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 MNT responsibilities and WINs must align with these L2 authorities.
The Maintenance (MNT) Process Family governs preventive maintenance, corrective maintenance, calibration, facility upkeep, and utility system control required to ensure that all equipment, tools, and infrastructure used in GMP operations remain suitable, safe, and capable of performing as intended. MNT ensures equipment reliability throughout its lifecycle and supports product quality, safety, and regulatory compliance.
MNT provides WHAT-level governance for:
This Family is critical because 21 CFR 111 requires manufacturers to ensure that:
NSF/ANSI 455-2 reinforces these obligations by requiring:
Key MNT risk themes include:
MNT requires strong cross-functional interaction with:
Risk Tier Classification: HIGH. Maintenance failures can compromise multiple batches, entire production lines, utility-dependent areas, environmental controls, and overall GMP compliance. Because equipment and facility integrity underpin the entire QMS, the Maintenance Process Family is classified as a HIGH-RISK governance domain.
The Maintenance (MAINT) Process Family defines the WHAT-level requirements for maintaining facility infrastructure, utilities, equipment condition, and calibration systems necessary to support compliant GMP operations. MAINT ensures that the physical plant, utility systems, and GMP-supporting equipment remain suitable for use, controlled, and capable of preventing contamination or quality risk.
MAINT governs infrastructure and system readiness. It does not define sanitation cleaning activities, manufacturing operations, or quality decision-making, which are addressed in their respective process families.
| SOP ID | SOP Title | Purpose (Control Intent) | Scope (Operational Boundary) | Regulatory Reference (Non-Authoritative) |
|---|---|---|---|---|
| SOP-MAINT-PM | Preventive Maintenance | Establishes requirements for planned, scheduled maintenance activities to ensure equipment and facility systems remain in a state of control and suitable for GMP use. | Applies to preventive maintenance of GMP-impacting equipment, facility systems, and supporting infrastructure. Excludes sanitation cleaning tasks and operational use. | 21 CFR 111.27(d), 111.30; NSF/ANSI 455-2 §4.3.2 |
| SOP-MAINT-CAL | Calibration | Defines requirements for calibration of GMP-critical instruments and controls to ensure measurement accuracy and reliability. | Applies to calibration execution, documentation, and status control for instruments affecting product quality or process control. | 21 CFR 111.27(b), 111.35; NSF/ANSI 455-2 §4.2.4 |
| SOP-MAINT-CAL-PROGRAM | Calibration Program Management | Establishes governance and oversight requirements for the calibration system to ensure completeness, schedule adherence, and effectiveness. | Applies to calibration program oversight, scheduling, review, trending, and program-level control. Does not define calibration execution steps. | 21 CFR 111.27(b), 111.35; NSF/ANSI 455-2 §4.2.4 |
| SOP-MAINT-FACILTIY | Facility Management | Defines requirements for maintaining the facility in a condition suitable for GMP operations, including structural integrity and infrastructure fitness-for-use. | Applies to facility design suitability, building structure, installed systems, and infrastructure readiness. Excludes routine sanitation cleaning activities. | 21 CFR 111.20, 111.15(b); NSF/ANSI 455-2 §4.3.2 |
| SOP-MAINT-UTILITIES | Utilities Management | Establishes requirements for control and maintenance of facility utility systems that support GMP operations and prevent contamination or quality risk. | Applies to all GMP-relevant utility systems, including potable and non-potable water, plumbing distribution, floor drains, sewage conveyance, backflow prevention, compressed air, and other building utilities. Excludes sanitation cleaning tasks and laboratory testing. | 21 CFR 111.15(e), (f), (g), (j); 111.27(d); NSF/ANSI 455-2 §4.3.2 |
| SOP-MAINT-FACILITY | Facility Maintenance & Hygienic Conditions | Defines requirements for maintaining hygienic facility conditions necessary to prevent contamination and support sanitation effectiveness. | Applies to the condition of floors, walls, drains, waste areas, and facility surfaces from a maintenance and repair perspective. Does not define sanitation cleaning execution. | 21 CFR 111.15(a), (b), (j); NSF/ANSI 455-2 §4.3.3 |
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 plan, perform, support, or document Maintenance (MNT) activities. These competencies ensure that maintenance, calibration, repair, and utility operations protect equipment suitability, product quality, facility readiness, and GMP compliance. These requirements do not include procedural HOW-to content.
This section defines WHAT-level responsibilities and high-level controls for all L0-approved roles that perform, supervise, support, or influence Maintenance (MNT) activities. This section does not describe HOW tasks are performed and contains no references to SOPs, WINs, or FORMs.
| Role | Primary Responsibilities (WHAT) | High-Level Controls (WHAT Requirements) |
|---|---|---|
| Maintenance Technician |
• Perform preventive and corrective maintenance activities as required for equipment and facility systems. • Identify abnormal conditions or deficiencies requiring escalation. • Maintain equipment and utilities in a state of control supporting operations. • Document maintenance activities accurately and contemporaneously. • Protect equipment and materials during maintenance work. |
• Follow equipment suitability and reliability controls. • Apply contamination-prevention practices during maintenance activities. • Maintain ALCOA+-compliant maintenance records. • Ensure equipment is safe and ready for use after maintenance is completed. • Maintain traceability of maintenance work affecting critical systems. |
| Maintenance Supervisor |
• Oversee maintenance workflows to ensure completion of required PM and corrective tasks. • Review maintenance documentation for completeness and alignment with requirements. • Identify systemic maintenance risks and escalate as needed. • Coordinate maintenance activities with impacted operational areas. • Maintain oversight of maintenance scheduling and resource allocation. |
• Ensure maintenance activities follow expected frequency, documentation, and quality requirements. • Maintain oversight of equipment status, downtime, and repair priorities. • Enforce controls preventing delays that may compromise equipment suitability. • Ensure readiness verification is completed before equipment returns to service. • Maintain alignment with enterprise maintenance governance expectations. |
| Facilities / Utilities Technician |
• Maintain facility infrastructure and utilities supporting operations. • Identify conditions affecting environmental or utility performance. • Support repairs, adjustments, and monitoring of building and utility systems. • Document facility and utility maintenance activities. • Escalate facility or utility risks that may impact product quality or operations. |
• Maintain environmental and utility systems within acceptable limits. • Apply controls preventing contamination or operational disruption during facility work. • Maintain traceable documentation of facility and utility conditions. • Follow controls for utility integrity affecting production and storage. • Support rapid response to facility conditions that affect GMP areas. |
| Production Operator |
• Identify equipment issues affecting production activities. • Maintain communication of equipment readiness needs. • Support safe handoff of equipment for maintenance activities. • Maintain documentation related to equipment condition observations. • Protect materials and areas during maintenance work in production zones. |
• Follow controls preventing use of equipment that is out-of-service or unverified. • Maintain traceability of equipment-related production disruptions. • Support readiness checks before returning equipment to use. • Maintain segregation of materials during maintenance events. • Ensure documentation remains ALCOA+-compliant. |
| Production Supervisor |
• Coordinate production schedules with maintenance requirements. • Identify production impacts linked to equipment or facility issues. • Communicate equipment readiness needs to maintenance teams. • Support escalation of equipment failures affecting production. • Maintain oversight of production readiness during maintenance events. |
• Ensure production does not resume with equipment lacking required readiness verification. • Maintain oversight of production documentation impacted by maintenance delays. • Ensure escalation pathways for equipment or facility issues are followed. • Align production scheduling with maintenance priorities where needed. • Maintain traceability of production interruptions due to maintenance. |
| Warehouse Operator |
• Identify issues with warehouse equipment or facility conditions affecting storage or movement. • Support equipment access for maintenance work. • Document equipment observations affecting warehouse operations. • Maintain protection of stored materials during maintenance activities. • Communicate facility or equipment concerns requiring maintenance intervention. |
• Follow equipment and facility readiness controls in warehouse areas. • Maintain segregation and protection of materials during maintenance work. • Ensure documentation supporting warehouse readiness is complete. • Prevent unauthorized use of impacted equipment. • Escalate warehouse-related equipment concerns promptly. |
| Warehouse Supervisor |
• Coordinate maintenance needs for warehouse infrastructure or equipment. • Ensure operators follow equipment readiness expectations. • Identify systemic risks related to warehouse utilities or equipment. • Support maintenance scheduling to minimize disruption. • Maintain oversight of warehouse readiness following maintenance. |
• Ensure warehouse equipment impacted by maintenance remains out of use until verified. • Maintain documentation supporting warehouse readiness post-maintenance. • Follow escalation pathways for systemic equipment issues. • Maintain environmental and facility controls for warehouse operations. • Ensure maintenance activities are properly documented and reviewed. |
| Sanitation Technician |
• Identify sanitation conditions influenced by equipment or facility maintenance. • Support readiness of areas following maintenance activities. • Document sanitation actions required after maintenance work. • Escalate cleanliness concerns created by maintenance activities. • Maintain communication with maintenance and operations regarding area readiness. |
• Maintain cleanliness expectations following maintenance events. • Ensure documentation supports area release for use. • Follow contamination-prevention controls during sanitation. • Ensure sanitation aligns with maintenance impacts on equipment or utilities. • Support risk controls associated with environmental cleanliness. |
| Document Control |
• Maintain controlled lifecycle of maintenance and calibration documents. • Ensure only approved templates and forms are used. • Maintain version control for maintenance-related documentation. • Support retrieval and archival of maintenance and calibration records. • Maintain access to controlled documents for maintenance teams. |
• Enforce document-control requirements across MNT records. • Prevent use of outdated maintenance forms. • Maintain metadata integrity for all controlled documentation. • Ensure archival meets retention and retrieval requirements. • Support documentation availability during audits. |
| Training & Competency |
• Maintain training requirements for maintenance personnel. • Ensure maintenance and calibration tasks are performed only by qualified individuals. • Update training when maintenance documents change. • Maintain traceability of training completion for maintenance staff. • Align competency expectations with equipment and utility risk profiles. |
• Enforce training completion before maintenance activities occur. • Maintain ALCOA+ integrity of MNT training records. • Align training with controlled maintenance documentation. • Support competency validation for specialized maintenance tasks. • Ensure training evidence remains audit-ready. |
| Planning / Scheduling |
• Maintain visibility of maintenance schedules affecting operations. • Communicate required downtime for equipment and utilities. • Identify scheduling risks associated with maintenance delays. • Maintain documentation supporting maintenance planning. • Coordinate adjustments across impacted operational areas. |
• Ensure planning decisions align with maintenance priorities and risk controls. • Maintain traceable scheduling documentation. • Prevent scheduling actions that bypass maintenance readiness requirements. • Support alignment of operational plans with maintenance constraints. • Maintain transparency of maintenance-related impacts. |
| Procurement Lead |
• Maintain visibility of parts, tools, or materials required for maintenance activities. • Communicate supplier risks impacting maintenance readiness. • Provide documentation supporting the suitability of purchased maintenance materials. • Support resolution of issues related to maintenance-related procurements. • Coordinate with maintenance on availability of required components. |
• Ensure purchased components align with maintenance suitability requirements. • Maintain controlled documentation supporting material verification. • Escalate supplier delays affecting maintenance schedules. • Maintain visibility of procurement conditions affecting maintenance operations. • Support traceability for maintenance-related purchased items. |
| BRM |
• Maintain cross-functional alignment of MNT processes with enterprise workflows. • Identify systemic risks associated with equipment or facility reliability. • Support evaluation of MNT-related changes across Families. • Maintain visibility of MNT impacts on dependent processes. • Support investigations and CAPA related to maintenance failures. |
• Apply enterprise risk controls affecting maintenance and utility operations. • Validate consistency of maintenance controls across impacted Families. • Ensure MNT-related changes maintain QMS alignment. • Maintain documentation supporting cross-family integration. • Ensure cross-functional impacts are communicated and managed. |
| BPO |
• Own operational governance of maintenance, calibration, and utility processes. • Maintain oversight of equipment and facility readiness controls. • Evaluate systemic maintenance risks and escalate appropriately. • Monitor effectiveness of maintenance programs. • Ensure alignment of MNT processes with enterprise requirements. |
• Ensure MNT activities comply with L0 governance. • Maintain uniform application of maintenance controls across the organization. • Validate documentation and evidence quality for maintenance activities. • Oversee risk mitigation and escalation pathways for MNT issues. • Ensure MNT processes remain aligned during operational or structural changes. |
Quality Unit roles (QA, QC, QA-SOD, QC-SOD) are intentionally excluded from this section.
Their responsibilities are defined globally in the L0 Unified Governance Document and within the QA and
QC Family Packs, and therefore apply uniformly across all Process Families.
This section defines the authoritative inventory of Auditable Artifacts (AAs) required to demonstrate execution of the Maintenance (MAINT) Process Family. Each AA provides objective evidence that facility, utility, calibration, and maintenance controls are executed in accordance with approved SOPs.
| SOP | WIN | AA Doc ID | AA Name | Type | Evidence Intent |
|---|---|---|---|---|---|
| SOP-MAINT-PM | WIN-MAINT-PM | AA-SOP.38-PM-CHK-APR | Preventive Maintenance Checklist | CHK | Verifies scheduled preventive maintenance activities are completed. |
| SOP-MAINT-CAL | WIN-MAINT-CAL | AA-SOP.39-CAL-REC-EVT | Calibration Record | REC | Documents calibration results and instrument status. |
| SOP-MAINT-CAL-PROGRAM | WIN-MAINT-CAL-PROGRAM | AA-SOP.40-CALPROG-LOG-QTR | Calibration Program Review Log | LOG | Provides evidence of calibration program oversight and review. |
| SOP-MAINT-FACILTIY | WIN-MAINT-FACILITY | AA-SOP.41-FAC-CHK-MTH | Facility Condition Inspection Checklist | CHK | Confirms facility suitability and infrastructure condition. |
| SOP-MAINT-UTILITIES | WIN-MAINT-UTILITIES | AA-SOP.42-UTIL-LOG-DLY | Utilities Monitoring Log | LOG | Documents monitoring of utilities including plumbing and sewage systems. |
| SOP-MAINT-FACILITY | WIN-MAINT-FACHYG | AA-SOP.43-FACHYG-CHK-MTH | Facility Hygienic Condition Checklist | CHK | Verifies hygienic facility conditions are maintained. |
System of Record (SOR): Authoritative MAINT AAs are maintained within the Enterprise Artifact System of Record. This section does not define retention or system ownership.
Emergency Use Only — Non-Controlled
Facility Condition Inspection Checklist [ ] No active plumbing leaks observed [ ] Floor drains intact and functional [ ] No sewage backup or odor detected [ ] Walls, floors, and ceilings intact [ ] No standing water or condensation 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.