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O QA DIRECTIVE 1
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ID.NO: Ceco-001 ,
l CLENT: Commonwealth Edison Company CT* All Nuclear Safety-Related Activities pegg log 2 Rev No. Date PREPARED REVEWED APPROVED Regional OA W Manager. Quaky Asawance Rogbnel Menegar 12/01/83
/,fg 3 TC Che RA Ayres MJ Scholtens gyMan$~xa i L.I
%$h Quality Assurance Manual O QA DIRECTIVE CLIENT: Commonwealth Edison Company REV. 3 PROJECT: All Nuclear Safety-Related Activities E 12/01/83 1.0 PURPOSE This Directive supplements the Impell Quality Assurance Manual and incorpo-rates the requirements of the Commonwealth Edison Company Standard Quality Articles latest revision received by Impel *.
2.0 APPLICABILITY This Directive applies to all nuclear safety-related projects contracted between Impe11 Corporation and Commonwealth Edison Company.
3.0 RESPONSIBILITIES The Project Manager or person designated by him is responsible for the issuance of a certificate of confomance or other equivalent statement.
4.0 PROCEDURES At the conclusion of work perfomed in accordance with a Commonwealth Edison Company Purchase Order, the Impe11 Project Manager or person designated by him, shall submit a signed statement attesting completion of the work specified in the Purchase Order, under the tems and conditions of the then existing Impe11/ Commonwealth Edison Agreenent for Consulting Engineering Services when required by the Purchase Order.
5.0 ATTACHMENTS None O
- l. 0 . N O .: Ceco-001 Page 2 g( 2
QUALITY ASSURANCE MANUAL QUALITY ASSURANCE MANUAL g REVISION HISTORY s MANUAL REVISION 9 10 11 12 13 14 15 16 17
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PLAN / PROCEDURE @ $ A 3 ) A E E PLAN 1 0 INTRG3UCT10N & PROGRAM (ESCRIPTION O 1 2 3 4 5 PLAN 2.0 ORGANIZATION & RESPONSISILITIEl . 0 1 2 3 4 5 6 QUAL!TY PROGRAM l QP-1 1 CONTROL OF QUALITY 0 1 2 3 4 ASSURANCE MANUAL QP-l.2 QUAL.!TY ORIENTATION O 1 2 3 4 V EW OF 0 2 3 4 5 6 7 QP-1.3Mg 1 QP-1.4 10CFR21 REPORTINS (PREVIOUSLY OLP PROCEDURE 10151 0 QP-t.5 PERSONNEL QUALIF! CAT 10N (PREVIOUSLY OLP PROCEDURE 301S3 0 PROJECT CONTROL QP-2 1 PROE CT INTERFACE CONTROL 0 1 2 3 4 QP-2.2 E O 1 2 3 QP-2.3 PROJECT ORGANIZATION &
00CulENTAT10N 0 1 2 3 QP-2.4 PROJECT TRAININS (PREVIOUSLY PART OF GAP-1.21 0 QP-2.5 PROA CT QUALITY PLAN O ENGINEERING CONTROL QP-3.1 TECHNICAL INPUT CONTROL 0 1 2 3 4 5 QP-3.2 IMPELL ORAWING CONTROL 0 1 2 3 4 QP-3.3 FOREIGN DOCUMENT CONTROL 0 1 2 3 4 5 8 QP-3.4 CALCULATIONS O 1 2 3 4 QP-3.5 OESIGN CONTROL 0 QP-3.6 INDEPENDENT VERIFICAfl0N O 1 2 3 4 Revistor. 17 Impell Corporation Da
k l QUALITY ASSURANCE MANUAL Q QUALITY ASSURANCE MANUAL 1
REVISION HISTORY - CONT'D MANUAL REVISION l 9 10 11 12 13 14 15 16 17 I
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, PLAN /PROCEOURE D b A - , E E E I
ENGINEERING CONTROL - CONT 'O QP-3.7 TECtedICAL QUALITY MVIEWS 0 1 2 3 4 5 (F-3.0 DESIGN SPECIFICATIONS (PREVIOUSLY GAP-6 1, REVISION 0) 1 GP-3.9 PROACT INSTRUCTIONS 0 1 2 3 4 5 QP-3.10 TEC)# DICAL REPORTS 0 1 2 3 l
l QUALITY RECOROS (F-4 1 QUALITY MCORDS 0 1 2 3 4 PROGRAM COMPLIANCE F -5.1 GA AUDITS 6 $URVEILLANCES 0 1 2 3 4 5 8 (F-5.2 AUDITOR QUALIFICATION O I 2 3 GP-5.3 STOP WORK O I l (F-5.4 g MPtRTINS 6 (PNVIOUSLY GAP-3.ll) 2 MVISION I COMPUTER APPLICATIONS
! GP-8.1 CSFUTER SIFTWAM RIALITY PRoutAM (PREVICRJBLY PART OF GAP-3.5) 0 GP-4.2 IPPEI.L STAfeAfW CGPUTER PROGRAMS (PREVIOUSLY PART OF GAP-3.5) 0 (F-6.3 PROACT SPECIFIC CGWUTER PROGRAMS (PREVIOUSLY PART OF GAP-3.5) 0 F-6.4 PLE.lC DEMAIN CWFUTER PROGRAMS (PREVIOUBLY PART OF GAP-3.5) 0 GP-6.5 MICR0CorruTER PROGRANS 0 PROCUREMENT CONTROL GP-7 8 PROCUM E NT GUALITY PROGRAM 0 1 (F-7.2 PRoctmEMNT 00CLNENTS 0 1 IF-7.3 SUPPLIER EVALUATION & SELECTI(m 0 1 (F-7.4 SLPPLIER PERFWMApCE EVALAJATICD4 0 1 Revision 17 Impell Corporation Date 7/15/85
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QUALITY ASSURANCE MANUAL TABLE OF CONTENTS 9(
QUALITY PLAN REVISION DATE 1.0 Introduction & Progran Description 5 7/15/85 2.0 Organization & Responsibilities 6 7/15/85 QUALITY PROCEDURES 1.0 QUALITY PROGRAM Q9-1.1 Control of Quality Assurance Manual 4 7/15/85 QP-1.2 Quality Orientation 4 QP-1,3 7/15/85 Management Review of Quality Progran 7 7/15/85 QP-1.4 10CFR21 Reporting 0 QP-1.5 7/15/85 Personnel Qualification 0 7/15/85 2.0 PROJECT CONTROL QP-2.1 Project Interf ace Control 4 7/15/85 QP-2.2 Correspondence & Doctment Control 3 7/15/85 QP-2.3 Project Organization & Doctmentation 3 7/15/85 QP- 2. 4 Project Training 0 7/15/85 QP-2.5 Project Quality Plan 0 7/15/85 3.0 ENGINEERING CONTROL QP-3.1 Technical Input Control 5 7/15/85 QP-3.2 Impe11 Drawing Control 4 7/15/85 QP-3.3 Foreip Doctanent Control 6 7/15/85 QP-3.4 Calcu ations 4 QP-3.5 Desip Control 7/15/85 0 7/15/85 QP-3.6 Independent Verification 4 7/15/85 QP-3.7 Technical Quality Reviews 5 7/15/85 QP-3.8 Design Specifications 1 7/15/85 QP-3.9 Project Instructions 5 7/15/85 QP-3.10 Technical Reports 3 7/15/85 l
t 7/15/85 Impe11 Corporation Revision 17 Page 1 of 2
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V QUALITY PROCEDURES REVISION DATE 4.0 QUALITY REC 0ROS QP-4.1 Quality Records 4 7/15/85 6.0 PR0bRAM COMPLIANCE QP-5.1 QA Audits & Surve111ances 6 7/15/85 09-5.2 Auattor Qualification 3 7/15/85 QP-5.3 Stop Work 1 7/15/85 QP- 5.4 Nonconfonnance Reporting, and Resolution 2 7/15/85 6.0 COMPUTER APPLICATIONS QP-6.1 Computer Sof tware Quality Progra 0 7/15/85 QP-6.2 Impell Standard Caputer Progres 0 7/15/85 c QP-6.3 Project Specific Caputer Progres 0 7/15/85
( QP-6.4 Public 0 main Caputer Progras 0 7/15/85 QP-6.5 Microcomputer Progres 0 7/15/85 7.0 PROCUREMENT CONTROL QP-7.1 Procurament Quality Progra 1 7/15/85 QP- 7. 2 Procurment Docments 1 7/15/85 QP-7.3 Supplier Evaluation & Selection 1 7/15/85 QP- 7.4 Supplier Perfonnance Evaluation 1 7/15/85 QUALITY DIRECTIVES Ceco-001 3 12/01/83 7/15/85 Revision 17 Impe11 Corporation . Page 2 of 2
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QUALITY ASSURANCE MANUAL 9
QUALITY PLAN CONTENTS
1.0 INTRODUCTION
AND PROGRAM DESCRIPTION 1.0 IMPELL QUALITY COMMITMENT & POLICY 2.0 PROGRAM APPLICABILITY 3.0 QUALITY ASSURANCE MANUAL 4.0 PROGRAM COMPLIANCE i
2.0 ORGANIZATION AND RESPONSIBILITIES 1.0 IMPELL ORGANIZATION 2.0 PROJECT ORGANIZATION 3.0 QUALITY RESPONSIBILITIES 4.0 RIGHT OF ACCESS AND STOP WORK AUTHORITY l
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Impell Corporation.
QUALITY ASSURANCE MANUAL O h Reviewec'- Co porate QA Manager
/.. 7/15/85 Apprp9ed - Sr. Vife President / Date PLAN
1.0 INTRODUCTION
6 PROGRAM DESCRIPTION 1.0 IMPELL QUALITY Impell Corporation is comitted to providing
, COPNITMENT & POLICY engineering and management services of superior quality that meet all client requirements and applicable codes, standards and regulations.
The company comitment to superior quality is achieved using the quality plan and procedures of this manual. Attachment A (Impell Quality Program) illustrates the relationship between this comitment, the plan and implementing procedures of O this manual, client requirements, regulations, and industry codes and standards, 2.0 PROGRAM APPLICABILITY Quality requirements in this manual apply to all nuclear safety-related work performed by Impell and its subcontractors when so defined in procurement l documents. This manual may also be applied to other projects as defined in project specific quality plans. Persons whose activities are governed by this manual shall familiarize themselves with the contents and implement the quality requirements appropriate to their work.
On certain projects Impell personnel may be directed by the client to work to the client's quality program. This should be specified contractually, and in these cases the client's program will be implemented in lieu of the Impell Quality Program.
O Plan 1.0 Revision 5 DrTnTLTLBOP~2nP&a N
QUALITY ASSURANCE MANUAL O
J.0 QUALITY ASSURANCE This Quality Assurance Manual is the governing MANUAL document of the Impell Quality Program and consists of two parts.
3.1 Quality Plan Plan 1.0 describes the Impell Quality Program, identifies applicable regulatory requirements, and indicates how each basic requirement is met by the program. Plan 2.0 defines Impell organization and position responsibilites for implementing the quality requirements specified in this manual.
3.2 Quality Procedures Quality procedures identify specific measures to be implemented for each work activity. These procedures define the responsibilities and activities necessary to satisfactorily implement the Impell Quality Program. Quality procedures are grouped into the following sections:
1.0 - Quality Program 2.0 - Project Control 3.0 - Engineering Control 4.0 - Quality Records 5.0 - Program Compliance 6.0 - Computer Applications 7.0 - Procurement Control l
3.3 Supplemental The quality plans and procedures are supplemented by
, Requirements project specific quality plans issued for each l proj ect. Project instructions further supplement the requirements of this manual.
l 4.0 PROGRAM COMPLIANCE The Impell Quality Program complies with the following federal regulations and the industry codes and standards as applicable to each project:
. a. 10CFR21
, b. 10CFR50 Appendix B l C. ANSI N45.2 (Regulatory Guide 1.28)
- e. ANSI N45.2.9 ((Regulatory Guide 1.88) i
\ O Plan 1.0 Revision 5 Impell Corporation D= ? d '
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QUALITY ASSURANCE MANUAL
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- h. ANSI .N45.2.13 (Regulatory Guide 1.123)
- j. ANSI-ASME NQA-1 & NQA l k. ASME Section III. NCA-4000 l
l Compliance is to the revision of each document in effect on the date this manual is issued, unless Contract documents specify otherwise. Attachment B identifies specific sections of the quality plan and specific procedures for implementing the various requirements in each regulation, code, and standard.
, 5.0 ATTACHMENTS A - Impell Quality Progem B - Quality Program Compliance l O .
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l Plan 1.0 I Revision 5 Impell Corporation Page 3 of 3
QUALITY ASSURANCE MANUAL O
QUALITY PROGRAM COMPLIANCE
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PROGRAM DESCRIPT!M 2 1,2 1,2 PLAN 2.0 - WIO!?lIZATIW4 &
RESFJNSIS!LITIES 1,2 1,2,3 1,2 QUALITY PROGRAM QP-1.1 CONTRG OF GA MANUAL 2 2 2 (P-1.2 QUALITY ORIENTATION 2 2 2 QP-l.3 MANAGDENT REVIEN OF 2 2 2 QUALITY PROGRAM QP-1.4 10CFR21 NEPORTING X QP-1.5 PERSONNEL QUALIFICATION l
- PROJECT CONTROL QP-2.1 PRO E CT INTERFACE 1,3,8 B,4,7 4,5, CONTROL 7,8 QP-2.2 ColWIESPOPENCE AND 3,8 4,7 4,7.
00CtMENT CONTR(L 8 QP-2 3 PROE CT ORGANIZATION & 1,3,5,8 3,4, 4,5.
00CLNENTAT10>6 6,7 7,S QP-2.4 PRO ECT TRAININS 2 2 2 QP-2.5 PROECT QUALITY PLAN 1,3, 3,4, 4,5, 5,8 S,7 S,7 l
O Plan 1.0 Revision 5 Impell Corporation Attachment B Page 1 of 2
QUALITY ASSURANCE MANUAL Q QUALITY PROGRAM COMPLI ANCE - Cont 0
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_ 18 Ib, I_N I I IN I I I ENGINEERING CONTROL GP-3.1 TECHNICAL INPUT CONTROL 3,a 4,7 4 OP-3.2 IMPELL ORAWINS CONTROL 3,s,8 4,6,7 4 s,7,e GP-3.3 FOREIGN 00 CUE NT CONTROL 3,4 4,7 4 GP-3.4 CALCULATIONS 3 4 4,5,7,0 GP-3.5 OESIGN CONTROL a 4 4,s,7,e j GP-3.8 INDEPENDENT VERIFICATION 8,te 4,17 4,ses j GP-3.7 TECHNICAL QUALITY REVIENS s,ts 4,87 4.s,a ;
QP-3.8 DESIGN SPECIFICATI(MS 3 4 4 s,7,e )
r-3.5 PROACT INSTRUCTI(NS 3,5,8 4.s,7 4,7 l
r-3.10 TECMd! CAL IIEPORTS 3 4 4,6,7,8 ;
i QUALITY RECORDS F-4.1 QUALITY RECGWS 17 to x to ,
! O PROGRAM COMPLIANCE l
QP-5.1 GA AUDITS & te,la 17,te e,tt x -
SURVEILLANCES ,
GP-5.2 AUDITOR QUALIFICATION 18 to 11 x x 17,10 x
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GP-5.3 STOP WORK is,se e,tt QP-5.4 NONCONFORMANCE REPORTINS AND RESOLUTION 3,1s,1s 4,86,17 4.s COMPUTER APPLICATIONS 3 4 4 e,7,e QP-S.1 COMPUTER SOFTWARE GUALITY PROGRAM GP-8.2 TA8SAlW CINFUTER , , ,,,,7,,
i QP-8.3 PROACT SPECIFIC a 4 4,s,7,e CoppuTER PROGRAMS GP-8.4 PUOLIC OEMAIN a 4 4,s,7,e CoppuTER PROGRAMS GP-8.5 MICRIED ruTER PROWtAng 3 4 4,6,7,0 PROCUREMENT CONTROL QP-7.1 PROCUREIENT (KAALITY PROGRAM 4,7 s,e x W-7.2 PREMMIEfENT IMEMENTS x i 4.7-10,13,13 gt, QP-7.3 SUPPLILER EVALUATION & 7 e x
, SELECTION
- ~ 4 7,80,13 B,II,13 x x E (Di Plan 1.0 Revision 5 Impell Corporation Attachment B i
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IMPELL QUALITY PROGRAM IMPELL CORPORATION QUALITY COMMITMENT o
FEDERAL I ' ITY
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S d'E INDUSTRY CODES REGULATIONS & STANDARDS MANUAL OESCRIPTION o REQUIREMENTS o o QUALITY - QUALITY -
PLAN PROCEOURES ,,
l INTRODUCTION PROGRAM -
l ORGANIZATION l PROJECT -
l ENGINEERING I RECOROS l COMPL!ANCE I COMPUTERS o I PROCUREMENT CLIENT _
PROJECT REQUIREMENTS QUALITY PLAN o
PROJECT INSTRUCTIONS O
Plan 1.0
QUALITY ASSURANCE MANUAL o L4 Reviewe'd - Corporfate QA Manager l @ d 7/15/85 Apprfved - Sr. VI,c4 President / Date PR0CEDURE QP-1.1 CONTROL OF QUALITY ASSlRANCE l MANUAL This procedure establishes requirements to control the preparation and issue of the Impell Quality Assurance Manual. Requirements in this procedure address the following and are summarized in Attachment A:
- a. Manual preparation
- b. Review and approval
- c. Issue and control
- d. Revision control
- e. Use of forms 1.0 MANUAL PREPARATION The Corporate Quality Assurance Manager (CQAM) shall direct preparation of the manual. The manual shall contain:
Table of Contents - A listing of all cuality plans and procedures in the manual. The table of contents shall also identify:
- a. Current manual revision level and issue date l b. Current revision level and issue date for each quality plan and procedure
- c. Quality Manual revision history listing revision dates for each quality plan and quality procedure Quality Plans - Documents which address company organization, quality program commitments, or generic quality provisions. These plans shall include a management statement directing Impell personnel to implement provisions of the quality program appropriate to their work. Each quality plan shall include a revision identifier and date.
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Quality Procedures - Specific quality requirements, includ' ng implementing methods and responsibiities.
Each quality procedure shall include a revision identifier and date.
2.0 REVIEW AND APPROVAL The CQAM shall coordinate internal Impell review.
Each quality plan and procedure shall be signed by the CQAM and the Sr. Vice President. The " reviewed" signature (CQAM) indicates that the document meets applicable regulatory requirements and the guidance of industry codes and standards. The " approved" signature (Sr. Vice President) indicates that the document reflects company policy and directs Impell employees to implement the requirements of the document. I 3.0 ISSUE AND CONTROL The CQAM shall issue the manual to regulatory bodies, and other organizations which do not maintain a specific regional office or project j relationship with the company. The CQAM shall also distribute copies to the Regional Quality Assurance g
Managers (RQAMs) who in turn shall issue copies to appropriate regional office personnel and clients within their specified regional area.
As a minimum within Impell, the manual shall be issued to supervisors and managers whose activites are governed by the quality program.
3.1 Manual Issue The manual shall be issued as a package containing:
- a. Complete manual, or appropriate revisions, with current table of contents
- b. Controlled copy page which identifies the manual number and name of the manual holder (when complete manual is issued)
- c. Manual revision history
- d. Issue memorandum from the CQAM describing contents of the package and directions for applying the manual to past work or work in progress on the effective date (date shown on the first s procedure)page of each quality plan and quality O
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QUALITY ASSURANCE MANUAL o
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- e. Receipt acknowledgement form listing all material being transmitted 3.2 Receipt Acknowledgement The individual receiving the manual shall comply with the instructions provided, sign the receipt acknowledgement and return it to the designated Quality Assurance Manager.
3.3 Distribution Log All copies of the manual issued for use shall be accountable. Each Quality Assurance Manager shall maintain a distribution log for the manual. This log shall identify manual numbers, designated manual holders, manual revision and receipt acknowledgement status.
3.4 Uncontrolled Copies Uncontrolled copies of the manual or individual procedures may be issued by the responsible Quality Assurance Manager provided the copies are marked l " Uncontrolled". A receipt acknowledgement form is not required and uncontrolled copies need not be listed in the distribution log.
Uncontrolle'd copies will not be updated with subsequent manual revisions.
4.0 REVISION CONTROL Revisions to the manual shall be prepared, reviewed, approved, issued and controlled the same as the l
original. Each revised quality plan or procedure shall be reissued as a complete document. Each manual revision shall be distributed to all l
controlled manual holders.
4.1 loentification The latest manual revisions shall be identified by a vertical bar in the margin adjacent to the change.
Documents which are completely revised may be identified by indicating sane in the text of the document or in the issue memorandum from the CQAM.
4.2 Superseded Material Manual holders shall either destroy superseded materials or mark them as such.
5.0 USE OF FORMS The RQAMs maintain forms which may be used to implement certain requirements of the quality program. These forms provide acceptable O
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QUALITY ASSURANCE MANUAL 9
implementation methods but may be altered, or other methods substituted, provided the intent of the program requirements are adhered to.
6.0 QUALITY RECORDS Each revision of the Quality Assurance Manual shall be retained as a quality record in accordance with QP-4.1. Signed receipt acknowledgements for the current version of the manual shall be retained by the responsible Quality Assurance Manager.
7.0 ATTACHMENTS A - Procedure Sunsnary i
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e QUALITY ASSURANCE MANUAL O
CONTROL OF QUALITY ASSURANCE MANUAL PROCEDURE
SUMMARY
REQUIREMENTS RESPONSIBILITY Prepare manual CQAM Impell review CQAM Coordinate Approval Sr. Vice President Issue memorandum CQAM
- Assemble & issue revision Responsible QA Manager Distribution:
Regulatory agencies, RQAMs and other CQAM d non-regional personnel Supervisors, managers & clients RQAMs Update manual (destroy superseded materials) Manual holder Sign and return receipt acknowledgement Manual holder Distribution log Responsible QA Manager Uncontrolled copies Responsible QA Manager
, Revisions:
Propose revisions All Prepare, review, approve Same as original Identify revisions CQAM Maintenance of forms CQAM & RQAMs l
QP-1.1 Revision 4
QUALITY ASSURANCE MANUAL 2L Revitiwed ' Gorf cyate QA Manager e
NX/ 7/15/85 Apprp9ed - Sr. Vice President / Date PR0CEDURE QP-1.2
- QUALITY ORIENTATION This procedure establishes requirements for quality program orientation training for Impell personnel.
Requirements in tnis procedure address the following
. and are sunnarized in Attachment A:
- a. Orientation schedule
- b. New employee notification
- c. Quality orientation
- d. Site personnel
- e. Update and refresher briefings Project quality training requirements are defined in QP-2.4.
l l 1.0 APPLICABLE PERSONNEL All Impell personnel performing nuclear safety-related work governed by this manual shall receive quality orientation training. This requirement includes all management personnel who perform, review or approve project work.
Impell is connitted to producing quality work, i indepenoent of any project or organizational I boundary. As a result, quality orientation training I
will also be given to other personnel as determined l appropriate by the Regional Quality Assurance Manager, or Corporate Quality Assurance Manager for corporate personnel.
l l 2.0 SCHEDULE New personnel shall receive quality orientation training within the first two months of emplopent.
l 3.0 NOTIFICATION OF Each Impell office shall establish methods to notify NEW EMPLOYEE 5 the responsible Quality Assurance Manager of all new l personnel who will be involved in nuclear safety-related work.
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4.0 QUALITY ORIFNTATION 4.1 Reading Assignment Personnel shall read portions of the Impell Quality Assurance Manual appropriate to the work they perform. The Quality Assurance Manager shall designate reading assignments.
4.2 Orientation Training The Quality Assurance Manager, or other individual designated by the Quality Assurance Manager, shall
! provide orientation training to appropriate personnel. A representative of Impell management should participate in the training to emphasize the importance of quality work to the company. Training methods (formal classroom, videotape, etc.) shall be determined by the Quality Assurance Manager.
Orientation training shall cover the following:
- a. Impell quality commitment and objectives
- b. Applicable industry quality requirements
- c. Impell Quality Assurance Manual requirements and implementation responsibilities 4.3 Documentation The Quality Assurance Manager shall document quality orientation activities for each employee.
Documentation shall include:
- a. Impell Quality Assurance Manual reading assignment and employee acknowledgement of completion
- b. Attendance at orientation training, date and subjects covered
- c. Si,qnature of Quality Assurance Manager responsible for the training 5.0 SITE PERSONNEL Impell personnel who will be working at a client's office or field site under the Impell Quality Program should receive orientation training prior to arrival at the site. Site personnel working under the client's quality program shall receive orientation training when they return to the Impell home office unless they received such training prior to the site assignment.
O QP-1.2 R
QUALITY ASSURANCE MANUAL O
o.O UPDATE & REFRESHER Briefings on significant quality program changes or BRIEFINGS quality concerns shall be given to Impell personnel as determined appropriate by the responsible Quality Assurance Manager. Briefing methods (i.e., reading assignment, formal training session, etc.) shall be determined by the Quality Assurance Manager..
7.0 QUALITY RECORDS Training documentation shall be retained as quality records according to QP-4.1.
8.0 ATTACHMENTS A - Procedure Sunnary 9
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O QUALITY ORIENTATION PROCEDURE SIM4ARY REQUIREMENTS RESPONSIBILITY Conplete' orientation within 2 months QA Manager New employee notification Impell management Orientation reading Employee j Orientation training (nuclear safety-related project QA Manager personnel plus others as the Quality Assurance Manager determines)
Orientation records QA Manager Upaate and refresher briefings QA Hanager l
O QP-1.2 Revision 4 Impell Corporation Attachment A
QUALITY ASSURANCE MANUAL l bb O, Revi(wecf k (70 orate QA Manager g/ 7/15/85 Approved - Sr. VIce President / Date PR0CEDURE QP-1.3 MANAGEMENT REVIEW 0F QUALITY PROGRAM l
This procedure establishes requirements for company manament to evaluate the effectiveness of the Impell Quality Program. Requirements in this procedure address the following and are sunnarized in Attachment A:
- a. Corporate audits of the regional offices
- b. Management review and action 1.0 CORPORATE AUDITS The Corporate Quality Assurance Manager (CQAM) shall audit eacli regional office once each year. This
, audit is to verify that the region is complying with the quality requirements in this manual.
Corporate audits shall be perfonned, documented, and closed out in accordance with QP-5.1. Results of the audits shall be transmitted to the Sr. Vice President and appropriate regional office management.
2.0 MANAGEMENT EVALUATIONS Every two (2) years, a management review team shall evaluate the Impe11 Quality Program. This evaluation is to determine whether compliance with the program is effectively producing quality work.
Reconnendations for improving the program shall also be provided.
2.1 Review Team The review team shall include one manager from each region (selected by the Regional Manager). The Sr.
Vice President shall appoint a review team leader from amon offices. g the managers selected by the regional O
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2.2 Review Criteria The management evaluation shall focus on company-wide quality issues and shall be conducted using written criteria issued by the team leader.
The evaluation shall address questions such as:
, a. Does the Quality Assurance Manual adequately l address the scope of Impell operations?
- b. Are quality requirements clearly stated with proper balance of detail and guidance?
- c. Are corporate audits effective in identifying implementation problems and are the regional offices responsive to correcting identified problems?
- d. Have action items from the previous management evaluation been satisfactorily resolved? '
- e. Do quality procedures allow implementation flexibility to prevent cost or schedule penalties which could in turn affect work quality?
- f. Do quality assurance managers administer the quality program in a positive and effective manner?
s g. Do operating division management and engineering personnel understand and support the quality program? ,
- h. Is the Quality Assurance Manual being implemented effectively and is the desired quality of work resulting?
- 1. Is the program consistent with industry and regulatory requirements?
- j. Is the management evaluation process effective?
2.3 Evaluation Results Results of the management evaluation, along with reconnended actions, shal, be suunarized in a report to the Sr. Vice President, Regional Managers, Corporate Quality Assurance Manger and Regional Quality Assurance Managers (RQAMs). This report shall include a listing of review team members and the review criteria used.
3.0 EXECUTIVE MANAGEMENT The Sr. Vice President in conjunction with other l
REVIEW AND ACTION appropriate company executives and the CQAM shall l review the management evaluation report and decide actions to be taken to improve effectiveness of the quality program.
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3.1 Action List The CQAM shall issue a list of required actions, due dates and responsibilities for completing same. The action list shall be distributed to the Sr. Vice President, Regional Managers, RQAMs and those assigned corrective action.
3.2 Action Followup The CQAM shall monitor the status of each action item to assure completion. The CQAM shall periodically report progress to the Sr. Vice President and request further attention towards 1 completion of those items behind senedule. The CQAM shall document satisfactory completion of each required action, with input fran the RQAMs as appropriate.
4.0 QUALITY RECORDS The management review teen report, action list, and
- CQAM closeout report shall be retained by the CQAM l as quality records in accordance with QP-4.1.
5.0 ATTACHMENTS A - Procedure Sunnary h l
O QP-1.3 Revision 7 Impell Corporation Page 3 of 3
QUALITY ASSURANCE MANUAL O MANAGEMENT REVIEW OF QUALITY PROGRAM PROCEDURE Su MARY REQUIREMENT RESPONSIBILITY Corporate audits CQAM Management evaluation Select review team Regional Managers Select review tea 1 leader Sr. Vice President Establish criteria & perfom review Review team Report results Review team leader Executive management review Sr. Vice President Action list CQAM Action follow-up CQAM l
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QP-1.3 Revision 7 Impell Corporation Attachment A I .
QUALITY ASSURANCE MANUAL h
Revieded ~ 'Codpofpte QA Manager e E NY/ 7/15/85 Appr9eed - Sr. Vice President / Date PR0CEDURE QP-1.4 10CFR21 REPORTING This procedure establishes requirements for identifying, evaluating and reporting potential safety-related defects or noncompliances as required by 10CFR Part 21. Requirements in this procedure address the following and are summarized in Attachment A:
- a. Reportable condition
- b. Safety Review Committee appointment
- c. 10CFR21 posting
- d. Impell procurement document requirements
- e. Employee identification of potential reportable condition
- f. Preliminary evaluation l . g. Technical / safety evaluation
- h. NRC and client notification
- 1. Corrective action l
1.0 PREREQUISITES 1.1 Reportable Condition A reportable condition is the product of any Impell nuclear safety-related service or any computer software which fails to meet client procurement
. document requirements and could create a substantial l safety hazard. i substantial safety hazard is a condition that jeopardizes:
- a. Integrity of the reactor coolant pressure boundary
- b. Capability to shut down the reactor and maintain it in a safe shutdown condition
- c. Capability to prevent or mitigate the consequences of accidents that could result in potential offsite exposures comparable to those l
referred to in 10LFR100 O
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sv 1.2 Safety Review The Safety Review Coninittee (SRC) plans, schedules committee Appointment and directs a technical / safety evaluation of each potentially reportable condition. A representative to the SRC shall be appointed by each Regional Manager. Each appointee should have experience in nuclear systens licensing and be a Section Manager or higher. The Sr. Vice President shall appoint the enairman of the SRC.
1.3 10CFR21 Posting Each regional office shall post a notice signed by tne Sr. Vice President requiring Impell employees to report potential defects or noncompliances to their SRC regional representative. Tnis notice shall include:
i
- a. Section 206 of the Energy Reorganization Act
- b. Reference to this procedure as the controlling Impell document for 10CFR21 reporting
- c. Definition of a substantial safety hazard
- d. Name of the SRC regional representative Q 1.4 Impell Procurement Impell procurement documents for nuclear b Document Requirements safety-related materials, equipment or services l snall specify that the provisions of 10CFR21 apply (refer to OP-7.2). The Regional Quality Assurance Manager (RQAM) can provide acceptable language for the procurement document.
2.0 EMPLOYEE IDENTIFICATION Any employee who identifies a defect or 0F REPORTABLE noncompliance which could create a substantial l CONDITION safety hazard shall report same by memorandum to the l
SRC regional representative. A standard memorandum fonn is available fran the RQAM for this pur,,ose.
l Questions regarding potentially reportable items or interpretation of the requirements of this procedure shall be addressed to the RQAM.
l 3.0 PRELIMINARY EVALUATION 3.1 SRC Regional Within one week, the SRC regional representative Evaluation shall perfonn a preliminary evaluation of the defect l
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or noncompliance. The evaluation shall:
- a. Verify existence of the identified condition
- b. Ascertain whether it represents a deviation from technical requirements or a noncompliance with regulatory requirements
- c. Determine whether tne provisions of 10CFR21 apply to the identified condition
- d. Determine whether a technical / safety evaluation by the SRC is necessary and, if so, outline the reconmended scope of that evaluation 3.2 Report of Findings The SRC regional representative shall stenarize results of the preliminary evaluation in a report to the SRC chairman. The report shall clearly state reasons why the identified condition is or is not potentially reportable. If the condition is potentially reportable, the report shall also include reconnendations for conducting the technical / safety evaluation. Copies of the report shall be distributed as defined in Attachment A.
3.3 Client Notification As decided by the Regional Manager, the applicable clients may be contacted to discuss results of the preliminary evaluation and reconenendations for conducting the technical / safety evaluation. If the client decides to conduct the technical / safety evaluation, a copy of the preliminary evaluation report shall be fonnally transmitted to the client.
The transmittal letter shall indicate that Impell will not take any further action towards reporting the condition unless specifically requested by the client.
4.0 IMPELL TECHNICAL / A technical / safety evaluation shall be conducted SAFETY EVALUATION when t.1e preliminary evaluation determines that the defect or noncompliance is a potentially reportable item and the client has not assumed responsibility for same. The technical / safety evaluation is to determine whether a substantial safety hazard might j exist as a result of the identified condition.
4.1 connittee Selection The SRC chairman shall select two (2) SRC regional representatives to assist with the technical / safety O
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U evaluation. The selection should be based on considerations such as where the work was originally performed, present location of required expertise and location of related records.
4.2 Plan ano Scnedule The SRC shall plan tne technical / safety evaluation and assign responsibility for completion of each task to the appropriate organization within, or outside Impell. The evaluation shall be completed within four (4) weeks. If, during the evaluation, it is determined that more time is needed for completion, one extension not exceeding two (2) weeks may be granted by the Sr. Vice President.
4.3 Completion The SRC shall direct the technical and safety of Evaluation evaluation. The SRC may terminate the evaluation at any time they determine that the condition is not reportable under 10CFRel. Otherwise, the evaluation shall be completed as planned.
4.4 Report of Findings The SRC shall issue a report to the President which includes the following:
- a. Ioentified condition
- b. Evaluation perfonned
- c. Results of evaluation
- d. Statement on whether the condition is reportable and reasons for reaching that conclusion
- e. If reportable, reconsnended actions to.be taken before reporting the condition to the NRC, including notification to potentially affected clients
- f. Recommended actions to be taken to correct the reported defect or noncompliance, and recommended organizations for taking such actions.
Copies of the report shall be distributed as defined in Attachment A.
5.0 NRC AND CLIENT If the condition was determined to be reportable, NOTIFIC ATION the following notifications shall be made with concurrence of the President:
- a. The Regional Manager shall notify clients that may be affected by the reported condition. The O
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notification shall include all pertinent information, including results of the technical / safety evaluation and any recomendations that may pertain to each client. The Regional Managers shall also determine what additional evaluations or actions are requested or required by each client.
- b. The President or Sr. Vice President shall notify the appropriate NRC office of the condition that has been determined to be a safety 5azard. The notification shall sumarize all pertinent information, including general results of the technical / safety evaluation. NRC notification shall be accomplished within two days of notification to the President.
- c. The President or Sr. Vice President shall submit a written report to the appropriate NRC office within five days of notification by the SRC.
6.0 CURRECTIVE ACTION The RQAM shall issue a nonconformance report (NCR) for any condition which is evaluated by this procedure and does not comply with the quality requirements of this manual. This requirement applies regardless of whether the condition is reported to the NRC and how far the condition proceeds through the evaluation process in this procedure. The NCR snall be issued, corrective l
action taken and the NCR closed out in accordance with QP-5.4.
7.0 10CFR21 LOG The CQAM shall maintain a 10CFR21 log which identifies each potentially reportable condition and its ultimate disposition.
8.0 QUALITY RECOROS The CQAM shall assemble a file of all material that contributes to an understanding of the course taken in the evaluation of the potentially reportable condition. This file shall include the following as O
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appropriate to the outcome of the evaluation:
- a. The initial memorandla report of potential defect or noncompliance
- b. Results of the preliminary evaluation with supporting documentation, including any client correspondence
- c. Results of the technical / safety evaluation with supporting documentation
- d. Records of notification provided to clients and the NRC
- e. Written report of defect or noncompliance submitted to the NRC The 10CFR21 file shall be retained as quality records in accordance with QP-4.1.
9.0 ATTACHMENTS A - Procedure Flowchart O
V O
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QUALITY ASSURANCE MANUAL 10CFR21 REPORTING PROCEDURE
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QUALITY ASSURANCE MANUAL o
V Reviewed - Cb*porate QA Manager
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7/15/85 Approved - Sr. Vice President / Date PR0CEDURE QP-1.5 PERSONNEL QUALIFICATION 1.0 PUR POSE This procedure establishes requirements for verifying the qualifications of Impell personnel who participate in nuclear safety-related work.
Recuirements in this procedure address the following anc are sunnarized in Attachment A:
- a. Procedure applicability
- b. Implementation responsibilities
- c. Protection of employee information
- d. New employee qualification
- e. Qualification of existing employees
- f. Compliance with ANSI /ASME N626.3 O' g. Resolution of qualification discrepancies 2.0 APPLICABILITY The requirements in this procedure apply to all personnel who originate, verify, review, or approve technical work governed by this manual.
Non-technical or other project support personnel qualifications shall be verified when determined necessary by the Section Manager (SM).
3.0 RESPONSIBILITIES The Regional Manager may designate alternate personnel to perform the verification activities defined in this procedure.
Personnel assigned verification responsibilies shall maintain the necessary forms to properly document activities required by this procedure.
4.0 PROTECTION OF Employee information is protected as follows:
EMPLOYEE TFORMATION 4. All qualifying information will be obtained with
- the employee's prior knowledge and permission O
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- b. Only information pertinent to the employee's technical qualifications will be retained
- c. Information obtained will be used only for the purpose of documenting personnel qualification
- d. Employees may inspect their file at any time 5.0 NEW EMPLOYEE QUALIFICATION 5.1 Verification of The new employee shall complete a degree Education verification fom which Human Resources (HR) shall send to tne institution awarding the employee's highest oegree pertinent to the employee's qualification. Where the highest degree is not a primary qualifying f actor, verification of other degrees shall be obtained.
Where a degree nas not been earned, a certified transcript shall be obtained.
HR shall confim that the returned oegree verification and/or certified transcript agree with tne employee's application or resume, and document the results on a personnel qualification form.
5.2 Verification of The new employee shall complete a work experience Experience verification form which HR shall send to past employer (s) requesting that they confim the most recent 3 years emplopent. HR shall confirm that returned verification forms agree with the employee's application or res m e and document the results on the personnel qualification form. As an alternative, HR may confirm emplopent by telephone to past employers and docurnent same on the personnel qualification fom.
5.3 Verification of New employees who are registered professional Professional engineers shall forward a copy of their registration Registration certificate with current validation to m for retention in their qualification file. HR shall document this registration on the personnel qualification fom.
5.4 Verification Schedule Verification of the employee's education, and experience shall be completed within 3 months of the 0
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r~x V .
- t date of hire. If both cannot be accomplished, HR shall notify tne responsible Division Manager (DM) ,
who shall either: /
- a. Reassign the employee to nonsafety-related J activities until the outstanding education or -
t experience verification is completed, or
- b. Complete an alternate method of qualification approved by the Regional Quality Assurance Manager.
HR shall document any such actions on the personnel qualification form.
b.0 QUALIFICATION OF The qualifications of current employees shall be '
CURRENT EMPLOYEES verified by HR prior to the employees' assignment to nuclear safety-related work. Qualification requirements are as follows and shall be verified as described in Section 5.0:
O
- a. Personnel who are registered professional
. engineers - copy of registration certificate
- b. Personnel with 3 or more years Impell experience
- education verification
- c. Personnel with less than 3 years Impell experience - education verification and l
emplopent verification l
7.0 COMPLIANCE WITH ANS!/ASME N626.3 establishes qualification standards ANSI / ASME No26.3 for professional engineers who certify designs or analyses to the ASME Code. These standards require that in addition to being a registered professional engineer, the individual must:
- a. Have four years of experience, with at least two of these in the specialized (certifying) field
- b. Maintain current knowledge of the Code through personal study, coursework, seminars, ASME comittee meetings, or company sponsored training sessions
- c. Have the qualification reviewed every three years by the responsible DM to assure
, qualifications have been maintained l
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5 Impell employees who certify designs or analyses shall complete a professional engineer qualification form provided by HR. The responsible DM shall sign this fom which certifies that the engineer has complied witn the certifying requirements. HR shall maintain a copy of the qualification form in the employee's qualification file.
The DM shall evaluate the engineer's qualifications every three years and recertify the engineer if the qualifications are acceptable and certification is still required. HR is responsible for this recertification process.
8.0 RESOLUTION OF HR and the responsible DM shall resolve any QUALIFICATION discrepancies between actual qualiflCations and those
, U15LMEPANLIE5 presented by the employee.
9.0 QUAL.IFICATION The following personnel qualification records shall RECORDS be maintained by HR for all current employees and retained for 2 years following termination: h
- a. Degree verification form
- o. Personnel qualification form
, c. Experience verification form
- d. Professional engineer registration
- e. Professional engineer qualification form 10.0 ATTACHHENTS A - Procedure Summary O
/
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PERSONNEL QUALIFICATION PROCEDURE
SUMMARY
REQUIREMENTS RESPONSIBILITY L.mplete degree verification form Employee Confinn oegrees obtained within 3 months HR
. Complete experience verification form Employee Confirm experience within 3 months HR Provide copy of professional engineer certificate Employee Canplete employee qualification form HR Complete professional engineer qualification form Employee Professional er.gineer certificaton DM i Resolve discrepancies HR & DM Maintain verification records HR l
O QP-1.5 Revision 0 t Impell Corporation Attachment A
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2.0 .P_ROJECT CONTROL C0hTENTS QP-2.1 PROJECT INTERFACE CONTROL 1.0 INTERFACE INSTRUCTIONS 2.0 INFORMATION RECEIVED FROM OUTSIDE ORGANIZATIONS 3.0 INFORMATION TRANSMITTED TO OUTSIDE ORGANIZATIONS [
4.0 INFORMATION TRANSFERRED BETWEEN IMPELL ORGANIZATIONS 5.0 INFORMAL C0muNICATIONS 6.0 RETURN OF INFORMATION 7.0 TRANSFER OF PROJECT WORK
=
QP-2.2 CORRESPONDENCE & DOCUMENT CONTROL 1.0 INCOMING CORRESPONDENCE 2.0 OUTGOING CORRESPONDENCE 3.0 DOCUMENT DISTRIBUTION 4.0 QUALITY ORGANIZATION CORRESPONDENCE 5.0 CORRESPONDENCE FILES QP-2.3 PROJECT ORGANIZATION AND DOCUMENTATION 1
1.0 PROJECT ORGANIZATION & CONTROL 2.0 MULTIREGION PROJECT CONTROLS l
3.0 PROJECT DOCUMENTATION & RECORDS QP-2.4 PROJECT TRAINING 1.0 PROJECT ENGINEER TRAINING 2.0 PROJECT INITIATION TRAINING 3.0 PROJECT UPDATE TRAINING QP-2.5 PROJECT,00ALITY PLAN 1.0 APPLICABILITY 2.0 PLAN PREPARATION & CONTENTS 3.0 REVIEW AND APPROVAL 4.0 DISTRIBUTION & USE b.0 REVISIONS S
Impell Corporation
QUALITY ASSURANCE MANUAL O $Nn -
Reviened7 Cdr rate QA Manager
/ . 7/15/85 Apprsved - Sr. Vite President / Date PLAN 2.0 ORGANIZATION AND RESPONS181LITIES 1.0 IMPELL ORGANIZATION The Impell organizational structure for implementing the quality requirements in this manual is shown in Attachment A. This chart defines reporting relationships for quality functions and the working interfaces netween Quality Assurance Managers and the operating divisions. Each Quality Assurance Manager shall be independent of operational cost, scheduling or production responsibilities which maf conflict with their quality responsibilities as
( defined in this manual. The Corporate Quality l f) Assurance Manager shall maintain a current v organization chart identifying each Quality l Assurance Manager and tneir specific reporting relationship to Impell management.
1.1 Corporate Organization The President is responsible for overall effectiveness of tne Impell Quality Program and for establishing company quality objectives. Vice Presidents direct implementation and administration of the Impell Quality Program in their respective organizations. The Corporate Quality Assurance Manager reports to the Sr. Vice President and General Manager - Engineering Services. The Corporate Quality Assurance Manager maintains the quality assurance manual, evaluates its I
effectiveness and periodically reports to the Sr.
Vice President on the status of the quality program. Access to this level of company management enables the Corporate Quality Assurance Mahager to obtain appropriate management action to resolve quality concerns.
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financial, contractual, and other operations of the ,
region. To ensure effective quality program l implementation within the region, the Regional !
Manager shall designate a Regional Quality Assurance !
Manager having the responsibilities listed in Section 3.0 below. The Regional Quality Assurance Manager shall be independent from any operational l cost, schedule, or production responsibilities which may conflict with the responsibilities defined in this manual. The Regional Quality Assurance Manager shall report to the Regional Manager for quality assurance functions.
2.0 PROJECT ORGANIZATION Impell performs contracted work on a project basis within the operating divisions.of each regional office. Each division is organized into sections which are assigned specific technical responsibilities. The structure of each project depends on project scope, applicable quality requirements and type of work to be performed.
2.1 Project Administration A Project Engineer is assigned for each project and is responsible to operating division management for the quality performance of the project. The Project Engineer directs and controls the project work, including implementation of appropriate quality requirements in this manual.
On certain projects a Project Manager may administer specific client interface and coordination functions. In these situations, the Project Engineer reports to the Project Manager for the l defined administrative functions.
2.2 Quality Compliance Project personnel are responsible for complying with all project technical and quality requirements defined in tne contract and this manual. The Project Engineer is responsible for assuring compliance to all requirements. The Project Manager
! is responsible for complying with any assigned project quality requirements.
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3.0 QUALITY Responsibilities for implementing the quality RESPONSIBILITIES. requirements in this manual are sununarized below:
3.1 Presioent a. Establish company quality objectives
- b. Provide direction to company management on accomplishing quality objectives 3.2 Sr. Vice President a. Create administrative and technical mechanisms to accomplish quality objectives established by the President
- b. Provide management direction to the Corporate Quality Assurance Manager
- c. Notify NRC of 10CFR21 reportable items
- d. Conduct management quality review meetings to assess quality trends and significant developments in the quality program
- e. Approve Impell Quality Assurance Manual 3.3 Corporate Quality a. Maintain Quality Assurance Manual consistent Assurance Manager with applicable regulatory requirements. Review O manual revisions and control non-regional manual distribution
- b. Report regularly to the Sr. Vice President on effectiveness of the quality program
- c. Perform periodic quality assurance audits of regional offices, and of specific functions or '
activities within regional or corporate offices
- d. Perform quality reviews of documents when applicable
- e. Interface with client quality representatives, or representatives of regulatory agencies, when appropri ate
- f. Participate in management quality review meetings to inform management of significant quality trends
- g. Provide general guidance to Regional Quality Assurance Managers 3.4 Regional Quality a. Monitor effectiveness of quality program Assurance Managers implementation within the regional office
- b. Perform periodic quality assurance audits of work within the regional office
- c. Perform quality orientation and training
- d. Report regularly to the Regional Manager and to the Corporate Quality Assurance Manager on the Plan 2.0 Revision 6 Impell Corporation Page 3 of 6
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O' status of quality program implementation within the region
- e. Interface with client and regulatory representatives when appropriate
- f. Perform quality review functions as prescribed by quality procedures
- g. Control regional office distribution of the Quality Assurance Manual, including clients
- h. Provide quality guidance to the Project Engineer Regional Quality Assurance Manager responsibilities defined in this manual may also be performed by other personnel reporting to the Regional Quality Assurance Manager.
In cases where the Regional Quality Assurance Manager determines tnat a situation adverse to quality is not correctible within the regional office, the Regional Quality Assurance Manager shall promptly notify the Corporate Quality Assurance Manager.
3.3 Regional Manage'rs Provide overall direction for quality related activities in the region.
3.o Division Managers a. Maintain visible management commitment to quality within the division
- b. Direct implementation of the quality program within their division 3.7 Section Managers a. Maintain technical adequacy of work within their sections
- b. Implement Quality Assurance Manual requirements within their sections
- c. Designate Project Engineers for work within their sections and assign appropriate project personnel
- d. Review the scope, methods, and results of technical quality reviews within their respective sections
- e. Provide technical and quality guidance to the Project Engineers within their sections
- f. Perform review and approval functions in accordance with quality procedures
- g. Provide corrective action response for audit findings and nonconformance reports g
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- f. Approve project instructions and other technical documents in accordance with quality procedures 3.8 Project Engineers a. Supervise engineering activities performed by project personnel
- b. Implement prescribed quality requirements on the project
- c. Provide project training to project personnel
- d. Establish and maintain project documentation and files
- e. Direct preparation of project instructions
- f. Approve documents as required by quality procedures
- g. Administer internal and external project interfaces as defined in project specific plans
- h. Receive and transmit project data to the client and other project participants
- i. Implement correspondence and document controls to provide for effective Impell/ client comunication J. Complete required corrective action for technical quality reviews and quality assurance audits 3.9 Project Personnel a. Perform tasks under supervision of the Project Engineer
- b. Understand and implement quality and project requirements applicable to their assigned task
- c. Identify and resolve quality problems at the task level and where resolution is not feasible.
report such cases to the Project Engineer
- d. Originate work that is error free utilizing proper technical input l e. Independently verify work according to written
! criteria
- f. Document the project work 4.0 RItiHT OF ACCESS & To provide for the effective administration STOP WORK AUTHORITY of the quality program, the Corporate and Regional Quality Assurance Managers have the following authority:
- a. Access to audit or review project documents and related materials and to contact persons whose activities affect quality Plan 2.0 Revision 6 Impell_ Corporation _ _ _ _ _ . ___ _ __ _ _
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- b. Stop work in those cases where the need for l corrective action is insnediate and the degree of deficiency is such that only stopping work will preclude the possibility of producing work which is not in accordance with the quality requirements of this manual This authority is not limited by regional or any other organizational lines.
5.0 ATTACHMENTS A - Impell Quality Assurance Organization O
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O rneett ountrry assoRaucs ORGANIZATION PRESIDENT SENIOR VICE-PRESIDENT REG ^' QUAL pANA R ANCE MANAGER I
I O DIVISION REGIONAL QA _ _ _ _ QA_ _ _ _ _j MANAGER MANAGER COORDINATION I
i 1
8 SECTION MANAGER '
I I
I I
PROJECT _______j l E p 1
THIS CHART SHOWS THE IMPELL CORPORATION QUALITY ASSURANCE ORGANIZATION ANO THE INDEPENDENCE OF THE CORPORATE AND REGIONAL QA FUNCTIONS. A TYPICAL REGIONAL ORGANIZATION IS INCLUDE 0.
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1.0 QUALITY PROGRAM O
CONTENTS QP-1.1 CONTROL OF QUALITY ASSURANCE MNUAL l
1.0 MANUAL PREPARATION 2.0 REVIEW AND APPROVAL 3.0 ISSUE AND CONTROL 4.0 REVISION CONTROL 5.0 USE OF FORMS QP-1.2 QUALITY ORIENTATION 1.0 APPLICABLE PERSONNEL 2.0 SCHEDULE i
3.0 NOTIFICATION OF NEW EWLOYEES 4.0 QUALITY ORIENTATION 5.0 SITE PERSONNEL 6.0 UPDATE AND REFRESHER BRIEFINGS QP-1.3 MANAGEMENT REVIEW OF QUALITY PROGRAM 1.0 CORPORATE AUDITS 2.0 MANAGEMENT EVALUATIONS 3.0 EXECUTIVE MANAGEMENT REVIEW AND ACTION h QP-r.4 10CFR21 REPORTING 1.0 PREREQUISITES 2.0 E WLOYEE IDENTIFICATION OF REPORTABLE CONDITION 3.0 PRELIMINARY EVALUATION l 4.0 IMPELL TECHNICAL SAFETY EVALUATION 5.0 NRC AND CLIENT NOTIFICATION b.0 CORRECTIVE ACTION 7.0 10CFR21 LOG QP-1.5 PERSONNEL QUALIFICATION l 1.0 PURPOSE 2.0 APPLICABILITY 3.0 RESPONSIBILITIES 4.0 PROTECTION OF EMPLOYEE INFORMATION 5.0 NEW EWLOYEE QUALIFICATION 6.0 QUALIFICATION OF CURRENT EMPLOYEES 7.0 COW LIANCE WITH ANSI /ASM N626.3 8.0 RESOLUTION OF QUALIFICATION DISCREPANCIES O
Impe11 Corporation
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QUALITY ASSURANCE MANUAL l l
N Reviewbd - Corfpotate QA Manager
[ 7/15/85 ,
Approptd - Sr. Vice/ President / Date l
1 PR0CEOURE QP-2.1 PROJECT INTERFACE CONTROL This procedure establishes requirements for controlling internal and external project
, interfaces. Requirements in this procedure address tne following and are suninarized in Attachment A:
i
- a. Interface instructions (Project Quality Plan)
- b. Information transferred between Impell and other organizations
- c. Information transferred between Impell organizations
- d. Document distribution V(3 e. Informal consnunications
- f. Return of information
- g. Transfer of project work 1.0 INTERFACE Prior to initiating project work, the Project INSTRUCTIONS Engineer (PE) shall prepare a Project Quality Plan which contains requirements for transmitting project infomation within and external to Impell.
Procedure QP-2.5 defines requirements for the Project Quality Plan.
2.0 INFORMATION RECEIVED Project infonnation formally transmitted from FROM OUT5IDE external organizations shall be received by the (RiiARITATTDRS Impell contact designated in the Project Quality l
Plan. Correspondence transmittals and project technical input documents shall be processed in accordance with QP-2.2.
3.0 INFORMATION Formal correspondence to external organizations ,
TRANSMITTED T0 snall be transmitted by the Impell contact !
OUT5IDE designated in the Project Quality Plan. These ORGANIZATIONS transmittals shall be made in accordance with QP-2.2.
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4.0 INFORMATION TRANSFERRED BETWEEN IMPELL ORGANIZATIONS 4.1 Project Instructions Project instructions (QP-3.9) define technical work methods and responsibilities. For projects involving more than a single Impell office, the PQP l
defines the technical information which must be transferred between the offices to properly perform the technical work defined in the project instructions.
4.2 Transmittal Methods Transmittals between Impell offices shall be made by memorandum or other written transmittal form which identifies the following:
- a. Documents transmitted and identification numbers where available
, b. Document revision, or date if no revision l
identifier
- c. Transmittal date
- d. Document status (final unless indicated otherwise). Prior to transmittal, all final Impell generated documents shall be independently verified and approved by the transmitting organization according to the procedures in section 3.0 of this manual All transmittals shall be approved in writing by the transmitting PE and shall be transmitted to the PE
- in the receiving office. Standard transmittal forms are available from the Regional Quality Assurance
. Manager (RQAM).
4.3 Receipt and Use of The receiving Impell office shall log all Information transmittals of technical documents as technical input in accordance with QP-3.1. Only tecnnical information that has been formally transmitted as defined above may be used for final work by the receiving office.
5.0 INFORMAL COMMUNICATIONS Meeting minutes, telecopies, o'r other informal transmittals of technical information from external organizations shall be distributed as defined in the project distribution chart (refer to QP-2.2).
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l Telephone and other informal verbal transmittals of
! technical information from external organizations
( shall be documented on " Record of Conversaticn" i
forms and distributed as defined in the project distribution chart.
All infomal technical information received from external organizations and used for final work shall be confirmed by the PE by letter to the transmitting organization prior to the end of the project. All technical infonnation transmitted informally to l external organizations shall be confirmed by letter to that organization prior to the end of the i project. Refer to QP-2.2 for correspondence I requirements.
6.0 RETLRN OF INFORMATION When specifically requested, information received I from external organizations shall be returned to that organization by the Impell contact designated .
in the Project Quality Plan.
O 7.0 TRANSFER OF The following is required when transferring ongoing PROJECT WORK project work between Impell regional offices:
(Ongoing Projects)
- a. The PE shall prepare all technical files, correspondence files and other project files, l logs, instructions, and materials for i transmittal. Prior to transmittal, these shall be reviewed to assure they are current, complete i and are adequately identified. An index of all l materials shall be prepared and transmitted with l the files for verification by the receiving organization.
- b. The PE shall document the status of all project work and the work to be completed by the receiving region. This docunentation snall list outstanding technical or quality problems or i concerns and reconnended actions for correcting I
same. It shall also list any outstanding client requests and reconinendations for answering these requests.
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- c. The PE shall review all completed documents to determine which should be transferred. A copy of the Records Center index for the project records shall be transmitted to the receiving region,
- d. The PE shall transfer all materials identified above to the PE in tne receiving region in accordance with Section 4.0 of this procedure.
- e. The RQAM shall issue a memorandum to the RQAM of the receiving region which identifies all outstanding nonconformance reports, internal and external audit findings, or other quality concerns. This memorandum shall also list any special or project specific quality requirements which will be applicable to the receiving region. A copy of the Project Quality Plan shall also be transmitted.
The PE in the receiving region shall verify that all materials are received, distribute these to appropriate project personnel and complete the project work according to the requirements in this manual . The RQAM in the receiving region shall verify that all outstanding quality concerns are resolved prior to project completion.
8.0 QUALITY RECORDS Infonnal communications, confirming letters, and
[ transmittal memorandums and forms shall be retained t
as quality records in accordance with QP-4.1.
9.0 ATTACHMENTS A - Procedure Sunnary l
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QUALITY ASSURANCE MANUAL PROJECT INTERFACE CONTROL PROCEDURE
SUMMARY
REQUIREMENTS RESPONSIBILITY Project Quality Plan Per QP-2.5 l
Info. received from external organizations Receipt Impell contact j Process Per QP-2.2 Info. transmitted to external organizations Impell contact per QP-2.2 Info. transmitted between Impell offices Project instructions PE per QP-3.9 Transmittal approval PE C's Log transmittal as project input Receiving PE O Assure appropriate information used Receiving PE Maintain document distribution chart PE per QP 2.2 Infonnal consnunications Define receipt / distribution PE per QP 2.2 Document verbal info. on R.O.C. fanns Receiving person Confirm by letter PE Return information when requested Impell contact Transfer of project work Prepare files, logs, instructions, index etc. PE Document project status PE Review completed documents / prepare list PE Tr4nsfer to receiving office PE Quality memorandum RQAM O
QP-2.1 Revision 4 Impell Corporation Attachment A
QUALITY ASSURANCE MANUAL M
Reviewed - Cdrpo, rate QA Manager O
/ 7/15/85 Approved - Sr. Vice President / Date PR0CEDURE QP-2.2 CORRESPONDENCE & DOCUMENT CONTROL This procedure establishes requirements for receipt, distribution, transmittal and control of project correspondence and technical documents.
Requirements in this procedure address the following and are sumarized in Attachment A:
- a. Incoming correspondence
- b. Outgoing correspondence
- c. Document distribution
- d. Quality related correspondence g e.
f.
Technical document control Correspondence files W
1.0 INCOMING CORRESPONDENCE Incoming correspondence shall be routed to the Impell contact designated in the Project Quality Plan (QP-2.5). The date received, job number and file should be indicated on all correspondence.
Correspondence includes letters, memorandums, and other fomal transmittals to Impell. Refer to the i procedures in Section 3.0 of this manual for control of technical documents received by Impell.
Incoming letters shall be listed in an incoming correspondence log. The log shall indicate letter number, date, subject and transmitting organization. Standard forms are available from the Regional Quality Assurance Manager (RQAM).
The Impell contact shall distribute correspondence in accordance with the project distribution chart (Section 3.0 of this procedure).
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2.0 OUTG0ING CORRESPONDENCE Correspondence transmitting technical information to outside organizations shall be transmitted by the Impell contact as defined in the Project Quality Plan. This correspondence shall be transmitted by either formal letter or transmittal form.
2.1 Fomal Letters Outgoing letters shall be identified by an Impell letter number and shall be traceable to the appropriate project. In addition, each letter (or the accompanying materials) shall include the following information:
- a. Documents transmitted and their identification numbers
- b. Document revision, or date if no revision identifier
- c. Transmittal date
- d. Document status (e.g., preliminary-for-coment, for-information, final-for-construction, etc.)
- e. Any restrictions on use of the transmitted materials Outgoing letters shall be signed by the Project Engineer, distributed as required by Section 3.0 of this procedure and listed in an outgoing correspondence log. Tnis log shall indicate letter number, date, subject and addressee. Standard forms "are available from the RQAM.
2.2 Transmittal Forms Transmittal foms may be used to transmit technical materials to outside organizations. Transmittal forms shall contain the same types of information as required for fomal letters above, shall be signed by the PE and shall be distributec as required in Section 3.0 of this procedure. Standard transmittal forms are available from the RQAM.
2.3 Status of Transmittal Infomation Only final results which have been independently verified and approved according to the requirements of this manual should be transmitted to outside organizations. If preliminary results are transmitted, they shall be appropriately identified and shall be approved for transmittal by the PE.
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QUALITY ASSURANCE MANUAL 9
3.0 DOCUMENT DISTRIBUTION The PE shall maintain a document distribution chart which identifies distribution requirements for each type of project document. Standard forms are available from the RQAM.
4.0 QUALITY ORGANIZATION Quality related correspondence (e.g. client audit CORRESPONDENCE reports or questions related to the Impell Quality Program) shall be the responsibility of the RQAM.
5.0 CORRESPONDENCE FILES The PE shall ensure that correspondence files are maintained for all incoming and outgoing information.
These files shall include letters, memorandums, telecopies, telexes, records of conversation, transmittal forms and other correspondence considered necessary by the PE to provide a complete history of the project.
6.0 QUALITY RECORDS Correspondence files, incoming and outgoing correspondence logs, and the project distribution chart shall be retained as quality records in accordance with QP-4.1.
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7.0 ATTACHMENTS A - Procedure Summary l
O QP-2.2 Revision 3 Impell Corporation Page 3 of 3
QUALITY ASSURANCE MANUAL O CORRESPONDENCE & DOCUMENT CONTROL PROCEDURE
SUMMARY
REQ'JIREMENTS RESPONSIBILITY Inconing correspondence Receipt Impell contact Log PE establish Distribute Impell contact Outgoing correspondence Transmittal Impell contact Letter approval & log PE Transmittal form approval PE Distribution -
PE establish Maintain document distribution chart PE Quality related correspondence RQAM Tecnnical document control Section 3 of manual Correspondence files PE maintain i
O QP-2.2 Revision 3 Impell Corporation Attachment A
O QUALITY ASSURANCE MANUAL 2?u -
Reviewe'd Wofpdrate QA Manager e
m /
MN Q 7/15/85 Appro,vefd - Sr. Vice, President / Date PR0CEDURE QP- 2.3 '
PROJECT ORGANIZATION AND DOCUMENTATION This procedure establishes requirements for organizing, controlling and doctanenting project acti vi ti es . Requiraments in this procedure address the following and are starnarized in Attactinent A:
Project startup, control and closecut
~
a.
- b. Multi-region project control
- c. Project doctsnentation and records 1.0 PROJECT ORGANIZATION
& CONTROL 1.1 Project Startup Prior to initiating project work, the Project Engineer (PE) shall review key project docisnents such as the contract, purchase order, proposal, and client correspondence defining requirenents for the
[ proj ect. Based on this review, the PE shall prepare i the Pr-ject Quality Plan in accordance with QP-2.5.
l This plan will include a definition of the project organization, division of project responsibilities, and any special quality requirements for the project.
The PE snall conduct a project initiation meeting with project personnel to discuss project organization and responsibilities, technical and quality requirenents, work methods, and project information interf aces. The Regional Quality Assurance Manager (RQAM) and Project Manager shall be notified of the project initiation meeting (attendance is discretionary). This meeting may also serve as project initiation training provided all requirements of QP-2.4 are met, o
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( l.2 Project Control Sections 3.0 and 6.0 of this manual define l requirments for performing technical work and using computer programs on a project. Section 7.0 of this manual defines quality requirments for nuclear safety-related procurment activities.
Administrative control requirments are defined in Section 2.0 of this manual. Project personnel shall j be aware of these and any other project specific i
requirments and shall perform project activities in accordance with same. The PE is responsible for i assuring that project work is performed properly by
( all project personnel.
l 1. 3 Project Closecut At project completion the PE shall review the technical output to assure it has been properly documented and signed by the originator, checker and approver. The PE shall also assure all deliverables have been transmitted to the client and that all
! project docunents are complete and appropriate documents have been submitted to the Records Center.
, 2.0 MULTI-REGION PROJECT In addition to the organization and control CONTROL requirments defined in Section 1.0 of this procedure the following shall apply to projects with l activities perfomed in more than one Impell regional office: -
- a. The region having client and contract responsibilities for the project is the lead region (defined in the Project Quality Plan).
- c. Project quality assurance activities shall be directed by the RQAM in the lead region (defined in the Project Quality Plan),
- d. The Project Quality Plan shall define the entire l
project organization and the technical information and responsibilities for transferring this information between regional offices. All technical information shall be 5 transferred between the appropriate PE of each r1gion.
- e. Toe lead PE shall distribute the Project Quality Plan, project instructions, and other relevant QP-2. 3 Revision 3 Impell Corporation Page 2 of 5
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documents such as purchase orders, proposals or l other docisnents defining project requirements to !
the appropriate PE in each regional office. 1
- f. Each regional office is responsible to perform i its designated scope of work in accordance with ;
the requirenents of this manual. Unl ess '
designated otherwise in the Project Quality Plan, each Impell office shall perfom the I verification, approval, technical quality review, and quality assurance audit of its own work.
- g. The lead PE should monitor projec': activities in other regional offices to assure the work is being done according to project requirements and that the proper technical infomation is being transferred between regional offices,
- h. At project ccmpletion all project records shall be transmitted to the lead office for retention and transmittal to the client unless specified otherwise in the Project Quality Plan.
When specifically defined in the Project Quality Plan, these requirenents also apply to projects where activities are perfomed at more than one office location within the region.
3.0 PROJECT DOCUMENTATION Project doctanents required by this manual shall be
& REwMD5 maintained in correspondence, quality assurance and technical files. Correspondence file requirements are defined in QP-2.2. Quality assurance and technical file requirements are defined in this procedure.
l 3.1 Project Quality A Project QA File shall be used by the PE to l Assurance File maintain project doctsnents. Whenever possible, this Project QA File (PQAF) should be used for all project doctments (correspondence, quality assurance and technical). For larger projects separate i correspondence and/or technical files may need to be
! established. The PQAF contains guidelines to help
( the PE organize the various project documents. It also contains standard foms which should be used to easily document many key project activities. At a O
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minime, the following shall be doceented and maintained in the PQAF:
- a. Pro;iect Quality Plan - A copy of the Project Quality Plan as required by QP-2.5, including all revisions
- b. Pro; ect Organization / Training - A listing of pro; ect personnel (roster) which doceents name,
, signature, initials, title, and project start date for engineering and technical support personnel assigned to the project. Project training doceentation shall be included
- c. Pro;iect Instructions - A log and all project Instructions and revisions
- d. Docuent Control - Project docuent distribution lists and correspondence log including actual correspondence if not maintained in separate files
- e. Project Logs - Project Input, Computer Program Use, Drawing, Procurement and any other project logs O f. Project Reviews - Technical quality review reports
- g. Project Output - A log of project deliverables and where possible the project technical output (results)
- h. References - A list of key reference materials maintained elsewhere in the project documentation The PE shall review the PQAF at project completion to assure all required documentation is complete and on file. The P@F shall be transmitted to the Records Center at project completion.
3.2 Technical Files Technical files include files of specifications, dravings, reports, calculations, analyses, other tecnnical input doceents and related computer input and output. The PE shall establish a simple, efficient systen for maintaining project technical documents. This systen should be easy to use (both filing and access), minimize the neber of docuents retained and avoid duplicate filing. Control requirenents for these doceents are defined in Section 3.0 of the manual.
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3.3 File Maintenance The PE is responsible for maintaining correspondence files, the PQAF and technical files.
- 4. 0 QUALITY RECORDS Correspondence and Project QA Files shall be retained as quality records in accordance with QP-4.1. Technical files shall be retained as defined in the procedures in Section 3.0 of this manual .
5.0 ATTACHMENTS A - Procedure Sunnary 9
Ol l
QP-2.3 Revision 3 JiGFDI1 Cr/FB2fR@@
QUALITY ASSURANCE MANUAL p
U PROJECT ORGANIZATION & DOCUMENTATION PROCEDURE
SUMMARY
REQUIREMENTS RESPONSIBILITY Project startup Review key documents & prepare Project Quality Plan PE per QP-2.5 Project initiation meeting PE Perform project work per project requirements Project personnel Project closeout Review technical work PE Assure all oeliverables transmitted to client PE Disposition of project records PE Multi-region project control s' Lead region Region with client responsibility Designate Lead PE and QA Mgr. Lead region Designate PE's Each region Distrioute project information to pes Lead PE Perform work, verify, review, approve & audit Each region Monitor project activities Lead PE Transmit records to lead region Each region Records retention / transmittal to client Lead region Project documentation & records Correspondence files PE per QP-2.2 Project QA File PE Technical files PE per Section 3.0 of manual I
QP-2.3 Revision 3 Impell Corporation GR9A C M19 A
l QUALITY ASSURANCE MANUAL l
E Review (d - Cotperate QA Manager o
d2 / 7/15/85 Approyed - Sr. Vice President / Date PR0CEDURE QP- 2.4 PROJECT TRAINING l
l This procedure establishes requirenents for training project personnel prior to initiation of project acti vi ties. Requirenents in this procedure address
, the following and are simnarized in Attachment A:
- a. Project Engineer training
- b. Project initiation training
- c. Project update training 1.0 PROJECT ENGINEER Engineers shall receive Project Engineer training TRAINING prior to their first assigrynent as a Project Engineer (PE). This training is to reinforce the PE's understanding of the Impell Quality Progran, and f aniliarize the PE with quality requirements which are the specific responsibility of the PE. PE training should be scheduled and conducted by operating division management with assistance from
- the Regional Quality Assurance Manager (RQAM),
l administration and others as required. PE training responsibilities may be assigned to the RQAM by the Regional Manager, but operating division managenent shall assist with the instruction. As a minimun, training subjects shall include:
- a. PE's responsibility for quality work
- b. Compliance with client and project quality requirements
, c. Project Quality Plan requirenants
- d. Project organization
- e. Personnel selection, assignment and training
- f. Work methods and project instructions
- g. Internal and external interface control
- h. Maintenance of project files
- 1. Camputer sof tware quality requirenents O
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- j. Doceentation and records
- k. Independent verification and technical quality review
- 1. Identification, control and resolution of technical problems A list of PE training participants, agenda and instruction personnel shall be forwarded to the RQAM for retention by the responsible division.
2.0 PROJECT INITIATION The PE shall conduct project initiation training for '
TRAINING engineering personnel and others as considered appropriate by the PE prior to their comencing project work. The RQAM and Project Manager shall be notified of the scheduled training. Attendance by the RQAM and Project Manager is discretionary.
Project initiation training shall stress:
- a. Technical work methods (project instructions) and results expected
- b. Compliance with all project requirments
- c. Applicable requirements from the Quality hS Assurance Manual and specific implenentation methods
- d. Project Quality Plan requirenents
- e. Project input required
- f. Internal and external interf aces 9 Use of computer programs
- h. Independent verification
- 1. Transmittals to clients J. Doceentation and records The PE shall doceent project training participants and agenda in the project records. Standard fonns are available from the RQAM.
3.0 PROJECT UPDATE As considered necessary by the PE, update training TRAINING shall be given to alert project personnel to major changes in project requirenents or work methods and to identify technical errors or quality problems.
The PE shall doceent update training in the project records.
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O i 4.0 QUALITY RECORDS PE training, project initiation training and update training doctmentation shall be retained as quality records in accordance with QP-4.1.
5.0 ATTACHMENTS A - Procedure Sumary l
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PROJECT TRAINING PROCEDURE
SUMMARY
l REQUIRER 4ENTS RESPONSIBILITY PE training i
Prior to first assignment Operations management I Documentation & transmittal to Operations management RQAM Documentation retention RQAM l Project initiation training
- Prior to commencing project work PE O(j' Documentation and record retention PE Update training Determined by PE I
l O
QP-2.4 Revision 0 Impell Corporation -
Attachment A
l QUALITY ASSURANCE MANUAL ENGINEERINGCONTROL(Cont'd) 9 QP-3.6 INDEPENDENT VERIFICATION 1.0 APPLICABILITY 2.0 PERSONNEL REQUIREMENTS 3.0 VERIFICATION METHODS 4.0 CHECKING 5.0 ALTERNATE CALCULATIONS 6.0 TESTING OR OTHER METHOD 7.0 RESOLUTION OF ComENTS 8.0 APPROVAL QP-3.7 TECHNICAL QUALITY REVIEWS 1.0 APPLICABILITY 2.0 REVIEW SCHEDULE 3.0 QUALITY REVIEW TEAM 4.0 REVIEW CRITERIA 5.0 QUALITY REVIEW 6.0 CORRECTIVE ACTION 7.0 REVIEW AND APPROVAL QP-3.8 DESIGN SPECIFICATIONS 1.0 APPLICABILITY 2.0 SPECIFICATION PREPARATION 3.0 INDEPENDENT VERIFICATION 4.0 APPROVAL 5.0 SPECIFICATION CONTROL LOG 6.0 SPECIFICATION DISTRIBUTION 7.0 REVISIONS QP-3.9 PROJECT INSTRUCTIONS 1.0 REQUIREMENTS FOR PROJECT INSTRUCTIONS 2.0 PREPARATION 3.0 DISTRIBUTION 4.0 USE OF PROJECT INSTRUCTIONS 5.0 REVISIONS QP-3.10 TECHNICAL REPORTS 1.0 PURPOSE 2.0 TECHNICAL REPORT DEFINITION 3.0 REPORT PREPARATION 4.0 REVIEW AND APPROVAL 5.0 REPORT ISSUE 6.0 REPORT LOG 7.0 REVISIONS Impe11 Corporation
QUALITY ASSURANCE MANUAL 0 $&
Rece(veD Cdrqbrate QA Manager
. / 7/15/85 Apprpved -5r. Vice President / Date PR0CEDURE QP-2.5 PROJECT QUALITY PLANS This procedure establishes measures for preparation and use of Project Quality Plans which define quality requirements for each project. Requirements in this procedure address the following and are suninarized in Attachment A:
- a. Plan preparadan and contents
- b. Plan review and approval
- c. Plan distribution and use
- d. Revisions to the plan 1.0 APPLICABILITY A Project Quality Plan (PQP) is required for all nuclear safety-related work performed by Impell. A l PQP is also required for other projects where !
considered necessar Assurance Manager (y by the Regional Quality RQAM).
1 2.0 PLAN PREPARATION & Prior to initiating project work the Project CONTENTS Engineer (PE) shall prepare a PQP for the project.
This PQP shall define quality requirements for the project and shall include the following types of infonnation:
- a. Definition of client, project / task and Impell job number (s)
- b. Project work scope
- e. Requirements and responsibilities for independent verification, technical quality review and QA audit / surveillance
- f. Computer software requirements QP-2.5 Revision 0 Impell Corporation Page 1 of 3
QUALITY ASSURANCE MANUAL O
- g. Documents to be developed during the project (i.e. calculations, technical reports, etc)
- h. Project work methods or requirements for separate project instructions
- 1. Quality records requirements (refer to QP-4.1)
- j. Project specific review and approval requirements
- k. Project specific requirements for technical input control, correspondence and doctanent control, design control and procurement control
- 1. Requirements for transmittal of project information (documents) between the various project organizations. These requirements shall define the following in sufficient detail to prevent technical errors resulting from inadequate or improper communications between project organizations:
- 1) Information to be provided to Impell by external organizations
- 2) Impell contact (s) for receipt of information provided by external organizations O 3) Information (deliverables) which Impell will provide to external organizations and the distribution for this information
- 4) Impell contacts for approval and transmittal of information to external organizations
- 5) Impell interoffice flow of technical information (responsible organization and docisnents)
Standard forms for the PQP are available from the
. RQAM. Where necessary, supplemental infomation may be attached to the PQP (e.g., more detailed interf ace instructions).
3.0 REVIEW & APPROVAL The PQP shall be reviewed and approved by the responsible Section Manager (SM) and RQAM. The Project Manager may approve in the absence of the SM.
4.0 DISTRIBUTION & USE The PE shall distribute copies of the approved PQP to lead project personnel in all Impell divisions and regions, and to external organizations as the PE detemines appropriate. Copies should also be provided to the client.
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Requirements in the PQP shall be included in project training given to project personnel (refer to QP-2.4). Project personnel shall comply with requirements of the PQP for their assigned scope of work.
5.0 REVISIONS The PQP shall be revised to reflect changes in quality requirements or to incorporate new scopes of work. Revisions may be made by either changing the original or issuing addendums. Revisions shall be prepared, reviewed, approved and distributed the sane as the original. Project personnel training on revisions shall be as determined necessary by the PE. The PE shall maintain a complete revision history of the PQP in the project files. Superceded revisions of the PQP shall be marked as such or destroyed.
6.0 QUALITY RECORDS All revisions of the Project Quality Plan (including g
attachments) shall be retained as quality records in accordance with QP-4.1.
7.0 ATTACHMENTS A - Procedure Summary l
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PROJECT QUALITY PLAN PROCEDURE SUPMARY REQUIREMENTS RESPONSIBILITY Determine need for Project Quality Plan (PQP) RQAM Prr3are PQP PE Approve PQP SM & RQAM Distribute approved PQP PE Include PQP requirements in project training PE Comply with quality requirements in the PQP Project personnel Revisions to the PQP Same as original Destroy or mark superseded revisions PQP recipients Maintain PQP with project records (complete PE revision history)
O QP-2.5 Revision 0 Impell Corporation Attachment A
4 QUALITY ASSURANCE MANUAL 3.0 ENGINEERIhG CONTROL O
CONTENTS QP-3.1 TECHNICAL INPUT CONTROL 1.0 DEFINITION OF TECHNICAL INPUT 2.0 SELECTION OF TECHNICAL INPUT 3.0 INPUT PROVIDED BY EXTERNAL ORGANIZATIONS 4.0 INTERNAL TRANSFER OF TECHNICAL INPUT 5.0 TECHNICAL INPUT DOCUMENT CONTROL 6.0 USE OF TECHNICAL INPUT QP-3.2 IMPELL DRAWING CONTROL 1.0 DRAWING PREPARATION 2.0 DRAWING IDENTIFICATION & TITLE BLOCK 3.0 USE DESIGNATION 4.0 DRAWING CHECK 5.0 APPROVAL 6.0 DRAWING STATUS LOG 7.0 DRAWING DISTRIBUTION / RETENTION 8.0 REVISIONS QP-3.3 FOREIGN DOCUMENT CONTROL 1.0 APPLICABILITY 2.0 DOCUMENT RECEIPT AND LOGS 3.0 DOCUMENT DISTRIBUTION 4.0 DOCUMENT MAINTENANCE QP-3.4 CALCULATIONS
~
1.0 PREPARATION 2.0 USE OF COPFUTER PROGRAMS 3.0 INDEPENDENT VERIFICATION 4.0 APPROVAL 5.0 CALCULATION LOG 6.0 REVISIONS 7.0 TRANSMITTAL OF RESULTS QP-3.5 DESIGN CONTROL 1.0 APPLICABILITY 2.0 PROJECT INSTRUCTIONS 3.0 DESIGN SPECIFICATION 4.0 DESIGN PROCESS CONTROL 5.0 DESIGN CHANGES 6.0 DESIGN DOCUMENT CONTROL 9
Impell Corporation
QUALITY ASSURANCE MANUAL I o
V MIM Reviewdd - Corfporfate QA Manager l
d / 7/15/85 Approyed - Sr. Vice President / Date P R 0 C~E D U R E QP-3.1 TECHNICAL INPUT CONTROL
)
1 This procedure establishes requirements for identifying, doctmenting, and using technical input for design, analysis and other engineering tasks.
Requirements in this procedure address the following and are slmenarized in Attachment A:
- a. Definition of technical input
- b. Selection of technical input
- c. Input provided by external organizations
- d. Internal transfer of technical input
- e. Technical input doctment control
- f. Use of technical input 9 Retention of technical input documents 1.0 DEFINITION OF TECHNICAL INPUT Technical input are those drawings, reports, specifications, and other technical documents that are required to perfonn Impell design, analysis, and other engineering activities. Technical input documents provide the general types of information listed in Attactnent 8 and shall be controlled to assure that only the appropriate documents, and the correct revisions of those documents, are used by project personnel.
2.0 SELECTION OF TECHNICAL INPUT The Project Eng'neer (PE) shall select the types of documents to be used as technical input and arrange for transmittal of same to Impell.
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3.0 INPUT PROVIDED BY EXTERNAL ORGANIZATIONS 3.1 Use of Transmittal The PE shall inform all external organizations that Letters Impell requires an itemized transmittal letter or transmittal form for each transmittal of technical input docisnents to Impell. The transmittal letter should name the documents submitted, including identification numbers and revision status, and should authorize Impell to use the data as input.
3.2 Document Receipt & External transmittals (letter and associated input l Distribution documents) shall be received by the Impell contact i defined in the Project Quality Plan (QP-2.5). These l transmittals shall be processed by the Impell t
contact (logged, distributed and filed) as defined in QP-2.2.
3.3 Confinnation of All technical input obtained informally by i Infonnal Impell and used for final work shall be confirmed as Transmittals required in QP-2.1 prior to completion of the j project.
3.4 Questions on Input Questions regarding the adequacy or accuracy of l Received transmittals received from outside organizations shall be resolved by the PE.
4.0 INTERNAL TRANSFER OF Technical input docuents (both supplied by external TECHNICAL INPUT organizations and developed internally) shall be transferred between divisions or regional offices as l
defined in QP-2.1.
5.0 TECHNICAL INPUT DOCUMENT CONTROL 5.1 Input Log The PE shall maintain a log which lists all docuents selected by the PE as technical input for the project. This applies to both technical input received from external organizations and input received from other divisions within Impell. A standard fann is available from the Regional Quality Assurance Manager. The input log shall describe the document, identify the document number and revision, 1
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QUALITY ASSURANCE MANUAL o
and should include the date received. Only the actual technical docurnent itself should be listed in the log. Transmittal forms and other similar correspondence need not be listed.
The PE may utilize an alternative to the above log system provided the alternative accomplishes an equivalent level of control and is defined in the Project Quality Plan.
5.2 Foreign Documents Supplemental requirements for controlling foreign (non-Impell) docurnents are defined in QP-3.3.
5.3 Superseded Documents Superseded technical input documents shall be marked as such or destroyed.
b.0 USE OF TECHNICAL INPUT 6.1 Input Identification Impell originated calculations, analyses, drawings, reports and other technical documents shall
(' reference the source documents used as technical input. At a minimum, this reference shall include the original document identification number and the revision used. Unless specified otherwise by memorandum from the PE, only the latest available revision of technical input documents shall be used. Acceptable methods for documenting the use of technical input are defined in other procedures in Section 3.0 of this manual.
6.2 Informal Input Calculations, analyses, drawings, reports and other !
technical documents using technical input received l infonnally shall be classified " preliminary" until l the technical input is confirmed as required in QP-2.1.
6.3 Extent of Input References to technical input shall be sufficiently Referenced detailed to enable a person performing an independent verification to make a complete ,
assessment of the selection and use of technical '
input.
7.0 QUALITY RECORDS The Technical input log (or alternative) and any A l V
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technical input documents that meet both of the following criteria shall be retained as quality records in accordance with QP-4.1:
- a. The input document cannot be traced to a controlled source (either Impell or external) ,
- b. The input document has not been physically i incorporated into the Impell originated document l 8.0 ATTACHMENTS A - Proceoure Sunnary B - Subjects Considered Technical Input O
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QUALITY ASSURANCE MANUAL 0 '
l TECHNICAL INPUT CONTROL PROCEDURE Sum ARY REQUIREMENTS RESPONSIBILITY Select types of input documents PE Input from external organizations Notify organizations of need PE for fonnal transmittals Receive input Impell contact per QP-2.5 Process input Impell contact per QP-2.2 Confirm informal connunications PE per QP-2.1 Resolve input questions PE Internal transfer of input Per QP-2.1 l
Document control
( Maintain input log PE Foreign document control Per QP-3.3 Destroy / mark superseded documents PE Use of tecnnical input Project personnel Retention of technical input documents PE decision O
QP-3.1 Revision 5 Impell Corporation Attachment A
QUALITY ASSURANCE MANUAL TECHNICAL INPUT CONTROL SUBJECTS CONSIDERED TECHNICAL INPUT
- 1. Basic functions of each structure, system, and component
- 2. Perfonnance requirements such as capacity, rating, system output l 3. Codes, standards, and regulatory requirements including the applicable issue and/or addenda
- 4. Design conditions such as pressure, temperature, fluid chemistry, and voltage
- 5. Loads such as seismic, wind, thermal, and dynamic
- o. Environmental conditions anticipated during storage, construction and operation
- 7. Interf ace requirements including definition of the functional and physical interf aces
- 8. Material, mechanical, structural, hydraulic, chemistry and electrical 9.
requirements g
Layout and arrangement requirements
- 10. Operational requirements under various conditions
- 11. Instrumentation and control requirements including indicating instruments, controls and alarms required for operation, testing, and maintenance
- 12. Access and administrative control requirements for plant security
- 13. Redunoancy, diversity, and separation requirements l 14. Failure effects requirements of structures, systems and components l
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- 15. Test requirements
- 16. Accessibility, maintenance, repair, and inservice inspection requirements
- 17. Personnel requirements and limitations
- 18. Transportability requirements
- 19. Fire protection or resistance requirements
- 20. Handling, storage, and shipping requirements
- 21. Other requirements to prevent undue risk to the health and safety of the public
- 22. Materials, processes, parts and equipment suitable for application
- 23. Safety requirements for preventing personnel injury G
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$$L Reviewed "Corpdrate QA Manager 6- / 7/15/85 Approved - Sr. Vice President / Date PR0CEDURE QP-3.2 l IMPELL ORAWING CONTROL 1
This procedure establishes requirements for controlling drawings prepa ed and issued by Impell.
Requirements in this procedure address the following and are summarized in Attachment A:
- a. Drawing preparation
- b. Drawing identification (title block)
- c. Use designation
- d. Drawing check
- e. Approval l f. Drawing status log l g. Distribution & retention
- h. Revisions The Project Engineer (PE) is responsible for assuring that Impell originated drawings are prepared and issued according to the requirements in this procedure.
L l
l.0 DRAWING PREPARATION 1.1 Ordwing Procedures Impell originated drawings shall be prepared according to written instructions which define the following:
l
- a. Drafting standards l b. Technical requirements appropriate to the intended design
- c. Client-prescribed drawing requirements (e.g.,
numbering system or use designations)
- d. Detailed implementation methods for the requirements contained in this procedure These instructions may reference other procedures, standards, etc., provided the appropriate revision of the referenced documents is listed and copies of the document are made available to project personnel, g QP-3.2 Revision 4 Impell Corporation Page 1 of 6
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V 1.2 Drawing Tecnnical Input Impell originated drawings shall identify key technical input documents (including revision) such as other drawings, specifications, criteria documents or design analyses / calculations. This identification may be limited to a few top level documents when the referenced documents include necessary supporting references.
Only the latest revision of these input documents (as listed in the technical input log, QP-3.1) may be used to prepare Impell drawings unless specifically approved otherwise in writing by the PE. A copy of any such approval shall be maintained with the technical input log.
Input documents for Impell originated drawings may be listed elsewhere in the project records when so specified in the Project Quality Plan.
1.3 Originator's Signoff When the drawing is completed, the originator (person responsible for the technical content of the drawing) shall sign the drawing in the title block.
C 2.0 DRAWING IDENTIFICATION Each drawing shall be uniquely identified in the AND TITLE BLOCK title block. This identification shall include the drawing number (unique sequential, system or other alpha / numeric identifier) and the drawing revision.
The title block shall also contain the following information:
- a. Impell job number
- b. Revision history and date for each revision
- c. Sheet number (may be incorporated into the drawing number) ,
- d. Purpose of each drawing revision (refer to the following section of this procedure) i
, The drawing title block shall be signed (or initialed) by the originator, checker and approver.
When the drawing and title block are redrawn only signatures for the latest revision are necessary provided a note is included on the drawing stating that signatures for all previous revisions are contained on the originals of those revisions.
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Page 2 of 6
QUALITY ASSURANCE MANUAL 9
Machine (computer) generated copies of drawings shall be signed by the same originator, checker and approver as on the original copy.
3.0 USE DESIGNATION The intended use of each drawing shall be specifically designated on the drawing and shall be sufficiently clear to preclude use of the drawing for purposes other than those intended. Acceptable designations include the following:
- a. Conceptual
- b. Preliminary (for comment, information, or approval)
- c. Final (for other design use, procurement, f abrication, construction, etc.)
1 Each designation is further described in the l following sections. '
1 Other use designations shall be defined in the g'
written instructions (Section 1.1 of this procedure).
3.1 Conceptual Drawings Conceptual drawings (or sketches) are issued to provide other organizations with the intended layout, location, or key features of the proposed design so that potential design interfaces or other ;
design considerations may be reviewed prior to :
initiating detailed design work. These drawings are )
a method of communicating design intent and are not considered design doctnents as such. They are not subject to the controls defined in this procedure 1 with the exception that they shall be traceable to the originator, shall include a title and date and I shall be clearly marked as conceptual drawings.
3.2 Preliminary Drawings Preliminary drawings are issued to obtain consnents or for client approval prior to final release. The following apply to preliminary drawings:
)
- a. Revision Identification - The revision status of preliminary drawings issued prior to the first l final drawing shall be identified in the title block (reconenend A, B, etc.). Preliminary copies of subsequent final drawing revisions e l QP-3.2 Revision 4 Impell Corporation Page 3 of 6
QUALITY ASSURANCE MANUAL O
shall be identified with the appropriate final drawing revision (refer to section 3.3 below).
- b. Preliminary -- For Comment - Preliminary orawings issued for connent may be issued at any point in the design process. They shall identify the originator, title, date, appropriate revision level and shall be marked as preliminary.
- c. Preliminary -- For Approval - Drawings requiring client approval shall comply with all requirements of this procedure and the written instructions (Section 1.1 of this procedure) prior to submittal for approval. They shall be fully documented as if they were final drawings, with originator, checker and approver signatures. The drawing shall be designated with the appropriate preliminary revision and date and shall be clearly marked as preliminary.
Drawing transmittals shall be controlled and comments resolved as defined in the Project D)
( Quality Plan (QP-2.5).
3.3 Final Drawings Final drawings shall comply with all requirements in this procedure and the written instructions (Section 1.1 of this procedure) prior to issue. Final drawings shall be designated with a unique identifier for each revision issued (reconinend 0,1, etc.).
4.0 DRAWING CHECK An independent check shall be performed on all drawings (including machine generated drawings) according to the requirements in QP-3.6. This check shall be based on written guidelines provided by the PE (may be in the written instructions). When all connents have been resolved, the checker shall sign in the appropriate space in the title block. Use of check prints is recommended.
5.0 APPROVAL Each drawing shall be approved by the PE, or the PE's line supervisor if the PE was either the originator or checker. The drawing date shall be the date the drawing was completed (approved).
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When required by the written instructions, drawings shall be stamped by the appropriate registered professional engineer.
6.0 ORAWING STATUS LOG The PE shall maintain a drawing log to identify and control the revision status of Impell originated drawings. The drawing log shall indicate:
- a. Unique drawing number
- b. Revision history and current revision
- c. Other descriptive data as considered appropriate by the PE This log shall include all final revisions plus preliminary revisions submitted for client approval. A standard drawing control log is available from the Regional Quality Assurance Manager.
The PE shall periodically distribute copies of the drawing log to individuals / organizations using Impell originated drawings. h 7.0 ORAWING OISTRIBUTION/ The PE shall distribute Impell originated drawings Rti tN HON as defined in the project document distribution chart (refer to QP-2.2).
l Drawing originals shall be maintained in an orderly l condition. At project completion, drawing originals I shall be retained or turned over to the client as defined in the Project Quality Plan.
8.0 REVISIONS Changes to final drawings shall be made as formal l
revisions. These revisions shall be prepared, checkbJ. and approved in the same manner as the original. Revision status shall be documented in the drawing title block.
I Revised portions of the drawing shall be backcircled, flagged or identified in some manner.
The nature of the revision shall be identified in the title block.
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O l 9.0 QUALITY RECORDS All final drawing revisions and the drawing control l log shall be retained as quality records in accordance with QP-4.1.
10.0 ATTACHMENTS A - Procedure Suninary O
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IMPELL ORAWING CONTROL PROCEDURE SIMtARY REQUIREMENTS RESPONSIBILITY Written instructions for Impell drawings PE use & identify tecnnical input documents Drawing originator Prepare title block Orawing originator use oesignation Drawing originator l Conceptual drawing control Drawing originator Preliminary drawings !
Revision identification Drawing originator Orawings issued for coment Orawing originator !
Orawings for client approval Drawing originator, l checker and PE l Final drawing contr'ols PE Orawing check Independent checker Approval PE or PE's line supervisor Drawing status log PE Orawing distribution / retention PE ,
Revisions Same as for original ,
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O QP-3.2 Revision 4 Impell Corporation Attachment A
QUALITY ASSURANCE MANUAL
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( ) Reviewed - Corporate r QA Manager
,[ NW 7/15/85 Approved - Sr. Vice President / Date PR0CEOURE QP-3.3 FOREIGN DOCUMENT CONTROL This procedure establishes supplemental requirements for controlling certain technical documents provided by external organizations for oesign, analysis, or other tecnnical engineering project tasks.
Requirements in this procedure address the following and are sumarized in Attachment A:
- a. Docment receipt
- b. Docuent distribution
- c. Document retention and control
- d. Status logs and reports
- e. Doceent disposition O
V 1.0 APPLICABILITY Procedure QP-3.1 establishes requirements for selecting, identifying, doceenting and using technical documents for engineering tasks. This procedure establishes additional requirements that in certain circumstances apply to drawings, specifications and other technical doceents provided by external organizations. This procedure shall be applied when either the Project Engineer (PE) or Regional Quality Assurance Manager (RQAM) determine that the requirements of QP-3.1 are not sufficient to control technical input documents used by the project.
The requirements of this procedure also apply when a single organization will control the documents for more than one project. The PE shall designate the
" Document Control" organization for the project.
2.0 DOCUMENT RECEIPT & LOGS 2.1 Technical Input Log The PE shall include references in the technical input log (QP-3.1) which identify the types of O
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documents controlled by the supplemental requirements of this procedure.
2.2 Document Receipt & Foreign documents to be controlled by this procedure Verification shall be transmitted to Document Control by the Impell contact receiving same (QP-2.5). Document
- Control shall verify the contents of each transmittal package by comparing items in the package against the transmittal letter or form. The PE shall resolve any transmittal discrepancies.
Document Control shall mark the date received on each document and acknowledge receipt of documents when required.
2.3 Supersedeo Documents Unless directed otherwise by the PE, Document Control shall destroy superseded documents.
Superseded documents may only be retained if they are marked as such.
2.4 Document Status Log Document Control shall maintain a document status log for each type of document being controlled (standard fonn is available from the RQAM). Each h
document received shall be entered in the log. The log shall identify:
- a. Client and project job number
- b. Document number, sheet number (if any), and title
- c. Date received
- d. Revision level
- e. Any special indexing numbers assigned by the PE as identification Document Control shall periodically distribute copies of the logs to each project organization using the documents. These logs shall be placed in the project work areas so that project personnel can verify current revision status of the documents when required.
2.5 Transmittal Letters / Transmittal letters or forms shall be maintained by Forms the PE in the appropriate project correspondence file.
3.0 DOCUMENT DISTRIBUTION The PE shall inform Document Control of the required 9
QP-3.3 Revision 6 Impell Corporation Pace 2 of 3 _ _ _ .
O QUALITY ASSURANCE MANUAL (O) distribution for each type of document. Document Control shall maintain a distribution chart or list defining these requirements.
Document Control shall duplicate as necessary and distribute each document as designated in the distribution chart. Project personnel shall file new or revised documents when received and shall either mark superseded documents as such er destroy them.
4.0 DOCUMENT MAINTENANCE 4.1 Document Control Document Control shall maintain copies of the latest revisions of documents received, as shown on the document status logs. Documents shall be maintained in an orderly condition such that they can be readily retrieved.
4.2 Project Personnel Working copies of documents distributed to project personnel shall be maintained together by document type and in a manner that allows ready retrieval for use and comparison against the Document Status Log prior to use.
4.3 Document Disposition When no longer required, documents controlled by this procedure shall either be destroyed or retained as required in QP-3.1.
5.0 QUALITY RECORDS Document status logs shall be retained as quality records in accordance with QP-4.1.
6.0 ATTACHMENTS A - Procedure Sumary A
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FOREIGN DOCUMENT CONTROL PROCEDURE
SUMMARY
REQUIREMENTS RESPONSIBILITY Determine procedure applicability PE or RQAM Designate document control point PE Designate supplementary document control in technical input log (if required) PE Receipt Transmit documents to document control Impell contact verify transmittal contents Document Control Resolve transmittal discrepancies PE Mark date received & acknowledge transmittal Docurnent Control Oestroy or mark superseded documents Document Control
& project users Maintain document status log and distribute Document Control Maintain transmittal letters / forms PE Distribution Define distribution PE Distribute documents Document Control File new/ revised documents Project user Maintain document files Document Control
& project users l
Verify latest revision prior to use Project users Document disposition -
Per QP-3.1 Oll t
l QP-3.3 Revision 6 Impell Corporation _ _ _ _ .__ _ __ _
Attachment A l
QUALITY ASSURANCE MANUAL I')
V --
b6 Review (d 'Cdr$0 rate QA Manager d / 7/15/85 Approved - 3r. Vice President / Date PR0CEDURE QP-3.4 CALCULATIONS This procedure establishes requirements for perfoming engineering calculations to support analyses, designs, or other engineering activities involving technical computations. Special studies performed to evaluate technical problems, nonconformances or other technical questions shall be performed as calculations in accordance with this procedure. Requirements in this procedure address the following calculational activities and are suninarized in Attachment A:
- a. Calculation preparation p(/ b. Use of computer programs
- c. Independent verification
- d. Approval
- e. Calculation Log
- f. Revisions 9 Transmittal of results Implementation methods may be modified by the Project Quality Plan (QP-2.5) provided the intent of this procedure is maintained.
1.0 PREPARATION 1.1 General Requirements Calculations shall be performed according to the technical methods and processes defined in the project instructions (QP-3.9). Only engineering personnel who are qualified in accordance with QP-1. Mand who have received project training in accordance with QP-2.4, shall prepare, verify, or approve calculations.
The preparer is responsible for perfoming calculations which are accurate and in compliance with all client and project requirements.
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Calculations shall be legible and have sufficient contrast for micrographic reproduction.
1.2 Format Calculations should be performed on standard Impell calculation sheets. Each calculation shall include a cover sheet which defines client / project, job number and title, calculation number, revision number, approval and date.
Each subsequent page of the calculation shall identify:
, a. Job number and project / task identifier as l
appropriate
- b. Calculation number
- c. Revision and date
- d. Signatures, or initials, and dates of the '
originator and verifier Calculation pages shall be numbered such that the completeness of the calculation can be verified. A table of contents or explanation may be provided which clearly indicates the number of sheets in each section and the revision status of each. A page h
revision log should be included which lists all pages in the calculation and the latest revision and date for each page of that revision.
1.3 Content Calculations shall comply with the following critoria:
- a. Purpose of the calculation shall be stated
- b. Specific assumptions, references or other technical criteria shall be identified
- c. Method shall be clearly defined indicating sequence of the calculational steps such that the person performing the independent verification can evaluate the calculational process an,d results without assistance from the originator
- d. Each major step of the calculation shall be l identified l e. Formulas and equations used shall be identified l and non-standard synbols or abbreviations defined
- f. Specific technical input shall be identified and O
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\J traceable to its source document for subsequent verification
- g. The unique computer run number or other identifier supporting the calculation shall be clearly referenced (final computer runs only)
- h. Calculations shall be neat and legible
- 1. Where preliminary data is used, the calculation shall identify this data as an assumption or open item requiring confirmation 2.0 USE OF COMPUTER Computer programs may be used in support of PROGRAMS calculations. Only programs which have been verified and are maintained according to the procedures in Section 6.0 of this manual may be used to support calculational results sent to the client. Section 6.0 procedures are not applicable to calculations that use computers to perform calculational processes which will be independently verified according to QP-3.6.
2.1 Computer Program Log A log of all computer programs and versions used Os shall be maintained by the PE (standard form is available from the Regional Quality Assurance Manager).
2.2 Caputer Output Caputer output is an extension of the base
, calculation and shall comply with the following:
- a. Machine generated program name and version shall appear on the first page of the output
- b. Output shall be identified by a unique identifier or run number (a day / time indicator on each page is preferred)
- c. Output shall include a machine listing of input. If not feasible, input shall be listed either in the calculation or written onto the output
, d. Computer runs shall be traceable to the calculation and revision
- e. Input and output shall be verified along with the calculation
- f. Originator and checker shall sign and date each
- computer run l
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The above only applies to final computer runs (not applicable to preliminary or test rur.s).
2.3 File Maintenance Final computer runs shall be maintained in an orderly condition such that they can be readily retrieved. They may be filed eitner with the calculation or maintained separately as decided by the PE.
2.4 Project Specific Project specific computer programs may be used b a
Programs provided they are verified and doctrnented in the calculation in accordance with QP-6.3.
3.0 INDEPENDENT Each calculation and revision shall be independently VERIFICATION verified in accordance with QP-3.6 prior to f transmittal of final results to the client. L_
=
4.0 APPROVAL Calculations shall be approved by the PE provided
- the PE was not the originator or verifier of the revision to be approved. PE approval signifies that the calculation has been perfomed in accordance with project requirements, independently verified, proper technical input was used, no outstanding assumptions or questions remain, and the results are correct and support the stated purpose.
' 4.1 Documentation Calculation approval shall be documented on the calculation cover sheet and shall be dated.
4.2 Approval by Others When the PE cannot approve the calculation (due to absence or when the PE was the preparer or verifier) une PE's line supervisor shall approve the calcul ation.
5.0 CALCULATION LOG The PE shall maintain a calculation log which identifies all calculations perfomed on the project (standard fonn is available frw the Regional Quality Assurance Manager). This log shall list the calculation number, title, revision, and date for each revision. The PE shall assign calculation numbers based on the numbering system in the log.
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U 6.0 REVISIONS Changes to approved calculations shall be prepared, verified and approved in the same manner as the ori ginal . Changes shall be clearly described, identified and verifiable.
6.1 Revision Ioentifier The original and each calculation revision shall be uniquely identified recontnend A, B, C, etc. for preliminary and 0,1(, 2, etc. for final). Each revision shall be identified on the calculation cover sheet and on the pages affected. The revision status of pages unaffected by the change shall renain unchanged.
6.2 Documentation Each calculation revision shall be a complete documentation package for that revision (i.e., all current pages of the calculation shall be included) . Void or superseded pages shall be marked as such or may be destroyed provided a record copy has been created. Void or superseded calculations shall be marked as such and so noted in the calculation log.
7.0 TRANSMITTAL OF RESULTS Only approved calculations (or results of approved I calculations) shall be transmitted to the client or other external organizations. When specifically approved by the responsible manager, preliminary results may be transmitted, but shall be identified as such and shall be considered by the PE te be the )
same quality as that expected for the final results.
Where it is not feasible to send the entire calculation, the results or a sunmary may be transmitted provided the sunmary is traceable to the approved calculation.
7.1 Transmittal to Outside Calculaticns shall be sant to outside organizations Organizations by letter or other transmittal form as designated in the Project Quality Plan (QP-2.5).
7.2 Internal Transmittals Calculation resuits shall be transmitted to Impell technical interf aces according to the requirements defined in the Project Quality Plan. This transmittal may be accomplished by any of the following:
k QP-3.4 Revision 4 Impell Corporation , Page 5 of 6
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QUALITY ASSURANCE MANUAL 9
- a. Sending a copy of the approved calculation
- b. Forwarding a copy of the transmittal letter (or fom) sent to the outside organization along with the referenced data
- c. By memorandum signed by the responsible PE
- d. Other method as defined in' the Project Quality Plan In all cases the transmittal shall identify the source calculation and revision level.
7.3 Internal Use of Only the results of approved calculations shall be Results used in final analyses, design or other technical work. If necessary, preliminary results may be used provided the work is identified as preliminary and the calculation results are treated as an open item requiring subsequent confimation.
8.0 QUALITf RECORDS Each revision of approved calculations shall be retained as quality records in accordance with QP-4.1.
9.0 ATTACHMENTS A - Procedure Sumary l
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CALCULATIONS PROCEDURE SlM4ARY REQUIREMENTS RESPONSIBILITY Perform technical activities according to project requirements Originator Personnel qualification Per QP-1.5 Personnel training Per QP-2.4 Calculation fomat and content Originator Use of computer programs Verification / maintenance Procedures in O Section 6 of manual Computer program list U Computer output PE Originator & verifying engineer File maintenance Originator Project specific programs PE i Independent verificat' ion Per QP-3.6 Approval PE/PE's supervisor Calculation log PE Revisions Same as original Transmittals ;
External Project Quality Plan Internal Project Quality Plan Use of final results User 1
b s.J QP-3.4 Revision 4 Impell Corporation Attachment A
QUALITY ASSURANCE MANUAL b
Reviewed - Coi(pfat,e QA Manager M c.w/ 7/15/85 Approvpd - Sr. Vice President / Date PR0CEDURE QP-3.5 DESIGN CONTROL This procedure establishes requirements to define and control design activities to assure Impell desic1s meet all project and client criteria.
Requirements in this procedure address the following design activities and are sunmarized in Attachment A:
- a. Project instructions (the design process)
- b. Design specifications (technical criteria for the design)
- c. Design process control
- d. Design changes
- e. Design docunent control 1.0 APPLICABILITY The requirenents of this procedure apply to all design and design modification projects regardless of size or discipline.
2.0 PROJECT INSTRUCTIONS Prior to initiating design work the Project Engineer (PE) shall prepare project instructions which define the design process and other procedural requirements and controls for the project (i.e., how the design process shall proceed). These instructions shall be prepared in accordance with QP-3.9. In addition to the requirements of QP-3.9, specific client and project requirements such as the following shall be included in the project instructions:
- a. Professional engineer certification of specifications, reports, drawings, calculations, !
including state and discipline required
- b. Stamping or marking of drawings, specifications, calculations, etc. with such infonnation as l
" Nuclear Safety Related", "QA Condition I", or other similar infonnation
- c. Client review or approval of documents, instructions, etc.
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- d. Peer group, interdisciplinary, constructability l or other special reviews of the design that will ;
be required
- e. Process for handling requests for client information
- f. Vendor information controls
- g. Process for handling incoming client comments and requests
- h. Process for identifying, preparing, checking, approving, doceenting and subsequent incorporation of design changes into the original design docment including any special design change notice, design change request, field change request or other design doceent change process that will be established for the project
- 1. Interf aces with other Impell design activities if not defined in the Project Quality Plan Design standards or procedures manuals (internal or
! s external) may be used in lieu of listing detailed requirements in the project instructions. When used, such doceents (including revision level) .-
shall be referenced in the project instructions and copies made available to project personnel.
- 3. 0 DESIGN SPECIFICATION When required by the project instructions, a design specification shall be prepared to define the technical criteria /requirenents for the design work. Alternatively, this specification may be supplied by the client.
3.1 Impell Design Design specifications prepare. by Impell shall be Specifications reviewed, approved and controlled in accordance with QP-3.8 or as otherwise required in the project i ns tructi ons . Design specifications shall be certified by a professional engineer when required by the project instructions.
3.2 Client Design Design specifications provided by the client shall Specifications be controlled as technical input in accordance with QP-3.1.
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l l 4.0 DESIGN PROCESS CONTROL Project personnel shall perform the design work in accordance with requirements in the project instructions and design specification. Requirements for specific activities in the design process are defined below:
4.1 Design Input Technical docuents used as input for the design process shall be controlled in accordance with QP-3.1. The supplemental requirements of procedure QP-3.3 shall also be used for further control of technical docments as defined in that procedure.
1 4'. 2 Procurement Procurement specifications shall be prepared, issued Specifi cations and controlled in accordance with precedure QP-7.2.
Material requisitions may be used as a short form of procurement specification when requested by the client for procurement of a specific item (e.g., i l specific type of equipment, including vendor and '
model neber). Material requisitions shall be prepared issued and controlled the see as procurement specifications with the exception that functional, design or other requirements may be i deleted because a specific item is to be purchased.
The PE shall determine required contents for the l
{
) materi al requisition. '
l 4.3 Install ation Installation specifications describe the technical !
Specifications requirements which must be met during installation of a specific item, system or structure. These l
specifications shall contain all information l required for installation, including the following:
- a. General project information
- b. Codes, standards and quality assurance requirements
- c. Applicable drawings
- d. Technical installation regirements j Installation specifications shall be prepared, issued and controlled as defined in the project i ns tructions, l
4.4 Testing & Other Specific requirments for preparing, issuing and Specifi cations controlling testing and other specifications (e.g.,
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operating or maintenance specifications) shall be defined in the project instructions.
4.5 Calcul ati ons All Impell designs shall be supported by calculations which are prepared, issued and !
controlled in accordance with QP-3.4. Thi s l requirement also applies to designs wnich are based on asseptions or engineering judgement.
4.6 Oruings Impell design drawings shall be prepared, issued and controlled in accordance with QP-3.2.
Client drawings shall be modified in accordance with QP-3.2. Client drawings shall be received and controlled as technical input according to Section 4.1 of this procedure.
4.7 Design Verification Impell design work shall be independently verified in accordance with QP-3.6 when required by the quality procedures referenced above.
A technical quality review shall also be conducted (n\
V in accordance with QP-3.7. In addition to the criteria defined in QP-3.7, this review shall also evaluate the design for:
- a. Impact on other design disciplines
- b. Past experience with similar designs
- c. Potenti al f abrication, installation, test, operations and maintenance problems
- 5. 0 DESIGN CHANGES Design docuents (specifications and drawings) shall be revised according to the scie method used to develop the original docment.
6.0 DESIGN DOCUMENT Design doceents shall be logged, distributed and CONTROL controlled by Impell as defined in the appropriate quality procedures. Design doceents shall be transmitted between Impell and the client in accordance with QP-2.1.
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QUALITY ASSURANCE MANUAL 9
7.0 QUALITY RECORDS Design specifications, drawings, design changes, supporting calculations, tecnnical quality reviews, and doctnent control logs shall be retained as quality records in accordance with procedure QP-4.1.
8.0 ATTACHMENTS A - Procedure Stenary I
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QP-3.5 Revision 0 Im8 ell Corgoration Page 5 of 5
QUALITY ASSURANCE MANUAL ;
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DESIGN CONTROL PROCEDURE
SUMMARY
REQUIREMENTS RESPONSIBILITY Prepare project instructions PE per QP-3.9 Prepare & issue design specifications PE per QP-3.8 Perform design activities per project requirements Project personnel Control design input PE per QP-3.1 and, if required, QP-3.3 Prepare & issue procurement specifications PE per QP-7.2
! Determine contents of material
- (' requisitions PE Prepare & issue installation specifications PE per project instructions Prepare & issue testing
& other specifications PE per project instructions Supporting calculations Per QP-3.4 Prepare & issue Impe11 drawings Per QP-3.2 Perform inoependent verification Per QP-3.6 l Design changes Same as original Design document control Per appropriate procedure l
3 MJ -
QP-3.5 Revision 0 Impell Corporation Attachment A
I QUALITY ASSURANCE MANUAL Review (d - Corgf (ite QA Manager
.m p d4/. er/ 7/15/85 Approved - Sr. Vice President / Date PR0CEDURE 09-3.6 INDEPENDENT VERIFICATION This procedure establisnes the proce! s for independent verification of engineering activities to assure they are performed according to project requirenents and that the results are correct, reasonable and meet specified criteria. 1 Verification requirenents in this procedure address !
the following and are sunmarized in Attachment A:
- a. Procedure applicability l b. Personnel requirenents
- c. Verification methods
- d. Checking
- e. Alternate calculations
- f. Testing or other methods
- g. Resolution of ccanents
- h. Approval i
Technical quality reviews are an additional form of verification which are used to confirm adequacy of the engineering work methods and reasonableness of results obtained. These reviews are performed by a quality review team in accordance with QP-3.7.
1.0 APPLICA8ILITY The requirenents in this procedure apply to calculations, design documents, computer sof tware and other engineering activities where independent verification is specifically required by the procedures in this manual.
2.0 PERSONNEL REQUIREMENTS The PE shall assign personnel to verify engineering activities. Personnel verifying engineering work shall be technically competent in the subject area to be verified and shall be qualified in accordance ,
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wi th QP-1.5. Only personnel who have received project training in accordance with QP-2.4 shall verify engineering work.
Unless approved otherwise in the Project Quality Plan verification personnel shall not have participated in the specific work activity to be verified. They should not be the originator's imediate technical supervisor for the work and ,
should not have been responsible for specifying the '
technical inputs or technical approach or have ruled out certain technical considerations.
3.0 VERIFICATION METHODS Verification may be accomplished by any of the following methods:
- a. Checking by review and confinnation of the original engineering work using criteria established by the Project Engineer (PE)
- b. Alternate calculations to confirm adequacy of s
the results of the original engineering work
- c. Testing or other method to confirm adequacy and accuracy of results 4.0 CHECKING The checker shall revia the engineering activities to assure they were pe< formed in accordance with project requirments and that the results are reasonable and correct. This review shall be accomplished using written criteria which are sufficiently detailed to assure the checker will review those elenents of the work or work process, which if not thoroughly checked, could result in a deviation from specified project requirenents.
4.1 Checking Criteria The PE shall issue written criteria to be used by.
the checker (a standard checklist is available fram the Regional Quality Assurance Manager). The criteria checklist shall identify the client, project task, job ntsnber or other specific project identifier, and the item and revision of the item to be checked.
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The following general criteria shall be used unless approved otherwise by the Section Manager:
- a. Originator followed defined procedures
- b. Title, purpose, and function of the work checked are adequately described
- c. Work method clearly stated and appropriate
- d. Assunptions identified. Open items flagged for subsequent verification where necessary
- e. Technical bases and references current and correctly selected and incor> 3 rated
- f. Technical inputs properly selected and adequately identified. Any specific inputs to be excluded are adequately identified
- g. Applicable codes, standards and regulatory requirements identified and properly used
- h. Analytical steps can be verified without I recourse to originator
- i. Each page of the work identified and traceable to originator, date and job or equivalent control number J. All markings legible and identifiable g
- k. Work clearly references any final supporting computer runs
- 1. Final caputer runs include input listing and output. Correct inputs used
- m. Final caputer runs contain unique nunber identifier ,
- n. Results consistent with inputs, technical procedures and other project criteria
- o. Results are reasonable
- p. Revisions are clearly docunented
- q. Technical interf ace requirements in the Project Quality Plan have been satisfied As an alternative, the project instructions may be used as the criteria for checking engineering activities provided they sufficiently detail the technical work process and include applicable l criteria above. '
- 4. 2 Checking Process The checker shall perform the review using the criteria provided by the PE. As part of the check, the checker shall trace the impact of any identified errors or discrepancies throughout the item being checked.
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When permitted by the format of the item being !
checked, the checker shall line through or otherwise i
, clearly identify any nunerical or procedural discrepancies and indicate the correct values or steps.
5.0 ALTERNATE CALCULATIONS When alternate calculations are used to verify engineering activities, they shall be perfonned using technical methods acceptable to the PE. They shall provide a clear comparison between results of the alternate calculation and those of the item being verified and shall demo'nstrate that the original results are reasonable and correct. They shall also demonstrate that the assunptions, technical input and original methods were appropri ate. Alternate calculations shall identify the purpose and nature of the calculation along with client, project task, job number or other specific
(
project identifier, and the work iten and revision being verified.
The person performing the alternate calculation shall initial and date same. The PE shall confirm adequacy of the alternate calculation.
6.0 TESTING OR OTHER Testing or other methods of independent verification l NE TH005 shall be specifically defined in the Project Quality P1an.
l l 7.0 RESOLUTION OF COPtiENTS When the verification is completed, the person i
performing the verification shall return the originals and any check-copies to the originator.
The originator shall resolve any coments and make any necessary changes to the engineering work. The PE shall resolve any verification connents which cannot be resolved by the originating engineer and the verifier.
After all items are resolved to the verifier's satisf action, the verifier shall initial and date l
the original work in the space provided.
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8.0 APPROVAL When all verification activities have been completed and.coments resolved, the PE shall ' approve the original work as required in the appropriate procedure of this manual. This indicates approval of the technical adequacy / accuracy of the results and that results satisfy client requirements.
9.0 QUALITY RECORDS Alternate calculations and documentation of test results or other verification methods shall be retained as quality records in accordance 4ith QP-4.1. Retention of check copies or other in-process docunents is the PE's decision.
10.0 ATTACHMENTS A - Proceoure Stamary 9
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b INDEPENDENT VERIFICATION PROCEDURE
SUMMARY
REQUIREMENTS RESPONSIBILITY Personnel requirements Assign verification personnel PE Personnel qualification Per QP-1.5 Project training Per QP-2.4 Personnel independence PE Checking Issue checking criteria PE Perfonn check per criteria Checker l Perform alternate calculations and sign Verifier Perform testing or gther verificaton method Assigned by PE & per Project Quality Plan Resolve verification coments Originator, and PE when required Sign and date original work Checker / verifier l
Approval , PE l
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l QP-3.6 i
Revision 5 Impell Corporation Attachment A
QUALITY ASSURANCE MANUAL bS-Reviewid < Corip@ ate QA Manager
( f2&f 4 7/15/85 Approveg- Sr. Vice P' resident / Date l
PR0CEDURE QP-3.7 TECHNICAL QUALITY REVIEWS l
' This procedure establishes requirements for performing technical quality reviews of engineering activities to assure that the technical work processes are acceptable and that the results are reasonable. Requirements in this procedure address j the following and are suninarized in Attachment A:
I
- a. Procedure applicability
- b. Technical quality review team
- c. Review schedule g
- d. Review criteria T
- e. Quality review and report
- f. Corrective action
- g. Review closecut & approval 1.0 APPLICABILITY Technical quality reviews (quality reviews) shall be performed on design, analysis and other Impell technical activities where specified by the l procedures in this manual.
Quality reviews shall be performed on each type of technical work perfonned (e.g., structural analysis, electrical oesign, mechanical equipment qualification, system design, piping analysis, etc.). Quality reviews shall also be performed when
, key project personnel or the technical work processes change. Quality reviews are not required for projects which meet the following criteria:
- a. Small scope as determined by the Regional Quality Assurance Manager (RQAM)
- b. PE and technical activities are the same as those used on similiar projects which were previously subject to quality review within the past 6 months.
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,a The PE shall document the waiving of any quality review on the Project Quality Plan (QP-2.5).
Waiving of quality reviews requires approval of the Section Manager (SM) and RQAM.
2.0 REVIEW SCHEDULE A quality review schedule shall be maintained by each section perfoming technical activities in accordance with this manual.
This schedule shall define the client, work scope, project start date, scheduled review date, and status of each review.
SMs are responsible for assuring quality reviews are properly scheduled for all work in their respective sections and that reviews are completed as scheduled.
Quality reviews should be performed at project 1
3 milestones, such as completion of a phase of work, but shall be done, as a minimtsn, prior to the transmittal of final results to the client. For ongoing projects (continuous work), quality reviews should be conducted every six months. Quality reviews should be initiated early in the project to assure adequacy of project work methods, i
3.0 QUALITY REVIEW TEAM SMs shall select individuals to act as quality review team leaders. Team leaders shall select appropriate personnel to perfonn each review.
Quality review personnel shall be technically competent in the subject to be reviewed and shall be qualified according to QP-1.5. Quality review team personnel shall not have performed or verified the work to be reviewed.
4.0 REVIEW CRITERIA The quality review team leader shall determine criteria to be used for the review. Criteria to be considered are contained in Attachment B. As a minimum, the following criteria shall be used for each quality review:
o a. Are appropriate technical work methods and Q assumptions used?
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- b. Are appropriate technical input (documents) used?
- c. Are the results reasonable for the input used?
5.0 QUALITY REVIEW, The quality review team leader shall select project activities to be reviewed and direct the review process using the established criteria. Actual review methods shall be determined by the quality review team leader.
The PE shall brief the quality review team on the work scope, work methods, technical criteria, and assumptions for the project. The quality review team shall then complete their review of the technical work as necessary to satisfy the criteria established for the review.
The quality review team leader shall document the review in a brief report which identifies:
a.
b.
c.
Quality review team members Criteria used for the review Project (s) and specific documents reviewed g
- d. Technical deficiencies (or recomendations) identified during the review and corrective actions taken by the PE
- e. Evidence supporting the corrective action taken for technical deficiencies as appropriate, or a clear reference to the doctsnents showing corrective action. A standard report form is available from the RQAM 6.0 CORRECTIVE ACTION The responsible PE shall correct the deficiencies identified in the quality review report and take any necessary action to prevent their recurrence in other work. The PE shall also implement quality review report recommendations as considered necessary. 1 In the event a deficiency is a result of or affects activities performed in another section, divisien, or region, the PE shall notify the affected l organization for their resolution. l O
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7.0 REVIEW AND APPROVAL After completion of satisf actory corrective action the quality review team leader shall approve the review report. The SM shall review and approve the report signifying technical adequacy of the review and corrective actions taken.
The RQAM shall approve the quality review report indicating that the review meets the quality requirements defined in this procedure.
The approved qualf ty review report shall be returned to the PE. The Fi. shall maintain a copy of the completed quality review in the Project QA File.
8.0 QUALITY RECORDS Completed quality review reports shall be retained as quality records in accordance with QP-4.1.
9.0 ATTACHMENTS A - Procedure Sumary B - Technical Quality Review Criteria O
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( Im@ ell CorBoroGien. _ f9e A d A
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TECHNICAL QUALITY REVIEWS PROCEDURE SLM4ARY REQUIREMENT RESPONSIBILITY Determine requirements for quality review on Project Quality Plan PE per QP-2.5 Approve waiving quality review SM & RQAM Maintain quality review schedule SM Select quality review team leader SM Select quality review team members Team Leader Select quality review team criteria Review Team Select work to be reviewed Team Leader Brief quality review team on project work PE O
Prepare quality review report Team Leader Take action to correct deficiencies PE Approve report & corrective action Team Leader, SM & RQAM Maintain report in Project QA File PE O
QP-3.7 Revision 5 Impe11 Corporation Attachment A
i QUALITY ASSURANCE MANUAL .
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(-
V TECHNICAL QUALITY REVIEWS !
l TECHNICAL QUALITY REVIEW CRITERIA
- 1. Have tne technical criteria been clearly identified?
- 2. Have the project scope and task responsibilities been adequately defined?
- 3. Has correct technical input been used?
- 4. Are assumptions adequately defined and reasonable?
- 5. Are methods correct, and have they been clearly defined and used?
- 6. Are there any problems with activities performed by other divisions or sections that are used by the project as technical input?
- 7. Is verification adequate? Have adequate verification criteria been established and followed?
- 8. Were computer programs properly used?
- 9. Are results reasonable based on defined allowables or factors of safety?
Do tney satisfy the design criteria?
- 10. Is tne technical package complete?
- 11. Are the specific items reviewed correct?
- 12. Do any deficiencies affect work performed in other divisions or sections?
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Qp-3.7 Revision 5 Impell CorBoration _
Attachment,B __.
QUALITY ASSURANCE MANUAL WS Revifwed'- Cbrporate QA Manager d d 7/15/85 Approved - Sr. Vicf President / Date l
PR0CEOURE QP-3.8 DESIGN SPECIFICATIONS This procedure establishes quality requirements for controlling design specifications prepared and issued by Impell. Requirements in this procedure address the following and are suninarized in Attachment A:
- a. Procedure applicability 1
- b. Specification preparation '
- c. Specification identification
- d. Review and approval ;
- e. Specification control log
- f. Distribution & retention 9 Revisions 1.0 APPLICABILITY This procedure applies to design specifications prepared by Impell for internal or client design purposes. Procurement specifications shall be prepared, issued, and controlled in ac-ardance with QP-7.2. Specific requirements for preparing, issuing, and controlling testing and other specifications (e.g., installation, operating or maintenance specifications) shall be defined in the 2.0 SPECIFICATION PREPAR ATION The PE shall prepare and issue Impell originated design specifications according to the requirements of this procedure and any applicable project specific requirements contained in the project instructions.
2.1 Content Unless otherwise defined by the project instructions, design specifications shall include the following:
- a. Specification cover page listing title, client name and address, system structure or component, h
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specification number, revision, date, Impell job s number, and use designation
- b. Approval sheet identifying who prepared, verified and approved the specification. The current revision shall also be identified
- c. Revision record identifying each revision, the date revised, pages revised and nature of each revision
- d. Table of contents sufficiently detailed so that completeness of the specification can be verified
- e. List of tables and figures
- f. Code certification (when required) performed by a registered professional engineer in accordance with applicable code requirements
- g. Design requirements as indicated in the following section of this procedure
- h. References and appendices 2.2 Design Requirements Design specifications should contain the following types of technical information:
- a. Functional requirements - specific functions to be served by the design. These may include the system purpose or a description of how the process side of the system works
- b. Design requirements - specific design life, reliability, availability, loading combinations, codes and standards, system transients, environmental, process, material, and f abrication requirements
- c. Installation, test operations & maintenance requirements, inclu, ding acceptance criteria for performance testing The Project Engineer (PE) is responsible for including appropriate requirements in the design specification.
2.3 Specification Technical Design specifications shall identify key technical Input input documents (including revision level) such as ~
drawings, other specifications, criteria documents or design analyses / calculations. This identification may be limited to a few top level documents when the referenced documents include l necessary supporting references.
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QP-3.8
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Unless specifically approved by the PE in writing, only the latest revision of input documents as listed in the technical input log shall be used to prepare design specifications (QP-3.1). A copy of any such approval shall be maintained with the technical input 109 Input documents for design specifications may be listed elsewhere in the project records when so specified in the project instructions.
2.4 Use Designation The intended use of each specification shall be designated on the specification cover page and shall be sufficiently clear to preclude use of the specification for purposes other then those intended. Acceptable designations include the following:
- a. Preliminary - for coment, information or &
approval W
- b. Final - for other design use, procurement, f abrication, construction, etc.
Other use designations shall be defined in the
- project instructions.
l 2.5 Originator's Signoff When the specification is completed, the originator I (person responsible for the technical content of the l specification) shall sign the specification approval sheet. A standard form is available from the Regional Quality Assurance Manager (RQAM).
3.0 INDEPENDENT Design specifications shall be independently VERIFICATION verified in accordance with QP-3.6. This verification shall be based on written criteria provided by the PE. When all consnents have been resolved, the person performing the independent verification shall sign the appropriate space on the specification approval sheet.
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i 4.0 APPROVAL The PE shall review technical content of the design specification and indicate approval on the specification approval sheet. The PE's line supervisor g
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shall approve the specification if the PE originated or verified the specification. On multi-discipline design specification, approval shall be by the lead engineer of each applicable discipline.
When required by the project instructions, the design specification shall be stamped by a registered professional engineer.
- 5. SPECIFICATION The PE shall maintain a specification log to LUNIROL LOfa identify and control the revision status of design specifications. This log shall indicate:
- a. Unique specification number
- b. Revision history and current revision
- c. Specification title and other descriptive data as considered appropriate by the PE This log shall include all final revisions plus preliminary revisions submitted for client -
i
-) approval. A standard specification control log is available from the RQAM. This log shall be maintained in the Project QA File.
t 6.0 SPEC'FICATION l DISTRIBUTION The PE shall distribute design specifications as i
defined in the project document distribution chart
} (refer to QP-2.2).
7.0 REVISIONS Revisions to design specifications shall be prepared and issued in the same manner as the original. Each revision to a design specification shall be uniquely identified. Revised portions of the specification shall be flagged along with the applicable revision identifiers. Specification revisions shall be documented on the specification revision record.
Superseded specifications (final versions only) shall be marked as such or destroyed.
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8.0 QUALITY RECORDS All final revisions of design specifications shall be retained as quality records in accordance witn QP-4.1.
9.0 ATTACHMENTS A - Procedure Sumary 0
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QP-3.8 Revision 1
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(a DESIGN SPECIFICATIONS PROCEDURE SlM%RY REQUIREMENT _ RESPONSIBILITY Procurement specifications Per QP-7.2 Determine specification contents and prepare PE Control technical input documents Per QP-3.1 Use designation PE Incependent verification Per QP-3.6 Specification review & approval PE or PE's line supervisor
,r Maintain specification control Log PE Distribute specifications Per QP-2.2 Revisions to specifications Same as original l
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Reviewed - Eor'potate QA Manager e
7/15/85 Approved - Sr. Vign President / Date PR0CEDURE QP-3.9 l
PROJECT INSTRUCTIONS E
This procedure establishes quality requirements for the preparation, use and control of project instructions. Requirements in this procedure address the following and are sumarized in Attachment A:
- a. Requirements for project instructions
- b. Project instruction preparation j c. Project instruction distribution i d. Use of project t'nstructions
- e. Revisions 1.0 REQUIREMENTS FOR PROJECT INSTRUCTIONS Impell engineering work shall be performed according to approved written project instructions._ These
?
instructions shall define the engineering work process, responsibilities and technical work methods. For projects involving more than a single division or regional office, the project Quality l Plan (QP-2.5) defines the technical information l which must be transmitted between Impall l organizations to properly perform the technical work.
In the following cases project instructions may be incorporated in the Project Quality Plan (QP-2.5):
- a. Instructions are brief and can be written in the space provided on the standard form for the Project Quality Plan.
t b. Instructions only reference other detailed procedural documents which are attached to the Project Quality Plan. When incorporated in the Project Quality Plan, project instructions must
! still meet the intent of the requirements in this procedure.
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(V Project instructions are only applicable to the specific project for which they have been prepared and approved. Uncontrolled memos or notes shall not be used to provide technical direction to project personnel.
Except for procurement activities defined in Section 7.0 of this manual, procedurcs for non-technical activities (e.g., project management, scheduling etc.) are not governed by the requirements in tnis procedure.
2.0 PREPARATION 2.1 Contents Project instructions shall be prepared by the Project Engineer (PE) and shall contain the following types of information:
- a. Gencral sequence of the wc-k
- b. Equations and formulas to be used along with p definition of any non-standard terms h c.
d.
Design bases, criteria and other technical input Assumptions
- e. Doc uentation requirements
- f. Fonnat, content and organization of the final results
- g. Computer programs to be used
- h. Criteria for independent verification, if not provided elsewhere
- 1. References to technical methods contained in other procedures, technical manuals, etc.
- j. Applicable regulations and industry codes and standards
- k. Specific client technical requirements Project instructions shall describe the technical work methods from receipt of technical input to transmittal of final results to the client.
Sufficient details shall be included to allow the individual engineer to perfonn the required work without continuous guidance from the PE.
Each project instruction shall include the title instruction number, status, effective date, client, and project indentification. Standard forms are available from the Regional Quality Assurance Manager (RQAM).
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2.2 State-of-the-Art On sane projects, the scope of work represents Tecnnology state-of-the-art technology and the specific technical work procedures can only be developed as the actual work progresses. For these projects, a comprehensive statement of the scope of work, general approach and expected results may substitute for the project instructions. This statement should be included in the Project Quality Plan.
2.3 Approval Praject instructions shall be reviewed for technical content and approved by the Section Manager (SM).
2.4 Instruction Log The FE shall maintain a log of project instructions which shows the current revision for each instruction issued for use. A standard fonn is available from the RQAM. This log should be maintained in the Project QA File.
3.0 DISTRIBUTION The PE shall distribute copies of approved project instructions, and all subsequent revisions, to each organization performing technical work on the project. Distribution requirements shall be defined in the project document distribution chart (QP-2.2).
A historical record of each project instruction shall be maintained with the project documentation.
l A copy of all current project instructions shall be
, maintained in the Project QA File.
4.0 USE OF PROJECT l INSTRUCTIONS Project personnel shall read the project I
instructions and perfonn the technical work according to the procedure therein.
During the course of the project, technical l
information shall be transmitted between divtsions and regions according to QP-2.1.
5.0 REVISIONS 5.1 Preparation & Issue The PE shall revise the project instructions as necessary to reflect required changes in technical work methods or the overall engineering process.
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Revisions to project instructions shall be prepared, approved and issued the same as for the original.
Revised portions of the instru:tions shall be clearly identified by either issuing a revision record sunnarizing the changes or by flagging the changes in the text of the instructions 5.2 Superseded Material Superseded project instructions shall be marked as such or destroyed.
6.0 QUALITY RECORDS A copy of each project instruction revision shall be retained as a quality record in accordance with QP-4.1.
7.0 ATTACHMENTS A - Procedure Summary O
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l QP-3.9 R $5'oa 5
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PROJECT INSTRUCTIONS PROCEDURE
SUMMARY
REQUIREMENTS RESPONSIBILITY Prepare project instructions PE Review & approve project instructions SM Maintain project instructions log PE Distribute project instructions PE Perfonn work according to project Project personnel instructions Transmittal of technical information between Impell organizations Per QP-2.1 Revisions to project instructions Same as tne original Oestroy superseded materials User O
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Reviewed - C'orpor' ate QA Manager A lYe-1" 7/15/85 Approved - SR. Vice fresident / Date PR0CEDURE QP-3.10 TECHNICAL REPORTS 1.0 PURPOSE This procedure establishas quality requirements for tne preparation, issue, and control of technical reports originated by Impell. This procedure addresses the following technical report requirements which are simnarized in Attachment A:
- a. Definition
~
- b. Outline
- c. Identification and control
- d. Review and approval Il LJ
- e. Retision control 2.0 TECHNICAL REPORT A technical report is a written presentation of a DEFINITION design, analysis, study, calculation, evaluation, assessment, investigation or a combination thereof.
Tecnnical reports may be a stand alone document or may be supported by engineering calculations or analyses performed according to quality program requirements.
Letters that transmit results of engineering calculations or analyses are not considered
. technical reports provided the supporting l calculations or analyses were performed according to i the requirements in this manual. Such letters are
! unly considered technical reports when they perform sane additional technical evaluation, assessment, ,
etc. on the information being transmitted.
3.0 REPORT PREPARATION The Project Engineer (PE) shall direct preparation of the technical report. The report shall consist of a suninarization and interpretation of the results of approved calculations, analyses, design or other A technical work performed.
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3.1 Content Unless otherwise dictated by project requirements, the technical report shall be organized as follows l
(standard forms are available from the Regional Quality Assurance Manager):
l
- a. The report title page shall list:
1 1 Report title 2 Client name and address 3 System, structure, or component name l
- 4) Report number
- 5) Job number
- 6) Revision number (as appropriate)
- 7) Date
- b. The approval cover sheet shall identify the preparer, reviewer and approver of the report revision.
- c. The revision record sumary shall identify the l pages revised and the nature of each revision.
- d. The table of contents shall be sufficiently l detailed so that the completeness of the report can be verified.
l e. A list of tables and figures shall be included
- f. Code certification (when required) - Certain types of reports, especially those dealing with compliance to ASME Boiler and Pressure Vessel Code, may require documentation certifying code compliance. In these cases, a specific code certification statement shall be employed.
Reports certified in accordance with ASME Section III or other code requirements shall be certified by a registered professional engineer competent in the subject field as designated by the responsible Section Manager,
- g. Abstract or sumary - A clear, concise indication of the object and scope of the report shall be stated. In addition, the results achieved or a clear conclusion shall be i provided. Where specific requirements are l prescribed for the technical activities, a statement of conformance to these requirements shall be provided. Otherwise the area and extent of non-conformity shall be clearly identified. ,
- h. Text - The main body of the report shall be divided into appropriate sections, such as:
- 1) Introduction QP-3.10 Revision 3
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(G
- 2) Scope
- 3) Assumptions / limitations
- 4) Methods
- 5) Results
- 6) Conclusions and recommendations if appropriate
- 1. References - The report shall reference its sources of design and analysis input. These sources may include codes and standards, drawings, specifications, cc respondence, document transmittals, other reports, engineering handbooks, and special studies.
Supporting calculations and analyses prepared by Impell as part of the report work scope shall also be referenced, so that there is clear traceability from the report to its source documents.
J. Appendices - Appendices shall include a description of computer programs used and any O special features of program use that have a l
! O direct bearing on the results of the report.
The computer program version shall also be identified.
3.2 Identification Reports shall be identified by a unique report number issued by the Records Center or other controlling organization. Report pages shall be identified by page number, report number and revision.
I 4.0 REVIEW & APPROVAL 4.1 PE Review The PE shall review the report to verify its completeness and technical adequacy. If the PE prepared the report, the PE's supervisor shall perfonn the review. Guidelines for reviewing the report follow:
- a. Is the title page complete?
- b. Is the certification complete (if required)?
- c. Is the approval cover sheet complete?
- d. Is the table of contents adequate?
- e. Is the purpose of the report clearly stated, and does the report accomplish what it states it O will do?
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f.
Are references to codes and standards correct?
- g. Is the overall method clearly explained?
- h. Are graphs, tables, and illustrations adequate?
- 1. Are supportive calculations properly docuented and approved?
- j. Are specialized terms defined, and is the nmenclature uniform?
- k. Are pages properly identified (page number, report number, revision status)?
- 1. Are the conclusions supported by the docuented resul ts?
- m. Are references adequate?
- n. Are appendices provided where necessary?
- o. Is the report number accurate?
- p. If the report has been revised, has the revision been properly documented?
4.2 Quality Review A technical quality review shall be performed on the supporting calculations or desims of each report prior to original issue (refer to OP-3.7). This review shall consider the reasonableness of the results based on initial asseptions, technical inputs, methodology, and conclusions. The review g may take into account previous reviews performed on other calculations, designs or analyses (i.e.,
elements which have previously been verified do not have to be verified a second time).
Quality reviews shall be performed on subsequent l
revisions of the report at the discretion of the Section Manager (SM), based on the significance of the revision (s).
4.3 Approval After completion of the quality review, the report shall be approved by the SM.
5.0 REPORT ISSUE Final reports shall only be issued after supporting calculations, drawings, analyses, and any applicable quality review have also been completed and approved in accordance with the procedures in this manual.
Reports issued for coment or review prior to final release shall be marked as such.
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6.0 REPORT LOG A report log showing report number, title, current revision and job number shall be maintained by the Records Center or other responsible organization approved by the Regional Quality Assurance Manager.
Each technical report shall also be listed as a deliverable in the Project QA File (refer to QP-2.3).
7.0 REVISIONS Revisions to technical reports shall be prepared, reviewed and approved the same as the ori ,!nal. At a minimum each revision shall be dated. The use of any revision identifier is at the option of the PE.
Where possible, each revision shall be issued as a complete report. Where this is not possible because of the size of the report or because of project requirements, the PE may issue the revised pages only, plus a new approval coversheet, a revised table of contents (if necessary), and a revision record page which explains the changes in full and the pages affected. The revision record shall be (m
() cumulative, such that the sunmary in the current report revision identifies all previous revisions.
Revised pages in the report shall indicate the new revision number. Pages which are unaffected by the revision shall remain unchanged. Changes in page numbering caused by a revision shall be identified and/or explained in the revision record summary, and shall be reflected in an updated table of contents, as appropriate.
8.0 QUALITY RECORDS Technical reports shall be retained as quality records in accordance with QP-4.1.
9.0 ATTACHMENTS A - Procedure Suninary O
QP-3.10 Revision 3
%rion (P<nc; woo (wa M
QUALITY ASSURANCE MANUAL O
TECHNICAL REPORTS PROCEDURE StMMRY REQUIREMENTS RESPONSIBILITY l
( Report preparation Person designated by PE Report review PE Report approval SM Report certification Registered Professional Engineer designated by SM Lampletion of supporting technical l activities (approved calculations etc) PE Report issue and revisions PE Report log Records Center or other responsible organization Transmittal of record copies to j Record Center. PE QP-3.10 Revision 3 l Impoll Corpo7atCon _
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4.0 QUALITY RECORDS CONTENTS QP-4.1 QUALITY RECORDS 1.0 QUALITY RECORDS 2.0 RECORDS COLLECTION AND SUBMITTAL 3.0 PECORDS CENTER PROCESSING 4.0 COMPUTER TAPES AND DISKS 5.0 RECORDS RETENTION AND DISPOSAL 6.0 RECORDS TURNOVER TO CLIENT 7.0 O 8.0 9.0 RECORDS TRANSFER BETWEEN REGIONAL OFFICES IN-PROCESS DOCUMENTS REGIONAL OFFICE RECORDS OPERATIONS 10.0 AUDITS O . .
QUALITY ASSURANCE MANUAL Reviewed ; Corpotate QA Manager
- 8. V 7/15/85 l
Approved - Sr. Vic,e' President / Date P R 0 C E O U R E QP-4.1 QUALITY RECORDS I
l
, This procedure establishes requirements for the ,
l collection, storage, maintenance, and disposition of {
quality records generated by Impell as specifically defined in this manual. Requirements in this i procedure address the following and are sisnmarized in Attachment A:
l
- a. Quality records definition and classification
- b. Records collection and submittal to Records Center !
- c. Records processing by Records Center l
- d. Computer tapes and disks
- e. Records retention and disposal
- f. Records turnover to client
- g. Records transfer between Impell regional offices
- h. Guidelines for in-process records
- i. Impell regional office records operations 1.0 QUALITY RECORDS
- 1.1 Definition Quality records are those documents that furnish l evidence of the quality of Impell services, products l and purchased items, and of the activities affecting I
this quality. A docisnent is considered a quality record when the document has been completed (e.g., ;
prepared, reviewed, and approved). l 1.2 Classifications Impell generates three (3) types of quality records:
- a. Engineering records which doctsnent the
! engineering process and its results (these records are generally delivered to the client at the completion of the project)
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- b. Project support records which document activities to ensure the quality of engineering operations and resulting engineering records
- c. Generic and Impell administrative records which apply to more than one project or are generated by organizations other than the engineering divisions Examples of each type of quality record are provided in Attachment B.
2.0 RECORDS COLLECTION Quality records are generated in accordance with AND SUBMITTAL the procedures of this manual. When completed, these records (either originals or copies) shall be submitted to the Records Center for retention in accordance with regional Records Center procedures and the schedule requirements in Attachment C.
All quality records submitted to the Records Center shall be legible and have sufficient contrast for micrographic reproduction.
3.0 RECORDS CENTER The Records Center shall perform records receipt, PROCESSING indexing and reproduction in accordance with Records Center procedures and any project specific requirements in the Project Quality Plan (QP-2.5).
Indexing and reproduction should be completed within two mcnths of receipt. Reproduction requirements are defined in Attachment C.
Af ter quality records reproduction, the originals of quality records shall be transmitted to the client or returned to the originator for retention until project completion, as defined in the Project l
Quality Plan.
Quality records may be hand written, printed, mechanical or magnetic recorded, or electronic impulse. All quality records shall be reproduced in either micrographic or hardcopy form.
4.0 COMPUTER TAPES '~
AND DISK 5 4.1 Conputer Programs The Software Librarian (QP-6.1) shall maintain the O
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QUALITY ASSURANCE MANUAL 9
computer program master and duplicate master tapes or disks at two separate locations and periodically replace these to prevent any loss of data.
4.2 Project Data Files Project data files are maintained on disk or tape at the computer center for duration of the project.
Backups are created according to nomal operating procedures. At project completion, the PE shall transfer disk project data files to tape (2 copies) and have these maintained at two separate storage locations 5.0 RECORDS RETENTION The Records Center shall retain copies of all AND DISPOSAL quality records in accordance with Records Center procedures for the minimum periods defined in l
Attachment 8. One copy shall be maintained at the i Records Center (or computer center for computer program tapes / disks) and one at a remote location.
The second location shall be sufficiently remote to preclude loss of both copies from a single event.
If one of the two copies should be lost or destroyed, another copy shall be made and again placed in a second location remote from the first.
Quality records may be destroyed at the end of the retention periods defined in Attachment B.
6.0 RECORDS TURNOVER TO CLIENT 6.1 Project Specific Quality records turnover and other project Requirements specific records handling requirements shall be defined by the Project Engineer (PE) in the Project Quality Plan at the beginning of the project. At a minimum, the Project Quality Plan shall define:
- a. Changes to Impell standard turnover requirements
- b. Turnover schedule (e.g. single revision basis or complete package at project completion),
including project specific exceptions to time requirements for Records Center indexing, reproduction, retention, and turnover
- c. Records fom and number of extra copies
- d. Hardcopy record disposition if not turned over to the client j O! l QP-4.1 Revision 4 RnmjUUPsanc.wnMyn __ _ _ _ _ _ A L a2 A-- - -----_
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- e. Records for which the client wants a complete revision history maintained 6.2 Turnover Process Impell quality records will be forwarded to the client during the course of the project or at project completion as specified in the Project Quality Plan. The final transmittal of records will be made at project completion. At that time, the PE shall make a final sort of all records, purge any unnecessary records and submit the complete project history to the Records Center for any final duplication.
The PE shall direct records turnover with assistance from the Records Center and Regional Quality Assurance Manager (RQAM) when requested.
7.0 RECOR05 TRANSFER Quality records may be transferred between l BETWEEN REGIONAL regional offices for use or retention in accordance l with QP-2.1.
G 8.0 IN-PROCESS DOCUMENTS In-process doceents are those docments which furnish evidience of work in progress and which have not met all requirements of the Quality Assurance Manual, i.e. checking, approval, etc. The follwoing guidelines are provided for dispositioning in-process documents when project work is placed on nold for an anticipated period of six months or &
longer.
All quality records should be forwarded to the Records Center in accordance with Quality Assurance Manual procedures, Records Center procedures and the Project Quality Plan. These records include, but i are not limited to job files, calculations, drawings, analyses, designs, reports and updated Project QA Files,
- a. All in-process docuents shall be reviewed by the PE or personnel designated by the PE. Those doc eents which can be completed with a minimum of effort should be completed.
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- b. Project QA Files - The Project QA Files shall be updated to reflect the current project status and then transmitted to the Records Center,
- c. Tecnnical Files - Each technical file snould contain a cover sheet which describes the status of the file and any information needed to complete the work. Potential problems shall be identified.
- d. Project specific reference materials and design input documents should be transmitted to the Records Center.
9.0 REGIONAL 0FFICE RECORDS OPERAfTONS 9.1 Records Center Records handling activities shall be governed by l Proceoures the general requirements of this procedure and by Records Center procedures defining specific regional implementation methods. Records Center procedures &
shall establish measures for the following: W
- a. Access control
- b. Records security
- c. Document receipt and status control
- o. Records index and filing system
- e. Reproduction operations
- f. Remote storage facility
- g. Records transfer and turnover
- h. Record disposal, as appropriate
- 1. Any region specific records requirements Records Center procedures shall be reviewed by the RQAH and approved by the responsible manager.
9.2 Regional Consistency Records Center procedures may vary in implementing techniques at each regional office, depending on project requirements and types of records generated. However, engineering work must be transferrable between regions. Records Center indexing and storage methods shall allow individual documents to be readily retrieved and transferred in usable form to other regions.
9.3 Responsinilites Records handling operations may be accomplished by personnel or organizations other than those h QP-4.1
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\s' specified in this procedure provided they are so defined in the Records Center procedures.
10.0 AUDITS Each regional Records Center and the Sof tware Librarian activities shall be audfied annually to verify implementation and compliance to the requirements in this procedure. Audit scope shall include a review of any Impell/ reproduction service bureau interf ace, adequacy of remote storage f acilities (including magnetic tape storage), and a review of Records Center operations.
14.0 ATTACHMENTS A - Procedure Simnary B - Quality Records Retention Schedule C - Quality Records Progran l
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1 1
QUALITY RECORDS i
PROCEDURE
SUMMARY
REQUIREMENTS RESPONSIBILITY
- f. cords collection and submittal to Recoros Center PE Recoros processing Records Center Records retention Records Center &
Software Librarian Client records requirements PE define in Project Quality Plan in-process records handling Recoros turnover to client PE h
PE Records center procedures Prepare Records Center Approve RQAM & Responsible Manager Records operations audit QA Manager QA Manager O
QP-4.1 Revision 4 Impell Corporation Attachment A
QUALITY ASSURANCE MANUAL l3 V
QUALITY RECOR05 QUALITY RECORDS RETENTION SCHEDULE IMPELL RETENTION ENGINEERING RECORDS TIME Analyses Lifetime (plant or facility)
Project specific computer program development and verification Lifetime Calculations Lifetime Specifications Lifetime Drawings Lifetime Tecnnical reports Lifetime l Procurement documents Lifetime
! Camputer program project data tapes 2 years PROJECT SUPPORT RECORDS Project training 10 years Project instructions 10 years Quality reviews 10 years Project logs 10 years Project job files 10 years Impe11 procurement quality records 10 years Vendor quality records Transmitted to j client l GENERIC AND ADMINISTRATIVE RECORDS Impe11 standard computer program development and maintenance files Lifetime Impell Quality Arsurance Manual Lifetime Nonconfonnance reports Lifetime Quality assurance audit flies 10 years i
Quality assurance auditor qualifications 10 years Quality training 10 years Quality program management review files 10 years OTHER 10CFR21 files Lifetime Computer program tapes Lifetime QP-4.1 Revision 4 i m nooryxmne a
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QUALITY RECORDS QUALITY RECORDS PROGRAM GENERIC AND ENGINEERING PROJECT SUPPORT ADMINISTR ATIVE RECORDS RECORDS RECORDS ORIGINAL TO RECORDS PE submit within PE submit at Originator CENTER 3 months of doc- project submit on an ument completion completion annual basis REPRODUCTION (within Two copies N/A Two copies 2 montns of receipt)
TlRNOVER TO CLIENT Final revision N/A N/A (within 3 months of one copy project completion)
IMPELL RETENTION Two copies--all One copy Two copies--
revisions all revisions e
9 QP-4.1 Revision 4 Impell Corporation _ ___ Attachment C _ _
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I l
5.0 PROGRAM COMPLIANCE CONTENTS QP-5.1 QUALITY ASSURANCE AUDITS & SURVEILLANCES 1.0 REQUIRED AUDITS 2.0 AUDIT SCHEDULE 3.0 AVOIT PREPARATION 4.0 PERFORMANCE OF AUDITS 5.0 POST-AUDIT MEETING b.0 AUDIT REPORT 7.0 CORRECTIVE ACTION 8.0 VERIFICATION OF CORRECTIVE ACTION 9.0 AUDIT CLOSE0VT 10.0 AUDIT LOG QP-6.2 AUDITOR QUALIFICATION 1.0 AUDITOR QUALIFICATION 2.0 LEAD AUDITOR QUALIFICATION 3.0 MAINTENANCE OF LEAD AUDITOR PROFICIENCY L
4.0 AUDIT PREPARATION LOG 5.0 REQUALIFICATION QP-5.3 STOP WORK 1.0 STOP WORK AUTHORITY 2.0 STOP WORK CONDITION 3.0 STOP WORK NOTICE 4.0 WORK RESTRICTIONS 5.0 CORRECTIVE ACTION 6.0 RESUMPTION OF WORK 7.0 DOCUMENTATION QP-5.4 NONCONFORMANCE REPORTING & RESOLUTION 1.0 NONCONFORMANCE DEFINITION 2.0 IDENTIFICATION AND REPORTING 3.0 NONCONFORMANCE RESOLUTION 4.0 VERIFICATION AND CLOSE0VT 5.0 DOCUMENTATION i
l Impell Corporation
QUALITY ASSURANCE MANUAL RevieGed '- Cdrpbrate QA Manager h / // 7/15/85 Approved - Sr. Vice President / Date PR0CEDURE QP-5.1 QUALITY ASSLRANCE AUDITS
& SURVEILLANCE 5
.iis procedure establishes a system for internal auditing of work perfomed by Impell to verify that quality requirements in this manual are complied with in an effective manner. Requirements in this procedure address the following activities and are surnnarized in Attachment A:
i
- a. Required audits (surveillances)
- b. Audit schedule
- c. Audit preparation
- d. Performance of audits
- e. Post-audit meeting
- f. Documentation of audit findings
- g. Corrective action and verification
- h. Audit closecut
- i. Audit log 1.0 REQUIRED AUDITS 1.1 Regional Office On an annual basis, the regional quality assurance Quality Audits staff shall audit each generic scope of work for each client in each Impell organization (Section).
Examples of generic scopes of work are piping analysis, pipe support design, electrical equipment qualification, structural analysis and design, thermal-hydraulic analysis, etc. Audits may be l
perfomed on a client, project or discipline basis.
More frequent audits shall be performed when considered necessary by the Regional Quality Assurance Manager (RQAM) due to the complexity of the work or the need to monitor identified problem areas.
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U The RQAM may request a more detailed technical evaluation of any project work where the quality assurance audit identifies a potential technical
- problem. The technical evaluation shall be l completed and written results transmitted to the RQAM within the time-tree specified by the RQAM.
Surveillances may be substituted for audits where prior audits have been completed within the previous 12 months on the same type of work performed by the sane organization. Surveillances may also be substituted for audits early in a project or as follow-up to a previous audit. Surveillances shall be perfomed according to the requirements of Section 1.4 below.
1.2 Corporate Quality Corporate quality assurance audits of each regional Assurance Audits office shall be perfonned annually to verify compliance with the requirements of this manual.
3 These audits shall include a review of the major x~ quality functions and responsibilities of the regional quality assurance organization. More frequent audits may be performed at the discretion of the Corporate Quality Assurance Manager (CQAM).
1.3 Audits of Project requirements may stipulate that Impell Subcontractors retain subcontractors for nuclear safety-related work. These subcontractors shall be audited by the Quality Assurance Manager in accordance with the requirements of this procedure. Schedule requirements for subcontractor audits are provided in QP-7.3 and QP-7.4.
1.4 Surveillances In addition to routine, periodic audits, the Quality Assurance Manager may perform supplemental surveillances to assess quality program implementation on topical or highly specific areas.
The following controls apply to surveillances:
- a. Surveillances shall be performed by qualified auditors or lead auditors
- b. Surveillances shall be numbered and logged
- c. A written report identifying results of the surveillance shall be issued to the responsible manager I
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- d. Unsatisf actory items shall be corrected within 30 days except when agreed otherwise by the Quality Assurance Manager
- e. Completion of satisf actory corrective action shall be verified by the Quality Assurance Manager
- f. Surveillance closeout shall be documented
- g. The surveillance report and doctanentation of correr+1ve action, follow-up, and closeout shall be maintained in a surveillance file Surveillances do not require audit plans, checklists, or prior notification.
2.0 AUDIT SCHEDULE The Quality Assurance Manager shall maintain an audit schedule which identifies activities to be audited (both ongoing activities and new projects),
the month to be audited, and the status of each audit. The audit schedule shall cover a period of at least three months and shall be distributed to the organizations to be audited. The schedule shall be updated and reissued as determined necessary by the Quality Assurance Manager.
The Quality Assurance Manager may schedule and audit any project activity at any time to verify compliance with the quality program.
3.0 AUDIT PREPARATION 3.1 Audit Team The Quality Assurance Manager shall select the Selection auoitors and lead auditor for each audit. Each audit team member shall be trained and qualified in accordance with QP-5.2. No member of the audit team shall have had any direct responsiblity for the work being audited.
Technical specialists may perform technical evaluations as part of the quality assurance audit.
These personnel need not be qualified to QP-5.2.
3.2 Audit Plan The audit team shall prepare a written audit plan documenting the audit scope and general types of 9
QP-5.1 Reeisisn 6
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G activities to be reviewed / verified. The audit team -
I leader shall approve the audit plan. l The audit team shall review the audit plan and )
checklist (Section 3.4) to assure their understanding of the activities to be audited and the audit methods to be used.
3.3 Notice of Audit The audit team leader shall provide reasonable advance notice to the organization or project to be audited. This notice shall identify the date(s) of the audit, the general scope, and any special assistance that will be needed. The notice should be in writing.
3.4 Audit Checklists The audit team shall prepare written checklists for l conducting the audit. These checklists shall define i the activities tc, be reviewed (as defined in the audit plan) and the Quality Assurance Manual procedure which governs each activity. Audit O checklists shall address all applicable controls prescribed in the Quality Assurance Manual, and shall include any special project, discipline, or contractual quality requirements.
3.5 Pre-Audit Meeting A pre-audit meeting should be held by the audit team to discuss the audit scope with responsible personnel from the organization to be audited.
f 4.0 PERFORMANCE OF AUDITS 4.1 Rignt of Access Audit team personnel have the right to review relevant doceents and contact appropriate personnel to properly perform the audit.
4.2 Audit Checklists The audit shall be conducted using written checklists. Each auditor shall identify the specific doceents or items reviewed during the audit. These may be identified on the checklist or in separate worksheets maintained in the audit file. The status of each checklist question shall be clearly identified on the checklist. There shall be no unresolved entries or comments on the checklist, all findings shall be identified, and QP-5.1 Revision 6
QUALITY ASSURANCE MANUAL O
there shall be complete traceability between checklist findings and the audit report.
Each completed checklist shall be signed by the responsible auditor (s) as evidence that the checklist criteria have been applied to the activities audited and that the findings are as indicated.
4.3 Classification of Audit findings shali be classified as deficiencies Audit Findings or recomendations as follows:
A deficiency is an unresolved violation of one or more quality requirements in this manual.
Deficiencies shall be documented in the audit report and resolved with a written statement of corrective action.
A recomendation is made to clarify a quality requirement or suggest a more expedient or effective means of complying with quality requirements. A written response to recommendations shall be provided when specifically requested in the audit report.
4.4 Personnel Contacted The audit team shall maintain a listing of key During Audit personnel contacted during the audit.
5.0 POST-AUDIT MEETING The audit team leader shall hold a post-audit meeting to discuss the audit, f actual bases for identified deficiencies, recomended corrective actions, and the due date for corrective action response. This meeting shall be attended by responsible management fran the audited organization and the audit team leader. Attendance shall be documented on the personnel contact form (Section 4.4).
6.0 AUDIT REPORT The Quality Assurance Manager or audit team leader shall issue a written audit report to the responsible manager of the audited organization. !
This report shall include:
- a. Sumary of the audit investigation QP-5.1 Revision 6 anmRLRnemnMen
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- b. Listing of the activities audited
- c. Each identified deficiency
- d. Recommended corrective action for each deficiency and action to prevent recurrence when determined appropriate by the Quality Assurance Manager
- e. Recomendations identified in the audit checklist
- f. Due date for completion of corrective action and written response to the report (normally 30 days) 7.0 CORRECTIVE ACTION The responsible manager of the auotted organization shall direct implementation of the required corrective action. Corrective action shall include action to prevent recurrence of similar deficiencies on other work when specifically requested in tne audit report. Actions taken shall be documented in a response to the audit report and the response returned to the Quality Assurance Manager as 1 required in the audit report. If the required
") action cannot be completed by the due date, the response shall include a scheduled completion date.
Any revision to the due date requires approval of the Quality Assurance Manager.
8.0 VERIFICATION OF, The Quality Assurance Manager or audit team CORRECTIVE ACTION shall review each deficient activity to assure adequacy of the corrective action and action taken to prevent recurrence. Closecut of each deficiency shall be documented in the audit file. This review shall be performed by a qualified auditor.
l l 9.0 AVOIT CLOSEOUT When all actions are completed and verified to the
! satisf action of the Quality Assurance Manager, the l
Quality Assurance Manager shall formally notify the audited organization of same and indicate the audit is closed. A copy of the audit closeout notification shall be included in the audit file.
10.0 AUDIT LOG Each Quality Assurance Manager shall maintain an auditlogwhichlistseachaudit(orsurveillance) to be performed, a unique number for each, date(s)
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the audit was performed, scheduled date for completion of corrective action and date corrective action was verified complete and the audit was closed.
11.0 QUALITY RECCROS Completed audit and surveillance files shall be maintained as quality records in accordance with QP-4.1. Each audit file shall include:
- a. Audit number, organization audited, activities audited, date(s) of the audit, audit team, and closecut signature of the Quality Assurance Manager
- b. Audit closeout notification
- c. Audit report
- d. Response from the audited organization
- e. Completed audit checklists
- f. Audit plan and any written pre-audit notification
- g. Other data (e.g. worksheets) considered necessary to document the audit process 12.0 ATTACHMENTS A - Procedure Sunnary O
QP-5.1 Revision 6 Impell Corporation Paoe 7 of 7
l QUALITY ASSURANCE MANUAL fm QUALITY ASSURANCE AUDITS PROCEDURE Suf9(ARY REQUIREMENTS RESPONSIBILITY Determine audits /surveillances to be QA Manager performed and scheduled Select audit team QA Manager Audit plan Prepare Audit team Approval Audit team leader Audit notification Audit team leader Prepare Audit checklists Audit team Pre-audit meeting Audit team leader Perfom audit & complete checklists Audit team Maintain personnel contact list Audit team Post-auait meeting Audit team leader Issue auait report QA Manager or audit team leader Take necessary corrective action Audited organization Verify corrective action QA Manager or audit team leader Issue audit closeout notification QA Manager A
V QP-5.1 m_m . - . _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _
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QUALITY ASSURANCE MANUAL 9
2k/
Retieted - Corpbrate QA Manager M l/ 7/15/85 Apprpved - Sr. Vice President / Date PR0CEDURE QP-5.2 AUDITOR QUALIFICATION This procedure establishes the methods by which Impell personnel are trained and qualified to perform quality assurance audits and surveillances.
Requirements in this procedure address the following activities and are stenarized in Attachment A:
- a. Auditor training & certification
- b. Lead auditor certification
- c. Maintenance of lead auditor certification
- d. Audit participation log
- e. Requalification Only persons qualified in accordance with this procedure shall participate as an auditor or lead auditor in quality audits and surveillances (QP-5.1). Auditors shall not audit any activity for which they have had responsibility for performing or supervising.
1.0 AUDITOR QUALIFICATION 1.1 Auditor Training To qualify as an auditor, an individual shall complete an auditor training course directed by the Corporate Quality Assurance Manager (CQAM), or a Regional Quality Assurance Manager (RQAM). Training session agenda and completion of required reading shall be doctsnented. Training criteria shall include the subjects listed below:
GENERAL BACKGROUND
- a. History and development of quality assurance
- b. Quality assurance within the nuclear industry
- c. Impell quality objectives and philosophy
' QP-5.2 Revision 3
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d- Impell quality organization
- e. Impell Quality Assurance Manual CODES AND STANDARDS
- b. ANSI N45.2 and daughter standards
- c. ANSI-ASME NQA-1/NQA-2
- d. NRC Regulatory Guidas applicable to Impell Quality Program AUDITS
- a. Audit objectives
- b. Contract or project quality requirements
- c. Audit techniques
- d. General and special checklists
- e. Performing the audit
- f. Documenting audit results 3 g. Audit report
- h. Corrective action i Audit follow-up and close-out 1.2 Audit Participation The auditor candidate shall participate in at least two audits as an auditor-trainee prior to qualification.
1.3 Auditor Certification The Quality Assurance Manager shall issue an auditor certification to each person satisf actorily completing the above qualification requirements.
This certification shall state name of the person qualified and month of qualification, and shall be signed by the Quality Assurance Manager.
2.0 LEAD AUDITOR To qualify as a lead auditor an individual shall QUALIFIC ATION meet the following criteria:
2.1 Auditor Training Complete the Impell auditor training course or present evidence of having completed an equivalent course.
2.2 Qualification Fonn Score ten (10) or more points on the lead auditor qualification fonn contained in ANSI N45.2.23.
O QP-5.2 l
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QUALITY ASSURANCE MANUAL 9
2.3 Written Examination Pass a written examination administered by the Quality Assurance Manager. The examination shall be documented and shall be suffft*ient to evaluate the individual's connunication skills and general comprehension of:
- a. Impell organization
- b. Impell Quality Program
- c. Appropriate quality standards and related codes and regulations
- d. Audit planning and execution techniques Quality deficiencies, corrective action, and e.
follow-up
- f. Reporting audit findings to management 2.4 Audit Participation Participate in at least five quality assurance audits in the previous three years, with at least one in nuclear quality assurance in the 12 months prior to qualification.
2.5 Lead Auditor The Quality Assurance Manager shall issue a 1,ead Certification auditor certification to each person satisf actorily completing the above qualification requirements.
This certification shall docuraent:
- a. ANSI N45.2.23 qualification points (Section 2.2 above) and related education, experience, professional certification or other justification
- b. Auditor connunication skills
- c. Auditor training courses
- d. Audit participation
- e. Results of written examination The certification shall be signed by the Quality Assurance Manager.
3.0 MAINTENANCE OF LEAD The Quality Assurance Manager shall perfonn an AUDITOR PROFICIENCY annual assessment of each lead auditor to determine their proficiency in quality assurance auditing.
Lead auditors shall maintain their proficiency through one or more of the following:
i
- a. Regular and active participation in the audit i process 9
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- b. Review and study of codes, -standards, procedures, instructions, and other documents related to quality assurance programs and auditing
- c. Participation ir, quality assurance or audit #
training programs RQAMs shall have their annual lead auditor assessment per#ormed by the CQAM. The CQAM assessment shall be performed by the Sr. Vice President.
4.0 AUDIT PARTICIPATION LOG The Quality Assurance Manager shall maintain an audit participation log for each qualified auditor and lead auditor actively participating in audits of their respective organizations. This log shall list l the audit number, audit date(s) and audit role I
(auditor or lead auditor). These audit participation logs shall be maintained by the C0AM or RQAM in their respective auditor qualification files.
5.0 REQUALIFICATION The Quality Assurance Manager shall requalify lead auditors who f ail to maintain their proficiency for a period of two years or more. Requalification requires retraining and re-examination in accordance with this procedure.
6.0 QUALITY RECORDS The Quality Assurance Manager shall maintain a qualification file for each auditor and lead auditor certified. These qualification files shall be maintained as quality records in accordance with QP-4.1.
l 7.0 ATTACHMENTS A - Procedure Suninary 9
G QP-5.2 Revision 3 ___
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QUALITY ASSURANCE MANUAL i l
O AUDITOR QUALIFICATION
, PROCEDURE SUtHARY REQUIREMENTS RESPONSIBILITY Auditor training QA Manager Auditor participation Auditor candidate Auditor certification QA Manager Lead auditor qualification Auditor training QA Manager Qualification " points" fom QA Manager Written exam Auditor candidate graded QA Manager Audit participation Auditor candidate Certification QA Manager Maintenance of proficiency QA Manager Audit participation log QA Manager Auoitor/ lead auoitor requalification QA Manager Retention of auditor certification records QA Manager
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QP-5.2' Revision 3 Impell Corporation Attachment A
OUALITY ASSURANCE MANUAL o
() $N-Revitfwed - Gorporate QA Manager
/ / 7/15/85 Approved - Sr. Vice President / Date PR0CEOURE QP-5.3 STOP WORK This procedure establishes requirements for stopping work on significant nonconfoming activities until i appropriate corrective action is taken. '
Requirements in this procedure address the following activities and are sunmarized in Attachment A:
- a. Stop work authority
- b. Conditions for stop work -
- c. Stop work notice
- d. Work restrictions
- e. Corrective action
- f. Resumption of nork l 1.0 STOP WORK AUTHORITY The Corporate Quality Assurance Manager (CQAM) and Regional Quality Assurance Managers (RQAM) have l authority to stop work in accordance with this l procedure. ,
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2.0 STOP WORK CONDITIONS Quality nonconfomances may be identified in the I course of quality assurance audits, technical quality reviews, or routine project surveillances.
A notice to stop work shall be issued whenever a ,
nonconformance shows evidence of a fundamental i breakdown in quality activities and when stopping l work and taking immediate corrective action is the only effective means of correcting the nonconfomance and preventing further recurrence. !
3.0 STOP WORK NOTICE Stop work conditions are invoked using a stop work !
notice. The notice shall specify: l
- a. Deficiency observed and nonconfomance report identifiying the deficiency l
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- b. Responsible manager (s) and organization (s)
- c. Location and description of work to be stopped A nonconformance report identifying the deficiency shall be prepared in accordance with QP-5.4 and attached to the stop work notice. The notice shall be signed by the responsible Quality Assurance Manager. Each stop work notice shall have a unique identifying number.
3.1 Distribution The stop work notice and nonconformance report shall be distributed to the following:
- a. Sr. Vice President
- b. Corporate Quality Assurance Manager
- c. Regional Manager
- d. Regional Quality Assurance Manager
- e. Other managers as appropriate 3.2 Posting The stop work notice shall be posted in the imediate area where the work is performed.
4.0 WORK RESTRICTIONS During the period of stop work the following work restrictions apply:
- a. No further work on the nonconforming task (s) shall be performed
- b. Work previously completed and still within Impell shall not be issued or released to other organizations within or outside Impell 5.0 CORRECTIVE ACTION Required corrective action shall be completed by the responsible manager (s) and the nonconformance report returned to the Quality Assurance Manager by the stated due date. Corrective action shall include any action necessary to prevent recurrence of similar nonconfonnances in the future.
The Quality Assurance Manager shall verify that required corrective action has been completed and is adequate to prevent recurrence of similar nonconformances.
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6.0 RESLNPTION OF WORK When corrective action has been completed and verified, the Quality Assurance Manager shall rescind the stop work notice so that work may restine.
7.0 DOCUMENTATION The Quality Assurance Manager shall retain a file of
, stop work notices, associated nonconformance reports, and any other infonnation necessary to document the action taken to identify, evaluate, and resolve each stop work condition.
8.0 QUALITY RECORDS Stop work files shall be retained as quality records in accordance with QP-4.1.
9.0 ATTACHMENTS A - Procedure sumary l
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STOP WORK PROCEDURE
SUMMARY
REQUIREMENTS RESPONSIBILITY Issue stop work order QA Manager Report stop work order to responsible management QA Manager Assign corrective action QA Manager Take corrective action to resolve nonconformance Responsible manager Take action necessary to prevent future recurrence of nonconformance Responsible manager Verify adequate corrective action taken QA Manager O Autnorize work resumption QA Manager Maintain stop work documentation QA Manager O
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RevieweA 'Corpdrate QA Manager Nh/ 7/15/85 Approved - Sr. Vicg President / Date PR0CEDURE QP-5.4 NONCONFORMANCE REPORTING & ,,
RESOLUTION This procedure establishes requirements for reporting and resolving technical errors or other quality nonconformances which are not identified and resolved through quality assurance audits, technical reviews, or other controlled processes defined in this manual. Requirenents in this procedure address the following activities and are samarized in Attachment A:
- a. Nonconformance definition
- b. Identification & reporting
- c. Resolution
- d. Nonconformances involving more than one region
- e. Verification of corrective action
- f. Docnentation 1.0 NONCONFORMANCE A nonconformance is a significant deviation from DEFINITION technical criteria or violation of procedural requirements such as:
- a. Technical error in completed work
- b. Failure to follow quality procedure requirements
- c. Incorrect doceentation
- d. Unauthorized changes to technical work or doc m ents
- e. Initiation of 10CFR21 proceedings (preliminary evaluation) in accordance with QP-1.4.
- f. Initiation of stop work proceedings in
, accordance with QP-5.3.
2.0 IDENTIFICATION &
REPCRTING 2.1 Nonconformance Engineering, management and/or quality assurance Identification staff personnel shall notify the responsible Quality QP-5.4 Revision 2 ,
QUALITY ASSURANCE MANUAL e
Assurance Manager of any potential nonconformance as ,
defined above. This notification shall be made l within one working day af ter initial knowledge of the potential nonconfomance.
2.4 Nonconformance Potential nonconfomances shall be evaluated by the Reporting Quality Assurance Manager to assess the extent of nonconformance and any potential impact on safety.
This assessment shall be perfomed with the assistance of eesponsible operating division personnel.
The identified nonconformance shall be documented on a nonconfomance report (NCR) approved and issued by the Quality Assurance Manager. The NCR shall specify:
- a. NCR number (serialized)
- b. Nature of the noncenformance
- c. Location (division, project, job No.)
- d. Reconsnended resolution (corrective action)
- e. Due date for completing corrective action The NCR shall be distributed to:
- a. Responsible manager (s)
- b. Regional Manager
- c. Corporate Quality Assurance Manager (CQAM)
- d. Regional Quality Assurance Manager (s) as appropriate 2.3 Client Notification Clients shall be promptly notified by the responsible manager of any Impell technical errors in work previously completed and transmitted to the client.
2.4 NCR Log The Quality Assurance Manager shall maintain a current status listing of open and closed nonconformance reports.
3.0 NONCONFORMANCE Rt50LUTION 3.1 Correcti ve Action The responsible Section Manager (SM) shall take QP-5.4 Revision 2
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QUALITY ASSURANCE MANUAL necessary action to correct the reported nonconfomance. For each nonconformance, the cause of the nonconfomance shall be determined and measures taken to prevent recurrence in the future.
The SM shall document resolution of the nonconformance (corrective action, identified cause and action to prevent recurrence) on the NCR and return same to the Quality Assurance Manager.
3.2 Nonconfonnances The following shall be completed for nonconformances Affecting which affect more than one Impell regional office:
Multiple Regions -
- a. The initiating Quality Assurance Manager shall notify the CQAM who in turn shall notify the appropriate regional offices and request that a review be perfonned. Each region shall provide a written response to the CQAM.
- b. The CQAM shall coordinate resolution of the C
"provide "' "'guidance
'"'" tothese regions on how to document the review / evaluation. The initiating region has the lead responsibility in resolving any technical issues.
- c. In cases where work for other clients is affected, such clients shall be promptly notified if the NCR affects completed work transmitted to the client.
- d. The RQAMs shall coordinate recomendations for corrective action with the CQAM to ensure that corrective measures are uniformly applied in all offices and are sufficient to cover the scope of Impell responsibility.
4.0 VERIFICATION & CLOSE00T Resolution of the nonconformance shall be verified by the Quality Assurance Manager. The nonconformance shall not be closed until all corrective and preventative measures have been completed, or long-term corrective measures established and implemented.
5.0 DOCUMENTATION The Quality Assurance Manager shall maintain each n
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NCR in a file along with the following supporting docunentation:
- a. Initial notification which resulted in the NCR
- b. Results of any Impell technical evaluation
- c. Other pertinent infonnation necessary to docisnent resolution of the NCR, including scope and significance of the problem 6.0 QUALITY RECORDS Completed (closed) NCRs and associated docunentation shall be retained as quality records in accordance with QP-4.1.
7.0 ATTACHMENTS A - Procedure Suntnary O
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NONCONFORMANCE REPORTING & RESOLUTION PROCEDURE SlM4ARY REQUIREMENTS RESPONSIBILITY Identify nonconformance end notify responsible Engineering, management, QA Manager witnin one working day QA sta/f Evaluate potential nonconformance QA Manager Prepare, approve and issue NCR QA Manager Notify affected clients Responsible manager Maintain NCR log QA Manager
( Take required corrective action, including N
action to prevent recurrence Responsible organization Coordinate resolution of multiple region nonconformances CQAM Verify necessary corrective action taken QA Manager Maintain nonconfonnance documentation QA Manager i
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6.0 COMPUTER APPLICATIONS CONTENTS QP-6.1 COW UTER SOFTWARE QUALITY PROGRAM 1.0 APPLICABILITY 2.0 SOFTWARE CLASSIFICATIONS 3.0 MICROCOMPUTER PROGRAMS 4.0 OTHER PROGRAM TYPES 5.0 COMPUTER PROGRAM INDEX 6.0 SOFTWARE LIBRARIAN 7.0 INSTALLATION TESTING 8.0 SOFTWARE ACCESS CONTROL 9.0 USE OF COMPUTER SOFTWARE 10.0 RELEASE OF SOFTWARE TO NON-IMPELL ORGANIZATIONS 11.0 COMPUTER OPERATING SYSTEM REVISIONS QP-6.2 IMPELL STANDARD COWUTER PROGRAMS 1.0 PROGRAM DEFINITION AND PROCEDURE APPLICA81LITY 2.0 PROGRAM IDENTIFICATION 3.0 PROGRAM DEVELOPMENT 4.0 PROGRAM VERIFICATION 5.0 RELEASE AND USE 6.0 PROGRAM MAINTENANCE 7.0 PROGRAM MODIFICATIONS QP-6.3 PROJECT SPECIFIC COMPUTER PROGRAMS 1.0 APPLICABILITY 2.0 PROGRAM DEVELOPMENT AND VERIFICATION 3.0 PROGRAM USE I 4.0 PROGRAM MAINTENANCE l 5.0 PROGRAM ARCHIVING 6.0 MICROCOMPUTER PROGRAMS 7.0 PROGRAMMABLE CALCULATORS QP-6.4 PUBLIC DOMAIN COMPUTER PROGRAMS 1.0 APPLICABILITY 2.0 SERVICE BUREAU QUALIFICATION 3.0 USER MANUALS 4.0 PROGRAM USE 5.0 RESPONSIBILITIES
.Igell Cor[3 oration - - - -
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COMPUTER APPLICATION (Cont'd)
QP-6.5 MICROCOWUTER PROGRAMS 1.0 APPLICA8ILITY 2.0 PROGRAM DEVELOPMENT y
3.0 VERIFICATION 4.0 PROGRAM IDENTIFICATION 5.0 PROGRAM COPIES 6.0 MICROCOMPUTER PROGRAM USE 7.0 MODIFICATIONS 8.0 PROGRAM AR6.i!VING 9.0 MICROCOWUTER STANDARD PROGRAMS O
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- / 7/15/85 Approped - Sr. Vice fresident / Date PR0CEDURE QP-6.1 COMPUTER SOFTWARE QUALITY PROGRAM This procedure defines the quality program for computer software used by Impell. The requirements in this procedure, along with the other procedures in Section 6.0 of this manual, assure that computer software used by Impell and that delivered to clients will perform as intended. Requirements in this procedure address the following:
- a. Applicability of computer software quality program
- b. Software classifications (Impell standard, project specific and public domain)
- c. Microcomputer (user controlled) programs
- d. Other programs (graphics display, data base manager and application generator programs)
- e. Sof tware Librarian responsibilities f Installation testing
- g. Software access control
- h. Use of camputer sof tware
- 1. Release of sof tware to non-Impell organizations J. Computer operating systen revisions Attachment A illustrates these quality requirements for ccmputer sof tware.
l 1.0 APPLICABILITY Requirements in the procedures in Section 6.0 of this manual apply to all computer sof tware developed, maintained and used by Impell for production engineering activities. These requirements also apply to sof tware developed under contract to a client. Project control requirenents defined in the other sections of this manual shall also be applied to projects developing computer sof tware under contract to a client when specifically defined in the Project Quality Plan (QP-2.5).
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e QUALITY ASSURANCE MANUAL lO Software used at client request and not controlled by Impell should be certified by the client to meet
- client quality requirements. If not certified, a i
disclaimer statenent shall be included with all l Impell transmittals to the client which includes computer program results or work that incorporates such results.
2.0 SOFTWARE CLASSIFICATIONS 2.1 Impell Standard Standard programs are those progr as developed, Programs verified and maintained by Impell for general use throughout the company and by Impell clients.
Procedure QP-6.2 defines quality requirements for Impell standard programs.
2.2 Project Specific Project specific programs are those programs Programs developed and verified by the project organization for a single project application. Project specific programs may be:
- a. Simple data fonnatting or minor computational operations that apply to only one calculation or to a specific task for a project
- b. Project specific versions of Impell standard programs.
Procedure QP-6.3 defines quality requirements for project specific programs.
2.3 Public Donain Programs Public domain programs are those progras controlled and maintained by organizations other than Impell and used by Impell on that organization's computer system. Procedure QP-6.4 defines quality requirements for public domain programs.
l Computer programs which are purchased or leased by Impell for use on Impell or other computer systems shall be verified and maintained according to the quality requirements for either Impell standard or project specific programs, as appropriate.
l 3.0 MICROCOMPUTER PROGRAMS Microcomputer programs are those programs which operate on individual work station hardware using QP-6.1 Revision 0 l
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QUALITY ASSURANCE MANUAL Oll disk, tape or other storage medium controlled by the user. Quality requirements for microcomputer programs are defined in QP-6.5.
4.0 OTHER PROGRAM TYPES 4.1 Graphics Programs Quality program requirements in Section 6.0 of this manual do not apply to graphic display or draf ting computer programs. Howe:.er, all plots that are used to prove assumptions, display geometric data input, show dynamic parameters versus time or arrive at analysis or design decisions must be independently verified in accordance with QP-3.6. Sufficient data points must be verified to confirm accuracy of the infonnation taken from the plot. In addition, each plot snall be signed by the originator and verifier. All final drawings generated by graphics programs shall be independently verified, approved and controlled in accordance with QP-3.2.
4.2 Data Base Manager Quality program requirements in Section 6.0 of this Programs manual do not apply to data base manager computer programs. However, computational results generated by data base manager applications that are used to support analysis, design or other technical engineering work shall be independently verified in
' accordance with QP-3.6. A sample of each program operation (i.e. sort, arrange, add, substract etc.)
i must be verified to confinn accuracy of the data used. In addition, each printout shall be signed by the originator and independent verifier indicating that the output has been properly reviewed.
4.3 Application Generator Application generator sof tware may be used Programs (Layered to develop Impell standard programs. Such Products) standard programs shall be developed, verified and maintained in accordance with the requirements in QP-6.2. In addition, the following requirements in QP-6.2 apply to the release, installation and use of application generators:
- a. A version log, copy control log and error notice system shall be maintained.
- b. User manual distribution shall be controlled.
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- c. Program source and executable copies shall be controlled by the Sof tware Librarian according to Section 6.0 of this procedure,
- d. A release meno shall be issued for each version.
5.0 COMPUTER PROGRAM INDEX The Corporate Quality Assurance Manager (CQAM) shall maintain an index of Impell standard computer applications which defines:
- a. Program name
- b. Unique version identifier
- c. Applicable operating hardware
- d. Program description
- e. Program status (i.e., developnent, test production, archived)
- f. Responsible progran engineer and office t
m This index shall be distributed to all Impell organizations who use Impell standard programs. The index shall be updated and periodically redistributed as determined necessary by the CQAM.
6.0 SOFTWARE LIBRARIAN A Software Librarian (SL) shall be established to control the installation and duplication of Impell standard canputer programs as follows:
- a. When verification testing has been successfully completed, the developing organization shall transf er the master copy of the program to the SL.
- b. The SL shall create a backup master which shall be maintained in a separate location as required in QP-4.1. A listing of the files on the master and backup shall be maintained with each copy.
Access to the master and backup copies shall be controlled by the SL. The master and backup shall be replaced as necessary to assure no loss of information during the life of the progran.
, c. After release of the production version is I authorized by the responsible Quality Assurance
, Manager, the SL may install the executable
! (refer to QP-6.2).
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- d. With approval from the Program Engineer, additional executable copies (including installation tests) may be created by the SL and sent to other computer centers for installation. Each executable copy shall be traceable to the master copy and traceability l documentation shall be maintained by the SL.
- e. Each copy of programs sent to other organizations shall be accompanied by a copy of the release notice for the pregram plus a certification from the SL stating that the copy is traceable back to the master copy.
Installation test acceptance criteria shall also be provided.
- f. The SL, and other organizations installing the progran, shall perfonn the installation tests provided with the progran copy. Refer to Section 7.0 of this procedure.
- g. The SL shall maintain a tape / disk program copy log. This log shall list the program master copy nunber, backup master number, all program copies created fran either master copy, the organization receiving each copy and the transmittal dates. This log shall be submitted to the Program Engineer annually for retention in the program maintenance file.
, A single SL may be used for all Impell computer operations, or a separate SL for each computer center. The responsible development organization may perfonn the SL function for programs as specifically approved by the Regional Quality Assurance Manager (RQAM).
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l 7.0 LNSTALLATION TESTING The organization having technical responsibility for an Impell standard program shall establish a set of installation tests and acceptance criteria for the progran. These shall be supplied with each copy of the program and shall be perfonned by the responsible operating organization prior to it being used for production work. The operating organization shall docunent satisf actory completion of the installation tests and maintain the docunentation wnile the specific version of the program is installed.
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8.0 SOF TWARE ACCESS CONTROL User access controls shall be established for main free or centrally controlled minicomputer systems.
The operating organization shall issue user names and passwords for each person using Impell standard and project specific programs for production work.
Only users issued passwords shall have access to standard and project specific prngrams. An Impell job number or account shall also be required each time a user accesses a standard or project specific program. The op rating or a record of users, date(s)ganization shallismaintain each program used, and associated job or account number.
9.0 USE OF COMPUTER SOF TWARE Use of computer sof tware on Impell projects shall be controlled and docmented as follows:
- a. All personnel using computer sof tware shall be trained in use of that specific version of the I software. This training shall be conducted and
! docmented in accordance with QP-2.4.
- b. Output for each final computer run shall be identified with progran nme and version and a unique run neber or identifier (a day / time indicator on each page is preferred).
- c. Output shall be traceable to the project and specific task.
- d. Output shall include an input listing if not l included elsewhere in the project doceentation.
l e. Project documentation shall reference the l program, version and unique run identifier.
! f. The Project QA File shall contain a listing of computer programs used, including applicable versions.
- g. Input data and correct use of output shall be independently verified according to QP-3.6.
j h. Sof tware may be developed as part of the project l
work scope but program output shall not be used
' for production purposes or delivered to the client until sof tware verification is complete and the program is released according to the j procedures in Section 6.0 of this manual.
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10.0 RELEASE OF SOFTWARE Unless approved otherwise by the RQAM only Impe11 TO NON-IMPELL standard computer programs that have been developed, URGANIZATTUR5 verified and is being maintained according to requirements in Section 6.0 of this manual shall be delivered to clients. Software copies shall be created and controll'ed by the SL as defined in Section 6.0 of this procedure. Installation tests and acceptance criteria defined in Section 7.0 of this procedure shall be provided with each software copy. Current user manuals and outstanding user notices shall also be provided with all software copies.
11.0 COMPUTER OPERATING Each operating system revision installed on main SYSTEM REVISIONS frame or centrally controlled minicomputer systems shall be tested by the operating organization as required by the supplier of the operating system software. This testing shall assure proper operation of the computer system. Results of tht.
l
( testing shall be documented and the documentation
( shall be retained by the operating organization while the operation system revision in installed.
Af ter operating system tests are satisf actorily
, completed, the SL shall reinstall controlled i sof tware applications and repeat the installation
, tests required by Section 7.0.
12.0 QUALITY RECORDS Specific records requirements for each type of computer software are defined in the other procedures in Section 6.0 of this manual.
13.0 ATTACHMENTS A - Computer Software Quality Program l
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COMPUTER SOFTWARE QUALITY PROGRAM 9
IMPELL COMPUTER SOFTWARE l
IN VENDOR RE STED 1. CLIENT CERTIFICATION c
CONTROLLED SOFTWARE
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QP 8'4 SOFTWARE I USE I
VENDOR IPPELL SOFTWARE QA AUDIT QUALITY ASSURANCE PROGRAM SOFTWARE QUALIFICATION C TROL & M NOTICE &
MAINTENANCE TON IMPELL CONTROLLED SOFTWARE o ,
CT OTHER PROGRAMS IMPELL STANDAR0 SPEC FgC MICROCDPPUTER PROGRAMS m PROGRAMS OP - 6.t QP - S.2 QP - S.3 QP - S.S GRAPHICS O! SPLAY PRO.KCT SPECIFIC 0 IMPELL STANDARD APPL! CATION GENERATORS OENERAL REQUIRErENTS QP - 8.1 COPPUTER PROGRAM IPCEX SOFTWARE LIBRARIAN INSTALLATION TESTING
- ACCESS CONTRG.
USE OF SOFTWAM RELEASE TO NON-IPPELL SYSTEMS OPERATING SYSTEM REVISIONS QP-6.1 Impell Corporation Revision 0 Attachment A
QUALITY ASSURANCE MANUAL b
Revie9ief ' Coriporate QA Manager
, . E 7/15/85 Approved - Sr. Vice, Fresident / Date i
P R 0 C E O U R E QP-6.2 l IMPELL STANDARD COMPUTER l PR0bRAMS This procedure establishes quality requirements for the development, verification and maintenance of Impell standard computer programs. Requirements in this procedure address the following and are suninarized in Attachment A:
l a. Standard program definition & procedure l
x applicability l b. Program identification
- c. Program development
- d. Program verification
- e. Release and use
- f. Program maintenance 9 Program modifications 1.0 PROGRAM DEFINITION &
PROCEDURE APPLICABILITY This procedure applies to standard programs developed and maintained by Impell. Standard programs are sof tware applications available for general use throughout the company. Only standard programs that have been developed, verified, released and are maintained as prescribed in this procedure shall be used in final engineering work supplied to the client.
2.0 PROGRAM IDENTIFICATION Each production version of a standard program shall be identified by a unique name and version number or date. This identification shall be imbedded in the program software and shall be readily apparent to the user on the terminal screen and on the printed output. The status of each program (development, demonstration or production) shall also be QP-6.2
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QUALITY ASSURANCE MANUAL G
identified in the program sof tware and shall be readily apparent to the user.
3.0 PROGRAM DEVELOPMENT 3.1 Program Specification Prior to initiating program design, the Program Engineer shall prepare a specification which defines I tne purpose and scope of the program. This specification shall include the following types of information:
1
- a. Functional requirements (capabilities, applications, limitations)
- b. Theoretical background, assumptions, general solution procedures (mathematical models and logic) and design code requirements
- c. Program coding standards (may reference standard programing proceduures)
- d. Program language, computer system, input / output requirements, and internal data storage structure
- e. Program block diagram and description of major components
- f. Use of system utility software
- g. User requirements The program specification may be issued in draf t fonn at the beginning of program development, but shall be updated prior to program release to reflect i
final program contents. The responsible Section Manager (SM) shall review and approve the program specification prior to proceeding with program desi gn.
3.2 Program Design The program shall be designed consistent with requirements of the program specification. The resulting program should be a group of small raodules with each module satisfying a specific functional requirement, or requirements, of the specification.
Each module should be as independent as possible to f acilitate debugging individually before assembly into major components and ultimately the complete program. Attachment B provides additional factors that should be considered when designing the program. Design documentation (i.e., flowcharts, O
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,y LJ variable identification, storage allocation) shall be retained as part of the permanent sof tware i documentation, j 3.3 Program Coding Program modules shall be coded according to program l specification and design requirements. During the I
I coding process, portions of the program which will not be verified shall either be excluded or disabled.
Program modules should be debugged individually, compared against design requirements, and combined into larger components. This process should be repeated until the complete program has been
. assembl ed.
3.4 Documentation The following types of development documentation shall be maintained by the Program Engineer in a program development file:
_ a. Program specification
- b. Design documentation
- c. Hard copy of source code, as determined appropriate by Program Engineer
- d. User manual
- e. Any other notes that help describe the program l and its capabilities or limitations t The program development file is considered Impell proprietary information and shall be transmitted to the Records Center for retention when the program is i released for production use.
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3.5 Quality Review A technical quality review of the program design shall be conducted to assure program development meets program specification requirements. This review shall be performed in accordance with QP-3.7, and any identified deficiencies shall be resolved prior to proceeding with program verification. The quality review should be performed prior to proceeding with program verification, but may be conducted in conjunction with the quality review of I program verification required in Section 4.0.
1 4.0 PROGRAM VERIFICATION The verification process is to confirm the computer program satisfies requirements of the program m
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specification and design and to assure the program produces valid results.
4.1 Methodology Computer program verification shall be accomplished by any of the following methods:
- a. Comparison with the results of another program having similar computational objectives and output. Such program shall have been previously verified and the verification doctanented according to a quality program comparable to that defined in this manual
- b. Comparison with established benchmark problem
- c. Comparison with hand calculations performed and documented in accordance with QP-3.4
- d. Conparison with accepted results published in technical journals, reports, manuals, or other similar publications
- e. Ccunparison with recognized experimental test data 4.2 Verification Test Plan Verification methods shall be defined in a verification test plan. This plan shall be
' prepared by the Program Engineer and shall define:
- a. Scope and approach of required testing activities
- b. Features to be tested and verification methods for each. Graphics output (plotting) routines shall be verified when they will be used as the results for engineertrig work or to define technical input for other engineering activities
- c. Acceptance criteria for test results
- d. Interactive computer use during testing
- e. Methods for documenting test results, including interactive use For new programs, verification testing shall cover all progran capabilities and options, the full range of program variables, and all anticipated ^
combinations of these.
The verification plan shall be reviewed and approved by the SM prior to initiating formal verification testing.
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4.3 Verification Testing Verification testing shall be performed according to the verification test plan. All verification tests shall be made using an executable copy of the l
' program traceable to the master source. Test results shall meet acceptance criteria defined in the verification test plan.
Program source code shall be modified as required to correct problems identified during verification testing. Development documentation and the verification test plan shall be revised and verification tests repeated as required on the revised program. All final test runs should be made on the same executable copy of the program. Where this is not practical, a limited number of test runs from prior development versions shall be repeated on the final development version to demonstrate proper l execution of the entire program, p Each final test run shall be identified by program name, version, specific test it applies to, and name v
of the person performing the test.
4.4 Independent Results of the verification testing shall be Verification independently verified and documented in accordance with QP-3.6.
, 4.5 Documentation The Program Engineer shall~ assemble verification documentation into a verification file traceable to l the program and version. This file shall contain the following:
- a. Cover page identifying program name and version, signed by the Program Engineer
- b. Computer program abstract identifying the l program and version, applicable user manual, and i
statement of program purpose and general capabilities
- c. Verification test plan
- d. As applicable, code compliance certification signed by the Program Engineer. This certification shall state that verification explicitly tested all code checking (i.e., ASME, ANSI, AISC) capabilities of the program.
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QUALITY ASSURANCE MANUAL 9
Applicable code editions and addenda shall be identified
- e. Sumary of the comparison of test results and their acceptability
- f. Compilation of completed test documentation end other computer program output, hand calculaf. ions and copies of benchmarks or other appropriate published materials
- g. Documentation showing traceability back to the master source for the executable copy of program used for verification testing
- h. Quality review report as required in Section 4.6 The responsible SM shall review the completed verification file and indicate approval on the cover page.
The verification file shall be transmitted to the Records Center for retention when the program is released for production use.
4.6 Quality Review A technical quality review of the program verification shall be conducted in accordance with QP-3.7 and any deficiencies shall be resolved prior to releasing the program for production use.
The Regional Quality Assurance Manager (RQAM) shall review the completed development and verification files for compliance to requirements in this manual.
5.0 RELEASE AND USE 5.1 Release Notice A program release notice shall be prepared by the Program Engineer and approved by the RQAM authorizing production use of the program. The RQAM shall not authorize release of the program until satisf actory verification and review of the program has been completed as required in Section 4.0 of this procedure. The release notice shall define:
- a. Effective date the version may be accessed for use
- b. Use restrictions for any preceding versions of the program and effective date any preceeding
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G versions will be inaccessible (generally 30 days after access to latest version is established)
- c. General capabilities of tne program
- d. Major differences from preceding versions
- e. Applicable computer hardware and operating system
- f. Any updates or changes to user data bases required for compatibility with the new release
- g. Any outstanding user notices 5.2 User Manual The Program Engineer shall prepare a user manual for the program. The manual shall identify the program version to which it applies and include a table of contents and sufficient identifiers and page numbers to allow any section to be verified for completeness. User manuals shall contain the following:
- a. Title and control copy pages
- b. Program version identification, and manual l revision identification if appropriate i
f" 3) y c. Applicable computer hardware and operating system
- d. Program version log
- e. Program description
- f. List of open program user notices and copy of each 9 User instructions, plus implementation procedures to setup databases for program use.
Implementation procedures may be included in the user manual or issued as a separate manual
- h. Limitations or restrictions on program use, including portions of the programs that were not verified and may not be used for production purposes
- 1. Input data requirements J. Output descriptions User manuals shall be approved by the SM and forwarded to the Corporate Quality Assurance Manager (CQAM) for distribution along with the release i notice signed by the RQAM.
I Revisions to user manuals shall identify tne
- applicable program version (s). An ongoing revision l record shall be included which identifies revised pages for each revision. The revised portion (s) of each page shall be identified, i
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5.3 Program Release The release notice, user manual (or manual revision), and open user notices shall be distributed to program users by the CQAM.
Distribution shall be made using a controlled copy / receipt acknowledgement system. User manual recipients shall be directed to update their copy of the manual and sign and return the receipt acknowledgement form to the CQAM. Superseded materials in the user manual shall be destroyed or marked as such or destroyed.
' The CQAM shall maintain a distribution list of user manual recipients and returned copies of receipt acknowledgements for the current revision. Manuals no longer being used shall be destroyed or returned to the CQAM and the distribution list revised accordingly.
5.4 Master / Executable The Program Engineer shall create a master copy of Program Copies the program which contains source, object files, executable, and required installation tests. This master shall be traceable to the source used for verification testing. The master tape or disk shall be labeled with program name and unique version identifier. A listing of the files on the master copy shall be maintained with the tape / disk. The Program Engineer shall purge all development and verification revisions.
Traceability documentation shall be maintained by the Program Engineer. Subsequent to RQAM approval of the release notice, the Sof tware Librarian (SL) shall create the backup master and executable copies (tape or disk) of the program from the master copy provided by the Program Engineer. Executable copies shall be " execute only" (i.e., source code shall not beincluded). These shall be created and maintained i in accordance with in QP-6.1. !
5.5 Installation The SL shall install an executable copy of the program on Impell hardware for production use as i stated in the release notice. Installation tests i shall be performed as requir2d in QP-6.1. The Program Engineer should request that clients provide written acknowledgement stating satisf actory test completion for client installations outside Impell. !
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QUALITY ASSURANCE MANUAL O
wJ 5.6 Program Access Except during the defined period following Restrictions installation of a new version of a program, only one version of a standard program shall be accessible for unrestricted general use at any time. Any use of prior program versions shall be approved by the l
RQAM. .
I Only the Program Engineer shall have access to the development, verification, and master copies of the program. The Program Engineer shall authorize release of additional executable copies of the program to other organizations (refer to QP-6.1).
Program source code shall only be accessible to the Program Engineer through the SL. No other copies of source code shall be provided to any other organization, either inside or outside Impell. Any exceptions shall be requested in writing and approved by the CQAM. In situations where source code is essential for installations not controlled h
uJ by the SL, the following apply:
- a. Executable subroutines shall be provided to the maximun extent possible. Source code shall be limited to those subroutines essential for the specific installation,
- b. If complete source code is required for the intrallation, Impell personnel shall be present and maintain control of the source throughout
, the installation process. At completion of the
( installation, all source code shall either be l purged or returned to the development l organization. Source code shall not remain at I the installation site.
If source code is supplied to another Impell organization for development purposes, copy is considered a new program, shall be given a new program name and shall be fully verified as a new l program prior to initial release for production use.
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6.0 PROGRAM MAINTENANCE 6.1 Maintenance File The Program Engineer shall maintain a current program maintenance file consisting of the following:
- a. Release notices
- b. User manuals and all revisions
- c. User notices and associated log
- d. Tape log or other record documenting traceability of master copy of program back to source code used 'or verification testing.
Records from the SL docunenting creation of backup master and executable copies of the program. Tape locations and installation dates shall be included in this d.ocumentation.
- e. User manual distribution lists provided by the CQAM
- f. Version log listing each version of the program issued for production use, date of release and applicable computer hardware and operating system A copy of the program maintenance file shall be transmitted to the Records Center for retention on an annual basis.
6.2 Error Notification & Defects in computer programs may be functional Resolution inconsistencies (which generally affect only program operations) or technical defects (which directly affect computational results). Both fun:tional and technical defects are considered computer program errors and shall be reported to the Program Engineer and resolved as follows:
- a. Error Identification - Program users observing an apparent error shall notify the Program Engineer in writing (standard fonn available from the RQAM). A copy of the error identification shall be distributed to the RQAM for the office responsible for the program,
- b. Error Evaluation - The Program Engineer shall l evaluate the reported error to determine if a !
program error does exist and respond in writing {
to the identifying party with the results of the i review within 30 days. Note: Reported errors may not always be verified errors.
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QUAL!TY ASSURANCE MANUAL n
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- c. Error Notification & Resolution - When an error does exist, tne Program Engineer shall prepare a a user notice summarizing findings of the error evaluation. This notice shall indicate any program options that may not be used until program corrections are completed. Each user notice shall oe numbered, listed in a user notice log (standard form available from the RQAM), and transmitted to the CQAM for distribution to user manual holder's and RQAMs.
- d. Corrective Action - The Program Engineer shall restrict program use as required in the error notice. Users shall take appropriate action to evaluate past use and/or revise current use of the program until the error is corrected. In cases where a program error may result in a design or analysis nonconformance, a nonconformance report shall be issued according to QP-5.4. The Program Engineer shall revise the program as necessary to correct the reported error (refer to Section 7.0 of this procedure).
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- e. Error Closeout - The Program Engineer shall document error closecut by recording the method l of resolution (corrective action) and the program version (s) which corrected the error in
! the user notice log.
l 6.J Transfer of Program responsibility may be transferred by Program Responsibility memorandum when approved by the responsible Division Managers. The transfer memorandum shall identify i all outstanding program issues and the following j shal accompany the memorandum:
- a. Development, verification and maintenance files l for the current version of the program,
- b. Documentation for any program revision work in progress.
A copy of the transfer memorandum shall be placed in the maintenance file and copies sent to the responsible RQAMs and tne CQAM.
o.4 Program Archiving The Program Engineer is responsible for archiving any program (or program version) no longer QP-6.2 Revision 0 Impell Corporation Page 11 of 14
QUALITY ASSURANCE MANUAL 9
required. This includes:
- a. Directing the SL and other appropriate organizations to purge all production copies
- b. Assuring master and duplicate master copies are
) retained by the SL with the duplicate in a l remote storage location
- c. Preparing a user notice stating the program is being archived and transmitting the notice to the CQAM for distribution
- d. Updating the maintenance file accordingly and sending all outstanding program documentation to the Records Center 7.0 PROGRAM MODIFICATIONS Revisions to verified programs shall be controlled to ssure only authorized changes are made, that all changes are properly verified and that users are notified of all changes. Requirements in this section are sumarized in Attachment C. Note: All program modifications should be upward compatible (i.e. compatible with current and prior use of the program).
7.1 Technical Modifications Technical modifications are changes to a program's computational methods, technical capabilities or range / accuracy of results. Technical modifications to programs shall be developed, verified, released and maintained the same as the original.
The program specification and development documen-tation shall be supplemented with additional sections to describe program changes. Each section shall clearly identify the program version and date of the modification. Program coding shall be made using a copy of source code traceable to the master source for the prior version of the program., Coding changes shall be consistent with that of the original version and shall meet all required programing standards. Revised portions of the code shall be identified and the applicable program version indicated for each revision.
The verification test plan shall be revised as required and a full range of test problems shall be 1 l
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QUALITY ASSURANCE MANUAL O
V executed to verify modified portions of the program. In addition, the Program Engineer shall repeat sufficient test problems from the original version to demonstrate continued proper execution of the entire program.
l The version identifier shall be changed for each technical modification, the user manual revised as necessary and the progra rereleased the same as the ori ginal .
e l 7.2 Non-Technical Non-technical modifications are minor changes to a Modifications progra which do not affect the computational results or technical capabilities of the original program. Examples of these changes include addition or deletion of comment statements, password changes, format modifications which do not alter input / output I
parameters or user evaluation of output, date and time routines, etc. Program coding changes shall be documented similar to that for technical
( modifications.
V)
Only those options of the program affected by the modifications need be verified. This verification shall be documented similar to that for the original.
The unique version identifier may be changed as considered necessary by the Program Engineer. The
, program modification need only be fonnally rereleased when the version identifier is changed.
The program maintenance file shall be updated as determined necessary by the Program Engineer.
7.3 System Conversions System conversions are modifications to a program that will allow it to run on another type of computer hardware or operating system.
Development documentation shall be supplemented to show progt am changes necessary for the system conversion. Source code used for the conversion shall be traceable to the master source for the current version of the program. Program coding changes shall be documented similar to that for ,
technical modifications.
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QUALITY ASSURANCE MANUAL 9
All program options and capabilities shall be re-verified to assure that results on the new system are comparable with results for the original. A quality review is not required for system conversions. Verification shall be documented the see as for the original version.
The unique version identifier shall be revised, the user manual revised as required and the system -
conversion released the same as the original.
7.4 Operating System Programs revised to run on upd3ted computer Updates operating systems shall be sufficiently retested to verify proper execution of the program on the updated system. Results shall be documented by the Program Engineer and maintained in the maintenance file. Programs shall not be used for production purposes on the updated operating system until retesting has been satisf actorily completed and documented.
8.0 QUALITY RECORDS The program development file, verification file and O
maintenance file shall be retained as quality records in accordance with QP-4.1, 9.0 ATTACHMENTS A - Procedure Suninary B - Standard Program Design Considerations C - Program Modification Requirements O
QP-6.2 Revision 0 Im3Oll CorBor0 tion _ _ _ _ _ _ _ _ _ - - - - - - - - - - _ -
Boao " ^# M
QUALITY ASSURANCE MANUAL -
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COMPUTER PROGRAM PROCEDURE SUMARY REQUIREMENTS RESPONSIBILITY Program identification Program Engineer Program specification Prepare Program Engineer Review & approve SM Program oesign Program Engineer
{
Design quality review Per QP-3.7 Program coding Program Engineer p dser manual Q Prepare Program Engineer Approve SM Program development documentation & file Program Engineer Review RQAM Verification test plan Prepare Program Engineer Approve SM Verification testing Program Engineer Incependent verification of results Per QP-3.6 Program verification documentation & file Program Engineer Approve SM Review RQAM Verification quality review Per QP-3.7 Create master copy of program Program Engineer Create backup master & executable copies St.
Release notice Prepare Program Engineer Approve RQAM QP-6.2 Rev 0 Attachment A Impell Corporation Page 1 of 2 _
l QUALITY ASSURANCE MANUAL G
PROCEDURE
SUMMARY
(Continued)
REQUIREMENTS RESPONSIBILITY Issue release, notice user manual & open CQAM user notices Maintain distribution list CQAM Update user manual and return receipt acknowledgements Manualholders Install executable program & test SL Control source code during installation outside Impell Program Engineer 00tain client confirmation of test Program Engineer Create program copies (no source code copies to be created) SL Establish maintenance file Program Engineer Transfer program responsibility Responsible Division Managers approve Program archiving Program Engineer i
Error notification & resolution Identification Program user Evaluation Program Engineer User notice Prepare Program Engineer Distribute CQAM Corrective action Users Revise program Program Engineer User notice log Program Engineer Program modifications Refer to Attachment C O
QP-6.2 Rev 0 Attachment A Impell Corporation Page 2 of 2
QUALITY ASSURANCE MANUAL b'
IMPELL STANDARD PROGRAM DESIGN CONSIDERATIONS MxTHEMATICAL MODEL o Problem to be solved o Data processing to be performed o Theory, references, math formulations ALGORITriMS o Algorithms for numerical solutions o Conventional mat r equations SUBROUTINES o Descriptions o Flow charts INPUT DATA o Control initial assignment o Simplified o Minimized (def ault values and library) o Checked for consistency, completeness, acceptability o User convenience and flexibility l USER OPTIONS o Permit tennination af ter input check o Check all input without termination o Flag input errors PROGRAM OUTPUT o Header (name, version, date, time, page) o Input list (echo), including units o List external data files created
' REPORTS o Primary output or separate files o Identification, labels, descriptions o Fonnat for standard size paper RESOURCES REPORT o Total memory used o Memory used.by variably dimensioned arrays o External data file size -
o Memory used for processing each data file CPU time used in various stages
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IMPELL STANDARD PROGRAM MODIFICATION REQUIREMENTS Operating Technical Non-Technical System System (
Modifications Modifications Conversions Updates J Program Specification Revise Program Revise Engineer decision Development Documen- Revise Program Revise ;
tation Engineer decision Source Code Revise Revise Revise Verification Test Revise Program Program Plan Engineer decision Enginear decision g
Verification Revisions Portions Full verifi- Test plus select affected by cation as required others modification Version Identifier Change Program Change Engineer decision Quality Review Yes No No No User Manual Revise Program Revise Engineer decision &
when version identifier changes Formal Release of Yes When version Yes No Program identifier changes Maintenance File Update Update Update Test document atioc, QP-6.2 Revision 0 wwmue _ --- - ----- -
QUALITY ASSURANCE MANUAL O h Revie fwe - Corporate QA Manager
/b L< / 7/15/85 Approved - Sr. Vice President / Date l
PR0CEDURE QP-6.3 PROJECT SPECIFIC COMPUTER PROGRAMS This procedure defines quality requirements for the development, verification, use and maintenance of project specific computer programs. Requirements in this procedure address the following and are l sumarized in Attachment A:
i
- a. Procedure applicability
- b. Program development & verification l c. Program use & maintenance
- d. Program archiving
- e. Microcomputer programs n f. Programnable calculators 1.0 APPLICABILITY This procedure applies to computer programs used by Impell for one calculation or for a specific task for a specific project. Project specific programs may be developed from scratch, may be project
' specific versions of Impell standard programs or may be public-domain programs used for a specific project. This type of program is developed, verified maintained and controlled by the Project Engineer,(PE) responsible for the project task.
2.0 PROGRAM DEVELOPMENT &
VtHAPILAllVN The PE shall direct development and verification of project specific programs using the requirements of i QP-6.2 as a guide. Development and verification of l project specific programs shall be documented as part of the calculation in which they are used, or in a separate project calculation as determined appropriate by the PE. The calculation shall be assigned a calculation number and shall be logged and controlled as defined in OP-3.4.
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2.1 Development The PE shall design the program and describe the following in the project specific program calculation:
- a. Program capabilities
- b. Theory and methodology, including assumptions and limitations
- c. Derivation or sources of equations
- d. Solution procedures
- e. .ist of references (if theory, methodology, derivation of equations, or solution procedures are available in literature, copies of the relevant literature shall be attached)
- f. Overall program block diagram
- g. Descriptions and/or flow-charts of all subroutines
- h. Internal storage structure of the program
- 1. Any development notes necessary to describe the above
- j. Programming standards if required
- k. Description of program use and user instructions
. The program shall be coded in accordance with standards established by the PE. A unique program name and version identifier shall be established and imbedded in tne program such that it is readily apparent to the user on the terminal screen and printed output.
2.2 Program Verification Project specific programs may be verif.ied by any of the methods acceptable for Impell standard programs. The verification method, specific tests to be perfomed, and acceptance criteria shall be identified in the project specific program calculation. Only those portions of the program that will actually be used, or are affected by project specific modification need be verified.
Test results shall be reviewed to confirm they are within acceptable limits and the results summarized in the project specific program calculation.
Computer input and ouput for test runs shall be traceable to the program name and version and the project on which the program will be used.
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LJ 2.3 Documentation The project specific program calculation and test run input and output shall be independently verified in accordance with QP-3.6. The PE shall approve the calculation as required in QP-3.4. The following documentation shall be maintained as part of the
{ project specific program calculation:
- a. Source code listing l b. Test run input and output l
3.0 PROGRAM USE Project specific program verification shall be l reviewed and approved by the Regional Quality Assurance Manager prior to use on the project. In l
cases where one project has need to use a project specific program developed by another, the program
' shall be reverified and the verification documented for the new application the same as required for the original. A copy of the original project development and verification documentation shall be maintained with each project on which the project specific program is used.
The PE shall authorize access to the program and only personnel working on the project for which the program was verified shall have access to the program.
4.0 PROGRAM MAINTENANCE If a program error is identified, the PE shall take necessary action to correct the error, reverify the program as required and revise the project specific l program calculation accordingly. All users shall be l
informed of the error. The PE shall also correct i any completed project work as required.
l Modifications to project specific programs shall be verified and documented the same as for the original, j 5.0 PROGRAM ARCHIVING At completion of the project, the PE shall purge the
! project specific program from all computers on which it was used. All program copies, (source object &
( executable) should be transmitted to the Software Librarian for retention.
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6.0 MICROCOMPUTER A special group of project specific programs are PRUGRAMS those used on computer systems where the program is contained on media such as disk, tape, or cartridge controlled by the user. Under these circumstances the program must be tested each time it is " loaded" and must be fully reverified for each project.
Procedure QP-6.5 defines requirements for this type program.
7.0 .10GRAPHABLE Progransnable calculators may be used CALCULAIDH5 to solve equations and formulae as part of an engineering calculation. When they are used, the calculation shall identify the equations used, nature of the calculation, input data and the results. This part of calculation shall be included in the independent verification performed on the ealcuiation.
8.0 QUALITY RECORDS Calculations used for development and verification of project specific computer programs are considered part of the documentation for the project on which the program was used. These calculations shall be retained as quality records in accordance with of QP-4.1.
' 9.0 ATTACHMENTS A - Procedure Suninary 9
QP-6.3 Revision 0 Im3 ell Cor(DoraGim _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _
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QUALITY ASSURANCE MANUAL O
PROJECT SPECIFIC COMPUTER PROGRAM PROCEDURE SupMARY REQUIREMENTS RESPONSIBILITY Establish calculation for project PE per QP-3.4 specific program i Design code and document program PE Define verification methods, perfom tests and review test results PE Perform inoependent verification of
. verification tests Per QP-3.6 1
Program use and access PE direct and e control Program modifications Same as original Archive program PE Microcomputer programs Per QP-6.5 l
Programable calculation use Document in calculation O
l QP-6.3 l
Revision 0 Impell Corporation Attachment A
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QUALITY ASSURANCE MANUAL .
M Reviewed - Gorporatg QA Manager M 7/15/85 Approgd - Sr. Vice P/esident / Date PR0CEDURE QP-6.4 PUBLIC DOMAIN COMPUTER PROGRAMS This procedure establishes qualification requirements for public dmain computer programs used by Impell. Requirements in this procedure address the following and are suninarized in Attachment A:
- a. Procedure applicability and public domain program definition
- b. Use of public domain programs
- c. Service bureau qualification
- d. Public dmain program user manuals and error notices Only public dmain computer programs provided by service bureaus qualified according to this procedure shall be used for final engineering work perfomed by Impell.
1.0 APPLICABILITY This procedure applies to public domain programs used by Impell personnel on computer systems not controlled or operated by Impell (i.e., service bureau systems). Public domain programs are those developed or procured by service bureaus and installed on the service bureau system for use by Impell.
Public domain programs which are procured by Impell for use on Impell computer systems shall be verified and maintained according to the quality requirements for Impell standard or project specific programs, as appropri ate. Program verification by Impell may take credit for testing performed by the supplier as detemined appropriate by the Program Engineer and approved by the Regional Quality Assurance Manager (RQAM).
O QP-6.4 Revision 0
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b 2.0 SERVICE BUREAU All service bureaus which provide public domain QUALIFICATION programs for Impell use shall be qualified as follows:
2.1 Quality Audit The RQAM shall audit the service bureau to assure it maintains a quality program having provisions for the following:
- a. Program development and verification
- b. Control of program modifications
- c. User manual controls
- d. Error notification and resolution
- e. Quality program requirements for suppliers that provide software to the service bureau
- f. Quality records identification and retention The audit shall also verify that the service bureau is satisf actorily implementing its quality program for the specific computer program or class of canputer programs to be used by Impell. The audit shall be performed in accordance with QP-5.1.
2.2 Service Bureau Impell and the service bureau shall execute Agreement an agreement which contains the following:
- a. Statement that the service bureau will procure, develop, test, maintain and otherwise control the program (s) according to their established quality program
- b. List of specific programs that comply with the service bureau's quality program and may be used under the agreement
- c. Provision for transmittal of user manuals for the current version of public domain programs as
! specifically requested by Impell
- d. Provision for transmittal of error notices to Impell to comply with 10CFR21
- e. Right of access for Impell personnel to audit service bureau's compliance to their quality program This agreement shall be reviewed and approved by the RQAM. A copy of the agreement shall be maintained with the quality assurance audit file.
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QUALITY ASSURANCE MANUAL.
O 2.3 Qualification The RQAM shall complete a supplier evaluation report for the service bureau similar to that required in QP-7.3. This report shall state acceptability of the service bureau's programs for use by Impell personnel. Copies of the evaluation report and list of acceptable programs shall be distributed to all RQAMs and the Corporate Quality Assurance Manager (CQAM).
2.4 Requalification Service bureaus shall be requalified every two (2) years.
3.0 USER MANUALS The RQAM shall maintain a reference copy of the user manual for the current version of each public domain program used by the regional office. Each manual shall contain all outstanding error notices for that program. The user manual and error notices shall be readily available to personnel using public domain programs. Additional copies of user manuals may be distributed to personnel in the region provided the RQAM maintains a distribution list which identifies the user and manual revision for each program.
Superseded versions of public domain computer program user's manuals shall be destroyed.
4.0 PROGRAM USE General requirements for use of public domain computer programs are as defined in QP-6.1.
5.0 RESPONSIBILITIES RQAM responsibilities may be performed by the CQAM.
6.0 QUALITY RECORDS Service bureau quality assurance audit report files shall be retained as quality records in accordance with QP-4.1.
7.0 ATTACHMENTS A - Procedure Sumary O
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QUALITY ASSURANCE MANUAL O
V PUBLIC DOMAIN COMPUTER PROGRAMS PROCEDURE
SUMMARY
i l
REQUIREMENTS RESPONSIBILITY Audit service bureau RQAM per QP-5.1 Service bureau agreement Appropriate Adninistrative Manager Service bureau qualification RQAM Requalification (every 2 years) RQAM User manuals and user notices RQAM l
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Revie6ed ' Cdrporate QA Manager 7/15/85 Apprped - Sr. Vic/ President / Date PR0CEDURE QP-6.5 MICROCOMPUTER PROGRAMS This procedure defines quality requirenents for development, verification, maintenance and use of microcomputer prograns. Requirements in this procedure address the following and are stanarized in Attachment A:
- a. Procedure applicability and microcomputer program definition I b. Microcanputer program development
- c. Verification
- d. Program identification
- e. Program copies
- f. Microcanputer progran use
- g. Modifications
- h. Program archiving
- i. Standard microcomputer programs 1.0 APPLICAB ILITY The requirenents in this procedure apply to
- microcomputer prograns used by Imell for technical engineering calculations. Microcomputer programs are computer applications which operate on individual work station hardware using disk, tape or other storage meditan controlled by the user.
Microcomputer programs are nomally project specific. Section 9.0 of this procedure defines additional quality requirenents for Impell standard
, microcomputer prograns. Only Impell standard
{ microconputer programs shall be sold for use outside Impell (i.e., client use).
This procedure does not apply to microcomputer prograns where:
- a. Methods, fomulas and results are doctsnented in l the engineering work in sufficient detail to l allow independent verification according to QP-3.6 QP-6.5 1
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QUALITY ASSURANCE MANUAL O
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- b. Methods and calculations are independently verified by other than the sane microcamputer ,
progra (i.e., hand calculations, calculator, or i other camputer progran verified according to the requirements in Section 6.0 of this manual) l This procedure does not apply to data manipulation prograns provided the results (output) will be independently verified in accordance with QP-3.6.
l 2.0 PROGRAM DEVELOPMENT Microcv.11puter prograns shall be developed and documented according to the requirenents for project specific prograns in procedure QP-6.3. Development docunentation for programs purchased outside Impell may include program docunentation provided with the purchased sof tware.
Development documentation for data base manager l programs is limited to defining the data base, data j manipulation and data calculational requirements of the progran.
O J.0 VERIFICATION ,
I i 3.1 Progran Master Progran verification shall be performed on a single master copy of the progran controlled by the Project Engineer (PE). 3 3.2 Verification Tests Test problems shall be developed and run for all algorithms and the results documented according to the requirments for project specific programs in QP-6.3. Verification tests shall include a check of user support (infonnation) messages, built-in error messages, self-diagnostic subroutines and other functions included to help the user prevent misule.
3.3 Data Base Manager For data base manager prograns, sample data Programs printouts shall be compared against progran requirenents to verify correct data entry, storage, manipulation and retrieval. Any arithmetic and logic / comparative capabilities shall also be tested.
The testing process shall be independently verified ' ,
according to QP-3.6. '
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QUALITY ASSURANCE MANUAL 9
4.0 PROGRAM IDENTIFICATION Microcomputer progra'is shall be identified with a unique name and version identifier embedded in the s of tware. The applicable hardware and operating system shall also be identified. Progran nane and version shall also be printed on hardcopy output and on the teminal screen.
5.0 PROGRAM COPIES Production copies of microcomputer programs shall be created by the PE from the master copy used for verification. Each copy shall be tested before it is released to the user to assure it executes properly. The PE shall determine required testing.
The PE shall maintain a log of each copy created to assure all copies are returned at completion of the project. A standard fom is available from the
. Re,gional Quality Assurance Manager (RQAM). Testing of each copy shall be docunented on this log.
6.0 MICROCOMPUTER PROGRAM Microcomputer programs shall only be used on the USE project for which they were developed and verified.
General requirements for use of microcomputer programs are defined in QP-6.1.
6.1 User Training Microcomputer program users shall receive training in program operation prior to production use.
Training may be provided in formal classroom sessions, interactively by the program on the terminal screen or by user instructions. Program training shall be documented according to QP-2.4.
6.2 User Testing The progran shall be tested to assure it executes l properly each time it is loaded and prior to use.
Test results shall be compared against acceptance criteria defined by the PE. This test is to assure that errors have not been introduced since the program wts verified.
6.3 Progran Errors The PE shall take necessary action to correct any
. program errors identified, reverify the program as required and revise the progran documentation accordingly. All users shall be infomed of the errors and provided revised copies of the program O
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QUALITY ASSURANCE MANUAL O
correcting the errors. The PE shall also correct any completed project work as required.
6.4 Reverification Microcomputer programs shall be reverified prior to:
- a. Initial use on other projects l
- b. Use on equipment other than that on which the program was originally verified 7.0 MODIFICATIONS Modifications to microcomputer programs shall be s developed and verified the same as the original.
Modifications made to permit operation on other operating systems or microprocessors shall be reverified the same as the original.
I 8.0 PROGRAM ARCHIVING At completion of the project, the PE shall purge the program from all computers on which it was used and
'- collect all program copies. All program copies i including the master should be transmitted to the Software Librarian (SL)for retention.
- 9.0 MICROCOMPUTR The following additional requireinents apply to i STANDARD PROTRAMS microcomputer applications which are classified as l Impell standard programs
n Program development and verification shall l
undergo a quality review according to QP-3.7.
I b. Source code access shall be limited to the l Program Engineer and only guarded (executable)
~
i copies shall be made for production or other use.
- c. The program master copy (disk or tape) and a backup shall be maintained by the SL or Records Center to prevent misuse or accidental damage.
The backup master shall be maintained at a separate location.
- d. Each program copy (disk or tape) shall be copy protected and identified with a unique number.
A log of all program copies shall be maintained by the Program Engineer listing program name, version, copy number, hardware operating system and recipient.
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- e. User manuals and user notices shall be prepared, distributed, and controlled according to QP-6.2. The RQAM shall control user manual and user notice distribution for standard microcomputer prograns.
10.0 QUALITY RECORDS Microcomputer progran development and verification documentation shall be retained as quality records in accordance with QP-4.1.
11.0 ATTACHMENTS A - Procedure Simnary O
O i
QP-6.5 ,
Revision 0 IODel1 Corooration _ _ _ Sna- S E23-.- --_ . _ --
QUALITY ASSURANCE MANUAL O
MICROCOMPUTER PROGRAMS PROCEDURE
SUMMARY
REQUIREMENTS RESPONSIBILITY
. Development & verification Per QP-6.3 Maintain program master Project Engineer
- Data base program testing and independent verification Project Engineer
- Program identification Project Engineer
- Creation of program copies & copy log Project Engineer
- I Program training User & docunent per QP-2.4 User testing User Error correction Project Engineer
- Reverification for use on other projects or equipment Project Engineer
- Mooifications to microcanputer prograrts Project Engineer
- Program archiving Project Engineer
- Standard program requirements Quality review of development and verification Project Engineer Source code access control Project Engineer Maintain master and backup master copies SL or Records Center Maintain program copy log Project Engineer Test program copies Project Engineer Prepare user manuals & user notices Project Engineer Controlled distribution of user manuals & user notices RQAM
- Program Engineer for standard program QP-6.5 Revision 0
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QUALITY ASSURANCE MANUAL 9
7.0 PROCUREMENT CONTROL CONTENTS QP-7.1 PROCUREMENT QUALITY PROGRAM 1.0 APPLICABILITY (Suppliers and Subtier Suppliers) 2.0 PROCUREMENT OF SERVICES 3.0 PROCUREMENT OF MATERIALS AND EQUIPMENT 4.0 PROCUREMENT DOCUMENTS 5.0 SUPPLIER EVALUATION AND SELECTION 6.0 SUPPLIER PERFORMANCE VERIFICATION 7.0 NONCONFORMANCE CONTROL AND CORRECTIVE ACTION 8.0 PROCUREMENT PROGRAM AUDITS QP-7.2 PROCUREMENT DOCUMENTS 1.0 PROCUREMENT DOCUMENT DEFINITION 2.0 PREPARATION, REVIEW, AND APPROVAL 3.0 ISSUE AND CONTROL 4.0 PROCUREMENT DOCUMENT CHANGES g
QP-7.3 SUPPLIER EVALUATION AND SELECTION 1.0 PROCUREMENT DOCUMENT CONTROL 2.0 SUPPLIER EVALUATION 3.0 REQUESTS FOR PROPOSAL (RFP) 4.0 BID EVALUATION 5.0 CONTRACT AWARD 6.0 DOCUMENTATION QP-7.4 SUPPLIER PERFORMANCE EVALUATION 1.0 SUPPLIER PERFORMANCE 2.0 VERIFICATION PLANNING 3.0 QUALITY ASSURANCE AUDITS
, 4.0 INSPECTIONS AND EXAMINATIONS l 5.0 CONTROL OF SUPPLIER DOCUMENTS l 6.0 SUPPLIER QUALITY PROGRAM EVALUATION 7.0 STOP WORK 8.0 ACCEPTANCE OF SERVICES 9.0 ACCEPTANCE OF MATERIALS AND EQUIPMENT l
O Impell Corporation
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U l
^
Revieke6- C6rporate QA Manager M 7/15/85 Apprp9ed - Sr. Vicf President / Date PR0CEDURE QP-7.1 PROCUREMENT QUALITY PROGRAM ,
This procedure defines the quality program for procurement of materials, equipment and services by Impell. The requirements in this procedure, along with supporting procedures QP-7.2, QP-7.3, and QP-7.4, will assure that purchased materials, equipment and services conform to procurement document requirements. Requirements in this procedure address the following:
- a. Applicability of the procedures in Section 7.0 of this manual
- b. Procurement of services
- c. Procurement of materials and equipment
- d. Procurement document control
- e. Supplier evaluation and selection
- f. Supplier performance verification (including acceptance)
- 9. Reporting and control of nonconformances and corrective action
- h. Quality records and retention
- 1. Procurement program audits.
The " Procurement Quality Program" flow chart in Attachment A illustrates the Impell procurement process.
1.0 APPLICABILITY Impell shall purchase materials, equipment and Suppliers & Subtier services according to the requirements of this Suppliers) procedure.
~
1.1 Services The requirements of this procedure, QP-7.2, QP-7.3, and QP-7.4 apply to nuclear safety-related technical n services purchased by Impell in support of Impell
()
QP-7.1
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QUALITY ASSURANCE MANUAL 9
engineering activities for a client on a specific proj ect. These requirements do not apply to purchased services which are technically supervised by Impell and the work perfomed according to this manual . These requirements also do not apply to conputer programs purchased, verified, and maintained by Impell, and access to the source code will be controlled by Impell according to the quality procedures in Section 6.0 of this manual.
Procedure QP-6.4 defines quality requirenents for the lease, rental, or use of computer programs from service bureaus where Impell does not maintain or control the progran.
1.2 Materials & Equipment Materials and equipment are nomally purchased by Impell under the client's quality progran using applicable client procedures. When the client requests otherwise, Impell will purchase materials and equipment according to the requirenents of this procedure QP-7.2, QP-7.3, and QP-7.4 as appropriate for the Impell scope of work.
This procedure does not apply to materials and equipnent purchased to support Impell technical activities (e.g., computer hardware, technical reference materials, or other equipnent purchased, leased, or rented).
2.0 PROCUREMENT OF SERVICES Technical services to support Impell engineering activities shall be purchased according to requirenents in the Project Quality Plan (QP-2.5) or other instructions prepared for the specific project and service being purchased. The Project Quality Plan or instructions shall:
- a. Define specific methods for implementing the applicable general requirements in this procedure and QP-7.2, QP-7.3 and QP-7.4
- b. Provide for client reviews and approvals as specifically requested by the client
- c. Be prepared, approved, issued, and controlled in accordance with QP-2.5
- d. Be issued prior to initiating procurement activities O
QP-7.1
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. QUALITY ASSURANCE MANUAL O
l Examples of technical support services purchased by l Impell include:
- a. Technical analyses and preparation of technical reports
- b. Technical labor assistance where the supplier acts as an extension of the Impell engineering organization working under the supplier's quality progra
- c. Materials, equipnent, and component testing used in support of Impell analyses and technical reports 3.0 PROCUREMENT OF MATERIALS AND EQUIPMENT l 3.1 Client Quality Responsibilities and methods for Impell purchase l Program of materials and equipment under the client's I
quality progra shall, be defined in the Project Quality Plan.
3.2 Impell Quality Materials and equipment purchased by Impell for Progr e the client under the Impell Quality Progra shall be purchased according to requirments in the Project Quality Plan or other instructions as defined in Section 2.0 above. The Project Quality Plan, or instructions, shall define procurenent
. responsibilities and interf aces between Impell and the client.
4.0 PROCUREMENT DOCUMENTS Impell procurenent documents will contain the
( regulatory, design bases and other requirements l
necessary to assure the quality of materials, equipment and services being purchased. Procurment documents and changes thereto shall be prepared, reviewed, approved and controlled according to the quality requirments defined in QP-7.2.
Quality requirenents for requests for proposal, purchase orders, subcontracts, or other Impell connercial docunents are limited to the specific reviews and approvals contained in QP27.3.
O QP-7.1 l Revision 1 L
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1 5.0 SUPPLIER EVALUATION Impell shall ' select suppliers of materials, AND SELECTION equipment and services based on the suppliers capability to provide these items in accordance with the requirenents of Impell (or client, as appropriate) procurenent documents. The quality requirenents for evaluating and selecting suppliers and for documenting this process are defined in QP-7.3.
6.0 SUPPLIER PERFORMANCE Impell shall monitor and evaluate supplier VERIFICATION perfonnance (post-award activities) against specific procurenent docunent requirements. Impell shall also verify that purchased materials, equipment and services conform to procurenent document requirenents. The quality requirements for supplier
. evaluation and procurenent verification are defined in QP-7.4.
7.0 NONCONFORMANCE CONTROL AND CURRECTIVE ACTION 7.1 Vendor Nonconformances Impell procurenent docunents shall require the supplier to notify Impell of nonconfonnances and obtain Impell approval of the recomended disposition as specified in QP-7.2. The Impell Regional Quality Assurance Manager (RQAM) and appropriate Section Manager shall approve all supplier nonconformance reports.
Materials, equipment and services which are provided by the supplier and do not meet procurenent document requirenents shall be identified, controlled, and dispositioned by Impell in accordance with QP-5.4.
7.2 Impell Nonconfonnances Nonconfonnances which are Impell generated shall be identified and corrective action shall be taken according to QP-5.4.
- 7. 3 Stop Work The stop work requirements in procedure QP-5.3 extend to supplier activites.
8.0 PROCUREMENT PROGRAM Impell shall audit procurenent activities defined AUDITS in this and other referenced quality procedures in QP-7.1
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QUALITY ASSURANCE MANUAL O
accordance with QP-5.1. These audits may cover individual activities or the entire quality progre
', of the supplier. When considered necessary by the RQAM, Impell shall also audit subtier suppliers to
, assure their quality programs adequately address l procurement docuent requirments.
9.0 QUALITY RECORDS 9.1 Supplier Records As required in QP-7.2, procurment docuents shall define the supplier generated docments to be transmitted to Impell, to the client, or retained by the supplier as quality records.
9.2 Impell Records Specific Impell generated documents considered quality records are defined in the quality procedures of this manual.
9.3 Retention or Impell shall retain or transmit quality records to l Transmittal to Client the client in accordance with QP-4.1, and any
/3 specific requirments identified in the Project C Quality Plan.
10.0 ATTACHMENT A - Procurment Quality Program l
l e
O QP-7.1 Revision 1 Impell Corporation Page 5 of 5
l QUALITY ASSURANCE MANUAL 9
PROCUREMENT QUALITY PROGRAM IMPELL PROCUREENT IffELL SUPPORT MATERIALS ANO EQUIPMENT M CES IMPELL USE CLIENT USE NO REQUIREMENTS 9
PROJECT CLIENT NORMAL gk-2. REQUEST PROCESS}
q CLIENT 'S QUALITY PROGRAM RGAM APF.10 VAL u
PROCUREENT QUALITY RECORDS 00CUENTS = ,
QP-4.1 1 F-7.2 l
~
PREPARATION SLPPLIER !!PE!.Lj REVlh APPROVAL '
CONTROL IP9 ELL CNANGES RECORDS CENTER EV 10 & ORMAKES SELECTION GP-7*3 g$ IPPELL SELECTION OF SUPPLIERS o SUPPLIER'S B10 EVALUAT10N NONCOPFORMANCE
, QUALITY b AWARD M TING &
- F u
{
SLPPLIER RQAM APPROVAL PERFGIMANCE VERIFICATICN "
SM APPROVAL
_ @-7. 4 _
EVALUATION OF STOP Wong SLPPLIER -
QP-5 3 PERFORMANCE VERIFI ON PROCUREENT 2 PROGRAM AUO!T ACCEPTANCE QP-5.I QP-7.1 i N _ ___f:bnEdAa 1 i
i I
l QUALITY ASSURANCE MANUAL O h RevieGed ' Cokpcfrat QA Manager l
/ .J</ 7/15/85 Approved - Sr. Vice President / Date <
! PROCEOURE 7.2 PROCUREMENT DOCUMENTS l~
This procedure establishes the quality requirements for preparation, review, approval, issue and revision of procurement docunents as part of the Impell procurement quality program defined in QP-7.1. The requirements of this procedure will assure that applicable regulatory requirenents, design bases and other requirements for assuring quality are incorporated into Impell procurement docunents transmitted to suppliers. Requirements in this procedure address the following and are i sumarized in Attachment A:
i
- a. Procurement docunent definition
- b. Procurenent document preparation, review and approval
- c. Issue and revision control of procurement docunents
- d. Changes to procurement docunents 1.0 PROCUREMENT DOCUMENT impell procurement docunents define Impell DEFINITION purchasing requirenents for potential bidders and selected suppliers. They shall contain all necessary technical, quality and regulatory requirenents and shall be issued and controlled i according to .this procedure. Docunents which define.
I these requirements are typically:
- a. Requests for proposal
- b. Procurenent specifications
- c. Purchase orders
- d. Subcontracts
- e. Attachments to any of the above The specific fann of procurement docunent to be used shall be defined in the Project Quality Plan or
, other instructions as specified in QP-7.1.
QP-7.2 Revision 1 Impell Corporation Page 1 of 6
QUALITY ASSURANCE MANUAL 9
2.0 PREPARATION, REVIEW AND APPROVAL l 2.1 Contents Procurement docments will typically include the f oll owing:
- a. Work scope statement
- b. Technical requirements for the materials, equipment or services to be provided. These requirements may reference (by title, neber, revision and date) specific drawings, specifications, regulations, codes, standards, procedures or instructions. Impell generated docuents shall be prepared and controlled according to the appropriate procedures in this manual . Procurement documents shall also identify any special requirements for activities such as design, identification, f abrication, cleaning, installation, packaging, handling, shipping and storage
- c. Test, inspection, and acceptance requirenents
- d. Requirements for the supplier's quality progra including:
- 1) Implementation of 10CFR50 Appendix B, ANSI N45.2 and other industry codes and standards, as applicable
- 2) Implementation of any additional client or Impell quality requirments
- 3) Submittal of supplier quality program and applicable procedures to Impell
- 4) Impell review and acceptance of supplier's quality program and procedures prior to supplier initiation of work
- 5) Qualification of procedures to code and standard requirements as necessary
- 6) Incorporation of appropriate quality requirements in suppliers' procurenent docments to subtier suppliers 4
- e. Provision for access to the supplier's and subtier supplier's f acilities and records for audit or inspection by Impell and/or others authorized by Impell (time requirements and methods for advanced notice should be included)
QP-7.2 nextwm3
QUALITY ASSURANCE MANUAL n
v
- f. Identification of mandatory witness and hold points requiring Impell presence at the supplier's f acility, such as final inspection and witnessing of final tests 9 Requirements for submittal of documentation and quality records for Impell review and acceptance, including submittal schedule
- h. Requirements for supplier retention of quality records
- 1. Requirements for supplier control of nonconformances (materials, equipment and services that do not meet procurement docment requirements). These requirments shall include provisions for:
- 1) Supplier identification, review and disposition of nonconfomances
- 2) Supplier submittal of nonconformances to Impell, including recommended disposition and technical justification
- 3) Impell review and approval of supplier recommended disposition
- 4) Supplier verification and docmentation of completed disposition, plus Impell verification when specifically requested
- 5) Supplier maintenance of nonconfomance records
- j. Requirment to implement a procedure for reporting defects and noncompliances as required in 10CFR21
- k. Impell authority to stop supplier's work as defined in QP-5.3.
Camercial terms and conditions (including client requirments) may be included in the procurement documents but are not quality related requirements.
2.2 Preparation The Project Engineer (PE) and the Regional Quality Assurance Manager (RQAM) shall determine appropriate procurement docment contents (Section 2.1 above).
The PE shall direct preparation of the procurement doceent.
O QP-7.2 ,
Revision 1 l
- - _ - - - - - _ - - - - . _ _ _ _ _ . - - _ - - - - % e ca a
QUALITY ASSURANCE MANUAL 2.3 Independent Technical requirements in the procurement document Verification shall be independently reviewed and verified in accordance with QP-3.6. The PE is responsible for coordinating this check and resolving any questions or concerns.
Personnel perfoming the independent verification shall have access to the reference information and docmentation necessary to perfom the check and shall understand the requirements and intent of t' a procurement doc e ent.
2.4 Code Certification When required, code certification shall be performed by a registered professional engineer in accordance with the requirements of the cited code and applicable state laws. The certification form shall be included in the procurement document.
2.5 Approval The completed procurement docuent shall be reviewed and approved:
- a. By the PE for technical adequacy and completeness
- b. By the RQAM to assure appropriate quality requirements (Section 2.1) are included
- c. By the client when required in the Project Quality Plan 2.6 Documentation The PE shall document the following information as the record for procurement doceent preparation, check, and approval:
- a. Procurement doceent title, and unique identifier if used
- b. Date of issue (original and each revision)
- c. Signature of originator i d. Signature doceenting satisf actory completion of the independent verification
- e. PE and RQAM approvals f.. Client approval when required Specific doceentation methods are the PE's option.
A standard procurement document cover sheet is available fra the RQAM.
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3.0 ISSUE AND CONTROL 3.1 Issue The PE shall issue procurenent documents to potential bidders and selected suppliers as defined
, in QP-7.3 and according to the methods specifically defined in the Project Quality Plan. Only procurenent documents which have been checked and approved according to Section 2.0 above shall be issued.
3.2 Distribution Distribution internal to Impell, to the client, and to others shall be according to the project distribution list (QP-2.2).
3.3 Revision Control The PE shall maintain a log which identifies the current revision of each procurement document and contains the following types of infonnation:
- a. Procurenent docunent title
(-)
k
- b. Unique identifier, if used
- c. Date of issue for original and each revision
- d. Applicable contract docunent title, date, and l changes thereto A standard procurement docunent log is available from the RQAM and should be maintained in the Project QA File.
3.4 Use Impell and supplier work shall be done according to the 1atest revision of procurement docunents.
Superseded revisions shall be marked as such or destroyed.
4.0 PROCUREENT Changes to procurement docunents shall be made DOCUMENT CHANGES following the same requirenents as those for the ori ginal . The PE shall review each change for appropriate content as required in Section 2.1 above, including additional or modified design criteria imposed. The PE review shall also assure that procurenent document changes will not have a negative impact on the quality of the material, equip'nent or service being purchased. <
O QP-7.2
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QUALITY ASSURANCE MANUAL
'O 5.0 QUALITY RECORDS The following shall be maintained as quality records and transmitted to the client in accordance with QP-4.1 and any specific requirements identified in the Project Quality Plan:
- a. Procurement doceents and each revision
- b. Procurement docuent preparation, check and approval docmentation
- c. Procurement docuent log i
- d. Technical doceents referenced in procurement doceent - (e.g. , equipment specifications, drawi ngs)
- e. Doceents (e.g., analyses) needed to develop item "d" technical documents 6.0 ATTACHMENTS A - Procedure Stannary O
l I
O QP-7.2 Revision 1 Imm11 CEPsPnRim (PonAfff
QUALITY ASSURANCE MANUAL
&g PROCUREMENT DOCUMENTS PROCEDURE SIMMARY REQUIREMENT RESPONSIBILITY Define procurement document procedure PE in Project Quality Plan Detennine procurement document contents PE and RQAM Prepare procurement document PE Independent verification of technical As assigned by PE requirements Code certification Registered professional engineer Approve procurement document PE, RQAM, client Maintain documentation PE Issue procurement documents per project distribution list PE Maintain procurement doctment log PE Use latest version of procurement documents Impell & supplier personnel Changes to procurement documents Same as the original O
QP-7.2 Revision 1
QUALITY ASSURANCE MANUAL 2%1' -
Review 6d'- C6rporatp QA Manager O
- / 7/15/85 Approvpti - Sr. Vice president / Date PR0CEDURE QP-7.3 SUPPLIER EVALUATION & SELECTION This procedure establishes quality requirements for the evaluation and selection of suppliers as part of tne procurement quality program defined in QP-7.1.
Requirements in this procedure will assure supplier evaluation and selection is based on the supplier's capability to provide the materials, equipment and services according to procurement document requirements. Requirements in this procedure address the following and are summarized in Attachment A:
- a. Supplier evaluation
- b. Requests for proposal
- c. Bid evaluation & supplier selection
- d. Contract award 1.0 PROCUR EMENT Impell procurement documents contain technical, DOCUMENT CONTROL quality, and regulatory requirements and are prepared and controlled according to QP-7.2.
Quality requirements for comerical documents, such as requests for proposal and contracts, are limited to the specific reviews and approvals contained in this procedure.
2.0 SUPPLIER EVALUATION 2.1 Schedule. Impell shall evaluate each supplier and their appropriate f acilities prior to contract award by either:
- a. Evaluating all potential suppliers prior to issuing requests for proposal, or
- b. Evaluating the prospective supplier selected during the bid evaluation process O
QP-7.3 Revision 1
%FnM [ff?gr.wpftc.wt.- __ _ _
QUALITY ASSURANCE MANUAL (a3 2.2 Methods Suppliers shall be evaluated based on their capability to provide the desired material, equipment or service in accordance with procurement
- document requirements. This evaluation shall be accomplished according to the following method, or l
methods, as determined appropriate by the Project Engineer (PE) and approved by the Regional Quality Assurance Manager (RQAM):
- a. Evaluation of the supplier's past history to provide impell like or similar products which comply with:
- 1) Procurement document quality requirements (RQAM evaluation)
- 2) Procurement document technical requirements (PE evaluation)
Historical data should be representative of the p supplier's current capability; otherwise, the d supplier shall supply additional data to indicate current capability. 1
- b. Quality audit of the supplier's current capabilities including:
- 1) Evaluation of current quality records including supplier's quality program and its l implementation (RQAM evaluation) i
- 2) Evaluation of current technical and quality capability of appropriate suppliers' f acilities and personnel (PE and RQAM evaluation)
QA audits shall be performed by the RQAM in accordance with QP-5.1. The PE shall provide technical assistance for the audit as required by the RQAM.
- c. RQAM verification through the client of current acceptable supplier listing by the Coordinating Agency for Supplier Evaluation (CASE)
- d. RQAM verification that supplier is on the client's list of approved vendors for the material, equipment or service to be supplied O
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QUALITY ASSURANCE MANUAL 9
- e. RQAM verification that supplier has ASME code certification for the material, equipment or service to be supplied 2.3 Documentation The PE shall document supplier evaluations in an evaluation report containing the following general types of infomation:
- a. Evaluationpethod(s)
- b. Reference (supporting) documents used
- c. Key personnel and f acilities evaluated
- d. Results (technical and quality evaluation)
- e. Supplier acceptability The specife report form is the PE's option. A standard supplier evaluation report form is available from the RQAM.
The evaluation report shall be approved by the PE and RQAM and should be placed in the Project QA File.
3.0 REQUESTS FOR PROPOSAL (RFP) 3.1 Contents Each RFP shall contain the following as a minimum:
- a. Transmittal letter (s) to supplier (s) requesting j the bid and referencing appropriate procurement r
documents
- b. Appropriate revision of the procurement documents checked and approved according to QP-7.2 Comercial terms and conditions are not quality related requirements, but are typically included in the RFP.
3.2 Preparation The PE shall determine appropriate bidders and and Issue prepare the RFP package. The RFP package ,shall be dated and shall be reviewed and approved by:
- a. Section Manager (SM) for technical adequacy and completeness
- b. RQAM to assure appropriate procurement documents are included QP-7.3 Revision 1
QUALITY ASSURANCL: MANUAL
)
The PE shall issue the RFP package to appropriate bidders.
3.3 Changes Changes to the RFP shall be made following the same requirements as for the original.
3.4 Documentation A copy of the RFP package, each transmittal letter and all changes should be maintained in the Project QA File.
4.0 BIO EVALUATION Each bid, including sole source bids, shall be evaluated to assure the bid conferms to procurement document requirements. The PE shall receive all bids and coordinate the evaluation. Evaluations shall include the following:
- a. PE evaluation of technical considerations
! b. RQAM evaluation of quality requirements, I
including suppliers quality program
- c. PE and RQAM evaluation of suppliers personnel l qualifications and f acilities capabilities
- d. Supplier evaluation according to Section 2.0 above if not accomplished prior to issuing RFP
- e. PE evaluation of bid alternatives and exceptions l 4.1 Bid Evaluation Each evaluator shall suntnarize the results of the Results evaluation in a report which includes the evaluator's reconnendation (acceptability) and identifies any unacceptable conditions. This report shall be transmitted to the PE along with the bid documents provided for evaluation.
4.2 Supplier Selection The PE shall review the bid evaluators' reports, and Evaluation select the potential supplier and prepare a stenary report which:
- a. Documents the supplier selection
- b. States reasons for the selection 4.3 Unacceptable Prior to contract award, the PE shall resolve, or Conditions obtain written connitments (including completion dates) from the supplier to resolve any unacceptable conditions identified during the bid or supplier evaluations. Quality connitments shall be reviewed l
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l QUALITY ASSURANCE MANUAL O.
I and approved by the RQAM and must be complied with by the supplier prior to starting work.
4.4 Procurement Prior to contract award, the procurement document (s)
Document shall be revised according to procedure QP-7.2 to incorporate any changes in the technical or quality conditions identified and agreed to during bid evaluation and selection.
5.0 CONTRACT AWARD 5.1 Original Contract The contract (e.g., purchase order or subcontract) shall reference the appropriate procurement documents and the referenced documents shall be included in the contract package transmitted to the supplier. The contract package shall be reviewed and approved by:
- a. SM for technical adequacy and completeness
- b. RQAM to assure the supplier has been qualified according to this procedure and that appropriate procurement documents are referenced and included The contract package shall be issued to the supplier according to the methods defined in the Project Quality Plan.
5.2 Contract Changes to the contract package shall be made Changes according to the same requirements as for the original.
6.0 DOCUMENTATION A copy of the bid evaluation reports, supplier selection report, contract package and all changes should be placed in the Project QA File. Comercial terms and conditions may be excluded.
7.0 QUALITY RECORDS The following shall be maintained as quality records and transmitted to the client in accordance with QP-4.1 and any specific requirements identified in the Project Quality Plan:
- a. Supplier evaluation reports for suppliers awarded contracts QP-7.3
_ Revision 1
QUALITY ASSURANCE MANUAL O
- b. RFP, transmittal letters, procurement documents and all changes for suppliers awarded contracts
- c. Bid evaluation reports and supplier selection reports for suppliers awarded contracts
- d. Contract packages, all changes and referenced procurement doctanents. Connercial terms and conditions may be excluded.
8.0 ATTACHMENTS A - Procedure Sunnary
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O l
t 9
1 O
l l
QP-7.3 Revision 1
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SUPPLIER EVALUATION & SELECTION l
PROCEDURE
SUMMARY
REQUIREMENTS RESPONSIBILITY Define supplier evaluation selection PE requirements in Project Quality Plan Determine timing for supplier evaluation PE Determine supplier evaluation methods PE with RQAM approval Perform supplier evaluation PE designate ,
Approve supplier evaluation report PE and RQAM Prepare RFP psckage PE Approve RFP package SM & RQAM Perform bid evaluation PE Designates Prepare bid evaluation report PE Resolve unacceptable conditions for PE & RQAM selected supplier Revise procurement document QP-7.2 Approve contract package SM & RQAM Changes to contract package Same as for Original Maintain procurement documentation PE O
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[. 7/15/85 Approved - Sr. Vice/ President / Date PR0CEDURE QP-7.4 SUPPLIER PERFORMANCE EVALUATION This procedure establishes quality requirements for evaluation and verification of supplier activities as part of the procurement quality program defined in QP-7.1. Requirements in this procedure will assure that supplier activites are monitored and evaluated such that purchased materials, equipment and services conform to procurement document requirements. Requirements in this procedure address the following and are suninarized in Attachment A.
- a. Supplier performance
- b. Verification planning
- c. Quality assurance audits
- d. Inspections and examinations (materials and equipment only)
- e. Control of supplier documents
- f. Supplier quality program evaluation
. g. Acceptance of materials, equipment and services 1.0 SUPPLIER PERFORMANCE Suppliers shall perform their activites according to the technical, quality and regulatory requirements contained in Impell procurement documents as defined in QP-7.2. Suppliers shall also perform verification activities necessary to assure conformance to Impell procurement document requirements.
The Project Engineer (PE) is responsible for monitoring supplier performance. The Regional Quality Assurance Manager (RQAV) is responsible for assuring supplier performance and will assist the PE as necessary.
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2.0 VERIFICATION Impell shall evaluate and verify supplier activities PLANNINLa aCCording to the Project Quality P1an or other instructions prepared and issued by the PE as defined in QP-7.1. The Project Quality Plan shall define specific implementation methods for the following as determined appropriate by the PE and RQAM:
- a. Comunication with the supplier to assure supplier's iderstanding of procurement document requirements
- b. Review of supplier's plans for meeting procurement document requirements and controlling receipt, distribution and use of documents and changes thereto
- c. Impell review acceptance and control of supplier gener,ated documents including schedule and frequency of submittal. Typical documents include design drawings, technical reports, procedures and test results for comparison against acceptance criteria
- d. Exchange of information and documents between Impell and the supplier
- e. Identification of acceptance methods and documentation requirements when not stated specifically in the procurement documents
- f. Identification of hold and witness points requiring surveillance, including methods and time requirements for notifying Impell
- g. Identification of quality audit requirements
- h. For procurement of materials and equipment, identification of additional in-process inspection / examination and receiving inspection requirements
- 1. Impell evaluation of supplier's quality program e'f ecti veness The extent of these evaluation and verification activities will depend upon the importance and complexity of the materials, equipment or service being purchased, along with the supplier's quality history.
Methods for the above shall be established as early as possible in the project and in no case later than QP-7.4
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l l initiation of the activity that each is intended to j control.
3.0 QUALITY ASSlRANCE As required by the Project Quality Pjan, the RQAM AUDITS (Materials, shall perform quality assurance audits (or Equipment, and surveillances) to verify the supplier is conforming Services) to procurement docuent requirements and the supplier's quality program and procedures.
3.1 Procedure & Quality assurance audits shall be conducted and the Personnel results documented and reported in accordance with QP-5.1. Audits shall be conducted by personnel qualified in accordance with QP-5.2. The PE shall provide technical assistance for the audit as required by the RQAM.
Audit reports shall be distributed as required in the project distribution list (QP-2.2).
3.2 Audit I
O Discrepancies The PE is responsible for coordinating resolution and corrective action of audit discrepancies with the supplier. The RQAM shall approve resolution of j all audit discrepancies in accordance with QP-5.1.,
3.3 Documentation Reports, checklists and other audit docuentation shall be maintained by the RQAM as required in QP-4.1.
4.0 INSPECTIONS AND Additional inspections and examinations may be EXAMINATIONS required to ascertain the quality of materials and (Materials and equipment purchased by Impell for the client. These EquipmentOnly) activities may include:
l a. In-process inspection
- c. Receiving inspection 4.1 Requirements When required by the Project Quality Plan or procurament doc ments, inspections and examinations shall be performed in accordance with the requirements of ANSI N45.2.13. "QA Requirements for Control of Procurement of Items and Services for Nuclear Power Plants".
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Control of Procurement of Items and Services for Nuclear Power Plants".
Inspections and examinations performed by the supplier shall be performed in accordance with procurement documents which incorporate the requirements of this procedure. When performed by Impell, inspections and examinations of materials and equipment shall be performed in accordance with written instructions prepared for the specific activity which raeet the PE Uirements of this a procedure, e
4.2 Responsibilities Inspections and examinations may be performed by the client, Impell, the suDDlier, or may be Vg s subcontracted by Impell to other organizations as defined in the Project Quality Plan. 4Y Subcontracting of inspections and examinations shall be conducted in accordance with the appropriate
- h requirements of this procedure,;QP-7.1, QP-7.2 and QP-7.3.
4.3 Personnel Personnel performing insper:1ons and examinations shall be qualified in accordance with ANSI N45.2.6,
" Qualification of Inspection, Examination and Testing Personnel for the Construction Phase of Nuclear Power Plants".
4.4 Measuring and and test equipment used for inspections Test Equipment Measurinfnations and exam shall be selected, calibrated and controlled in accordance with ANSI N45.2.13.,
5.0 COMTROL OF SUPPLIER Impell shall rective, distribute and control DOCUMENT 5 supplier documents ~(e.g., design drawings, e procedures, reports) in accordance with QP-2.2.
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Supplier documento shall be reviewed and accepted in accordance with the procedure oefined in the Project
, fualityPlan.
c 6.0 SUPPLIER QUALITY Periodically, the RQAM shall review reports of.
- PROGRAM EVALUATION quality assurance audits, supplier surveillances,
! sapplier quality activities and other inspections QP-7.4 l nRevision]
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and examinations to determine the effectiveness of the supplier's quality program. Frequency of these evaluations shall be determined by the RQAM based on the supplier's history of performance (typical frequency is once per year).
6.1 Documentation The RQAM shall document results of the evaluation in a report to the PE. Specific reporting methods are the RQAM's option, but shall include the following:
- a. Suppl ? tr and date of evaluation !
- b. Applicable procurement document and contract
- c. Documents and activities evaluated
- d. Suninary of results and acceptability
- e. Discrepancies requiring corrective action l i
6.2 Cc/rerEve The PE is responsible for coordinating corrective l Acti on actions with the supplier and shall establish a follow-up system to assure implementation.
6.3 Follow-up 8
When determined appropriate by the RQAM, follow-up Quality Assurance audits of the supplier shall be conducted as defined Audits in Section 3.0 above. l l
i 7.0 STOP WORK The stop work requirements of QP-5.3 shall be
! applied to supplier activites when determined j appropriate by the RQAM.
8.0 ACCEPTANCE OF Technical services and related materials supplied to
, SERVICES Impell shall be accepted as follows prior to their use within Impell or transmittal to the client. ,
8.1 Supplier k Procurement documents state criteria for Impell Verification acceptance of services (technical materials). The supplier shall verify services meet these criteria prior to transmittal to Impell.
8.2 Impell Acceptance Impell may accept technical materialt or other Methods services by any of the following methods:
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- a. Technical verification of materials
- b. Quality assurance audit of supplier activities
- c. Review of objective evidence for confonnance (e.g. stress reports, certifications).
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'O Other methods may also be used for acceptance of services as determined appropriate by the PE and RQAM.
8.3 Acceptance and The PE shall coordinate acceptance activities and Documentation document the results in a sumary report. The RQAM shall review Impell and supplier quality documentation to assure there are no outstanding audits, surveillances, or other discrepancies or nonconfonnances.
l A copy of the acceptance report should be placed in the Project QA File.
8.4 Corrective The PE shall coordinate resolution of corrective Action actions, assure all acceptance criteria are satisfied, and amend / update the acceptance report to indicate satisf actory resolution of all corrective actions.
9.0 ACCEPTANCE OF O
MAltKLAL5 ANU EQUIPMENT 9.1 Supplier Prior to shipment, the w, lier shall verify that Verification materials and equipnient comply with procurement document requirements.
9.2 Methods The Project Quality Plan shall state the specific method for acceptance of materials and equipment.
Materials and equipment may be accepted by any of the following:
- a. Source verification or receiving inspection in accordance with Section 4.0 above. Source verification should be used when the materials or equipment are vital to plant safety, present difficulty in verifying quality af ter delivery, are complex in design, or difficult to manufacture or test
- b. Supplier certificate of conformance or post installation test in accordance with ANSI N45.2.13.
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l 10.6 QUALITY RECORDS The following shall be maintained as quality records and transmitted to the client in accordance with QP-4.1 and any specific requirements identified in the Project Quality Plan:
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- a. Documents verifying the planning for supplier l
performance evaluation and verification activities
- b. Supplier generated technical documents submitted
.to Impell for review and acceptance or submitted to attest to the quality of materials, equipment des orservicesbeingprovided(e.g.
drawings, procedures, certificat Ions)ign
- c. Reports documenting results of inspections and examinations of materials and equipment
- d. Personnel qualifications for inspection and examination personnel
- e. Measuring and test equipment calibration reports
- f. Reports documenting evaluation of supplier quality program effectiveness
- g. Acceptance reports for materials, equipment and services
- h. Nonconformance reports
- 1. Quality assurance audits (both pre-award and post-award) 11.0 ATTACHMENTS A - Procedure Summary l
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SUPPLIER PERFORMANCE EVALUATION PROCEDURE
SUMMARY
REQUIREMENT RESPONSIBILITY Define supplier perfonnance evaluation procedure in Project Quality Plan PE Plan verification process PE and RQAM Perform quality assurance audits RQAM & PE for technical per QP-5.1 support -
Coordinate resolution of audit ~
discrepancies Inspections and examinatior.s PE h
per ANSI N45.2.13 By supplier Per procurement documents By* Impell Per Project Quality Plan Personnel qualifications Per ANSI N45.2.6 g Measuring ) test equipment Per ANSI N45.2.13 Control of supplier documents Per QP-2.2 Supplier quality program evaluation RQAM corrective action PE Stop work authority RQAM l
Acceptance Verify items comply with procurement documents Supplier Impell perfonn acceptance activities PE & RQAM i Corrective action PE coordinate i
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