Bilingual Reading

ID

Chinese Traditional (繁体中文)

English (US)

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標準作業程序 Standard Operating Procedure

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變更管理管制程序 Change Control Procedure

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發行部門 Released by

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分發部門 Distributed to

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版次 Version

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發行日期 Release date

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生效日期 Effective date

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目的 Objective

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為避免因品質相關之變更引起不可接受之風險或造成損失,特訂定本辦法。 This regulation is formulated to avoid unacceptable risks or losses that may be caused by quality related changes.

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職責 Responsibilities

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各部門提出之變更,由品保部門審核。 The changes proposed by each department shall be examined by the quality assurance department.

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1.變更/修改:現有、設備、技術之任何更改均稱為變更或修改,包括永久性及暫時性變更。 1. Change/Modification refers to the changes that are made to the existing equipment and technologies (including permanent and temporary changes).

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2.永久性變更:係指經研討或測試後決定之永久性修改。 2. Permanent changes refer to the changes that are decided after research or testing is conducted.

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3.暫時性變更:係指針對某特殊狀況需要進行之臨時性變更例如客戶要求特殊規格產品,此等變更必須清楚界定變更之期間,且於期滿時,恢復變更前之狀況。 3. Temporary changes refer to the changes that are made temporarily based on the need of special circumstances (for example, the customer requires products of a particular specification). The period of time should be cleared defined for these kinds of changes, and things should be restored to the former state after the expiration of that period of time.

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4.製程技術:對原物料、試驗、設備可用性、新增設備、新產品及操作條件有影響之 製程領域。 4.rocess technologies refer to the processes that might affect raw materials, testing, equipment availability, new equipment, new products and operating conditions.

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5.製程設備:係指製程裝置之本體及其配件。例如:、熱交換器、警報裝置、分析儀 器、程序控制軟硬體、公用設備、走道、平台、安全閥等。 5. Process equipment refers to the process apparatus and its accessories. For example, heat exchanger, alarm device, analysis instruments, process control software and hardware, utilities, walkways, platforms and safety valves.

Industry

Financial/Business/Economics/Law

Subject

Business/Commerce (general)

Product

General

Our Task

TEP (translation, edition, proofreading)

Source File Format

word

Skills Involved or Tools Used

Transee, DTP