Based on the commment gives in the report, update ...

I’ll update the investigation report directly in the Word file, using the embedded reviewer comments as the basis. I’ll also tighten the logic between findings → 5-Why → root cause → CAPA, and keep the report’s existing format and terminology intact.

I found 27 reviewer comments. Several are already marked “updated,” but there are still substantive gaps—especially the date format, the SOP/training linkage, the interview wording, the 18-instrument impact, and the CAPA logic. I’m treating the missing SAP e-mail as a contributing control gap, not the primary root cause, because the report evidence points more directly to unclear/unharmonized TECO responsibility plus lack of training.

I’ve also found two internal inconsistencies that affect the investigation conclusion: the report calls the event “isolated” even though multiple contemporaneous SAP gaps were found, and it treats the missing e-mail as the main reminder for TECO even though the reviewer clarifies that one e-mail was sent before calibration and another only after TECO completion. I’m correcting both so the CAPAs address the actual failure mechanism rather than just the symptom.

The substantive edits are now in place and the reviewer comments have been incorporated into a clean copy. I’m doing the required page-by-page render check now, especially around the revised 5-Why, root-cause/CAPA sections, and expanded CAPA tables where layout problems are most likely.

The revised 5-Why now renders cleanly, and I removed the reviewer arrow/markup shapes that were floating over the impact/root-cause page. The CAPA tables also render without clipping; I’m finishing the remaining page checks for tables, screenshots, and page breaks.

I caught one layout/data corruption during the full-page check: an investigation-plan sentence had landed in the SAP “Type” column, which stretched the order-history table across a page. I’m correcting that now and moving the wording to the intended investigation-plan row before the final verification.

The order-history table is now corrected and the report is back to a normal flow. The remaining review pages are rendering cleanly so far, including the 18-record table and the SOP comparison.

The content/layout review is complete. I’m removing the last pieces of reviewer-style formatting (a yellow highlight, one red training date, and a red bullet used as markup) so the delivered file is a clean approval-ready report rather than a commented working copy.

I updated the investigation report based on the reviewer comments and completed a full document/layout check.

The major corrections include: reframing the root cause as the procedural + training control gap because SOP/EN/168 and SOP/DT/002 were not harmonized and responsible personnel were not trained; treating the missing S/4HANA e-mail notification as a contributing/detection-control gap rather than the primary root cause; revising the 5-Why analysis; correcting the 18 SAP records/17 unique instrument IDs logic; strengthening the impact assessment; and expanding the corrective/preventive actions with ownership, reconciliation controls, master-data/planner remediation, training, and CAPA effectiveness verification. These changes align with the investigation evidence regarding SOP responsibility gaps and missing training. (Commented Investigation_Report_DR_PL3_26_022 (2) (1).docx) (Commented Investigation_Report_DR_PL3_26_022 (2) (1).docx)

I also corrected the e-mail logic because the report confirms that the notification functionality was discontinued after migration, while the core PM04 process remained available. (Commented Investigation_Report_DR_PL3_26_022 (2) (1).docx) All reviewer comments/markup have been removed from the final copy.

One factual item was not invented: the SAP maintenance notification number for the equipment shown as “Under maintenance” was not provided in the source report, so the revised report requires it to be documented in Annexure-1. (Commented Investigation_Report_DR_PL3_26_022 (2) (1).docx)

Download the fully updated Investigation Report