Notice of Conyac Termination

Translator Reviews ( Japanese → English )

Rating: 52 / 0 Reviews / 26 Oct 2017 at 17:05

kohashi
kohashi 52 米国10年、オランダ2年、英国3年駐在。製薬業界出身。
Japanese

1.経緯
2016年12月15日に発送させて頂いた製品30本の内、20本に破損が確認されたとの御連絡を
受けたので、弊社製造工程調査を行った。

2.調査結果
当該ロットと他ロットとの、4M(人/物/設備/方法)変化点の比較について
・ 人 :製作担当者/検査担当者/梱包担当者に変化無し(力量有資格者が作業)
・ 物 :サプライヤーより納入する材料品質データに大きな差異無し
   ・設備:製作機器/検査機器に変化無し(点検記録に異常無し)
   ・方法:製作方法/検査方法/梱包方法に変化無し

English

1.Back ground
As we were informed that 20 units of our product out of 30 units that were sent on December 12, 2016, had some damages we investigated our production processes.

2. Investigation results.
Comparison on 4M (personnel/material/production utilities/method) were made between the lot with damages and another lot.
・ Personel: No change of personnel was made in production personnel, inspection personnel, and package personal (handed by those with sufficient capability)
・ Materials: No significant difference is observed among those bought from suppliers
・ Utilities: No change has been made in production machines and inspection machines (no abnormality observed in inspection log)
・ Method: No change was made in production process, inspection method, and packaging method

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