Equipment & Maintenance
User stories for equipment registry, calibration, cleaning, and maintenance scheduling
Equipment & Maintenance
Manage facility equipment lifecycle from commissioning to decommission.
US-T01: Register Equipment
As a Maintenance Technician (Nina), I want to add new equipment to the system with specifications and calibration requirements, so that all equipment is tracked and scheduled for maintenance.
Acceptance Criteria:
- Equipment record: name, manufacturer, model, serial number, location (room)
- Classification: critical (direct product contact) or non-critical
- Calibration requirements: frequency, method, acceptable range
- Status starts as
active - Upload commissioning/qualification documents (IQ/OQ/PQ)
- Equipment assigned unique asset ID
Priority: P1 | Sprint: 5
US-T02: Schedule Calibration
As a Maintenance Technician (Nina), I want to set calibration schedules and receive reminders before due dates, so that no equipment falls out of calibration.
Acceptance Criteria:
- Per equipment: calibration frequency (monthly, quarterly, semi-annual, annual)
- Due date auto-calculated from last calibration + frequency
- Reminder notification 14 days and 3 days before due
- If not calibrated by due date status auto-transitions to
out_of_calibration - OOC equipment cannot be referenced in batch records (system-enforced)
Priority: P1 | Sprint: 5
US-T03: Record Calibration
As a Maintenance Technician (Nina), I want to record a calibration event with reference standards and pass/fail results, so that calibration history is documented.
Acceptance Criteria:
- Calibration record: date, technician, method, reference standard used
- As-found and as-left readings recorded
- Pass/fail determination based on acceptable range
- If fail equipment transitions to
out_of_calibration+ deviation created - If pass next due date auto-set
- E-signature: "Calibration performed by"
- Calibration certificate uploadable
Priority: P1 | Sprint: 5
US-T04: Record Cleaning
As a Maintenance Technician (Nina) or Compounding Technician (Maria), I want to log cleaning activities for rooms and equipment, so that cleaning is documented and room status is current.
Acceptance Criteria:
- Cleaning record: item/room, cleaning agent, method, date/time
- Cleaning agent rotation tracking (prevent pathogen adaptation)
- E-signature: "Cleaned by"
- Room status updated:
cleanedwith clean-hold expiry - Clean-hold expiry: configurable per room (e.g., 24 hours)
- Expired clean-hold room status =
requires_cleaning
Priority: P1 | Sprint: 5
US-T05: Schedule Preventive Maintenance
As a Maintenance Technician (Nina), I want to create recurring preventive maintenance schedules, so that equipment is maintained before failure.
Acceptance Criteria:
- PM schedule: equipment, frequency, task checklist, expected duration
- Auto-generate work orders per schedule
- Work order assigned to technician with due date
- Dashboard shows: upcoming PMs this week/month
- Overdue PMs highlighted and escalated
Priority: P1 | Sprint: 6
US-T06: Complete a Work Order
As a Maintenance Technician (Nina), I want to complete maintenance tasks via a checklist on iPad, so that work is documented with signatures.
Acceptance Criteria:
- Work order displays: equipment, task checklist, parts needed
- Each checklist item: description, pass/fail, notes
- Parts consumed from inventory (optional integration)
- Completion triggers e-signature
- Work order history maintained per equipment
- If issue discovered deviation creation
Priority: P1 | Sprint: 6
US-T07: View Equipment Status Dashboard
As a Maintenance Technician (Nina), I want to see the status of all equipment at a glance, so that I can prioritize calibration and maintenance work.
Acceptance Criteria:
- Table: equipment name, location, status, next calibration, next PM
- Status: active, out_of_calibration, maintenance_required, decommissioned
- Filter by status, location, category
- Calendar view of upcoming calibrations and PMs
- Click equipment full detail page
Priority: P1 | Sprint: 5
US-T08: Decommission Equipment
As a QA Manager (David), I want to decommission equipment that is no longer in use, so that it is excluded from production activities.
Acceptance Criteria:
- Decommission requires: reason, QA Manager approval
- Status transitions to
decommissioned(irreversible) - Decommissioned equipment excluded from batch record equipment selection
- Equipment record preserved for historical reference
- E-signature: "Decommissioned by"
Priority: P2 | Sprint: 7
US-T09: Track Equipment Qualification
As a QA Manager (David), I want to track IQ/OQ/PQ qualification status for critical equipment, so that qualification documentation is current.
Acceptance Criteria:
- Qualification records: IQ (Installation), OQ (Operational), PQ (Performance)
- Each record: date, performer, result, next due
- Upload qualification protocols and reports
- Re-qualification triggers: after maintenance, after move, periodic
- Qualification status visible on equipment dashboard
Priority: P2 | Sprint: 7
US-T10: Cleaning Agent Rotation
As a the system, I want to enforce cleaning agent rotation per room, so that microbial resistance is prevented.
Acceptance Criteria:
- Define cleaning agent rotation schedule per room (e.g., Agent A Agent B Agent A)
- System suggests next agent based on rotation schedule
- Alert if same agent used consecutively beyond allowed count
- Cleaning agent lot tracking for traceability
- Rotation compliance visible on EM dashboard
Priority: P2 | Sprint: 7
US-T11: Water System Monitoring
As a Maintenance Technician (Nina), I want to record water system sampling and test results, so that USP purified water quality is documented.
Acceptance Criteria:
- Sampling points defined per water system
- Test parameters: conductivity, TOC, microbial count, endotoxin
- Results auto-checked against USP limits
- Out-of-spec results trigger alert + potential deviation
- Trend charts for water quality parameters
Priority: P2 | Sprint: 8
US-T12: Equipment Alarm Management
As a Maintenance Technician (Nina), I want to manage equipment alarms and document responses, so that alarm events are tracked and resolved.
Acceptance Criteria:
- Alarm record: equipment, alarm type, severity, timestamp
- Response documentation: action taken, resolution time
- Unresolved alarms escalate after configurable timeout
- Alarm history per equipment
- Future: integration with equipment sensors
Priority: P3 | Sprint: Backlog