ML19350A496
| ML19350A496 | |
| Person / Time | |
|---|---|
| Site: | 07100403 |
| Issue date: | 02/20/1981 |
| From: | Shourd R SCHLUMBERGER TECHNOLOGY CORP. (SUBS. OF SCHLUMBERGER |
| To: | |
| Shared Package | |
| ML19350A493 | List: |
| References | |
| 18577, NUDOCS 8103160318 | |
| Download: ML19350A496 (18) | |
Text
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iO QUALITY ASSURANCE PROGRAM FOR TYPE B RADIO ACTIVE M ATERIAL t
SEALED SOURCE TR ANSPORT PACKAGES SCHLUMBERGER WELL SERVICES SCHLUMBERGER OFFSHORE SERVICES S000 GULF FREEWAY, BOX 2175 HOUSTON, TEXAS 77001 ATTENTION:
C. E. R AC STER CHAIRMAN R ADIATION SAFETY COMYITTEE i
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D ATT.
A4 w /,, si APPROVAL I
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R. R. SHGtJRD PRESIDENT, SCHLUMBERGER WELL SERVICES T
8108160
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O INDEX PAGES I.
ORGANIZATION 1.
R e s ponsib ili t y................................................. I 2.
O A / Q C Fun c tion s............................................. 1 (a)
En gine e rin g............................................. 1 (b)
Material................................................1 (c)
Op e ra t ions.............................................. 1 (d)
Safety.................................................. 2 3.
Organiz ational Char t.......................................... 2 4.
Job Func t ion................................................. 2 (a)
Th e Pre si d en t............................................ 2 (b)
VP o f Engin eering....................................... 2 (c)
VP o f M at e ri al........................................... 2 (d)
VP O p e r a t i ons............................................ Z (e)
Radiation Safe ty O f ficer.................................. 2 (f)
Director of Product Systems............................... 2 (g)
Department Head of Engineering Physics.................... 2 (h)
Product Quality M anager.................................. 2 (i)
Manager of Planning and Control........................... 3 (j)
Managet of Manuf acturing Engineering...................... 3 (k)
Quality Assurance M anager................................ 3 (1)
M anager o f Pur chasin g.................................... 3 5.
Au th o r i t y.................................................... 3 6.
Work S t opp age................................................ 3 II.
QUALITV ASSURANCE PROGR AM 1.
Ao vacy.................................................... 3 2.
Q A f anual D is tribution.............................
...... 3 3.
M andat o ry Require ments.....................................
.3 4.
Safety.......................................................4 5.
Resolution o f Disputes........................................ 4 6.
Traini n g Pr o g r a m............................................. 4 7.
Quality Related Measurements.................................. 4 i
III.
DESIGN CONTROL 1.
D e si gn Plannin g............................................... 4 2.
R egula t ory Require m ent s...................................... 4 i
3.
D e si gn Re v ie w................................................ 4 4.
D e sign Veri fi cation............................................ 4 5.
Independen t Design Revie w..................................... 5 6.
Qua lity S t andard s............................................. 5 7.
Ch ang e Re v ie w............................................... 5 8.
Responsibility Control......................................... 5 IV.
PROCUREMENT DOCUMENT CONTROL 1
Procedures................................................... 5 2.
- A pp li c abl e C ode.............................................. 6 i
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e 3.
Design Basis Technical Requirements............................ 6 4.
D ocu m en t a t i on............................................... 6 5.
Records......................................................6 6.
Agency's Rights.............................................. 6 7.
Ch ange & Re visions........................................... 6 V.
INS
- RUCTIONS, PROCEDURES, AND DRAWINGS 1.
Pre s urib ed I.c tivit ie s.......................................... 6 2.
Est ab lished Provisions......................................... 6 3.
QAReviews..................................................6 VI.
DOCUMENT CONTROL 1.
Procedural Contro?........................................... 6 2.
Changes.................................................... 7 3.
Im ple m en t a t ion............................................... 7 4.
Av ail ability.................................................. 7 5.
M as t e r Lis t................................................... 7 VIL CONTROL OF PURCHASED M ATERIALS, PARTS AND COMPONENTS 1.
Personn el Quali fic ations....................................... 7 2.
Eva lu ation B as is.............................................. 7 (1)-
N RC App rov a l........................................... 7 (2)
Review.................................................7 (3)
Survey.................................................. 7 3.
D ocu m en t at i on............................................... 7 4.
Surv e ill an c e.................................................. 7 5.
Furn ish ed R e c ords............................................. 7 (1)
Iden tifi c ation............................................ 7 (2)
N oncen f or m anc e......................................... 8 6.
Re c e iving Inspec tion........................................... 8 (1)
Id en ti fi c a t i on............................................ 8 (2)
Inspec tion Instructions...............................,.... 8 (3)
Inspe c tion R ecords......................................8 (4)
Inspe c tion St a tus......................................... 8 VIII.
IDENTIFICATION AND CONTROL OF M ATERIALS, PARTS & COMPONENTS 1.
Procedures.................................................. 8 2.
Id en ti fi c a t i on................................................. 8 3.
Tra c e ab ili t y.................................................. 8 4.
Location of Identification...................................... 8 5.
Identification Verification..................................... 8 IX.
CONTROL OF SPECIAL PROCESSES 1.
Proc e dural Con trol............................................ 9 2.
Pr ocess Ouali fication.......................................... 9 3.
Re c o rd s...................................................... 9 ii 2/20/81
9 X.
IN SPEC'ITON 1.
Co n fo r m anc e................................................. 9 2.
Indep endence..... -.......................................... 9 3.
Qu a li fi c at ions................................................ 9 4.
Modifications, Repairs, & Replacements.......................... 9 5.
Ins pec tion Ho ld Po in t s......................................... 9 XI.
TEST CONTROL 1.
Te st Pro gra m................................................ 10 2.
Modifications, Repairs, & Replace ments......................... 10 3.
Docu m en t a tion.............................................. 10 XII.
CONTROL OF MEASURING AND TEST EOUIPVENT 1.
C a li b ra t i o n.................................................. 1 0 2.
Test Equip m ent Tr aceability................................... 10 3.
Validity o f Inspe c tion......................................... 10 4.
S t andard Trace ability......................................... 10 XIII.
HANDLING, STORAGE. AND SHIPPING 1.
Special Require m ent s......................................... 10 2.
NRC Conditions Satis fied..................................... 10 3.
Shipp ing P ap e rs.............................................. 1 1 4.
Tr snsportation of the Package................................ 11 XIV.
INSPEC'ITON, TEST AND OPERATING STATUS 1.
Id en t i fi c at ion................................................ 1 1 2.
App li c at i on.................................................. 1 1 3.
Byp ass ing.................................................. 1 1 4.
Status.......................................................'1 XV.
NONCONFORMING MATERIAL, PA'RTS, OR COMPONENTS 1.
Proc edural Contro l........................................... 11 2.
Dispo sition Approva1.......................................... 11 3.
Seg reg a t ion................................................. 1 1 4.
Re work or Repair o f Ma terials................................. 11 XVI.
CORRECTIVE AC'ITON 1.
Evaluation of Adverse Conditions............................... 12 2.
Correc tive Ac tion............................................ 12 3.
Fo ll o w up................................................... 1 2 XVII.
OUALITY ASSURANCE RECORDS 1.
Re cord Main ten anc e.......................................... 12 2.
Pr oce du re s.................................................. 12 3.
Record Iden tification & Re trieval.............................. 12 4.
R e c ord L is t................................................. 1 2 lii 2/20/81
5.
Re c o rd Re t e n t ion............................................ 12 1
6.
Applicable Records........................................... 12 (1)
De s crip tion............................................. 12 (2)
Evidence o f Completion.................................. 12 (3)
Da t e & R e sult s......................................... 13 (4)
A dverse Condit ions...................................... 13 (5)
Record er Iden tification.................................. 13 (6)
Evidence o f Accep t ability................................ 13 XVIII. AUDITS 1.
Procedures.................................................. 13 2.
R e sult s..................................................... 13 3.
R e - Au d it s................................................... 1 3 4.
C orrec tive Ac tion............................................ 13 5.
Fre quen cy................................................... 13 i
i iv 2/20/81
_ LEGEND SWS Schlumberger Well Services Q&RI Quality and Reliability Instructions Manual RS&C Radiation Sources and Controls Manual WSM Workmanship Standards Manual Mat. Proc.
Material Procedures Manual PDP Product Developrnent Plan Rad. Sf ty. Com.
Radiation Safety Committee SES Schlumberger Engineering Standards F1d. Op. Mn.
Field Operations Manual SWS Maint. Mn.
SWS Maintenance Manual PO Purchase Order Modification PD Program Development RPE Responsibility of Product Engineer QVM
" Qualification of Vendor" Memorandum VPE Vice President - Engineering (Technique)
V 2/20/81'
QUAllTY ASSURANCE PROGRAM FOR TYPE B RADIOACTIVE MATERIAL SEALED SOURCE TRANSPORT PACK AGES INTRODUCTION 1.
PURPOSE His SWS Quality Assurance Program is promulgated to comply with the re-quirements of Section 71.51, 10 CFR Part 71 Appendix E, " Packaging of Ra-dioactive Material for Transport and Transportation of Radioactive Material Under Certain Conditions" of the U.ited States Nuclear Regulatory com-mission.
2.
SCOPE nis SWS Quality Assurance Program, as required by 10 CFR Part 71 Appen-dix E, applies to the design, purchasing, fabrication, assembly, testing, use, repair, handling, shipping, sorting, cleaning, inspection, modifying, and main-tenance of the radioactive transpr-t package.
I.
ORGANIZA~ITON 1.
He responsibility for the overall corporate Ouality Assurance Pro-gram rests with the President of CWS, who established this program, to assure a Quality Product, and f; comply with applicable Federal Regulations.
2.
The SWS quality assurance program is divided into four broad areas of respc: sibilty as follows:
a.
Engineering All design and engineering test data are generated by SWS En-gineering Physics Department. Independent design review and revision level control are performed by SWS Product Engi-neering Department.
b.
Material ne fabrication and testing of shipping packages are under the control of the Material Department, who procures them from vendors with NRC approved quality assurance programs.
These vendors construct and test the packaga in accordance with Product Engineering's engineering documents.
c.
Operations The Operations Department is responsible for proper usage, i.e., shipping, handling, and maintenance.
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d.
Safeg The Radiation Safety Comn-ittee 3 chaired by the corporate Radiation Safety Officer, who coordinates the overall corpo-rate program.
3.
A current organizationa) chart is included with this document, attachment #1.
4.
Corporate Responsibilities relative to the Quality Assurance Pro-gram:
The President is responsible for the overall corporate Quality a.
Assurance Program, which is established to assure a quality product and to comply with the applicable Federal regulations.
b.
VP of Engineering - It is the responsiblity of Engineering to produce shipping package designs which meet the objective of the corporation and fulfill requirements set forth by the NRC and DOT. When the design criteria is satisfied, the Production File is released, and the announcement is signed by the VP of i
Engineering.
VP of Material - It is the responsibility of the VP of Material c.
to assure that all products are manufactured and/or procured in compliance to the Production file as promulated by the En-gineering Department.
d.
VP Operations -It is the responsibility of the VP of Operations to assure that the packages are used, maintained, and repaired to maintain compliance with the regulations of NRC and DOT.
Radiation Safety Officer -It is the responsibility of the Radia-e.
tion Safety Officer to audit and review the activities of the various departments, to assure that the Ouality Assurance Program is operating to assure a quality product, and to com-ply with the applicable federal regulations, f.
Director of Product Systems - It is the responsibility of the Director of Product Systems to assure that independent design evaluations relative to the Product Development Plan and this criteria are implemented.
Department Head of Engineering Physics - It is the responsi-g.
bility of the Department Head of Engineering Physics to assure that the design responsibility relative to the Product Develop-ment Plan and this criteria are implemented.
h.
Product Ouality Manager - It is the responsibility of the Pro-duct Quality Manager to assure that follow-up corrective ac-tion, initial acceptance, and package loading is performed ac-cording to SWS procedures, as represented by this acceptance
. criteria.
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4 i.
Manager of Planning & Control - It is the responsibility of the Manager of Planning and Control to assure that the Material Department orders, stores, and ships the transport packages according to the SWS procedures, as represented by this accep-tance criteria.
l j.
Manager of Manufacturing Engineering -It is the responsibility of the Manager of Manufacturing Engineering to assure that the Material Department participates in Production File Re-view, that process instructions are available, that transport package purchasing dccumentation represents current design, and that suppliers are capable of complying with applicable SWS procedures, as represented by the criteria of this docu-m ent, k.
Ouality Assurance Manager - It is the responsibility of the Quality Assurance Manager to assure that the Quality and Re-liability instructions, and the workmanship standards relative to this document's criteria are being implemented.
1.
Manager of Purchasing -It is the responsibility of the Manager of Purchasing to assure that all transport packages are pur-chased from suppliers who have NRC approved Quality Assur-ance Programs, and that all pertinent documentation is re-ceived, retained, and maintained according to SWS procedures, as represented by the criteria of this document.
5.
The duties and qualifications of the individual who manages the over-all SWS QA program are described in Attachment 2.
6.
Each of the personnel noted in L4 and II.4 have the responsiblity and authority, by the President's approval of this document, to stop unsa-tisfactory work and control further processing, delivery, or installa-tions of nonconforming material.
II.
OU AllTY ASSURANCE PROGRA>f 1.
The Chairman of the Radiation Safety Committee regularly assesses the scope, status, implementation, and effectiveness of the overall corporate QA program to assure that the program is adequate and comolies with 10 CFR Part 71 Appendix E.
2.
The Material Department's Ouality Assurance Mancal is distributed, and revisions thereto are controlled by the..ianager of Ouality Assur-ance.
3.
The Chairman of the Radiation Safety Committee, as a part of II.I above, communicates to all responsible organizations and individuals that quality policies, QA manuals, and procedures are mandatory re-quirements which must be implemented and enforced.
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4.
He Quality Assurance Program controls the pertinent coc2ponents of each safety related system through the Radiation Safety Committee audits of the: PDP, SES, Material Procedures, Q&RI, WS'i, RS&C, Field Operations Manual, SWS Maintenance Manual, etc.
5.
He Chairman of the Radiation Safety Committee has the responsi-bility and authority to resolve disputes involving quality, arising from a difference of opinion between QA personnel and other departments (Engineering, Procurement, Manufacturing, Operations, etc.) person-nel.
6.
hdoctrinations and training programs are established, such that per-sonnel responsible for performing quality-related activities are in-structed as to the purpose, scope, and implementation of the Q A manuals instructions and procedures. Bey are trained and qualified in the principles and techniques of the activity being performed, and their proficiency is maintained by retraining, reexamining, and recer-tifying. The scope, the objective, and the method of implementing the above program is documented.
7.
The Material Department's equipment necessary to accomplish speci-fied quality-related measurements is maintained and applied under environmental conditions suitable for that equipment. b addition, prerequisites for the inspection and test are satisfied prior to that activity.
III.
DESIGN CONTROL 1.
It is the responsibility of the Engineering group to produce equipment designs which meet predetermined objectives. This is accomplished through a formal procedure entitled Product Development Plan."
2.
Engineering Physics makes calculations, tests, literatu-2 surveys, first drawings, models, and other activities in pursuit of t.: classical design function. His includes attention to the applicable codes, in-dustry practices, and regulatory requirements.
3.
Near the conclusion of the design phase of development, an initial design review is held. The review is attended by representatives of Product Engineering, Manuf acturing Engineering, and Operations. As a part of this phase, a design prototype has been constructed and tested.
4.
Product Engineering receives drawings from Engineering Physics. A study is conducted to determine suitability of parts, materials, and construction techniques for quality and reliability, maintenance, eco-nomy, standards, and compliance to specifications. Corrections are made, and a set of engineering drawings are created from which engi-neering prototypes can be constructed. Included with the set of drawings are Engineering Specifications, Test and hspection Proce-dures, Maintenance Instructions, etc. Next, a small number of engi-neering prototypes (usually two) are built from the drawings. These prototypes are subjected to functional tests, environmental tests, and, when applicable, field trials.
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5.
When it is proven that the prototypes are proper and the drawings are adequate, the second formal review occurs. The drawings and test results are examined by Manufacturing Engineering, Operations, En-ginecring Physics & Production Engineering.
The decision is then made to do additional engineering work, or to continue in the Product Developm ent Plan. This review is called the Pilot Series Launch Meeting.
Pilot Series consists of a small number of initial production units (us-ually ten). During the Pilot Series, adequate time is scheduled by Product Engineers to solve problems which usually occur during a first production run.
Two units of the Pilot Series are subjected to functional and environ-mental tests by Product Engineering, and a report is written detrdling results of the tests.
When all is judged in order, a Production File Release is made. Do-cuments which constitute the Production File are signed by the Drafting Technician, Design Engineer, and Product Engineer. The release announcement is signed by the Vice-President of Engineering.
6.
The design function requirement noted in III.2 assures that classical Quality Standards are specified in the design document. Any Product deviation or change from the design document is controlled and do-cumented by a formal system using the " Authorized Engineering De-viation" with approval of a Product Engineer and the signature of the Product Engineering Supervisor.
7.
Design changes for all drawings are under the same revision control, starting with Pilot Series and continuing through the life of the draw-ings. Any change to the drawing ic mandatory cause to raise the revi-sion level of that drawing. The change document is called the "Engi-neering Change Notice," which requires approval of both an engineer and an engineering supervisor. Records of historic drawings, "Engi-neering Change Notices," and " Authorized Engineering Deviations,"
are preserved on archival microfilm.
8.
Product Engineering is identified, by written and controlled Engi-neering documents, to be the authority and have the responsibility for design review and verification activities.
i IV.
PROCUREMENT DOCUMENT CONTROL 1.
The procurement document process is initiated by Production Plan-ning, who forwards the SWS requirements to Purchasing by means of a "TR" card. Purchasing requests a production deawing summary of the required items from Synems Engineering (Data Entry); upon receipt of the summary, a oy is forwarded to Engineering Records, who provides the drawings and specifications relative to the itera to be purchased.
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2
Purchasing attaches copies of the above file documentation to a Ouo-tation Request and forwards it to the appropriate vendors for quotes. A copy of the file is also sent to Manufacturing Engineering, who reviews it and incorporates updates immediately prior to placing the purchase order with a vendor.
All records, certifications, and file updates are filed by Purchasing with the purchase order for a minimum of two years.
2.
Procurement documents identify, where applicable, the 10 CFR Part 71 requirements which require compliance and must be described in the supplier's QA program.
3.
Procurement documents contain or reference the design basic tech-nical requirements including the applicable regulatory requirements, material and components identification requirements, drawings, spe-cifications, codes and industrial standards, test and inspection re-goirements, and special process instructions necessary to efficientiv manufacture a quality product.
4.
Procurement documents identify the documentation to be prepared, maintained and submitted to the purchaser for review and approval.
5.
Procurement documents identify those records to be retained, con-trolled, and maintained by the supplier, and then delivered to the pur-chaser prior to use or installation of the hardware.
6.
Procurement documents contain the procuring agency's right to ac-cess to supplier's facilities and records for source inspection and au-dit.
7.
Changes and revis',ns to procurement documents are subject to at least the sante review and approval as the original documents.
V.
INSTRUCTIONS, PROCEDURES, AND DRAWINGS 1.
The " Product Development Plan," " Material Department Procedures,"
and " Quality and Reliability Instructions" assure that activities af-fecting quality are prescribed and accomplished in accordance with documented instructions, procedures, or drawings.
2.
The " Product Development Plan" clearly delineates the sequence of actions to be accomplished in the preparation, review, approval, and control of instructions procedures and drawings.
3.
The OA organization on a timely basis reviews and concurs with in-l spection plans; test, calibration, and special process procedures; drawings and specifications; and changes thereto.
VI.
DOCUMENT CONTROL 1.
The " Product Development Plan" administered by Product Engi-neering assures that the review, approval, and issue of documents and changes thereto, prior to release, are procedurally controlled to as-sure that they are adequate and that quality requirements are stated.
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2.
The " Engineering Standards" administered by Product Engineering as-sures that changes to documents are reviewed and approved by the same organizations that performed the original review and approval.
3.
The " Engineering Standards" administered by Product Engineering as-sures that approved changes are included in instructions, procedures, drawings, and other documents simultanously with the implementa-tion of the change.
4.
The Materian Gepartment Procedures assure that documents are available at the location where the activity will be performed prior to commencing the work.
5.
The " Engineering Standards" aciministered by Product Engineering as-sures that a master list, or equivalent, is established to identify the current revision number of instructions, procedures, specifications, drawings, and procurement documents.
VII.
CONTROL OF PURCHASED MATERIALS, PARTS, AND COMPONENTS 1.
The Quality Assurance Procedures provide for qualified personnel to evaluate the suppliers capability to provide acceptable quality service and procedu: es.
2.
The evaluation of radioactive transport package suppliers is based on (1) as a minimum. Items (2) end (3) are also performed on vendors intended to produce significant parts.
(1)
The supplier having an NRC approved Quality Assurance Pro-gram.
(2)
A review of previous records and performance of suppliers who have provided similar articles of the type being procured.
(3)
A survey of the supplier's facilities and QA program to deter-mine his capability to supply a product which meets the design, manufacturing, and quality requirements.
j l.
The letters documenting the results of the supplier evaluations are 3.
filed with the Radiation Safety Committee.
(-
l 4.
Surveillance, if required, of suppliers during fabrication, inspection, l
testing, and shipment of materials, equipment, and components is planned and performed in accordance with written procedures to as-l sure conformance to the purchase order requirements.
l 5.
The radioactive transport package supplier furnishes the following records as a minimum to the purchaser:
l (1)
Documentation that identifies the purchased material or equipment, and the specific procurement requirements (e.g.,
codes, standards, and specifications) met by the items.
I I
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(2)
Documentation that identifies any procurement requirements which have not been met, together with a description of those nonconformance dispositioned " accept as is" or " repair."
6.
Receiving Inspection of the supplier-furnished material, equipment and services is performed to assure:
(1)
The material, component, or equipment is properly identified and corresponds with the identification on receiving documen-tation.
(2)
Material, components, equipments, and acceptance records are inspected and judged acceptable in accordance with predeter-mined inspection instructions, prior to installation or use.
(3)
Inspection records or certificates of conformance attesting to the acceptance of material and components are available prior to installation or use.
(4)
Items accepted and released for use are identified as to their inspection status prior to forwarding them to a controlled sto ge area or releasing them for further work.
VIII.
IDENTIFICATION AND CONTROL OF M ATERIALS, PARTS, AND COMPONENTS Schlumberger Well Services verifies that all transport packages are procured solely from vendors who have NRC approved quality assurance programs:
and that they comply with 10 CFR Part 71 Appendix E. Therefore, the SWS transport package is manufactured according to all the requirements out-lined under this section:
1.
Procedures are established to identify and control materials, parts, and components, including partially fabricated sub-assemb'.ies.
2.
.Tdentification and control procedures assure that identification is maintained either on the item being produced or on records traceable to the hem to preclude use of incorrect or defective items.
3.
Identification of materials and parts important to the function of safety-related systems and components can he traced to the appro-priate documentation, such as drawings; specificatiens; purchase or-ders; manufacturing and inspection documents: deviatic,n reports; and physical and chemical mill test reports.
4.
The location and the method of identification of the product does not affect the fit, function, or quality of the item being identified.
5.
"Ihe accuracy of identification of materials, parts, and components is verified and documented prior to release for fabricatien, assembling, and installation.
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IX.
CONTROL OF SPECIAL PROCESSES Schlumberger Well Services verifies that all transport packages are procured solely from vendors who have NRC approved quality assurance programs; and that they comply with 10 CFR Part 71 Appendix E. Therefore, the SWS transport package is manufactured according to all the requirements out-lined under this section:
1.
Special processes, such as welding, heat treating, nondestructive test-ing, and cleaning are procedurally controlled.
2.
Procedures, equipment, and personnel connected with special pro-cesses are qualified in accordance with applicable codes, standards, and specifications.
3.
Qualification records of procedures, equipment, and personnel asso-ciated with special processes are establisb:d, filed, and kept current.
X.
INSPECTION Schlumberger Well Services verifies that all transport packages are procured solely from vendors who have NRC approved quality assurance programs; and that they comply with 10 CFR Part 71 Appendix E. Therefore, the SWS transport package is manufactured according to all the requirements out-lined under this section:
1.
The Quality Assurance Group has established and implemented a do-cumented program with written and controlled procedures for an in-spection program which verifies conformance of quality affecting ac-tivities.
2.
The inspection personnel are independent from the individuals per-forming the activity being inspected.
3.
The inspectors are qualified in accordance with applicable standards and company training programs; and their qualifications and certifi-cation are kept current.
4.
Modifications, repairs, and replacements are inspected in accordance
- with the original design and inspection requirement.
5.
The vendor is notified by Purchasing of the requirement to assure that provisions are established that identify 1iandatory inspection hold points for witness by an inspector.
XI.
TEST CONTROL Schlumberger Well Services verifies that all transport packages are procured solely from vendors who have NRC approved quality assurance programs; and that they comply with 10 CFR Part 71 Appendix E. Therefore, the SWS transport package is manufactured according to all the requirements out-lined under this section:
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e a
SWS also maintains a broad independent Product Development Plan, Engi-neering Standards and Ouality Assurance Program which provides for vendor evaluation and internal material and document control as follows:
1.
A test program to demonstrate that the item or component will per-form satisfactorily in service is established, documented, and accom-plished in accordance with written controlled procedures.
2.
Modifica ions, repairs, and replacements are tested in accordance with the original design and testing requirements.
3.
Test results are documented, evaluated, and their acceptability de-termined by a qualified, responsible individual or group.
XII.
CONTROL OF MEASURING AND TEST EOUIPMENT Schlumbergcr Well Services verifies that all transport packages are procured solely from vendors who have NRC approved quality assurance programs; and that they compiv with 10 CFR Part 71 Appendix E. Therefore, the SWS transport package is manufactured according to all the requirements out-lined under this section:
1.
Manufacturing measuring and test instruments are calibrated at spe-cified intervals based on the required accuracy, purpose, degree of usage, stability characteristics, and other conditions affecting the measurement.
2.
Manufacturing measuring and test equ5 ment is identified and trace-able to the calibratitn test data.
3.
Veasures are taken and documented to determine the validity of pre-vious inspections performed when measuring and test equipment is found to be out of calibration.
4.
Reference and transfer standards are traceable to nationally recog-nized standards; or, where national standards do not exist, provisions are established to document the basis for calibration.
XIII.
HANDLING, STOR AGE, AND SHIPPING Schlumberger Well Services verifies that all transport packages are procured solely from vendo s who have NRC approved quality assurance programs; and that they comply with 10 CFR Part 71 Appendix E. Therefore, the SWS transport package is manuf actured according to all the requirements out-lined under this section:
1.
Special handling, preservation, storage, cleaning, packaging, and ship-ping requirements are estalished and accomplished hv qualified indi-viduals in accordance with predetermined work and inspection in-struction.
2.
All conditions (operations, tests, inspections, specifications, etc.) of the NRC package approval and the U. S. Department of *transporta-tion shipping' requirements are satisfied by the vendor prior to ship-ment.
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3.
All necessary shipping papers are prepared as required.
~
4.
Departure, arrival time, and destinations of a package will be estab-lished and monitored by the vendor to a degree consistant with the safe transportation of the package.
XIV.
INSPECTION, TEST AND OPERATING STATUS Schlumberger Well Services verifies that all transport packages are procured solely from vendors who have NRC approved quality assurance programs; and that they comply with 10 CFR Part 71 Appendix E. Therefore, the SWS transport package is manufactured according to all the requirements out-lined under this section:
1.
Identification of the inspection, test, and operating status of pach-ages and components is known by affected organizations.
2.
The application and removal of inspection and welding stamps, and status indicators, such as tags, markings, labels, and stamps, are pro-cedurally controlled.
3.
The vendor does not knowingly bypass any required inspections, tests, or critical operations.
4.-
The status of nonconforming, inoperative, or malfunctioning packages or components is identified to prevent inadvertent use.
X7.
NONCONFORMING MATERIAL, PARTS, OR COMPONENTS Schlumberger Well Services verifies that all transport packages are procured solely from vendors who have NRC approved quality assurance programs; and that they comply with 10 CFR Part 71 Appendix E. 'Iherefore, the SWS transport package is manufactured according to all the requirements out-lined under this section:
1.
The identification, documentation, segregation, review disposition, and notification to affected organizations of r.onconforming mater-fals, parts, components, or services, are procedurally controlled.
2.
Documentation identifies the nonconforming item, describes the non-conformance, the disposition of the nonconformance, the inspection requirements, and includes signature approval of the dispostion.
3.
Nonconforming items are segregated from acceptable items and iden-tified as discrepant until properly dispositioned.
4.
The acceptability of rework or repair of materials, parts, compo-nents, and systems is verified by reinspecting and retesting the item as originally inspected and tested; or by a method which is at least equal to the original inspection and testing method.
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i XVI.
CORRECTIVE AC' HON Schlumberger Well Services verifies that all transport packages are procured
(
solely from vendors who have NRC approved quality asstrance programs; and that they comply with 10 CFR Part 71 Appendix E. Therefore, the SWS transport package is manufactured according to all the requirements out-lined under this section:
1.
'Ihe evaluation of conditions adverse to quality (such as nonconfor-mances, failures, malfunctions, deficiencies, deviations, and defec-l tive material and equipment) is conducted to determine the need for corrective action in accordance with established procedures.
I 2.
Corrective action is initiated following the determination of a condi-tion adverse to quality to preclude recurrence.
l 3.
Follow up reviews are conducted to verify proper implementation of corrective actions and to close out the corrective acticn documen-tation.
XVII.
QUALITY ASSURANCE RECORDS Schlumberger Well Services verifies that all transport packages are procured solely from vendors who have NRC approved quality assurance programs:
and that they comply with 10 CFR Part 71 Appendix E. Therefore, the SWS transport package is manufactured according to all the requirements out-lined under this section:
1.
Sufficient records are maintained to provide documentary evidence of the quality and safety of items, and the activities affecting quality and safety.
2.
QA records include operating logs; results of reviews, inspections, tests, audits, and material analyses; procedures and equipment; and other documentation, such as drawings, specifications, procurement documents, calibration procedures, and reports; and corrective action reports.
3.
Records are identifiable and retrievable.
4.
A list of the required records and their storage locations will be maintained by the chairman of the Radiation Safety Con 2mittee.
5.
Design related records are maintained for the life of the shipping package, and the vendor is notified by Purchasing that all other re-cords are to be maintained for a minimum of two years.
6.
Where applicable, the inspection and test records contain the fol-lowing:
(1)
A description of the type of observations.
(2)
Evidence of completing and verifying a manufacturing, inspec-tion, or test operation.
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'2/20/81
(3)
The date and results of the inspection or test.
(4)
Information related to conditions adverse to quality.
(5)
Inspector or data recorder identification.
(6)
Evidence as to the acceptability of the res 21ts.
XVIII.
AUDITS 1.
He Radiation Safety Committee will perform audits of the SWS Ouality Assurance Program using the 10 CFR Part 71 Appendix E ac-ceptance criteria and the O A Program description as acceptance cri-teria.
2.
The results of audits and their corresponding corrective action will become a part of the permanent records of the Radiation Safety Commit tee.
'Ihe Radiation Safety Committee will review the audit results with the VP of each department audited.
3.
The VP of each department will take the necessary action to correct the deficiencies revealed by the audit.
4.
Deficient areas will be reaudited on a timely basis, not to exceed three months, to verify implementation of corrective actions which minimize recurrence of deficiencies.
3.
The Chairman of the Radiation Safety Committee is responsible for an ongoing corporate QA program audit. A yearly audit of each de-partment is considered a minimum.
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