Quality Control Operation Manual FUJIFILM Healthcare Corporation 1 Abbreviation Describe the abbreviations used on this document. FHC : FUJIFILM Healthcare Corporation Language Language used on this document is English. Other points to note Based on the protection of personal information, when transporting parts that contain personal information, please transport them according to your company's standards. Table Of Contents 1. Operational procedures of quality and safety information ...................................................................... 3 2. 3. 4. 5. 1.1. Purpose ................................................................................................................................................. 3 1.2. Form ...................................................................................................................................................... 3 1.3. Operating procedure ............................................................................................................................ 3 1.4. FPR issue conditions ............................................................................................................................ 3 Operation procedure for technical information ......................................................................................... 4 2.1. Purpose ................................................................................................................................................. 4 2.2. Form ...................................................................................................................................................... 4 2.3. Operating procedure ............................................................................................................................ 4 Operating procedures for Field Change Order.......................................................................................... 4 3.1. Purpose ................................................................................................................................................. 4 3.2. Form ...................................................................................................................................................... 4 3.3. Operating procedure ............................................................................................................................ 4 3.4. Case of Recall corrective action ........................................................................................................... 4 Form description.......................................................................................................................................... 5 4.1. FPR (Field Problem Report) ................................................................................................................ 5 4.2. SERVICE INFORMATION (Information/Revision Notice) .............................................................. 5 4.3. SERVICE INFORMATION (Corrective Action with Recall, Corrective Action without Recall) .... 6 Contact Person............................................................................................................................................. 8 2 1. Operational procedures of quality and safety information 1.1. Purpose The purpose is to inform the quality and safety related information related to device to FHC. 1.2. Form Field Problem Report (FPR) (Form No. FHC001). 1.3. Operating procedure １） You obtain information on product quality and safety. ２） You consider whether or not you match "1.4. FPR Issue Criteria". ３） If it’s information match FPR Issue Criteria, you create FPR document. ４） You send FPR to the person in charge of FHC listed in Contact Person at the end of this document. ※For safety information, contact FHC within 3 days of obtaining the information. ※If safety information becomes available and needs to be reported to the government, please contact the FHC representative before reporting to the government, if possible. ５） In accordance with our regulations, FHC contact your company to respond. 1.4. FPR issue conditions Indicate our service suppliers' criteria to decide whether an escalation is needed for a product-related complaint. ○ Criteria an escalation of a product-related complaint is necessary Conditions(A) １） Patient or user injury or potential patient or user injury related to the use of the equipment. ２） Investigation within your side was unable to determine the cause of the issue the customer is experiencing. ３） Complaint trending data indicates failures that are higher than expected based on historical data. ● Criteria an escalation is not necessary Escalation is not necessary if a product-related complaint meets any of the conditions below as it indicates that FHC has already investigated the same or similar product related complaint as a known issue. Conditions(B) １） Past communication between FHC and you documenting the investigation. ２） Service Information Bulletins (SIBs) issued by FHC. ３） The latest service manual or instructions manuals contains the information. ４） MRI, CT and Ultrasound system components (PCB’s, coils, probes, etc) are trended. It is not necessary to escalate every part failure to FHC unless is meets one of the criteria shown Condition(A). 3 2. Operation procedure for technical information 2.1. Purpose The purpose is to inform you of any changes to the device, such as changes in parts and adjustment methods. 2.2. Form SERVICE INFORMATION (Information/Revision Notice) (Form No. FHC002). Classification Revision Notice : To inform about changes in the system's revision Information Information other than the above : 2.3. Operating procedure FHC send SERVICE INFORMATION to your company to inform the device's technical information. 3. Operating procedures for Field Change Order 3.1. Purpose The purpose is to inform the details of corrective action when the product shipped from FHC requires corrective action. 3.2. Form SERVICE INFORMATION (Corrective Action without Recall/ Corrective Action with Recall) (Form FHC003). Classification Corrective Action without Recall In the case of corrective action without an administrative report Corrective Action with Recall In the case of corrective actions for the implementation of administrative reports * Provided that if it is determined that the issued SIB corrective action requires an administrative report in the area under your control, please contact the person in charge of the FHC before filing an administrative report. 3.3. Operating procedure FHC send SERVICE INFORMATION to your company to inform the corrective action of the device and send it to your company. 3.4. Case of Recall corrective action For each SIB issued, we attach [Attachment 1] SIB RECALL Notice (FHC) document, so please follow the instructions. 4 4. Form description 4.1. FPR (Field Problem Report) [Appendix 1] (Form No. FHC001) FPR(Field Problem Report) is the form for contacting FHC with complaint information. The items described in FPR are described below. Complaints content is used by FHC to analyze it. Please describe it as closely as possible. Originator : The name of the person making FPR document. Issued date : Date the complaint was received. Ref.number : FPR control number. Unique number to manage FPR in your company. Customer's name : The name of the facility using the device. Date of occurrence of the accident: Date occurred the accident. The address : The address of the facility using the device. Title : Summary of Complaints Modality : Modalities in which Complaints occurred S/N : Serial number of the device Model name : Device Name Installation date : Date the device was installed Urgency Safety : Select one of the following options: : In case of safety or health hazard of equipment Very Urgent : In the event of a very urgent need Urgent : When an emergency is required for the event that occurred Routine : When the event is not urgent Frequency of problem per site: Frequency of Complaints How many sites have this problem: This Complaints occurs at several institutions Report : Describe the details of Complaints (please describe the details to the extent that you know about the following matters). ○ In the event of a health hazard, please describe the information as detailed as possible to determine the health hazard. ○ If an accident occurs, please describe the information to analyze the details of the accident. (Who did what? What happened as a result?) 4.2. SERVICE INFORMATION (Information/Revision Notice) [Appendix 2] SERVICE INFORMATION (Information/Revision Notice) is the form used when contacting your company with information about device. Explain the items listed in SERVICE INFORMATION(Information/Revision Notice). SI．No． : The number of SERVICE INFORMATION document. 5 Date : Date FHC issued SERVICE INFORMATION System : Device Name Subsystem : The unit that corresponds to SERVICE INFORMATION content. If the content is known only from System, this section should not be included. FIRST MODEL TO WHICH THE PRESENT SERVICE INFORMATION IS APPLIED : Application start serial number, unit revision, etc. Subject : Subject. Purpose : Objective. Outline : Outline of the communication content. Contents : Details of liaison content. Detail of the Corrective Action, working methods. Signature of Prepared by: Signature of the SIB creator(FHC) Checked by: Signature of the SIB reviewer (FHC) Signature of Approved by: Signature of the SIB Approver (FHC) Signature of Checked by(QA Section Manager): Signature of the QA product certification manager(FHC) To be signed by Checked by(QA Manager): QA Manager Signature(FHC) REVISION AFTER THE MODIFICATION: Revision or Subsystem Revision of the System after Change MANUAL AFFECTED: Changed manuals, etc. DESIGN CHANGE INFORMATION ISSUANCE No: N.A. are provided outside the United States. 4.3. SERVICE INFORMATION (Corrective Action with Recall, Corrective Action without Recall) [Appendix 3] (Form FHC003)SERVICE INFORMATION(Corrective Action with Recall, Corrective Action without Recall) is a form for notifying the content of corrective action when corrective action is required for products shipped from FHC. Explain the items listed in SERVICE INFORMATION(Corrective Action with Recall, Corrective Action without Recall). Recall symbol : The "Recall" symbol in the upper left corner of the form is deleted if SIB document is Corrective Action without Recall. (may be a double line) SI.No. :SERVICE INFORMATION document number. (Example) TI-CT-23-0111. If the revision changes due to modifications, etc., it will be TI-CT-23-0111-1. Date : Date FHC issued SERVICE INFORMATION 6 PRIOLITY : Set according to severity. Top Urgent (Recall) : When a very rapid response is required, the corrective treatment is recalled. As Soon As Possibke : When it is necessary to cope as quickly as possible Next Time Visit : When a service member visits a client on the next occasion. When the Symptom Again : When a phenomenon occurs. System: device name Subsystem : The unit that corresponds to SERVICE INFORMATION content. This section should not be included if the content is known only from System. Subject : Subject. Purpose : Objective. Signature of Prepared by: Signature of the SIB creator(FHC) Checked by: Signature of the SIB reviewer (FHC) Signature of Approved by: Signature of the SIB Approver (FHC) Signature of Checked by(QA Section Manager): Signature of the QA product certification manager(FHC) To be signed by Checked by(QA Manager): QA Manager Signature(FHC) Checked by(PM Manager): In the case of recall, the safety control manager shall sign it. N.A. shall be used except for recovery. Checked by(Devision Manager,QA): In the case of recall, the general manufacturing and marketing supervisor signs it. N.A. shall be used except for recovery. OUTLINE OF THE CORRECTIVE ACTION: Outline of the task DETAILS OF THE CORRECTIVE ACTION : Working Methods. SPECIAL TOOLS:when special tools are required for the task, indicate the name of the tool. PARTS TO BE SUPPLIED: If a special tool is required for the work, enter the name of the tool. CHECK PROCEDURE AFTER THE task: Describes how to check on the actual machine after work is completed. CHANGE OF SYSTEM REVISION: Describe the system's revision change. STANDARD WORKING TIME: The standard required man-hours are described in hours per person. DESIGN CHANGE INFORMATION ISSUANCE No.: N.A. for SIB outside the United States. 7 5. Contact Person FHC GVP Main About FPR Name: Email: Member About FPR Name: Email: About SERVICE INFORMATION Name: About SERVICE INFORMATION Name: Email: FUJIFILM Healthcare Corporation Post Marketing Surveillance and Regulatory Affairs Group Email: FUJIFILM Healthcare Corporation Post Marketing Surveillance and Regulatory Affairs Group Yasuo Okamoto yasuo.okamoto.af@fujifilm.com Mitsuru Ueda mitsuru.ueda.cy@fujifilm.com Yoshihiko Harada yoshihiko.harada.qe@fujifilm.com Katsuyuki Minagawa katsuyuki.minagawa.aj@fujifilm.com Sincerely yours, Signature: Date: Name: Official Position : Department : Company Name : Signature: Date: Name: Yasuo Okamoto Official Position : Manager Department : Post Marketing Surveillance and Regulatory Affairs Group Company Name : FUJIFILM Healthcare Corporation 8
