ML19242B888
| ML19242B888 | |
| Person / Time | |
|---|---|
| Site: | 07100234 |
| Issue date: | 06/01/1979 |
| From: | X-RAY, INC. |
| To: | |
| Shared Package | |
| ML19242B881 | List: |
| References | |
| NUDOCS 7908090495 | |
| Download: ML19242B888 (3) | |
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10 CFR PART 71 QA PROGRAM FOR X-RAY, INC.
1.
OPGANIZATION THE FINAL RESPONSIBILITY FOR THE QUALITY ASSURANCE (QA)
PROGRAM FOR PART 71 REQUIREMENTS RESTS WITH X-RAY, INC.
DESIGN AND FABRICATION SHALL NOT BE CONDUCTED UNDER THIS QA PROGRAM.
THE QA PROGRAM 15 IMPLEMENTED USING THE ORGANIZATION SHOWN ON THE ORGANIZATIONAL CHART.
THE RADIATION $AFETY OFrlCER 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 RECORD KEEPING.
2.
QUALITY ASSURANCE PROGRAM THE MANAGEMENT OF X-RAY, INC. ESTA3LISHES 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 VILL 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 $AFETY OrrlCER SHALL ASSURE THAT ALL RADIO-ACTIVE MATERIAL SHIPPlNG PACKAGES ARE DESIGNED AND MANUFAC-TURED UNDER A QA PROGRAM APPROVED BY NUCLEAR REGULATORY COMMISSION FOR ALL PACKAGES DESIGNED OR FABRICATED AFTER THE EFFECTIVE DATE OF THE QA PROGRAM.
THIS REQUIREMENT CAN BE SATISFIED BY RECEIVING A CERTIFICATION TO THIS EFFECT FROM THE MANUFACTURER.
3 DOCUMENT CONTROL ALL COCUMENTS RELATED TO A SPECIFIC SHIPPING PACKAGE WILL BE CONTROLLED THROUGH THE USE OF WRITTEN PROCE URES.
ALL DOCUMENT CHANGES WILL BE PERFORMED ACCORDING TO WRITTEN PROCEDURES APPROVED BY MANAGEMENT.
THE RADIATIC.J $AFETY OrrlCER SHALL INSURE THAT ALL QA FUNCTIONS ARE CONDUCTED IN ACCORDANCE WITH THE LATEST APPLICABLE CHANGES TO THESE DOCUMENTS.
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4 HANDLING STORAGE AND $ HIPPING WRITTEN SAFETY PROCEDURES CONCERNING THE HANDLING, STORAGE AND SHIPPING OF PACKAGES FOR CERTAIN SPECIAL FORM RADIO-ACTIVE MATERIAL WILL BE FOLLOWED.
$HIPMENTS 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 SHALL PERFORM THE CRITICAL HANDLING, STORAGE AND SHIPPING OPERATIONS.
5 INSPECTION, TEST AND OPERATING STATUS lNSPECTION, TEST AND OPERATING STATUS OF PACKAGES FOR CERTAIN SPECIAL FORM RADIOACTIVE MATERIAL WILL BE INDICATED AND CONTROLLED BY WRITTEN PROCEDURES.
$TATUS WILL BE INDICATED BY TAG, LABEL, MARKING OR LOG ENTRY.
STATUS OF NONCONFORM-ING PARTS OR PACKAGES WILL BE POSITIVELY MAINTAINED 8Y WRITTEN PROCEDURES.
RADIOGRAPHY PERSONNEL SHALL PERFORM THE REGULATORY REQUIRED INSPECTIONS AND TESTS IN ACCORDANCE WITH WRITTEN PROCEDURES.
THE RADIATION $AFETY OrriCER SHALL ENSURE THAT THESE FUNCTIONS ARE PERFORMED.
6.
QUALITY ASSURANCE RECORDS RECORDS OF PACKAGE APPROVALS (INCLUDING REFERENCES AND DRAWINGS), PROCUREMENT, INSPECTIONS, TESTS, OPERATING LOGS, AUDIT RESULTS, PERSCNNEL TRAINING AND QUALIFICATIONS AND RECORDS OF SHIPMENTS WILL BE MAINTAINED.
DESCRIPTIONS OF EQUIPMENT AND WRITTEN PROCEDURES WILL ALSO BE MAINTAINED.
THESE RECORDS WILL BE MAINTAINED IN ACCORDANCE WITH WRITTEN PROCEDURES.
THE RECORDS WILL BE IDENTIFIABLE AND RETRIEVABLE.
A LIST OF THESE RECORDS, WITH THElR STORAGE LOCATIONS, WILL BE MAINTAINED BY THE RADIATION $AFETY OFrtCER.
7 AUDITS ESTABLISHED SCHEDULES OF AUDITS OF THE QA PROGRAM WILL SE 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 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 NOT BE DIRECTLY INVOLVED IN THE ACTIVITY BEING AUDITED.
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