Identified frequent NC COSTCO質(zhì)量審核都會(huì)出現(xiàn)的不符合項(xiàng)

1. 員工不了解工廠的質(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)別部門有設(shè)定質(zhì)量可測(cè)量的目標(biāo)；未定期考核目標(biāo)的執(zhí)行情況。當(dāng)目標(biāo)未達(dá)到時(shí)，無(wú)相應(yīng)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(nèi)審和管理評(píng)審未包括GMP方面；

Internal audit and management review do not include the content related GMP.

4. 工廠的外來(lái)文件清單不完整，比如缺客戶標(biāo)準(zhǔn)、產(chǎn)品銷售地相關(guān)法規(guī)標(biāo)準(zhǔn)，產(chǎn)品標(biāo)準(zhǔn)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(xiǎn)評(píng)估不完整，比如：缺程序，記錄不完整（生產(chǎn)，包裝或存儲(chǔ)過程中物理，化學(xué)，生物方面對(duì)產(chǎn)品的污染），控制措施，人員的職責(zé)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. 工廠沒有對(duì)供應(yīng)商/分包商的初選評(píng)估或定期評(píng)估記錄。

No pre- assessment assessment or regular assessment records for suppliers/subcontractors.

7.倉(cāng)庫(kù)物料，半成品，成品無(wú)日期或批號(hào)標(biāo)識(shí)，不能確認(rèn)工廠先進(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(yīng)急計(jì)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(chǔ)

 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(dǎo)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. 車間和倉(cāng)庫(kù)無(wú)自動(dòng)關(guān)閉門/門簾。窗戶打開,沒有安裝紗窗。生產(chǎn)和存儲(chǔ)區(qū)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.

13. 工廠無(wú)清潔計(jì)劃和實(shí)施記錄。

No Master Sanitation Schedule (MSS) and implementation records

14. 工廠無(wú)預(yù)操作檢驗(yàn)程序驗(yàn)證設(shè)備已有效清潔且狀態(tài)良好

No pre-operative inspection program to verify that cleaning methods are effective and that equipment is in good repair

15. 木棧板存儲(chǔ)不合適、破損、無(wú)程序、清潔檢查記錄。

Wood pallets are not properly stored. They are broken. No Wood pallets control procedure. No sanitary checking records for being used Wood pallets.

16. 無(wú)蟲害控制人員培訓(xùn)記錄/第三方蟲害公司的資質(zhì)證明。無(wú)蟲害控制記錄。無(wú)捕鼠裝置、滅蠅燈裝置、無(wú)分布圖、位置安裝不合適。

Internal pest control operator has not training records. No copy of the licenses for the pest control company and current license for inspectors. No pest control records kept. No rodent traps and no fly-killer lamps or not properly installed. No map indicating the locations of all rodent traps and fly-killer lamps which should be cleaned regularly.

17. 員工不懂AQL, 內(nèi)審員無(wú)內(nèi)審培訓(xùn)記錄或不熟悉內(nèi)審要求，年度培訓(xùn)計(jì)劃無(wú)GMP相關(guān)的培訓(xùn)課題；或者無(wú)考核記錄。

Employees are not familiar with AQL. Internal auditors are not trained or not familiar with internal audit requirement. Annual training plan do not including the topic on GMP. No validation records for each training.

18. 部分測(cè)試設(shè)備校準(zhǔn)已過期。

Some of test equipments are out of calibration date.

19.機(jī)器設(shè)備的生產(chǎn)參數(shù)未按規(guī)定的要求控制。

Required production control parameters are defined but not controlled well during the production process.

20. 食物或飲料帶入生產(chǎn)和存儲(chǔ)區(qū)域

 Food or beverage are found in production and storage area.

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