Subido por Luis Carlos Almonte

Quality Control Operation Manual

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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
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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).
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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.
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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.
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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
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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.
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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
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