METADATA
last updated: 2026-03-16 RT
file_name: _context-commentary_guides-qms-sops.md
category: guides
subcategory: qms-sops
gfile_url: https://docs.google.com/document/d/1S2HbDM9dEC4xZ4GBZoF9V0LBe0gpqWat_mO1szrpR6c
words: 585
tokens: 818


CONTENT

## Context
The `guides/qms-sops` subcategory contains seven files that comprise FloodLAMP's formal Quality Management System standard operating procedures for its colorimetric LAMP-based COVID-19 surveillance testing operations. These SOPs were designed as practical, field-ready documents. Most were printed and kept in folders or clipboard containers at testing sites for staff to reference and fill out during routine testing.

The collection covers the full testing workflow: reagent preparation (`SOP-101-A_2 1X Inactivation Saline Solution Prep - Table Form`, `SOP-102-A_2 Reaction Mix Prep - Table Form`), the core amplification assay procedure (`SOP-103-A_1 Amplification - Run Form`), training protocols for new operators (`SOP-104-A_1 Test Training - Run Form`), quick-reference visual aids (`SOP-105-A_1 QuickColor Test Diagrams` and `SOP-105-B_1 QuickColor Test Signage`), and logistics (`SOP-030-A_1 Shipping - Run Form`).

The `SOP-103-A_1 Amplification - Run Form` served as the central operational document — the form staff completed for each testing run, which was then scanned to create the Run Form Report (RFR) and entered into a Google Form for record-keeping. The training run form (SOP-104) is the most detailed document in the collection, walking new operators through the complete workflow with specific contamination-control procedures, handling rules, and timing requirements.

Each SOP follows a consistent format with document numbers, effective dates, versioning, and write-in fields for traceability, including lot numbers, reagent IDs, operator names, and timestamps. This structure reflected FloodLAMP's approach to maintaining quality documentation while operating under surveillance testing guidance rather than FDA-authorized clinical use.

Related materials can be found in the `guides/test-training` subcategory (additional training documentation), the `guides/test-validation` subcategory (assay validation work), and the `guides/operations` subcategory (broader operational workflows and site management).


## Commentary
These SOPs originated from templates provided by a quality systems consultant. We considered adopting Greenlight Guru, a common quality management software package used in the medical device and diagnostics industry, and worked with a consultant who supported its implementation. Ultimately, I think we wisely decided it was not needed given our size, as it would have been overkill for a small operation like ours.

There were primarily two reasons for building a formal QMS. The first was the practical need to understand and control changes to our protocols and files, since we were distributing them to multiple pilot sites. The second was that we applied multiple times for FDA authorization — a process that extended into October 2021, when we received what was our last denial and closure of our submissions. The IRB work and QMS formalization in 2021 were undertaken with the plan of continuing to pursue FDA authorization.

The forms themselves were generally effective in practice. They served their purpose, and we were happy with where they ended up. Most sites used them without complaint or negative feedback. Having the full set of SOPs in place prior to the initial training at a pilot site was helpful. Sites that started with the forms adopted them readily, whereas sites that were already operating when the forms were developed were more reluctant to incorporate them, though there is uncertainty about this. One part of the Amplification Run Form that was not frequently used was the lookup map on the second page. These were infrequently used overall and some pilot sites, like Abrome, put participant initials rather than tube IDs into that form. A tool that would have been particularly useful, and this cross-references to the `guides/software` subcategory, was a way to intake tubes and register their position in the custom tube racks at the same time. This is discussed further in the software subcategory context and commentary (`guides/software/_context-commentary_guides-software.md`).