Infrastructure and work environment

Product Records Infrastructure and Management Review: infrastructure and work environment. This is part of chapter 31 of the NormaQMS User Guide.

Infrastructure and Work Environment

Open: Equipment > Infrastructure & Work Environment. Typical leads: Quality Manager and Department Manager.

Choose Log record and enter title, kind, and what it covers. Kinds are Infrastructure, Work environment, and Contamination. Complete Coverage and Controls — the controls and their verification — save, then choose Close record when both required areas are complete.

A useful control describes the actual preventive or corrective measure. Verification identifies evidence such as temperature logs, preventive-maintenance records, cleaning checks, or environmental results. A specific FOD occurrence belongs in Product Integrity; an instrument calibration belongs in Equipment & Calibration. Use references to connect them when one exposes an infrastructure issue.

In the user guide

This article is part of chapter 31, "Product Records Infrastructure and Management Review", of the NormaQMS User Guide (NORMA-UG-001), which is under Help > User guide. Chapter numbers in the text refer to that guide. The same chapter also covers: Device and Product Records; Management Review.