ROE-CTRL | Rules of Engagement compliance verification |
| SOP-SALES-ROE | WIN-SALES-ROE-CTRL | AA-REC-SALES-ROE-CTRL | Controlled customer interaction record |
All AAs are maintained within the Enterprise Artifact System of Record (SOR). SOR governance is defined at the enterprise (L0) level.
AA-CHK-SALES-RFQ-REL — Emergency Use Only
[ ] Customer requirements documented [ ] Product and formulation defined [ ] Packaging and labeling requirements identified [ ] Testing and release expectations defined [ ] Manufacturing capability confirmed [ ] Quality Unit review completed Operator: ____________________ Date: __________ Reviewer (QA): ________________ Date: __________
This Family Pack inherits all enterprise-level governance defined in the L0 Unified Governance Document (L0-QMS-UGD), which serves as the authoritative source for quality, documentation, data integrity, and system requirements. All SOPs, WINs, and FORMs within this Family must be created, maintained, and executed in alignment with L0 rules, including:
L0 requirements apply uniformly and supersede all Family-level content. This Family Pack does not replace or modify L0 governance and operates fully within the enterprise-wide QMS architecture.