What Data for This Category Looks Like
Data sources for this category include design history files, device and material batch records, MES systems, clean environment monitoring equipment, sterilization equipment, and inspection and calibration systems. Daily documentation covers production process specifications, batch production records, clean zone environment records, sterilization batch records, inspection reports, software version records, and adverse event traceability materials. Data updates are performed per product batch or per device. Clean environment monitoring updates follow a fixed schedule. Document fields include unique device identification, material batch numbers, sterilization temperature and duration, clean zone temperature and humidity, software version numbers, and some fields must match the traceability format required for medical device registration.
Constraints on the Citation Sources and Traceability Process
Data for this category is scattered across multiple types of systems and documents. Citation and traceability require cross-referencing multiple data sources including design, production, and inspection workflows. High-frequency updates per batch or fixed schedule require precise matching of core fields such as batch numbers and unique device identification during citation. Documents must meet compliance requirements for medical device traceability. Cited content must directly correspond to specific production batches or environmental monitoring nodes. Field units and formats must strictly match registration materials. Citation processes must verify field consistency to avoid incompatible cross-batch citation content. Incorrect traceability may lead to product recalls or patient harm. Precision and traceability of citation sources must be ensured.
How to Configure Settings
| Configuration Item | Recommended Setting | Rationale |
|---|---|---|
| Similarity Threshold | 0.7–0.9 | Matches the term density of specialized medical device documentation, filters general documents unrelated to current assembly reviews |
quoteMaxToken | 800–1200 token | Covers core traceability fields of a single batch production record or sterilization batch record, avoids truncating critical batch information |
| Single Search Limit | Top 6 results | Matches the number of documents across processes, inspection, sterilization and other categories involved in single-batch production, ensures full coverage of data across all links |
responseData | Enabled | Only returns data sources directly related to the current review task, filters redundant historical batch data |
| Context Cache Duration | 24–48 hours | Matches the data update cycle of this category per batch, avoids loading expired environmental monitoring or sterilization records |
| Reranking | Enabled | Prioritizes documents directly related to the current technical review task |
| Citation Source Display | Enabled | Displays unique identifiers and batch information of source documents in the standard format of FastGPT v4.17.0 |
detail | Enabled | Displays complete field details of cited documents to facilitate verification of traceability information |
Three Common Errors
- Phenomenon: After setting the similarity threshold to 1, a large number of unrelated clean zone records or sterilization records still appear. Reason: The threshold was not adjusted with consideration of specialized term weights for medical device documents. Pure literal matching cannot distinguish between documents from the same batch and cross-batch content.
- Phenomenon: Key unique device identification fields are missing from citation sources. Reason: The
quoteMaxTokenvalue was set too small, truncating the tail of documents containing identification information and resulting in lost traceability fields. - Phenomenon: Unable to link to sterilization equipment calibration records in Notion format. Reason: The knowledge base was not configured to support link synchronization for external non-standard web documents, and only supports preset local documents or general web links.
How to Confirm Configuration Is Successful
- Manually enter review questions for a single batch production, check if cited documents in returned results match the batch scope of the current task, adjust the similarity threshold to control relevance.
- Review the displayed citation source content, confirm that core traceability fields such as unique device identification and batch number are included, adjust
quoteMaxTokento ensure complete display of fields. - Import multiple types of documents from the same batch, verify that the single search limit covers the required number of documents to avoid missing critical data.
- Test the citation traceability path, confirm that the displayed source information can directly locate the corresponding production batch or environmental monitoring node.
The values provided are common starting points and should be measured against the reader's own samples.