FCCA的CAP报告,有几点客户不接受,大家帮我看一下如何回复最好

iluvlinda

For 1.1.2 Not acceptable. Please provide the photo of test equipment.

此处增加一个图片：电/风批扭力测试工具

For2.0.1 Notacceptable.Please provide inventory of incoming materials.

此处提交2~3份来料库存单，最好是电子档的，打印后拍照。

For 2.0.6 Not acceptable. Factory should establish the procedures for the risk of physical,

chemical and biological contamination that may damage the product and personnel as well.

Risk audit procedure should cover the risk audit team, risk audit criteria, risk level,

when the risk audit conducted, risk audit result and monitoring plan for critical point.

此处工厂首先需要建立一个风险评估程序，评估内容包括物理，化学和微生物等可能对产品和物品造成污染和危害。

风险评估程序内应该包括建立一个评估队伍，评估标准，风险水平；评估报告和监测计划是关键点。

提交证据：也就是需要提供程序文件一份，评估报告2~3份（最好一份对人，一份对产品），之后就是一个年度监测计划表。

程序建立后应该执行程序培训记录

For 2.0.7 Not acceptable. Factory should conduct risk assessment to analyze the risk form physical,

chemical and biological in each process. And risk assessment should according to production flow,

and analyze the risk level, give the control method.

同2.0.6

备注：你找下LEC评估表，最好给我看过后再用。呵呵

For 3.0.13 Not acceptable.

The training plan didn't mention the training department.

And please provide training record and supplier assessment record.

此处比较麻烦的是，贵厂的qa应该不是iso的内审员吧？这样子吧，贵厂找一个资格的内审员协同qa人员对下属供应商（主要部件供应商）进行iso的审核，保留审核报告和改善计划。

至于提交的证据的话，一是，内审资格员证书，二是，工厂审核报告和改善计划

如果做得更好一点就是，让内审员或外部培训公司对qa进行体系培训并保留培训记录

For 6.0.2 Not acceptable. Please provide the documented sampling plan for WM products and related inspection record.

此处更简单，提交一份抽样检查计划，（内容应该是aql那一套的做法,程序文件可以适用于来料、制程和最终检查3个方面的抽验）

哥们，这费用吗就按1小时算，给钱吧！！！！

[em140][em140]

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Johnz

[em140]哥找兼职

Johnz

QUOTE:

以下是引用谭顺元在2011-08-09 21:43:01的发言：
没结识过FCCA，学习了。

就是GMP和质量体系那套嘛。。简单的很。

Johnz

这贴N久了。