Data Profile for This Category
Data for this category comes from design history files, device and material batch ledgers, MES systems, clean environment monitoring equipment, sterilization equipment, and inspection and calibration systems. Daily documentation includes production process specifications, batch production records, clean zone environment records, sterilization batch records, inspection reports, software version records, adverse event and traceability materials. Data is updated synchronously for each production batch or when each device is produced. Clean environment data is updated per a fixed monitoring plan. Document fields include unique device identification, sterilization temperature and duration, clean zone differential pressure values, batch numbers, and other items, with corresponding physical or measurement units attached.
Constraints on Workflow Orchestration
Data sources for this category are scattered and have diverse formats. They include structured ledgers, numerical monitoring data, and unstructured documents. Workflows must support multi-source data access and format adaptation. Data update frequency changes with production batches or environmental monitoring plans. Workflows must support batch-triggered or scheduled synchronous update mechanisms. Document fields have strict measurement or identification units attached. Workflows must include built-in field compliance verification steps to prevent unit mismatches or missing identifications. Additionally, due to the high product risk level, the cross-review link in workflows must have a mandatory approval node that cannot be skipped.
Configuration Settings
The following configurations are developed based on the workflow function of FastGPT v4.17.0.
| Configuration Item | Recommended Setting | Rationale |
|---|---|---|
| Maximum Context | Top 10-15 historical records | Documents and production records for this category are lengthy. Excessive context consumes processing resources. Batch review scenarios do not require excessive historical data. |
| Single Search Limit | Top 8 recall results | Must cover multiple document types including production processes, sterilization parameters, and clean environment conditions. 8 results balance recall coverage and processing efficiency. |
variables | Bind batch number and clean zone number variables | Reviews for this category must associate exclusive data for the corresponding production batch. Variables enable precise matching of various records from the same batch. |
| Node Timeout Threshold | 600 seconds | Must read historical data from sterilization equipment and clean environment monitors. Some device data retrieval requires long wait times. 600 seconds covers most scenarios. |
nodeId | Bind node IDs in the order of review links | Cross-review requires verifying documents in the order of the process specification. Fixed node IDs ensure stable workflow execution logic. |
Three Common Configuration Mistakes
- Phenomenon: A timeout prompt appears during workflow execution, with no clear error log. Cause: A reasonable node timeout threshold is not set, or the timeout duration is not adjusted for multi-source data retrieval links. This category requires reading data from sterilization and clean environment equipment. The default timeout duration is insufficient to cover the data loading process.
- Phenomenon: Conversation nodes in the workflow cannot retain multi-turn context, only supporting single-turn interaction. Cause: The maximum context parameter is not configured correctly, or the context count is incorrectly limited to 0. This causes each node execution to only load the current request data, unable to continue the conversation history.
- Phenomenon: A page jump node added to the workflow fails to trigger normally. Cause: The
nodeIdparameter for the corresponding page is not bound, or the trigger condition and the association logic with the current review link are not configured. This causes the jump node to fail to match the execution timing.
How to Confirm Proper Configuration
- Check the workflow's data source binding nodes. Confirm that all required data sources for this category are associated, including design history files, MES systems, and sterilization equipment data.
- Verify the
variablesparameter binding content. Confirm that exclusive identification variables such as batch number and clean zone number are included. - Validate the node timeout threshold configuration. Confirm that the value matches the actual data retrieval requirements of this category. Test trigger conditions by simulating a single-batch review process.
- Check multi-turn conversation related configurations. Confirm that the context parameter value logic matches the review interaction scenario of this category.
The values provided are common starting points and should be measured against the reader's own samples.