rivariva
Registered
Contract medical device manufacturing company here:
-The customer ordered ×××× product
-The customer received ×××× product through lot number yyyy
- 6 products ×××× in one box is how it was packaged
- The product itself has marking and was also packaged in a pouch before packing it to the box. Meaning, Pouched product was being packed in the box.
- 1 pouched product in a box of 6 pouched product had incorrect part number on the pouch but correct part in the pouch. Pouch was mislabeled.
My thoughts after an initial investigation is :
- Line clearance was not followed well
- The inspection plan was not followed well
I did observe from the the Part Specification that the incorrect part number was directly under the correct part number which makes me believe that may be the incorrect part number was printed in advance?
What could be a better corrective action for this? Other than training operator on line clearance and Quality Inspection. Does it help to make the inspection of the label on the inspection plan where it points to the part number area of the label 100%?
-The customer ordered ×××× product
-The customer received ×××× product through lot number yyyy
- 6 products ×××× in one box is how it was packaged
- The product itself has marking and was also packaged in a pouch before packing it to the box. Meaning, Pouched product was being packed in the box.
- 1 pouched product in a box of 6 pouched product had incorrect part number on the pouch but correct part in the pouch. Pouch was mislabeled.
My thoughts after an initial investigation is :
- Line clearance was not followed well
- The inspection plan was not followed well
I did observe from the the Part Specification that the incorrect part number was directly under the correct part number which makes me believe that may be the incorrect part number was printed in advance?
What could be a better corrective action for this? Other than training operator on line clearance and Quality Inspection. Does it help to make the inspection of the label on the inspection plan where it points to the part number area of the label 100%?