ML20214B334
| ML20214B334 | |
| Person / Time | |
|---|---|
| Site: | 07100574 |
| Issue date: | 01/31/1986 |
| From: | IOWA STATE UNIV., AMES, IA |
| To: | |
| Shared Package | |
| ML20214B323 | List: |
| References | |
| NUDOCS 8602200538 | |
| Download: ML20214B334 (4) | |
Text
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r 10 CFR PART 71 QUALITY ASSURANCE PROGRAM FOR IOWA STATE UNIVERSITY January,1986
- 1. Organization The final responsibility for the Quality Assurance (GA) Program for Part 71 requirements rests with Iowa State University. Design and fa'brication sha11 not i
be conducted under this GA Program. The QA Program is implemented using the-l organization shown in Figure 1.
The Radiation Safety Officer is responsible for overall administration of the program, training and certification, document control, and auditing.
4 The Environmenta1 Health and Safety Department is responsible for handling, i
storing, shipping, inspection, test, operating status, and recordkeeping.
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- 2. Quality Assurance Program The management of Iowa State University establishes and implements this GA Program. Training, prior to engagement, for all GA functions is required according to written procedures. QA Program revisions will be made according to l
written procedures with management approval. The QA Program will ensure that l
all defined QA procedures, engineering procedures, and specific provisions of the package design approval are satisfied. The QA Program will emphasize control of j
the characteristics of the package which are critical to safety.
The Radiation Safety Officer shall assure that all radioactive material shipping i
packages are designed and manufactured under a QA Program approved by the Nuclear Regulatory Commission for all packages designed or fabricated after i
January 1,1979. This requirement will be satisfied by receiving a. certification to this effect.-
- 3. Document Control All documents related to a specific shipping package will be controlled through -
i the use of written procsdures. All document changes will be performed according i
to written procedures approved by management.
l The Radiation Safety OHicer shall insure that al1 GA functions are conductolin i
accordance with the latest applicable changes to these documents.
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- 4. Handling, Storage, and Shipping f
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Written safety procedures concerning the handling, storage, and shipping of packages for certain radioactive materials will be followed. Shipment will not be made unless all tests, certifications acceptances, and finat inspections have w
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been completed. Work instructions will be provided for handling, storage, and shipping operations.
Environmental Health and Safety personnel shall perform the critical handling, storage, and shipping operations.
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- 5. Inspection Test, and Operating Status Inspection, test, and operating status of packages for certain radioactive materials will be indicated and controlled by written proceducts. Status will be indicated by tag, label, marking, or log entry. Status of nonconforming parts or ~
packages will be positively maintained by written procedures.
Environmental Health and Safety personnel shall perform the regulatory-required inspections and tests in accordance with written procedures.
The Radiation Safety Officer shall ensure that these functions are performed.
- d. Quality Assurance Records 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. Descriptions of I
equipment and written precedures will also be maintained.
These records will be maintained in accordance with written procedures. The records will be identified and retrievable. A list of these records, with their storage locations, will be maintained by the Radiation Safety OHicer.
- 7. Audits Established schedules of audits of the QA Program will be performed using written check lists. Results of audits will be maintained and reported to management. Audit reports will be evaluated, and deficient areas will be' 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 the quality assurance records.
Members of the audit team shall have no responsibility in the activity being audited.
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LEVEL 1 UNIVERSITY PRESIDENT p
3 i r VICE PRESIDENT VICE PRESIDENT ACADEMIC AFFAIRS e
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DEAN OF
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-- - COMITTEE MOEERSHIP Figure 1.
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