Adding Defect References to CAPAs

Linking Defects References

Product Defects can be added to the CAPA record under the Reference tab for CAPAs created against a product.

1. From the CAPA record, Reference tab, Defects section, click the New button.

2. Select the Part . 

3. Optionally, enter the Lot Number (transfers from the Lot information of the selected Part).

4. Optionally, select the standardized Defect Code (if selected, the predefined Defect Failure and Defect Category fields will autopopulate).

5. Defect/Failure  and Defect Category  are autopopulated if Defect Code has been selected (can be modified but not recommended for proper trending). If values are not autopopulated, add the Defect/Failure and Defect Category manually.

6. Enter the Defective Quantity .

7. Enter the No. of Defects (for example: if one Part is found defective, how many Defects were found on that Part?).

8. Optionally, enter the Defect Description.

9. Click the Save button or Save & New for additional Defects.