docs: develop Procedure 07 — Facilities and Environmental Conditions

Full procedure covering facility layout and separation, access
control, utilities, critical environmental parameters with
battery-lab-specific ranges, monitoring and review frequency,
excursion response workflow, housekeeping and contamination control
for trace analysis, and facility change management.

Appendix:
- 07-App-01: Record of Laboratory Environmental Controls (controlled
  areas register, monitoring log, excursion records with impact
  assessment, annual summary)

Co-Authored-By: Claude Opus 4.6 <noreply@anthropic.com>

Author: Pablo Lebed

docs/07-facilities-environment/appendix-01-environmental-controls.md

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+---
+sidebar_position: 1.1
+title: "07.1 Appendix 1 – Record of Laboratory Environmental Controls"
+description: Template for recording environmental parameters, monitoring data, and excursion responses.
+---
+
+# Appendix 1 — Record of Laboratory Environmental Controls
+
+**Parent procedure:** [07 – Facilities and Environmental Conditions](./)
+
+## Purpose
+
+To document the critical environmental parameters for each laboratory area, the acceptable ranges, the monitoring arrangements, and any excursions with their assessment and response.
+
+## Instructions
+
+1. The **Technical Manager** completes **Part A** for each controlled area, defining the parameters and acceptable ranges.
+2. **Analysts** record manual readings in **Part B** or ensure data loggers are functioning for continuous monitoring.
+3. When an excursion is detected, the **Quality Manager** or **Technical Manager** completes **Part C**.
+4. This record is reviewed during management review and internal audit.
+
+---
+
+## Part A — Controlled Areas and Acceptance Criteria
+
+Complete one row per critical parameter per area. Review and update annually or when methods, equipment, or facilities change.
+
+| Area | Parameter | Acceptable range | Basis (method / instrument spec / CRM cert.) | Monitoring method | Monitoring frequency | Review frequency |
+|---|---|---|---|---|---|---|
+| ICP-OES room | Temperature | 20 ± 3 °C | *[Instrument manual ref.]* | Data logger | Continuous | Daily |
+| ICP-OES room | Relative humidity | 30–60% RH | *[Instrument manual ref.]* | Data logger | Continuous | Daily |
+| HPLC room | Temperature | 20 ± 3 °C | *[Column spec / method ref.]* | Data logger | Continuous | Daily |
+| XRD room | Temperature | 20 ± 2 °C | *[Instrument manual ref.]* | Data logger | Continuous | Daily |
+| Balance room | Temperature | 20 ± 2 °C | *[Balance spec / method ref.]* | Data logger | Continuous | Daily |
+| Balance room | Relative humidity | 30–60% RH | *[Balance spec]* | Data logger | Continuous | Daily |
+| Sample preparation | Temperature | 18–28 °C | *[General suitability]* | Manual / data logger | Daily | Weekly |
+| CRM storage (ambient) | Temperature | 15–25 °C | *[CRM certificates]* | Data logger | Continuous | Weekly |
+| CRM storage (refrigerated) | Temperature | 2–8 °C | *[CRM certificates]* | Data logger with alarm | Continuous | Daily |
+| *[Add areas as needed]* | | | | | | |
+
+**Defined by:** *[Technical Manager name]* — **Date:** *[Date]* — **Approved by:** *[Quality Manager name]*
+
+---
+
+## Part B — Environmental Monitoring Log (Manual Readings)
+
+For areas monitored by manual readings. Continuous data logger records are maintained as electronic files referenced below.
+
+| Date | Time | Area | Parameter | Reading | Within range? | Recorded by | Notes |
+|---|---|---|---|---|---|---|---|
+| *[Date]* | *[Time]* | *[Area]* | *[Temp / RH / etc.]* | *[Value + unit]* | ☐ Yes · ☐ No | *[Initials]* | |
+| | | | | | | | |
+| | | | | | | | |
+| | | | | | | | |
+
+### Data Logger File References
+
+| Area | Logger ID | File location / name | Period covered | Downloaded by | Download date |
+|---|---|---|---|---|---|
+| *[Area]* | *[Logger serial / ID]* | *[Path or filename]* | *[From – To]* | *[Initials]* | *[Date]* |
+| | | | | | |
+
+---
+
+## Part C — Excursion Record
+
+Complete one record for each environmental excursion. Attach supporting data (logger printouts, photographs) as needed.
+
+### Excursion details
+
+| Field | Entry |
+|---|---|
+| **Excursion ID** | *[EXC-YYYY-###]* |
+| **Date detected** | *[Date]* |
+| **Detected by** | *[Name]* |
+| **Area affected** | *[Area]* |
+| **Parameter** | *[Temperature / humidity / etc.]* |
+| **Acceptable range** | *[From Part A]* |
+| **Observed value(s)** | *[Value(s) + unit]* |
+| **Duration of excursion** | *[Start time – End time, or estimated duration]* |
+| **Cause** (if known) | *[e.g., HVAC failure, door left open, power outage]* |
+
+### Immediate action taken
+
+| Action | By whom | Date/time |
+|---|---|---|
+| *[e.g., Adjusted thermostat, contacted facilities]* | *[Name]* | *[Date/time]* |
+| | | |
+
+### Impact assessment
+
+| Question | Response |
+|---|---|
+| Were any instruments in use during the excursion? | ☐ Yes · ☐ No — If yes, list: *[Instruments]* |
+| Were any samples being analyzed during the excursion? | ☐ Yes · ☐ No — If yes, list: *[Sample IDs / batches]* |
+| Were any results reported during or after the excursion period? | ☐ Yes · ☐ No — If yes, list: *[Report IDs]* |
+| Do QC data from the period show anomalies? | ☐ Yes · ☐ No · ☐ Not applicable |
+| Is the affected method sensitive to this parameter at the observed magnitude? | ☐ Yes · ☐ No · ☐ Uncertain |
+
+### Decision
+
+| Decision | Detail |
+|---|---|
+| ☐ No impact on results | Justification: *[Enter]* |
+| ☐ Results potentially affected — re-analysis required | Samples to re-analyze: *[Enter]* |
+| ☐ Results potentially affected — customer notification required | Reports affected: *[Enter]* |
+| ☐ Corrective action initiated | CAR reference: *[Enter]* |
+
+### Signatures
+
+| Role | Name | Signature | Date |
+|---|---|---|---|
+| **Assessed by** (Technical Manager) | *[Enter]* | | *[Date]* |
+| **Reviewed by** (Quality Manager) | *[Enter]* | | *[Date]* |
+
+---
+
+## Part D — Annual Summary
+
+Completed annually for management review input.
+
+| Period | Total excursions | By area (breakdown) | Recurring causes | Actions taken | Status |
+|---|---|---|---|---|---|
+| *[Year]* | *[Count]* | *[e.g., ICP room: 2, Balance room: 1]* | *[e.g., HVAC aging]* | *[e.g., HVAC upgrade scheduled]* | ☐ Open · ☐ Closed |
+
+**Reviewed by:** *[Quality Manager]* — **Date:** *[Date]*
+
+:::tip Adapt this template
+Adjust areas, parameters, and ranges to match your laboratory. If all monitoring is via continuous data loggers, Part B may be minimal — but retain it for areas where manual readings supplement or replace loggers (e.g., temporary setups, field work).
+:::