This is a ready-to-use, task-level work instruction for the specific job of building the data trail behind an environmental monitoring (EM) excursion, as distinct from the full investigation, root cause, and CAPA record. It sits under the parent SOP <<FILL: EM excursion investigation SOP-ID, e.g. SOP-QC-028>> and should be used alongside a full excursion investigation form. Replace every <<FILL: ...>> placeholder. A filled specimen follows. This is general guidance to adapt and verify, not legal or regulatory advice.
Header
| Field | Entry |
|---|---|
| Work instruction number | <<FILL: WI-ID, e.g. WI-QC-028-01>> |
| Parent SOP | <<FILL: EM excursion investigation SOP-ID>> |
| Version / effective date | <<FILL>> |
| Applies to | <<FILL: EM analysts, micro lab supervisors, QA>> |
When to use this work instruction
Use it the moment any EM result crosses an alert level, an action level, any Grade A recovery, or a non-viable particle limit. It builds the contemporaneous evidence trail that the full investigation (root cause, CAPA, batch impact) will depend on; a strong investigation cannot be built on a data trail assembled from memory afterward.
Tools and materials
- The EM data sheet or electronic record, and the site’s EM sampling plan/map.
- A camera or imaging device approved for plate photography.
- The deviation system or logbook per
<<FILL: SOP-ID for deviation management>>. - The isolate chain-of-custody log per
<<FILL: form/log ID>>.
Task A: capture the detection moment
| Step | Action | Acceptance for this step |
|---|---|---|
| A1 | At the moment the excursion is recognized, note the date, time, site ID, method, and result directly on the EM data sheet. | Entry is contemporaneous, not written up later from memory. |
| A2 | Record the operation in progress at that site at the time of detection (fill in progress, at rest, cleaning cycle). | The operational context is captured, not reconstructed afterward. |
| A3 | Do not discard or move the plate before step B1. | Physical evidence is preserved for imaging and potential re-examination. |
Task B: retain and image the physical evidence
| Step | Action | Acceptance for this step |
|---|---|---|
| B1 | Photograph the plate with its identifier and location label visible in frame. | Image ties unambiguously to the plate, sample, date, and analyst. |
| B2 | Name and store the image per <<FILL: imaging/storage procedure>> so it is retrievable by sample ID. | Image is findable weeks later without relying on memory of the filename. |
| B3 | Hold the physical plate for the defined retention window before disposal. | A re-read or challenge remains possible while the plate is still viable evidence. |
Task C: open the deviation and notify
| Step | Action | Acceptance for this step |
|---|---|---|
| C1 | Open a deviation the same working day, referencing the EM data sheet entry from Task A. | Deviation number exists and is cross-referenced on the EM record within 24 hours. |
| C2 | Notify the EM program owner and QA the same working day, with date and time of notification recorded. | Notification is evidenced, not asserted after the fact. |
Task D: build the isolate chain of custody
| Step | Action | Acceptance for this step |
|---|---|---|
| D1 | Assign a unique isolate identifier to any recovered colony requiring identification, on the same record as the excursion. | The isolate number is traceable back to the specific plate and sample. |
| D2 | Record a preliminary Gram stain or morphological observation contemporaneously, before the isolate is subcultured or shipped. | The preliminary call is dated and tied to the isolate number. |
| D3 | Log every physical transfer of the isolate (to an internal ID group or an outside laboratory) with date, time, and signatures on release and receipt. | No gap exists between “isolate recovered” and “isolate in the identifying party’s hands.” |
| D4 | Record the final identification result against the isolate number, and confirm the trace back to the originating plate. | A reviewer can follow the number from plate to final species with no missing link. |
Task E: assemble the reconciliation package
| Step | Action | Acceptance for this step |
|---|---|---|
| E1 | Pull the EM sampling plan for the affected period and confirm every scheduled site for that session is accounted for (sampled and recorded, or a documented reason it was not). | No scheduled site is silently missing from the record. |
| E2 | Pull the incubator’s actual temperature record for the incubation period and link it to the affected plates. | Incubation conditions are evidenced, not asserted from a setpoint label. |
| E3 | Compile the reconciliation package (data sheet, image, deviation number, custody log, identification result, incubator record) into the investigation file. | The full data trail is in one place before root cause analysis begins. |
What to do if you are unsure
If a plate appears to have been mishandled, if an image is missing for a result that should have been imaged, or if the isolate’s custody chain has a gap, stop and notify your supervisor and Quality Assurance the same working day. Do not backfill a missing step to make the record look complete; a documented gap with a stated reason is defensible, and a silently closed gap is not.
Filled specimen
Task A. Detected 2026-07-14 15:40 by R. Nazarov (EM operator). Suite FS-2, Grade A critical zone, site A-01. Method: settle plate. Result: 2 CFU. Operation in progress: fill of batch BX-2607-009.
Task B. Plate photographed 15:42, image filed as EM-2026-0714-A01-settle.jpg, tied to the EM record. Plate held in the micro lab retention fridge, disposal scheduled 2026-07-17.
Task C. Deviation DEV-2026-0301 opened 16:05, referenced on the EM data sheet. EM owner (L. Farida) and QA (P. Odom) notified 2026-07-14 16:10.
Task D. Isolate ISO-2026-0642 assigned at recovery. Preliminary Gram stain recorded 2026-07-14 (Gram-positive cocci). Custody log shows release to the identification lab 2026-07-15 09:00, signed by R. Nazarov, received 2026-07-15 09:20, signed by the identification lab technician. Final identification 2026-07-18: Staphylococcus hominis, tied to ISO-2026-0642, traced back to site A-01 settle plate with no gap.
Task E. EM plan for the shift confirmed all 14 scheduled sites sampled and recorded; site A-01’s incubator datalogger showed 31.2 to 32.6 C across the incubation window, linked to the plate. Reconciliation package assembled and handed to the investigation team the same week, with every element traceable and dated.
Common mistakes this work instruction prevents
- The EM data sheet completed from memory after the analyst leaves the cleanroom, rather than at the point of detection.
- A Grade A recovery photographed days later, after the plate has already degraded or been discarded.
- An isolate sent for identification with no custody log, so a “clean” result cannot be traced back to the plate it came from.
- A reconciliation package assembled only after root cause analysis begins, so early investigative decisions were made on an incomplete data trail.
How to adapt
- Set your WI number and parent SOP, and confirm the deviation, imaging, and custody-log references point to your real procedures.
- If your site uses a single combined EM excursion form (see the paired Form: Environmental Monitoring Excursion Investigation for a full example), align this work instruction’s task boundaries to that form’s sections so nothing is duplicated or dropped between the two documents.
- Confirm the retention window and imaging triggers against your site’s actual imaging and retention procedure.