Title CQI No. Start Date Review Date
Omron, Labeling issues EDC 176
EDC 177 25-03-2008
1. Team 2. Problem Description
Mark van den Akker
Haci Yilmaz
Seyni Niang
Niels Helmond
We received two complaints relating to labeling on 25-03-08. Both were shipped on 20-03-08.
• EDC 176: Slipnr 7D2688461. Goods delivered in two boxes, one of 20 pcs and one of 8 pcs. Labels were swapped.
• EDC 177: Slipnr. 7D2688518 / 7D2688747. Slipnr. 7D2688518 was delivered correctly. Slipnr. 7D2688747 did not have the right label, instead there was a label concerning 7D2688518 pasted on the bag.
3. Containment Action (e.g. Product Quarantine)
• The pickslips are collected and the operators who have performed the packing and check-after-pack process are confronted individually with the complaints.
• The person who performed the check after pack in both cases has been replaced to another process-step.
• In the kick off meeting the next morning all personnel have been informed about the complaints and the consequences for the customer, and have been instructed to take extra care regarding labeling and checks. The WH Supervisor has emphasized the importance of quality.
25-03
25-03
26-03
% Effective
4. Root Cause
EDC 176:
Why were the labels swapped?
Theoretically this could have been caused during packing (swap of labels) as well as during the check by p ...