NQA-1-2000 NQA-1-2004 NQA-1-2008 - EFCOG

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NQA-1-2000NQA-1-2004NQA-1-2008Wednesday, July 23, 2008REQUIREMENT 1Organization100 BASICResponsibilities for the establishment andimplementation of the quality assurance programshall be defined.The organizational structure, functionalresponsibilities, levels of authority, and lines ofcommunications for activities affecting quality shallbe documented.200 STRUCTURE AND RESPONSIBILITY201 GeneralThe organizational structure and responsibilityassignments shall be such that:(a) senior management establishes overallexpectations for effective implementation of thequality assurance program and is responsible forobtaining the desired end result;(b) quality is achieved and maintained by thoseassigned responsibility for performing work;(c) quality achievement is verified by those notdirectly responsible for performing the work; and(d) those responsible for verifying qualityachievement have sufficient authority, direct accessto management, organizational freedom, and accessto work to perform their function.REQUIREMENT 1Organization100 BASICResponsibilities for the establishment andimplementation of the quality assurance program shallbe defined.The organizational structure, functional responsibilities,levels of authority, and lines of communications foractivities affecting quality shall be documented.REQUIREMENT 1100 BASIC200 STRUCTURE AND RESPONSIBILITY201 GeneralThe organizational structure and responsibilityassignments shall be such that:( a) senior management establishes overall expectationsfor effective implementation of the quality assuranceprogram and is responsible for obtaining thedesired end result( b) quality is achieved and maintained by thoseassigned responsibility for performing work( c) quality achievement is verified by those notdirectly responsible for performing the work( d) those responsible for verifying quality achievementhave sufficient authority, direct access to management,organizational freedom, and access to work toperform their function202 Delegation of WorkThe individual(s) or organization(s) responsible forestablishing and executing a quality assurance202 Delegation of WorkThe individual( s) or organization( s) responsible forestablishing and executing a quality assurance program200 STRUCTURE AND RESPONSIBILITY201 GeneralThe organizational structure and responsibilityassignments shall be such that(a) senior management establishes overall expectationsfor effective implementation of the quality assuranceprogram and is responsible for obtaining the desired endresult(b) quality is achieved and maintained by those assignedresponsibility for performing work(c) quality achievement is verified by those not directlyresponsible for performing the work(d) those responsible for assuring that an appropriate qualityassurance program has been established and those verifyingactivities affecting quality have sufficient authority, directaccess to responsible levels of management, organizationalfreedom, and access to work to perform this function,including sufficient independence from cost and schedulewhen opposed to safety function considerations. Theseverification functions include thefollowing:(1) identifying quality problems(2) initiating, recommending, or providing solutions toquality problems through designated channels(3) verifying implementation of solutions(4) assuring that further processing, delivery,installation, or use is controlled until proper dispositionof a nonconformance, deficiency, or unsatisfactory conditionhas occurred.202 Delegation of WorkThe individual(s) or organization(s) responsible forestablishing and executing a quality assurance programResponsibilities for the establishment and implementationof the quality assurance program shall be defined.The organizational structure, functional responsibilities,levels of authority, and lines of communications foractivities affecting quality shall be documented.

NQA-1-2000NQA-1-2004NQA-1-2008program under this Standard may delegate any or allof the work to others but shall retain responsibilitytherefore.300 INTERFACE CONTROLWhere more than one organization is involved in theexecution of activities, the responsibilities,interfaces, and authority of each organization shallbe clearly defined and documented.The external interfaces between organizations andthe internal interfaces between organizational units,and changes thereto, shall be documented.REQUIREMENT 2Quality Assurance Program100 BASIC(a) A documented quality assurance program shallbe planned, implemented, and maintained inaccordance with this Part (Part I), or portionsthereof.The program shall identify the activities and items towhich it applies.The program shall provide control over activitiesaffecting quality to an extent consistent with theirimportance.The program shall include monitoring activitiesagainst acceptance criteria in a manner sufficient toprovide assurance that the activities affecting qualityare performed satisfactorily.The program shall be established at the earliest timeconsistent with the schedule for accomplishing theactivities.The program shall provide for the planning andaccomplishment of activities affecting quality undersuitably controlled conditions.Controlled conditions include the use of appropriateequipment, suitable environmental conditions foraccomplishing the activity, and assurance thatprerequisites for the given activity have beensatisfied.The program shall provide for any special controls,processes, test equipment, tools, and skills to attainthe required quality of activities and items and forverification of that quality.The organization shall establish and implementunder this Standard may delegate any or all of the workto others but shall retain responsibility therefore.under this Standard may delegate any or all of the workto others but shall retain responsibility therefore.300 INTERFACE CONTROLWhere more than one organization is involved in theexecution of activities, the responsibilities, interfaces,and authority of each organization shall be clearlydefined and documented.The external interfaces between organizations and theinternal interfaces between organizational units, andchanges thereto, shall be documented.REQUIREMENT 2Quality Assurance Program100 BASIC( a) A documented quality assurance program shallbe planned, implemented, and maintained in accordancewith this Part ( Part I), or portions thereof.300 INTERFACE CONTROLWhere more than one organization is involved in theexecution of activities, the responsibilities, interfaces, andauthority of each organization shall be clearly defined anddocumented.The external interfaces between organizations and theinternal interfaces between organizational units, and changesthereto, shall be documented.REQUIREMENT 2Quality Assurance Program100 BASIC(a) A documented quality assurance program shall beplanned, implemented, and maintained in accordance withthis Part (Part I), or portions thereof.The program shall identify the activities and items towhich it applies.The program shall provide control over activitiesaffecting quality to an extent consistent with theirimportance.The program shall include monitoring activities againstacceptance criteria in a manner sufficient to provideassurance that the activities affecting quality are performed satisfactorily.The program shall be established at the earliest timeconsistent with the schedule for accomplishing theactivities.The program shall provide for the planning andaccomplishment of activities affecting quality undersuitably controlled conditions.Controlled conditions include the use of appropriateequipment, suitable environmental conditions foraccomplishing the activity, and assurance thatprerequisites for the given activity have been satisfied.The program shall identify the activities and items to whichit applies.The program shall provide control over activities affectingquality to an extent consistent with their importance.The program shall provide for any special controls,processes, test equipment, tools, and skills to attain therequired quality of activities and items and forverification of that quality.The organization shall establish and implementThe program shall provide for any special controls,processes, test equipment, tools, and skills to attain therequired quality of activities and items and for verification ofthat quality.The organization shall establish and implement processes toThe program shall include monitoring activities againstacceptance criteria in a manner sufficient to provideassurance that the activities affecting quality are performedsatisfactorily.The program shall be established at the earliest timeconsistent with the schedule for accomplishing the activities.The program shall provide for the planning andaccomplishment of activities affecting quality under suitablycontrolled conditions.Controlled conditions include the use of appropriateequipment, suitable environmental conditions foraccomplishing the activity, and assurance that prerequisitesfor the given activity have been satisfied.

NQA-1-2000NQA-1-2004processes to detect and correct quality problems.(b) The program shall provide for indoctrination,training, and qualification as necessary of personnelperforming or managing activities affecting qualityto assure that suitable proficiency is achieved andmaintained.(c) Management shall regularly assess the adequacyand effective implementation of the qualityassurance program.200 INDOCTRINATION AND TRAININGIndoctrination and training shall be commensuratewith scope, complexity, importance of the activities,and the education, experience, and proficiency of theperson.201 IndoctrinationPersonnel performing or managing activitiesaffecting quality shall receive indoctrination in theirjob responsibilities and authority; general criteria,including applicable codes and standards, regulatorycommitments, company procedures, and qualityassurance program requirements.202 TrainingThe need for a formal training program forpersonnel performing or managing activitiesaffecting quality shall be determined.Training shall be provided, if needed, to achieveinitial proficiency, maintain proficiency, and adaptto changes in technology, methods, or jobresponsibilities.processes to detect and correct quality problems.( b) The program shall provide for indoctrination,training, and qualification as necessary of personnelperforming or managing activities affecting quality toensure that suitable proficiency is achieved andmaintained.( c) Management shall regularly assess the adequacyand effective implementation of the quality assuranceprogram.200 INDOCTRINATION AND TRAININGIndoctrination and training shall be commensurate withscope, complexity, importance of the activities, and theeducation, experience, and proficiency of the person.detect and correct quality problems.(b) The program shall provide for indoctrination, training,and qualification as necessary of personnel performing ormanaging activities affecting quality to ensure that suitableproficiency is achieved and maintained.201 IndoctrinationPersonnel performing or managing activities affectingquality shall receive indoctrination in their jobresponsibilities and authority; general criteria, includingapplicable codes and standards, regulatorycommitments, company procedures, and qualityassurance program requirements.202 TrainingThe need for a formal training program for personnelperforming or managing activities affecting qualityshall be determined.Training shall be provided, if needed, to achieve initialproficiency, maintain proficiency, and adapt to changesin technology, methods, or job responsibilities.201 IndoctrinationPersonnel performing or managing activities affectingquality shall receive indoctrination in their jobresponsibilities and authority that includes general criteria,technical objectives, requirements of applicable codes andstandards, regulatory commitments, company procedures,and quality assurance program requirements.202 TrainingThe need for a formal training program for personnelperforming or managing activities affecting quality shall bedetermined.Training shall be provided, if needed, to achieve initialproficiency, maintain proficiency, and adapt to changes intechnology, methods, or job responsibilities.300 QUALIFICATION REQUIREMENTSThe responsible organization shall designate thoseactivities that require qualification of personnel and theminimum requirements for such personnel.The responsible organization shall establish writtenprocedures for the qualification of personnel, and forthe assurance that only those personnel who meet therequirements are permitted to perform these activities.On-the-job training shall be used if direct hands-onapplications or experience is needed to achieve and maintainproficiency.300 QUALIFICATION REQUIREMENTSThe responsible organization shall designate those activitiesthat require qualification of personnel and the minimumrequirements for such personnel.The responsible organization shall establish writtenprocedures for the qualification of personnel, and for theassurance that only those personnel who meet therequirements are permitted to perform these activities.Specific qualification requirements for personnelperforming nondestructive examination inspection andSpecific qualification requirements for personnel performingnondestructive examination inspection and tests to verify300 QUALIFICATION REQUIREMENTSThe responsible organization shall designate thoseactivities that require qualification of personnel andthe minimum requirements for such personnel.The responsible organization shall establish writtenprocedures for the qualification of personnel, and forthe assurance that only those personnel who meetthe requirements are permitted to perform theseactivities.Specific qualification requirements for personnelperforming nondestructive examination inspectionNQA-1-2008(c) Management shall regularly assess the adequacy andeffective implementation of the quality assurance program.200 INDOCTRINATION AND TRAININGIndoctrination and training shall be commensurate withscope, complexity, importance of the activities, and theeducation, experience, and proficiency of the person.

NQA-1-2000NQA-1-2004and tests to verify quality and auditing are asfollows.301 Nondestructive Examination (NDE)This section specifies requirements for thequalification of personnel who perform radiographic(RT), magnetic particle (MP), ultrasonic (UT), liquidpenetrant (PT), electromagnetic (ET), neutronradiographic (NR), leak testing (LT), acousticemission (AE), and visual testing (VT) to verifyconformance to the specified requirements.The American Society of Nondestructive TestingRecommended Practice No. SNT-TC-1A, December1988 Edition, and its applicable Supplements shallapply as requirements to NDE.tests to verify quality and auditing are specified inparas. 301 through 304 of this Requirement.301 Nondestructive Examination (NDE)This section specifies requirements for the qualificationof personnel who perform radiographic (RT), magneticparticle (MP), ultrasonic (UT), liquid penetrant (PT),electromagnetic (ET), neutron radiographic (NR), leaktesting (LT), acoustic emission (AE), and visual testing(VT) to verify conformance to the specifiedrequirements.The American Society of Nondestructive TestingRecommended Practice No. SNT-TC-1A, December1988 Edition, and its applicable Supplements shallapply as requirements to NDE.302 Inspection and TestThe initial capabilities of a candidate shall bedetermined by an evaluation of the candidate'seducation, experience, training, and either testresults or capability demonstration.The job performance of inspection and testpersonnel shall be reevaluated at periodic intervalsnot to exceed 3 years.Reevaluation shall be by evidence of continuedsatisfactory performance or redetermination ofcapability in accordance with the requirements ofsection 200 of this Requirement.If during this evaluation or at any other time, it isdetermined by the responsible organization that thecapabilities of an individual are not in accordancewith the qualification requirements specified for thejob, that person shall be removed from that activityuntil such time as the required capability has beendemonstrated.Any person who has not performed inspection ortesting activities in the qualified area for a period of1 year shall be reevaluated.303 Lead AuditorThe Lead Auditor organizes and directs audits,302 Inspection and TestThe initial capabilities of a candidate shall bedetermined by an evaluation of the candidate'seducation, experience, training, and either test results orcapability demonstration.The job performance of inspection and test personnelshall be reevaluated at periodic intervals not to exceed 3years.Reevaluation shall be by evidence of continuedsatisfactory performance or redetermination ofcapability in accordance with the requirements ofsection 200 of this Requirement.If during this evaluation or at any other time, it isdetermined by the responsible organization that thecapabilities of an individual are not in accordance withthe qualification requirements specified for the job, thatperson shall be removed from that activity until suchtime as the required capability has been demonstrated.Any person who has not performed inspection or testingactivities in the qualified area for a period of 1 yearshall be reevaluated.303 Lead AuditorThe Lead Auditor organizes and directs audits, reportsNQA-1-2008quality and auditing are specified in paras. 301 through 304of this Requirement.301 Nondestructive Examination (NDE)This section specifies requirements for the qualification ofpersonnel who perform radiographic (RT), magnetic particle(MP), ultrasonic (UT), liquid penetrant (PT),electromagnetic (ET), neutron radiographic (NR), leaktesting (LT), acoustic emission (AE), and visual testing (VT)to verify conformance to the specified requirements.The American Society of NondestructiveTesting (ASNT) Recommended Practices or Standardsprovide acceptable qualification requirements for NDEpersonnel.Applicable Codes and Standards or design criteriacontrolling the qualification of NDE personnel shall beutilized to establish the applicable ASNT qualificationrequirement and edition or to specify an equivalentalternative requirement.302 Inspection and TestThe initial capabilities of a candidate shall be determinedby an evaluation of the candidate’s education, experience,training, and either test results or capability demonstration.The job performance of inspection and test personnel shallbe reevaluated at periodic intervals not to exceed 3 years.Reevaluation shall be by evidence of continued satisfactoryperformance or redetermination of capability in accordancewith the requirements of section 200 of this Requirement.If during this evaluationor at any other time, it is determined by the responsibleorganization that the capabilities of an individual are not inaccordance with the qualification requirements specified forthe job, that person shall be removed from that activity untilsuch time as the required capability has been demonstrated.Any person who has not performed inspection or testingactivities in the qualified area for a period of 1 year shall bereevaluated.303 Lead AuditorThe Lead Auditor organizes and directs audits, reports audit

NQA-1-2000NQA-1-2004reports audit findings, and evaluates correctiveaction.An individual shall meet the following requirementsprior to being designated a Lead Auditor.audit findings, and evaluates corrective action.findings, and evaluates corrective action.An individual shall meet the requirements of paras.303.1 through 303.6 of this Requirement prior to beingdesignated a Lead Auditor.303.1 Communication Skills.The prospective Lead Auditor shall be capable ofcommunicating effectively, both in writing and orally.An individual shall meet the requirements of paras. 303.1through 303.6 of this Requirement prior to being designateda Lead Auditor.303.1 Communication Skills. The prospective LeadAuditor shall be capable of communicating effectively, bothin writing and orally.These skills shall be attested to in writing by the LeadAuditor's employer.303.2 Training.Prospective Lead Auditors shall receive training to theextent necessary to assure auditing competenceincluding:(a) Knowledge and understanding of this Standard andother nuclear-related codes, standards, regulations, andregulatory guides, as applicable.(b) General structure of quality assurance programs asa whole and applicable elements as defined in thisStandard.(c) Auditing techniques of examining, questioning,evaluating, and reporting; methods of identifying andfollowing up on corrective action items; and closing outaudit findings.( d) planning audits of activities affecting quality( e) on- the- job training to include applicable elementsof the audit program303.3 Audit Participation. Prospective Lead Auditorsshall participate in a minimum of five quality assuranceaudits within a period of time not to exceed 3 yearsprior to the date of qualification, one audit of whichshall be a nuclear quality assurance audit within theyear prior to qualification.Participation in independent assessments includingteam assessment activities such as operations readinessreviews and regulatory inspections/surveys may be usedto satisfy up to four of the five required qualityassurance audits, provided that the activities candemonstrate the following:(a) independence from the functional areas beingassessed(b) planning that establishes the scope of the activitiesThese skills shall be attested to in writing by the LeadAuditor’s employer.303.2 Training.Prospective Lead Auditors shall receive training to the extentnecessary to assure auditing competence including303.1 Communication Skills.The prospective Lead Auditor shall be capable ofcommunicating effectively, both in writing andorally.These skills shall be attested to in writing by theLead Auditor's employer.303.2 Training.Prospective Lead Auditors shall receive training tothe extent necessary to assure auditing competenceincluding:(a) Knowledge and understanding of this Standardand other nuclear-related codes, standards,regulations, and regulatory guides, as applicable.(b) General structure of quality assurance programsas a whole and applicable elements as defined in thisStandard.(c) Auditing techniques of examining, questioning,evaluating, and reporting; methods of identifyingand following up on corrective action items; andclosing out audit findings.(d) Planning audits of activities affecting quality.(e) On-the-job training to include applicableelements of the audit program.303.3 Audit Participation. Prospective LeadAuditors shall participate in a minimum of fivequality assurance audits within a period of time notto exceed 3 years prior to the date of qualification,one audit of which shall be a nuclear qualityassurance audit within the year prior to qualification.NQA-1-2008(a) knowledge and understanding of this Standard and othernuclear-related codes, standards, regulations, and regulatoryguides, as applicable(b) general structure of quality assurance programs as awhole and applicable elements as defined in this Standard(c) auditing techniques of examining, questioning,evaluating, and reporting; methods of identifying andfollowing up on corrective action items; and closing outaudit findings(d) planning audits of activities affecting quality(e) on-the-job training to include applicable elements of theaudit program303.3 Audit Participation. Prospective Lead Auditors shallparticipate in a minimum of five quality assurance auditswithin a period of time not to exceed 3 years prior to the dateof qualification, one audit of which shall be a nuclear qualityassurance audit within the year prior to qualification.Participation in independent assessments including teamassessment activities such as operations readiness reviewsand regulatory inspections/surveys may be used to satisfy upto four of the five required quality assurance audits, providedthat the activities can demonstratethe following:(a) independence from the functional areas being assessed(b) planning that establishes the scope of the activities and

NQA-1-2000NQA-1-2004NQA-1-2008associated evaluation criteria(c) performance by technically qualified and experiencedpersonnel(d) results that are documented and reported to management303.4 Examination.Prospective Lead Auditors shall pass an examinationwhich shall evaluate comprehension of and ability toapply the body of knowledge identified above.The examination may be oral, written, practical, orany combination thereof.303.5 Maintenance of Proficiency.Lead Auditors shall maintain their proficiencythrough one or more of the following:and associated evaluation criteria(c) performance by technically qualified andexperienced personnel(d) results that are documented and reported tomanagement(e) appropriate corrective action initiated and tracked toresolutionSuch participation shall be subject to review andacceptance by the organization responsible for qualityassurance audits and/or the certifying authority prior totheir use for qualification.303.4 Examination.Prospective Lead Auditors shall pass an examinationwhich shall evaluate comprehension of and ability toapply the body of knowledge identified above.The examination may be oral, written, practical, or anycombination thereof.303.5 Maintenance of Proficiency.Lead Auditors shall maintain their proficiency throughone or more of the following:regular and active participation in the audit process;(a) regular and active participation in the auditprocess(a) regular and active participation in the auditprocessreview and study of codes, standards, procedures,instructions, and other documents related to qualityassurance program and program auditing;(b) review and study of codes, standards, procedures,instructions, and other documents related to qualityassurance program and program auditing(b) review and study of codes, standards, procedures,instructions, and other documents related to qualityassurance program and program auditingor participation in training program(s).Based on annual assessment, management mayextend the qualification, require retraining, orrequire requalification.303.6 Requalification.Lead Auditors who fail to maintain their proficiencyfor a period of 2 years or more shall requirerequalification.Requalification shall include retraining inaccordance with the requirements of para. 303.2 ofthis Requirement, reexamination in accordance withpara. 303.4 of this Requirement, and participation asan Auditor in at least one nuclear quality assuranceaudit.304 Auditors(c) participation in training program(s)Based on annual assessment, management may extendthe qualification, require retraining, or requirerequalification.303.6 Requalification.Lead Auditors who fail to maintain their proficiency fora period of 2 years or more shall require requalification.(c) participation in training program(s)Based on annual assessment, management may extend thequalification, require retraining, or require requalification.Requalification shall include retraining in accordancewith the requirements of para. 303.2 of thisRequirement, reexamination in accordance with para.303.4 of this Requirement, and participation as anAuditor in at least one nuclear quality assurance audit.Requalification shall include retraining in accordance withthe requirements of para. 303.2 of this Requirement,reexamination in accordance with para. 303.4 of thisRequirement, and participation as an Auditor in at least onenuclear quality assurance audit.304 Auditors304 Auditors(e) appropriate corrective action initiated and tracked toresolutionSuch participation shall be subject to review and acceptanceby the organization responsible for quality assurance auditsand/or the certifying authority prior to their use forqualification.303.4 Examination.Prospective Lead Auditors shall pass an examination thatshall evaluate comprehension of and ability to apply thebody of knowledge identified above.The examination may be oral, written, practical, or anycombination thereof.303.5 Maintenance of Proficiency.Lead Auditors shall maintain their proficiency through oneor more of the following:303.6 Requalification. Lead Auditors who fail to maintaintheir proficiency for a period of 2 years or more shall requirerequalification.

NQA-1-2000NQA-1-2004Auditors are participants in an audit.Auditors shall have, or be given, appropriate trainingor orientation to develop their competence forperforming audits.Competence of personnel for performance of thevarious auditing functions shall be developed by oneor more of the following methods:(a) Orientation to provide a working knowledge andunderstanding of this Standard and the auditingorganization's procedures for implementing auditsand reporting results.(b) General and specialized training in auditperformance where the general training shall includefundamentals, objectives, characteristics,organization, performance, and results of qualityauditing and the specialized training shall includemethods of examining, questioning, evaluating, anddocumenting specific audit items and methods ofclosing out audit findings.(c) On-the-job training, guidance, and counselingunder the direct supervision of a Lead Auditor.Such training shall include planning, performing,reporting, and follow-up action involved inconducting audits.Auditors are participants in an audit.Auditors shall have, or be given, appropriate training ororientation to develop their competence for performingaudits.Competence of personnel for performance of thevarious auditing functions shall be developed by one ormore of the following methods:(a) orientation to provide a working knowledge andunderstanding of this Standard and the auditingorganization's procedures for implementing audits andreporting results.(b) general and specialized training in auditperformance where the general training shall includefundamentals, objecti

NQA-1-2000 NQA-1-2004 NQA-1-2008 processes to detect and correct quality problems. processes to detect and correct quality problems. detect and correct quality problems. (b) The program shall provide for indo

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