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Protocol · VAL-P08

Alarm and Excursion Management Procedure

Alarm configuration, response, excursion assessment, product impact and CAPA.

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Purpose

To define how alarm limits and delays for temperature-controlled equipment and areas are set and verified, how alarms are responded to, escalated and documented, and how temperature excursions are investigated, assessed for product impact, dispositioned and closed, so that product quality is protected and every excursion is handled consistently and traceably.

What is inside

13 sections, about 3 pages when printed.

  1. 1. Purpose
  2. 2. Scope
  3. 3. Responsibilities
  4. 4. References
  5. 5. Definitions
  6. 6. Setting alarm limits and delays
  7. 7. Alarm response
  8. 8. Excursion investigation and product impact assessment
  9. 9. Records
  10. Deviations
  11. Data integrity
  12. Report
  13. Approval

How to complete it

  1. 1.Define the excursion: equipment / area, points affected, start and end times (from EMS data, not the alarm time), maximum / minimum value, duration outside the storage limit, MKT over the excursion period, and the product(s) and batches present (from inventory records).
  2. 2.Determine the cause: door, loading, equipment failure, power, HVAC, sensor error (verify with a reference), human error; attach evidence (EMS trend, engineering report).
  3. 3.Assess product impact for each product / batch: compare the excursion (temperature, duration, cumulative history of the batch) with the manufacturer's or marketing authorisation holder's stability data and excursion allowances; obtain the manufacturer's written assessment where the site has no data; consider cumulative excursions for the batch; consider the monitoring uncertainty (add it to the observed deviation when the assessment is marginal).
  4. 4.Decide disposition: release (excursion within allowance), quarantine pending manufacturer assessment, additional testing, or reject / destroy; record the decision and the approver (QA / Qualified Person as applicable).
  5. 5.Determine corrective and preventive actions (SOP-05): repair, alarm limit review, procedure or training change, backup capacity, requalification (VAL-P10) where the equipment's performance is in doubt.
  6. 6.Close the investigation within [30 days] with QA approval; log in the excursion register; trend excursions by equipment and cause quarterly and report at management / quality review.

Before you use it

  • Replace every square-bracket token, starting with [LABORATORY NAME], [ADDRESS] and [EFFECTIVE DATE]. The full token list is in GD-01 Read Me First.
  • Have the content technically reviewed against how your laboratory actually works, then approved by the responsible manager before it becomes a controlled document.
  • Update the Word fields after editing so the table of contents and page numbers are correct: select all, then press F9.
  • Record the document in your own document register and set its review date.

Related documents

This is an original template published by ValiTrac. It does not reproduce the text of ISO/IEC 17025 or of any accreditation body publication, and it does not by itself confer or guarantee accreditation. Customise, review and approve it before use.