QC — Lot Setup (define control lots and target ranges)

Use the Lot Setup form to add or edit control lots used in quality control. Lots capture the lot number, effective/expiration dates, and (optionally) target ranges so QC results post to the correct lot and are evaluated properly.

What a QC Lot represents

• A specific manufactured lot of a control material (e.g., Level 1, Level 2) with defined start/end dates.
• The anchor for targets/ranges (mean, SD, acceptable limits) applied during QC evaluation.
• The linkage point to QC Controls so instruments and manual entries attribute results to the correct lot.

What you can configure

• Lot Type: Numeric (quantitative) or Alpha (qualitative) format (choose via radio buttons)
• Effective and Expiration dates (controls when the lot is valid for use)
• Associations:
  • QC Controls linked to this lot
  • Ranges/targets per test/control (mean, SD, acceptable limits, units)
• Comments/notes (e.g., manufacturer insert references, storage conditions)

📘 Instructions: Add or edit a QC Lot

1. Click QC.
2. Click Lot Setup.
3. Enter the required information (asterisked fields).
   • Lot Type: Select Numeric or Alpha.
   • Dates: Use the date picker to set Effective Date and Expiration Date.
4. Click Add.
5. Use the advanced buttons to assign:
   • QC Controls (link this lot to the appropriate control definitions)
   • Ranges (enter targets such as mean, SD, acceptable limits by test/control)
   • Comments (optional notes or instructions)
6. Click Update to save.

Ensure your QC Controls (and any related Tests/Instruments) exist before assigning them to a Lot.

Best practices

• Enter ranges from the manufacturer insert (and your lab-validated adjustments) before first use.
• Align lot Effective Date with the validation go-live; set Expiration per insert and local policy.
• Deactivate or let lots expire to prevent accidental selection after expiration.
• Create separate lots per control level (e.g., L1, L2) to keep trending clear.
• If multiple instruments use different evaluation limits, document this in Comments or define instrument-specific ranges (if supported).
• Standardize lot naming/notes (e.g., “Vendor Control L1 — Lot 12345 — exp 2026-03-31”) for quick identification.

Troubleshooting

• Lot not selectable during QC entry: Confirm it’s Active, within effective/expiration dates, and linked to the correct QC Control; click Update after changes.
• Ranges not applying or flags missing: Verify ranges were added to the correct test/control and units match.
• Wrong lot type (alpha vs numeric): Edit the lot to match the printed lot format to avoid confusion and search issues.
• Posting to an expired lot: Adjust dates only if compliant with policy, otherwise create a new lot and relink.