ML20128N215
| ML20128N215 | |
| Person / Time | |
|---|---|
| Site: | 07100609 |
| Issue date: | 10/02/1996 |
| From: | SCIENTIFIC MEASUREMENT SYSTEMS, INC. |
| To: | |
| Shared Package | |
| ML20128N119 | List: |
| References | |
| NUDOCS 9610160325 | |
| Download: ML20128N215 (3) | |
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l QUALITY ASSURANCE PROGRAM 1.
Oraanization The f!nal responsibility for the Quality Assurance (QA) Program for Part 71 j
Requirements rest with Scientific Measurement Systems, Inc. (SMS). Design and Fabrication shall not be conducted under this QA Program. The QA Program is implemented using the l
organization depicted in Fig.1.
The Radiation Safety Officer is responsible for overall administration of the program, training and certification, document control, and auditing.
The Radiographers/Tomographers are responsible for handling, storing, shipping, inspection, test and operating status and record keeping.
2.
Quality Assurance Proaram 1
The management of the SMS Radiation S3fety Program establishes and implements this QA Program. Training, prior to engagement, for all QA functions is required according to written i
procedures. QA Program revisions will be made according to written procedures with management approval. The QA Program will ensure that all defined QC procedures, engineering prodders, and specific provisions of the package design approval are satisfied. The QA program will emphasize control of the characteristics of the package which are critical to safety.
The Radiation Safety Officer shall assure that all radioactive material shipping packages are designed and manufactured under a QA Program approved by the Nuclear Regulatory Commission for all packages designed or fabricated after January 1,1979. This requirement will be satisfied by receiving a certification to this effect from the manufacturer.
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Document Control All Documents related to a specific shipping package will be controlled through the use of written procedures. All document changes will be performed according to written procedures j
a and approved by management.
3 The Radiation Safety Officer shall insure that all QA functions are conducted in accordance with the latest applicable changes to the documents.
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Handlina. Storace. and Shinoina Written safety procedures conceming the handling, storage, and shipping of packages form certain special form radioactive material will be followed. Shipments will not be mado unless all test, certifications, acceptances, and final inspedions have been completed. Work instructions will be provided for handling, storage, and shipping operations.
Radiography / Tomography personnel shall perform the critical handling, storage, and shipping operations.
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Insoection. Test. and Ooeratina Status inspection, test, and operating status of packages for certain special form radioactive material will be irkilcated and controlled by written procedures. Status will bo indicated by tag, label, marking, or log entry. Status of nonconforming parts or packages will be positively maintclned by written procedures.
9610160325 961002 PDR ADOCK 07100609 C
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Radiography / Tomography personnel shall perform the regulatory required inspections and test in accordance with written procedures. The Radiation Safety Officer shall ensure that these functions are performed.
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Quality Assurance Recorda Records of package approvals (including references and drawings), procurement, inspections, tests operating logs, audit results, personnel training and qualifications and records of shipments will be maintained.
These records will be maintained in accordance w'th written procedures. The records will be identified and retrievable. A list of these records, with there storage locations, will be maintained by the Radiation Safety Officer.
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Audits 4
Established schedules of audits of the QA Program will be performed using written check l
lists. Results of audits will be maintained and reported to management. Audit reports will be evaluated and deficient area corrected. The audits will be dependent on the safety significance of the activity being audited, but each activity will be audited at least once per year. Audit reports will be maintained as part of the quality assurance records Members of the audit team shall have no responsibility in the activity being audited.O
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i PRESIDENT 6
CEO l
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RADIATION SAFETY OFFICER 1
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SECURITY OFFICER t
QUALdY ASSURANCE MANAGER i
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SALES AND RESEARCII AND ADMINISTRATIVE MARKETING DEVELOPMENT SERVICES Sales Orders Contract Research Accounting j
Customer Liaison In-house Development Purchasing Product Brochure Scanning Services Contract Administration J
Advertising Application Studies Inventory Control J
Trade Shows t
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Scientific Heasurement Systems Ft:nctional Organization Chart a
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