MM007-00 原辅料、包装材料的出入库管理程序

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瑞登梅尔天然纤维制造(常州)有限公司

Rettenmaier Natural Fiber Manufacturing (Changzhou) Co., Ltd

1 目的Purpose

建立一个原辅料和包装材料的出入库管理程序。

Establish a set of procedures for the management of warehousing and delivery of raw & auxiliary materials and packaging materials.

2 范围Scope

适用于本公司所有品种的原辅料和包装材料。

Applicable for all kinds of raw & auxiliary materials and packaging materials of the Company.

3 职责Responsibility

采购物流部和质量部负责执行本规程。

The PLD and the QAD shall be responsible for the execution of these Procedures.

4 程序Procedures

4.1 入库管理

Warehousing management

4.1.1 做好物料的接收工作,到货物料,仓管员及时填写《物料收料记录》(附件1)。

Receive materials properly; once any material is received, the warehouse keeper shall fill in the Material Warehousing Records (Annex 1).

4.1.2 按照以下的初检程序对货物逐一进行检查,并及时填写《物料验收记录》(附件2)。

Check materials one by one according to the following initial check procedures, and fill in the Material Acceptance Records (Annex 2).

4.1.2.1 核对合格供应商目录,物料供应商必须是经质量部批准的供应商。如果该批原辅料、包装材料的供应商不在合格供应商清单中,仓管员有权拒收。

Check the list of approved suppliers; material suppliers must be the approved suppliers of the QAD. If the supplier of certain batch of raw & auxiliary materials and packaging materials is not included in the list of approved suppliers, the warehouse keeper reserves the right to reject those materials.

4.1.2.2 检查物料的运输是否按照物料贮存要求运输。

Check if the materials are transported according to the requirements on material storage or not.

4.1.2.3 检查外包装:容器应密闭、完整、无破损、无污染;外包装应清洁,无受潮、水渍、霉变、虫蛀、鼠咬;如有铅封轧印必须清楚,并无启动迹象。

Check external packages: containers should be sealed, complete, without any damage or contamination; external packages should be clean, without moisture, water logging, mould or damage

by worms or rats; any lead seal must be clear and is not opened.

4.1.2.4 核对标签:确保每一件外包装以及每件内包装上有标签,标签内容至少包括品名、批号、规格、制造厂家名称、地址、生产日期、有效期等信息,上述信息应与送货单相符。

Check labels: make sure every external package and internal package are affixed with labels; those labels should include at least item, batch number, specification, name and address of manufacturer, date of production, and expiration date, etc.; and the aforesaid information should be consistent with those in the delivery note.

4.1.2.5 复核随货文件:所有物料必须随货附有生产厂家出厂检验报告书,进口原辅料还应具有口岸药品检验所出具的报告书,逐件检查品名、数量(毛重、净重)、规格、批号、有效期、生产厂家以及所规定的标志是否正确等。

Recheck the documents provided together with goods: all materials must be provided with the factory inspection report issued by the manufacturer; besides, the imported raw & auxiliary materials should also be provided with the report issued by the port inspection office of pharmaceutical products; check if item, quantity (gross weight, net weight), specification, batch number, expiration date, manufacturer and required mark of materials are correct or not one by one.

4.1.2.6 数量验收:采用抽检方式称重或计数,内包材除外。抽检原则:5件以内,逐件称重计数;5件以上100件以内,按5件称重计数,100件以上1000件以下,按5%抽样称重计数;超过1000件,超出部分以1%抽样称重计数。非定量规格的物料,逐件称重。

Quantity acceptance: weigh or count by spot check, except external packaging materials. Rules of spot check: if within 5 pcs, weigh and count one by one; if over 5 pcs but within 100pcs, weigh and count 5 pcs; if over 100 pcs but within 1,000 pcs, take 5% samples, weigh and count; if over 1,000 pcs, take extra 1% samples from the exceeding part, weigh and count. Materials without fixed specifications are weighed one by one.

4.1.3初检合格,仓管员接受物料,将物料转移至相应的货区,填写《货位卡》(附件4),并在每批物料明显标识处悬挂”待检标签”,并填写《请检单》(附件5),附随货文件一并递交QC检验。

After materials pass the initial check, the warehouse keeper will accept the materials, transfer them to the corresponding area, fill in the Material Allocation Card(Annex 4), hang a “To be Inspected” label at an obvious position of every batch of materials, fill in the Inspection Application Form (Annex 5) and submit it and other documents provided together with the materials to QC for inspection.

4.1.4对于初检不合格物料,仓管员有权拒收;如是印有公司品名、商标等公司特有标记应立即封存、登记,移入仓库不合格区域,并按QA015《不合格品处理管理规程》执行。

The warehouse keeper reserves the right to reject any material which fails to pass the initial check; if they are marked with item, trade mark and other distinctive mark of the Company, they

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