ML20058M943
| ML20058M943 | |
| Person / Time | |
|---|---|
| Site: | 07100354 |
| Issue date: | 09/28/1993 |
| From: | Stein S ADVANCED MEDICAL SYSTEMS, INC. |
| To: | Haughney C NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS) |
| References | |
| NUDOCS 9310070178 | |
| Download: ML20058M943 (2) | |
Text
{{#Wiki_filter:w .7/-D35+ i, i . Advanced Medical Systems,.Inc. 121 North Eagle Street. Geneva, Ohio 44041 .) ..(216)4,66-4671 TWX 4332135 ATC Ul FAX (216) 466-0186 'i i i September 28, 1993 Mr. Charles J. Haughney, Acting Chief j Source Containment & Devices Branch Division of Industrial & Medical Nucsear Safety [ NMSS l U. S. Nuclear Regulatory Commission a Washington, D. C. 20555-0001 i RE: NPC Inspection Report No. 710354/93-06 l t Your Letter Dated September 15,1993 i
Dear Mr. Haughney:
i At the time we responded to the Notice of Violation and Notice of Nonconformance,. we also enclosed our revised Quality Assurance Procedures, QA1000 et seo., which I were classified as confidential. These documents were returned with instructions j to submit them with an Amendment. Request, which we did. They were then returned again because of their confidentiality. We have since reclassified QA2000. l 1.0 Quality Assurance policy for Compliance with 10 CFR part 71 and QA2000 2.01Q DFR Reporting of Defects amd Non-Comp))ance and Procedures for Compliance with JO CFR part 21 as nonconfidential, and resubmitted them. It appears, however, j from your requests for clarification that your letter was sent prior to your staff l having the opportunity to review our actual procedures. For your convenience, I am, therefore, enclosing additional copies of these two procedures which should i clarify your inquiries. I Because of this, we will respond only briefly to your inquiries since your questions will be more easily resolved by your staff's ability to'actually see the procedures rather than our reiterating them in this letter. Our brief responses are set forth below: 10 CFR fi 21.31: Nonconforman_pe A21 Your request for verification that overpack replacement parts are evaluated for their importance to aafety and are controlled in an appropriate manner: As set. forth in QA20001.0, Section 3.0 covers package design control. Section 4.0 ' covers procurement document control, with Subpart 4.1.1 ensuring that purchase i orders will be acccmpanied by a current blueprint and contain a statement that the ltem and service being purchased must be supplied in compliance with 10 CFR Part
- 21. - Further, Subpart 4.3 provides that procurement documents.will. contain a reference, if necessary, to the design basis technical requirements including the tumljeable regulatorv req uiremente, material and components identification j
requirements, drawings, specifications, codes and industrial standards, test and inspection requirements, and special process instructions. {/ g -aa^^8 m l.:1 9310070178 930928 M <( PDR ADOCK 07100354 .J i C PDR t -.s-,. h
Mr. Charles J. liaughney September 28,1993 Control of nurchased materials, parts, and components are covered by Section 7.0 with ide_rdfli.gation and control of materials, parts. and components set forth in Section 8. Honconfp_rmance B4: Your request for corrective actions to address the requirement for procurement documents to identify test and inspection requirements and special process instructions. procurement documents are now being reviewed to ensure that applicable test and inspection requirements and special process instructions where applicable, are included. In addition, where applicable, procurement documents state that the requirements of 10 CFR part 21 and/or 71 apply. Nonconformance Dl: Isotope Committee approval of revisions to written procedures. QA20001.0 Quality Assurance pollev for Compliance with 10 CFR, Part 1, Section 2.1, states that QA program revisions will be made according to written procedures with Isotope Committee approval. QA1000' has been revised. QA1000 1.3 Quality Assurance Inspection and Test procedures, Section 3.0, which governs formal written procedures, indicates that procedures are generated by the Isotope Committee with the assistance of other knowledgeable personnel, as considered necessary. QA1000 1.3, Subpart 3.6, which governs revisions to procedures, indicates that the Isotope Committee approve all revisions. Thus, the discrepancy has been rectified. Should your staff have any addit.ional questions following their review of QA2000 1.0 and QA1000 2.0, please feel free to contact me. Sincerely, ^ Ie )g'I b N'(ki4 m '[ l y 511.RRY J.l$7EIN Director of Megulatory Affairs SJS/cs Enclosures e.
~. i s Procedure No: QA 2000 1.0 QUAI,ITY ASSURANCE POL]CY FOR COMPLI ANCE WITH Hevision: I 10 CFR PART 71 Date Issued: 11 79 ] i Page 1 of 12 1.0 ORGANIZATION The final responsibility for the Quality Assurance (Q.A.) Program for Part 71 requirements rests with ADVANCED MEDICAL SYSTEMS, INCORPORATED (AMS). 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 p 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 i has been given to the Quality Assurance Department. The Q. A. Department being an i independent reporting group, is responsible to the Engineering Manager. l All package design and fabrication shall be conducted under this Q.A. Program. The Director of Regulatory Affairs is responsible for overall administration of the program, training and certification, document control and auditing. Q.A. individuals, have the responsibility and authority to stop unsatisfactory work and control further processing, delivery, or installation of non-conforming material. 2.0 QUALITY ASSURANCE PROGRAM 2.1 The Management of AMS establishes and implements this Q. A. Program. 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, i Engineering Procedures, and Specific Procedures 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 AhtS lsotole Committee reviews the status and adequacy of the Q. A. Program 2.2 i at 12 month intervals. 2.3 A copy of the Q.A. manual is distributed to Regulatory Affairs, to the Engineering Manager, Radiation Safety Officer, Purchasing and Quality Control. Advanced Medical Systems, Inc. Quality Assurance Department l Prepared by Approval Revisions 4yAD ri~ 7 r B d 7 ^. 2 9 n # b T 1 % y -
~._, 1 P s Procedure No: QA 2000 1.0 QUALITY' ASSURANCE POLICY FOR COMPLI ANCE WITil Revision: 10 CFR PART 71 i Date Issued: 11 79 i I Page 2 of 12 t 2.4 Revisions to the Q.A. manual must be approved by the Isotope Committee,. as 1 outlined below, and will become effective immediately upon approval. The manual will be reviewed every 12 months to verify all revisions are contained. I 2.4.1 [{fXlSION: When it becomes necessary to revise the wanual, the i proposed changes will be reviewed by the Isotope Committee, to i incorporate revisions, the following steps will be followed* 2.4.2 For historical purposes, the copy of the obsolete procedure i will be marked obsolete, dated and placed into the appropriate history file. i 2.4.3 The master procedure will be revised to reflect the changes approved by the Isotope Committee._ In the revision block of j the bottom of Page 1, the change will be noted. For each page .e in the procedure, the revision block will be changed to reflect the current revision. 2.4.4 The revised procedure will be returned to the Isotope Committee for review. If in agreement with the content, the Committee Chairman will sign the approvel block, i
2.4.5 DISTRIBUTION
Each approved procedure will be distributed as follows: a) Director of Regulatory Affairs b) Radiation Safety Officer c) Purchasing Department i d) Engineering Department l e) Quality Control i 4
2.4.6 REVIFW
The manual will be reviewed every twelve (12) months to verify that all procedures are correct and current. Results of the review will be indicated on the manual review form following i the table of contents. The results of the review will also be discussed during the appropriate Isotope Committee meeting and a notation made in the minutes of the meeting. 2.5 The Director of Regulatory. Affairs will communicate to all departments l and individuals that quality policies, Q.A. manuals, and procedures are mandatory requirements which must be implemented and enforced. Advanced Medical Systems, Inc. Quality Assurance Department Prepared by Approval Revisions h / 1
4 Procedure Noi QA 2000 1.0 -QUALITY ASSURANCE POLICY FOR COMPL!ANCE WITil Revision: ) 10 CFR PART 71 Date Issued: 11 79 Page 3 of 12 2.6 All items purchased, manuf actured, or used by AMS in the manufacturing or service of its package are subject to Q.A. Control. j 2.7 Any disputes involving quality between Q.A. personnel and other department j personnel, will be resolved by the Engineering Manager. ) 2.8 An indoctrination and training program is established such that: I Personnel responsible for performing quality-related activities are a. instructed as to the purpose., scope and implementation of the Q.A. manuals, instructions and procedures. b. Personnel performing quality-affecting activities are trained and qualified in the principles and techniques of the activity being i performed. 2.8.1 PERSONNEL REQUIREMENTS: Employees involved with this program will be given on the job training as necessary to perform the job assigned. i Training will be documented and these records placed in the employee's ] O.A. training files kept at the Geneva facility. l 2.8.2 10 CFR Part 71 training will be conducted by the. Director of Regulatory Affairs or designate. Training will be-documented and kept in the employees Q.A. training files, j 2.9 Quality-related activities are performed with appropriate equipment under suitable environmental conditions, and prerequisites have been satisfied prior to inspection and test. 3.0 P,ACKAGE DESIGN CONTROL 3.1 Measures are established to carry out design activities in a planned, controlled 3 i and orderly manner. 3.2 Measures are established to correctly translate the applicable regulatory requirements and design bases into specifications, drawings, written procedures. and instructions. 3.3 Quality standards are specified in the design documents, and deviations and changes from these quality standards are controlled. Advanced Medical Systems, Inc. Quality Assurance Department Prepared by Approval Revisions W [N u i 4 4 e w w T .ir 't u-e a w--_+.y
l 4 i s -QUAllT ASSURANCE Pol. ICY FOR COMPLIANCE WITH Revision: 10 CFR PART 71 Date lasued: 11 79 i E Page 4 of 12 9 3.4 Designs are reviewed to assure that. (1) design characteristics can be controlled,- [ inspected and tested and (2) inspection and test criteria are identified. 3.5 Proper selection and accomplishment of design verification or checking processes such as by design reviews, alternate calculations or qualification test of a ~ prototype or sample unit under design conditions be used. / 3.6 Individuals or groups responsible for design verification are other than the original designer and the designer's immediate supervisor. 3.7 Design and specification changes are subject to the same design controls and approvals that were applicable to t.he original design, unless the licensee designates another qualified responsible organization. t 4.0 PROCUREMENT DOCUMENT CONTROL I 4.1 Sect. ion 4.1.1 delineates the sequence of actions to be accomplished in the preparation, review, approval and control of nrocurement documents. 4.1.1 Procurement Procedurg* Procurement documents (purchase orders) will be initiated by either a written or verbal request for a component or service / repair. Purchase orders will be accompanied by a current blueprint. Purchase orders will be logged in a purchase order record book; records wi11 be kept of Purchase Order number, date, requested by, vendor, description, due date and cost. s The purchase orders for package components will contain a statement that the item or service being purchased must be supplied in compliance with 10 CFR Part 71. Special instructions, if any, will be indicated on the purchase order form. 4.2 Procurement documents identify the applicable 10 CFR Part 71 requirements, which must be complied with by the supplier's Q.A. Program. 4.3 Procurement documents contain or reference, if necessary, the design basis technical requirements including the applicable regulatory requirements, material and component identification requirements, drawings, specifications, codes and industrial standards, test and inspection requirements, and special process j instructions. Advanced Medical Systems, Inc. 1 Quality Assurance Department l l Prepared by Approval Revisions ( j pi--(-P -tT-+-4 t-w
i Procedure No: QA 2000 1.0-QUALITY ASSURANCE p0LICY FOR COMpLI ANCE WITH y Revision: 10 CFR PART 71 Date Issued: 11 79 I I i i Page 5 of 12 4.4 Procurement documents identify the documentation (e.g. drawings, specifications, procedures, inspection and fahrication plans, inspection and test ; records, i personnel and procedures qualifications, and chemical and physical test results j of material) to be prepared, maintained, and submitted to the purchaser for review and approval. i 4.5 Procurement documents identify those records to be retained, controlled, and/or maintained by the supplier, and those which will be delivered to the pu rchaser-prior to use or installation of the hardware. 4.6 Procurement documents contain AMS' right of access to supplier's facilities and j records for source inspection and audit. 4.7 Changes and revisions to procurement documents are subject to at least the same review and approval as the original document. l ? 4,8 Procurement documents will be reviewed by the Engineering Manager and signed prior i to being issued to suppliers of package components. 1 I 5.0 INSTRUCTIONS, PROCEDURES AND DRAWINGS I 5.1 Activities affecting quality are prescribed and accomplished in accordance with documented instructions, procedures or drawin*s. i 5.2 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. 5.3 The Q A. organization reviews and concurs with inspection plans; test, allilrrtion and special process procedures; drawing and specifications; and changes tiereto. I l 6.0 DOCUMENT CONTROL .1 6.1 The review, approval and issue of documents and changes thereto, prior to release, are controlled to assure they are adequate and the quality requirements are stated. [ 6.2 Changes to documents are reviewed and approved either by the same organizations that performed the original review and approval or by other qualified responsible organizations delegated by the applicant. Advanced Medical Systems, Inc. Quality Assurance Department i Prepared by Approval Revisions 1 h h ( r.
Procedure No: QA 2000 1.0 QUALITY ASSURANCE POLICY FOR COMPLI ANCE WITH Revision: 10 CFR PART 71 Dats Issued: 11 79 I Page 6 of 12
6.2.1 CHANGES
All changes, revisions, and new package drawings must be reviewed by the Isotope Committee and' approved by the Chairman. The Isotope Committee will record the results of their review in the Isotope Committee minutes. 6.3 Approved changes are included in instructions,. procedures, drawings and other I documents prior to the implementation of the change. 6.4 Documents are available at the location where the activity will be performed. 6.5 A master list, or equivalent, is established to identify the current revision number of instructions, procedures, specifications, drawings and procurement documents. I 6.5.1 MASTER LIST: In addition to the master list, all traveling requisition j forms will be tagged to indicate that the package component must. comply l .to 10 CFR 71. This information will also be entered into the inventory l cont rol computer. ".0 CONTROL OF PURCHASED MATERIALS. PARTS AND COMPONENTS 7.1 Qualified personnel evaluate supplier's capability to provide acceptable quality services and products. l t 7.1.1 The Directory of Regulatory Affairs, assisted by the Engineering -{ Manager, will evaluate suppliers. 7.2 The evaluation of suppliers is based on one~or more of the following: The supplier's capability to comply with the elements of 10 CFR Part 71 a. 1 that are applicable to the type of material, cquipment or service being procured. b. A feview of previous records and performance of suppliers who have I provided similar articles of the type being procured. i c. A survey of the supplier's facilities and Q.A. Program to determine his capability to supply a product which meets the design, manufacturing, i and quality requirements. .i l .1 Advanced Medical Systems Inc. Quality Assurance Department Prepared by Approval Revisions b A
- ~..-. 4 [ I~ } Procedure No: QA 2000 1.0 QUA1 ASSURANCE p0LICY FOR COMPLI ANCE WITH l Revision: 10 CFR PART 71 Date Issued: 11 79 l t e Page 7 of 12 7.3 The results of supplier evaluations are documented and filed. 7.3.1 SUPPLIER EVALUATION: The results of the supplier's evaluation l will be maintained in a file located at the Geneva facility. 7.4 Surveillance, if required, of suppliers during fabrication, inspection,-testing and shipment of materials, equipment and components, is planned and perforried in accordance with written procedures to assure conformance to the purchase order i reouirements. 7.5 The supplier will furnish documentation to the purchaser that the material supplied or service performed meets the' performance specification required by the Purchase Order. 7.6 Receiving inspection of the supplier-furnished material, equipment and services is performed to assure: i n. The material, component or equipment is properly identified and i corresponds with the identification on receiving documentation. b. Material, components, equipment and acceptance records are inspected and judged acceptable in accordance with predetermined i L inspection instructions, prior to installation or use. c. Inspection records or certificates of conformance attesting.to the acceptance of material and components are available prior to installation or use. i d. Items accepted and released are identified as to their inspection j status prior to forwarding them to a contro led storage area or releasing them for further work. 8.0 1RENILELC3] ION AND CONTR0h 0F MATERI ALS. PARTS AND COMPONENTS 8.1 Measures are established to identify and control materials, pa4 ts and components including partially fabricated subassemblies.
8.1.1 CONTROL
Parts will be kept in the stock area until needed. The i stored parts will be tagged with their part number and inventoried. I Advanced Medical Systems, Inc. Quality Assurance Department Prepared by Approval Revisions i / } ik 1 ths
~ 4 Procedure No: QA 2000 1.0 QUALITY ASSURANCE POLICY FOR COMPLI ANCE WITH l Hevision: 10 CFR PART 71 Date Issued: 11 79 I Page 8 of 12 f 8.2 The identification and control measures assure that identification is maintained either on the item or on records traceable to the item so as to preclude use of - incorrect or defective items. 8.2.1 Items purchased in lot quantities will be kept together and marked. i with the part number and revision level as specified on the blueprint and also reference the Purchase order number under which the lot I was purchased. Items will be used from one lot only before proceeding t.o another. Inventory will be pulled on a "First In - First Out" basis. 8.3 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. 8.4 The location and the method of identification do not affect the fit, function or quality of the item being identified. + 1 i 8.5 Coi rect identification of materials, parts and components is verified and documented prior to release'for assembling and installation. i 9.O CONTROL OF SPECI AL PROCESSES 9.1 Special processes such as welding, heat treating, non-destructive testing and cleaning are procedurally controlled and accomplished by qualified personnel. 9.1.1 No special processes are performed by AMS personnel. 9.2 Procedures, equipment and personnel connected with special processes are qualified in accordance with applicable codes, standards and specifications. 9.3 Qualification records of procedures, equipment and personnel associated with special processes are established, filed and kept current. 10.0 J_NSPECTIONS i 10.1 An inspection program of activities affecting quality to verify conformity with requirements is established, documented and accomplished. 10.1.1 QA 1014 is to be followed to insure the package is acceptable. Advanced Medical Systems, Inc. Quality Assurance Department Prepared by Approval Revisions ' ' * + -
l i Procedure No: QA 2000 1.0 QUALITY ASSURANCE POLICY FOR COMPLI ANCE WITH Revision: 10-CFR PART 71-f Date Issued: 11 79 1 Page 9 of.12 -l 10.2 Inspection personnel are independent from the individuals performing the setivity being inspected. 10.3 Inspectors are qualif.ied in accordance with applicable codes, standards and [ company training programs; and their qualifications and certifications are kept current. ~ i 10.4 Modifications, repairs and replacements are inspected in accordance 'with the i original design and inspection requirements, or acceptable alternatives. 4 10.4.1 All inspections will be performed against the part drawings specified in the approval package. [ 11.0 TEST CONTROI, 11.1 A test program to demonstrate that the package or components will perform i satisfactorily in service is established, documented and accomplished in accordance with written procedures. i 11.1.1 TEST PROGRAM: The results of the original drop test are on file i and part of the package history. Unless there are major changes to the current design, no further drop tests will be performed. Any changes must be submitted and approved by the USNRC prior to being implemented. 11.2 Test results are documented, evaluated and their acceptability determined by a qualified, responsible individual or group. l 1 12.0 CONTROL OF MEASURING AND lEST FQUIPMENT 12.1 Measuring and test instruments are calibrated at specified intervals based on the required accuracy, purpose, degree of usage, stability characteristics, and other condit' ions af fecting the measurement. 12.2 Measuring and test equipment is identified and traceable to the alibration test data, if applicable. 12.3 Measures are taken and documented to determine the validity of previous inspections performed when measuring and test equipment is found to be out of calibration. 1 Advanced Medical Systems, Inc. Quality Assurance Department Prepared.by Approval Revisions & ]f 3 i -l
i Procedure No: QA 2000 1.0 l QUALITY ASSURANCE POLICY FOR COMPhlANCE WITH i Revision: I 10 CFR PART 71 i Date Issued: 11 79 i .Page 10 of 12 i 12.4 Reference and transfer standards are traceable to nationally recognized standards; j or where national standards do not exist, provisions are established to document -l the basis for calibration. i 13.0 HANDLING, STORAGE AND SHIPPING' 13.1 Special handling, storage, cleaning and shipping requirement s are established and accomplished by qualified individuals. 13.2 All condi tions (operations, tests, inspections, speci fications, etc. ), of the NRC package approval and the U.S. Department of Transportation shipping requirements are satisfied prior to shipment. I 13.3 All necessary shipping papers will be prepared, as required. i 14.0 J_NSPECTION TEST AND OPERATING STATUS i 14.1 Identification of the inspection, test and operating status. of packages and components is known by affected organizations. 1 14.2 Non-conforming, inoperative or malfunctioning packages er components are clearly marked to prevent. inadvertent use. l i. 15.0 NON-CONFORMING MATERTAI,t_ PARTS OR COMPONENTS f 15.1 The identification, documentation, segregation, review dinposition ..and components or services are procedurally. controlled. _ parts, 'l notification to affected organizations of non-conforming mat 4 rials, 15.2 Documentation identifies the non-conforming item; describes the non-conformity, i the disposition of the non-conformity, and the inspection requirements;. and inciddes signature approval of the disposition. t 15.3 Non-conforming items are segregated from acceptable items and identified as discrepant until properly dispositioned. 15.4 Acceptability of rework or repair of materials, parts, components and systems is verified by reinspecting-- the item as originally inspected or by a method c which is at least equal to the original inspection met. hod. l Advanced Medical Systems, Inc. Quality Assurance Department i Prepared by Approval Revisions l b vb 1 e _y y
~. 4 0 l Procedure No: QA 2000 1.0 QUALI'TY ASSURANCE POLICY FOR COMPLIANCE WITH Revision: 10 CFR PART 71 l Date Issued: 11 79 i Page 11 of 12 16.0 CORRECTIVE ACTION 16.1 Conditions adverse to quality (such as non-conformities, failures, malfunctions,. deficiencies, deviations, and defective material and equipment) are promptly identified and the cause determined. 16.2 Corrective action is initiated to preclude repetition. 16.3 Follow-up reviews are conducted to verify proper implementation of corrective 1 actions and to close out the corrective action documentation. 17.0 Rl3ALITY ASSURANCE RECORDS ) 17.1 Sufficient records are maintained to provide documentary evidence of the quality and safety of items and the activities affecting quality and safety. 17.2 Q.A. records include design reco rds, operating logs, results of reviews, inspections, tests, audits and material analysis; qualification of personnel, i procedures, and equipment; and other documentation such as
- drawings, specifications, procurement dccuments, calibration procedures and. reports; non-conformity reports; and corrective action reports.
17.3 Records are identifiable and retrievable. I 17.4 A list of the required records and their storage locations will be maintained. j 17.5 Design related records (e.g., drawings, calculations, etc. ) are maintained for t tho 1i;e of the package. 17.6 Inspection and test records contain the following, where applicable: A description of the type of observation. a. h. Evidence of completing and verifying a manufacturing, inspection or test operation. The date and results of the inspection or test. c. d. Informat. ion related to conditions adverse to quality. Inspector or data recorder identification, c. f. Evidence as to the acceptability of the results. Advanced Medical Systems, Inc. Quality. Assurance Department Prepared by Approval Revisions l .]
l 1 Procedure No: QA 2000 1.0 QUALITY ASSURANCE POLICY FOR COMPLI ANCE WIT 11 i Revision: 10 CFR PART 71 j Date Issued: 11 79 i r Page 12 of 12 J 18.0 AUDIIS - YEARLY I l 18.1 Audits of compliance with this procedure are conducted by personnel not having direct responsibilities in the areas being audited. i 18.2 Audit results are documented and then reviewed with management having j responsibility in the area audited. 18.3 Responsible management takes the necessary action to correct the deficiencies revealed by the audit. 18.4 Deficient areas are reaudit.ed on a timely basis to verify imple.aentation of corrective actions which minimize recurrence of deficiencies. 18.5 Audits of the Q.A. Program are performed based on safety significance of the ~ activity being audited. l l l Advanced Medical Systems, Inc. Quality Assurance Department 1 Prepared by Approval Revisions k [93
-,a J. e .A. ..e- 's 9 DATE OF IfEVIEW ltEVIEWER SUGGESTED CilANGES f l ? 't P f 0 L i a 9 a w w I 4
AMS ORGANIZATIONAL CIIART FOR PURIOSES OF 10 CFR PART 71 CONTROLS l GENEVA LONDON ROAD CEO MANAGEMENT TEAM RADIATION ENGINEERING SAFETY OFFICER I I I I QUALITY SALES SERVICE PURCilASING CONTROL PRODUCTION QUALITY CONTROL OF SilIPMENTS AND SOURCES { DIRECTOR OF REGULATORY AFFAIRS I l 1 PROCEDURAL { AUDITS TRAINING UPDATES f h 9 i k b f 5 l
l l l 1 i PROPOSED TRAINING DOCUMENTATION RECORD AMS Quality Assurance Policy for Compliance with 10 CFR Part 71 Procedure 2000 1.0 Training Acknowledgement I have reviewed both 10 CFR Part 71 and QA 2000 1.0 and am familiar with their contents. I have been instructcd in the principles and techniques of AMS' quality assurance procedures as they affect my i job. h r r Date Name b I i t s l l
provision No. QA 2000 2.0 10 CFR Reporting of Defects and Non-Compliance and prot idures Revision: A for Conpliance wit h 10 CFR part 21 i g Date Issued: 9/29/89 Page 1 of 5 NOTE: This Procedure should be followed in conjunction with QA 1000 8.1 Procedure For Handling of Customer Complaints and QA 1000 8.2 Erpcedure' for Handling of Incident Reports. 1.0 _ SCOPE: l 1. This procedure has been established to indicate the practice which will be used by any individual director or responsible officer of AMS who obtains information reasonably indicating that a teletherapy unit's operations, functions, parts, maintenance or repairs thereto present a substantial safety hazard. e The individual director or responsible officer is to immediately notify the NRC of such failure to comply or such defect, unless he has actual i knowledge that the NRC has been adequately informed of such defect or failure to comply. 2. The AMS Engineering and Quality Control ("QC") Departments will evaluate suspected defects or failures to comply within 60 days of discovery in order to identify a reportable defect or failure to comply that could create a substantial safety hazard were it to remain uncorrected. The suspected defects or failures to comply will have been brought to their attention by the Safety Committee through review of Service Reports, by customer input or in-house observations. The evaluation will include, but not be limited to, past QC history checks, past customer problems, part specification checks, and if necessary, in-house testing to isolate and define the defect. If the problem is beyond the technical expertise of the AMS staff, outside consultants / experts will be used. Within five days af ter completion of the evaluation, a written report of the deviation will be submitted to the Isotope and AMS Safety Committees for their review and action. 3. Results of the evaluation and recommendations will be reviewed by the Safety C~mnittee. The Director of Regulatory Affairs, as a responsible o officer, or a delegate will notify the appropriate Regulatory Agency in writing within 30 days following receipt of this information, as set forth - F in sections 5.2 and 5.3 of this procedure, if a reportable defect or failure to comply is determined to exist. The report will be made in accordance with 10 CFR Part 21 and this procedure. l l 1 Advanced Medical Systems, Inc. -Quality Assurance Department Prepared by Approval Revisions E. Svigel
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t i l ~ t Provision No. QA 2000 2.0 10 CFR Reporting of Defects and Non-Compliance and Procedures Revision: A for Compliance with 10 CFR'Part 21 Date Issued: 9/29/89 Page 2 of 5 3 2.0 DEFINITIONS r (A) " Defect" means: i 1. A deviation (see 10 CFR S21.3(e)) in a basic component delivered to AMS for use in an AMS teletherapy unit is subject to the regulations in this - part if, on the basis of an evaluation (see 10 CFR S21.3(g)), the deviation could create a substantial safety hazard; or 2. the installation, use or operation of a basic component of a teletherapy unit containing a defect as defined in paragraph (a)(1) of this section. (B) " Deviation" means a departure from the technical requirements for teletherapy unit components included in a procurement document (see 10 CFR S21.3(i)). (C) " Director" means an individual authorized to manage and direct the affairs of AMS. (D) " Substantial safety hazard" means a loss of safety function in a teletherapy unit to the extent that there is a major reduction in the degree of protection provided to public health and safety for any facility or activity licensed, other than for export, pursuant to Parts 30, 40 or 71 of 10 CFR Chapter 1. (E) " Supplying" or " supplies" means contractually responsible for a basic com-poaent used or to be used in the manufacture or repair of teletherapy units. q 3.0 WHOM TO NOTIFY All communications and reports concerning the regulations in this part should be addressed to the Director, Office of Nuclear Material Safety and Safeguards, U.S. Nuclear Regulatory Commission, Washington, DC 20555, FAX No. (301)492-8187, or Telephone No. (301) 951-0550, or to the Administrator of a Regional Office ) at the* address specified in Appendix D of Part 20 of Chapter 1. Communications and reports may be delivered in person at the Commissioner's offices at 2120 L Street, N.W., Washington, DC or at 11555 Rockville Pike, Rockville, i Maryland. Advanced Medical Systems, Inc. Quality Assurance Department Prepared by Approval Revisions E. Svigel b i i
Provision No. QA 2000 2.0 1 10 CFR Reporting of Defects and Non-Compliance and Procedures Revision: A for Compliance with 10 CFR Part 21 Date Issued: 9/29/89 l Page 3 of 5 b 4.0 LOSTING REQUIREMENTS 1. AMS shall keep current copies of the following documents in a conspicuous-position on any prer: -s within the United States where the activities subject to Part 21 a re aducted; (1) the regulations in 10 CFR Part 21, (2) Section 206 of to-aergy Reorganization Act of 1974, and (3) proce-dures adopted pursuant to the regulations in 10 CFR Part 21. 5.0 NOTIFICATION OF FAILURE TO COMPhY OR EXISTENCE OF A DEFECT 1. A director or responsible officer, subject to the regulations of 10 CFR Part 21, or a designated person shall notify the NRC when he obtains infor-mation reasonably indicating a failure to comply or a defect affecting a-basic component of a teletherapy unit that is within AMS' responsibility and is supplied for a facility within the United States that is subject-to the licensing requirements under Part 30, 40 or 71 of 10 CFR Chapter 1. j Notification is not required if such individual has actual knowledge that the NRC has been adequately informed of such defect or such failure to comply. 2. Initial notification required by this paragraph must be made by facsimile to the NRC Operations Center at (301) 492-8187 or by telephone at (301) 951-0550 within two days following receipt of information of a defect or a failure to comply by a responsible officer. Written notifi-cation to the Director, Office of Nuclear Material Safety and Safeguards, USNRC, Washington, DC 20555, with a copy to the Regional Administrator, USNRC, Region III, 799 Roosevelt Road, Glen Ellyn, IL 60137, must be submitted within 30 days following receipt of information on the identifi-cation of a defect or a failure to comply, j 3. In the event that an evaluation of an identified deviation or failure to comply potentially associated with a substantial safety hazard cannot be completed within 60 days from discovery of the deviation or failure to cohply, as set forth in Section 1.2 of this procedure, an interim report will be prepared and submitted to the NRC. The interim report will describe i the deviation or failure to comply that is being evaluated and when it is i expected that the evaluation will be completed. This interim report will be l submitted in writing within 60 days of discovery of the deviation or failure to comply. I i Advanced Medical Systems, Inc. Quality Assurance Department Prepared by Approval Revisions kb 7/7 D E. Svigel ,/ ^1
l Provision No. QA 2000 2.0-10 CFR Reporting of Defects and Non-Compliance and Procedures Revision: A for Compliance with 10 CFR Part.21 Date Issued: 9/29/89 Page 4 of 5 4. The written report shall include, but need not be limited to, the following information, to the extent known* (i) Name and address of the individual informing the NRC. (ii) Identification of the basic teletherapy unit component supplied byfor for AMS within the United States which fails to comply or contains a defect. (iii) Identification of the firm supplying the basic teletherapy unit component which fails to comply or contains a defect. (iv) Nature of the defect or failure to comply and the safety hazard which is created or could be created by such defect or failure to' comply. (v) The date on which the information of such defect or failure to comply was obtained. (vi) In the case of a basic teletherapy unit component which contains a defect or fails to comply, the number and location of all such' components in use'at, supplied for, or being supplied for one or' more facilities or - activities subject to the regulations in 10 CFR Part 21. (vii) The corrective action which has been, is being, or will be taken; the name of the individual or organization responsible-for the action; and the length of time that has been or will be taken to complete the action. (viii) Any advice related to the defect or failure to comply about-the activity or basic component that has been, is being, or will be given to purchasers or licensees. 5. The director or responsible officer may authorize an individual to provide tha notification required by 10 CFR Part 21.21, provided that this shall not relieve the director or responsible officer of his or her responsibility under 10 CFR Part 21.21. Advanced Medical Systems, Inc. Quality Assurance Department Prepared by Approval Revisions E. Svigel.
Provision No. .QA 2000 :2. 0 l .10 CFR Reporting of Defects j and Non-Compliance and Procedures Revision: A f for Compliance with 10 CFR Part 21 j Date Issued: 9/29/89 ~l ) Page 5 of 5 1 6.0 PROCUREMFNT DOCUMENTS AMS shall assure that each procurement document for a basic teletherapy unit. j component issued by him, her, or it on or af ter January 6,.1978, -specifies, I when applisable, that the provisions of 10 CFR Part 21 apply. ~ 6.1 Procurement documents for basic components utilized in the following assemblies shall specify that the provisions of 10 CFR Part 21 apply: l sourcebead; rotor; C-Arm; Yoke and source capsule. j i 7.0 INSPECTIONS AMS shall permit duly-authorized representatives of the NRC to inspect its records, premises, activities and basic components as necessary to effectuate the purposes of 10 CFR Part 21. .] 1 8.0 MAINTENANCE OF RECORDS j 1. AMS shall maintain such records in connection with teletherapy unit. d operations, functions, parts, maintenance or repairs as may be required to assure compliance with the regulations in 10 CFR Part 21. i (i) Retain evaluations of all deviations and failures to comply for a minimum of five years after the date of the evaluation; (ii) Rettin any notifications sent.to purchasers of basic components ard affected licensees for a minimum of five years af ter the date of the notification. (iii) Retain a record of the purchasers of basic components for 10 years after delivery of the basic component or service associated with a basic component. 2. Records that are prepared only for the purpose of assuring compliance with the regulations in 10 CFR Part 21 and are not'related to evaluations or notifications to the Commission may be destroyed after delivery of the teletherapy unit component. Advanced Medical Systems, Inc. Quality Assurance Department Prepared by Approval Revisions' j i 7b E. Svigel d l
y l ~ l i i PROPOSED TRAINING DOCUMENTATION RECORD i AMS Quality-Assurance Policy i for Compliance with 10 CFR Part 21 Procedure 2000 2.0 Training Acknowledgement I have reviewed both 10 CFR Part 21 and QA 2000 2.0 and am familiar i with their contents. I have been instructed in the principles and l techniques of AMS' quality assurance procedures as they affect my job. i i l Date Name W e i l y t i t -}}