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I N' O TABLE OF CONTENTS Section Pm Cove r S h ee t......................................................
I Tab le o f Con t en t s.................................................
Ii 1.0 P UR P O S E...................................................
I s
2.0 SCOPE.....................................................
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' n 3.0 DEFINITIONS AND RESPONSIBILITIES.........................
I 4.0 I NS TR U CT I O N..............................................
4 5.0 D O CU ME NT AT I ON..........................................
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TN-85-6262/16 li i
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COMANCHE PEAK RESPONSE TEAM - DESIGN ADEQUACY PROCEDURE x
- I,i Number: D AP-16
Title:
AUDITS s
Revision: 2 V
l.0 PLRPOSE This procedure sets forth requirements for internal Quality Assurance Audits and Surveillance of the implementation of the Design Adequacy Program (DAP) procedure manual. The audit program and associated requirements described here will:
o Provide objective evidence of the correct implementation of Design Adequacy Program procedures o
Assess the adequacy of those procedures o
identify nonconformances for proper resolution.
The surveillance program may be performed on individual subjects / activities at the request of DAP management.
(3 U
2.0 SCOPE The procedure applies to internal oudits and surveillances of the Design Adequacy Program. This procedure does not apply to audits or surveillances of organizations external to the DAP. Section 4.1 establishes requirements for Auditor qualifications. Sections 4.2,4.3 and 4.4 set for;h requirements for audit k
scheduling, performance and reporting.
Sections 4.5 and 4.6 set forth requirements for performance and reporting of surveillances.
Section 5.1 controls the preparation of Audit Reports and Section 5.2 controls the preparation of Surveillance Reports. The content and maintenance of the DAP Ouality Assurance files are controlled by Section 5.3, while their submittal as a permanent record to the DAP General File is discussed in Section 5.4 3.0 DEFINITIONS AND RESPONSIBILITIES 3.1 Definition A
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COMANCHE PEAK RESPONSE TEAM - DESIGN ADEQUACY PROCEDURE i
Number: DAP-16
Title:
AUDITS Revision: 2 3.1.1 Audit i
An audit is o documented activity performed in occordance with written procedures or checklists to verify, by examination and evoluotion of objective evidence, that opplicable elements of a quality assurance program have been developed, documented and effectively implemented. An audit should not be confused with surveillance or inspection for the sole purpose of process control or product acceptance.
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~ 3.1.2 Internal Audit
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Internal audits comprise audits of those portions of an organization's quality assurance program retained under its direct control and within its organizational structure.
3.l.3 Auditor d
An Auditor is any individual who performs any portion of on audit, including Lead Auditors, technical specialists, and others such as management representatives and auditors-in-training.
3.1.4 Lead Auditor 4
i A Lead Auditor is on individual qualified to organize and direct on audit, report audit findings, and evoluote corrective action.
3.1.5 Surveillance A surveillance is a documented activity performed by Quality Assurance personnel to verify compliance with requirements or effectiveness of implementation of a porticular activity or function being performed within the O
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COMANCHE PEAK RESPONSE TEAM - DESIGN ADEQUACY PROCEDURE
'O Number: DAP-16
Title:
AUDITS Revision: 2 V
DAP. Performance of surveillances does not displace or substitute for required audit activities. There are no CPRT Program Plan or DAP requirements to g
perform surveillances within the DAP Program.
3.2 Responsibilities 3.2.1 Review Team Leader The Design Adequacy Review Team Leader is ultimately responsible for the implementation of the Design Adequacy Program in accordance with the DAP procedures. He oppoints the DAP Ovality Assurance Manager. He monitors the quality of DAP work through review of Audit Reports, Surveillance Reports, lg Corrective Action Reports, Observations, DAP generated documentation, and through interaction in the normal course of business with the DAP Quality
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Assurance Manager, DAP Manager, Discipline Coordinators, and Reviewers.
V 3.2.2 Design Adequacy Program Manager The DAP Manager is responsible for the implementation of the Design Adequacy Program in accordance with DAP Procedures on a day-to day basis.
3.2.3 Discipline Coordinators l
Discipline Coordinators are responsible within their respective disciplines for the implementation of the Design Adequacy Program in accordance with DAP procedures. They shall assist Auditors in planning audits of activities within their respective disciplines and assist in making documentation and oppropriate l
personnel available for Auditor review or interview.
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COMANCHE PEAK RESPONSE TEAM - DESIGN ADEOUACY PROCEDURE Number: DAP-I6
Title:
AUDITS Revision: 2 3.2.4 DAP Ouolity Assurance Manager The Quality Assurance Monoger interacts directly with the Review Team Leader.
He is responsible for scheduling, organizing, planning, executing, reporting, and following up on DAP Ovality Assurance Audits. He is responsible for evaluation of Corrective Action Reports or.d Observations within the DAP, and oversees the activities of DAP Ovality Assurance Auditors. He is responsible for conducting special surveillances as requested by the Review Team Leader or Design
'd Adequacy Program Manager.
He informs DAP management of the status of the DAP quality program. This is accomplished through forwarding Audit Reports, Surveillance Reports, Corree-ld tive Action Reports and Observations to appropriate management and apprising
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oppropriate management of quality trends. During the course of the DAP, he maintains records of the DAP audit program os required by Section 5.3 of this ld procedure.
4.0 INSTRUCTION 4.1 Auditor Qualifications 4
4.1.1 Auditors Auditors shall be qualified in occordance with ANSI /ASME N45.2.23-1978. They shall be independent of the work which they are auditing, j
4.1.2 DAP Ouality Assurance Manager The DAP Ouality Assurance Manager shall quollfy as a Lead Auditor per ANSl/ASME N45.2.23-1978, and shall be independent of the pressures of cost and schedule with respect to the Design Adequacy Program.
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L COMANCHE PEAK RESPONSE TEAM - DESIGN ADEQUACY PROCEDURE Number: DAP-16
Title:
AUDITS Revision: 2 4.1.3 Documentation of Qualifications The DAP Ooolity Assurance Manager shall document Auditor and Lead Auditor cerfification in accordance with ANSI /ASME N45.2.23-1978.
4.2 Audit Schedule Audits shall be conducted in each DAP discipline at a minimum frequency of every three months. Multi-discipline audits may be conducted to ratisfy this requirement. Audits shall be held more frequently if significont nonconpliances have been observed or if the DAP procedures or the DAP organization has been e
significantly revised.
4.3 Audit Performance 4.3.1 Audit Scope During any three month audit cycle, the audits of the DAP shall be across all disciplines and shall sompte material from each. During a particular audit cycle, all elements of the DAP quality program should be verified within each discipline; however, the DAP Guality Assurance Manager may direct that selected elements in a discipline not be audited in a given cycle because of satisfactory results in previous osdits, the size of the available sample or for any other appropriate reason. After completion of an audit cycle, all elements shall l
have been reviewed. Subsequent audits should sample elements of the program within specific disciplines which had not previously been sampled in that I
discipline.
At the discretion of the audit team, the audit scope may be expanded during the course of the audit for the conditions given below.
The identification of nonconformances in the implementation of a given procedure, may warrant auditing against that procedure over additional disciplines. The identification of l
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r COMANCHE PEAK RESPONSE TEAM - DESIGN ADEQUACY PROCEDURE L
Number: DAP-16
Title:
AUDITS Revision: 2 o significant number of nonconformances within a specific discipline over more than one procedure may worront expanding the scope of the audit within that discipline. Additionally, the planning of future audits shall consider the results of previous audits with respect to the compliance noted within disciplines and for specific procedures.
4.3.2 Audit Notification The DAP Ouality Assurance Monoger or his designee shall coordinate with the DAP Manager, the Discipline Coordinators, and other necessary personnel to ensure that the oppropriate documentation is ovalloble and that appropriate personnel be available to assist the Auditors during the audit. Audit notification shall be early enough to facilitate the preparation of information oad availability of personnel, and shall include the general scope of audit within specific disciplines.
4.3.3 Audit Checklists Audit checklists shall be prepared based on the DAP Procedures and utilized during the audit. Checklists, however, shall in no way restrict the Auditor in review of information.
4.3.4 Objective Evidence Auditors shall complete checklists noting the specific documents examined and the Auditors' observations with respect to those documents.
4.4 Audit Reportino Reports documenting the conduct and findings of the audit shall be prepared under the direction of the DAP Ouality Assurance Manager. The contents of O
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COMANCHE PEAK RESPONSE TEAM - DESIGN ADEGUACY PROCEDURE D
Number: DAP-16
Title:
AUDITS Revision: 2
- (d Audit Reports are described in Section 5.1 of this procedure. Audit Reports shall be distributed within 30 days of audit completion to the Review Team Leader, DAP Manager, Discipline Coordinators, and other individuals as appropriate.
4.5 Surveillance Performance There are no requirements for conducting surveillances. Surveillances will be used at the discretion of the Review Team Leader, the Design Adequacy Program Manager, or the DAP OA Manager. They may be performed to provide a detailed evaluation of a specific DAP octivity in response to a suspected problem or to assess effectiveness of corrective actions implemented in response e
to previously identified problems. Surveillances will be used to supplement audit activities and shall be performed by DAP QA personnel who meet qualifications requirements of Sections 4.1.1 or 4.1.2 of this procedure. Their qualifications b
h shall be documented as per Section 4.1.3.
v 4.6 Surveillance Reporting Reports documenting the conduct and findings of the surveillance shall be prepared under the direction of the DAP Ouality Assurance Manager.
The contents of Surveillance Reports are described in Section 5.2 of this procedure.
Surveillance Reports shall be distributed within 30 days of surveillance completion to the Review Team Leader, DAP Monoger and other individuals os appropriate.
4.7 Follow-Up Follow-up on open-ite s, Observations, and Corrective Action Reports shall be completed in a timely manner. Follow-up activities may be held independent of the required audit schedule or may be incorporated into o scheduled cudit OV TN-85-6262/16 Page 7 of 10
COMANCHE PEAK RESPONSE TEAM - DESIGN ADEQUACY PROCEDURE Number: DAP-16
Title:
AUDITS Revision: 2 depending on the urgency of the particular open-item. Follow-up octivities shall comply with the other requirements of this procedure.
5.0 DOCUMENTATION 5.1 Audit Report 5.1.1 Cover Page Audit Reports shall include o cover page to identify the particular audit. The e
cover page shall include a control identification number of the form "DAP--QAAR--XX" where QAAR means Quality Assurance Audit Report. DAP identifies the report os a DAP Audit report and "XX" refers.to a sequence number identifying successive audits (01, 02, etc.). Other information on the cover page shall include a descriptive title, audit date, place (s) of audit, audit team members, persons contacted, and place for approval signatures.
5.1.2 Report Contents The report shall contain statements of audit purpose and the scope of audit activities. The scope statement should be brief and describe the general scope.
of activities, while the body of the Audit Report will contain more detailed information on the audited activities within individual disciplines.
The body of the Audit Report shall include o discussion of results by procedure audited. Under each procedure there shall'be a brief description of the audited material within specific disciplines upon vhich the Auditor's conclusions are based. Any nonconformances shall be discussed and Corrective Action Reports or Observations referenced as oppropriate.
Scope expansions due to audit findings during the audit shall also be described.
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COMANCHE PEAK RESPONSE TEAM - DESIGN ADEQUACY PROCEDURE 6 (].
Number: DAP-16
Title:
AUDITS Revision: 2 L.)
The Auditor's conclusions with respect to satisfactory implementation of the procedure shall be stated and, if applicable, his conclusions on the effectiveness of the procedure.
The Audit Report shall contein sufficient summary information and rationale under each procedure to provide a clear basis for the Auditor's conclusions.
The essential conclusion of the audit including a summary of conclusions by procedure shall be given in a " Conclusions" section of the report This section will provide a brief overview of the audit whereby management, or other parties, con efficiently review oudit results. Statements of conclusion in this section shall reference the body of the Audit Report should the reader wish greater detail on a particular point.
5.2 Surveillance Report G
5.2.1 Format Surveillance Reports may be written in memo form or such other form os may be effective in communicoting the activity. The reports shall be uniquely identified by means of a control number of the form DAP-OASR-XX, where QASR means Quality Assurance Surveillance Report. DAP identifies the report as a DAP report, and "X X" refers to o sequence number identifying successive surveillances. The control number should be displayed on the front page of the report and should be readily apparent to the reader.
5.2.2 Report Contents The Surveillance Report shall contain, as a minimum, a description of what was done, o description of the results, and copies of any Corrective Action Reports or Observations generated as a result of the surveillance. The report should in addition, contain a title, statements of purpose and scope, a summary, if the O
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COMANCHE PEAK RESPONSE TEAM - DESIGN ADEQUACY PROCEDURE
- !.-~)
V Number: DAP-16
Title:
AUDITS Revision: 2 report is lengthy or detailed, a list of personnel contacted during the surveillance, a list of references if applicable, on overall listing of evidence reviewed which support the conclusions, and the dates and locations of the surveillance, g
5.3 DAP Audit and Surveillance Files The DAP Quality Assurance Manager shall maintain record copies of the following documentation pertaining to DAP audits and surveillances:
o An audit schedule including the time frame and projected scope of future audits, as well as date audited o
A record of the Audit Reports for all DAP audits and the completed checklists used in the audits hl A Corrective Action Log and copies of all Corrective V
o Action Reports and Observations, as required by DAP-17 Records of the qualifications of DAP Auditors as required o
by this procedure o
Record of all communicatio :s to or from the DAP Audit Manager with respect to DA.' audit activities o
All issued Surveillance Reports.
5.4 Submittal of Records to DAP General File A
After complettor f all activities associated with a porticular audit cycle, the l
DAP Ovality Assurance Manager shall submit the DAP Audit and Surveillance Files (maintained per Section 5.3) to the DAP Manager for inclusion in the DAP General File in accordance with Procedure DAP-14.
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