Appendix 3 — Equipment Maintenance and Fault Log
Parent procedure: 08 – Equipment Maintenance, Calibration and Verification
Purpose
To document all maintenance activities (preventive and corrective), equipment faults, repairs, and out-of-service periods. This log provides the historical record needed for trend analysis, root cause investigation, and decisions about calibration intervals, equipment replacement, and resource planning.
Instructions
- Analysts record routine preventive maintenance activities as they are performed (Part A).
- When a fault occurs, the analyst or Technical Manager completes a fault and repair record (Part B).
- Out-of-tolerance findings and their impact assessments are recorded in Part C.
- The Quality Manager reviews the log periodically and prepares an annual summary (Part D) for management review.
- One log is maintained per major item of equipment. Supporting items (pipettes, loggers) may be grouped.
Equipment identification
| Field | Entry |
|---|---|
| Equipment ID | [e.g., AI-001] |
| Description | [e.g., ICP-OES spectrometer] |
| Manufacturer / Model | [Enter] |
| Serial number | [Enter] |
| Location | [Enter] |
Part A — Preventive Maintenance Record
| Date | Maintenance activity performed | Performed by | Next scheduled | Notes |
|---|---|---|---|---|
| [Date] | [e.g., Cleaned torch, replaced peristaltic pump tubing, inspected nebulizer] | [Name / initials] | [Date] | [e.g., Tubing showed wear; replaced ahead of schedule] |
| [Date] | [e.g., Annual manufacturer preventive maintenance — service report attached] | [Service engineer name / company] | [Date] | [Service report ref.: SR-YYYY-###] |
Part B — Fault and Repair Record
Complete one record per fault event.
Fault report
| Field | Entry |
|---|---|
| Fault ID | [FLT-YYYY-###] |
| Date fault detected | [Date] |
| Detected by | [Name] |
| Description of fault | [What was observed — e.g., ICP-OES plasma would not ignite; error code displayed; unstable signal on Mn 257.610 nm line] |
| Equipment placed out of service | ☐ Yes — Date: [Date] · ☐ No — Justification: [Enter] |
| Samples / batches in progress at time of fault | [List sample IDs or batch numbers, or "None"] |
Diagnosis and repair
| Field | Entry |
|---|---|
| Root cause (if determined) | [e.g., Worn peristaltic pump tubing causing unstable sample uptake; nebulizer partially blocked] |
| Repair action taken | [e.g., Replaced pump tubing, ultrasonically cleaned nebulizer, ran torch alignment] |
| Repaired by | [Name / company] |
| Date repair completed | [Date] |
| Spare parts used | [e.g., Peristaltic pump tubing P/N xxxx, qty 1] |
| External service report reference | [If applicable — report number, attach copy] |
Post-repair verification
| Field | Entry |
|---|---|
| Verification performed | [e.g., Full wavelength calibration, QC check standard recovery, sensitivity check] |
| Verification results | [e.g., All elements within ±3% of certified values; sensitivity restored to specification] |
| Meets acceptance criteria? | ☐ Yes · ☐ No — Action: [Enter] |
| Authorized for return to service by | [Technical Manager name] |
| Date returned to service | [Date] |
| Total out-of-service time | [e.g., 2 days] |
Impact assessment (if equipment was in use at time of fault)
| Field | Entry |
|---|---|
| Period potentially affected | [From last satisfactory QC check to fault detection — e.g., 2026-03-15 to 2026-03-17] |
| Results produced during affected period | [List report / sample IDs, or "None — fault detected before sample runs"] |
| Assessment of impact on results | [e.g., QC check standards from 2026-03-15 and 2026-03-16 were within acceptance criteria, indicating the fault developed after sample runs on 2026-03-16. No impact on reported results.] |
| Decision | ☐ No impact — no further action · ☐ Re-analysis required (samples: [list]) · ☐ Customer notification required (reports: [list]) · ☐ Nonconformity raised (NCR ref.: [ref.]) |
| Assessed by | [Technical Manager name] — [Date] |
| Reviewed by | [Quality Manager name] — [Date] |
Part C — Out-of-Tolerance Record
Complete when calibration or verification results exceed acceptance criteria ("as found" out of tolerance).
| Field | Entry |
|---|---|
| Event ID | [OOT-YYYY-###] |
| Date of finding | [Date] |
| Calibration / verification type | [e.g., Annual external balance calibration, monthly internal weight check] |
| Parameter out of tolerance | [e.g., Balance reading at 100 g test point] |
| Acceptance criterion | [e.g., ≤ ±0.2 mg] |
| As-found result | [e.g., +0.4 mg deviation at 100 g] |
| As-left result (after adjustment) | [e.g., +0.05 mg deviation at 100 g] |
| Affected period | [From last satisfactory calibration/check to this finding] |
| Results produced during affected period | [List or summary] |
| Impact assessment | [e.g., 0.4 mg error on typical 0.5 g sample = 0.08% mass error, within method uncertainty of ±0.5%. No impact on reported results.] |
| Decision | ☐ No impact on results · ☐ Re-analysis required · ☐ Customer notification required · ☐ Nonconformity raised |
| Corrective action | [e.g., Calibration interval shortened from 12 to 6 months; monthly verification frequency increased to weekly] |
| Assessed by | [Technical Manager] — [Date] |
| Reviewed by | [Quality Manager] — [Date] |
Part D — Annual Equipment Performance Summary
Completed annually for management review input. Summarizes maintenance, faults, and calibration performance for this item of equipment.
| Metric | Period: [Year] |
|---|---|
| Total faults reported | [Count] |
| Total out-of-service days | [Days] |
| Out-of-tolerance findings | [Count] |
| Results affected by OOT findings | [Count, or "None"] |
| Customer notifications issued | [Count, or "None"] |
| Preventive maintenance completed on schedule? | ☐ Yes · ☐ No — Details: [Enter] |
| Calibration interval changes | [Any changes made and justification] |
| Recommended actions for next period | [e.g., Schedule manufacturer service, plan replacement, adjust interval] |
| Overall equipment status assessment | ☐ Satisfactory · ☐ Monitor · ☐ Replacement recommended |
Prepared by: [Quality Manager] — Date: [Date]
Reviewed by: [Technical Manager] — Date: [Date]
:::tip Adapt this template Maintain one log per major instrument. For groups of similar items (e.g., all pipettes, all data loggers), a combined log is acceptable as long as each item is individually identified. If you use a LIMS or CMMS (Computerized Maintenance Management System), these records can be generated from that system — but ensure controlled, reviewable versions are available for audit. :::