二、工廠檢查之申請人為商品之生產廠場。
2 An applicant for factory inspection shall be a manufacturer of commodities.
If a manufacturer is located outside the territory of Taiwan, the applicant shall appoint a representative that has its domicile or business location in Taiwan.
生產廠場不在國內時,應委任國內有住所或營業所之代理人辦理。
2 An applicant for factory inspection shall be a manufacturer of commodities.
If a manufacturer is located outside the territory of Taiwan, the applicant shall appoint a representative that has its domicile or business location in Taiwan.
前項檢查每年至少一次,必要時得增加檢查次數。
The follow-up factory inspection mentioned in the preceding paragraph shall be conducted at least once per year; however, the frequency of the inspection may be increased if necessary.
十、 後續 工廠 檢查時應取樣,以查核與原驗證產品型式之一致性,必要時執行測試。
10 When the inspection authority conducts the follow-up factory inspection, sample(s) shall be taken to verify conformity and consistency with the type as tested in type-testing procedure of the RPC or VPC Scheme, and when necessary, testing shall be conducted.
It shall be deemed as a major defect if the result of verification or testing does not comply with the requirements.
查核或測試不符合檢驗規定者,視為主要缺點。
10 When the inspection authority conducts the follow-up factory inspection, sample(s) shall be taken to verify conformity and consistency with the type as tested in type-testing procedure of the RPC or VPC Scheme, and when necessary, testing shall be conducted.
It shall be deemed as a major defect if the result of verification or testing does not comply with the requirements.
三、 申請工廠檢查,應檢具申請書、工廠基本資料表及下列文件向經濟部標準檢驗局、其所屬分局或其認可之工廠檢查機構(以下簡稱檢查機關、構)辦理:
3 The application form for factory inspection, basic information of the manufacturer and other relevant information, as described below, must be submitted to the Bureau of Standards, Metrology and Inspection (BSMI) , its branches or factory inspection bodies recognized by the BSMI (all hereinafter referred to as the inspection authority):
(一)工廠位置圖。
(1) A route map of the factory location;
(二)工廠平面配置圖。
(2) Diagrams showing the layout of the factory;
(三)製造流程圖。
(3) A flow chart of the relevant production processes;
(四)檢測方法概要。
(4) A brief description of the inspection and / testing methods;
(五)產品之型式試驗報告或已申請型式試驗之證明文件。
(5) The type test reports of the commodities or documents demonstrating that the application for type test is filed;
(六)代理國外生產廠場申請工廠檢查者,應檢附委任書及證明文件。
(6) A letter of authorization and legal identification of the appointed representative, in case the production premises are not based in Taiwan; and
(七)其他經標準檢驗局指定之文件。
(7) Other relevant documents designated by the BSMI.
前項所附文件為外文者,檢查機關(構)得要求申請人加附中文譯本。
If the submitted documents described in the previous paragraph are in a language other than Chinese, the inspection authority may request the applicant to provide Chinese translations of the documents.
四、 檢查機關 ( 構 ) 受理工廠檢查申請後,經核對申請資料無誤,派員執行初次工廠檢查。
4 When the inspection authority receives an application for factory inspection, it shall designate inspectors to conduct the initial factory inspection after reviewing the correctness of application documents.
工廠檢查時得聘請學者、專家會同執行。
Technical experts may be invited by the inspection authority to participate in the factory inspection.
五、工廠 檢查 應 依下列檢查項目執行:
5 Factory inspection shall cover the following items:
(六)測試設備之校正。
(6) Calibration of the inspection and testing equipment;
(九)已驗證產品之情形與變更。
(9) The status of and modifications made to the products certified under the RPC Scheme; and
(十)經濟部標準檢驗局對個別商品種類訂定之工廠檢查特定要求。
(10) Other requirements prescribed by the BSMI for a specified product category.
檢查人員應填具「工廠檢查紀錄」一式二份,經檢查人員及工廠代表人簽名或蓋章確認後,發給工廠代表人一份。
The inspector shall fill out the Factory Inspection Record in duplicate.
The record shall be signed by the inspector and the representative of the production premises.
A copy of the record will be provided to the representative of the production premises.
六、 具有經濟部標準檢驗局或其 認可之 CNS 12681 ( ISO 9001 )品質管理系統登錄證書者,得免檢查前點第一項第五款至第八款之項目。
6 If the production premises have established quality management systems in accordance with the CNS 12681/ISO 9001 series of standards and have obtained registration certificates issued or recognized by the BSMI, the requirements set out in subparagraphs (5) to (8), Paragraph 1 of the preceding Clause may not be required.
七、 工廠經檢查有主要缺點者,申請人應於規定期限內申請複查,屆期未申請複查或經複查結果仍有主要缺點者,判定為不符合規定。
7 If major defects are found during factory inspection, the applicant shall apply for re-inspection within a given time limit.
If these major defects remains after re-inspection or the application for re-inspection is not made within the given time limit, they shall be considered as non-compliance with the requirements.
有次要缺點而仍可有效運作者,應於期限內提具矯正計畫(含具體矯正措施及時程),檢查機關(構)必要時得就該矯正計畫執行 查核。
If minor defects are shown but the production premises still can operate effectively, the applicant shall submit a corrective action plan (including the specific corrective measures and time schedule) within a required time limit.
The inspection authority may conduct checks to verify the performance of the corrective action plan, where necessary.
If no submission is made within the required time, or the corrective action plan is determined as failing to effectively correct the defects, the result shall be determined as non-compliance with the requirements.