醫(yī)療器械GMP文件QA-OP-017 預(yù)警和忠告性通知控制程序

1、更改歷史版本號文件更改號更改概要修改人批準(zhǔn)人01首發(fā)行/發(fā)放范圍 SCOPE 范圍This document describes the procedures to be followed when any safety alert and advisory notice is necessary to be handled. 本文件描述的程序是用于處理預(yù)警和忠告性通知發(fā)布所必須遵守的流程。PURPOSE 目的 To handle safety alert and advisory notice in time so as to avoid the re-occurrence of simil

2、ar affairs.為及時處理預(yù)警、忠告性通知，防止同類事件的再次發(fā)生。ASSOCIATED DOCUMENTS 相關(guān)文件Advisory Notice 忠告性通知書 Adverse Event Reporting Procedure 不良事件報告控制程序 Corrective & Preventive Actions Control Procedure 糾正和預(yù)防行動控制程序DEFINITIONS AND ACRONYMS 定義和縮寫 Advisory Notice of medical devices: After the delivery of medical devices, the

3、 complementary information or advisory actions issued by organization related to the aspects in usage, modification,recall and destruction of devices. 醫(yī)療器械忠告性通知：在醫(yī)療器械交付后，由組織發(fā)布的通知，在器械的使用、改動、召回、銷毀方面給出的補(bǔ)充信息或建議采取的措施。RESPONSIBILITIES 職責(zé)5.1 Quality dept. is responsible for the analysis, investigation, man

4、agement of quality informations, and reporting the related situation. 質(zhì)量部統(tǒng)籌對質(zhì)量信息的分析、調(diào)查、處理工作，并協(xié)調(diào)通報相關(guān)的情況。5.2 Production dept., Engineering dept., Material dept., Purchasing dept. should take part in the analysis, investigation, and management of the quality information. 生產(chǎn)部門、工程部、物料部、采購部參與對質(zhì)量信息的分析、調(diào)查、處

5、理。5.3 Related personnel responsibility of early safety alert system refer to attachment oneSafety alert system Function matrix. 早期預(yù)警系統(tǒng)的各部門相關(guān)人員職責(zé)詳見附件一 “預(yù)警系統(tǒng)職能矩陣表”。PROCEDURE 程序Early safety alert system早期預(yù)警系統(tǒng) 6.1.1 If ATL recognized the delivered products couldnt reach the expected purpose and the poss

6、ibility and potential hurt will done to the patients because of some poor quality, the Engineering dept. and Quality dept. should analyze the causes and effects for the poor quality. 如本廠發(fā)現(xiàn)已發(fā)運(yùn)后的產(chǎn)品未能達(dá)到預(yù)期用途及由于某種質(zhì)量缺陷懷疑產(chǎn)品可能對病人造成傷害或潛在的傷害，由工程部及質(zhì)量部對質(zhì)量缺陷進(jìn)行原因及影響分析。 6.1.2 Engineering dept. and Quality dept. sh

7、ould take relevant actions according to the severity degree of issues. For example, start the early safety alert system. Releasing the “Advisory Notice” to customer after approved by the management. 工程部及質(zhì)量部依據(jù)問題的嚴(yán)重程度采取應(yīng)的行動措施，如：啟動早期預(yù)警系統(tǒng)。交于管理層審批，經(jīng)批準(zhǔn)后向顧客發(fā)出“忠告性通知書”。 6.1.3 Carrying on the risk analysis af

8、ter early safety alert system started, and implementing relevant actions according to “SOP-B12-2011 Corrective & Preventive Actions Control Procedure”. 啟動早期預(yù)警系統(tǒng)后，要進(jìn)行風(fēng)險分析并按“糾正和預(yù)防行動控制程序”規(guī)定執(zhí)行相應(yīng)措施。Note: Pay attention to the local national laws and regulations during the process of application. 注：應(yīng)用時要注意當(dāng)

9、地的國家或法規(guī)的要求。 Advisory Notice忠告性通知 6.2.1 When below situations occurred, quality dept and Engineering dept. could hold a meeting for the consideration of releasing “Advisory Notice”. 當(dāng)發(fā)生以下情況時，質(zhì)量部、工程部召開會議研討考慮發(fā)出“忠告性通知書”。 a) Any supplement information about the usage of medical device 醫(yī)療器械在使用時應(yīng)注意的補(bǔ)充事宜； b

10、) The modification of medical device 醫(yī)療器械的改動c) Medical device return to company or agent 醫(yī)療器械被退回公司或代理商 d) The destroy of medical device 醫(yī)療器械的銷毀 e) The recall of medical device 醫(yī)療器械需要召回 6.2.2 Advisory Notice shall include following content: 忠告性通知包括下列內(nèi)容： a) The name, Lot No,specification and quantity

11、about the involved product出現(xiàn)問題的產(chǎn)品名稱、批號、規(guī)格和數(shù)量 b) The reason which lead to release Advisory Notice 發(fā)布忠告性通知的理由 c) Possible occurred hazard可能產(chǎn)生的危害 d) Follow up actions 隨后采取的措施 6.2.3 Engineering dept. and quality dept. are responsible for collecting relevant information, and calling for the concerned dep

12、artments to have a meeting for discussing, when the comments showed recall is unnecessary and the same effect could be reached through other ways, the detailed advisory notices should be prepared and released to customer after approved by management. 工程部、質(zhì)量部負(fù)責(zé)相關(guān)資料收集，并召集相關(guān)部門開會研討，當(dāng)分析討論認(rèn)為不需要采取召回形式，可通過其

13、它方式處理，也可達(dá)到同樣的效果時，應(yīng)編制詳細(xì)的忠告性通知書，經(jīng)管理層批準(zhǔn)后向顧客發(fā)出“忠告性通知書”。 6.2.4 Market shall confirm the distribution address, receiver and contact information of involved product according to the delivery record, inform and release D-QA035 Advisory Notices to customer or agent timely, and keep the relative releasing and

14、 following record. 市場部依照產(chǎn)品分銷記錄，確定需發(fā)布忠告性通知的該批產(chǎn)品的銷往地址、負(fù)責(zé)收貨人姓名和聯(lián)系電話等，及時告知并發(fā)放給相關(guān)顧客或代理商“D-QA035忠告性通知書”。并保持忠告性通知發(fā)布和跟蹤確認(rèn)的記錄。 6.2.5 If the national or local regulation require to report advisory notice to local FDA Bureau, quality dept conduct it after approved by General Manager. 如果國家和地區(qū)法規(guī)要求本廠將忠告性通知報告給當(dāng)?shù)厮幤?/p>

15、監(jiān)管部門，經(jīng)總經(jīng)理審核批準(zhǔn)后由質(zhì)量部負(fù)責(zé)執(zhí)行。6.3 If applicable, adverse event report refer to Adverse Event Reporting Procedure. 適用時，不良事件報告按“不良事件報告程序”執(zhí)行。Flow Chart 流程圖 N/AAttachment 附件 Attachment One Safety alert system Function matrix 附件一：預(yù)警系統(tǒng)職能矩陣表人員 Personnel客戶Customer總經(jīng)理General manager管理者代表Management representative項目經(jīng)

16、理Project manager工程師EngineerQA員QA inspectorQE生產(chǎn)負(fù)責(zé)人Production responsible person 職責(zé) Responsibility收集相關(guān)資料 Collection of relevant information客戶信息溝通（包括忠告性通知及調(diào)查表的發(fā)出及收回）Information communicated with customer(including the send and reclaim of advisory notice and investigation form)對客戶的抱怨進(jìn)行評審 Review customer complaint編制忠告性通知 Compile advisory notice編制召回產(chǎn)品報告 Compile product recall report 產(chǎn)品檢驗(yàn)和試驗(yàn)分析Product inspection and testing analys