ML19209B471
| ML19209B471 | |
| Person / Time | |
|---|---|
| Site: | 07100264 |
| Issue date: | 09/17/1979 |
| From: | Santoro M AUTOMATION INDUSTRIES, INC. |
| To: | |
| Shared Package | |
| ML19209B469 | List: |
| References | |
| NUDOCS 7910090764 | |
| Download: ML19209B471 (24) | |
Text
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- AUTOMATION INDUSTRIES, INC.
SPERRY PRODUCTS DIVISION l
P O. Box 245
, PHOENIXVlW. PA.19460 l
.. (215) 933-8961 f
AUTOMATION INDUSTRIES, INC.
SPERRY DIVISION l
l ROUTE 113 SOUTH P.O. BOX 245 PHOENIXVILLE, PA.
19460 PHONE (215) S33-8961 NRC BY-PRODUCT MATERIALS LICENSE NO. 37-00611-09 QUALITY ASSURANCE PROGRAM COVERING DESIGN, FABRICATION, TESTING, MAINTENANCE, AND USE OF SHIPPING PACKAGES---RADIOACTIVE MATERIAL (10 CFR PART 71) 1117
',89 8910 0 90 76V
} AUTOMATION INDUSTRIES, INC.
SPERRY PRODUCTS DIVISION P O. Box 245 PHCENIXVILLE, PA.19460
..__, -~.a (215) 933-8961 CA Pm- (10-CR-71)
ALNCN DECSTRIES, DiC.
bFlauf DIVISICN PECENIXVIILE, PA.
19460 EEV.#
CCMETIS DATE AFPDE t
PREPARED BY:/'I j /[ f
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'lMITc pso & E 'L MGR.
12-15-78 i
<.n TITLE DL5 1117 190
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F AUTOMATION INDUSTRIES, INC.
s I
- SPERRY DIVISION l
P.O. BOX 245 PHCENIXVILLE, PA.19460
",,,j (215) 933-8961 Issued: 12-15-78, 7-9-79, & 9-17-79 Revised:
QA Program (10-CFR-71)
TABLE OF CONTENTS 0.'O INTRODUCTION...................................................PAGE 1 & 2 1.0 ORGANIZATION...................................................PAGE 3 & 4 2.0 QUALITY ASSURANCE PLLGRAM......................................PAGE 4, 5, & 6 3.0 DESIGN CONTR0L.................................................PAGE 6 & 7 4.0 PROCUREMENT DOCUMENT CONTR0L...................................PAGE 7 & 8 5.0 INSTRUCTIONS, PROCEDURES, & DRAWINGS...........................PAGE 8 6.0 DOCUMENT CONTR0L...............................................PAGE 8 & 9 7.0 CONTROL OF PURCHASED MATERIALS, PARTS, & COMPONENTS............PAGE 9 & 10 8.0 IDENTIFICATION & CONTROL OF MATERIALS, PARTS, & COMPONENTS.....PAGE 10 9.0 CONTROL OF SPECIAL PRCCESSES...................................PAGE 11 10.0 INSPECTION.....................................................PAGE 11 & 12 11.0 TEST CONTR0L...................................................PAGE 12 12.0 CONTROL OF MEASURING & TEST EQUIPMENT.......................... PAGE 13 13.0 HANDLING, STORAGE, & SHIPPING.................................. PAGE 13 & 14 14.0 INSPECTION, TEST, & OPERATING STATUS...........................PAGE 15 15.0 NONCONFORMING MATERIAL, PARTS, & CCMP0NENTS....................PAGE 15 & 16 16.0 CORRECTIVE ACTION....................,
.....................PAGE 16 17.0 QUALITY ASSURANCE RFCCED5............
.........................PAGE 16 & 17 18.0 AUDITS..........................................
..............PAGE 17 APPENDIX "A" ORGANIZATION CHART...................................... PAGE 18 1.ii/-
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AUTOMATION INDUSTRIES, INC.
- SPERRY DIVISION i
P.O. 50X 245 Issued: 12-15-78, 7-9-79, & 9-17-79 j PHCENIXVILLE, PA.19460 a'_, w (215) 933-8961 Revised:
QA Program (10-CFR-71)
INTRODUCTION The Sperry Division of Automation Industries, Inc. operates a Hot-Cell located in Phoenixville, Pennsylvania. This facility processes tnd distri-butes sealed sources of Iridium-192 and Cobalt-60 for use in industrial radiographic inspection. The group also designs, fabricates, and distributes radiographic exposure devices and shipping packages for transporting these radioactive sources.
All sealed sources which are distributed meet the requirements of Special-Form hterial and/or Special-Form Encapsulation. All sealed sources are of Type "A" or Type "B" quantities, and are packed within shipping containers which are designed and tested to meet the requirements of Type "A" or Type "B" packaging. We also use (for domestic shipments only) DOT-55 Spec. containers which were manufactured prior to the March 1975 cut-off date.
The above packages are also received at our facility, containing decayed sources which customers consign to us for disposal.
The facility also receives and (re-ships empty) shipping packages which are not of our manufacture. These packages are supplied by the irradiating reactor who supply us with the Iridium-192 and Cobalt-60 source material.
The facility also ships low-level waste products in 55 gallon drums (Spec.
DOT-17H). These drums are picked-up at our facility by a licensed waste dis-posal contractor who we retain for these services.
This Quality Assurance (QA) h aual specifies the program to be implemented by Sperry Division, Phoeniriille, Pa. in order to comply with the requirements of 10-CFR-71 " Pack 2ging of Radioactive Material for Transport and Transportation of Radioactive h terial under Certain Conditions."
Radioactive Mterials referenced in the QA hnual are those Special-Form Materials for which we are licensed by the Nuclear Regulatory Cc= mission to receive, possess, process, and ship under NRC License No. 37-00611-09.
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AUTC)MAirlON INDUSTRIES, INC.
SPERRY DIVISl(1N Issued: 12-15-78, 7-9-79, & 9-17-79 P.o. Box 245 PHCENIXVILLE, PA.19460
[
/ ___j 215) 933-8961 Revised:
l QA Program (10-CFR-71)
INTRODUCTION (CON'T)
This QA Program is a mandatory requirement and shall be administered by the Management of The Sperry Division, Phoenixville, Pennsylvania.
This QA Manual supplements the requirements as defined in the ccmpanies':
By-Product Materials License No. 37-00611-09 Administrative Manual Operating and Emergency Procedures Manual l
1ii7 193 Page (2)
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AUTOMATION INDUSTRIES, INC.
- SPERRY DIVISION i
Issued: 12-15-78, 7-9-79, & 9-17-79 p.o. Box 245 J
PHCENIXVILLE, PA 19460 l
Revised:
i
/
(215) 933-8961 i
QA Program (10-CFR-71) i
.l.0 ORGANIZATION 1.1 GENERAL The final responsibility for administering this QA Program rests with the hnagement of the Sperry Division, Phoenixville, Pa.
The QA Program will f
be i=plemented using the Organization Chart in Appendix "A".
I l
1.2 RESPONSIBILITIES 1.2.1 The Radiation Safety Of ficer (RS0). The RSO has the primary respon-sibility for implementing this program. He will assure that the procedures required by this k nual are prepared, distributed, and administered accordingly. He will monitor implementation of this Program as part of the Radiation Safety audits.
i 1.2.2 Tae responsible hnagement (General k nager, RSO, and the k nufact-uring knager) will have direct control of all engineering, design, fabelcation, procurement, testing, use, receiving, storage, and trantport Mg of all shipping packages.
1.2.3 The responsible knagemene will direct and delegate those duties which are incident to the day-to-day functions which sustain the continued operation of this facility. These functions will be ac-complished only by individuals who have been trained in Radiation Safety and/or are radiation oriented. The responsible h nagement have the responsibility and authority to stop unsatisfactory work and control further processing, use, delivery, or marketing of non-conforming material.
1117 194 Page (3)
) AUTOMATION INDUSTRIES, INC.
1 SPERRY DIVISION P.O. BOX 245 Issued: 12-15-78, 7-9-79, & 9-17-79 PHCENIXVILLE, PA.19460
/j (215) 933-8961 Revised :
QA Program (10-CFR-71) 1.2.4 (History and Comments) This facility consists of a small, close-knit group consisting of six (6) individuals. Personnel breakdown consists of (2) knagement, (2) Radiation Technicians, (1) Machinist, and (1) Secretarial & Office. The number of employees has remained constant for the past ten years. We experience minimal personnel turnover. Over 80% of our staff has been employed by the facility for more than 12 years. We have an excellent wc: & g team. We know our products, have excellent co=munications, and function as a very efficient group.
2.0 OUALITY ASSURANCE PROGRAM 2.1 The knagement of Sperry Division, Phoenixville, Pa. shall be responsible for implementing this Program.
2.2 TRAINING 2.2.1 The two (.2) Managers who will administer this Program are both graduate Engineers and both have been with this organization in knagement capacity, directing all phases of Hot-Cell operations.
They are both acquainted and versed with current requirements of NRC, DOT, and FAA regulations governing design, testing, shipping, use, and storage of radioactive shipping packages.
2.2.2 Radiation Technici %-
amd other employees who may have direct in-volvement with functions relating to shipping packages, will receive indoctrination in the h nual and its Procedures. The indoctrination shall be provided by the responsible Manager, and documented. Each employee will receive a copy of this Manual, ccmplete with a copy of 10-CFR-71 and Appendix "E".
iii7 195 Page (4)
i AUTOMATION INDUSTRIES, INC.
SPERRY DIVISION i
P.O. BOX 245 Issued: 12-15-78, 7-9-79, & 9-17-79 PHCENIXVfLLE, P A.19460 m
_/
215) 93t-4961 Revised:
1 QA Prog 7;as (10-CFR-71) 2.3 Revisions to this Program require the approval of the Radiation Safety Officer.
2.4 The key elements of this Program is to govern the design, fabrication, testing, storage, and use of radioactive shipping packages. These elements are: --
2.4.1 The assurance by the Radiation Safety Officer that all shipping Packages of our own manufacture are designed, fabricated, and tested in accordance to the requirements of this QA Program.
The RSO must also assure that shipping packages which are not of our manufacture, were also designed and fabricated under a QA Program approved by The Nuclear Regulatory Commission. This assurance =ust be satisfied for all shipping packages designed and/or fabricated af ter July 1,1978.
2.4.2 That all defined Quality Control (QC) procedures, engineering procedures, and specific provisions of the package design and approval are satisfied.
2.4.3 Tha t the characteristics of the package critical to safety are controlled.
2.4.4 That required tests ha"e been performed to qualify the package for its intended use.
2.4.5 That all quality-related inspections and tests are performed with desingated fixtures, tools, and instru=ents under suitable enviro-mental conditions; and that all design and manufacturing prereq isites have been satisfied prior to inspection and testing.
1;i7 196 Page (5)
) AUTOMATION INDUSTRIES, INC.
SPERRY DIVISION lP.Osox245 Issued: 12-15-78, 7-9-79, & 9-17-79
( PHCENIXVILLE, P A 19461 Revised:
__s
-_J
'215) 9316961 QA Program (10-CFR-71) 2.4.6 That all shipments of Radioactive Packages satisfy the require-ments for:
(a) Adequate labeling of shipments (b) Proper preparation of shipp163 documents (c) Inspection, testing, and surveying of shipments for permissible levels of radistica 3.0 UESIGN CONTROL 3.1 The RSO will establish ceasures and standards to insure that all design activities are performed in a planned controlled, and orderly manner.
i 3.2 All designs will be verified by dcsign reviews, alternate calculation, j
i qualification testing, or other appropriate means to substantiate validity of the design perimeters.
3.3 All designs originated by the General Manager will be reviewed and ver-ified by the Production Manager and that rhis review will assure that:
(a) All design characteristics can be controlled, inspected, and tested (b) All inspection and test criteria are identiflad The design verification authority and responsibilities of the Production Manager are identified and documented within his job classification.
3.4 The RSO wiIL establish measures to assure that all regulatory requirements are satisfied within the design of a shipping package. These requirements must be clearly included as part of the engineering drawings, design Spec-ifications, and fabrication and assembly procedures.
3.5 The RSO will insure that suitable controls and engineering effort is utill:ed to such act!.vities as radiation shielding, structural strength, accident cenditions, compatibility of materials, maintenance, and repair.
11i7 197 Page (6)
} AUTOMATION INDUSTRIES, INC.
SPERRY DIVISK]N
]
P.O. sox 245 Issuad: 12-15-78, 7-9-79, & 9-17-79 PHCENIXVILLE, PA.19460 215) 933-8961 Revised:
QA Program (10-CFR-71) 3.6 When =echanical or enviro = ental tests are required to verify design adequacy, these tests will be performed on a prototype unit under design. All test results must be documented and retained.
3.7 Revisions and changes to design and specifications are subject to same design controls and approvals tha were applicable to the original design.
3.8 Prior to release for productions, the RSO will submit all engineering drawings, specifications, operating instructions, and prototype test results to the NRC and/or DOT for approval, comments, and/or certification.
4.0 PROCUREMENT DOCUMENT CONTROL 4.1 The responsible Management will insure that all procurement documents are prepared, reviewed, approved by signature; and these documents are retained and filed in an orderly and systematic manner.
4.2 When applicable, procurement documents will identify and make reference to specific 10-CFR Part 71, Appendiz "E" requi e=ents which become part of the procurements document.
4.3 Procurement documents will identify all drawings, specifications, fabrication procedures, inspections, test results which when required beceme part of the procurement, and are to be prepared, maintained, and submitted to Automation Industries for review and approval.
4.4 When applicable, procurement documents will reference applicable regulatory requirements or specifications; or standard industrial codes which constitute the technical design basis fer the purchased ites.
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) AUTOMATION INDUSTRIES, INC.
- SPERRY DIVISION i p o. Eox 245 Issued
- 12-15-78,7-9-79, & 9-17-79 j PHCEN'XV!LLE, PA. 19460
+
...[ Q (215) 933-4961 Revised:
QA Program (10-CFR-71) 4.5 When applicable, procurement documents will include Automation Industries right of access to suppliers facility and records for purpose of inspection and audit.
5.0 INSTRUCTIONS, PROCEDURES, AND DRAWINGS 5.1 The responsible h nagement will prescribe and docu=ent by procedures or drawings all design and =anufacturing activities affecting quality of the product.
5.2 Instructions, precedures, and drawings will be prepared, reviewed, and approved by the responsible hnagement prior to distribution. These pre-parations will be acccuplished using generally accepted engineering practices.
Any changes to these instructions, procedures, or drawings will be documented and approved by the responsible h nagement.
5.3 Prior to release, all inspection plans; test, calibration, and special process procedures; drawings and specifications; and changes thereto will be independently reviewed by either the General Manager or the Production hnager.
6.0 DOCUMENT CONTROL o.1 The RSO will maintain direct control of reviewing, approving, and issuance of all docu=ents pertaining to the design, engineering, specifications, procurement of components, fabrication, assembly, testing, use, storage, and transporting of radioactive shipping packages.
6.2 All docu=ents will be available at the location where the quality-related activity will be performed prior to ec=mencing the work.
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AUTOMATION INDUSTRIES, INC.
'1 SPERRY DIVISION Issued: 12-15-78, 7-9-79, & 9-17-79 l
P.o. Box 24s PHCENIXVILLE PA. 19460
- 215) 333-e961 Revised :
a
_4 QA Program (10-CFR-71) 6.3 Changes to any of these documents will require authorized approval by the RSO, and records of these changes will be retained.
I 6.4 Obsolete drawings or discontinued specifications will be segregated to prevent inadvertent use.
6.5 Originals or copies of all documents relating to design, testing, fab-rication, and use of shipping packages shall be controlled and retaired at the Sperry Division's, Phoenixville, Pa. facility.
7.0 CONTROL OF PURCHASED MATERIALS, PARTS, AND COMPONENTS 7.1 The responsible Management will evaluate all vendors capabilities to provide acceptable quality services and products.
7.2 All vendors will be evaluated with regards to ability to comply with requirements of Appendix "E" of 10 CFR Part 71 when applicable; or evaluated against past perfor=ance records of acceptability and quality for similar articles provided on previous contracts. When necessary, a survey of the suppliers facility and quality program will be evaluated l
to insure his capability to provide the desired end product.
i 7.3 Results of suppliers grading or evaluations will be documented and retained.
7.4 When required, surveillance of suppliers progress during manufacturing, inspection and testing of materials or ccmponents, will be monitored in accordance with designed procedures to assure complete procurement re-quirements.
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T AUTOMATION INDUSTRIES, lHC.
j SPERRY DIVISION p.o. sox 245 Issued: 12-15-78, 7-9-79, & 9 17-79 g PHCENIXVILLE P A. 19460
=
j".w 215) 933-8961 Revised:
QA Program (10-CFR-71) 7.5 As a minimum, all suppli*rs will furnish documents that identifies the purchased material or equipment by part of drawing number, and Purchase Order number, and incorporate any specific codes or standards which were included as part of the procurement requirements.
7.6 Receiving inspection of vendor furnished material will be performed to assure that purchased items are properly identified; inspected, and judged acceptable prior to storage or release for further processing.
7.7 All inspection records or certificates of conformance attesting to the acceptability of the material and components will be on file and available prior to installation or use of the material or components.
8.0 IDENTIFICATION AND CONTROL OF MATERIALS, FARTS, AND COMPONENTS 8.1 All materials, parts and components will be identified by part number or drawing number, which will allow traceability to design drawing, design specifications, procurement documents, and manufacturing and inspection procedures.
3.2 Identification of all materials, parts, and components will be verified and documented prior to release for storage as finished goods, or prior to release for further processing, fabrication, and/or further assembly or installation.
i 8.3 The location of identification and the nethod of identification will not I
affect the fit, function, or quality of the item being identified.
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AUTOMATION INDUSTRIES, INC.
~); SPERRY DIVISl(lN P.O. BOX 245 Ie3ued: 12-15-78, 7-9-79, & 9-17-79 l PHOENIXVILLE. PA.19463 a"w i215) 033-8961 1.evised :
QA Program (10-CFR-71) 9.0 CONTROL OF SPECIAL PROCESSES 9.1 All special or critical procesces such as welding, heat treating,
=echanical testing, cicaning, decontamination will be procedurally controlled.
9.2 All procedures, equipment, and personnel connected with special or critical processes are trained and/or qualified in accordance with applicable standards or requirements of our operating NRC License.
9.3 Qualification records of procedures, equipment, and personnel associated with special for critical processes are established, filed, and kept current.
10.0 INSPECTION 10.1 The responsible Management personnel will implement an inspection program to assure conformance with specific requirements of design, specifications, aad drawings for all shipping packages.
10.2 Particular inspection e=phasis shall be placed on radiation shiciding, and locking and sealing, devices which are used in securing the packages.
10.3 Radiation shields (Depleted Uranium or poured lead type) will be inspected for shielding integrity, both prior to, and af ter final assembly. Survey results will be documented by shield serial number.
10.4 All Shielding surveys shall be performed by using a praperly operating, and recently calibrated instrument.
10.5 The responsible Manager will provide a check list which will designate acceptance and rejection criteria based en permissible levels of radiation.
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3 AUTOMATION INDUSTRIES, INC.
i SPERRY DIVISION Issued: 12-15-78, 7-9-79, & 9-17-79 P.O. Box 245 PHCENIXVILLE, DA,19460
__, j
<215) 933-8s61 Revised:
QA Program (10 CFR 71) 10.6 Provisions will be established that identify mandatory inspection hold points for witness and review by an inspector and responsible Management.
10.7 Final approval of radiation survey data rests with the responsible Manager.
10.8 All non-acceptable components shall be segregated, and returned to manufacturing for rework, replacement, or disposal.
10.9 All mechanical components will be inspected for dimensional toler-ance and fits using standard machinist's gauges. Acceptance and rejection criteria will be in accordance to tolerances specified on engineering drawings.
11.0 TEST CONTROL 11.1 The responsible Management will establish a test program to demon-strate that items or' ccmponents will perform satisfactorily in ser-vice. These test programs will be docusented, and accomplished in accordance with regulatory or written etntrolled procedures.
11.2
'4 hen repairs or modifications are incorporated into an existing com-ponent or assembly, these repaired or modified items will be tested to the original design requirements.
11.3 The responsible Management will evaluate all test results to determine acceptability criteria. Test results will be documented and retained.
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T AUTOMATION INDUSTRIES, INC.
,J SPERRY DIVISION l P o. aox 245 Issued: 12-15-78, 7-9-79, & 9-17-79 PHCENIXVILLE, P A.1946]
_f
- d '215) 933-8961 Revised:
QA Program (10-CFR-71)
I 12.0 CONTROL OF MEASURING AND TEST EQUIPMENT 12.1 Measuring and test instruments are calibrated as required based on the required accuracy, use and purpose, degree of usage, age of instrument, inherent stability of measuring elements, and other conditions affecting accuracy.
12.2
- sures will be established and documented to determine the validity of previous inspections performed when measuring and test equipment is found to be out of calibration.
12.3 When required, measuring and test equipment is identified and trace-able to calibration test data.
1 12.4 Where applicable, reference and transfer standards and traceable to nationally recognized standards, or to documented basis of calibra-tion procedures.
13.0 HANDLIC STORAGE, AND SHIPPING 13.1 Only qualified radiation technicians shall perform the critical handling, storage, and shipping functions as required in the normal operation and the facility.
13.2 Shipping packages shall be haadled, stored, and shipped in accordance to our operating and emergency procedures and/or the specific operating and instruction manual for the particular package.
13.3 All incoming shipping packages shall be surveyed for radiation levels at time of delivery. The shipper's name, package model and serial number, and results of surveys shall be documented and recorded in the daily receiving log.
iii7 204 Page (13)
) AUTOMATION INDUSTRIES, lHC.
SPERRY DIVISION Issued: 12-15-78, 7-9-79, & 9-17-79 P.o. sox 245
__fid' PHCENIXVILLE. P A.19460 (215) 933-8961 Revised:
QA Program (10-CFR-71) 13.4 All out-going shipping packages shall be checked to insure proper operation of mechanical components and locking devices. Packages will be closed and decontaminated to within permissible levels.
13.5 All out-going shipping packages shall satisfy the requirements for:
(a) Adequate markings and labeling l
(b) Proper preparation of shipping documents (c) Surface radiation levels and transport index (d) Certificates of Conformance and/or Compliance (e) Shipper's Certificate for radioactive materials (f) Peligro labels for air shipment 13.6 All safety-related conditions (operations, tests, inspections, and specifications) of the NRC package apprival and the U.S. Department of Transportation shipping require =ent are satisfied prior to shipment.
13.7 For all radioactive shipments, the departure, routing, arrival time, and destination of the package will be established and monitored to a degree consissent with the safe transportation of the package.
13.8 When a package is found to be defective and not conforming to all re-i quirements regulating its use, the nature of the defect shall be reported to the responsible Manager. The Manager will verify the item of non-conformance; tag the pack &ge as defective; segregate the package from normal inventory to prevent inadvertant use; and arrange for repair of t e defect, or disposal of the package.
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} AUTOMATION INDUSTRIES, INC.
] SPERRY DIVISION P.o. sox 245 Issued: 12-15-78, 7-9-79, & 9-17-79 PHCENIXVILLE. PA.19460 s
w (215) 933-8961 Revised:
~
QA Program (10-CFR-71) 14.0 INSPECTION, TEST, AND OPERATING STATUS i
i' 14.1 Each shipping package shall be metal engraved or stamped with model and I
serial number. Work order tags shall be attached to each package as a means of controlling the package as it progresses through the various phases of production.
14.2 Non-confoming shipping packages are defined as those which fail any t
of the inspection tests wh3.ch are safety-related to transporting of radioactive materials.
14.3 Defective of non-conforming packages shall not be processed beyond the point of defect detection. Defective packages shall be tagged accord-ingly, segregated, and not be used until final disposition of the pack-age is determined by Management.
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Sy-passing of any required inspections, tests, and other critical operations will be procedurally controlled and documented. These deviations must have the direct written approval of the responsible Management.
l 15.0 NONCONFORMING MA M IAL, PARTS, OR CCMPONENTS 15.1 Nonconforming items will be identified and tagged, documented, segre-gated, reviewed for rework or disposition, and all affected organiza-tions shall be notifiad of the nature of nonconformance.
15.2 Reject documentation will identify each nonconforming itam; describe i
the nonconfor=ance, the disposition of the nonconformance, and the subsequent inspection requirements; and shall include signature approval of the final disposition.
15.3 All nonconforming ite=s shall be segregated from acceptable inventory and will be tagged as discrepant until properly reworked or disposed of.
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AUTOMATION INDUSTRIES, INC.
'] SPERRY DIViblON j
P.o. Box 245 Issued:
12-15-78, 7-9-79, & 9-17-79 PHOENIXVILLE, PA.19460 y
Revised:
~~
(215) 333-6961 g s QA Program (10-CFR-71) 15.4 All nonconforming items which are reworked or repaired will be sub-jected to the same acceptability and inspection tests by retesting to original equipment inspection requirements.
16.0 CORRECTIVE ACTION 16.1 The responsible Management will evaluate all nonconformances ad-versary affecting quality and implement corrective action in ac-cordance with established procedures.
16.2 For all nonconformances affecting quality, the responsible Manage-ment will initiate corrective action to preclude recurrence.
16.3 Follow-up reviews are conducted to verify proper implementation of correct _ive actions and to close-out the corrective action documentation.
17.0 QUALITY ASSURANCE RECORDS 17.1 Records as required by NRC and DOT regulations and all complimentary documents generated by the QA Program shall be retained at the Phoeniriille, Pa. f acility.
17.2 All QA records are identified and retrievable.
17.3 A chronological log listing all QA records will be maintained.
17.4 All design related records such as drawings, calculations, test results, etc., will be maintained for the life of the shipping pack-age and all other records will be =aintained for a minimum period of two years.
1117 207 Page (16)
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] AUTOMATION INDUSTRIES, INC.
')
SPERRY DIVISION Issued: 12-15-78, 7-9-79, & 9
-/9 l
P.o. Box 245 PHCENIXVILLE P A. 19463
_. f" _a (215) 933-a961 Revised:
QA Program (10-CFR-71) 17.5 Where applicable inspection and test records will document the fe a
,g:
(a) A description of the type of observatica (b) Evidence of completing and varifying (c) The date and results of the Inspection or test (d) Any information related to conditions advarse to quality of the component or assembly (e) Identification of the inspector or person recording test data (f) Written evidence as to the acceptability of the results 18.0 AUDITS l
18.1 Due to the small size of the organization, it becomes rather difficult to implement a pre-established comprehensive auditing procedure. In reality, the two responsible Managers who work in close harmony, are auditing each other's responsibilities on a daily and informal basis.
18.2 We shall however, establish written procedures and/or check list for objectively evaluating or upgrading our QA Program. The entire QA assurance program will be ofjectively reviewed per:adically and at least anually.
18.3 Deficient areas uncovered by these objective evaluations will be reviewed and re-evaluated on a timely basis to assure that corrective actions have been taken to minimize recurrence.
18.4 Results of these audits will be documented and retained as part of our Radiation Safety Committee records.
P lii7 208 Page (17)
AUTOMATION INDUSTRIES, I tJC.
KIMBERTOtt ROAD, RT. ti l l 3 SOUTil SPERRY DIVISION PitOENIXVILLE, PF neiYLVANI A 19 % 0 ORGANIZATION STRUCTtlRE (REVISED JUNE 15, 1978)
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PRESIDtNT CORW i t'.>. DENNEY CORPORATE OFFICE RADIATION SAFETY COMMITTEE LOS ANGELES, CALIFORtJIA CtIAIRMAN:
M.P.
SANTORO SECRETARY:
STEPHEN BOYKO PRESIDENT COtJSULT ANT ; RADI AT ION MANAGEMEt.T JOliN E.
DW I GitT CORPORATION SPERRY DIVISION DAtJBe.Y, CONNECTICUT o
NUCLEAR PRODUCT MANAGER FACILITY
{l}
FACILITY RADIATION PROTECTION OFFICER SECREIARY MICilAEL P.
SANTORO DEBRA B RUtJOVS KY SPERRY DIVISION PtiOEN I XV I LLE, PEtJNSYLVANIA MACillNE StilP PRODUCTION MAf1AGER MACilll11ST (1)
STEPilEt1 BOYKO SPERRY DIVISION PtiOENIXVILLEJBPENNSYLVANIA (2.)
CONSULTANT liEALTit PtiYSICIST RADIATIOt1 TEClitJIC I ANS SPERRY DIVISION RADIATION MANAGEMENT CORPORATION IJ Pilo E N I XV I L L E, PEritJSYLVANI A CD Page (l8)
(Appervlix "A")
- PART 71 e PACKAG!NJ OF RADIOACTIVE MATERIAL FOR TRANSPORT-fAPPENDtB S=4UA1JTT Assvaases Carrum2a ros 3-. ncmom,on -an~.rm m=zu.
Ifstmsseawne-In asesedarass with I T1.24.
every app 11 cant for an approval for use of a stilpptag paczage le requtr d to desertbo his g
quaatty assurance program, and every lleensee
'/
1a Twquired by 9 71.11 to estabusta and maan-tain a quauty nasurance program for the dents.n. f=m * "a=_
menemmy, tesung, use, gg g nm b ap na gg gg.
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.e a s n.an a n em ined in I 7L4W.
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T2Lis appendis asuhtfahas qua!!ry assur-unce requzrements whLc.h apply to an ao-t17ttles agecting the canpenenta of the j
packaging wtLica are signitimat to safety.
a Tlamme activittas includs "f"tna purtaas.
Ing. fa.tricaung. %anamng szupptag atoring.
e' a= n in g assembung. Ev'a = tasting, operating.. n. as n eal aing g and snodifying.
As used in this appendtz. quauty assur-ence* comprisse an shame pisaned and s7e-arnaata actanes m to prtreme ade-pt
,mn mar. taas a system or aannnan=st win perfarm attatactortly la ssretee. Quanty i
assurance includes quauty control, wtuch comprians those quauty assursace actions ratated to conarus W tae palpusemi charmetar-1suce and quauty of tas matartal er cosapo-nant to predaterentnad requiremante.
l s
amma==ma' East De 1:ommene
- ehan be reopeasable !se the manansenwn.cs and emmentaan of the quausy easurance proerna. The ucenase army doingene so etaeru. aman sa -==-. agents. or con-3 sultants, the work of==> a= mots and eaa.
M cutLag tae quauty anstrance programa,or any g part therect, not anan retain r
^"'ty merefer. T*.re sottrar*ty sad dut2es of perstma gu. and erg==*=an=aa performing acttytties af.
ce Mag es afary-related functions of strue-
- tares, ayummumm. amL r===p===t=
aman to clear 6r essaeumma.: and dennessed ta wTtting.
T2name actarttaas include tota tae performing inneesana of aztainsag quanty c4}ectises and tha quamy assurance f"*ama The quanty
-)
assurance functacus are those of ta) assar-tag that se oppetyrtate quality essaranas pressam is estan11aned end eeneesvely ens-seind and (Di vettytng. suca as Df cwvng aud! ting, and inspectica. that act17ttama ei-footing tne safety-fglated funacces have basa eerreecy m...
- 4. The persons and org*mm-performing quality amurance f-*<==
anan bare suscsant asthartty and orgs n'e=t*enal freedom to identLfy stundty pretamme: to tmt2 ate, ree m mend or pzwetee enewtsams; mod to verify La-7a====*=#==
et entwatona. Stasen persons and creassastamme pararming queuer assur-amaa tamattas aman report so a man.
nemanna level suon same tais aquared authority and organisatasaal freedosa, in.
Cuding su!5ciant independaara from cost and senseu2e vtnen opposed to safety con-assernassam. ar, pseviews. necause at tme many varinMas tavedved pren es 12se numster at per===ama toe type of aseretty e.ene per-asemed. and me assassem er 9.=-
we-.
esuvtsses are perfr-==== sne ers===r==s serussure ear esecutang the genuty ammurance programa may smaa serious sorms psessend taas tne paremme and <=rma-ame nessanas me gemaar memesse fusamenes ammme earse.
epussedammaartesad & m sammapassame aan--
amressmee, gas w-tanarW anagnad the etay ser====tna esmouve examat:ma af any pe-tasa e sne gantny amro sam programas any 1'I17 90 m.~m.
- - mets. ans quanar naarean requmemommme are my,uemme is wasss==r emagn. --
aame, a===ary and tassag at tae passase as
-feavd with tempact to a pacange pesar to cze tazas a pentage appewena to lassed.
September 1,1978 7132 b
(a
PART 71
- PACKAGING OF RADIOACTIVE MATERIAL FOR TRANSPORT-location whera activttles subject to this Ap.
for morttinauon among parucipating dattgn mentary evidence that tnatertal and equ2p.
ment conform to the procurement spec 13 I
pendix are being performed stad have direct organizauona. Rene measures shall includa access to such ;evela ci management as may the estaDU d man t of written procedurse cations shall be availaote prior to inatalla.
l De necessary to perform thia function.
a.:nong part1C1pating design orgentwicna for tion or use of suC.h material and equipment.
I the rettaw approval. roleseo. distribuuon.
Ela documentary evidence shad be retained I
- s. evalm aasvaama nsaans and rettaton of documents involving design by or be aradable to the licensee and shall te no licensee shad ee'ahttah && the earliest laterfaces. De design control measures saa.1 su?.cled t to idenufy the speciac require.
practicable time, consistent with the ached.
provide for vertfring or checking the ade.
menta met by the purchased material and ule for accomrl'tMLg the activstles, a qual.
quacy of desigm sucn as by the performance eeutpment. no efec-17enese of the control of design rettaws. by the use of alternate or of qus11ty by contractors and subcontractors try assurance program which compues wtta atmouhad calculational methods. or by the shall be saseased by the licensee or designee the requirementa of this append 13. De qual.
performance of a suitable tat 1ng program.
at intervaLa consistent with the importance, ity assurance program shall be documanted ne vertlytsg or checaing process saa.1 be complesity and quantity of the product cr by written procedures or instructions, and shM be carried out in accordance with those performed by individuals or groups other
- serytcas, j
procadurve throughout the period during than thces who performed the artginal de.
- 4. 3MT:FICATEDN a2O CONMOL or Marta2aLs.
wtLich pacanging la used, ne uctasse shall algn. but who InaF be from the same orgsni.
Paars aun coupowsarts tdenufy the material and componauta to be sauon. Where a test prcgram is used to rer.
covered by the quauty amourance program and ify the adequacy of a spec 1Sc design feature Messuno shall be estahuahed for the iden.
the major organizations partsc2pating in the in usu of other verifytng or checaing proc
- t1acation and control of matertala, parts and program togemer with the daelgnated func.
esame. It shalt include suitsolo quallacation components. Reas measures snau nasure con of these orr.m w_. ne quauty as.
tasung of a prototype or sample unit under that identiccauon of the item is mamtained the tcost adeerse dest (n Conditions. Design by heat number. part number. or other ap.
oursace pmgram shall provide control over control messuno snau ne applied to items prepriate maaan elmer on the sum or on activittes n.cecting the quauty of the identi.
Sed matartals and components to an extens such as the fonowing: crtucality physace.
records traceabu m me item, as nquired constatant with their Laportance to safety, radiation shielding. strees, thermal hydrau.
mroughout fabrication. l' #.tian, and use
!!c. and accident analyses 1 compatibtuty of of the item. Does identia' cation and control i
and as necessary to aneure conformance to matartada; accesalbutty for inaervtco inspec.
ng.asures shall be designed to prevent the use me the apprtreed des gn of each 1mdividual pach.
uon. maintenance and sepairt features to fa.
f ncornet or defacute c'.ater*A paru and nge used for the shipment of radioactive me.
tartal. Activttles asecung quality shall be cultate decontammmHan; and delinenmon of composants.
accompushed under sultaD1y controued con.
acceptance enterta ter inspecuans and testa.
dittons.- Controlled ancluons include the Design changes including fold chtages, s coarrsoL oF srEC2aL PacCNE I
une of appropriata equipment; suitable en.
shall be subject to design control measures Mesaures can k estabEM 2 anwe I
vtronmental conditioos for
.~~a"M commensurate with thoes appued to the ortg.
tus sm! procum. Inclumng wM M the activity, such as adequate clesanone: and ir.a4 design. Changes in the conditions spect.
- mo aon.,mameforme,ven had m me p.mge a,,,ovai mqmre -
,,,,,, eating, and _nonde,st,ru,cu,vo testing.,,me, heat tr
,,ued,,,,,,,,
-umy ove - a=.sh.d. ne p-
-n mmvai.
,e, nal u m,
.,_ edu,es 1, ac.
= = ta= m= G=o==t = - r n a==1 m_ _ comm.
. nmace m m m ucam. code,..o nda,da.
UU E
E criterta. and other speClat amus m omm me regere quaan. and m.
Me es.o eenamh.dma een spec 1Scation,s.
,,,m,e man need f r verNMm of quauty by inspection apc11 cable requirements of this part ehich l
is.nennenen are necemary w u.un adequate quauty are and tut.
no ucen.ee beae me -=
emsauy memd.d o, -ferenced m m. 4-u.
f.
'e manta ter procurement of material. equip
- a M
e 3 e,d proceiums of his quauty assurance pro. E mam. and.,vt-s. wbemer pmchased by 2.
%,,e,n,,,,,,, m,,,,,,,,,,,,e,,,,,,,,
i an on.he fouo ng - namers o n. c..
nmg me comme,1, and,ro-o.d u.e of a
.ns.e or by hla mm,act-s or.obcontrac.
uc m
,,,,,,,,,,,,,,,,,,,,,,,,,,,,m, c
m m. = m e a m o n-
. m. ucena.e m.,emg. and ne -Es:
A CC (1) De importance of malfunction or { aha;1 require centractors or subcontractors kd or accomp a 8 th ac 1 Y Su
- rs11ure of the item to safety!
to provide a quauty assurance program con.
u be o od y art I a: stent with the pertinent provisions of this Q E
(2) ne dealgs and fabr! canon complexity g
>=
bemg ms,.t.d.r.. _ auon.mesau,,mema.
- muque=- of me --1 or testa cf matartal or products processed (3) no need for special controls and sut*
- s. nrsrstrcTtown. raocrotrazs awo ouwtxas anan be performed for each woric cperation vetuance o"r prn=ama and equipment; Activttles afecting quality sha11 be pre
- where nunnary to usun quality. If 'aspe.
(4) ne degree to which ftmettonal com.
acnbed by documentec 'nstructions, proce*
tion of processed material or products is pliance can M demonstrued by mspuuon durse or drawings of i. type appropriate m impcasible or disadvantageous. Indirect con.
or tast; and
- I I " ** *"#**I E' **'**"8
- D
(5) no quauty history and degree of in ce wt then atr-ns.
s E*
n "and standardization of the itsm.
dures, or art wings. name shau include appro.
a oc pmcess znonitumg De prwant shall provide for tndoctrin&*
prtate quantitative or qus11tauve acceptance w en W e ntn1 is in.
tion and training of personnet performing criteria for determming taat impcrtant ac.
a equa aw ut both. U mandatMy inspw.
I act17tues afecting quauty as necessary to na*
tivitise have been satisfactorily accomplished.
Wn hold pointa, which Mqmn witnnstng sure thaa sustable prodctancy ts acateved and or inspecting by the licensee's designated
- e. DoctruzwT cornos, maintained. ne ucansee than review the status ad a
e Measures snau be established to ecatrol the t r
- t. out the t of d 4 C'
8 68 8.
nated nomeentatin an mqmnd, the spe.
agement of other organizations partictpating P
M1 ed ;n appm.
In the quauty assurance program shall recu.
h to[w'h1 7
s af a
g larty review the status and acequacy of that Ing quauty. These measures snau assure that pan of the quaun asemance pregnas which documents. Including changes, are reviewed it. TEST cowraoh they art esecuung.
for adequacy and approved for reles*e by au.
g g,g g
thortzed personnel and are distr:buted and nasure that all tastinI "Sutred to demon.
- 3. Danser cowTeot.
used at the location where the prescrtbed ace strs*4 that the pechaging components will Measwee shan be estabushed W MeUn t19117 la perfertned. Changes 13 documence perform satisfactority in serMce 18 !denti$ed mat appuesMe MgWatory mqmrernenu and shall be reviewed and approved by the same and performed in accordance wit 3 wnt:en the package design as spec 1hed in the 11*
Organizations that performed the original re.
test proemima unich inewpcn'a the M.
conse. for thee materials and canponsnm v;ew and scoroval uniese the appi: cant den, quarementa of thLs part and the requirements to which this appendix appues, are correctly ignates anothe* crgana:ation.
and acceptance 11 mats contained ;n the pact.
translated into spec 1Scations. dnwings, pro.
cadures and instructions. Bene measures T. CONTROL or rtraCman uaTEsza1.
age approval. The procedures shan include tectruxwT. amo stavtcxs protts;ons for nasuring that all prerequisites ans11 include proviatons to assure thas sp.
for the ginn test have been met, that ade.
pregnate clanty standards an spec 1had and kaasures ahan be established to nasure that quate test instrumentation is avsuatie and includsd in design documents and that dert*
purchased ma:ertal, equipment. and services, used. and tnat the test is performed under astons frosa such standards an contreued.
whether purchaasd directly cr througa con, euttabie enttronmental conditicca. Test re.
Measures anan be estanushed tw the selec*
tractors and s lecontractors, conform to the suits snau be docuented and evalustad *.o tion and review for sultactuty of appdcation procurement documents. These measures aseum that *ms nqmnmenta han been of matarius, paru. equipment, and proemes a;su include provtsnons, as sopreprtate, for A&# **
that are eenential to the safety.related func*
sourre evaluation and selection, oOjective tions of the materials parta, and componenta evidence of quauty furnished by the con
- 1s. ccwrnot, or wrastra:No awo Tr3T of the panafwe tractor or suocontracter. inspection at the termuswT Measures anan be estaottahed fcr the iden*
cont actor or subcontracter scurce. and ex.
Measures shC1 de estan11shed to usure
- "an and control of design interfaces and amination of producta upon delivery. Docu.
PART 71
- PACKAGING OF RADIOACTIVE MATERIAL FOR TRANSPORT-saat toots rag =. tnetruments.==4 othe i neeuranc= program and to detarmine th. af.
measuring and tasting dettces used in ac. I factiveness of the program. The audits staa uvittee adecuns quancy are property con. g be performed in menordance with the wrts.
troned. caubrated. and adjusted at spectaed ten procedures or chaca uste by approprtataly times to maintain accuracy within neces. A trained personnet nos having direct respon.
)
s cc. e Dulues tn the arene botag audited. Audit
,)
eary unute, h results shall be documented and rettewed by 1s. auroLove. Grosaas aare surperme
- c. mana,-nant having responatttury in the Steneures shan be estabushed to controg ' area austed. Pocowup ecuan. Including re=
audit of danMant arena, abad be laten eaafo the hanating storage. shipping. cleaning and pressrvation of matertala and equipment to jd'**d' be used in packaging in accordance vita instructions to prevent damage or detertors.
taan. When necessary for particular producta, spec an prosecuve enetronments, such as inert gae atmcephere, spectSe moisture content leTels and temperatupo isvale shall be specie Sad and provided.
- 38. tarerecTzow. TaeT aJrs opuearzze stafoe Measures aban be ee'ahrkh=4 to indicate.
by the use of martings suc4 as stampe. tags.
l labete. touting carta or other euttable m ana, the status of inspections and testa performed
.i upon Indartdua4 ttame of the -Wng i
These measures saan provide for the iden-uncanon of items wnica have sausfactorur passed required inspect 1one and teste. where necessary to proctude inadvertant by-paesing of such inspecunna and testa.
Measures anau also be established for in.
dicating the operating statue of components of the packaging, such as tagging valves and switches.,te prevent inadvertant operation.
Es.maartzzarrosamre asarmazata, raars. os coasroarmrre Measures shan be estabushed to control materiale. parte, or components which do not conform to requiremente in order to pre.
Tent their inadvertent use or instauauon.
These meneures shan include, as appro=
, pris,r,s procedures for ident12cauon, docu.
$ mentauon, segregation. dispoettion, and g notinematon to maected organizauone. Hon.
' confortning items shan be rettawed and no.
u.' copted rejected repaired or reworked in ac.
,, cordance vtta documented procedures.
t e. - m.
acTIow Maamuros shall be telahllaned to secure that conditions adverse to quality, such as deficiencise, devtstiona. defective matertal and equipment. and nonconformances, are prompuy identined and ccerected. In the case of a signtAcant condation adverse to quanty, the maneures shall neeure that tas cause of the conditaca to determined and corrective actson tamen to proctuda repots.
t1oa. The idenuncation of the sign 1 Scant condttson adverse to quauty, the cause of the condittorn and the correcuve scuon taken shad be documented and* reported to appas levels of management.
q g
- 17. evaLETT assotaarcs -"*
l t l gufBetent wvitten reecede than be insane tained to furtuah evidence of activtues af.
!Weting (taality. The recorde shah fnclude the inDowingt destga recorde. restede of use and the results of twriese. inspections, teste, endia monstortue of wort perfemance, and nasaartels analyene. The reenrde eBau also tastufu closely-reested daan each as quanS.
ent&one of personnet prosedures, and equip =
imant. Inapoedon and test records eBall, as a 21stannt. tdantLfy 17
- Inspector or data remereer, the type of of
% the reenita, the asseptabuity, aaf 44. antaca taken in
-aa vtta any - noesse. See-een aman be waam and fuertovanta.
rm==aa t wtsa appuoiale requissory re=
quiremana the :1cenese aban estabusa re-quaremente concerning record retention, saca se doemstem.1ecesaca, and esadOed respone ebbGaty.
- te.A - rw A oemprobendv0 oTeteen at paennan and pertodas endste anan be carried out to verify mn=aaa with an aspects of the quauty Septembef 1,1978 71 14 ggg W