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首頁(yè) >新聞中心80%工廠(chǎng)進(jìn)行COSTCO質(zhì)量審核都會(huì )出現的不符合項
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Identified frequent NC COSTCO質(zhì)量審核經(jīng)常出現的不符合項：
1. 員工不了解工廠(chǎng)的質(zhì)量和產(chǎn)品安全方針; Employees are not familiar with factory quality and products safety policy.
2. 只有個(gè)別部門(mén)有設定質(zhì)量可測量的目標；未定期考核目標的執行情況。當目標未達到時(shí)，無(wú)相應的原因分析和改善方案。Only several departments have established measurable quality objectives. No regular monitoring of the achievement of Quality objectives. There is no root causes or improvement actions when objectives are not achieved.
3. 內審和管理評審未包括GMP方面；Internal audit and management review do not include the content related GMP.
4. 工廠(chǎng)的外來(lái)文件清單不完整，比如缺客戶(hù)標準、產(chǎn)品銷(xiāo)售地相關(guān)法規標準，產(chǎn)品標準等， 且未按受控要求發(fā)放。The external documents lists are not complete, such as Client‘s requirements, Laws and Regulations of products sale markets, product related standard, etc are not listed and under controlled distribution.
5. 風(fēng)險評估不完整，比如：缺程序，記錄不完整（生產(chǎn)，包裝或存儲過(guò)程中物理，化學(xué)，生物方面對產(chǎn)品的污染），控制措施，人員的職責等Risk assessment is not complete, such as no documented risk assessment procedure, risk assessment records do not include physical(sharp tool, glass)，chemical (heavy metal) or biological(pest, mould) contamination during the production, packaging or storage processes, no control method, no responsible person, etc.
6. 工廠(chǎng)沒(méi)有對供應商/分包商的初選評估或定期評估記錄。No pre- assessment assessment or regular assessment records for suppliers/subcontractors.
7.倉庫物料，半成品，成品無(wú)日期或批號標識，不能確認工廠(chǎng)先進(jìn)先出是否有 效實(shí)施，不能實(shí)施追溯。No receiving date or batch number for materials, semi-products, final products to make sure FIFO policy or traceability is implemented in audited factory.
8. 無(wú)模擬召回記錄，或者沒(méi)有保存召回中追溯的記錄。No simulation recall drill records, or the simulation recall drill records are not complete, such as the tracing records are missed.
9. 文件備份無(wú)周期要求；無(wú)應急計劃 No back up period requirement on data or server. No emergency contingency plan.
10. 物料/產(chǎn)品未離地離墻靠窗存儲 Materials or products are stored on the floor directly， closed to the outside wall and window.
11. 墻皮脫落發(fā)霉、地面臟、有蜘蛛網(wǎng), 屋頂破導致地面積水等 Wall surface are peel off or have significant mould sign, dirty floor, spider web observed， broken roof result in wet ground.
12. 車(chē)間和倉庫無(wú)自動(dòng)關(guān)閉門(mén)/門(mén)簾。窗戶(hù)打開(kāi),沒(méi)有安裝紗窗。生產(chǎn)和存儲區域的燈無(wú)屏蔽罩。No self-closing door or curtain for production and storage area. Open window without screen. Lights are not shielded or shatterproof in all production and storage areas including receiving, docks and storage areas.
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