ML20207P022
| ML20207P022 | |
| Person / Time | |
|---|---|
| Site: | 07100621 |
| Issue date: | 12/02/1986 |
| From: | Burgess W, Fatkin H, Horowitz M POLAROID CORP. |
| To: | |
| Shared Package | |
| ML20207P012 | List: |
| References | |
| 27722, QAP-1, NUDOCS 8701140554 | |
| Download: ML20207P022 (13) | |
Text
POLAR 0ID CORPORATION QUALITY ASSURANCE PROGRAM FOR TYPE B PACKAGING N x AS REQUIRED BY 10CFR PART 71 SUBPART H DOCUMENT NO.
QAP-1 REVISION NO.
I DATE 12/2/86 pll f
PREPARED BY ft//wi 0
'l MARTIN HOROWITZ ASSISTANT RADIATION SAFETY OFFICER
/ N.0VED BY
//h Ad/
WILLIAM A. B GESS RADIATION SAFETY OFFICER l
CORPORATE INDUSTRIAL HYGIENE MANAGER
/p TARRY FATKIN DIRECTOR HEALTH, SAFETY AND ENVIRONMENTAL AFFAIRS COPY NO.
ASSIGNED T0:
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D C
PDR I
RECORD OF REVISIONS Prepared By Revision Number Date of Revision
TABLE OF CONTENTS 1.0 Introduction and Scope 2.0 Quality Assurance Organization and Responsibility 3.0 Quality Assurance Program 4.0 Procurement Document Control 5.0. Instructions, Procedures, and Drawings 5.1 Inspection of Packaging 5.2 Repair of Packaging 5.3 Loading and Unloading Contents 5.4 Transport of Package 6.0 Document Control 7.0 Control of Purchased Materials, Equipment, and Services 7.1 Supplier Evaluation 7.2 Receipt Inspection 8.0 Identification and Control of Type B Packaging 9.0 Internal Inspection 10.0 Handling, Storage, and Shipping Controls 11.0 Quality Assurance Records 12.0 Audits 12.1 Audit Schedule 12.2 Audit Personnel 12.3 Audit Reports 12.4 Audit Follow-Up
1.0 INTRODUCTION
& SCOPE 1.1 Polaroid Corporation possesses and uses radioactive materials under a specific byproduct materials license of broad scope.
In general this
.. license limits the quantities that can be possessed to small amounts that can be shipped as Type A packages. However, Polaroid is licensed to possess a one curie Americium-241 sealed source, a Type B quantity.
1.2 This-Quality Assurance (QA) program describes the policies and proce-dures to be followed by Polaroid Corporation to control-safety-related functions involved in the procurement, handling, shipping, storing and inspection of Type B packaging.
1.3 All Type B packaging must be purchased or rented from a manufacturer or other supplier of Type B containers. Polaroid Corporation does not design,. fabricate or modify Type B containers; The QA criteria for these functions are delegated to the container manufacturer and consequently sections 71.107, 123, 127 and 129 will not be addressed by this document.
1.4 The management of Polaroid Corporation has approved and requires adherence to-the policies, procedures and objectives of this program.
1.5 Revisions or additions to this program will be made as necessary to con-form to current requirements. When such revisions have been incorpor-ated the revised QA program will be sent to those people on the numbered distribution list for this document.
2.0 QUALITY ASSURANCE ORGANIZATION AND RESPONSIBILITY (71.103.)
The administration of this QA program within Polaroid Corporation is the responsibility of the Quality Assurance Committee (QAC). This committee is made up of the following individuals.
The Radiation Safety Officer (RS0)
The Corporate Manager of Package Development The Divisional Safety & Health Manager or his delegate The individual responsible for the source being moved Within the scope of this program, the functions of this committee shall be directed by the RSO.
The RSO reports to the Director of Health, Safety, and Environmental Affairs, a member of senior management. This reporting structure makes possible the effective implementation of the QA program by providing the RSO with the required authority and organizational freedom, including sufficient independence from cost and schedule when opposed to safety considerations.
2.2.1 The RSO is responsible for implementing the corporate radiation protec-tion program.
In this capacity he is responsible for all aspects of the use of Type B packaging that are related to radiation safety.
This individual is responsible for the management of the QA program.
2.2.2 The Corporate Manager of Package Development is responsible for compliance with the DOT hazardous materials regulations.
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2.2.3 The Safety and Health Manager for the Division owning the source is responible for assuring that the QA program is properly implemented at the Divisional level.
- 2.2.4 The individual in the Division responsible for the Type B quantity source is responsible for originating the procurement document for.the Type B packaging. This document shall include all the elements discussed in Section 4:
Procurement Document Control.
2.3 The OAC shall have the authority to perform the following functions effectively:
Identify quality problems, specify corrective action and control the disposition of nonconforming material.
Recommend and/or approve solutions.
Verify implementation of corrective action.
3.0 QUALITY ASSURANCE PROGRAM (71.105)
This QA program applies to the purchase or lease, use, handling, storage and shipping of Type B containers.
The purpose of the QA program is to assure that the Type B packaging performs according to the design specificiations, and that it is used in a safe manner consistent with Polaroid's effort to keep radiation exposure of personnel to a level that is as low as is reasonably achievable.
4.0 PROCUREMENT DOCUMENT CONTROL (71.109)
The procurement of Type B containers is accomplished with a written purchase order (P.O.).
The P.O. is originated by the individual responsible for the source to be transported.
The originator of the P.O. is responsible for ensuring that this procurement document specifies the following items to be provided by the supplier of the Type B packaging:
1.
Appropriate certification verifying that the designated (model and serial number) packaging was manufactured under the control of an NRC-approved QA program.
l 2.
Identification of the type of verification activities required during use and maintenance.
3.
Designation of other pertinent documentation to be furnished with the packaging (e.g. certificate of compliance, design specifications, drawings, use and maintenance manuals, and all other documentation referred to in the certificate of compliance).
The P.O. and associated documentation shall be sent to the RSO for i
approval prior to being sent to the Purchasing Department.
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The originator of the P.O. is responsible for ensuring that all the requested documentation is provided by the supplier prior to the use of the Type B packaging.
The members of the QAC shall examine all the procurement documentation to ensure that all the necessary information has been provided.
Original and revised P.O.s and associated procurement documentation shall be clearly annotated to indicate the completion of the review and approval by the QAC.
Record copies of all P.O.s and associated procurement documentation shall be kept by the RSO.
Procurement of replacement parts must follow the same procedure as pro-curement of the original packaging.
5.0 INSTRUCTIONS, PROCEDURES AND DRAWINGS (71.111) 5.1 INSPECTION OF PACKAGING All Type B packaging shall be inspected prior to use. As the source to be packaged is sealed and requires no special environmental conditions, this inspection will be a visual one intended to determine that:
The packaging meets the design specifications in the procurement document.
The packaging has not been significantly damaged.
The closure of the package and any sealing gaskets are present and free from defects.
The shielding has not been damaged and is free from defects.
The mechanism for holding the source in place is functional.
The package is properly labelled.
5.2 REPAIR OF PACKAGING If the packaging is found to be defective or noncompliant in any way that may affect the safety of its use, the packaging must be withdrawn from service, clearly labelled as defective, and then returned to the supplier for repair or reworking.
The supplier shall repair the packaging and once complete, shall provide Polaroid with the following documentation:
Description of defect and work performed to correct the problem.
Certification that the package now meets the desired design criteria.
Certification that the work was performed under an NRC approved QA program.
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9 5.3 LOADING AND UNLOADING CONTENTS 1..
The loading and unloading of the sealed' radioactive source shall be performed by an individual authorized to do so by the RSO.
- This individual must have appropriate and documented training in radiation protection and the safe handling of radioactive sources.
2.
The packaging shall be inspected prior to the loading of the source, as specified in section 5.1.
If it does not pass this inspection it shall not be used to move the source until it has been repaired or is replaced by packaging that is free from defects or other items of noncompliance.
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3.
Access to the area where loading and/or unloading is to be performed shall be restricted during these operations to prevent entrance of unauthorized personnel.
4.
All personnel not directly involved in the loading and/or unloading of the source shall be prohibited from entering the restricted area until these operations are complete and the source is adequately shielded making restriction of access to the area unnecessary.
5.
Appropriate measures shall be taken during the loading and unloading of the source to assure that radiation exposure to those 4
involved in the operation is kept as low as is reasonably achievable. These measures may include but are not limited to shielding and special remote handling tools.
6.
Radiation levels during the loading and unloading operations shall be monitored using appropriate detection equipment (e.g. GM Survey Meter) by the RSO.
In addition all individuals performing the operation shall wear personal dosimeters.
7.
The closed package shall be monitored on all sides after loading and before unloading to determine direct radiation levels at 0 and 3 ft. After initial loading this will determine the Transport Index of the package.
Before unloading this will verify that the j
shielding integrity was maintained during transport.
8.
The package and source holder shall be wipe tested before and after shipment to determine that the source was not leaking prior l
to departure, and did not leak during transport.
9.
The loaded package shall be appropriately labelled to assure com-l pliance with applicable DOT and NRC regulations, including informa-tion regarding the model and license registration numbers.
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- 10. A security seal shall be attached to the package in such a way i
that the package cannot be opened without breaking this seal.
l 11.
If, upon receipt, the package appears damaged or the security seal g
is broken, the package shall be carefully monitored to determine whether the shielding has been affected in any way. Appropriate i
procedures shall be followed during this monitoring to ensure that personnel exposure to radiation is minimized.
12.
If a damaged package is received and/or its security seal is broken, an investigation shall be made into how the damage or breaking of the seal occurred. This investigation shall be fully documented and shall cover not only the causes of. the damage but also the steps to be taken to correct the situation and minimize the possibility of recurrence.
5.4 TRANSPORT OF PACKAGE 1.
The authorized individual who packaged the source shall complete the. shipping documents necessary to comply with applicable D0T and NRC regulations (e.g. Hazardous Material Bill of Lading, Shipping Certificates). These documents shall be reviewed by the RSO to ensure that all the necessary information is present. The reviewed documents shall be given to the driver of the transport vehicle.
2..
Once the package is ready for transport, it shall be conveyed to the shipping vehicle. The timing of transport and the route to be used through the building to and from the loading dock shall be chosen to minimize the potential for contact with unauthorized personnel.
3.
The loaded package shall be secured inside the transport vehicle in such a way as to prevent its movement inside the vehicle, and thereby minimize the potential for damage to the package during transport.
4.
The transport vehicle shall post the appropriate placards necessary for compliance with DOT regulations.
6.0 DOCUMENT CONTROL All documents relevant to this QA program shall be controlled. These documents include but are not limited to package specifications, pro-l curement documents, handling instructions, and this QA document which covers ' procedures for inspection, loading and unloading, transport, maintenance, repair, document control and program auditing.
Execution of an effective document control program will be accomplished by the following procedures:
1.
Each document shall have an ide'::fying number and a complete descriptive title.
2.
Each document shall have a means for identifying the revision status and effective date of each revision.
3.
The number of copies made and issued of a document shall be controlled by a document distribution list maintained in the document file.
4.
The removal of obsolete documents, procedures, forms, etc...
shall be accomplished immediately once such material is made obsolete by new or revised documents.
5.
Obsolete documents shall be destroyed except for a historical copy kept in the document file.
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6.
Pr:cedur:s and their chang:s shall be distributed on a formal basis.
7.
In case of emergency, however, approved handwritten procedures or marked-up changes can be considered satisfactory as long as they are formalized and made official in a timely manner.
8.
All document files shall be maintained by the RSO.
9.
All documents shall be reviewed and approved by the Q.A.C.
- 10. All proposed changes to controlled documents shall be reviewed and approved by the Q.A.C. prior to implementation.
- 11. All relevant Q.A. documents shall be available at the location where Type B packaging is to be used, prior to the use of the packaging.
7.0 CONTROL OF PURCHASED MATERIALS, EQUIPMENT AND SERVICES (71.115) 7.1 SUPPLIER EVALUATION Type B packaging shall be purchased o: leased from supplier who can demonstrate that the design and fabrication of the packaging were performed under the control of an NRC approved QA program.
The choice of supplier will be based on evaluation of the following items:
Ability to provide packaging of an appropriate design for the source to be shipped.
Historical performance data, particularly in product quality and delivery records.
Review of the supplier's QA program.
In addition, a site visit to the manufacturing facility will be performed if the QAC considers it necessary for effective evaluation of the supplier.
As the lease or purchase of Type B packaging is an infrequent event at Polaroid, a complete supplier evaluation shall be performed each time a purchase order is to be submitted.
All documentation regarding the evaluation of suppliers shall be main-tained by the RSO.
7.2 RECEIPT INSPECTION Type B packaging shall be inspected upon receipt to assure that:
Material is properly identified and corresponds to the receiving documentation.
Material is acceptable in accordance with specified requirements prior to use.
Inspection records attesting to the acceptance of material are available and are filed with the RSO.
Items accepted and released are identified as to their inspection status prior to forwarding them to controlled storage areas or releasing them for use.
See section 9.0 for procedures to be filed if the packaging does not pass inspection.
8.0 IDENTIFICATION AND CONTROL OF TYPE B PACKAGING (71.117)
Type B packaging shall be identified by the model and serial number provided by the supplier.
9.0 INTERNAL ~ INSPECTION (71.121 & 71.131 & 71.133)
' All Type B packaging shall be inspected upon receipt and prior to each-use to ensure compliance with procurement documents and to determine that the packaging is free from damage and defects that may affect its function.
(See section 5.1)
If any items of noncompliance (e.g. damage, deviation from design specifications) are found, the packaging shall be clearly marked as being unacceptable and it shall not be put to use until all problems are corrected.
If the noncompliant item affects the integrity of the packaging (e.g.
shielding, structure or mechanical operation), then the packaging must be returned to the vendor for repair, reworking or replacement.
If the noncompliant item does not affect the integrity of the packaging (e.g. labelling), then the problem may be corrected at Polaroid, assuming in-house capability for correcting the problem is available.
The discovery of a noncompliant item, and the corrective measures taken, shall be documented and reported to the appropriate members of manage-ment. A copy of this documentation shall be sent to the RSO for filing.
l An " inspection log" sticker shall be affixed to each Type B package upon receipt. This sticker shall be signed and dated by the person inspect-ing the package once the package has passed inspection.
A written record shall be kept of each inspection. These inspection records shall be kept with the package and a copy shall be sent to the l
RSO for filing.
10.0 HANDLING, STORAGE AND SHIPPING CONTROLS i
All instructions from the supplier, concerning the handling, storage, shipping, cleaning and preservation of the Type B packaging shall be l
documented and strictly adhered to.
All relevant conditions identified in a certificate of compliance shall be adhered to.
Prior to the shipment and/or transportation of a container, all conditions of the QA program shall be satisfied, and the shipment properly described, and the container properly marked and labelled according to the applicable regulations of the DOT and NRC.
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11.0 QUALITY ASSURANCE RECORDS (71.135)
All records relevant to the QA program shall be maintained by the RSO.
These records shall include but not be limited to:
1.
Procurement documentation (e.g. P.O.s, design specification, supplier QA program documentation, records'of the evaluation of the supplier).
2.
Packaging inspection records including inspection survey records, documentation of items of noncompliance, corrective actions taken, and verification of correction of any items of noncompliance.
3.
Shipping documents required by DOT and NRC regulations.
4.
Records of radiation surveys and leak testing performed during the loading and unloading of the source from the Type B packaging.
5.
Audit records.
6.
Personnel training and authorization records.
All records pertaining to the use of Type B packaging shall be retained for a period of 2 years after the last shipment. All records pertaining to the fabrication of the packaging shall be retained for the life of the package to which they apply.
12.0 AUDITS (71.137)
Audits shall be performed to provide comprehensive verification and evaluation of Polaroid's QA program for Type B packaging. The following items shall be evaluated in the audit:
1.
The elements of the QA program to determine if they adequately address the QA issues.
2.
Effectiveness of the implementation of the QA program.
3.
Monitoring of operations involving Type B packaging.
4.
Adequacy of pertinent documentation.
5.
Document control.
A checklist will be developed to aid the auditing process.
12.1 AUDIT SCHEDULE The audit will be performed every time that the QA Program is 1
implemented, 12.2 AUDIT PERSONNEL The audit will be performed by the members of the QAC.
12.3 AUDIT REPORTS A written report of the findings, conclusions and recommendations of the audit will be prepared by the QAC and distributed to the management personnel affected by the audit findings. The audit report shall include an assessment of how well the QA program meets regulatory and other requirements.
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J 12.4. AUDIT FOLLOW-UP.
The QAC shall follow up on all open items in the audit report until they are resolved satisfactorily. QA personnel shall act promptly to resolve any open items in the action report.
Records shall be maintained, of all corrective actions taken, by the RSO.
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