ML20203P708
| ML20203P708 | |
| Person / Time | |
|---|---|
| Site: | 07100550 |
| Issue date: | 04/07/1986 |
| From: | Balter S, Protomastro D PHILIPS MEDICAL SYSTEMS, INC. |
| To: | |
| Shared Package | |
| ML20203P702 | List: |
| References | |
| NUDOCS 8605080051 | |
| Download: ML20203P708 (12) | |
Text
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Quality Assurance Policy for Teletherapy Container XK6007 B860301 7 April 1986 Philips Medical Systems, Inc.,
l Shelton, CT 06484 1
I Approvals:
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- Balter, Ph.D.,
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Peotomastro, Radiation Safety Office-President e
8605000051 860409 PDR ADOCK 07100550 C
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B860301 QA Policy for Container XK6007 April 1986 page 2 O. Introduction O.1 This document describes the quality assurance procedures used in conjunction with Teletherapy Source Shipping Container XK6007.
This container is used for the transport of teletherapy sources and for the servicing of Teletherapy Units XKS105/33.
The sources are classified as type B (Special Form).
O.2 Containers in this series are manufactured in France.
Their original license was granted by the French Competent Authority under the IAEA B(U) classification.
For normal operations, this license requires endorsements from the Canadian Atomic Energy Control Board and from the US Department of Transportation.
O.2.1 Original French License:
F/096/B(U)
BOO O.2.2 Canadian Endorsement:
CDN(E12)
REV 8 0.2.3 US DOT Certificate:
USA /0110/D(U)
REV 3 0.2.3.1 The certification of this container by the US DOT limits USA transportation activities to import and export functions.
O.2.4 The uniform date of expiration of these certificates is 13 Aug 1988.
O.3 PMSI conducts its teletherapy activities, other than transportation, under authority of USNRC license 06-10081-02.
This license expires 31 Aug 1990.
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B860301 QA Policy far Container XK6007 April 1986 page 3
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1.
Organization 1.1 The organization of Philips Medical Systems, Inc. is shown in Figure 1.
1.1.1 Figure 1 President PMSI Sr. VP Sr. VP VP Technology Operations Sales & Service RSO Director Q.A.
VP Service Cobalt-60 Operations QA Manager Director National Service OA Specialist RT Service Mgr.
RT Service Engineer 1.2 This document authorizes.and directs those individuals performing
- service, quality assurance, or quality control functions in reference to Cobalt Shipping Container XK6007 to take the following actions:
1.2.1 Assure that container XK6007 conforms tc the stated requirements before it is released for use.
1.2.2 Stop unsatisfactory work, unsatisfactory processing, or the installation of nonconforming material.
1.2.3 Access to appropriate management personnel.
Normal access is via the organization chart shown in 1.1.1.
In addition, all personnel have immediate access to the RSO and emergency access to the President of PMSI.
1.3 The RSO for Cobalt-60 Operations has overall responsibility for the quality assurance program described in this document.
He has the management authority to approve or disapprove all activities described below.
The RSO is a member of the Corporate Administration and is functionally independent of both the Quality Assurance and Radiation Therapy Service Departments and their respective divisions.
B860301. GA Policy for Container XK6007 April 1986 page 4 1.4 The Radiation Therapy Service Engineering Group is responsible for performing all physical quality assurance activities related to container XK6007, under the control of the Director of Quality Assurance.
These activities are documented in the " Instruction Manual for Container XK6007" (453580023241).
1.5 The Quality Assurance Department is responsible for oversight while servicing of container XK6007 is in progress and after the completion of servicing.
The Quality Assurance procedure is documented in Acceptance Test Procedure 260 (ATP260).
The completed check list found in container QA inspection document (ATP260) must be approved by the director of quality assurance prior to any use of the container.
2.
Quality Assurance Frogram 2.1 Philips Medical Systems, Inc.
provides basic training in radiation safety for all employees designated as radiation workers.
This designation includes all of the Radiation Therapy Service Engineers and key members of the Quality Assurance Department.
Only those individuals in the OA department who have been designated as radiation workers will be permitted to work on this project.
2.2 The RSO is an individual holding an appropriate certificate from the American Board of Radiology, American Board of Health Physics, or equivalent qualifications.
The RSO for Cobalt-60 Operations is that individual designated as such on the USNRC license described in section O.3.
2.3 An annual retraining course is held for all container users at NV Philips in Europe.
At least one of our Radiation Therapy Service Engineers is required to attend each session of this course.
Each year different individuals are rotated through this course.
2.3.1 Servicing of container XK6007 shall be performed by an individual successfully completing the above course.
2.4 The radiation safety instrumentation described in our USNRC license (0.3) is available to those individuals assigned to these tasks.
In addition, the RSO, or his designee, is required to perform a radiation protection and contamination survey of the container before commencing any operations under this program.
Radiation safety policies are given in section 6
of this document.
B860301 GA Policy for Container XK6007 April 1996
-page 5 2.5 The key documents relating to this program are:
2.5.1 Instruction manual for Cobalt Container XK6007:
Manual Number 453580023231.
This is the supplier's container instruction manual.
It contains all of the manufacturer's
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instructions for use and servicing of the container as well as key mechanical drawings.
2.5.1.1 The maintenance of this document is the. responsibility of the Manager of Radiation Therapy Service Engineering.
2.5.1.2 Reference copies of this document are available from the RSO, and from the Radiation Therapy Service Engineering Group.
2.5.1.3 A copy of this document is in the case containing the radiation measuring instruments assigned to Cobalt Service.
2.5.1.4 A copy of this document is included in the documentation package accompanying the container when.it is shipped.
2.5.2 Service Procedure for Cobalt Container XK6007:
Manual Number 453580023241.
This document was prepared by the Radiation Therapy Service Engineering Group.
It describes the proceduro used for inspecting the container before use.
This document provides a step-by-step check list to the servicing of the container.
It is used in conjunction with the instruction for XK6007 (2.5.1).
2.5.2.1 The maintenance of this document is the responsibility of the Manager of Radiation Therapy Service Engineering.
2.5.2.2 The working copy of this document is available from the Manager of Radiation Therapy Service.
2.5.2.3 Reference copies of this document are available from the RSO, and from the Director of Quality Assurance.
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.B860301 GA Policy for Container XK6007 April 1986 page 6 2.5.3 Acceptance Test Procedure 260:
This document includes instructions for inspection of the container as well as the the check list used for recording the results of the inspection of the container prior to use.
A separate copy of this document is used for each inspection.
Provision is made for the OA/QC inspector's logging of measurements and observations directly on this form.
This document is used as the permanent record of the inspection.
2.5.3.1 The maintenance of this document is the responsibility of the Director of Quality Assurance.
2.5.3.2 The working copy of this document is available from the Director of Quality Assurance.
2.5.3.3 The Director of Quality Assurance is responsible for the filing of completed and approved copies of ATP260.
2.5.3.4 Reference copies of this document are available from the
- RSO, and from the Manager of radiation Therapy Service Engineering.
2.5.4 Shipping Check List:
Document Number XK6007SCL.
This check list is used to assure that the container is shipped with the correct accompanying package of instructions, documentation, and other required materials.
2.5.4.1 The maintenance of this document is the responsibility of the Manager of Radiation Therapy Service Engineering.
2.5.4.2 The working copy of this document is available from the Manager of Radiation Therapy Service Engineering.
2.5.4.3 The Director of Quality Assurance is responsible for the filing of completed and approved copies of this document.
This document will be filed with the corresponding copy of ATP260.
2.5.4.4 Reference copies of this document are available from the RSO, and from the Radiation Therapy Service Engineering Group.
B860301 QA Policy for Container XK6007 April 1986 page 7 3.
Package Procurement 3.1 Containers, type XK6007, are procured from NV Philips in Holland.
The manufacturer of these containers is Lemer et Cie, Nantes, France.
The containers are licensed by the French Competent Authority under an IAEA type B(U) certificate.
3.1.1 New containers are required to have a certificate from Lemer et Cie, verifying that the designated package (by serial number) was manufactured under an NRC-approved DA program.
This certificate will be approved by the RSO prior to first use of the container.
The certificate (s) shall be filed by the RSO.
3.1.1.1 New containers received by Philips Medical Systems, Inc.
(PMSI) will be subject to inspection and approval under Acceptance Test Procedure 260 prior to first use.
3.2 Ordinary replacement
- parts, and their frequency of replacement, are listed in the documentation described above.
The OA Acceptance Test Procedure (ATP260) requires the replacement of overaged expendable parts prior to use of the container.
3.2.1 The replacement items and small parts which require replacement as a result of operational or shipping damage will be inspected by the quality control department prior to their installation.
3.2.2 Major parts will not be replaced by PMSI.
Any container requiring the replacement of major parts will be taken out of use and returned to the manufacturer for servicing.
3.2.2.1 Rebuilt containers are required to have a certificate from the rebuilder, verifying that the designated package (by serial number) is in compliance with USNRC regulations.
This certificate will be approved by the RSO prior to first use of the container.
The certificate (s) shall be filed by tne RSO.
3.2.2.2 Rebuilt containers received by Philips Medical Systems, Inc. (PMSI) will be subject to inspection and approval under Acceptance Test Procedure 260 prior to use.
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B860301 QA Policy for Container XK6007 April 1986 page O 4.
Instructions, Proceduros, and Drawings 4.1 PMSI is not licensed to possess a telethorapy source on its premises.
All loading and unloading operations involving an active source are performed on the premises of a
licensed teletherapy source supplier.
4.1.1 PMSI personnel are authorized to use the container for the transfer of sources between the XK6007 container and teletherapy head XK5005/33 under terms of our USNRC license.
4.1.2 Procedures for safe handling of the container during operations related to the handling of active sources are detailed in the instruction manual for Container XK6007 (2.5.1).
5.
Document Control 5.1 General corporate manuals for radiation
- safety, quality assurance, and quality control are
- issued, maintained, and controlled according to company policy.
5.2 The documents directly used in this program are available to the Radiation Therapy Service Engineers and Quality Assurance department at all times.
In particular, they must be available when operations are in progress.
The following matrix reviews the responsibility for control of these documents.
Document Source Procure Approval Latest Container Instruction NV Philips Service RSO Revise to USNRC
(*)
PMSI Service Service RSO Service Procedure PMSI Service Service RSO Acc. Test Proc. 260 PMSI OA Q.A RSO Shipping Check List PMSI Service Service RSO Document List
(*)
Any revisions of Container Instruction XN6007 submitted to us by NV Philips will be reviewed by the Therapy Service Department.
Changes in these instructions which are requie=d to bring the document into conformance with USNRC requiremer,tr will be written by the PMSI Teletherapy Service Department's staff.
The newly-revised document, including revisions prepared by PMSI, will be reviewed and approved by the RSO prior to issue.
B860301 OA Policy for Container XK6007 April 1986 page 9
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6.
Handling, Storage, and Shipping 6.1 Receipt of an empty container at PMSI:
6.1.1 Upon receipt, the container will be surveyed for the presence of a source or the presence of radioactive contamination by the RSO or designee.
6.1.2 If the container is found to be safe for operations it shall be tagged es such.
The tag is to be signed and dated by the surveyor.
6.1.2.1 Once the container is tagged as safe, it will be stored in the PMSI warehouse.
6.1.3 If a source is de.tected or the container is found to be contaminated, the RSO shall be notified immediately.
6.1.3.1 If a
source is
- detected, the RSO shall arrange immediate shipment of the container to a licensed source supplier for unloading.
6.1.3.2 If contamination is detected, the RSO shall arrange for decontamination.
6.1.3.3 The RSO shall notify competent authority as required by the appropriate regulations.
6.2 Shipment of Empty Container:
6.2.1 Containers XK6007 are inspected on arrival at PMSI per policy 6.1.
Any containers present in the warehouse shall be properly tagged in accordance with this policy.
6.2.2 RSO or designee shall resurvey the container prior to trans-shipment to insure that no source is present and that the container is free from radioactive contamination.
6.2.2.1 RSO or designee shall sign the necessary shipping documents.
6.2.3 The service department shall service the container prior to its shipment for any activity that involves source handling.
6.2.4 The Quality Control Department shall inspect the container, under supervision of the Director of Quality Assurance prior to such shipment.
6.2.4.1 The procedures to be followed are described in this document and the operating documents for the container.
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B860301 QA Policy for Container XK6007 April 1986.
page 10 6.2.4.2 If the eventual shipment of the empty container is for its use in returning a teletherapy source from a customer to a licensed source supplier, the Shipment Check list shall be used to assure that the proper documents (needed for shipment of the source) are shipped to the customer site with the container.
6.3 Shipment of a New Teletherapy Source from a Source supplier:
6.3.1 Compliance of applicable regulations is the responsibility of the source supplier under the source supplier's license.
6.3.2 PMSI will service the empty container per section 6~.2 of this document prior to its shipment to the source supplier.
6.4 Shipment of Old Teletherapy Source to a Source Supplier:
6.4.1 Shipment shall be directly from the licensed user to the licensed source supplier.
6.4.2 Applicable USNRC and USDDT requirements, as well as the requirements imposed by the source supplier's National Competent authority, are the responsibility of PMSI under the USNRC license described in section O.3.
6.4.3 Operational responsibility is assigned to the on site responsible individual described in the above license.
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r B860301 OA Policy for Container XK6007 April 1986 page 11 7.
Inspection, Test, and Operating Status 7.1 Responsibilities 7.1.1 The Radiation Therapy Service Department is responsible for the maintenance and testing of the container.
7.1.2 The Quality Assurance Department is responsible for completing the inspection and the inspection document Acceptance Test Procedure 260, prior to any use of the container.
7.1.3 The Director of Quality Assurance is responsible for supervision of the activities described in sections 7.1.1 and 7.1.2.
7.1.4 Prior to any shipment of the container for operational purposes, the RSO, or designee, will sign an authorization for shipment of the container after inspection of the completed and approved ATP
- 260, and the shipping document package (if required).
7.1.5 The responsible individual, under USNRC License 06-10081-02 will perform required radiation surveys and contamination surveys when the container is at the licensed teletherapy user's site.
7.1.6 The RSO, or designee, will survey the container for the presence of a source or the presence of radioactive contamination j
upon receipt of the container at PMSI.
The procedure is outlined I
in section 6.1 of this report.
7.2 The responsibilities for document control are outlined in l
section 2.5 and 5.5 of this policy.
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7.3 Frequency of Inspection:
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7.3.1 These policies assure that the container is subject to 100% inspection upon receipt at PMSI and in relation to any operational use.
7.3.2 Due to the uncertainty in the time and frequency of use of this container, this policy is preferred to a
testing procedure based upon chronological intervals.
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B860301 CA Policy for Container XK6007 April 1986 page 12 8.
Quality Assurance Records 8.1 Documentation of container procurement (Section 3),
and radiation survey ecords will be maintained by the RSO.
8.2 Operational documentation, inspections and test results, and miscellaneous reports will be maintained by the Director of Quality Assurance.
8.3 Audit Records will be maintained by the RSO.
8.4 These records will be maintained and preserved using the same policies which are used for all federal records.
8.4.1 The records relating to any specific container will be maintained for at least two years after that container is taken out of service.
8.4.2 Records relating to the program in general will be maintained for at least two years after the expiration of the USNRC license (0.3).
9.
Audit 9.1 The RSO will have audit responsibility for compliance with this program.
Audits will be performed during and after each operation involving container XK6007.
The audit procedure will include the observation of activities and inspections in progress, the inspection of documentation and the inspection of DA documentation.
This audit procedure provides 100% coverage in relation to actual operation of the container.
The Senior Vice President
- Technical Director will have audit responsibility for the activities of the RSO.
The frequencies of such audits are the responsibility of this individual.
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