ML20009E069
| ML20009E069 | |
| Person / Time | |
|---|---|
| Site: | 07100458 |
| Issue date: | 05/05/1981 |
| From: | Duplissey J, Lamay U, Titano J CATALYTIC, INC. (SUBS. OF AIR PRODUCTS & CHEMICALS |
| To: | |
| Shared Package | |
| ML20009E066 | List: |
| References | |
| 19105, CI-QAP-712.5, NUDOCS 8107270042 | |
| Download: ML20009E069 (15) | |
Text
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CATALYTIC, INC.
Sheee i of
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Centre Square West,1500 Market Street, Philadelphie, Pennsylvanie 19102 f,
l Rev.
0 CI-QAP-712.5 Date: 5/5/81 CATALYTIC, INC.
QUALITY ASSURANCE PROGRAM i
l FOR INDUSTRIAL RADIOGRAPHY IN COMPLIANCE WITH 10CFR PART 71 APPROVED BY:
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'If Rh Lamah Yrl Director - Qual ty Assurance APPROVED BY _
,M io DATE: f,f- [/
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James
- D pl[ssey 6
Acting Radi on Safety Officer
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A APPROVED BY:
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John A. Titano~
551' DATE:
orporate Level III, Non-Destructive Examiner 8107270042 810507 PDR ADOCK 071004S8 C
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CATALYTIC, INC.
Sheet 11 of lii Centre Square West,1500 Market Street, Philadelphia, Pennsylvania 19102 I
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Rev.
0 CI-QAP-712.5 Date: 5/5/81 EFFECTIVE PAGE LIST Page No.
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5/5/81 Attachments Revision Level Effective Date A-1 0
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' Sheet 111 of lii Centre Square West,1500 Market Street, Philadelphia, Pennsylvania 19102 E
Rev.
O CI-QAP-712.5 Date: 5/5/81 1
TABLE OF CONTENTS SECTION DESCRIPTION PAGE 1.0 PURPOSE AND SCOPE 1
2.0 ORGANIZATION 2
3.0 QUALITY ASSURANCE PROGRAM 5
4.0 DOCUMENT CONTROL 6
5.0 HANDLING, STORAGE AND SHIPPING 7
1 6.0 INSPECTION, TESTS, AND OPERATING STATUS 8
1 7.0 QUALITY ASSURANCE RECORDS 9
8.0 AUDITS 10 l
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aeosa_ scree CATALYTIC, INC.
Sheet 1 of 11 c
Centre Square West,1500 Merket Street, Philaoelphia, Pennsylvania 19102 I
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CI-QAP-712.5 Date: 5/5/81 1.0 PURPOSE AND SCOPE 1.1 This program is intended to a'sure that the requirements of 10CFR71*
are met as they apply to Catalytic, Inc.'s industrial radiographic operctions. This program applies to all Catalytic, Inc. operations governed by License No. 37-12931-02 issued to Catalytic, Inc. by the U. S. Nuclear Regulatory Commission.
1.2 This program applies to procurement, maintenance and repair, handling, storage, shipping, inspection and test ig, records, and audits of activities relating to Type B shipping containers used 1
for radiographic sources.
- 1. 3 Design and fabrication of shipping containers shall not be con-ducted under this program.
- 10CFR71: Nuclear Regulatory Commission Rules and Regulations, Title 10, Chapter 1, Code of Federal Regulations - Energy, Part 71, " Packaging of Radioactive Material for Transport and Transpcrtation of Radioactive Material Under Certain Conditions".
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,1, CATALYTIC, INC.
Sheet 2 of 11 Centre Square West,1500 Market Street, Philadelphia, Pennsylvania 19102 l,
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0 CI-QAP-712.5 Date: 5/5/81 2.0 ORGANIZATION 2.1 The final responsibility for the Quality Assurance (QA) Program for Part 71 requirements rests with Catalytic, Inc. The QA Prograa ic implemented by the Organization shown in Figure 1.
2.2 The Radiation Safety Officer reports to the Vice President and Chief Engineer. He is responsible for indoctrination, training and certifi-cation of radiography personnal in the radiation safety aspects of this program. He 10 also responsible for auditing the radiation safety aspects of the program.
2.3 The Radiographic Auditor reports to the Radiation Safety Officer.
He is responsible for performing on-site audits of the performance of radiographic operations as directed by the RSO.
2.4 The Director - Quality Assurance has been delegated overall respon-sibility and authority for the Catalytic Quality Assurance Program by the Senior Vice President and General Manager - Operations Division.
The Director - Quality Assurance and his staff shall have unlimited accees to all departments, jobsites and other areas involving the radiographic program and shall receive the cooperation of all per-sonnel in carrying out their responsibilities.
n es sene CATALYTIC, INC.
Sheet 3 of 11 Ce'stre Square West,1500 Merket Street, Philadelphia, Pennsylvania 19102
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Rev.
O CI-QAP-712.5 Date: 5/5/81 2.4 (Continued)
The Director - Quality Assurance is assigned the responsibility, authority and organizational freedom to establish and execute such quality assurance methods cnd systems us are required to insure that the radiographic program is conducted in full compliance with applicable manuals, procedures and instructions.
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The Supervisor - Quality Assurance Audits reports to the Director -
l Quality Assurance. He schedules periodic audits of field QA activities to evaluate the effectiveness of the QA program. He also assures that auditors are independent of the function being audited.
The Director - Quality Assurance assures development of training plans and instructions for quality related work as necessary to imple-ment this program. He issures that all perconnel performing quality related work are qualified in the area of their activities.
He provides for an annual management review of the effectiveness of the Quality Assurance program.
g 2.5 The Manager - Field Quality Assurance, Corporate Level III Non-Destruc-tive Examiner reports to the Director - Quality Assurance. He is responsible for the Corporate NDE program. He develops, maintains and distributes all NDE procedures for NDE methods.
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2 s t e 2._ t 373JD CATALYTIC, INC.
Sheet 4 of 11 Centre Square West,1500 Merket Street, Phi!adelphia, P onsylvania 19102 k,
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Rev.
0 CI-QAP-712.5 Date:
5/5/S1 2.5 (Continued)
He provides technical direction to NDE personnel, including train-ing in NDE methods and qualifying and certifying NDE Level I and Level II personnel.
2.6 The Radiographic Supervisor reports to the Manager - Field Quality Assurance through onsite supervision. He is responsible for handling, atoring, shipping, inspection, test and operating status of radio-graphic equipment and record keeping for all radiographic operations.
2.7 The Radiographer reports to the Raviographic Supervisor.
He is i
responsible for handling, storing, shipping, inspection, test and operating status of radiographic equipment and record keeping for all radiographic operations.
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CATALYTIG, INC.
t Centre Square West,18iOO Merket Street, Fhiladelphia, Pennsylvania 19102 j
Sheet 5 of 11
,1 Rev.
0 CI-QAP-712.5 Date: 5/5/81
- 3. 0 QUALITY ASSURANCE PROCRAM 3.1 The management of the Catalytic, Inc. radiography program establishes and implements this QA program.
3.2 Training for all quality assurance functions 13 required and shall be performed as described in Catalytic written procedures before the activity is performed.
3.3 Quality Assurance program revisions will be made according to written procedures and shall be approved by the Director - Quality Assurance, by the Radiatien Safety Officer and by the Corporate Level III Non-Destructive Examiner.
3.4 The QA program will ensure that all defined QC procedures, engineer-ing procedures, and specific provisions of the package design approval are satisfied as described in Catalytic's Operating and Emergency Procedures.
The QA program will emphasize control of the charac-teristics of the package that are critical to safety.
3.5 The Pnd',. ion Safety Officer shall assure that all radioactive meterial packages used by Catalytic personnel are designed and manufactured under a QA program approved by the Nuclear R2gulatory Commission for all packages designed or fabricated af ter January 1, 1979.
This requirement will be satisfied by receiving a certifica-tion to this effect from the manufacturer.
meres _ssne CATALYTIC, INC.
M eet 6 of 11 Centre Square West,1500 Market Street, Philadelphie, Prusylvanie 19102 Rev.
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Cl-QAP-712.5 Dets:
5/5/81 4.0 DOCUMENT CONTROL 4.1 All documents related to a specific shipping package shall be con-trolled through the use of written procedures. All instructions, procedures and drawings shall be properly identifie 1, controlled, distributed, and maintained to assure that the latest revision is in use and that superseded docuraents are destroyed or marked void.
4.2 The Radiation Safety Officer shall insure that all QA functions are conducted according to the latest changes to these documents.
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I inner enow CATALYTIC, INC.
Sheet 7 of 11 Cer.t.e Square West,1500 Market Street, Philadelphia, Pennsylvania 19102 E
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Rev.
O CI-QAP-712.5 Date: 5/5/81 5.0
_ HANDLING. STORAGE AND SHIPPING 5.1 All handling, storing and shipping of packages for special form material shall be conducted according to approved written proce-dures and shall be documented as required.
5.2 Shipments shall not be made unless all tests, certifications, acceptances, and final inspections have been completed.
5.3 Only those radiography personnel authorized by the Radiation Safety Officer shall perform the critical handling, storage, and shipping operations.
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3 tp 4 2 94P4P C ATALYTIC, INC.
Sheet 8 of 31 y
Centre Square West,1500 Market Street, Philadelphia, Pennsylvania 19102 E,
5 Rev.
0 CI-QAP-712.5 Date:
5/5/81 6.0 INSPECTION, TESTS, AND OPERATING STATUS 6.1 Inspection, test, and determinacion of operational status of packages for special form material shall be performed according to written procedures.
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6.2 These activities shall be performed by personnel trained in the i*
proper procedures and techniques and authorized by the Radiation Safety Officer.
6.3 The results of inspections, tests and status checks shall be docu-mented as required by the applicable procedure.
6.4 Any exposure device, shipping container, or package for special form material found to be defective as a result of an inspection, test, or check of operational status shall be immediately removed from service and conspicuously tagged or marked and secured to avoid inadvertent use.
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e s ee,a r snow CATALYTIC. INC.
Sheet 9 of 11 y
Centre Square West,1500 Maehet Street, Philadelphia, Pennsylvania 19102 E
f Rev.
O CI-QAP-712.5 Date: 5/5/81 7.0 QUALITY ASSURANCE RECORDS 7.1 Written records shall be maintained to furnish evidence of compli-ance with operating procedures and instructions and this program.
7.2 Records shall be maintained in a legible, orderly and retrievable manner by the Radiation Safety Officer or other assigned and respon-sible radiographic personnel.
I 7.3 Records shall include the following:
Package approval (including references and drawings)
Procuremerit documents Inspections Tests Operating logs Audit results Personnel training and qualification Monitoring of work performance Records of shipment Operating procedures Equipment descriptions Other procedures as described or referenced in this program.
7.4 The Radiation Safety Officer or his designee shall be responsible for maintaining these records and for establishing the location i
and duration of retention for record storage.
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CATALYTIC, INC.
Sheet 10 of 11 Centre Square West, IliOO Merket Street, %iladelphia, Pennsylvania 19102 l
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Rev.
0 CI-QAP-712.5 D*t':
5/5/81 8.0 AUDITS 8.1 The Radiation Safety Officer or his designee shall be responsible for performing audits to assure com;.liance with this program.
8.2 The Directc r - Quality Assurance shall be responsible for providing an annual management review of this Quality Assurance Program.
8.3 Audits shall be conducted according to a schedule established by the Radiation Safety Officer and shall include announced, unannounced, specific and randomly selected evaluations of radiographic operations, shipping and receiving of radiographic sources, and associated activities. These activities will be audited for compliance with Catalytic Operating and Emergency Procedures and other directives and instructions established by the Radiation Safety Officer.
8.4 Audits shall be performed by suitably qualified personnel having no direct responsibility for the activity being audited.
8.5 A written check list shall be prepared and used during the perfor-mance of each audit.
6.6 The results of all audits shall be distributed to appropriate levels of management and operating personnel.
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m naar eerse CATALYTIC, INC.
Sheet 11of 11 Centre Square West,1500 Market Street, Philadelphia, Pennsylvania 19102 E
E e
Rev.
O CI -QAP-712.5 Date: 5/5/81 8.7 Audit reports identifying unsatisfactory results shall be distri-buted using a Letter of Transmittal showing the full distribution of the report.
8.3 Audit renorts shall identify.he person responsible for resolution of unsatisfactory conditions and shall specify a time period for response.
8.9 Audits shall be conducted on t least an annual basis, or as estab-lished by other applicable Catalytic, Inc. procedures.
Audit fre-i quency will be dependent on the safety significance of the activity.
l 8.10 Audit records, including distribution, reply, and resolution of a
unsatisfactory items shall be maintained by the Radiation Safety Officer.
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- s s a_ i e n, CATALYTIC, INC.
SheetA-1 of A-1 t
Centre Square West, Qa0 Markst Street, Philadelphia, Pennsylvania 19102
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,1 Rev.
0 CI-QAP-712.5 Date: 5/5/E1 0
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