ML20137Q663
| ML20137Q663 | |
| Person / Time | |
|---|---|
| Site: | 07100192 |
| Issue date: | 01/28/1985 |
| From: | PACIFIC NUCLEAR SYSTEMS, INC. |
| To: | |
| Shared Package | |
| ML20137Q631 | List: |
| References | |
| QA-78-1, NUDOCS 8512050332 | |
| Download: ML20137Q663 (19) | |
Text
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10 CFR 71 QUALITY ASSURANCE PROGRA'4 FOR j
SHIPPING PACKAGES FOR IRRADIATED FUEL, HIGH LEVEL WASTE AND PLUTONIUM l
LETTER NUMBER QA-78-1 REVISION 4 DATE: : January 28, 1985 PACIFIC NUCLEAR SYSTEMS, INC.
1010 South 336th Street Federal Way, WA 98003 APPROVALS Approved By Date R.OC: A ~
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January 28, 1985 Letter QA-78-1, Rev. 4 INTRODUCTION Pacific Nu' clear Systems, Inc. (PNSI) has developed a quality system to assure traceability and control the quality of all materials and processes utilized in the production of radioac-L tive shielding, cask, containers, and other equipment pertaining to shipping packaging for irradiated fuel, high level waste, and plutonium.
The Quality Manual delineates requirements and procedures necessary to exercise control over design, documentation, procurement, material, fabrication, inspection, operational testing, equipment operation and use, maintenance,
- repair, rodification, inventory, shipment and quality data retention.
PNSI Quality System and implementing Quality Procedures are de-signed and administered to meet the 18 criteria of 10CFR71, Sub-part H.
Figure 1 is a matrix delineating the relationship be-tween the 17 PNSI Quality Procedures and the 18 10CFR71, Subpart H criteria.
The Quality System is implemented throughout the company and its subsidiaries.
The Subsidiaries include: Pacific Nuclear Systems,
- i Inc., Nuclear Packaging, Inc., NuPac Leasing, Inc., and Pacific Nuclear Systems & Services, Inc.
DESCRIPTION DE TE PNSI 10CPR71. SUBPART H OUALITY PROGRAM Criterion L. Organization Full responsibility for the Quality Assurance (QA) Program ad-herence to 10CFR71, Subpart H criteria rests with PNSI. Quality Program activities include calibration of measuring equipment, NDE and materials testing.
PNSI surveys and qualifies all or-ganizations performing these services to assure adherence to the 18 criteria prior to their use.
All other quality activities are performed by PNSI quality personnel.
However, the responsibility of the control of quality in the other organizations continues to rest with PNSI.
PNSI's President has full authority over all functions of the company, and delegates authority and responsibility for selected functions to other personnel within the company.
The administrative function includes financial, legal, and marketing activities.
Procurement department personnel perform purchasing activities and maintain supplier performance records.
The Engineering
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Department is responsible for research and development of shipping container technology, design of casks for licensing and fabrication and design documentation.
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JanuOry 28, 1985 Letter QA-78-1, Rev. 4 The PNSI Quality Department has sufficient authority and organizational freedom to identify quality programs, implement corrective. action and verify corrective action effectiveness.
Additionally, the Quality Department is independent from other organizations within PNSI and reports directly to the President of PNSI.
The Quality Department is headed up by the Corporate Quality Director who is responsible for the development, implementation and administration of the entire PNSI Quality Program.
He must have sufficient expertise in the entire field of Quality to enable him to direct the entire quality function in close adherence to the 18 criteria and the PNSI Quality Manual.
Responsibility for development of quality acceptance requirements, inspections, and NDE activities rest with the Corporate Quality Director.
It is his responsibility to delegate and evaluate the performance of all quality related tasks for PNSI through the authority of the president.
It is delineated in writing through the Corporate Quality Director that designated QA personnel have the authority to prevent the continued processing, fabrication, installation or delivery of unsatisfactory work.
This authority also extends to the quality monitoring of special processes utilizing PNSI equipment, personnel and procedures such as waste processing, in-service inspections, etc.
Production responsibilities include scheduling or in-service i
inspection and administration of all fabrication activities, both l
within PNSI and at qualified suppliers.
The shipping and receiv-ing function is also the responsibility of the Production Depart-ment.
On-site activities such as waste processing, in-service inspec-tions, etc. are administered as a joint effort of the operations and engineering personnel.
Quality supports these activities with written procedures that provide methods, process controls and check points.
Inspection personnel perform monitoring acti-vities and verifications of regulatory, contractual and technical requirements during these operations.
The Corporate Quality Director and all other quality personnel and/or organizations within, or utilized by PNSI, are fully qualified for their quality responsibilities.
Qualification records are maintained in the PNSI Quality Record File.
Typical organizational charts are shown at the end of this synop-sis.
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January 28, 1985 Letter QA-78-1, Rev. 4 Ctiterion L. Quality Assurance Program PNSI has established and implemented a QA Program for the control of quality in the designr fabrication, operation and maintenance of shipping containers for nuclear products.
Training and/or evaluation of personnel qualification are required for all QA functions in accordance with written procedures and are approved by the Quality Manager.
The QA Program assures that all quality requirements, engineering specifications, and specific provisions l
of any package design approval are met.
Those characteristics l-critical to safety are emphasized.
The President of PNSI regularly evaluates the PNSI QA program for i
adherence to the 18 criteria in scope, implementation, and effectiveness.
Further, the President requires that the Quality System, including the QA Manual Policies and Procedures, be implemented and enforced on all applicable programs at PNSI.
A Material Review Board, consisting of Engineering, Procurement Production, and Quality Personnel has been established to dispo-sition all discrepancies or disagreements pertaining to the ac-ceptability of material, hardware, or safety related operations.
Their dispositions are final and binding.
Criterion L. Design Control PNSI Quality Procedures (QP's) have been developed, approved, and implemented to control design review in such a manner to assure that the following occur:
(a)
Design activity is planned, controlled, and documented.
(b)
Regulatory and design requirements are correctly translated into specification,
- drawings, and procedures.
(c)
Design documents contain quality requirements.
(d)
Deviations from quality requirements are controlled.
(e)
Design verification is performed by Quality Assurance personnel independent of the design activity.
These verifications may include tolerance studies, alternate calculations or tests.
Qualification tests are con-ducted in accordance with approved test programs and procedures (f)
Design verification is performed by Quality Assurance personnel independent of the design activity.
These verifications may include tolerance studies, alternate calculations or tests.
Qualification tests are conducted in accordance with approved test programs and procedures.
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January 28, 1985 Letter QA-78-1, Rev. 4 (g)
Interface control is established and adequate.
(h)
Design and specification changes are reviewed and approved by the same organization (s) as the original issue.
(i)
Design errors and deficiencies are documented and corrective action to prevent recurrence is taken.
(j)
Design organization (s) and their responsibilities and authorities are delineated and controlled via written procedure.
Criterion 1,_ Procurement Document Control The PNSI QA Program assures that all purchased material, compo-nents, equipment, and services adhere to design specifications.
Supplier evaluation and selection, objective evidence of supplier
- quality, assignment of quality requirements to procurement documents, and related design documents, and source, in-process and receiving inspection are all administered and controlled in accordance with approved PNSI QA procedures.
All procurement activity is performed in accordance with written procedures delineating requirements for preparation, review, approval, and control of procurement documentation, Particular emphasis is placed on assuring that revisions to procurement documentation are reviewed and approved by the same cognizant groups as the original.
Quality Assurance clause sheets are included with all request for quotes and purchase orders.
Quality Assurance personnel assign clauses from the sheets to the procurement document referencing 10CFR Part 71, Subpart H requirements appropriate to the contract.
In addition, material information including grade, type, size, special physical and chemical data. requirements is included on the procurement documents.
Other documentation and information such as drawings, procedures, inspection and test requirements, hold points, welding and other process qualification requirements are delineated on the procurement documents by the Quality Assurance personnel ss appropriate to the contract.
The Quality Assurance personnel assura that requirements for acceptance of hardware and documentr. tion appropriate to the contract are included in procurement documentation.
PNSI Quality Assurance personnel maintain the right of access to all supplier facilities and documentation for source inspection and/or audit activities.
A statement to this effect is included on procurement documentation when it.is appropriate to the contract.
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January 28, 1985 Letter QA-78-1, Rev. 4 Criterion 1,.,Tnstruction. Procedures and Drawings Quality planning is developed for all activities requiring quality participation in accordance with approved PNSI QA procedures by qualified Quality Engineers (QE's) and are approved by the Corporate Quality Director.
All design documents, i.e., drawings, specifications, special processes, etc. affecting quality are reviewed by the Quality Department and referenced in quality planning as necessary to assure adherence to package design approvals and the applicable criteria of 10CFR71, Subpart H.
All instructions, procedures, and drawings are developed, reviewed, approved, utilized and controlled in accordance with the requirements of written quality assurance procedures.
Criterion L Document Control Policy and procedure for review, approval, release and change control of all controlled, quality related documents are delin-eated in approved PNSI QA Procedures.
Provisions are provided in the QA Procedures for identification of individuals / organizations responsible for review, approval and issuance of documents.
Doc-ument control responsibilities, facilities and distribution re-quirements are also addressed.
Controlled documents include, but are not limited to:
(a)
Design specifications (b)
Design manufacturing drawings (c)
Special process specification and procedures (d)
QA Procedures and manuals (f)
Quality Planning for receiving, in-process, source and in-service inspections (g)
Source surveillance and evaluation reports (h)
Test procedures (i)
Audit reports (j)
Operational test procedures and data.
When revised documents appear in other documents as references, supplements or exhibits, appropriate revisions are made to those documents prior to the release of the basic approved change.
Documentation listings are maintained delineating the title, number and current revision for all drawings, procedures, specifications, and purchase orders.
The Quality Personnel assure that all required support documentation is available at the work area prior to the initiation of the work effort.
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January 28, 1985 Letter QA-78-1, Rev. 4 Criterion L Control of Purchased Materials, Parts Ansi components Procurement documents are reviewed for acceptability of suggested suppliers based on the PNSI approved supplier lists.
In addition, and as required, supplier surveys are conducted by qualified PNSI personnel to further assure supplier accepta-bility.
These evaluations are based on one or all of the fol-lowing criteria:
(1)
The supplier's capability to comply with the requirements of 10CFR Part 71, Subpart H,
that are applicable to the contract.
(2)
A review of previous records and performance of the supplier.
(3)
A survey of the supplier's facilities and QA program to determine his capability to supply a product which meets the
- design, manufacturing, and quality requirements.
Results of all supplier evaluations are recorded.on Supplier Evaluation forms and are retained in the Quality Data File.
Quality requirements and standard clauses are added to procure-ment documents to require suppliers to identify material, provide test reports, control special processes, certify equipment and personnel, etc.
Requirements to identify material and specific codes, specifications and/or design requirements pertaining to the fabricated items and procurement specifications not adhered to with justification for " accept-as is" or " repair" dispositions are imposed on supplier as a minimum.
Quality planning is prepared and approved by the Quality Department for performance of all source, test, shipping and/or receiving inspections in accordance with approved design requirements, applicable 10CFR71 criteria procurement document requirements and contract specifications.
Receiving inspection is performed to determine that the following, as appropriate to the contract, are assured:
(1)
The material, component, or equipment is properly identified and corresponds with the identification on receiving documentation.
(2)
Material, components, equipment, and acceptance records are inspected and are acceptable in accordance with inspection instructions, prior to installation or use.
(3)
Inspection records and/or certificates of conformance attesting to the acceptance of material and components are available prior to installation or use.
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January 28, 1985 Letter QA-78-1, Rev. 4 (4)
Items accepted and released are identified as to their inspection status prior to forwarding them to a controlled storage area or releasing them for further work.
All described activities are delineated in approved PNSI QA procedures.
Criterion L Identification and Control d Materials. Parts, and Components The identification and control of materials, parts, components and completed and in-process assemblies is administered by the Quality Department in accordance with approved PNSI QA Proce-dures.
These procedures address quality status tags, maintenance of material identification and traceability, part identification, and related documentation.
Some of the details of these proce-dures follow:
(1)
Material identification procedures included in inspection planning and fabrication drawings require that identification of material, components, and/or hardware be maintained on the item or in traceable records to prevent use of incorrect or defective items.
(2)
When appropriate, due to contractual or safety related requirements, Quality Assurance personnel assure that identification of materials, components, specifica-tions, procurement documentations, manufacturing, and inspection records, discrepancy reports, and material test data.
(3)
Quality Assurance personnel assure, via drawings and inspection planning requirements, that identification locations do not affect the fitment, interfacing t
capability, performance or overall quality of the finished product.
Identification, in accordance with drawings and inspection planning requirements, is verified prior to releasing the item for further processing or delivery.
Criterion h Control d Special Procesaes l
PNSI approved QA Procedures delineate the policies and procedures l
established to control such special processes as: welding, heat treating, lead pouring, non-destructive examination, waste pro-cessing, etc.
in accordance with applicable codes, standards, specifications, 10CFR71 criteria and other requirements.
Special processes developed by PNSI suppliers and by PNSI are documented.
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i Janunty 28, 1985 Letter QA-78-1, Rev. 4 All procedures for special processes and the personnel required to perform them are qualified under the cognizance of the Quality Department in accordance with applicable codes, standards, specifications and contract requirements.
All qualification records and support data are retained in the Quality Data file, and are maintained in a current status by Quality Assurance personnel.
These documents are controlled as delineated in Criterion 6 of this Quality System description.
Criterion & Inspection All receiving, source, in-process and in-service inspection acti-vities are performed in accordance with approved PNSI QA proce-dures.
All inspection personnel and/or organization qualifica-tions are reviewed and accepted by the Quality Manager prior to inspection activity.
The inspection activity is performed in strict accordance with approved quality planning prepared by qualified QA personnel (See also Criterion 5 discussion).
Quality Inspection personnel are independent from all other organizations within PNSI and report directly to the Corporate Quality Director or the Subsidiary Quality Manager.
Inspection personnel qualifications are based on their capability to perform the required inspection functions in accordance with i
applicable codes, standards, professional society programs such as the ASQC quality technician certification and PNSI training programs.
Qualification reviews are performed periodically to maintain personnel proficiency and assure current qualification.
Mandatory hold points, inspection equipment requirements, accept-reject criteria, personnel requirements, characteristics to inspect, variable / attributes recording instructions, reference documentation and other requirements are included in the inspec-tion planning.
The Quality Assurance department assures that any replacements, modifications, or repairs performed af ter final acceptance of
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i material, components or hardware are inspected in accordance with l
the original inspection planning or new planning prepared as appropriate.
Criterion L Test Control
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A test control program, as it applies to quality, is addressed in approved PNSI QA Procedures and assures, via required planning, y
that all required testing, such as proof and acceptance tests, are identified and performed in accordance with test procedures, design requirements, and limitations.
Prerequisites, 8
January 28, 1985 Letter QA-78-1, Rev. 4 accept / reject criteria, data recording criteria, instrumentation calibration, environmental conditions, documentation and evaluation requirements, etc. are delineated in the test procedures.
Changes to the test procedures are required to be reviewed / approved by the same organization (s) as the original issue.
Whenever equipment, components, and/or assemblies require modification, repairs, or replacement which could result in requirements for re-test or additional testing, Quality Assurance personnel assure that original or new test inspection planning is prepared and adhered to as appropriate.
In any case, test results are documented, evaluated and accepted by qualified personnel as required by the test inspection plan prepared for the test under the cognizance of Quality Assurance personnel.
Criterion & Control of Measuring and Testing Eauipment Administration of the calibration of measuring equipment and instrumentation is performed by the Quality Department in accor-dance with approved PNSI QA Procedures.
The calibration system assures that all standard measuring instruments (SMI) used in the acceptance of material, equipment, and assemblies are calibrated and properly adjusted at specified intervals to maintain accuracy within pre-determined limits.
Calibration is performed using equipment traceable to national standards.
All calibrated equip-ment is identified and is traceable to the calibration test data.
Whenever SMI are found to be out of calibration during or immediately after use, all items inspected during that period are rejected by inspection and are submitted to review action for possible re-inspection or other appropriate corrective action.
Criterion & Handling Storage. And Shinoino PNSI approved QA Procedures require that handling, storage, and shipping requirements adherence verification criteria be included in quality planning.
These requirements are designed to prevent damage or deterioration of material and equipment.
Information
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pertaining to shelf life, environment, packaging, temperature, cleaning, handling, preservation, etc., is included as required to meet design, NRC package approval and/or U.S. Department of Transportation shipping requirements.
Shipping documentation preparation, departure, and arrival time and destination data recording is also addressed in the planning, when applicable.
The requirements in quality planning pertaining to shipping must be met prior to release for shipment.
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January 28, 1985 Letter QA-78-1, Rev. 4 Criterion & Tnspection. Test and Operating Status The use of-inspection status tags, quality inspection stamps, and other means to indicate inspection and test status at, or for, PNSI are delineated in approved PNSI QA Procedures.
The clarity of the status indication, prevention of inspection, and/or test step by-passing, and prohibition of removal or modi-fication of status indications, except with Quality Department approval / Material Review disposition is assured via these proce-1 dures.
The Quality Assurance Department assures via Quality Procedure, interoffice memoranda, training sessions, and audit that all PNSI personnel are aware of and understand the meaning and uses of status tags on all hardware, material, and test setups.
(See also Criterion 15 discussion.)
Criterion & Non-conforming Material, Parts nr. Components PNSI approved QA Procedures require that material, components, and equipment that do not conform to requirements are controlled to prevent their inadvertent use.
Identification, segregation, discrepancy reporting, disposition of non-conformances by authorized individuals and re-inspection activities are performed and controlled in strict accordance with these procedures.
Quality Discrepancy Reports (QDR) are utilized by the PNSI quality department to identify discrepant items, describe the discrepancy, provide disposition and re-inspection requirements.
The signatures of authorized cognizant personnel are placed on the QDR to signify approval of the disposition.
These personnel must be approved by the Co'rporate Quality Director and President and must be from the same groups approving the original design.
In conjunction with repair or re-work dispositions, quality assu-rance personnel provide supplemental inspection planning to verify proper implementation of the QDR disposition.
This as-sures that the item is re-tested and/or re-inspected to a degree at least equal to the original acceptance activity.
Criterion & Corrective Action Failures, malfunctions, and deficiencies in material, components, equipment and services are identified and reported to the Corporate Quality Director and the President. The cause of the condition and corrective action necessary to prevent recurrence is identified, implemented and then followed up to verify corrective action effectiveness.
Detail requirements for this activity are delineated in approved PNSI QA Procedures.
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Janunty 28, 1985 Letter QA-78-1, Rev. 4 Criterion & Ouality Assurance Records A quality records system is in effect at PNSI and is administered in accordance with approved PNSI QA procedures.
The purpose of the quality record system is to assure that documented evidence pertaining to quality related activities is maintained and avail-able for use by PNSI, its customers, and/or regulatory agencies as applicable.
Quality Records include, but are not limited to, inspection and test records, audit reports, quality personnel qualifications, design reviews, quality related procurement data, supplier evaluation reports etc.
All. records are identified by work order number, part number, contract number, or drawing number as appropriate to the record type.
A complete list of all quality records is maintained and provides cross reference be-tween the different identity methods described above and pin-points the record location.
Derign related records such as calculations, drawings, research and development test reports, etc., are retained in the Quality Assurance records system for the life of tl.e shipping package.
All other quality related records are retained for a minimum of two years, but no more than five years unless otherwise specified by contract.
Inspection records retained in the Quality Assurance records system provide the following data when applicable:
(1)
Inspection type, i.e.,
in-process, in-service, testing, receiving, and shipping.
(2)
Evidence of completion and verification of manufacturing, inspection, or test operation.
(3)
The date and results of the inspection or test.
(4)
Information related to noted discrepancies.
(5)
Inspector or data recorder identification.
(6)
Evidence of acceptance.
Criterion & Audits Quality program audits are performed on a periodic, scheduled basis by personnel without direct responsibilities in the areas being audited.
Audit personnel are certified quality assurance lead auditors who have met all requirements of ANSI N 45.2.23.
Written planning sheets and check lists are utilized.
Audit results and corrective action activity are reported to manage-ment, in writing, and are retained in the quality assurance record file.
Responsible management personnel are required to 11 l
January 28, 1985 Letter QA-78-1, Rev. 4 respond to audit findings with the necessary action to correct the noted deficiencies.
Current PNSI practice is to audit all quality functions on an annual basis.
Areas found deficient during audits are reaudited on a first priority basis to verify corrective action implementation and effectiveness.
Details of the PNSI Audit System are delineated in approved PNSI QA Proce-dures.
References (1) 10 CFR 71, Subpart H, Criteria 1-18 dated August 24, 1983,
" Quality Assurance Criteria for Shipping Packages for Radioactive Material."
(2)
PNSI Corporate Quality Manual, dated August 13, 1984 Attachments Figure 1: " Quality Requirements Matrix - 10 CFR 71, Subpart H, Criteria 1-18 vs. PNSI Quality Procedure Numbers 1-17".
Figure 2: " Organization Chart, Pacific Nuclear Systems, Inc.
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January. 28, 1985 Letter QA-78-1, Rev. 4 FIGURE 1 QUALITY REQUIREMENTS MATRIX 10 CFR vs PNSI 10 CFR 50, Appendix B PNSI Corporate Quality Manual 10 CFR 71, Subpart H I.
Organization Quality. Program & Organization Chart QP 1 - Quality Control Manual QP 14 - Quality Assurance Training II.
Quality Assurance Program Same as Above III.
Design Control QP 2 - Design Review QP 15 - Engineering Holds QP 17 - Design Control IV.
Procurement Document QP 4 - Procurement Control Control QP 15 - Engineering Holds V.
Instructions, Procedures QP 3 - Document control and Drawings QP 5 - Quality Planning QP 15 - Engineering Holds VI.
Document Control QP 3 - Document Control QP 15 - Engineering Holds VII.
Control of Purchased QP 4 - Procurement Control Material, Equipment QP 12 - Material Control and Services VIII.
Identification and Control QP 3 - Document Control of Materials, Parts and QP 12 - Material Control Couponents II.
Control of Special Process QP 4 - Procurement Control QP 5 - Quality Planning QP 6 - Inspection and Verifica-tion QP 16 - Special Process Qualifi-cations and Control 1
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January 28, 1985 Lettsr QA-78-1, R;v. 4 I.
Inspection QP 6 - Inspection and Verifica-tion II.
Test Control QP 5 - Quality Planning QP 6 - Inspection and Verifica-tion QP 15 - Engineering Holds III.
Control of Measuring and QP 11 - Calibration Control Test Equipment XIII.
Handling, Storage and QP 12 - Material Control Shipping XIV.
Inspection, Test and QP 6 - Inspection and Verifica-Operating Status tion IV.
Nonconforming Materials, QP 7 - Discrepancy Reporting Parts, or Components and Control XVI.
Corrective Action QP 8 - Corrective Action IVII.
Quality Assurance Records QP 1 - Quality Control Manual QP 9 - Quality Records QP 10 - Quality Forms Control XVIII.
Audits QP 13 - Audits l.
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QA-7 8-1, Rev. 4 l
FIGURE 1 l
ORGANIZATION CHART PACIFIC NUCLEAR SYSTEMS, INC.
01 airman / President D.F. Jones Executive V. Pres.I Marketing J.C. Ritchie 4
Controlier/ Chief Financial Officer D.J. Cook Director Quality Assurance J.R. Olivadoti i
President.PN President-NuPac President-NuPac services services x
R.T. Haelsig J.
B.
Droste
,M. P. Carson See Exhibit A-1 for Typical Subsidiary Organization Chart l
QA-7 8-1, Rev. 4 FIGURE l-A l
TYPICAL bR(fAi[IZATION CHART PNSI SUBSIDIARY President Office Manager Mariager Manager Manager Mana Manager l
Engineerin9 Procurement ASa flarkegerin9 Operations e
Engineers
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Project Mgr See Exhibit A-2 for Typical.0A Org ization Design Production Drafting Ship / Receive.
QA-78-1, Rev. 4 FIGURE l-B TYPICAL ORGANIZATION CHART QA DEPARTMENT QA Manager Quality Inspection Quality Eng, Quality Audit Records Special. Process I,nternal Receiving Control Audit IN-PR0' CESS /'
Design ASSEMBLY Control Testir'g/
Procurement Operctions Control Document Final / Shipping Control
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