1、Designation: C1188 04 (Reapproved 2011)Standard Guide forEstablishing a Quality Assurance Program for UraniumConversion Facilities1This standard is issued under the fixed designation C1188; the number immediately following the designation indicates the year oforiginal adoption or, in the case of rev
2、ision, the year of last revision. A number in parentheses indicates the year of last reapproval. Asuperscript epsilon () indicates an editorial change since the last revision or reapproval.1. Scope1.1 This guide provides guidance and recommended prac-tices for establishing a comprehensive quality as
3、surance pro-gram for uranium conversion facilities.1.2 This standard does not purport to address all of thesafety concerns, if any, associated with its use. It is theresponsibility of the user of this standard to establish appro-priate health and safety practices and determine the applica-bility of
4、regulatory limitations prior to use.1.3 The basic elements of a quality assurance programappear in the following order:FUNCTION SECTIONOrganization 5Quality Assurance Program 6Design Control 7Instructions, Procedures & Drawings 8Document Control 9Procurement 10Identification and Traceability 11Proce
5、sses 12Inspection 13Control of Measuring and Test Equipment 14Handling, Storage and Shipping 15Inspection, Test and Operating Status 16Control of Nonconforming Items 17Corrective Actions 18Quality Assurance Records 19Audits 202. Referenced Documents2.1 ANSI Standard:2ANSI/ASME NQA-1 Quality Assuranc
6、e Program Require-ments for Nuclear Facility Applications3. Terminology3.1 Definitions:3.1.1 operationthe terms operation, operations, and op-eration activities are used interchangeably to describe collec-tively all activities and functions executed by the conversionfacility.3.1.2 special processa p
7、rocess, the results of which arehighly dependent on the control of the process or the skill ofthe operators, or both, and in which the specified quality cannotbe readily determined by inspection or test of the product.3.1.3 uranium conversion facilitya chemical processingplant whose primary function
8、 is to convert uranium oreconcentrates or uranium oxide to purified uranium hexafluo-ride.4. Significance and Use4.1 Quality assurance provides a planned and systematicapproach for establishing practices to meet requirements ofsafe facility operation and product quality.4.2 In the operation of a ura
9、nium conversion facility thereare many requirements established by regulatory bodies, codes,customers, and the facility itself. These requirements areidentified by facility management and acted upon by variousfacility groups. Implementation of the practices described inthis guide are intended to ass
10、ist with compliance with theserequirements.4.3 In the operation of a uranium conversion facility there isa potential for both chemical and radiological exposure toemployees, the public, and the environment. This potential isreduced by implementation of the practices described in thisguide. The devel
11、opment of this guide, as part of soundmanagement practice, provides a means for ensuring consis-tency between facilities, and documentation and formalizationof existing practices.4.4 To establish a quality assurance program for a uraniumconversion facility, the practices in use should be evaluatedag
12、ainst the recommended practices of this guide. Existingpractices may then be modified or new practices implementedto correct any identified deficiencies. This approach highlightsthe fact that the basic foundation of a quality assuranceprogram is already present.4.5 ANSI/ASME NQA-1 is a quality assur
13、ance standardthat is being applied broadly across the nuclear industry.1This guide is under the jurisdiction of ASTM Committee C26 on Nuclear FuelCycle and is the direct responsibility of Subcommittee C26.08 on QualityAssurance, Statistical Applications, and Reference Materials.Current edition appro
14、ved June 1, 2011. Published June 2011. Originallyapproved in 1991. Last previous edition approved in 2004 as C1188 04. DOI:10.1520/C1188-04R11.2Available from American National Standards Institute (ANSI), 25 W. 43rd St.,4th Floor, New York, NY 10036, http:/www.ansi.org.Copyright ASTM International,
15、100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United StatesNOTICE: This standard has either been superseded and replaced by a new version or withdrawn.Contact ASTM International (www.astm.org) for the latest information1NQA-1 was used as guidance in the development of theprog
16、ram elements of this guide.4.6 The program functions detailed in this guide should beselected based on the particular needs and applications at thefacility. Those activities or programs to be included in auranium conversion facility should be defined in that program.5. Organization5.1 SummaryThe org
17、anizational structure of a facility isthe basis from which authority, functional responsibility, linesof communication and interfaces are derived. Since, in everycase, facilities are composed of smaller organizations ofvarious functions, it is necessary to define the organizationalstructure and the
18、controls and responsibilities delegated to eachcomponent.5.2 Recommendations:5.2.1 Organizational StructureAll facilities have an inter-nal organizational structure. The organizational structureshould be defined and documented. This is necessary to definerelationships between groups and to assign re
19、sponsibilities forthe accomplishment of required activities. Without a definedorganizational structure, the efficiency and quality of output ofthe organization will be adversely affected. The most commonmethod of documenting the organizational structure is via theorganization chart.5.2.2 Functional
20、ResponsibilitiesEach position detailedon the organization chart should be defined. This can be donevia a position description or other method. The job descriptionshould include the functional responsibilities and relationshipto the organization.5.2.3 Levels of AuthorityIncluded with functional respo
21、n-sibilities should be the authority level of the position. Thisauthority should include decision making and approval ofactions necessary to carry out the assigned functional respon-sibility. The delegation of authority should also be addressed.This may be necessary in order to most efficiently or e
22、ffectivelyaccomplish the assigned responsibilities.5.2.4 Communication Lines of communication for formalinteraction between groups should be defined. This is espe-cially important when more than one group is responsible forthe completion or performance of an activity. Interfaces, bothinternal and ex
23、ternal to the facility, may be defined throughposition descriptions. Specific interfaces may be detailed in thequality assurance program in order to clarify or emphasize theproper protocol. It should be stressed that the quality assurancepersonnel be formally given, via appropriate lines ofcommunica
24、tion, the organizational freedom and access tomanagement to effectively perform quality assurance func-tions.6. Quality Assurance Program6.1 SummaryA quality assurance program should beestablished, documented and implemented. The programshould consist of suitable policies, programs, and writtenproce
25、dures that provide for the planning and accomplishmentof activities affecting quality under controlled conditions. Theprogram should provide for training, as necessary, of personnelto ensure that adequate proficiency is achieved and maintained.The quality assurance program should provide for routine
26、assessment of policies, programs, and procedures to ensuretheir continued effectiveness, to ensure compliance, and toidentify opportunities for improvements.6.2 Recommendations:6.2.1 The uranium conversion facility should document thequality assurance program in sufficient detail to demonstratethat
27、the recommendations of this guide have been met. This isusually provided by means of a quality assurance manual,which is approved and signed by senior facility management.6.2.2 The quality assurance function should be staffed bypersonnel who are independent of the organizations respon-sible for perf
28、orming quality related functions.6.2.3 Personnel involved in quality assurance activitiesshould have training or experience commensurate with thescope of the activities. This training and experience should bedocumented.6.2.4 Quality assurance activities may utilize other person-nel in order to obtai
29、n the necessary knowledge or expertise toproperly perform the function in question. The quality assur-ance organization should maintain ultimate responsibility forthe results of the actions of the other persons.TABLE 1 NQA-1 Basic Requirements Related to Principles of Conversion Facility Quality Ass
30、uranceNQA-1 BASIC REQUIREMENTSElements of Conversion Facility QualityAssurance12345678910112131415161718Organization XQuality Assurance Program XDesign Control XDocument Control X XInstructions, Procedures & Drawings XProcurement XIdentification and Traceability XProcesses XInspection XXControl of M
31、easuring and Test Equipment XHandling, Storage, and Shipping XInspection, Test and Operating Status XControl of Non-conforming Items XCorrective Actions XQuality Assurance Records XAudits XC1188 04 (2011)26.2.5 Quality assurance program documentation should besubmitted, if so required, to the approp
32、riate regulatory body,customer or other jurisdiction for approval prior to implemen-tation. Any substantive changes made after receipt of approvalshould be approved in the same manner.6.2.6 The quality assurance program documentation shouldcontain the following as a minimum:6.2.6.1 Policy statement
33、by senior executive, directing com-pliance to the quality assurance program,6.2.6.2 Organizational description meeting the requirementsof Section 5, Organization, of this guide,6.2.6.3 A description or reference of the program proce-dures that implement the requirements of this guide,6.2.6.4 Identif
34、ication of the interrelationship and hierarchyof documents used in the program,6.2.6.5 Identification of programs items, procedures, andservices to which the program applies, and6.2.6.6 Provision for the periodic review of the program todetermine its adequacy, effectiveness, and opportunities forimp
35、rovement. The method of review, frequency, and documen-tation should be stated.7. Design Control7.1 SummaryThis section describes design control mea-sures required to ensure that design bases, design calculations,and specifications are correct. It also provides the means forensuring that new or modi
36、fied designs are in compliance withapplicable codes, standards, and regulations.7.1.1 Uranium conversion facilities, based on proven designand technology, have been in operation for many years. Assuch, the application of design control should focus on changesmade to these original designs based on f
37、acility operatingexperiences, changes in process technology, emissionsrequirements, etc.7.2 Recommendations:7.2.1 Change Control Changes to approved designs thatmay alter the performance of the design should be subject toreview and verification similar to that used for the originaldesign. Changes sh
38、ould be requested and documented in aformal change request letter or form.7.2.2 Design Analysis Design input should be solicitedfrom each affected organization in order to provide for ad-equate initial design. Information for design should be obtainedfrom appropriate production, maintenance, technic
39、al, or otherpersonnel to ensure that all requirements are anticipated andsatisfied.7.2.3 Design Verification:7.2.3.1 Designs, including pertinent drawings,specifications, and calculations should be reviewed accordingto any or all of the following, as appropriate:(a) Upon completion of the design and
40、 prior to constructionor implementation,(b) By a competent individual or group not directly in-volved in the preparation or selection of the design methods,and(c) For accuracy, compliance with regulatory stipulations,compliance with plant or company standards.7.2.3.2 Extent of design verification sh
41、ould be commensu-rate with the scope and complexity of the design.7.2.3.3 Acceptable verification methods include, but are notlimited to, any one or a combination of the following: designreviews, alternate calculation and verification testing.7.2.4 Documentation Sufficient records should be gener-at
42、ed to provide evidence that design processes are performed inaccordance with the requirements of this guide. Documentationshould include such items as drawings, specifications, designbases and design input that support the final design. Documen-tation should also include any revisions to the design
43、includingthe appropriate review and verification documentation.8. Instructions, Procedures and Drawings8.1 SummaryTypically, in industry, there are many activi-ties that, when performed incorrectly, could adversely affectthe quality of the products, the health and safety of workers andthe public, th
44、e environment, or a combination thereof. It iswidely accepted that the best way to ensure that these activitiesare consistently performed in the proper manner is to define therequirements and the actions to be taken. This is done inappropriate documents such as instructions, procedures, anddrawings.
45、 For simplicity, when the term procedure is used inthis guide, it will refer to any of these types of documents.8.2 Recommendations:8.2.1 In the operation of a uranium conversion facility,procedures should be used to help ensure the proper perfor-mance tasks by employees. The following activities ar
46、e somecandidate areas for the development of procedures. Note thatwhen procedures are designated “appropriate to” theseactivities, the activity often defines a category or type ofprocedure (for example, operating procedures.)8.2.1.1 Process operations,8.2.1.2 Maintenance and calibration,8.2.1.3 Labo
47、ratory analyses,8.2.1.4 Emergency actions, and8.2.1.5 Quality assurance (including inspections, tests,audits, etc.).8.2.2 Procedures should be written to ensure consistency inthe operation of a facility. For operating procedures (and asappropriate for other types of procedures) the following shouldb
48、e considered as the minimum to be included:8.2.2.1 Start-up and shutdown sequences,8.2.2.2 Normal conditions and monitoring activities,8.2.2.3 Emergency conditions and expected responses,8.2.2.4 Identification of chemical and radiological hazards,and8.2.2.5 Identification of significant environmenta
49、l aspects ofthe operation.8.2.3 Procedures should be designed to match the way theywill be used. Consideration should be given to the use ofspecial documents such as operating checklists, log books, shiftreports, etc.8.2.4 Whenever possible, quantitative or qualitative criteriathat help determine the proper course of action or define theresult of step or process should be included in procedures.C1188 04 (2011)38.2.5 The requirement to follow procedures should bedocumented and employees should be made aware of thisrequirement.8.2.6 The system for develop
