ML20035H458
| ML20035H458 | |
| Person / Time | |
|---|---|
| Site: | 07100238 |
| Issue date: | 04/30/1993 |
| From: | AGRICULTURE, DEPT. OF |
| To: | |
| Shared Package | |
| ML20035H455 | List: |
| References | |
| NUDOCS 9305050108 | |
| Download: ML20035H458 (16) | |
Text
._ _. -
1 United States Agricultural Radiological 6303 Ivy Lane
. Departr6ent of _
Research Safety Greenbelt Maryland Agriculture Service Staff 20770-1433 i
i i
7 Quality Assurance Program for Radioactive Materials Packages l
i Program Manual f
r t
Date of Publication: April,1993 Revis:on No. 0 I
g5050108930429 ADocK 07100238 c
i Quality Assurance Program for Radioactive Afaterials Packages r
TABLE OF CONTENTS 1
i Page l
General...................................................................................1 I.
O rg an i zati on.............................................................................. I II.
Quality A ssurance Program........................................................ 2 III.
Design Cont rol........................................................................ 3 IV.
Procurement Document Control....................................................... 4 V.
Instructions, Procedures, an d Drawings.............................................. 5 VI.
Docu m ent Con trol...................................................................... 5 VII.
Control of Purchased Materials, Parts, and Components.......................... 5 i
Vill.
IdentiUcation and Control of Materials, Parts, and Components................. 7 IX.
Control o f Special Processes........................................................... 7 X.
I n specti on................................................................................ 8 XI.
Tes t Con trol.............................................................................. 8 XII.
Control of Measuring and Test Equipment........................................ 8 XIII.
H andling, Storage, and Shipping...................................................... 9 i
XIV.
Inspection, Test and Operating S tatus............................................... 9 i
i XV.
Ncnconforming Material, Parts, or Components................................. 10 XVI.
Corrective A ctio n...................................................................... 10 XVII.
Quality Assurance Records........................................................... 10 i
XVIII.
Auaits....................................................................................I1
?
i Rev 0,4/93 i
t J
Quality Assurance Program for Radioactive Materials Packages General The U.S. Department of Agriculture, Agricultural Research Service, Radiological Safety Staff has developed this quality Assurance Program to meet the requirements of Title 10 CFR Part 71 and to assure that all areas important to safety in the construction, transportation, and maintenance of irradiators are properly reviewed and controlled. Title 10 CFR Part 71 Subpart H requires that a QA Program applicable to the construction and transportation of packages used in the shipment of radioactive material be in effect by the using company.
I.
Organization A.
The responsibility for the QA Program is retained and exercised by the U.S.
Department of Agriculture. This responsibility is delegated to the Administrator, Agricultural Research Service in title 7 CFR Part 2.106. Day-to-day responsibility is further delegated to the Director, Radiological Safety Staff in Administrative Memorandum 124.1. An organizational chart is si.own in Figure 1.
B.
QA functions performed shall include but not be limited to:
(1)
Periodic design reviews.
(2)
Review of procurement documents for 10 CFR 71 Subpart H control.
(3)
Review of design control procedures.
(4)
Review and concur with inspection plans, calibration and test procedures, drawings and specifications, and changes thereto.
(5)
Review of outside vendor facilities to assure fabrication compliance with specifications.
(6)
Participate in the evaluation of suppliers' capabilities to provide acceptable quality products / services.
(7)
Periodically inspect materials, parts and components to assure that their identification and control is adequate.
(8)
Perform inspections to verify conformance with quality-affecting activities.
l t
(9)
Periodically review test instrument calibrations to determine calibration is performed at specified intenals.
l 1
Rev 0,4/93
t Quality Assurance Program for Radioactive Materials Packages (10)
Maintain Quality Assurance records.
(11)
Maintain Audit records.
C.
The overall responsibility for the quality Assurance Program is zested with the USDA Radiological Officer. Specific program areas will be delegated to a QA Program Manager and members of the Radiological Safety Staff. A responsibility matrix is l
shown in Figure 2.
D.
The Radiological Safety Officer will appoint a men.ber of the staff as a QA Manager.
i The duties of the QA manager are to implement and pursue those specific activities outlined in Item 2 above, and to assure general compliance with applicable regulations.
The QA Manager's qualifications shall include:
(1)
Previous experience in QA related activities.
(2)
A working knowledge of applicable regulations.
(3)
A background technically sufficient to enable accomplishment of assigned tasks.
E.
The designated QA Manager shall have the responsibility and authority to stop unsatisfactory work and to control further processing, delivery or installation of I
nonconforming material.
II.
Quality Assurance Program A.
The Director of the U.S. Department of Agriculture, Radiological Safety Staff or a designated representative shall periodically assess the scope, status implementation and effectiveness of the QA Program to assure its adequacy and compliance with 10 CFR 71, Subpart H.
B.
All activities important to safety in the design, purchase, fabrication, and testing of
[
packages will be described through written procedures and instructions.
These prodecures will be approved and in place prior to their use.
C.
This QA Manual and subsequent revisions shall be limited in its distribution to the Radiological Safety Staff, unless otherwise authorized by the Director.
j D.
Provisions are established to assure that applicable organizations and individuals are apprised that quality policies, QA manuals and procedures are mandatory requirements which must be implemented and enforced.
i 2
Rev 0,4/93
Quality Assurance Progrant for Radioactive Materials Packages E.
Safety-related elements controlled by the QA Program include:
(1)
Assurance that welds conform to speciGcations.
(2)
Assurance that external dose rates (where applicable) are within specined limits.
(3)
Assurance that the final product is adequately packaged for shipment.
F.
Disputes between QA and other department personnel shall be resolved by the Administrator, ARS, or a designated representative.
G.
An indoctrination and training program is established such that:
(1)
Personnel responsible for performing quality related activities are instructed as to the purpose, scope and implementation of the QA manual, instruction and procedures.
(2)
Personnel performing quality-affecting activities are qualined in the principles and techniques of the activities being performed.
(3)
The scope, objective and method of implementing the indoctrination and training program are documented.
(4)
Pronciency of personnel performing quality-affecting activities is maintained by periodic retraining.
H.
Where applicable, quality related activities are performed with speciSed equipment under suitable environmental conditions, and prerequisites have been satisfied prior to inspection and test.
III.
Package Design Control A.
Measures are established to carry out design activities in a planned, controlled and orderly manner.
B.
Measures are established to correctly translate applicable regulatory requirements and design bases into specifications, drawings, written procedures and instructions.
C.
Quality standards are specified in the design documents. Deviations and changes are controlled.
~
D.
Designs are reviewed to assure that design characteristics can be controlled, inspected 3
Rev 0,4/93
Quality Assurance Program for l
Radioactive Materials Packages t
t and tested, and inspection and test criteria are identified.
l l
E.
Selection and accomplishment of design verification of Husman irradiator l
characteristics are accomplished by design reviews.
I F.
Individuals responsible for design verification are other than the original designer or his i
immediate supervisor.
G.
Design and specification changes are subject to the same design controls and approvals applicable to theoriginal design, except where those controls and approvals have l
become more stringent.
H.
Persons responsible for design reviews and verification activities and their authority and responsibility are identified and controlled bywritten procedures.
J IV.
Procurement Document Control l
t A.
Procedures are established that clearly delineate the sequence of actions to be j
accomplished in the preparation, review, approval and control of procurement documents.
l B.
Procurement documents identify the applicable 10 CFR 71, Subpart H requirements which must be complied with and described in the QA Program.
C.
Procurement documents reference the design basis technical requirements, including
{
applicable regulatory requirements, material and component identification l
requirements, drawings, specifications, codes and industrial standards, test and inspection requirements, and special process instructions.
1 i
1 l
D.
Procurement documents identify the documentation to be prepared, maintained and submitted to the purchaser forreview and approval.
2 E.
Procurement documents identify those records to be retained, controlled and maintained by the supplier,and those to be delivered to the purchaser prior to use or installation of
-l the hardware.
F.
Procurement documents contain the procuring agencies right of access to suppliers' j
facilities and records for source inspection and audit.
l l
G.
Changes and revisions to procurement documents are subject to at least the same review l
and approval asthe original document.
l 4
Rev 0, 4/93
Quality Assurance Program
~
for Radioactive Materials Packages l
V.
Instructions, Procedures, and D:m me l
A.
Activities affecting quality are prescribed and accomplished in accordance with documented instructions, procedures, or drawings.
B.
Provisions are established which clearly delineate the sequence of actions to be accomplished in thepreparation, review, approval, and control of ins' ructions, j
procedures, and drawings.
C.
The QA organization reviews and concurs with inspection plans; test, calibration, and special process procedures; drawings and specifications; and changes thereto or acceptable alternatives are described.
l VI.
Document Control A.
The review, approval, and issue of documents and changes thereto, prior to release, are i
procedurally controlled to assure they are adequate and the quality requirements are stated.
B.
Changes to documents are reviewed and approved by the same organizations that i
performed the original review and approval or by other qualified responsible l
organizations as delegated.
l C.
Approved changes are included in instructions, procedures, drawings, and other i
documents prior to implementation of the change.
D.
Documents are available at the location where the activity will be performed prior to l
commencing the work.
i E.
A master list is established to identify the current revision number of instructions, procedures, specifications, drawings, and procurement documents.
F.
Documents to be controlled include design drawings, procurement specifications, operating and maintenance procedures, inspection and test procedures, and nonconformance and corrective action reports.
VII.
Control of Purchased Materials, Equipment and Services A.
Qualified personnel evaluate the supplier's capability to provide acceptable quality services and products.
i B.
The evaluation of suppliers is based on one or more of the following:
5 Rev 0,4/93 1
Quality Assurance Program for Radioactive Materials Packages (1)
The supplier's capability to comply with the elements of Subpart H to 10 CFR Part 71 that are applicable to the type of material, equipment, or service being procured.
(2)
A review of previous records and performance of suppliers who have provided similar articles of the type being procured.
(3)
A survey of the supplier's facilities and QA Program to determine his capability to supply a product which meets the design, manufacturing, and quality requirements.
C.
The results of supplier evaluations are documented and filed.
D.
Surveillance, if required, of suppliers during fabrication, inspection, testing, and shipment of materials, equipment and components is planned and performed in accordance with written procedures toassure conformance to the purchase order requirements.
E.
The supplier furnishes the following records as a minimum to the purchaser:
(1)
Documentation that identifies the purchased material or equipment and the specific procurement requirements (e.g., codes, standards, and specifications) j met by the items.
i (2)
Documentation that identifies any procurement requirements which have not been met together with a description of those nonconformances dispositioned
" accept as is" or " repair" F.
Receiving inspection of the supplier-furnished material, equipment, and services is performed to assure:
(1)
The material, component, or equipment is properly identified and corresponds with the identification on receiving documentation.
l i
(2)
Material, components, equipment, and acceptance records are inspected and l
judged acceptable in accordance with predetermined inspection instructions, 1
prior to installation or use.
l (3)
Inspection records or certificates of conformance attesting to the acceptance of materials and components are available prior to installation or use.
l i
l 1
6 Rev 0,4/93
Quality Assurance Program for Radioactive Materials Packages (4)
Items accepted and released are identified as to their inspection status prior to forwarding them to a controlled storage area or releasing them for further work.
YllI. Identification and Control of Materials, Parts, and Components l
A.
Procedures are established to identify and controlmaterials, parts, and components including partially fabricated subassemblies.
B.
The identification and control procedures assure that identification is maintained either on the item or on records traceable to the item to preclude use of incorrect or defective items.
C.
Identification of materials and parts important to the function of safety-related systems and components can be traced to the appropriate documentation such as drawings, specifications, purchase orders, manufacturing and inspection documents, deviation reports, and physical and chemical mill test reports.
l D.
The location and the method of identification do not affect the fit, function, or quality of the item being identified.
i E.
Correct identification of materials, parts, and components is verified and documented prior to release for fabrication, assembling and installation.
i F.
If a shelf life is indicated on the manufacturer's documentation, an expiration date will be calculated and written on the material or ots container. Any material whose shelf or i
useful life has expired will be removed from service.
IX.
Control of Special Processes A.
Special processes such as welding, heat treating, nondestructive testing, and cleaning are procedurally controlled.
B.
Procedures, equipment, and personnel connected with special processes are qualified in accordance with applicable codes, standards, and specifications.
r C.
Qualification records of procedures, equipment, and personnel associated with special l
processes are established, filed, and kept current.
X.
Internal Inspection A.
An inspection program which verifies conformance of quality-affecting activities with requirements is established, documented, and accomplished in accordance with written i
i 7
Rev 0,4/93 I
'l l
Quality Assurance Program for l
Radioactive Materials Packages i
and controlled procedures.
B.
Inspection personnel are independent from the individuals performing the activity being inspected.
C.
Inspectors are qualified in accordance with applicable codes, standards, and company f
training programs; and their qualifications and certifications are kept current.
I D.
Modifications, repairs, and replacements are inspected in accordance with the original i
design and inspection requirements or acceptable alternatives.
1 E.
Provisions are established that identify mandatory inspection hold points for witness by an inspector.
i i
XI.
Test Control A.
A test program to demonstrate that the item or component will perform satisfactorily in f
service is established, documented, and accomplished in accordance with wntten controlled procedures.
B.
Modifications, repairs, and replacements are tested in accordance with the original
}
design and testingrequirements or acceptable alternatives.
I C.
Test results are documented, evaluated, and their acceptability determined by a qualified, responsible individual or group.
l 1
XII.
Control of Measuring and Test Equipment A.
Measuring and test instruments are calibrated at specified intervals based on the i
required accuracy, purpose, degree of usage, stability characteristics, and other conditions affecting the measurement.
t B.
Measuring the test equipment is identified and traceable to calibration test data.
j C.
Measures are taken and documented to determine the validity of previous mspections l
performed when measuring and test equipment is found to be out of calibration.
)
D.
Reference and transfer standards are traceable to nationally recognized standards; or,-
l where national standards do not exist, provisions are established to document the basis for calibration.
l XIII. IIandling, Storage, and Shipping Control j
.i f
8 Rev 0,4/93 l
i
Quality Assurance Program for j
Radioactive Materials Packages i
k A.
Special handling, preservation, storage, cleaning, packaging, and shippmg requirements are established and accomplished by qualified individuals in accordance with predetermined work and inspection instructions.
i B.
All conditions (operations, tests, inspections, specifications, etc.) of the NRC package approval and the U.S. Department of Transportation shipping requirements are satisfied prior to shipment.
l C.
All necessary shipping papers will be prepared, as required.
[
D.
Departure, arrival time and destination of a package will be established and monitored to a degree consistent with the safe transportation of the package.
I XIV. Inspection, Test and Operating Status A.
Identification of the inspection, test, and operating status of packages and components is known by affected organizations.
B.
The application and removal of inspection and welding stamps and status indicators such as tags, markings, labels, and stamps are procedurally controlled.
I C.
Bypassing of required inspections, tests, and other critical operations is procedurally controlled.
D.
The status of nonconforming, inoperative or malfunctioning packages or components is j
identified toprevent inadvertent use.
XV.
Nonconforming Material, Parts, or Components t
i A.
The identification, documentation, segregatian, review, disposition, and notification to affected organizations of nonconforming materials, parts, components, or services are procedurally controlled.
B.
Documentation identifies the nonconforming item; describes the nonconformance, the f
disposition of the nonconformance, and the inspection requirements; and includes signature approval of the disposition.
j C.
Nonconforming items are segregated from acceptable items and identified as discrepant until properly disposed.
j D.
The QA Manager will review all nonconformance reports to determine is appropriate i
9 Rev 0,4/93 l
Quality Assurance Program for l
Radioactive Materials Packages responses have been initiated. The QA Manager will review all reports on a quarterly basis, or as needed, to determine if any trends affecting quality are apparent. The QA Manager will transmit this review to the Director, RSS.
E.
Acceptability of rework or repair of materials, parts, components and systems is i
verified by reinspecting and retesting the item as originally inspected and tested or by a method which is at least equal to the original inspection and testing method.
XVI. Corrective Action l
A.
Evaluation of conditions adverse to quality (such as nonconformances, failures, malfunctions, deficiencies, deviations, and defective material and equipment) is conducted to determine the need for corrective action in accordance with established procedures.
B.
Corrective action is initiated following the determination of a condition adverse to quality to preclude recurrence.
C.
Follow-up reviews are conducted to verify proper implementation of corrective actions and to close out the corrective action documentation.
D.
Corrective actions include suppliers of materials used for rauicactive matmerials packages. Any materials found to be defective will be documented and no further purchases from that supplier will be approved until a review of the supplier's corrective l
action report is approved.
XVII. Quality Assurance Records i
A.
Sufficient records are maintained to provide documentary evidence of the quality and safety ofitems and the activities affecting quality and safety.
B.
QA records include operating logs; results of reviews, inspections, tests, audits, and material analyses; qualification of personnel, procedures, and equipment; and other documentation such as drawings, specifications, procurement documents, calibration procedures and reports; nonconformance reports; and corrective action reports.
C.
Records are identifiable and retrievable.
(
D.
A list of the required records and their storage locations will be maintained.
j E.
Design related records (e.g., drawings, calculations,etc.) are maintained for the life of l
the shipping package and all other records are maintained for aminimum of two years.
i 10 Rev 0,4/93 l
D
l Quality Assurance Program i
for Radioactive Materials Packages F.
Inspection and test records contain the following where applicable:
(1)
A description of the type of observation.
(2)
Evidence of completing and verifying a manufacturing, inspection, or test operation.
(3)
The date and results of the inspection or test.
I (4)
Information related to conditions adverse toquality.
(5)
Inspector or data recorder identification.
(6)
Evidence as to the acceptability of the results.
j XVIII. Audits r
A.
Audits are performed in accordance with pre-established written procedures or check lists and conducted by personnel not having direct responsibilities in the areas being i
audited.
l B.
Audit results are documented and then reviewed with management having responsibility in the area audited.
r C.
Responsible management takes the necessary action to correct the deficiencies revealed i
by the audit.
D.
Deficient areas are reaudited on a timely basis to verify implementation of corrective actions which minimize recurrence of deficiencies.
i E.
Audits of the QA Program are performed at least annually based on safety significance-l of the activity being audited.
F.
Audits of major contractors will be conducted at least every three years to assess the i
implementation and effectiveness of their QA programs.
t l
l r
11 Rev 0,4/93
' l T
i Quality Assurance Prograrn for i
Radioactive Materials Packages i
Figure 1.
Delegation of Authority for Quality Assurance I
l i
Secretary, Department of Agriculture I
r Assistance Secretary, Science and Education j
Administrator, Agricultural Research Service I
t' Radiological Safety Committee Director, Radiological Safety Staff (Radiological Safety Officer)
I QA Manager l
.i i
12 Rev 0,4/93 l
Quality Assurance Program for Radioactive Materials Packages Figure 2.
Responsibility Matrix for Quality Assurance Functions QA Function Director, RSS QA Manager RSS Staff Qa Program D
A,B,C B
Audits A,C,D B
Training C,D A,B Certification C,D A,B Testing C,D A,B Document Control C,D A,B Specifications C,D A,B Shipping A,D C
B Where:
A = Initiate, B = Perform, C = Accept, D = Approve l
t i
l a
J h
I k
4 13 Rev 0. 4/93
(.
b)
.;. Y;.
lii O M E O l X -
January 7,1993 Dan Sharpe USDA, ARS, RSS 6303 Ivy Lane Room 534 Greenbelt, Md. 20770
Dear Dan,
Enclosed is a copy of our QA manual utilized for fabrication of the Husman irradiator together with NRC's Quality Assurance Program approval No. 0009. The approval was -
terminated as of September 4,1991, after the unit had been fabricated,' but before sources were purchased and loaded. At that time it was questionable as to whether the unit would be completed because of questionable availability of sources.
The unit has been in storage since mid-1990, but without sources, since their procurement has been unavailable.
USDA is currently deciding whether or not to complete the unit. If we proceed, sources 'should be available in the May-June,1993 timeframe, at which time they will be loaded into the irradiator and the unit shipped to Mission, Tx.
We need to resolve whether USDA or Isomedix will reactivate the QA program with NRC, and we will await your decision.
You 'are free to utilize the enclosed manual as desired.
Very truly yours,-
2" George R. INtz.
Executive Vice President.
/st Enclosure
- CORPORATE OFFICES
- 1'1 APOLLO DRIVE, WHtPPANY, NEW JERSEY 07981 * (201) 887 4700
- FAX 8871476
.