ML20237A681
| ML20237A681 | |
| Person / Time | |
|---|---|
| Site: | 07100370 |
| Issue date: | 10/15/1987 |
| From: | AMERSHAM CORP. |
| To: | |
| Shared Package | |
| ML20237A661 | List: |
| References | |
| 28756, NUDOCS 8712150170 | |
| Download: ML20237A681 (41) | |
Text
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Amersham Corporation Quality Assurance Program For Type B Radioactive Material J
Transport Packages 4
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8712150170 871104 PDR ADOCK 07400370 C
PDR Revised October 15, 1987
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o Amersham Corporation Quality Assurance Program For Type B Radioactive Material Transport Packages Introduction Purpose This Amersham Corporation Quality Assurance Program is promulgated to comply with the requirements of Subpart H Section 71.51 and Appendix E of 10 CFR Part 71 " Packaging of Radioactive Material for Transport and-Transportation of Radioactive Material", of the United States Nuclear Regulatory Commission.
Scope This Amersham Corporation Quality Assurance Program, as required by 10 CFR Part 71, applies to all activities affecting the components of the packaging which are significant to safety.
Those activities include designing, purchasing, fabricating, handling, shipping, storing, cleaning, assembling, inspecting, testing, operating, maintaining, repairing and modifying.
I.
Organization A.
The overall responsibility for the Quality Assurance Program is retained and exercised by Amersham Corporation.
B.
The responsibility for the Amersham Corporation Quality Assurance Program is shared by a number of departments within the company.
The responsible departments, by function, include:
1.
Facilities and Procurement a.
The responsibility for design control; instructions, procedures and drawings in support of the design; assuring that all parts and components are manufactured to specifications; evaluation of the capability of a supplier to provide an acceptable service; all testing requirements; receiving inspections and the control of measuring and test equipment rests with the Engineering i
l Department.
b.
The responsibility for communicating to the manufacturers, via procurement documents, all applicable 10 CFR Part 71, requirements rests with the Purchasing Department.
2.
Environmental Regulatory Affairs The responsibility for overall coordination and monitoring of the handling, storage and shipping of these containers related to the containment of activity and operator safety rests with the Environmental Regulatory Affairs Department.
1 t
e Environmental Regulatory Affairs also has responsibility for advising other departments on regulatory requirements and auditing the program to see that the requirements are being met.
3.
Manufacturing The responsibility for proper handling, loading and unloading of containers rests with the Manufacturing Department.
4.
Operational Services The responsibility for proper usage of containers during preparation for shipping and after receipt, routine
)
inspection, handling and maintenance rests with the Operational Services Department, j
C.
A current organizational chart is included with this document as Attachment #1.
D.
The key positions within Amersham Corporation that are involved in the administration of the Quality Assurance Program and included in the departments listed in I.B. are listed below with a brief description of each.
The specific responsibilities of each position, or of those under the person in the position described, are spelled out in Standard Operating Procedures.
1.
The President has overall responsibility for Quality Assurance at Amersham Corporation.
This responsibility is delegated to:
a.
Manager. Operations who has the responsibility for seeing that the following persons in the following departments carry out their listed responsibilities.
Shipping Supervisor has responsibility for the o
receipt, routine inspection, storage, handling and shipping of Type B packages.
Manager. Manufacturing has the responsibility for o
proper handling loading and unloading of Type B packages.
o Manager. Procurement and Facilities has responsibility for the coordination and implementation of all engineering aspects of the QA Program.
This includes design control, producing instructions, procedures and drawings in support of a design evaluating the capability of supplier to provide nn acceptable service, assuring that all parts and components are manufactured to specifications, ensuring that testing requirements are met performing receiving inspections and the exercising control over measuring and test equipment.
2 j
e Senior Buyer has responsibility for purchasing o
some Type 8 packages and communicating to participating organizations the QA requirements which must be met, c.
Manager. Scientific and Regulatory Affairs has the responsibility to see that the program is being administered effectively, o
Manager. Environmental and Safety Regulatory Affairs has the responsibility for seeing that the following person carries out her listed responsibilities.
o Environmental Safety Officer has responsibility for reviewing the activities of other departments with regard to operator safety, for ensuring that all departments are advised of regulatory requirements which must be met and for auditing the Quality Assurance Program to assess if it is in compliance with 10 CFR Part 71.
This person also acts as Transport Container Officer for the company.
d.
Vice President. Finance and Industrial Products who has the responsibility for seeing that persons in the Industrial Products Department carry out their listed responsibilities.
Supervisor Customer Service has responsibility for o
purchasing some Type B packages and communicating to participating organizations the QA requirements which must be met.
E.
The Transport Container Officer maintains overall responsibility and authority for the Type B Package Quality Assurance Program and ensures that any deficiencies found in the program are noted and corrected.
The Transport Container Of ficer should be a technically-degreed, exempt employee who has had sufficient professional experience to judge that the safety-related issues involved in the manufacture and use of a Type B container are addressed in the Quality Assurance Program.
F.
It is the responsibility of all individuals listed in I.D. to ensure that quality products are produced.
Therefore, each person listed has been delegated the necessary authority to stop unsatisfactory work and control further processing, delivery or installation of nonconforming material until proper disposition of the material is made.
II.
Quality Assurance Program A.
The Manager, Environmental and Safety Regulatory Af f airs regularly assesses the scope of the QA Program to assure that it is adequate and complies with 10 CFR Part 71 Appendix E.
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l B.
The Manager, Scientific and Regulatory Af fairs regularly assesses the status, implementation, and effectiveness of the QA Program for Type B Radioactive Material Packages.
C.
Procedures are established to control the distribution of Type B container quality assurance manuals and revisions thereto.
This will be the responsibility of the Standards and Specifications Department.
D.
The Transport Container Of ficer communicates to all responsible organizations and individuals that quality policies and procedures are mandatory requirements which must be implemented and enforced.
E.
Amersham Corporation Engineering will ensure that all 4
safety-related systems, structures and components are identified and reviewed.
These systems will be subject to the QA fabrication and inspection programs.
F.
The Transport Container Of ficer has the responsibility and j
authority to resolve disputes involving quality arising from a difference of opinion betWEen personnel having QA responsibilities and personnel f rom other departments.
G.
Indoctrination and training programs are established, such that personnel responsible for performing quality-related activities are instructed as to the purpose, scope and implementation of the QA instructions and procedures.
They are trained and qualified in the principles and techniques of the activity being performed, and their proficiency is maintained by retraining, reexamining and decertifying. The scope, the objective, and the method of j
implementing the above program is formally documented.
H.
All quality-related activities are to be performed with proper equipment under suitable environmental conditions and all prerequisites will have been satisfied prior to inspection and testing.
III.
Desian Control A.
Measures are established to carry out design activities in a planned, controlled, and orderly manner.
B.
Measures are established to correctly translate the applicable regulatory requirements and design bases into the specifications, drawings, written procedures and instructions.
C.
Quality standards are specified in the design documents and deviations or changes from the quality standards are controlled.
D.
Designs are reviewed to ensure that:
1.
The design characteristics can be controlled, inspected and tested and 2.
Inspection and testing criteria have been identified and requirements for handling, storage, cleaning and maintenance are addressed.
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E.
Proper selection and accomplishment of design' verification or checking processes such as design reviews, alternate calculations, or qualification testing are performed. When a test program is-used to verify the adequacy of a design, the prototype is subjected to the most adverse design conditions.
F.
Design verification will be conducted by a person other than the original designer.
G.
All design and specification changes are subject to the same design controls and approvals as the original design.
H.
The authority and responsibility of persons performing design I
reviews and other design verification activities are identified and controlled by written procedures.
IV.
Procurement Document Control A.
Procedures are established that clearly delineate the sequence of actions to be accomplished in the preparation, review, approval and control of procurement documents.
1 B.
Procurement documents identify the applicable 10 CFR Part 71 requirements which must be addressed and complied with during j
fabrication of the container.
C.
The procurement documents contain or reference the design technical requirements including the applicable regulatory requirements, and any applicable material and component identifications, drawings, specifications, codes and industrial i
l standards, test and inspection requirements and special process i
instructions.
1 D
The procurement documents identify the documentation to be I
prepared, maintained, and submitted to the purchaser for. review and approval.
E.
The procurement documentation identifies those supporting records l
to be retained, controlled, and maintained by the supplier, and those delivered to the purchaser prior to use of the hardware.
F.
Procurement documents contain the procuring agency's right of access to a supplier's facilities and records for source.
inspection and audit.
I G.
All changes and revisions to the procurement documents are subject to the same review as the original document.
V.
Instructions. Procedures and Drawinas A.
Activities affecting quality are prescribed and accomplished in i
accordance with documented instructions, procedures or drawings.
B. ' Procedures are established which delineate the sequence of actions to be accomplished in the preparation, review, approval, and control'of instructions, procedures and drawings.
5 l
C.
The QA organization outlined in I.B. reviews, and concurs with the inspection plans; test, calibration and special process procedures; drawings and specifications; and changes thereto or acceptable alternatives.
VI.
Document Control A.
The review, approval and issuance of documents and changes thereto, prior to release, are procedurally controlled to assure that they are adequate and that quality requirements are stated.
B.
Changes to documents, including instructions, procedures, and drawings are reviewed by the same organization that performed the original review and approval or by other qualified, responsible organizations as delegated by Amersham Corporation.
C.
Approved changes are included in instructions, procedures, drawings and other documents simultaneously with the implementation of the change.
D.
Current issues of applicable documents will be available at the location where an activity is being performed.
This will preclude the use of obsolete or superseded documentation.
E.
A master list, or equivalent, is established to identify the current revision number of instructions, proctiores, specifications, drawings and procurement docurants.
VII.
Control of Purchased Materials. Parts and Components A.
Qualified personnel evaluate the supplier's capability to provide acceptable quality services and products.
B.
The evaluation of a supplier will be based on one or more of the following:
1.
The supplier's capability to comply with the elements of Appendix E of 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 the supplier l
on similar articles of the type being procured.
j 3.
A survey of the supplier's facilities and QA procedures to determine his capability to supply a product which meets the design, manufacturing, and quality requirements.
C.
The results of the 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 to assure conformance to the purchase order requirements.
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E.
The supplier will furnish the following records to Amersham Corporation when the container is delivered:
1.
Documentation showing which of the purchased material or equipment meets the requirements in the procurement document.
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.
A 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.
2.
Materials, components, equipment and acceptance records are inspected and judged acceptable in accordance with predetermined inspection procedures, prior to installation or use.
3.
Inspection records or certificates of conformance attesting to the acceptance of material and components are available prior to installation or use.
4.
Items accepted and released for use are identified as to their inspection status prior to forwarding them to a controlled storage area or releasing them for further work.
VIII.
Identification & Control of Materials. Parts & Components j
A.
Procedures are established to identify and control materials, parts and components, including partially fabricated sub-assemblies.
B.
Procedures are established to ensure that identification of an item is maintained by part number, serial number, or other appropriate means, 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 will be traceable to the appropriate documentation, such as drawings, specifications, purchase orders, manufacturing and inspection documentation, deviation reports, and physical and chemical mill test reports, i
D.
The location and method of identification will not affect the fit, function, or quality of the item being identified.
E Correct identification of materials, parts and components is verified and documented prior to release for fabrication, assembling and installation.
7 1
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t IX.
Control of Special Processes A.
All special processes, uch as welding, are procedurally controlled.
i B.
All procedures, equipment, and personnel connected with special
{
processes are qualified in accordance with applicable codes, standards and specifications.
C.
The qualification records of procedures, equipment, and personnel associated with special processes are established, filed, and kept current.
X.
Inspection A.
An inspection program which verifies conformance of quality affecting activities with requirements is established, documented and accomplished in accordance with written and controlled procedures.
B.
The inspection personnel are independent from the individuals performing the activity being inspected.
C.
The inspectors are qualified in accordance with applicable standards and company training programs.
Their qualifications are kept current through continued retraining on revised procedures.
D.
Modifications, repairs and replacements are inspected in accordance with the original design and inspection requirements or acceptable alternatives.
E.
Provisions are established that identify mandatory inspection hold points for witness by 6n inspector.
I XI.
Test Control l
A.
A test program to demonstrate that the item or component will perform satisfactorily in service is established, documented and accomplished in accordance with written, controlled procedures.
B.
Modifications, repairs and replacements are tested in accordance with the original design and testing requirements or acceptable alternatives.
C.
Test results are documented, evaluated, and their acceptability determined by a qualified, responsible individual or group.
XII.
Control of Measurina & Test Ecuipment A.
Measuring and test instruments are calibrated at appropriate intervals based on the required accuracy, purpose, degree of usage, stability characteristics and other conditions af fecting the measurement.
l B.
Test equipment is identified and traceable to the calibration test l
data.
l l
8
1 a
l C.
Measures are taken and documented to determine the validity of previous inspections performed when measuring and test equipment l
I 1s found to be out of calibration.
l 0.
Reference and transfer standards are traceable to recognized standards; or, where recognized standards do not exist, provisions are established to document the basis for calibration.
XIII.
Handling. Storage and Shipping l
A.
Any special handling, preservation, storage, cleaning, packaging l
and shipping requirements for Type B containers are established and accomplished by qvalified individuals in accordance with predetermined instructions.
.i. All conditions of the NRC package approval and US Department of Transportation shipping requirements are satisfied prior to shipment.
C.
All necessary shipping papers will be prepared as required.
D.
The departure, arrival time and destination of any Type B containers will be established and monitored to a degree consistent with the safe transportation of the package.
XIV.
Inspection. Test and Operating Status i
i A.
The appropriate identification of packages as to the status of l
inspections and testing and therefore the overall operating status of the unit, 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.
C.
The bypassing of required inspections, tests and other critical operations is procedurally controlled.
D.
The status of nonconforming, inoperative, or malfunctioning I
packages or components is clearly indicated in such a manner to l
prevent their unauthorized use.
XV.
Nonconforming Material. Parts or Components l
A.
The identification, documentation, segregation, disposition, review and notification to affected organizations of nonconforming materials, parts components or services are procedurally controlled.
B.
Documentation identifies a nonconforming item; describes the nonconformance, the disposition of the nonconformance and the inspection requirements; and includes the appropriate approval signature related to the disposition.
C.
Nonconforming items are clearly segregated from acceptable items and are identified as discrepant until properly dispositioned.
9
D.
All rework or repair of materials, parts, components and systems is verified by reinspecting and retesting the item as it was originally inspected and tested or as verified by a method which is at least equal to the original inspection and testing method.
XVI.
Corrective Action A.
The evaluation of conditions detrimental to quality (such as nonconformances, deficiencies, failures, malfunctions, 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 formally close out the corrective action documentation.
XVII.
Quality Assurance Record A.
Sufficient records are maintained to provide documentary evidence of the quality and safety of items, and the activities affecting quality and safety.
B..The QA records maintained for Type B containers include qualification of personnel, procedures and equipment; list of nonconformances; corrective action reports for nonconformances; results of reviews, inspections, tests, audits and material analysis; other documentation such as drawings, specifications, procurement documents and calibration procedures.
C.
Records are identifiable and retrievable.
D.
A list of the required records and their storage locations will be maintained.
E.
All design related records (e.g., drawings, calculations, etc.)
are maintained for the life of the shipping package and all other records are maintained for a minimum of two years.
F.
The 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.
4.
Information related to conditions adverse to quality.
5.
Inspector or data recorder identification.
6.
Evidence as to the acceptability of the results.
10
XVIII. Audits A.
Audits are performed in accordance with pre-established written procedures or check lists and conducted by personnel not having direct responsibilities in the area being audited.
B.
The results of audits are documented and reviewed with responsible management of areas audited.
C.
The responsible management takes the necessary action to correct deficiencies revealed by the audit on a timely basis.
D.
Deficient areas will be reaudited on a timely basis to verify implementation of corrective actions to minimize recurrence of j
deficiencies.
j E.
Audits of the QA program are performed at least annually based on the safety significance of the activity audited.
F.
The audit plan includes:
a.
purpose or objective of audit; b.
scope; c.
specific organizations to be audited; I
d.
names of team members and team leader; e.
approximate schedule; f.
written notification to audited organization; g.
pre-audit conferences; h.
post-audit conferences (exit interview); and 1.
method of reporting and evaluating findings.
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