ML19340D058
| ML19340D058 | |
| Person / Time | |
|---|---|
| Site: | 07100354 |
| Issue date: | 11/07/1979 |
| From: | Arndt R, Kelbley N ADVANCED MEDICAL SYSTEMS, INC. |
| To: | |
| Shared Package | |
| ML19340D057 | List: |
| References | |
| QA-1000-1.4, NUDOCS 8012190611 | |
| Download: ML19340D058 (9) | |
Text
.
t cumsEn GUAUTY ASSURANCE DEPARTMENT ADVANCED MEDICAL QUALITY ASSURANCE POLICY FOR COMPLIANCE.WITH SY" MS, INC.
10 CFR PART 71 APPENDIX E 0A 1000 1.4 DATE 155UED o,...on, Pr.eue.
T*"
h November 7, 1979 I.
ORGANIZATION The final responsibility for the Quality Assurance (0A) Program for Part 71, requirements rests with ADVANCED MEDICAL SYSTEMS, INCORPORATED.
The Q.A. function is developed about the concept that all products are produced and controlled to comply with all specified and implied standards of performance and quality, at the most economical cost.
In essence, the quality assurance function can be considered a coordinated responsibility aimed at eliminating defective work, which can be generated as' the result of poor design, poor production workmanship, and vendor and customer errors.
Because of the magnitude of such a function, the responsibility of coordinating this has been given to the Quality Assurance Department.
The Q. A. Department being an independent reporting group, is respon-sible to the General Manager.
All Design and Fabrication shall be conducted under this Q.A. Program.
The Q.A. Program is implemented as shown on the attached organization chart.
The Radiation Safety Officer /Q.A. Manager is responsible for overall administration of the program, training and certification, document control, and auditing.
Q.A.
individuals, via the Q. A. Manager, have the responsibility and authority to stop unsatisfactory work and control further processing, delivery, or installation of non-conforming material.
II. OUALITY ASSURANCE PROGRAM The management of ADVANCED MEDICAL SYSTEMS, INCORPORATED, establishes and implements this Q.A. Program.
Training, prior to engagement, for all Q.A. functions is required according to written procedures.
Q.A.
Program revisions will be made according to written procedures with Isotope Committee approval.
The Q. A.
Program will ensure that all defined Q.A. Procedures, Engineering Procedures, and Specific Provisions of the package design approval are satisfied.
The Q.A. Program will emphasize control of the characteristics of the package which are critical to safety.
The ADVANCED MEDICAL SYSTEMS, INCORPORATED Isotope Committee regularly 8 012 ro oW/ reviews the total Q.A. Program.
The Q.A. manual is a confidential publication containing proprietory information for ADVANCED MEDICAL SYSTEMS, INCORPORATED.
It's distri-
~
8 CATALOG
- REVislONs PREPARED BY AP ROVAL l 11-18-80 (N
// - /T-TO
-h A
y
Q:
bution is, therefore, limited to corporate Q.A., the General Manager, Engineering Manager, Manufacturing Manager, and Quality Assurance.
Revisions to the Q.A. manual must be approved by management, as out-lined below, and will become effective immediately upon approval.
Document Control requires the approval of the Manager, Engineering.
All sections also require the approval of the Manager, Quality Assurance.
The manual will be reviewed every 12 months to verify all revisions are contained.
The General Manager will communicate to all departments and individuals that quality policies, Q.A.
manuals, and procedur es are mandatory requirements which must be implemented and enforced.
All items purchased, manufactured, or used by ADVANCED MEDICAL SYSTEMS, INCORPORATED, in the manuf acturing or service of its products are subject to Q.A. control.
Any disputes involving quality, between Q.A. personnel and other department personnel, will be resolved by the General Manager.
An indoctrination and training program is established such that:
1.
Personnel responsibility for performing quality-related activities are instructed as to the purpose, scope and imple-mentation of the Q.A. manuals, instructions, and procedures.
2.
Personnel performing quality-affecting activities are trained and qualified in the principles and techniques of the activity being performed.
3.
The scope, the objective, and the method of implementing the indoctrination and training program are documented.
4.
Proficiency of personnel performing quality-affecting activi-ties is maintained by re-training, re-examining, and/or re-certifying.
Quality-related activities are performed with specific equipment under suitable environmental conditions, and prerequisites have been satis-fied prior to inspection and test.
III. DESIGN CONTROL 1.
Measures are established to carry out design activities in a planned, controlled, and orderly manner.
2.
Measures are established to correctly translate the applicable regulatory requirements and design bases into specifications, drawings, written procedures, and instructions. _
\\
l 3.
Quality standards are specified in the design documents, and deviations and changes from these quality standards are controlled.
4.
Designs are reviewed to assure that (1) design characteristics can be controlled, inspected, and tested, and (2) inspection and test criteria are identified.
5.
Proper selection and accomplishment of design verification or checking processes such as by design reviews, alternate calcula-tions, or qualification testing are performed.
When a test program is used to verify the adequacy of a design, a qualifica-tion test of a prototype unit under design conditions should be used.
6.
Individuals or groups responsible for design verification are other than the original designer and the designer's immediate supervisor.
7.
Design and specification changes are subject to the same design controls and approvals that were applicable to the original design, unless the licensee designates another qualified respon-sible organization.
8.
The positions or groups responsible for design reviews and other designs verification activities and their authority and responsi-bility are identified and controlled by written procedures.
i i
IV. PROCUREMENT DOCUMENT CONTROL 1.
Procedures are established that clearly delineate the sequence of actions to be accomplished in the preparation, review, approval, and control of procurement documents.
2.
Procurement documents identify the applicable 10 CFR Part 71, Appendix E requirements, which must be complied with and described in the supplier's Q.A. Program.
3.
Procurement documents contain or reference the design basis technical requirements including the applicable regulatory requi-rements, material and component identification requirements, drawings, specifications, codes and industrial standards, test and inspection requirements, and special process instructions.
4.
Procurement documents identify the documentation (e.g., drawings, specifications, procedures, inspection and fabrication plans, inspection and test records, personnel and procedures qualifica-tions, and chemical and physical test results of material) to be prepared, maintained, and submitted to the purchaser for review and approval.
5.
Procurement documents identify those records to be retained, controlled, and maintained by the supplier, and those delivered to the purchaser prior to use or installation of the hardware. !
i__,.
.~.
6.
Procurement documents contain the procuring agency's right of access to supplier's facilities and records for source inspection and audit.
7.
Changes and revisions to procurement documents are subject to at least the same review and approval as the original document.
V.
INSTRUCTIONS, PROCEDURES, AND DRAWINGS 1.
Activities affecting quality are prescribed and accomplished in accordance with documented instructions, procedures, or, draw-ings.
2.
Provisions are established which clearly delineate the sequence of actions to be accomplished in the preparation, review, approval, and control of instructions, procedures, and drawings.
3.
The Q.A. organizaticn reviews and concurs with inspection plans; test, calibration, and special process procedures; drawings and specifications; and changes thereto or acceptable alternatives are described.
VI. DOCUMENT CONTROL 1.
The review, approval, and issue of documents and changes thereto, prior to release, are procedurally controlled to assure they are adequate and the quality requirements are stated.
2.
Changes to documents are reviewed and approved by the same organi-zations that performed the original review and approval or by other qualified responsible organizations delegated by the appli-cant.
3.
Approved changes are included in instructions, procedures, draw-ings, and other documents prior to implementation of the change.
4 Documents are available at tne location where the activity will be performed prior to commencing the work.
5.
A master list, or equivalent, is established to identify the current revision number of instructions, procedures, specifica-tions, drawings, and procurement documents.
I I
VII. CONTROL OF PURCHASED MATERIALS, PARTS, AND COMPONENTS 1.
Qualified personnel evaluate the supplier's capability to provide acceptable quality services and products.
2.
The evaluation of suppliers is based on one or more of the follow-ing:
I 1.
The supplier's capability to comply with the elements of l
Appendix E 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.
~ :b 3.
A survey of the supplier's facilities and Q.A. Program to determine his capability to supply a product which meets the design, manufacturing, and quality requirements.
3.
The results of supplier evaluations are documented and filed.
4.
Surveilance, if required, of suppliers during f abrication, inspection, testing, and shipment of materials, equipment and componants, is planned and performed in accordance with written 3
procedures to assure conformance to the purchase order require-ments.
5.
The supplier furnishes the following records as a minimum to the purchaser:
l.
Documentation that identifies the purchased material or equipment and the specific procurement requirements (e.g.,
C codes, standards, and specifications) met by the items.
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".
6.
Receivng 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 documen-tation.
2.
Material, components, equipments, and acceptance records are inspected and judged acceptable in accordance with prede-termined inspection instructions, 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 are identified as to their inspec-tion status prior to forwarding them to a controlled storage area or releasing them for further work.
1 VIII. IDENTIFICATION AND CONTROL OF MATERIALS, PARTS, AND COMPONENTS 1.
Procedures are established to identify and control materials, e
parts, and components including partially fabricated subassemblies.
2.
The identification and control procedures assure that identifica-I tion is maintained either on the item or on records traceable to the item to preclude use of incorrect or defective items.
3.
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.
4 The location and the method of identification do not affect the fit, function, or quality of the item being identified.
5.
Correct identification of materials, parts, and components is verified and documented prior to release for fabrication, assembl-ing and installation.
IX. CONTROL OF SPECIAL PROCESSES 1.
Special processes such as welding, heat treating, nondestructive testing, and cleaning are procedurally controlled.
2.
Procedures, equipment, and personnel connected with special processes are qualified in accordance with applicable codes, standards, and specifications.
3.
Qualificaiton records of procedures, equipment, and personnel associated with special processes are established, filed, and kept current.
X.
INSPECTION 1.
An inspection program which verifies conformance of quality-affec-ting activities with requirements is established, documented, and accomplished in accordance with written and controlled procedures.
2.
Inspection personnel are independent from the individuals perform-ing the activity being inspected.
3.
Inspectors are qualified in accordance with applicable codes, standards, and company training programs; and their qualifications and certifications are kept current.
4 Modifications, repairs, and replacements are inspected in accor-dance with the original design and inspection recuirements, or acceptable alternatives.
5.
Provisions are' established that identify mandatory inspection hold points for witness by an inspector.
XI. TEST CONTROL 1.
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.
6-
2.
Modifications, repairs, and replacements are tested in accordance with the original design and testing requirements or acceptable alternatives.
3.
Test results are documented, evaluated, and their acceptability determined by a qualified, responsible individual or group.
XII CONTROL OF MEASURING AND TEST E0VIPMENT 1.
Measuring and test instruments are calibrated at specified intervals based on the required accuracy, purpose, degree of usage, stability characteristics, and other conditions affecting the measurement.
2.
Measuring and test equipment is identified and traceable to the calibration test data.
3.
Measures are taken and documented to determine the validity of previous inspections performed when measuring and test eculp-ment is found to be out of calibration.
4.
Reference and transfer standards are traceable to nationally recognized standards; or where national standards do not exist, provisions are established to document the basis for calibration.
XIII. HANDLING, STORAGE, AND SHIPPING 1.
Special handling, preservation, storage, cleaning, packaging, and shipping requirements are established and accomplished by qualified individuals in accordance with prefetermined work and inspection instructions.
2.
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.
3.
All necessary shipping papers will be prepared, as required.
4.
Departure, arrival time, and destination of a package will be established and monitored to a degree consistent with the safe transportation of the package.
XIV. INSPECTION, TEST, AND OPERATING STATUS 1.
Identification of the inspection, test, and operating status of packages and components is known by affected organizations.
2.
The application and removal of inspection and welding stamps and status indicators such as tags, markings, labels, and stamps, are procedurally controlied..
and other critical Bypassing of required inspections, tests, operations is procedurally controlled.
3.
i The status of nonconforming, inoperative, or malfunction ng inadvertent packages or components is identified to prevent 4.
use.
NCNCONFORMING MATERIAL, PARTS, OR COMPONENTS _
The identification, documentation, segregation, review dispo XV.
forming tion, and notification to affected organizations of noncon l.
lly control-materials, parts, components, or services are procedura led.
item; describes the Documentation identifies the nonconformingthe nonconformance, and the the disposition ofand includes signature approval of the 2.
nonconformance, inspection requirements; disposition.
Noncenformiris items are segregated from acceptable item identified as discrepant until properly dispositioned.
3.
Acceptability of rework or repair of materials, par 4.
is at inspected and tested or by a method which and systems least equal to the original inspection and testing method.
as originally XVI. CORRECTIVE ACTION Evaluation of conditions adverse to quality (such as nonc deviations, and deficiencies, 1.
mances, failures, malfunctions, is conducted to determine the and equipment) l h d proce-defective materialneed for corrective action in acco l
dures.
initiated following the determination of l
Corrective action is a condition adverse tc quality to preclude recurrence.
2.
i Follow-up revios are cor. ducted to verify proper implemen i
of corrective actions and to close out the correc 3
documentation.
XVII. _0UALITY ASSURANCE RECORDS _
l Sufficient records are maintained to provide documentary l
i of the quality and safety of items and the activities affect n l
1.
l quality and safety, Q.A. records include operating logs; results of reviews, 8
tions, tests, audits, and material analyses; qualificatio 2.
tion such personnel, procedures, and equipment; and other documen procurement documents, calibration and corrective as drawings, specifications,nonconformance reports; procedures and reports; action reports.
3.
Records are identifiable and retrievable.
4.
A list of the required records and their storage locations will be maintained.
5.
Design related records (e.g.,
drawings, calculations, etc.),
are maintained for a minimum of two years.
6.
Inspection and test records contain the following, where appli-cable:
1.
A description of the type of observation.
2.
Evidence of completing and verifying a manufacturing, inspec-tion, 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.
XVIII. AUDITS 1.
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 audited.
2.
Audit results are documented and the reviewed with management having responsibility in the area audited.
3.
Responsible management takes the necessary action to correct the deficiencies revealed by the audit.
4.
Deficient areas are reaudited on a timely basis to verify imple-mentation of corrective actions which minimize recurrence of deficiencies.
5.
Audits of the Q.A. program are performed at least annually, based on safety significance of the activity being audited.
.g.