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.

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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]

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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]

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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]

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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]

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).