ML19350E977
| ML19350E977 | |
| Person / Time | |
|---|---|
| Site: | 07100444 |
| Issue date: | 05/28/1981 |
| From: | Macdonald C NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS) |
| To: | Schnell C NIC TESTING SERVICES, INC., (FORMERLY NATIONAL INSPEC |
| References | |
| NUDOCS 8106230710 | |
| Download: ML19350E977 (3) | |
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NUCLEAR REGULATORY COMMISSION
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' National Inspection & Consultants Inc.
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-Radiation Safety Officer 4621 Royal Ave., P.O. Box 10 Coropolis, PA 15108 Gentlemen:
We have reviewed your quality assurance (QA) program dated April 8,1981,
-in -support of transportation activities for radiographic devices.
Unfortunately, the QA program description included asSection IX cf your Radiation Safety Manual does not meet our requirements for a self-contained document.
While there.can be flexibility in how-the QA program is presented, we cannot A
accept your extensive reference to other sectOns of the Radiation Safety Manual as an adequate commitment.
In order to assist you in preparing an acceptable submittal, we have enclosed as guidelines "10 CFR Part 71, Program for Industrial Licensees" dated March 27,1980. We suggest you follow its format in preparing your QA program description.
If-you have any questions on what we require, or need further assistance, we would be pleased to meet with you and your staff.
Sincerely, Y& f&- k Charles E. MacDonald, Chief Transportation Certification Branch Division of Fuel Cycle and Material Safety, NMSS
Enclosure:
As stated l_
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n 3.x March 27, 1980 (Revision 2)'
10 CFR PART 71 OA PROG' RAM FOR ~ INC'JSTRIAL RADIOGRAPHY LICENSEES
' ' El. Organization
-The final responsibility for the' Quality Assurance (QA) Program for
.Part 71 Requirements rests with (Company Name).
Design and Fabrication shallinot'be conducted under this QA Prograu. The QA Program is imple-mented using the following organization:
Note:.The Organizational Chart as used in the license application should be presented.
It may be advisable to designate the Radiation Safety Officer as the responsible individual for the-Part 71 QA Requirements.
ine Radiation Safety Officer is responsible for overall administration of the program, training and certification, document control, and auditing.
The Radiographers are responsible ~for handling, storing, shipping, inspection, test and operating status and recordkeeping.
- 2. -Quality Assurance Program The management of (Company Program) establishes and implements this QA-Program. Training, prior to engagement, for all QA functions is required according to written 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 procedures, 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
~ hippirg packages are designed and manufactured under a QA Program approved s
by the Nuclear Regulatory Commission for all packages designed or fabri-cated after January 1,1979. This requirement will be satisfied by receivhig-A certification to this effect from the manufacturer.
- 3..Cocrent Centrol All documes.ss. elated to a specific shipping package will be controlled through the use of wr itten procedures. All document changes will be cerformed according to written procedures approved by management.
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The ' Radiation Safet/ Officer shall insure that all QA functions are
. conducted in acccrdance with the latest applicable changes to tnese documents.
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t L4; -Handling, Storage,.a,nd Shipping 1 Writtenssafety procedures concerning the handling, storage, and shipping
- ofL packages for
- certain special form radioactive material will be'folicwed.
o Shipments.will not be made unless all-tests, certifications, acceptances,.
and final' inspections-have been' completed. Work instructions will be.
provided-for-handling, storage, and shipping operations.
Radiography personnel sha.ll perform the' critical handling, storage, and -
-shipping operations.
5.
Inspection, Test, and Operating Status
- spection, test, and a:erating status of packages for certain scecial n
form radioactive material will be indicatad and
... rolled by written precedures. Status will tre indicated by tag, label, marking, or leg entry. Status of nonconforming parts or packages'will be posinively maintained by written procedures.
a Radiography personnel shall perform the regulatory required inspections
~ and tests in accordance with written procedures. The Radiation Safety 0fficer shall ensure that these functions are performed.
- 6. LQuality Assurance Records Records of package approvals (including references and drawings),
procurament, inspections, tests, operating logs, audit ~ results, personnel training.and qualifications and records of shipments will be maintained.
Descriptions of equipment and written procedures will also be mair.tained.
These records will be maintained in accordance with written procecures.
The records will be' identified and retrievable. At list of these _ records, with their storage locations, will be maintained by tne Radiation Safety Officer.
7.
Audits
. Established scheaules 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 corrected. The audits will be dependent on the safety significance of the i
activity being. audited, bnt each activity will be audited at least once per year. Audit reports will be maintained as part of the cuality assurance records. Members of the audit taam shall have no resconsibility in the activity being audited.
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