ML20206F859
| ML20206F859 | |
| Person / Time | |
|---|---|
| Site: | 07100603 |
| Issue date: | 06/02/1986 |
| From: | JAN X-RAY SERVICES, INC. |
| To: | |
| Shared Package | |
| ML20206F850 | List: |
| References | |
| 27054, NUDOCS 8606240638 | |
| Download: ML20206F859 (5) | |
Text
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JAN X-ray Services, Inc.
QUALITY ASSURANCE PROGRAM 1.
Organization The QA Program shall be implemented using the following organizational structure:
John A. Newland - President, Radiation Safety, Officer, Purchasing Agent, QA Manager Beth A. Newland - Vice President, Bookkeeper, Secretary Steve Bartosek - Assistant Radiation Safety Officer, Assistant QA Manager Randell Wells - Assistant Radiation Safety Officer, Assistant QA Manager.
Keith Kelligan - Assistant Radiation Safety Officer, Assistant QA Manager All assistant RSO's and assistant QA managers will have the authority to stop unsatisfactory work, processing, installations, or equipment. They shall t
have direct access to the management. The establishment, execution, and overall assessment of the QA Program rests with John A. Newland. All suggestions from the assistant managers and radiographers will be taken into consideration in the assessment of the Program.
2.
Quality Assurance Program Design and fabrication of packages will not be a part of this program.- The program shall include the use, handling, storage, shipping, and documentation of Industrial Radiography. All packages will be provided with a certification document from the manufacturer insuring that the~ package was designed and manufactured under a QA Program approved by the NRC. Equipnent shall be inspected in accordance with JAN X-ray Services' Operating and Emergency Procedures Manual. Training shall also be in accordance with the.O & E Manual.
The following references to the O & E Manual will be used by this QA Program:
- a. Training - administrativa manual pages.2 through 83
- b. Management control of radiation safety.- administrative manual page 84
- c. Recordkeeping forms - administrative manual pages 85 through 100
- d. Operating-insstructions - radiographer's manual pages 157 through 167
- e. Source leak testing - radiographer's manual page 168
- f. Source changing radiographer's manual pages 176 through 179
- g. Movement of radiation devices - radiographer's manual page 180
- h. Inspection & maintenance - radiographer's manual pages 168 through 172 3.
Document Control A certificate will be provided by the manufacturer for each package received that will insure that the package was designed & manufactured under a QA Program approved by the NRC. Other documentation as. required in the O & E Administrative Manual pages 85 through 100 vill be maintained for all packages & operations. All documentation of shipping via an outside contractor such as Federal Express, etc. will be maintained.
All purchase orders for spare or replacement parts shall be approved by John A. Newland. Only qualified manufacturers will supply parts to JAN X-ray Services as identified in the Radiographer's Manual page 174.
Radioactive material transfer from one projector to another will be done in accordance with the' Radiographer's Manual pages 176 thr'ough 179.
All documents shall be reviewed by management,and any changes in documentation shall be approved by management. Accurate and current forms for documentation shall be on hand where ever activities occur.
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_y 4.
Handling, Storing, & Shipping Handling, storing, & shipping of radioactive. packages shall be done in accordance with JAN X-ray Services' O & E Manual. Direct management approval and review of documentation shall be obtained before delivery of a package to a carrier for transport.
5.
Inspections, Tests; & Operating Status Inspections & tests shall be done & maintained'in accordance with the 0 & E Manual. The status of the tests & inspections shall be identifiable through labels, tags, or log entries as indicated in the manual.
6.
Quality Assurance Records All records shall be maintained and retrievable for at least five years.
They shall include the following:
- a. Package certifications
- b. Procurement of packages
- c. Inspections t
- d. Tests
- e. Operating logs
- f. Audit results
- g. Training & qualification of personnel
- h. Shipnents
- i. Equipment descriptions
- j. Written procedures
- k. Non-conformance & corrective reports
- 1. Maintenance, repair, or replacement reports 7.
Audits The QA Program shall be audited yearly to insure that the practices, procedures,.and instructions important to safety and the effective uses of their implementation are in accordance with management objectives. This will be accomplished by using the auditor's report and will be conducted by the RSO.
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1' JAN X-ray Services,.Inc.
QA PROGRAM AUDITOR'S REPORT 4
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i Date Auditor Training:
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- 1. Are all personnel trained in accordance with company procedures?
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- 2. If not, so indicate and-show corrective action taken.
- 3. Are there current written procedures for training and certification?
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QA Program Revisions:
- 1. Are there any revisions?
- 2. If so, has management approved them?
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- 3. Do documents reflect these changes?
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i Packages:
- 1. Do all radioactive material packages have a certificate from the manufacturer l
stating that its design has been approved by the NRC?
- 2. If not, what corrective action has been taken.
Documentation:
- 1. Are there written procedures for package documentation?
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- 2. Do all packages have the required documentation?
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- 3. If the answer to 1 or 2 above is no, show what corrective action is being taken.
- 4. Have there been any changes in documentation?
- 5. If yes, are all QA functions being conducted in accordance with these changes?
f Handling, Storage,-Shipping:
- 1. Are there written procedures for.the handling, storage, and shipping of l
radioactive packages?
- 2. If not, show what corrective action is being taken.
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- 3. Have all safety procedures been followed?
- 4. If not, show corrective action taken.
l S. Does documentation show who did the handling, storage, and shipping functions?
- 6. If not, indicate the corrective action implemented.
Inspection, Test, & Operating Statusi
- 1. Are there written procedures for inspections,_ tests, and operating status for-radioactive packages?
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- 2. If not, show corrective actions taken.
- 3. Have nonconforming parts or packages been documented and maintained according to program?
- 4. If not, show corrective action taken.
- 5. Have radiography personnel performed the required inspections and tests in accordance with company procedures?
- 6. If not, show corrective actions taken, i1' i
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JAN X-ray Services, Inc.
QA Program Auditor's Report, cont.
Records:
- 1. Are records of the following being maintained?
- a. Package approvals
- b. Procurement
- c. Inspections
- d. Tests
- e. Operating logs
- f. Audit results
- g. Personnel training
- h. Personnel certification
- i. Shipments
- j. Descriptions of equipment
- k. Written procedures
- 2. If not, show corrective action taken.
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- 3. Are records retrievable and identifiable?
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- 4. If not,'show corrective actions taken.
- 5. Is there a list of'these records and their location?'~
- 6. If not, show corrective action t aken. ;.,
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This audit has been presented to management on (date).
It shall be include.1 as part of the QA record.
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