Case Study · Fictional teaching example

RAG procedure reviewer: a citation can still be wrong

A retrieval-augmented generation assistant answers questions using an approved procedure collection. It helps users locate and interpret relevant passages. Users must verify the current controlled source before taking a quality action. The assistant cannot approve exceptions or authorize manufacturing work.

Author
Sandip Thorat
Published
12 September 2026
Last reviewed
12 September 2026
Version
1.0
Content type
Practitioner guidance
Primary references
See related regulations, guidance, and approved procedures

Standard case study record

Scope and decision fields

Read these fields before the detailed worked case. All organizations, identifiers, test outcomes, and decisions are fictional teaching material.

GxP Assessment
The assistant supports review of validation records but cannot approve or release them. Parsing, retrieval, findings, source display, and reviewer disposition can affect Quality decisions.
Change or Issue
Retrieval-augmented generation may omit a relevant passage, select an obsolete source, or present a plausible but unsupported finding.
Functions Affected
  • Document parsing and retrieval
  • Potential-finding generation
  • Source citation and version display
  • Reviewer disposition and export
Potential Impact
A qualified reviewer may miss a material validation gap or initiate unnecessary remediation based on an incorrect potential finding.
Deviations / Known Issues
Performance for scanned tables and handwritten initials remains uncertain in the fictional study. Those records remain manual-review only.

Situation and intended use

A retrieval-augmented generation assistant answers questions using an approved procedure collection. It helps users locate and interpret relevant passages. Users must verify the current controlled source before taking a quality action. The assistant cannot approve exceptions or authorize manufacturing work.

Failure paths

It retrieves an obsolete revision, quotes a passage from the wrong site, omits an exception, invents a source, combines incompatible instructions, or obeys malicious instructions embedded in a retrieved document. A source can be authentic yet irrelevant to the user’s situation.

Separate retrieval from answer evaluation

First check whether the relevant authorized passage is available and retrieved. Then check whether the answer accurately represents it. Finally check whether the user recognizes limits and acts correctly. A combined score can hide which stage failed.

Worked challenge set

Use a current procedure question, a superseded-version question, two similarly named site procedures, a question with insufficient information, a conflicting-source question, and a document containing instruction-like text that the assistant must treat as content rather than authority.

Completed test extract — fictional: “RAG-T14 asks about a process outside the available approved corpus. The assistant states that it cannot support an answer from the available sources and directs the user to the controlled process owner. It does not manufacture a procedure reference.”

Worked outcome

The assistant cites real passages but sometimes selects an obsolete procedure. The pilot remains restricted while source filtering and version handling are corrected and retested. An impressive answer style does not resolve incorrect source selection.

Monitoring and reassessment

Track unsupported answers, wrong-source findings, source refresh failures, access issues, and user overrides. Reassess changes to documents, chunking, retrieval, prompts, models, and access rules.

Challenge: All citations open correctly. Is groundedness established?

Worked answer: No. Check whether each source supports the specific claim and applies to the question’s version, site, product, and process.