ML19345G952
| ML19345G952 | |
| Person / Time | |
|---|---|
| Site: | 07100402 |
| Issue date: | 03/10/1981 |
| From: | C&R LABORATORIES, INC. |
| To: | |
| Shared Package | |
| ML19345G951 | List: |
| References | |
| 18817, QA-01, QA-1, NUDOCS 8104220871 | |
| Download: ML19345G952 (11) | |
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i C & R LABORATORIES TESTING & INSPECTION SERVICES 1^
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THROUGHOUT THE PACIFIC l
i E L T # M St-FEAFL QTV. HAWAit 96782
.508:455 4054 QUALITY ASSURANCE MANUAL i
J Document No. CA-01
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I.ABORAIDRIES LOCATICN:
2321 AUHUU STREET PEARL' CITY, HANAII 96782 j
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18817 l
910422e871 i
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RECORD OF REVISIO:S l
Revision 1; umber Entered by Date Pk i
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TABLE OF CONTENTS Section Page 1.
Organization.
.1 2.
Quality Assurance Program.
.2 5
3.
Document Control.
.2 4.
Handling, Storage and Shipping.
.2 5.
Inspection, Test and Operating Status.
.3 6.
Quality Assurance Records
.3 7.
Audits.
.4 8.
Specific Provisicas
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1.
Organization C & R Laboratories, Corp.
President Roland L. Watson t
Executive Secretary Carole Watson Radiation Safety Manager Quality Assurance Manager Roland L. Watson Roland L. Watson Nicola Rinaldi (alternate)
Philip J. Manly (alternate)
Destructive Testing Field Operations Non-Destructive Testing Responsibility Matrix Pres.
Exec.
QA QA Field Rad Sec.
Mgr.
Ops.-
Mgr.
l 1.
QA Progrdm x
x 2.
Document Control x
x x
3.
Handling, Stor., Ship x
x 4.
Insp., Test & Operating x
x 5.
Q/A Records x
x x
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6.
Audits x
x x
2.
Quality Assurance Program 2.1 By use of this document, C & R Laboratories, Corp.,
hereby establishes a quality assurance program for the company.
Implementation of the program is accomplished by this manual and by the operating procedured established by the company for use and transport of the radiography sources.
2.2 All revisions to the quality assurance program will approved by the Quality Assurance Manager before being incorporated in the appropriate manual.
A record of all changes will be made on the record revision sheet at the beginning of each manual.
2.3 The quality assurance program will assure that all defined quality control procedures, engineering procedures, and specific provisions of package design approval are satisfied, and will emphasize the control of those char-acteristics of the package which are critical to safety.
3.
Document control e
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3.1 All documents relating to each shipping package for shipping radiography sources will be maintained in a master file in the corporate offices.
3.2 All changes to the quality assurance manual or oper-ating manuals that Luplement quality control procedures will be made as follows:
3.2.1 The change will be entered in the appropriate manual.
3.2.2 The person making the change will annotate the change number, along with the individual's name and the date of change, on the record revision sheet at the beginning of the manual.
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3.2.3 A master copy of each manual will be kept in the corporate offices for use in checking the currency of all other manuals'.
4.
Handling, Storage, and Shipping 4.1 The established procedures for handling, storage, and shipping of radiography sources will be followed.
These procedures are contained in the operating procedures for C
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fs the radiography sources.
4.2 No shipment will be made unless all tests, certifica-tions, acceptances, and inspections outlined in the oper-ating procedures have been completed.
4.3 Work instructions for handling, storage, and shipping of radiography sources are outlined in the operating proc-edures for the sources.
5.
Inspections, Test and Operating Status 5.1 Inspection, test and operating status of packages for transport of radiography sources will be controlled by the operating procedures and indicated through use of log entries.
5.2 A check of the condition of the source shield will be made each day, in accordance with the operating procedures for radiography.
The satisfactory condition of the shield will be indicated as a log entry for the daily check list.
5.3 Non-conforming or deficient parts or equipment will C,
be removed from service and red-tagged to prevent unauthor-ized use.
These deficient parts will not be placed back in service until the deficiencies have been corrected.
6.
Quality Assurance Records 6.1 The following records will be kept:
6.1.1 Daily check of radiography equipment and source shield.
6.1.2 Quarterly check of radiography equipment.
6.1.3-Quarterly audit of quality assurance program.
6.1.4 Records of shipment and receipt of radiography sources.
6.1.5 Records of personnel qualifications of personnel responsible for the quality assurance program.
6.2 Records outlined above will be maintained in accordance with the operating procedures for radiography operations.
I 6.3 Records will be identifiable and retrievable.
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AUDITS 7.1 A quarterly audit of the quality assurance program will be performed.
This frequency may be increased or decreased depending on the findings of previous audits and the safety significance of the findings.
7.2 The results of the audit will be maintained and re-ported to the President of C&R Laboratories.
7.3' Audit reports will be evaluated by the President and any deficient areas corrected. A record of the correc-tive action taken will be maked.
7.4 At least one quarterly audit will be performed by C& R Laboratories (Radiation Safety Officer, General
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Manager or President) or Radiation Safety Officer's Per-Attached Resumes) which will act as alternate.
7.5 Audit reports and reports of corrective action taken will be maintained as part of the quality assurance records.
8.0 SPECIFIC PROVISIONS 8.1 A cerification will be obtained from the manufacturer I
and maintained on file that each source shield has met the applicable regulations for Type B Packaging outlined in 49_CFR.
8.2 The radi,ography sources in their shields will always be loaded into shipping containers or into the truck for transport to field location in accordance with the in-structions outlined in the operating procedures.
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4 RESUME PERSONAL INFORMATION Philip James Manly Name 36 Age Marital Status Married, 3 children EDUCATION Massachusetts Institute of B.S.
1967 Technology.
major in physics, minor in electrical engineering.
Rensselaer Polytechnic Institute.
M.S.
1971 Major in health physics and envirommental engineering.
C HONORS Associate member of Sigma Xi; Academic Listed in American Men and Women of Science; Listed in Who's Who in the West.
Professional Certified Health Physicist WORK EXPERIENCE I.
Gamma Corporation P. O. Box 430 Wahiawa, HI 96786 President of health physics 1/78-consulting company.
Services include writing operating procedures, conducting training, and perfooning environmental monitoring for protecting man and his environment from the harmful effects of radiation.
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Clients include most users of radiatior in medicine and industry in the state.
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C RESUME - PHILIP J. MANLY page 2 II.
Health Physics Associates P.
O. Box 430 Wahiawa, HI 96786 4/74-1/78 (part-time)
Owner of consulting firm.
Services include audits for compliance with regulations, training of personnel, x-ray machine and room shielding surveys.
III. Pearl Harbor Naval Shipyard Pearl Harbor, HI 7/71-1/79 Worked in Radiological Control Office, which is responsible for all procedures, training, personnel monitoring, and environmental monitoring for operations involving radioactive materials.
Held positions as Head of Technical Division, Senior Health Physicist, and Head of Training
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Division.
COMMUNITY AFFAIRS 12/75 Formed organizational committee for Hawaii Chapter of Health Physics Society; elected chairman.
7/76 Elected first President of Hawaii Chapter of Health Physics Society.
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7/78 Obtained approval from Health Physics Society to hold Mid-year Symposium in Hawaii in 1979; named chairman of Symposium Committee.
12/79 Conducted 13th Mid-year Topical Symposium for Health Physics Society on Health Physics Training.
C September, 1980
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RESUME PERSONAL INFORMATION Name Nicola Rinaldi Age 33 EDUCATION A.A.S. 1972 Hartford State Technical College.
Major in nuclear engineering.
B.S. 1974 Lowell Technological Institute.
Major in radiological health physics.
WORK EXPERIENCE I.
Gamma Corporation
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P. O. Box 430 Wahiawa, HI 96786 1/78-11/80 (part-time)
Health Physicist providing 11/80-(full-time) radiation protection services to nuclear medicine, research, and industrial facilities, including training sessions to radiation workers.
Consultation on non destructive methods of nuclear moisture detectors.
II.
Health Physics Associates P. O. Box 430 Wahiawa, HI 96786 i
7/75-11/80 (part-time)
Health physicit a performing radiation and contamination surveys, environmental surveys, and health physics support for decontamination operations.
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L RESUME - NICOLA RINALDI PAGE 2 III. University of Hawaii 2002 East-West Road Honolulu, HI 96822 10/76-11/80 Health physicist in charge of maintaining the University's broad scope license; inspection of non-medical x-ray installations and laser installations.
IV.
Pearl Harbor Naval Shipyard Pearl Harbor, HI 1/76-10/76 Health physicist in charge of non-nuclear radiation safety program.
V.
Cambridge Nuclar Radiopharmaceutical Corp.
575 Middlesex Turnpike Billerica, MA 01865
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t 1/75-7/75 Radiation Safety Officer providing radiation protection for chemists.
Maintained counting room, personnel dosimetry, environmental sampling, isotope inventory, and instrument calibration.
VI.
Maine Yankee Atomic Power Company Box 450, RFD 2 Wiscasset, Maine 04578 5/74-9/74 Health physics technician providing coverage for maintenance personnel.
COMMUNITY AFFAIRS 6/76 Elected first Secretary of Hawaii Chapter of Health Physics Society.
11/78 Elected President of Hawaii Chapter of Health Physics Society.
10/80 Nominated and elected chairman of
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State Advisory Committee to Study j
Radiological Safety.
I March, 1981 1SS17