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RemedialInvestigation/FeasibilityStudy Work Plan
Pines Area of InvestigationAOCIIDocket No. V-W-'04-C-784
Volume 7
Quality Management Plan
ENSR Corporation
September 16,2005
Document Number 01776-020-156
The following personnel have prepared and/or reviewed thisreport for accuracy, content and quality of presentation.
Lisa JN Bradley, Ph.D., DABTProject Manager
W Debra McGrathProject QA Officer
September 16,2005
AOCII-Docket No. V-W-XM-C-784-RI/FSWP-V7QMP Septomtar 16,20CC
CONTENTS
1.0 MTROOUCTION ------------ 1-1
1.1 Background on QuaHy Systems ..................................................... __________ ......................... 1-1
1.2 Purpose of the QMP ___ ........................................................................ _______ ......................... 1-2
13 Approval of QMP by ENSR Management and Managers ___________________________ ........................ 1-3
2-1
2.1 ENSR*s Quafty Poky...- 2-1
22 Organization „ „ 2-2
23 ResponsHttes of ENSfTs Key Personnel for Quafty Assurance 2-2
2.4 ActvBes and Programs that Require Quality Management 2-3
2JS Dispute Resolution „ 2-4
34 QUALITY SYSTEM COMPONENTS 3-1
3.1 OiinBy Tpinm Dm liimntirtii mATMT 3-1
32 Project Quafty Assurance Planning 3-1
3 J3 Project Quafty Assurance Documentation - QAPP 3-2
3.4 Standard Operating Procedures 3-2
3.5 Project-Level Evaluafon 3-2
3.5.1 Control of Measurement Data „_ 3-2
3JS2 Document Control and Record-Keeping 3-3
3A3 Subcortfractor/Vendor Management 3-3
3.5.4 Peer Review/Senior Review 3-4
3.5.5 Project Review and Improvement Process _ 3-4
i S^Mntarie.2006
CONTENTS (Cont'd)
3.5.6 Client Feedback 3-5
3.6 Quality System Personnel Standards - Quality Assurance Training 3-5
3.7 Quality Monitoring 3-5
4.0 PERSONNEL QUALIFICATIONS AND TRAINING 4-1
4.1 ENSR Policy on Personnel Qualification and Training 4-1
4.2 ENSR Process to Ensure Personnel Maintain Necessary Qualifications 4-1
4.3 Training, Indoctrination, and Performance Proficiency 4-2
5.0 PROCUREMENT OF ITEMS AND SERVICES 5-1
5.1 Subcontract Services 5-1
5.1.1 ENSR Personnel Roles, Responsibilities, and Authorities :...5-1
5.1.2 Reviewing and Approving Subcontract Documents 5-1
5.1.3 Subcontractor Selection : 5-2
5.1.4 Subcontractor Source Selection, Qualification, and Approval Process 5-2
5.1.5 ENSR's Basic Ordering Agreement (BOA) Program 5-3
5.2 Procurements of Items ...5-3
5.2.1 ENSR Personnel Roles, Responsibilities, and Authorities 5-4
5.2.2 Receipt Inspection and Verification of Measuring and Test Equipment 545.2.3 Receipt Inspection and Verification of Supplies 54
6.0 DOCUMENTS AND RECORDS 6-1
6.1 Roles, Responsibilities, and Authorities 6-1
6.2 Document Review 6-1
6.3 Confidentiality Procedures 6-2
6.4 Chain of Custody 6-2
7.0 COMPUTER HARDWARE AND SOFTWARE CONFIGURATION CONTROL 7-1
7.1 Roles and Responsibilities 7-1
AOCII-Docket No. V-W-t04-&784-RVFSWP-V7QMP ij September 16,2005
CONTENTS (Confd)
72 Commercial Software and Hardware 7-1
73 AnalyticdAppicaaons.- „ 7-2
7.4 Experimental and Beta-Test Software 7-2
7.5 NuUBeaUuii Requirements 7-2v nr m • • • • • • • ********* w*m* ••••»•••••••••••••••••••»••••••••••••»•••«•»»••••*••*••«»••«»•»«••««»»«> .•••.«...»...«. ~_
8J PROJECT PLANMNG 8-1
8.1 Systematic Ptarring Process. 8-1
83 Project Team Planning „ 8-1
8.3 Project Management Planning 8-2
8.4 QuaBy Assurance Project Plans (QAPPs) 8-2
94 MPLEMBfTATION OF WORK PROCESSES 9-1
9.1 QMP Implementation 9-1
9.2 Project QA Implementation 9-1
9.3 Standard Opening Procedures (SOPs) 9-29.3.1 Purpose and Scope 9-29.33 SOP Acceptance and Distribution 9-29.33 ReaponsMbes. _ 9-39.3.4 SOP Content 9-39.3.5 Review. Approval. Distribution, and Indoctrination 9-3
110 QUALITY ASSURANCE ASSESSMENT AND CORRECTIVE ACTION 10-1
10.1 ResponsMUes „ „ 10-1
103 QA Assessor Quaffcabons 10-1
103 QA Assessment Scope 10-2103.1 Laboratory Audfe 10-210.3.2 Reid Audte 10-2
10.4 QA Assessment Schedule...- „.„ 10-2
AOCI-IMMNoiVW.lDtC.7M-mFSWI»-V7aM> Si <j*p*mt> it 18.2005
0CONTENTS (Cont'd)
10.5 QA Assessment Reporting 10-2
10.6 QA Assessment Corrective Action 10-3
11.0 QUAUTY IMPROVEMENT 11-1
11.1 Internal Reviews 11-1
11.2 SOP Reviews 11-1
11.3 Project Peer Review/Senior Review 11-1
11.4 Project Review and Improvement Process 11-2
11.5 Client Feedback 11-2
12.0 REFERENCES 12-1
APPENDICES
A ENSR's Corporate Quality Management Plan
B ENSR's Corporate Standard Operating Procedures
AOCII-DocfcalNo.V-W-i04-C.784-RI/FSWP-V7QMP jy September 16.20(15
LIST OF FIGURES
Hgure 2-1 Project Organization Chart „ 2-5
Figure 6-1 Senior Review Record 1 6-3
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ACRONYMS
AOCII Administrative Order on Consent, 2004; Docket No. V-W-'04-C-784
ANSI American National Standards Institute
ASQC American Society for Quality Control
ASTM American Society for Testing and Materials
BOA Basic Ordering Agreement
CSC Client Service Center
DOT Department of Transportation
DQO Data Quality Objective
ENSR ENSR Corporation
EMR Experience Modification Rate
ERA Ecolocial Risk Assessment
FSP Field Sampling Plan
CIS Geographical information systems
HASP Health and Safety Plan
HHRA Human Hearth Risk Assessment
IEEE Institute of Electrical and Electronics Engineers
IS Information Systems
ISO International Organization for Standardization
NCP National Contingency Plan
NIPSCO Northern Indiana Public Service Company
OSHA Occupational Safety and Health Administration
PDF Portable Document Format
QA Quality Assurance
QAPP Quality Assurance Project Plan
QC Quality Control
QMP Quality Management Plan
RI/FS Remedial Investigation and Feasibility Study
SAP Sampling and Analysis Plan
AOC II - Dock* No. V-W-1M-C-784 - RI/FS WP - V7 QMP vi S«pt»n*»r 16.2005
oSOW Statement of Wortc
SOP StandanJ Opening Prooedue
USEPA Untod States Environmental Protection Agency
1*2005
oDISCLAIMER
This document is a document prepared under a federal administrative order on consent andrevised based on comments received from the U.S. Environmental Protection Agency (USEPA).This document has been approved by USEPA, and is the final version of the document.
AOCII-Docket No. V-W--04-C-784-RVFSWP-V7QMP yjjj Soptembw 16.2005
1.0 INTRODUCTION
In Apr! 2004. the Unted Slates Environmental Protection Agency (USEPA) and the Respondents(Brown bvx. Ddat Corp.. Buk Transport Corp., and Northern Mora Pubic Service Company(NPSCOX skjned an Administrative Order on Consent (AOC II) (Docket No. V-W-i04-C-784) toconduct a Remedial Investigation and FeasttBy Study (RI/FS) at the Pines Area of Investigation, asset farlihExr I to AOC II. located* the environs of AOC II (SectionVI-20) and the Statement of Work (SOW) (Task 2). which is provided as an atlachmeiit to AOC II.requires the Respondents to develop a Work Plan. The Work Plan has been developed in sevenvolumes, which together provide the comprehensive approach and specific detals forconducting the RI/FSfor the Area of Investigation. These volumes are as follows:
• Volume 1- Wortc Plan Overview• Volume 2- Field Samping Plan (FSP)• Volume 3 -Quafty Assurance Project Plan (QAPP)• Volume 4-Health and Safety Plan (HASP)• Volume 5 -Human Health Risk Assessment (HHRA) Work Plan• Volume 6 -Ecological Risk Assessment (ERA) Work Plan• Volume 7-Quatty Management Plan (QMP)
This QMP has been prepared to foBow the requirements in AOC II and Task 2.4 of the SOW. as weNas to be compfert with the National Contingency Plan (NCP) (USEPA, 1990).
The purpose of the QMP is to demonstrate that the proposed contactor for the work under AOC II hasa quaBy system in place that compies with American National Standards Institute (ANSI) andAmerican Society for QuaBy Control (ASQC) guideines. As such, this document provides the QMPfor ENSR Corporation (ENSR). who is the cuKiaOm selected by the Respondents and approved byUSEPA for performing the environmental investigation work under AOC II.
1.1 Background on flnaBy Systems
For enHes conducting environmental programs that are supported or mandated through contracts,regulations, or other fannsized agreements, the USEPA requires parfdpatfon in a cenlraly managedquaBy system. A quaBy system includes poities and procedures for ensuring that work processes,products, or services satisfy atutod expectations or specifications. USEPA requires documentation ofthis quaBy system through the dovotopmont of a QMP.
MCI-OKMN*\MM-TMC4M-raFSWP-V7aM> 1-1 fllllfciHill 16.2005
1.2 Purpose of the QMP
The QMP describes the management policies, objectives, procedures, organization authorities, rokis.and responsibilities tor ensuring that environmental data collected and evaluated for the Pines Area ofInvestigation project are of the type and quality needed for their intended use. The QMP documentsmanagement practices, including quality assurance (QA) and quality control (QC) activities, used toensure that the results of technical work are of the type and quality needed for its intended use.
This QMP was prepared to document the QA policies and management structure to be used inimplementing ENSR's quality system for the collection and management of environmental data for theRI/FS for the Pines Area of Investigation. This QMP was prepared in accordance with USEPARequirements lor Quality Management Plans (QA/R-2) (EPA/240/B-01/002, March 2001) (USEPA,2001 b). and has been approved by the Project Manager and Project QA Officer (refer to signaturepage at the front of this document). Overall, this QMP documents:
• The mission and quality policy of ENSR;
• The specific roles, authorities, and responsibilities of management and staff with respect toQA and QC activities;
• The means by which effective communications with personnel performing the work areassured;
• The processes used to plan, implement, and assess the work performed;
• The process by which measures of effectiveness for QA and QC activities will t>eestablished and how frequently effectiveness will be measured;
• The continual improvement process based on lessons learned from previous experience;and
• Subcontractor procurement and contracting.
The QMP reflects ENSR's commitment to quality management principles and practices. The elementsto be addressed in a QMP include: management and organization; quality system description;personnel qualifications and training; procurement of items and services; documentation and records;computer hardware and software; planning; implementation of work processes; assessment andresponse; and quality improvement. These elements are discussed in the remaining sections of thisplan.
Appendix A of this QMP provides ENSR's corporate Quality Program Manual. This manual isreferenced throughout this QMP, and provides specific detail relative to ENSR's corporate qualitymanagement program. Further, this manual provides the signatures of ENSR's Senior Management.The remainder of this QMP provides more specific detail regarding the quality management program
AOCII-Oocfca(No.V-W->04-C-784-RI/FSWP-V7QMP 1-2 September 16.20(15
for tie Pfnas Area of Investigation. ENSRs cuporate QuaRy Program Manual is rofcroncod asnecessary to provide a I'duonuu for more specific detai on various aspects of the overai QMP.
13 Approval of QMP by ENSR Management and Hanagwv
The approval pege for tWsdoo^ent is provktedmnecSa^^ ENSRsProject Manager. Dr. Lisa JN Bradtey, and ENSFTs Project QA Officer, Ms. Debra McGrath, haveapproved IMs document for RWFS work related to the Pines Area rf Investigation.
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2.0 MANAGEMENT AND ORGANIZATION
This section documents the overall policy, scope, applicability, and management responsibilities ofENSR's quality system.
2.1 ENSR's Quality Policy
ENSR's quality policy is based on a definition of quality as conformance to requirements; and further,on the premise that the requirements are governed by project objectives as well ascorporate/government agency policies and standard operating procedures.
ENSR is committed to the philosophy that productivity and profitability result from quality achievement,and that optimum quality is best achieved through preventive rather than curative measures. Qualityperformance requires consensus on the requirements of each project and design of project strategiesbased on those requirements. Therefore, ENSR's quality program is a cyclical process based onthese three steps:
1. Development of project plans, representing agreement between ENSR, its client, and approvinggovernment agencies that define project-specific requirements and the organization andprocedures established to meet those requirements;
2. Quality assessment through a program of project reviews, senior review, client feedback,assessments, and QC activities to ensure that each project is meeting its requirements; and
3. Periodic re-evaluation and updating of project plans and procedures to ensure compatibility withchanging project requirements and conditions, and to improve quality whenever possible.
ENSR's policy is that the primary responsibility for improving quality in operation, production, datacollection, processing and analysis, documentation, and report writing remains with the personnelperforming the work. ENSR personnel will perform their work in accordance with client requirements,project plans, standards of their profession, accepted quality practices, and applicable regulations. Inthe absence of specific guidelines, they will follow best scientific or technical judgment.
ENSR's quality program is based upon the applicable guidelines of the International Organization forStandardization (ISO), the American Society for Testing and Materials (ASTM), ANSI, and the USEPA.As stated earlier, Appendix A of this QMP provides ENSR's corporate Quality Program Manual.
AOCU-DockMNo.V-W-W-C-TM-RI/FSWP-VTQMP 2-1 September 16. ZOD5
The President of ENSR Corporation is responsfcte for fiuMBng ENSRTs corporate commRmeiit toto dents of quafty products and services. The President is aided by a Director of Quatty
ernent fcnJJoBvos, who is responsive for reviewing the offootivonofts of quaHy pmyidms in placeENSR International, and oho is leaping the development off a cient feetijach process.
The Regional Vtoe Presidents and dent Service Center (CSC) Managers are responsfcte tor the— - u^— Jl ^ —.—. ^ l i ^ K^ ^ MaAa b_._ABjLKM. ^M ___ •*• __ — • ii !-••!! alii n &^v 4BV«h -JE— - J— •»— _ - fc«fcJ jfc r»»ar
j— — - §•• 11 n »JH«S««overai praparann ana iujmnonupon of ojuaMy programs forme (•supanes ana service anes wnnm
their arganizattons, and for conducting periodic project reviews to assess project performance andachievement of dent requirements. These managers may be assisted by a Director of QualityPiugidim. who is responsMe for providng overai direction and cumultaliun of ENSR QualityPi ugiamB for the Region.
Reaource Monagora (or Line Managers) and Project Managers are responsMe for preparation andofa^aa^
The Regional Vice Presidents. CSC Managers and the Resource/Project Managers may appointQueHy Program Comdbiutuis (i.e., Pioject QA Officers) to help thorn fuM thev ojuaBy responslNbbes.
Figure 2-1 provides an organization chart representative of this structure.
23 Reaponefca<lesofEIISR^KeyPer»onnelforniiiilyAs«uraric«
The responsMBea of the Director of Qia% Programs/Quaity ImpioviMiert InBahves are to:
• Provide overall direction to and coordination of ENSR QuaKy Programs;
• Render advice and comment to both corporate and operational managemont required tomnintniM and effuct ttw Corporate Quatty Pofcy and Programs;
• Maintain and daafmte quafty program documentation such as Quafty Pofcy Statements.Quafty Program Manuals, and non-project-specific Standard Operating Procedures(SOPs);
• Assist and guide the efforts of those assigned quafty piuujuui responsMties on projectsand for spedBc technical dacipines or service Bnes;
• Sofct. summarize, and report quaRy assessments provided by ENSR dents;
• Conduct or supervise periodic reviews of project-specific and dbqpfne-specific QualityPiuyi£bm, and
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• Advise Line and Project Managers and Quality Program assignees of deficiencies in QualityPrograms or performance thereto.
The responsibilities of the Project Managers (or their designees, for example, the Project QA Officer),for their particular projects, are to:
• Understand the client's requirements and ensure that the project team understands them;
• Generate and distribute project plans, manuals and/or standard procedures to define theproject requirements and the procedures by which they will be achieved, and to establishproject-specific quality criteria;
• Conduct project reviews and inspections to monitor performance and correct conditions thatmight interfere with achievement of project requirements;
• Review and update project plans as necessary to adjust to changing project requirements;and
• Maintain hard-copy and electronic project records to ensure that all project plans, workproducts, and supporting documentation are retrievable and accessible by ENSRManagement.
The responsibilities of Resource/Line Managers (or their designees), for the resources they manage,are to:
• Indoctrinate personnel in the ENSR Quality Policies and Procedures;
• Conduct performance appraisals annually and include assessment of each person'sattentiveness to quality and compliance with project plans and procedures as well as ENSRQuality Policies and Procedures; and
• Continually review service line strategy and delivery systems to ensure that they areadjusting effectively to changing client requirements.
ENSR's corporate Quality Program Manual (Appendix A) discusses how ENSR management willassure that applicable elements of and criteria for the quality system are understood by managers andstaff, and implemented in its environmental programs (refer to Sections 1.4, 2.3, 3.3, 4.2, 5.2, 6.2, 7.3,8.4, 9.2, and 10.2 of Appendix A).
2.4 Activities and Programs that Require Quality Management
Several activities and programs that would require quality management for the Pines Area ofInvestigation project are:
AOCn-Dock*No.V-W-'04-C-784-Rl/FSWP-V7QMP 2-3 September 16. 2005
• AcquMfan or development of faid measurements or analytical data;
• Sttng of field locations (e.g., samplng site selection, etc.);
• OvnsJyht of stdyjonU actor poffuiiiiuitce;
• Records management;
• Engineering;
• bwoiting;
• Oefverabtes; and4
• Communicafon. progress reporting, and information management
2.5 Dispute fleiohioon
For ffwee siuations in which issues regardrng quafty assurance are in depute, resolution wi besought at the looprt appropriate management level. Such dfeputes may occur in siuations involvingtechnical issues (e.g.. data quaRy aMOMmonto) or management issues (e , QMP roviews, QualityAssurance Project Plan (QAPP) reviews, or management system reviews). Al parties wl make everyefcrt to resolve dfeputes through dtocussion and negotiation. If agreement cannot be reached at thelowest appropriate level, the issue wl be resolved by invo^ ENSIT s Dirertor of Qualty PnDyamsand the next level of management (e.gM CSC Manager or Regional Vice Ftesidert) as appropriate.
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AOCII - Docket No. V-W-'04-C-784 - RI/FS WP - V7 QMP
Figure 2-1ENSR Organization ChartQuality Management PlanPines Area of Investigation
Porter County, IndianaSeptember 16,2005
3.0 QUALITY SYSTEM COMPONENTS
ENSRfe quafty program is supported by several key otomonts. This section documents how ENSRmanages is quaBy system through these elements, and defines the pfiitaiy iBSponstoBbes formanaging and iiiulBiiMMrtiiy each otomont of the system.
3.1
This QMP contains the QA poUes, procedures, and management systanv governng ENSR*s quaitysystem for the coiocbon and management of environmeKal data on assessment and remediationprojects, and. in particular, the RVFS for the Pines Area of Investigation. The QMP describes thequaVy system in terms of the organizational structure, functional responsMBes of management andstaff, enes of authority, and interfaces for those planning, imptemoiiliig and evaluating activities.
The Project Monngorfcr the Pines Area of Investigation is responsfcte far preparing (or overseeing thepiepaiaUun of), reviewing, and revising the QMP. The QMP was developed by the Pines Area ofInvestigation Piuject Team wflh the approval of the Project Manager and wflh assntance, asappropriate, from the Director of QuaMy Programs and the Project QA Officer. The QMP is intendedfar use by ENSR staff coioctirtgaiKi managing envwt ^Approval of the QMP is made by the Project QA Officer and Project Manager. This QMP is appfcabtefor the duration of the project. punJhiy changes to the organi/Hlioii or resuBs ftom project reviews. It isnoted fiat OCR's corporate QuaMy Piugram Manual (Appendbt A) describes the systems appfcabteto the ENSR ofgai alkjn (refer to Section 1.3 of Append* A for appicaMBy delate); this manual isappfcabte to al ENSR staff at alfcnes
The ENSR project planning process b a common sense, graded approach to planning projects toensure that the level of detal in project ptanrang is commonsurab witti the vnportance and ntendeduse of the work and ovoiafcto resources. Section 8.0 provides addBonal detal on the use of project
ENSRTs ouipuiate QuaMy Program Manual (Appendbt A) provides rtnMh about the systematicplanning process used during development of the QAPP. Appicabte guidance used to develop theQAPP far tie Pines Area of Irivesfgation (whichisVoltme3oft)iisRI SWorkPlan)iriclude:
01/003. Defines specOcations for Quafity Assurance Project Plans; these specifications areequvafent to Chapter 5 of EPA Manual 5360 (USEPA. 2001a).
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• Guidance for Quality Assurance Project Plans fG-51 - December 2002, EPA/240/R-02/009.Guidance on developing Quality Assurance Project Plans that meet EPA specifications(USEPA, 2002). Note: This document replaces EPA/600/R-98/018 issued in February, 1998.
3.3 Project Quality Assurance Documentation - QAPP
A QAPP is prepared at the start of complex projects to describe project organization, quality objectives,operating procedures, data validation procedures and criteria, assessment and inspectionrequirements, and quality reporting requirements for the project The Project QA Officer assigned tothe project is responsible for preparing the QAPP. Further detail on the development andimplementation of the QAPP is provided in Sections 8.3 and 9.2.
ENSR's QAPP for the Pines Area of Investigation is provided as Volume 3 of this RI/FS Work Plan.The QAPP provides the data quality objectives (DQOs) for the investigation (refer to Section A7 of theQAPP). These DQOs were developed using applicable EPA guidance, including:
• References/guidance listed above in Section 3.2 of this QMP;
• Guidance for the Data Quality Objectives Process K3A/G-41 EPA/600/R-96/005, August 2000(USEPA, 2000b).
• Data Quality Objectives Process for Hazardous Waste Site Investigations (G-4HW1EPA/600/R-00/007, January 2000. (USEPA, 2000a)
3.4 Standard Operating Procedures
Routine SOPs are prepared or adopted for each project to provide a guide and control for trieperformance of work. SOPs implement quality requirements by ensuring the appropriate andconsistent performance of a repetitive task. Further detail about ENSR's SOPs is provided in Section9.3.
3.5 Project-Level Evaluation
The components of this quality program element are discussed below.
3.5.1 Control of Measurement Data
The quality of field measurement and analytical laboratory data at ENSR is controlled through asystem of project-specific planning, laboratory subcontracting procedures, SOPs, quality controlchecks, standard documentation forms, auditing, and data validation. This system functionsthroughout a sampling and analysis program to ensure that Data Quality Objectives (DQOs) are
AOCH-DoekMNo.V-W-'04-C-784-Rl/FSWP-V7QMP 3-2 S^Mnter 16.2005
developed and understood by the project team and the dent torn the beginning, and that each phaseof tieprugi wn contributes to achievement of those objectives.
3u&2 Document Control and Record-Keeping
ENSR*» recants management piugiam has been designed and jnyternented to ensure that ai project"Mwf* are luuJiy retrievable (hriig each project and after Ms completion. The system includespiuviaionB for short-term and long twin stexaye, and is based on a slanduid He organization patternwed throughout the company.
a project flespecficaly for the PH^ The project fite wi bethe cenfcal repoaiory for al documents that constitute evidence relevant to the investigationsconducted as per AOC U. Records associated with the investigations wl be retained with al theproject nwDnte far the A*aton erf AOC II and for a rrtnimum USEPA,MPSCO and Brawn Inc. wl be notifed in writing 90 days pnw to destnxfion of the records (per AOCH Section XW. 44.),
&5i3 Subcuimactor/Vendor Manigniunt
ENSRfe procurement and management systems for materials, equipment, and subcontractors ensurethat, torn the outset, the requirements for the procured tem(s) or services) are clearly defined.achievable, and consistent win project objectives. Specifications far an tern or service to be procuredare fret defined in a requbiion or subcontract request form, which are subject to peer/senior review.ENSRs rigorous incoming inspection and testing piogram verifies that procured equipment conforms
ENSR*s Contacts Department maintains a system of Basic Ordering Agreements (BOAs) forsubcontractors. In this system, subcontractors are quaffed for BOA status based on ther abity tocontinually demonstrate conformance to ENSR"s requirements. The specific ENSR requirementsdepend on the nature of each subcontractor's services, but generaiy include conformance to EMSffsproject work plans. OA plans, and HeaMi and Safety Plans. This indudes giiaBrahnn by ENSFfsItooBi and Gafaty Department based on safety record and responses to ENSR"s subcontractor healthand safety questionrtare. B4SR ip4o-date 1st o(qua*fied BOA subccrtractorsb posted a^
on the Corporate Intranet so that Project Managers can easiy identify a qtoMedsuboontractor to meettheir prefect needs.
Laboratory subcontractors are assessed based on ENSRs specific laboratory terms and condHionsand the projectrspeciic requirements, as defined in the project-specie QAPP (which is Volume 3 ofthis RVFS Work Plan).
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3.5.4 Peer Review/Senior Review
ENSR's Peer Review/Senior Review Program is in effect throughout the life of a project This programoperates independently and in addition to, project- or discipline-specific quality control review systemssuch as QA assessments and the reviews discussed below. The ENSR Project Manager assigns theSenior Reviewer at the initiation of each new project The reviewer is kept apprised of projectobjectives and progress, and is required to review all project deliverables and work with the ProjectManager to complete the Senior Review Record.
3.5.5 Project Review and Improvement Process
ENSR's principal monitoring and improvement process is a Project Performance Review program, inwhich every project is reviewed at least quarterly. ENSR CSC Managers are responsible for ensuringthat Project Performance Reviews are conducted and documented in accordance with the policy andthat documentation of Project Reviews is maintained. Each review covers the following topics:
• Progress towards completion of the scope of work and fulfillment of the client'srequirements;
• Schedule versus approved project plan;
• Costs and invoicing versus approved project plan, including adherence to ENSRprocurement policy and client's invoicing and progress reporting requirements;
• Project task structure and associated budgets;
• Senior review assignments and documentation (including adherence to dual signaturepolicy);
• Compliance with hard copy and electronic file management requirements;
• Compliance with Health and Safety requirements;
• Client relationship development; and
• Future client needs.
Documentation of each review and its findings is maintained in the project management section of theproject file. For any problems identified in the review, the reviewers work with the Project Manager todevelop a corrective action plan. Corrective action is implemented promptly to ensure that deliverablesand invoices are not affected.
AOCII-DockitNaV-W-t)4X>784-RI/FSWP-V7QMP 3-4 September 16.2(05
o344 Otent
acBvaly soldBB feedback from cianls through regularly scheduled meetings and through anrtemet-based performance uvnluaDon system. ENSR *• meet win the Respondents for the PinesArea of Investigation approximately every six months to soldi feedback on is pufcjiiunco on theproject Further, ENSKscforte are iivilBd to comptete a survey farm cn-im The surveyinstrument is designed to gtvo ENSR dotaiud information about the kind of work being evaluated andtfw specfic aspects of ENSRTs performance that could be improved, hi these inootinga or via thesurvey form, al nsports of performance are addressed, induing ttie timefness and cjuafty ofdetvorabtes. the performance of ENSR personnel, and budget and schedule performance. Theaccumulated resute are drectty logged in an on-ine dtent foodbock datohasft. »nidi can be queriedby ENSR staff through a web page on the Corporate Intranet This system provides teal-time'mcrtton^ of cfants* assessment of ENSR'sp ribmiance. ENSR uses that information to develop and
i Internal ojuaHy improvement initiatives.
QA training b an integral part of the successful implemented rf the ENSR QA pofcy statarmnt andthe achmvomont of ENSR*s stated mission. ENSR provides QA framing as appropriate such that QAfesponsfesTbes are recognized, understood, and implemented by the appropriate ENSR staff.Personnel involved vdh eiMiuignental date generation or maragenrait are provided QAtiaining. Thespedfc QA kaMng requirements for the ollerent teve*so( personnel are detaiedii Section 4.0 of thisQMP.
3.7
Designatod QA personnel peifjiiii assessiiieite and Bispocttom. AaaossmoiJa and nspedJons forma basis lor conecsVeaeson and eatnMah a record rf The Project QAOHuBi or assessor perfums assessments to voiiry compiancft v/ith the project QA plan. Findngsarereported to the Project Manager, nxho is responsUe for efleding corrective action.
MCI-lhdMNBLVW-'OU>7M-raFSWP-VraM> 3-5 SmMw 16.2006
o.4.0 PERSONNEL QUALIFICATIONS AND TRAINING
This section documents the policies and procedures for assuring that personnel performing work furENSR have the necessary skills to effectively accomplish their work.
4.1 ENSR Policy on Personnel Qualification and Training
ENSR and its subcontractors will ensure that personnel working on ENSR projects have the education,training, and experience commensurate with their job responsibilities. Personnel will be required todemonstrate proficiency in performance of their assigned work initially and periodically thereafter.
ENSR's corporate Quality Program Manual describes the ways in which its management encouragesprofessional development beyond initial qualifications (refer to section 4.0 of Appendix A).
4.2 ENSR Process to Ensure Personnel Maintain Necessary Qualifications
Project and Resource Managers have a combined role in ensuring that project personnel have aridmaintain the appropriate knowledge, skill, and statutory, regulatory, professional or other certifications,accreditations, licenses, or other formal qualification necessary to perform work for specific projects, asfollows:
• Project Managers will ensure that project personnel have the education, training, aridexperience commensurate with their job responsibilities on a particular project.
• Resource Managers are responsible for encouraging personnel to obtain further educationand for ensuring that personnel receive training before their responsibilities are expanded tonew areas.
• Resource Managers and Line Managers are responsible for conducting periodicperformance appraisals of the personnel reporting to them.
Personnel qualifications will be reviewed in individual performance evaluations, which are conductedannually. Performance evaluation criteria emphasize those elements of performance that most directlycontribute to QA, including:
• Completeness;
• Reliability and consistency;
• Clarity and precision in receiving and transmitting communications;.
~ • Proactive rather than reactive management;
\J —AOCII-DockalNo.V-W.>04-C-7B4-RVFSWP-V7aMP 4-1 Scptwntar 16.2O)5
• Teamwork; and
• EWcs.
ENSRTs corporate Dually Pro-am Manual describes how quaKed fcainers are ttentfed, how theofctlMUiimn of fcaMng is asaoMnd. and the process tor identity* HJ the need fcr quaBy related re-buiMiy hasnd on changing requirements (refer to section 4.0 of Appendrx A).
Spedfc to tw Pines Area of Invesagabon, ENSR wi provide a oertfted Professional Geologist in theStale of Indana. Elzabeth Peny. to oversee the technical work being conducted as per AOCII. ENSRatoo has Professional Engineers legJstered in the state of Irxfana.
M m TPmm^m^**m k»«A«»^^Hk»^AlMdM • D^M&KflVMKAflKA^ PujLJi-ni»« nmm4*3 ITtmlmtQ, mtOOLUmHUOn, atlO I <IIUIIIHIR* rimiCKncy
Training wl be conducted as necessary to quaMy personnel for the tasks they are to perform. Theextent of the training «• be commensurate with the scope, complexly, and nature of the work.Training wrii emphasize correct completion of work, an understanding of the basis of quaMyrequfceinents. documentation requirements, and the appropriate response to non-confarming productsor processes. Protkjenuy wl be demonstrated periodcaly to ensure adequate performance.Performance cntehawfl be derived torn project anoTor cfcrt reo jirements. \
MCI-IM«ll&V«*-l»C-7M-MFSWP-V7aM» 4-2 Tuifciitu 16.200S
5.0 PROCUREMENT OF ITEMS AND SERVICES
This section documents the procedures for services (i.e., subcontracts) and purchased items thatdirectly affect the quality of environmental programs.
5.1 Subcontract Services
ENSR projects may include subcontract services. Examples of such subcontracted services includedrilling and excavation, construction, surveying, and sample analyses. The purpose of subcontractorQA is to provide assurance that work is performed to a known and predictable standard.
5.1.1 ENSR Personnel Roles, Responsibilities, and Authorities
Approval and signature authority of subcontract services is designated and updated by the President.Authority to approve contracts is assigned to the three Regional Subcontracts Administrators. Termsand conditions that require negotiation are assigned to the Senior Subcontract Administrator.
The Project Manager will be responsible for the quality of subcontracted services. The ProjectManager will finalize precise subcontract work scope specifications and establish subcontractagreements, working with the appropriate Regional Subcontracts Administrator or the SeniorSubcontracts Administrator.
The Project Manager will also oversee the subcontractors, monitor the quality of their work, keep themon schedule and on budget, and ensure that the subcontractor's invoices are timely and accurate.
5.1.2 Reviewing and Approving Subcontract Documents
The Project Manager is responsible for correctly identifying the technical scope of work and definingthe technical capabilities required of subcontractors. These are documented in a subcontractagreement Each subcontract agreement must be approved by a Subcontracts Administrator and bythe appropriate Resource Manager, as appropriate.
The Regional Subcontracts Administrators or the Senior Subcontracts Administrator will providesupport and assistance to Project Managers by helping them identify qualified subcontractors; obtainproposals, bids, and supporting documentation from prospective subcontractors; negotiate anddocument favorable subcontract agreements; and adhere to ENSR's subcontracting policy andprocedures (refer to Section 5.0 of Appendix A).
ENSR's corporate Quality Program Manual describes the process for reviewing and approvingapplicable responses to solicitation to ensure that they satisfy all technical and quality requirements,
ACttU-Docket No. WW-'04-C-784-RI/FSWP-V7QMP 5-1 September 16,2005
and desabes tie process for review and approval of subcontractors' quafity-rolntod documentation(refer to Section 5.6 of Apperxfix A).
Subconkactor selection wl be based on a set of abjective criteria, inducing the faiowing:
• Technical capebBty and competence to perform the specific scope of services required -this should be demmeOiatod objectively with descriptions of relevant project experience andof appficabte facfifies and equipment;
• Commtted equipment and resources;
• Financial stabity — this is confirmed through pubfished financial reports and financial reportservices (&£.. Dun & Bradstreet, TRW, or those obtained from other non-profit
GiriBr ntinnii nf |iraim»¥J aifirmlmrtnr pm iiimml mmi hnnu n kvnt (if n»|iinii»ii <i mileducation commensurate wth their responstoBrJes; technicians and analysis who performmoosumimte, analyses, or evaluations, or who upoi*4k4 nsfeuments or ecjupment musthave demonstrated proficiency at the specific procedures to which they are assigned;personnel wl have and inafcdaii specific fcenses. where appficable;
QA program - subooi*actois must implement a documented QA pioyiaiii appropriate forflw qualty impact of their rote in the particular EMSR project; and
• Heafih and Safety program — when stfojunlmctod work wB nvotve potential exposure tochemical or physical hazards, the subcontractor must nave a health and safety program thatensures the fitoess of mslgned peisoniiel (JncHrihg capabBhy to lae respiratory protection),and in al respects compfias win ENSFTs Heefth and Safety Pbficies and Procedures.
Rrafiy, bofbie contracts are accepted, the selected subcontractors wB be reviewed against criteria fororganizational conftcts of interest Other criteria may also be used in each case to reflect added valueto the project, such as cunyatMty of methods or systems with ENSR or cfient invoicing.
As appropriate, and as requvad by ENSR*s cfient contract, new subcontracts wl be subject tocornpettve bid by throo or more comparaes. However, companies that have boon approved byENSfts quiJfir bnn process and maactod through a BOA may be selected wihout the use ofcompettve bid process, wih prior cfient approval.
N>.VW.lM^>7M-raF3W>-V7QM> 5-2 SmtMtarW.2006
During the competitive bid process and the qualification for BOA contracts, the Senior SubcontractsAdministrator will request satisfactory documentation in the following general areas:
• A superior Health and Safety program, as demonstrated by a superior (lower) rate 'forExperience Modification Rate (EMR) compared to industry averages, and a superior (lower)rate of Occupational Safety and Health Administration (OSHA) reportable incidents(Subcontractor Safety Data Sheet);
• Satisfactory insurance for general commercial, liability, and vehicle policy;
• Satisfactory environmental insurance (pollution liability);
• Satisfactory negotiation of terms and conditions for the bid or BOA; and
• Evidence of prior experience working successfully on ENSR projects and demonstrating theabove.
5.1.5 ENSR's Basic Ordering Agreement (BOA) Program
ENSR's Contracts Department maintains a system of BOAs for subcontractors. In this system,subcontractors are qualified for BOA status based on their ability to continually demonstrateconformance to ENSR's requirements. The specific ENSR requirements depend on the nature of eachsubcontractor's services, but generally include conformance to ENSR's project work plans, QA plans,and Health and Safety Plans. ENSR's up-to-date list of qualified BOA subcontractors is posted at alltimes on the Corporate Intranet so that Project Managers can easily identify a qualified subcontractorto meet their project needs.
Following acceptance of BOA status, the qualification must be updated and subject to the re-approvalprocess after three years. If the health and safety, technical, or contractual performance of thesubcontractor has deteriorated, the contractor will be allowed probation status for one year to regainapproval or be terminated from the program. Records are retained in active storage for three yearsand transferred to permanent storage. These records include the information required by the Healthand Safety questionnaire, and quality assessments performed. For specific types of subcontractor,including laboratories, drillers, and riggers, deficiency findings for technical quality are recorded. Thefirst deficiency results in a warning, the second involves penalties under the terms and conditions ofthe contract, and a third is cause to remove the subcontractor from BOA status and future work withENSR. In such a case a subcontractor may be given subsequent opportunities to work with ENSR ona project-by-project basis, rather than through a BOA, only if they can demonstrate that they haveachieved compliance with ENSR's requirements.
5.2 Procurements of Items
Aspects of quality control with respect to procurement are discussed below.
AOCII-DoctatNaV-W-t>4-C-784-RI/FSWP-V7QMP 5-3 September 16,2005
The Project Manager wfl assign a member(s) of the project team as the requisiioner. Therequisiioner wl be responsfeto for accurately selecting and specifying Anna to be purchased, forcompleting the appropriate reojuisiion and/or purchase order documentation, and for promptlyinspecting defvered terns to verify their operabaty and conlbmiance to the purchase order.
The Project Manager *• review the procurement docurnsnts and changes prior to any purchase, toensure that itectocurnefteirKJude adequate spedfka<ky«^
The ENSR Purchasing Department is responsible for inai Gaining the Purchasing Pofctes and
&Z2 Rscelptln»peciionandVertflcjlionofllein»ingandTe««EqiJpinent
Upon doKory of purchased isms, the requisiioner inspects themlccaji iiiaiiustothespearkationson the purchase order, with respect to quantity, model or part runbw. arid other observabte features.
The reojuJMBonor is responsMe for perfarrnitTg runcfonal tests to assure that procured •sliumenb and . Aeojufvnent are in operating condHon and satisfy putfLNimiH^ spooficHbuns. Faiures w9 be brouyhtto the attention of the Purchasing DupuiliiNMil immediately. The dettcwnt or iionouiJuiminy items wflbe segregated immedtatety. lortictod from use, and clearly tagged until returned to vendor, or untilconceive action and acceptable performance have been <
The Purchasing Department «• contact the vendor of any instninerrt or eojuipmer* that fais incominginspection or functional testing and obtain replacement or refunds as appropriate.
The recipient of supples confirms receipt by verifying terns and quartiies, martirig a^on tie receiving report of fee reojuisiion, signing the receiving report or reojuisiion. and returning theform to the Purchasing Ropresoi dative.
5-4
6.0 DOCUMENTS AND RECORDS
ENSR maintains a document and records management program to provide orderly, timely, andaccurate documentation of the correct performance of ENSR's contract commitments, including projectand data quality programs. Project quality-related documents and records (both printed and electronic)are identified and maintained in the project files by the Project Managers. ENSR's corporate QualityProgram Manual describes the process for maintaining documents (i.e., records management) (refer toSection 8.0 of Appendix A).
6.1 Roles, Responsibilities, and Authorities
Project Managers are responsible for
• Implementing the provisions of this section and/or the applicable contractual recordsretention requirements for their projects;
• Identifying, organizing, and accumulating all project-related quality records (both printed andelectronic) during the life of the project that require document control;
• Maintaining project-related quality documents and records including transmittal, distribution,retention, access, preservation (including protection from damage, loss, and deterioration),traceability, retrieval, removal of obsolete documentation, and disposition;
• Preparing the records for off-site storage after project closure; and
• Authorizing destruction of the records after the appropriate retention time has elapsed.
The Project QA Officer is responsible for preparing, reviewing for conformance to technical and qualitysystem requirements, approving, issuing, using, authenticating, and revising quality-related documentsand records.
6.2 Document Review
The Project Manager or Project QA Officer reviews all project-related quality records and documents toensure that they accurately reflect the work completed.
Further, ENSR maintains a Peer Review/Senior Review Program, which is in effect throughout the litreof a project. This program operates independently and in addition to, project- or discipline-specificquality control review systems, such as those discussed in Section 10.0. The ENSR Project Managerassigns a Senior Reviewer at the initiation of each new project The reviewer is kept apprised ofproject objectives and progress, and is required to review all major project deliverables and work withthe Project Manager to complete the Senior Review Record, an example of which is provided as
AOCII-Doc*atNo.V-W-'04-C-784-RI/FSWP-V7QMP 6-1 September 16.20D5
Figure 6-1. The Senior Reviewer also intervenes whenever he/she befeves the project ofluil andobjectives may be Diverging, ether in terms of technical obtectives or in temis of budget and schedule.
Rnal project reports of a conldenlfal nature are kept in a secured (locked) area. Access is imited andcheckout procedures are striofy moratored by the Project or CSC Manger or their designee.
Work-product fites (those fibs generated by the project team members, and includhg al figures, plans,laboratory inputs, •Bpp*|nrEt?Bii. cunusuondence, and relevant uiucliumc modui such as computerdbfcs) are nrinlained by the members of the individual project team in their offices, where access tothem is confrofed. Once the project work is completed, the fites become inactive and are turned overto lie Piujeut Manager for the protect-spodflc retention period.
Chain of Custody
/SI sample py^^n^g and shipment procedures for environmental testing (pnckxing chain-of-custody)*• be performed in accordance wtti mandated procedures provided by USEPA, Department ofTransportation (DOT) and other agencies regulating the shipment of samples. Addtfonal detatereganfng environmental sample custody are provided in the RI/FS Work Plan or the QAPP. "
6-2 ii|iM»im in.Tonr
Figure 6-1 Senior Review Record 1
Senior ReviewRequested by.
Reviewer
For (Project): Pines Area of Investigation
AOCH
Docket No. V-W-'04-C-784
Dete:
Title of Document Reviewed:
Section(s) Reviewed):
ENSR Document Number
Document Type: | | Major Deliverable | | Final Report | | Protocol Document/Workplan | | Proposal [~] Other(To select a checkbox, dick on It and then on the red diamond in the toolbar. To deselect one. use the black dub in the toolbar)
Findings(To select a checkbox, click on It and then on the red diamond in the toolbar. To deselect one, use the black dub In the toolbar)
| | Reviewer has had advance communication sufficient to understand the client's needs and properly schedule this review. (SR)
[ | Document satisfies client's regulatory and submission date requirements and other requirements stated In contract/workorder/purchase order. (PM)
| [ Project methodology Is consistent with project objectives and ENSR standard operating procedures. (PM and SR)
| | Procedures, numerical analyses, conclusions and recommendations are presented clearly and professionaHy. (SR)
| [ All data and references forming the basis for conclusions and recommendations re presented or dted. (SR)
| | Reviewer has verified with the project manager that technical reviews of numerical analyses, computer programs, and datavalidation procedures have been performed and documented, in accordance with ENSR procedures. (SR)
| | Reviewer has verified with the project manager that an editorial review has been performed. (SR)
Reviewer's Comments:
Reviewer's Signature: Date:
Author's Response Final Resolution
Author's Signature: Date:
\JAOCII - Dodcat No. V-W-1M-C-784 - RI/FS WP - V7 QMP 6-3 Septombar 16.20(6
7.0 COMPUTER HARDWARE AND SOFTWARE CONFIGURATION CONTROL
The ofctont and effective management of information technology is essenBal to the success of theproject InfamMfon technology rtrasfcucture must be capable of supportiig fte eflhaent ootecBon andliaiidliy of environmental data and ongoing communications about the data among project personnel.
ENSRTs corporate QuaMy Program Manual describes the process far computer hardware and softwareoor*guraoon control (refer to Section 7.0 of Appendix A). In addttn. ENSR maintains several SOPsregardng computer hardware and software; these SOPs are included in Appcndrx B of this QMP.
7.1
The PiujBd Manager is responsible for ensuring that the project compfes wih the provisions of this
The ENSR lidbrmallun Systems (IS) Department is responsfcte for maiHailing the standard forconfiguration of the ENSR computer network.
The ENSR Purchasing Department is reeponsMe for procuring computers and ensuring that they are jconfigured h accordance with ENSR* standards, and furnished with software that compfes with v—**ENSR'sQuaBy Program Manual Onduded in Appendix A).
7.2
ENSRTs cut pur ate QuaMy Piuyiam Manual describes the process for computer hardware and softwareconfiguration control (refer to Section 7.4 of Appendbc A). This manual, and the SOPs included inAppendK B. also dscuss the process for evaluating purchased hardware and software.
ENSR has a set of approved hardware and software items. Other hardware and software wl be usedff requested by a clont or otiorwiM) required for a specific project.
Commercial uses, such as word processing, spreadsheet appfications, presentation authoring, and e-mai. must meet the fblowwig i
• The corporaliuii s 1st of supported software/h<wd*are; or
• A dent request for support of a specific software/hardware; and in eihercase.
• Requirements for trareferaMty and uuiiipaUbBty to supported software.
7-1 1Hi|ill«till 16.2M5
If an unsupported software product is obtained to match a client request, conversion software will beobtained if necessary to maintain the link to the company standard.
7.3 Analytical Applications
ENSR maintains that software used for specialized purposes such as numerical modeling, datavisualization and interpretation, and geographical information systems (GIS), and data managementwill be used in accordance with the developer's guidance.
Computer components and software integrated into analytical or test equipment, monitors, andcommunications equipment that are calibrated for a specific purpose do not require further testing ofthe supporting software, unless:
• The scope of the software use changes; or
• Modifications are made to the hardware/software configuration.
7.4 Experimental and Beta-Test Software
ENSR or its subcontracted laboratories or vendors may develop or use new software to supportanalytical projects. If such software and hardware configurations are developed, they will tiedeveloped to meet current standards, such as the Institute of Electrical and Electronics Engineers(IEEE) Standard for Software Quality Assurance Plans (ANSI/IEEE Standard 730-1989). Newapplications will be tested to specific acceptance criteria before they are used for ENSR projects. It willnot be assumed that beta-test software has been tested adequately to be applied to analytical woifc,even though ft might appear acceptable for non-technical applications.
As a minimum, algorithms and equations used for modeling or other analyses will be submitted toSenior Review and approval. All software must be completely documented as to its purpose andapplicability, limitations, and testing.
7.5 Notification Requirements
Immediate notification of the Project Manager and the Director of Quality Programs, within onebusiness day, is required for discovery of a software design error that could affect data quality. Theimpact of design error will be assessed and the client immediately informed of the error and deviation.Similarly, viruses that may affect data quality will be addressed by the Project Manager and theDirector of Quality Programs, as well as the ENSR IS Department
AOCII-DodiKNo.V-W-'04-C-784-RI/FSWP-V7QMP 7-2 Septan** 16,2015
8.0 PROJECT PLANNING
This secSon describes the processes, induing the rates, responsMEes, and authorities ofmanagement and staff, for planning environmental data operations, and developing, reviewing,approving, ir jternenting, and revising a QAPP.
8.1
ENSR uses a common-eense systematic planning process for its environmental investigation projects.The Project Manager is responsMe for ensuring that such a process is used. Guidance and technicalsupport for systematic planning of envbonmental data coiection and liandbig is provided by the QAstaff, as managed by the QA Officer for the project For is projects. ENSR uses the data quattyobjectives process as described in the most current version of the Guidance for the Data QualityObjectives Process (EPA QVG-4) (USEPA. 2000b). or as recommended by the QA Officer, where
^^__>^.^A YA^^M n^KMM^MMM *rrajeci team nanrang
ENSR incitements projects by assigning Project Teams. A Project Team consists of indrviduals havingexpertise and atts necessary to perform the work, ted by an assigned Protect Manager. ENSR uses amatrix organizational approach to manage the hundreds of Project Teams active at any one time. Keyelements of this approach are dtenussod heroin.
Line Management has the autarky, responstoHy. and accountably for achieving ENSRfe overalbusness resute. In ENSR. Line Management consists of the Mowing posSonx President RegionalVice President dent Service Manager, and Department Manager. A Line Manager assigns a ProjectManager to each project, delegating the necessary authority and responslxHy. In this process, thePiujucl Managers business and pufuiiiianoe accountabCty are also cJuniiud. The projects size,complexly, andror strategki importance wB dtatate which Line Manager sutouts and assigns the
The Piujeut Manager, wMh the concunence of Line Managers, uoiucls the remainder of the ProjectTeam. Once assigned, the Project Team Staff report dredry to the Project Manager for al project-rotaled dbBcton and docoions. The project stairs normal Line Manager continues to exercisefunctional supervision of the stairs work qualty, and technk^ or regiialory correctness.
The Project Manager has ful responsfcMy. and accountabiity for •iyta»«'U"U the assigned projectIn this rate, the Protect Manager continues to report to. and is subject to direction and managementfrom, his/her normal Line Manager. Further, although a Project Team Member's Line Manager
ft-1 SmtartMr 16.2005
\Jcontinues to exercise functional supervision of the Project Team Members' work, the Project Manageris ultimately responsible for the work his/her project personnel perform on the project.
8.3 Project Management Planning
The Project Manager is responsible for documenting in the appropriate project plans the following:
• A description of the project goal, objectives, and questions and issues to be addressed; and
• The project schedule, resources (including budget), milestones, and any applicablerequirements (e.g., regulatory and contractual requirements).
8.4 Quality Assurance Project Plans (QAPPs)
The process for developing, reviewing, approving, implementing, and revising QAPPs is described inENSR's corporate Quality Program Manual (refer to Section 3.0 of Appendix A). Further, QAPPs areprepared, reviewed, and approved in accordance with the most current USEPA requirements forQAPPs (refer to Section 3.3 of this QMP for a list of references used to develop the QAPP for thePines Area of Investigation).
The purpose of a QAPP is to establish management systems to ensure that work and work productsmeet quality objectives. These systems are implemented by the project team and by contractors wtioprovide construction, exploration, technology development and/or testing, laboratory analyses, orenvironmental data acquisition, analysis, and interpretation. Ultimately, the QAPP constitutes anagreement among the ENSR project and task managers, subcontractors, client, and regulatoryagencies as to the organization, objectives, schedules and methodology for the project. Thedevelopment of the QAPP is the responsibility of the Project QA Officer.
A QAPP is developed to provide project-specific procedures ensuring conformance to clientrequirements for the following:
• Acquisition or development of field measurements or analytical data;
• Field activities such as sampling, exploration, or construction;
• Siting of field locations (e.g., sampling site selection, wetlands delineation, establishment ofexcavation or construction site boundaries, etc.);
• Oversight of subcontractor performance;
• Custody procedures;
• Data handling including collection, analysis, storage, management, verification/validation;
AOCII-Docket No. V-W-i04-C-784-RI/FSWP-V7 QMP 8-2 September 16.20J5
• Racuds management; ,
• Defverabtes; and
• Communication, progress reporting, and iilminalion management.
Each QAPP adopts approaches, or loforonce SOPs, designed to first prevoirt. and, firing that, todetect quaBy problems during planning, implementation, and assessment of technical work. TheQAPP defines the methods by which processes and niethodctogies wl be oonhxiiBd and documentedto permi evaluation and improvement Documentation of decisions, exceptions, and changes isrequired, as t provides evidence of vafdty and dofonabHy. Fnaly. the QAPP provides theprocedures for re-analysis of environmental samples if quaity expectations are not met
The process far evaluating and quai»\)ng data cotected tor the Pines Area of Invualigalion and theacceptance criteria for reauls or measurements of ueifuiiiiuiKjo by wriritli customer satefautimi wii bedeto n • ml is described in the QAPP. which is provided as Volume 3 of the RVFS Work Plan (refer toSedbnD).
8-3 ?lp*««lll 16.2005
9.0 IMPLEMENTATION OF WORK PROCESSES
This section describes the processes for ensuring that work is performed according to approvedplanning and technical documents.
9.1 QMP Implementation
This QMP was developed to document how ENSR plans, implements, and evaluates the effectivenessof QA/QC operations applied to the collection and handling of environmental data, especially asapplied to the Pines Area of Investigation. The Project Manager and Project QA Officer areresponsible for the implementation of the QMP for the Pines Area of Investigation. Further, trieperformance of ENSR staff participating in the project will be measured against adherence to thisQMP.
The Project Manager and/or Project QA Officer will periodically review the QMP to ensure that triedocument remains relevant to project conditions. The findings of the review will be summarized in amemorandum, which will be placed in the project file. If changes to the QMP are recommended in triereview, the following will occur.
• A summary of changes necessary will be written and distributed to the project team viaelectronic mail;
• The QMP will be updated as necessary; and
• A new QMP approval page will be completed.
Approval of the QMP is made by the Project QA Officer and Project Manager. This QMP will beapplicable for the duration of the project, pending changes to the organization or results from projectreviews.
9.2 Project QA Implementation
ENSR staff participating in the project will be responsible for adhering to all documents prepared forproject-level planning purposes (e.g., QAPPs, Sampling and Analysis Rans (SAPs), Health and SafetyPlans, SOPs, etc.). Changes in such planning-level documents may be necessary throughout thecourse of the project. The Project Manager is responsible for assigning the appropriate project-levelresources to make appropriate changes to the appropriate document, and obtain Senior Review andProject QA Officer review as needed. The Project Manger is ultimately responsible for verifying thatappropriate changes have been made.
AOCN-Docket No. V-W-tM-C-ZM-RVFSWP-WQMP 9-1 September 16,2005
ENSRTs processes for ensuing that work is perfofmed accordbig ID planning and btJuucd documents,which wsl be adhered to during al phase of the protect, is provided in te SOP for Senior Review. ThisSOP, which also dbcussos the verification process used to ensure that changes are made asprescribed, is provided in Appondbc B of this QMP.
BISITs corporate QuaBy Prognm Manual, which is provkled as Apperrfx A of this QMP, descrbesthe process far maintaining documents (Le., removal of obsolete documertatton from work area) (referto Section 8.0-X and the process for on <ro»ng and documenting the idooso. change, and use of SOPs(SedonZO).
13 Standard OpeitflngProcedWM (SOPs)
ENSR. routine SOPs are prepared or adopted for each project to provide a guide and control forthe performance of work. SOPs implement quaflty roquron tents by ensuiig the appropnale andconsistent porfmnmice of a ropetHve task. SOPs far the Pines Area of InvMslirjntiun wB be providedin appropriate project-level planning documents (e.g., the QAPPs, the Itocih and Safety Plan, theFSP. tie SAPS, etc.).
»X3.1 Purpos* and Scope
SOPs am formal, revision-controled documents that
• Deine the methods used by ENSR in the perfannance of tasks having an effect on thequaBy of data, findings, or conclusions;
• Provide standard methods far execution and documentation of work, so as to maximizeUIIB\JHI Ay and rafabtty of products; and
> cuuuliaiun among indhnduab performing separate but iniardopondent tasks.
9J&2 SOP Acceptance and Distribution
There are three general categories of ENSR SOPs:
• General, corporate SOPs. governing tasks that apply to most projects, such as seniorreview and ducunertabun of calculations;
• Project-spedfc SOPs. governing tasks that must be talored to project pecfc requfrementsand circumstances; and
• Laboratory SOPs. (Note: Generaty, laboratory SOPs are more detaied. less subject tovanabMy from project to project, and require organizational acceptance by laboratorymanagement These SOPs typicaly are supplied by the laboratory.)
-vrttF 9-2 iQiiiin in. Tim
ENSR SOPs are developed by technical specialists in the appropriate disciplines, subjected to peer orsenior review, and approved by the Director of Quality Programs or their designee. SOPs aredistributed both in hard-copy form and electronically. Electronic versions of SOPs are posted in theQuality Assurance area of ENSR's Corporate Intranet. Corporate SOPs are distributed as "read-only,"Adobe™ Portable Document Format (PDF) files. SOPs for project-level work are posted asMicrosoft™ Word files within the project-specific electronic files.
9.3.3 Responsibilities
The Director of Quality Programs will ensure that up-to-date, approved revisions of corporate SOPsare available to projects for reference and use.
The Project Manager is responsible for the development and approval of project-specific SOPs thatmeet client and ENSR quality requirements. Further, the Project Manager is responsible for thedistribution and implementation of the SOPs on a specific project and for ensuring that the SOPsdeveloped for his/her project are distinguishable from those posted on the intranet and thosedeveloped to govern the same tasks on other projects. This is done by using the unique projectidentification in the SOP numbers and titles, and by assigning the appropriate revision numbers and
9.3.4 SOP Content
SOPs are associated with analyses, sampling, equipment operation/maintenance/calibration, training,construction, engineering, corrective action, and other subjects addressed in this QMP. SOPs shouldbe consistent in format, units of measure, and other editorial standards. Such consistency providesdear, defensible, traceable, and credible content
9.3.5 Review, Approval, Distribution, and Indoctrination
New corporate SOPs are submitted for senior review by knowledgeable staff members, revised (asnecessary), and submitted for approval and signature as required. This same process is followed fornew project-level SOPs.
AOCN-DOCMNO.V-W--M-C-7M-RI/FSWP-V7QMP 9-3 Saptombv 16.2C05
10.0 QUALITY ASSURANCE ASSESSMENT AND CORRECTIVE ACTION
QA assessment refers to the fomwl evaluation of ounfjnnance to the QA/QC pruymm and theefectiveness of ft. Specific asssaamont procedures, schedules, and corrective action processes aredetermined on a prefect-specific basis and are described in the appropriate QAPPs. This section ofhe QMP for Vie Pines Area of Investigation dtecusses jj*wwwal provisnns that are sicorpm ted ntopiujuct specific plans. ENSR's corporate Quafty Piuyidiii Manual (see Appondbc A) specifies theassessment tools that are used to examine the effectiveness of the techriical and QA/QC activities in aproject (refer to Section 1.8 of Appendbc A).
10.1
The Director of firth; Proujans is responsMe far maintaining ENSR's standard QA guidefnes andfar ensuring that QA assessments are conducted in a consistent manner.
The Project QA Officer is responsMe for scheduNng and planning pnifect-specsfe QA assessments,assigning a QA Assessor's) to conduct the assessment, and for repoiliig results and issuingcorrective action requests to the Project Manager.
The QA Assessor is responsMe for conducting the QA assessment, and repeals ig results to theProtect QA Officer. The Project QA Officer can act solely as the QA Assessor.
Project Managers are responsMe for detenrarang and budyuttig the appropnate level of QAnmimamnrt for their projects. *Mi the advice of the Director of QuaHy Programs and Project QAOfficer. The project manager is also responsMe far assigning responsixBy wihin the projectorpjanizalionforooractionofdefkSonctoaandforresp
10JE QAi
QA Asseeeors should hove, at a nvramum, thefolovMng quaMRcabons:
• Jmiependence - independent of the project team responsMe for u iaattig. complng. andevaluating the enviiomiuirtjl data;
• Educafon - bachetor% or Inylioi Jb^ob in science or enujneuiiy, preferably, but notnecessarily, in chemistry, environmental engineering, environmental science, geology, or arelated science: and
• Experience - fve years' professional experience in chemistry, engineering, geology, or inthe environmental feW. in which ski in the design, implementation andfor crRical evaluationof methods and procedures has been demonstrated.
-AWI-OKMMlLV4*-<OM>n4-mFSWP-V7aM> 10-1 IMI»I llM. 2005
10.3 QA Assessment Scope
Project-specific QA assessments address all aspects of the project QAPP, this QMP, and SOPs.Project QA assessments cover both project-specific and general considerations.
10.3.1 Laboratory Audits
A project assessment may or may not include a laboratory audit. Audits of subcontract laboratoriesare conducted by qualified ENSR auditors) with experience in both analytical chemistry and QualityAssurance and who are experienced in evaluating laboratory procedures. Laboratory audits take twoforms - performance audits and systems audits. Performance audits involve submittal of blind spikesto the laboratory for assessment of analytical accuracy. Systems audits consist of a thorough reviewof project procedures and documentation to confirm that work was performed in accordance with theproject-specific QAPP and the laboratory's QA program and that adequate documentation exists tosatisfy the project requirements.
10.3.2 Field Audits
The Project QA Officer or Quality Assessor will conduct an audit at the start of significant field woirkunder the sampling program for the project, and at least once every six months thereafter. Theseaudits will occur to ensure the early and continued detection and correction of deficiencies, if present.The audits will cover the execution of sample identification, field documentation, and samplingoperations, and compliance with QA/QC objectives. The audits will involve a review of field logbooks,standardized forms, and instrument calibration records.
10.4 QA Assessment Schedule
A project-specific QA assessment will be conducted at the request of the QA Officer or ProjectManager, and in accordance with the schedule outlined in the QAPP.
10.5 QA Assessment Reporting
Each QA assessment is documented in a written report addressed to the Project Manager. Eachassessment report summarizes the scope of the assessment, the assessment findings, andrecommended corrective action.
The assessment report is first issued in draft to the ENSR Project Manager to solicit comments and/orrebuttals. After discussion to clarify findings and corrective action recommendations, the assessmentreport is finalized and filed in the project files for the Pines Area of Investigation. As specified earlier,these files are maintained with the Project Manager.
AOCII-DodMtNo.V-W-'04-&784-RI/FSWP-V7QMP 10-2 S*ptomb«r 16.2C05
There are two types of corrective actions: Type 1 and Type 2. Type 1 corrective actions involve suchactions that are roady addressed, such as correction of procedtaes. repair of irairurnents that are notworking property, or correction of errors or deficiencies in documentation. Those corrections are•lytemented iiniedinsaly by me Project Manager or project team. Type 2 corrective actions areactions mat require evaluation as to the root cause of the prcMem; a preservative approach is folowBdto eJMnate the source of problems, and usualy results in canection of systematic enors in samplingor analysis, levising procedures that produce questionable results, and identifying and addressing theroot causes of me problem. Those corrections are mptomonted by the Project QA Officer.
The ENSR Project Manager responds to a corrective action request as foiows:
• ^ ••• • IrMa n ft fcu faM Miailiai faiia «B aBsgneo nr •ivosmauiy
• The root cause is determined;
• Spetifc corrective acton(s) are determined;
• AirnesoheduteissctandresponsiiatylbriiiiplemenlingconBC^
• The eifecUveness of the actton is verified and documoiitod; and
• The dent is notBod as appropriate.
The Project QA Officer *• v»ork wNh the Project Manager and project team to develop a correctiveaction plan addressing each of the inoTngs. Subsequent assessments md be performed to evaluate
of the correcttve action plan and its effectiveness.
For mose sfluations hi which issues regardng OA are in dispute, resolution^ to soijght at the lowestappropriate rnonogoment teveL Al parties wB make every oflurfl to resolve deputes throughDiscussion and negotiation. If agreement cannot be reached at the lowest appropriate level, the issuewl be resolved by involving ENSfTs Director of Quafty Programs and the next level of management(e.g CSC Manager or Regional Vice President) as appropriate.
AOCI-OKMN>.V4V-V»07M-mFS1M>-V7aM> 10-3 Tj>lllllll "T.1 T
W
11.0 QUALITY IMPROVEMENT
ENSR staff at all levels are accountable for continuous improvement in the quality of environmentaldata collection and management. The process of continuous quality improvement leads to a betterand more responsive quality system.
Because Project Managers and other staff assigned to each project are responsible for the day-to-dayproject operations, they typically have the most direct experience with quality system processes.These staff are encouraged to identify opportunities for improving the quality system by contacting theProject QA Officer directly.
Several activities will be conducted by ENSR to ensure continuous quality improvement. Theseactivities are discussed in this section.
11.1 Internal Reviews
The Project Manager and/or Project QA Officer will periodically (and at least annually) review the QMPto ensure that the document remains relevant to project conditions. The QMP will be modified, andENSR staff will be notified, as specified in Section 9.1.
Further, the Project QA Officer will meet with the Project Manager periodically (and at least quarterly)to review project QA procedures, identify potential QA issues, and address any QA issues arising fromaudits conducted. If changes to project QA are necessary, the Project QA Officer, or designee(s), willinitiate special projects to address and correct QA issues identified in the review.
11.2 SOP Reviews
As appropriate, SOPs relevant to the Pines Area of Investigation will be reviewed periodically todetermine if they remain relevant to the mission of the Quality Program and property describe theprocedures used to obtain and manage environmental data of known and sufficient quality to supportproject decisions. Ensuring that this review occurs is the responsibility of the Project QA Officer.Actions (if needed) will be developed by the Project QA Officer or designee to correct any GAdeficiencies and communicated to the Project Manager.
11.3 Project Peer Review/Senior Review
The ENSR Peer Review/Senior Review Program is in effect throughout the life of a project The ProjectManager assigns the Senior Reviewer at the initiation of each new project. The reviewer is keptapprised of project objectives and progress, and is required to review all project deliverables, and woi-kwith the Project Manager to complete the Senior Review Record.
AOCII-DockalNo.V^V-'OM>784-RVFSWP-V7QMP 11-1 Saptombar16.20DS
11.4 Pivjsct Revfew and iMpnvMnent Process
ENSRs principal monitoring and improvement process is the Project Peribnnance Review program, in
whk* every projec* is reviewed at least Quarterly ENSR CSC Managers are responsUe for ensuringtat Project Peribnnance Reviews are conducted and documented in accontanue wlh the pofcy and
. Each review covers the Mowing topics:
Progress towards completion of the scope of work and fuMbnent of the dents
• Schedule versus approved project plan;
• Costs and invoicing versus approved project plan, inducing adherence to ENSRprocurement poicy and dent's invoicing and progress reporting requirements;
^ MMM^ AMA^ j.fc- ...J. .. --- • ---- nii ii ij til irin nin• Ktojeci mnir svudure and OMOciflsoo ouugets,
• Senior review assignments and documentation (inducing adherence to dual signaturepofcy):
• Compiance wth hard copy and otoctim ik, He nwnaqement requirements;
• Oertrelationshto development and
• Future dent needs.
Documentation of each review and is tndTngs is maintained by the CSC Manager. For any problemsidentified in the review, tie reviewers work with the project manager to develop a corrective actionplan. Corredve action is implemented promptly to ensure that deiveraUes and invoices are not
11.5
ENSR advoty aoidb fsedback torn dents through reguVarty-scheduted meetings and through anMemetbased psribrrnance evaluation system. ENSR wl meet wth the Respondents for the PinesArea of Investigation approximately every six months to soirit feedback on Ms performance on theproject Further. ENSR*s dents are invited to compteto the survey form on-fne at any tine. Themooting* and survey insfcumei* are designed to give ENSR delated information about the kind ofwork being evaluated and the specMic aspects of performance that could be improved. Al aspects ofperformance are addressed, induing the fimefness and quafty of defverabtes, the performance ofpersonnel, and budget and schedule performance. The accumulated resuts are dvecVy logged inENSfTs on-ine dent feedback database, which can be quened by ENSR staff through a web page on
Corporate Intranet This system provides "real-time" monitoring of dents' assessment of
M>CI-aMMN*¥4IM»C-n«-mFSVM>~V7aM» - g||ih ill ill* 2006
performance. ENSR uses that information to develop and prioritize internal quality improvementinitiatives.
AOCII-Docta(No.V-W-I04-C-784-ra/FSWP-V7QMP 11-3 September 16.2005
12.0
USEPA. 1980. National CM and Hazardous Substances Potution Contingency Plan. Final Rule.55FR808B. US. Envfconmentol Protection Agency Match 8.
f
USEPA. 20008. Data QuaRy Objectives Process far Hazardous Waste Ste Investigations (G4HW)EPAfflOOJR-001007. January. 2000.
USEPA. 2000b. Guidance for the Data Quafty Objectives Process (QA/G4) BW600/R-96A)05.AunuBt. 2000.
USEPA. 2001a. EPA Rsqufrements for Quafty Assurance Project Plans (QA/R-5), EPA/240/B-01AXG.March. 2001.
USEPA. 2001b. Requirements for QuaHy Management Plans (CWR-2X EPA/240yB-01/002. March.2001.
USEPA. 2002. Guidance far QuaBy Assurance Project Plans (G-5), EPAC40/R-02/D09. February.2002.
12-1
o
Appendix A
ENSR's CorporateQuality Management Plan
QAOCII -Docket No. V-W-04-C-784 - RI/FS WP - V7 QMP September 16,2005
Quality Program Manual
RmrisionOAugust 2003
0Quality Program Manual
Section: AcceptanceOats: 2003Revision: 0Page; 1 of 1
SIGNATURE
Robert C.Weber."7
Thomas C. Hipp*
ACCEPTANCE SIGNATURES
TITLE
President
Vice President. Eastern Region
Senior Vice President. Central Region
Senior Vice President, Western Region
Director, Quality Programs
Vice President, Quality ImprovementInitiatives
DATE
9/120003
9/4/2003
9/2/2003
8/19/2003
6/19/2003
&/ZC/
H:\QiMKjAOA Minu«
Sector 1August 2003 ' \
J
1.0 INTRODUCTION
1.1
The purpose of ENSFTs Quafty Program is to provide adequate confidence that work performed is ofknown and deferable quatty. This program is dynamic and accommodates continuousImprovornont baaed on feedback torn our dents, from our own project operations, and fromopportunities created by changing technologies. TTie purpose of this manual is:
• To estabfah ENSR* tt Pofcy and define hw^evaluated This pofcy rulucta ENSR^ rnanagemer* phtosophy to focus on dentQOCDOCttDOnS flOu !
To estabisri a generic mettiodology for consistent, cost effective, execution of ENSR projectsregardtess of geographic location, type, or scientific dBcjpine.
To provide direction far project managers in how to imrjtement(>jaay Assurance and QuaftyConfeol in their protects such that both ENSR and our dents' latiettin are nwmiZBd. our
nance is defensiite. and we meet whatever specific QA and QC dkectivesareappfcabte to the scope and juriaoiction of the project
1.2 Scope
The program scope encompasses the products and activities related to meeb cfent otjectives.AJdMunal reojulroineiits that may affect quaity or safety wB be addressed in statements of work,CM tracts, or task descriptions. This document defines ENSR ConsuUng and Engineering poicy andprocedures governing the usiMumnont and control of product GjuaHy as ft pertans to envionmentalconsuUng and engjnooring protects. These projects are defined, for the purpose of this manual toinvolve the ooioction. interpretation and reporting of biological, geophysical, hydrotogical, chemical,ecological, biological. toxJcotogical. sodoeconomic. ambient air, and onginooring data, far thepurpose of stecharacterizaferuenvironrnental planning a^romodkri measures as wel as imptoiwonhny or supervising the implementation of remedBl actions.
The goal of this manual is to provide a formal system of practical mechanisnis far o^efining the quaityobjectives, designing the projects to achieve those objectives, criocaly reviewing performanceagainst the objectives, and assuring ENSR and its clients that the products meet the objectives.
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1.3 Applicability
The program requirements apply to ENSR projects, analytical contractors, subcontractors, andprocured goods and services. Each project will determine the extent of controls to be applied to anitem or activity as a function of the degree of confidence needed regarding the quality of the item oractivity. A list of quality program documents, Figure 1-1, presents the Quality Program hierarchy.
Figure 1-1Quality Program Hierarchy
ENSR Health and Safety Policies & Procedures
Client Contract
Quality Assurance Project Plan
ENSR Administrative Policies and Procedures
ENSR Quality Program Manual & Standard Operating Procedures
The above hierarchy emphasizes that no-action or contract will have greater importance thanemployee safety and safe practices. Client contracts will shape the project goals and plans, and thismanual and ENSR SOPs are established as a baseline in the absence of other guidance. No planor contract will be considered valid guidance if it violates the laws and regulations of the local, state,or national or federal government in which work is conducted.
1.4 Organization and Responsibility
The Quality Program Manager, reporting to the President, is the independent, authorized party whoapproves Quality Policies, Programs, and Procedures for the corporation. Each Project Manager, ordesignee, is responsible for establishing the most appropriate quality program for individual projectsin accordance with ENSR policy, client requirements, and project jurisdiction. The Health & SafetyOfficer, the Project Manager, Project QA officer or ENSR Manager of QA Programs are equallyauthorized to issue a Stop Work Order when quality, safety, or integrity are severely or imminentlythreatened.
\UraaOT\SWntteTOnsS\aualilyWA ManualWpproved2003\Chapt01.doc Page 1-2
The responsMMy far program and procedure reviews is shown in Table 1-1. Approval Signature^% n •• iTa • ^ n •>•K8C]Ui 1N1MM U.
ENSRHmk^^^^^^^^^_ ^^^ jlMBHnW rlBHI
Ph^Pinoadww
ofVltafk
Program Ptan
ENSRCoporato
^ •• •U ^1
Proosdurav
The QuaMy Piogiain Manager and Project Managers wl actively support training programs relevantto manlanng quafity to maet cfinit ul octiwu.
- The extant to which an iam or process conforms to the requirements and expectations
QuaKy Control - Operational techniques & activities used to fuffii therequrementsof Quafity.
- Al those planned or systematic actions necessary to provide adequatethat a service/product wl satisfy given requirements for QuaHy.
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Quality Program Manual
Quality Assurance Project Plan (QAPP) - A project-specific document stating the objectives andQuality goals of the project and defining the mechanisms that will be employed to ensure that thoseobjectives and goals are achieved.
Standard Operating Procedure (SOP) - A written document which provides directions for step-by-step execution of an operation, analysis, or action.
Quality Assurance Program - An integrated system that provides the managerial, technical, andadministrative requirements and controls to ensure the acquisition of data of known and acceptedquality, to ensure that processes are appropriate and defensible, and to ensure that products meetor exceed client requirements.
1.6 Program Revision and Distribution
The Quality Program Manager of has discretion to revise this manual. Revisions, except forinconsequential editorial corrections, will receive the same review and approval as the originaldocument. Reviews, whether or not they result in a revision, will be conducted within two years ofthe last documented review. This Plan shall be treated as a controlled document. Distribution willinclude on-line read-only files, which disseminate the most recent revision in a definitive edition.
1.7 Program Indoctrination and Orientation
Project Managers and Resource Managers should ensure that all project personnel comply with theENSR Quality Programs. Quality Program Indoctrination will be incorporated in the ProjectManagement training program. The primary demonstration of satisfactory orientation will becompliance with the program. Specific projects may establish formal training and documentationrequirements.
1.8 Assessments of Programs and Performance
1.8.1 Project Reviews
Each Project Manager will be assessed periodically for the adequacy of QA planning andimplementation on his or her projects. The principal form of review will be ENSR's project reviewprogram. Additional reviews may be conducted by:
• Client,
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• QuaHy Program Manner. B4SR. and
• Peerrovto*or, when appropriate.
The criteria far such assessments wil indude
• Qua^ofpen^annanceaspetcoivodbylhecient:
mnuB to Piujectoost. soop6 of vnoric, schedule;
• CUfMIKUUOl (JURJIImii/o; and
• QuaMy kifNuwnont denimisfeulBd by improved responsivunosa to the dent, reduced cycletime or accelerated raaiAs, and improved effectiveness of resources or staff.
1A2
Management wlperiodkaiy assess the adequacy of the QA Program and identify p•nprovements. Senior nidnayement wii hove ovorol responsfciHy tor stJI os?tossment activities and\iHidfcBcaV participate in the set OB aeaament process to ensure that proper focus is given, adequateresources are provided, and dfficuR issues are resolved. AM levels of management wl participate in
The management aolf pgaoBMnonta wl indude. but wi not be imited to. the fotowing:
• Assessmentof the extant to which ENSf s quatty program objectives have been achieved;
program objBulivus,
ment systems required for quaHy achn
• Evakjagonof the effectiveness of nnanagernent(X)n(n)teestabEshed to achieve and assureouaBy;and
• Evaluabon of the adequacy of resources and personnel provided to achieve and assure
Fnfngs and resuUng reoommendatfons of management self-assessments vni be documented.Senior management wl take prompt action and document decisions in response torecommendations resulting from setf-assessment
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1.8.3 Independent Assessments
Trend analysis, observed problems, or complaints may trigger an assessment to more dearlyidentify a perceived problem and develop appropriate corrective action. When appropriate orrequired by external regulations, independent assessments will be planned and implemented by anassessment team to focus on improvement of item and process quality. Personnel performingindependent assessments will act in a management advisory function, be technically knowledgeable,focus on improving the quality of the processes leading to the end product, and will not have directresponsibilities in the area they are assessing. The responsibilities of the personnel performingindependent assessments include, but are not limited to, the following:
• Monitoring work performance;
• Evaluating compliance with applicable procedures, plans, and contractual requirements;
• Identifying opportunities for improvement;
• Reporting results to a level of management having the authority to effect corrective action;and
W » Verifying satisfactory resolution of problems..
Assessment results will be reviewed and resolved by management having responsibility in the areaassessed. Responses to assessment results will include: action to correct the deficiency; root causeidentification; actions to prevent recurrence; lessons learned; and actions to be taken forimprovement, as appropriate.
1.8.4 Field Program Assessments
•• , Reviews of procedures and audits of performance for collection and evaluation of environmental? : data in field work are discussed in Section 9, Review.
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Revision: 0
2.0 STANDARD OPERATING PROCEDURES
2.1
Standard Operating Procedures (SOPs) are prepared or adopted for each project to provide a guideand control for the performance of work. SOPs implement o jaty requirements by ensuring theappropriate and consistent performance of a repetitive task. These requirements are not fcnited tothe accuracy of work. MethocVilogytealsosubtecttoquaityrequirernents. Documenting the controlof processes and methodologies permits process evaluation and improvement Simiarty. controlingand documenting decisions, exceptions, and changes provide evidence of va&dty and defensbiity.
Standard Operating Procedures (SOPs) are formal. revistornantroled documents that
• defne. to BtSRsdents and to regulatory agencies, the methods used by ENSR in theperformance of tasks having an effect on the quaMy of data, findngs or conclusions;
• provide standard methods for execution and documentation of work, so as to maxirnizBunfcm%andreiabKy of products; and
• fadBate couioliutimi among indMduals performing separate but •ituulupuiident tasks.
SOPs describe standard methodologies that may at times be inappropriate for a sfjvcriic project Insuch cases, the SOPs may be revised to accommodate project-specific circuiiislaimes. Wheneveran SOP is revised tor a project, the SOP Number shal be revised by incorporating the protectnumber and the SOP Revision Date shal be revised to reflect tte date of tte project-specific
Standard procedures spedfc to HeaMh and Safety are provided in ENSFTs HeaMh and SafetyPoicies and Procedures.
22 SOP Acceptance and DMributton
ENSR SOPs are in three general categories
• general, corporate SOPs. governing tasks that apply to most protects, such as senior reviewand documentation of calculations;
• project-specie SOPs. governing tasks that must be tatored to project-specie lec irenieritsand circumstances; and
Page 2-1
Section: 2Date: August 2003Revision: 0
Quality Program Manual
• laboratory SOPs. Generally, laboratory SOPs are more detailed, less subject to variabilityfrom project to project, and require organizational acceptance by laboratory managementThese SOPs typically are supplied by the laboratory.
ENSR SOPs are developed by technical specialists in the appropriate disciplines, subjected to peeror senior review, and approved by the Quality Program Manager or his designee.
SOPs are distributed both in hard-copy form and electronically. Electronic versions of SOPs areposted in the Quality Assurance area of ENSR's intranet. Corporate SOPs are distributed as read-only, Adobe™ Portable Document Format (PDF) files. SOPs for tasks that require project-specificcustomization (e.g. monitoring well installation) are posted as Microsoft™ Word files.
2.3 Responsibilities
The Quality Program Manager will ensure that up-to-date, approved revisions of corporate SOPs areavailable to projects for reference and use.
The Project Manager is responsible for the development and approval of project-specific SOPs thatmeet client and ENSR quality requirements. Further, the Project Manager is responsible for thedistribution and implementation of the SOPs on a specific project and for ensuring that the SOPsdeveloped for his/her project are distinguishable from those posted on the intranet and thosedeveloped to govern the same tasks on other projects. This should be done by using the uniqueproject identification in the SOP numbers and titles, and by assigning the appropriate revisionnumbers and dates. (See Section 2.4.)
Projects that require initiation and completion within a week or month may choose to adopt SOPs byreference. However, since projects of such short duration are often repeated, the project managershould ensure that project staff are fully oriented in the SOPs being referenced. A divisionaccustomed to such projects may implement annual refresher training in SOPs in anticipation ofshort-duration work.
2.4 SOP Revision Control and Identification
SOP integrity is maintained by through revision control and identification. SOPs residing on the intranetserver can only be revised by the Quality Program Manager or his designee. Copies of these SOPscan be downloaded for local use. Corporate SOPs downloaded from the intranet are in PDF format andare not editable, but the other SOPs are posted in Microsoft™ Word format to facilitate customizationfor project-specific requirements.
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In order to ensure that tie process of project npucific custtxnbation docs not produce muBpte versionsof tie same SOP. each customized SOP is assigned a projectepedfc ktenScation in te «te Mock, asfotows (see Figure 2-1):
• The prefect number or some olher project-specific idenWer is appended to the SOP numberin to IHe btodc As an aftamattve. the Project Manager or Project QA Officer may elect todevelop a SOP numbering system specificaly for the project In tws case the Project numbersal must be Sncorporated in the SOP We Mock to ensure that the SOP veraton is uniquely
• The project number (PPPP-NNN) is entered in the l evism Nuntoer" space in to tiUe blockand a dfo£ representing the current project-specie revision is appended to i.
• The nameofthe project is inducted in the SOP titte.
• The name of to oersonwto authored to project-sped^
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oSection: 2Date: August 2003Revision: 0
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Figure 2-1 - Revision of an SOP Tttto Block for a Project-Specific SOP
A. 0
B. C
riglnal SOP as Downloaded
Ambient Monitoring FieldCalibration Control Plan
D*tK 2*Qtt:1993RwMon Number 3
AirthoR MM Dobfowonkim**lMll«A« AwkKl*l* kjAMltAMMJ*
1JO PURPOSE AND APPLICABILITY
• This Standard Operating Procedure (SOP) describes the overal caforation control
ustombced SOP
Ambient Monitoring FleMCalibration Control Plan for theBaJrd & McGuIre Perimeter Airmonnonng frograjn
1 JO PURPOSE AND APPLICABILITY
Date: October 1999
RtvMon Number: 56SW02-1
Author Scott WMBwnor*
Dtedpllm: Ainbimt Monitoring
• This Standard Ooeratina Procedure (SOP) describes the overal caibration control
2.5 SOP Content
u
SOPs are associated with analyses, sampling, equipment operation/maintenance/calibration,training, construction, engineering, corrective action, and other subjects addressed in this ProgramPlan. SOPs should be consistent in format, units of measure, and other editorial standards. Suchconsistency provides clear, defensible, traceable, and credible content. As a minimum, all SOPsshould dearly state
• Who is responsible for the performance of work;
• What regulatory or project goal is being met; •
• What standard is used to measure adequate performance of work; and
• What actions are required when the SOP fails to produce the required and anticipated quality
of process or item;
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0
• What equipment or materials are required for the procedure and which materials are optionalor generic;
• WMtadrnMsfcattve cento* requirements are appicalte^requirements, document control data (Revision, date, etc.), or references.
Prior to use. new procedures should be documented in new SOPs to ensure appropriate and
Analytical and laboratory SOPs should be sufficiently o tated to ensure and document that themethodologies used *• achieve moosuromont objectives. These SOPs must be writtenappropriately. Mowed accurately, and any variations, deviations, or deficiencies documented fufly.Faiure to confbnn to these requirements could result in personal iabHy. fraud charges, or corporate
4ft m M . ^^— Aa»BttflM^Lfl nkABflM IlMB * Jj-jliBJBI •jj|l,12^ KMWJW, Mpprow, uvmouDon, ana naocinmaon
New corporate SOPs wi be submtted for senior review by krawledgeabte staff members, revised (asnecessan/X and submttad for approval and signature as required in Table 1 -1.
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3.0 PROJECT QUALITY ASSURANCE PLANNING
3.1 Purpose and Scope
Quality Assurance Project Plans (QAPP) exist to meet clients' goals. These goals are not solelytechnical compliance goals. Correct and timely billing, schedule and cost control, responsive andaccessible staff, communication, and technology transfer are client goals that must be emphasizedin planning and executing the project. The QAPP process is the specific vehicle for defining,planning, committing to, and assessing progress towards the quality goals of the project. If a client'sobjective is not a goal of the project team, and its achievement not planned and actively pursued,then achieving it could only be purely accidental.
The purpose of a QAPP is to establish management systems to ensure that work and work productsmeet quality objectives. These systems will be implemented by the project team and by contractorswho provide construction, exploration, technology development and/or testing, laboratory analyses,or environmental data acquisition, analysis, and interpretation.
Quality assurance planning may range in level of effort from a single-page memorandum to acomprehensive revision-controlled document. The level of effort appropriate for a given project isdictated by several factors, including the project's scope, complexity and objectives, the number ofdifferent organizations involved, and the probability of litigation or public controversy involving theresults of the project.
Project Health and Safety planning is described in H&S SOP Number 3.1.
In the absence of a quality assurance plan for a given project, applicable provisions of this manualshall be considered the project quality assurance program.
The QAPP should be part of, or a partner document to, the work plan (or equivalent) and the healthand safety plan (HASP) for the project, if such documents exist.
The quality assurance Project Plan should be developed prior to commencement of work on theproject tasks to which it pertains. It should constitute an agreement among the ENSR project andtask managers, subcontractors, client, and regulatory agencies as to the organization, schedulesand methodology for the project.
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A QAPP vfli be developed to provide project-specific procedures ensuring confonmance to cfientrequirements far any or al of the Mowing, as appfcabte:
• ReM acttvBes such as samping. exploration, or construction:
n or consttudion ste boundaries, etc.);
• Oversight of suboonfcadDT pertbrmar
• Records management;
• Cnyjneertng, oonshuubon, or design;
• Invoicing;
• Communication, progress reporting, and information management
The Proposal Manager is responsMe for
• UnderelanuTng dtenfs objecaves and requiieiiieito as oommunicalBd in the request forproposal and other communication during the procurement process; and
• tackling the appropriate QAPP effort in the proposed scope of woric. budget, and schedule.
The Project Manager to responsfcto far
• Detsmrintag the objedtos of the pniject based mtrough dbcussion **th the ciuiA, dearly commuiiicaliiig those objectives to the project team;and ensuring that tone objectives are addressed in and satisfied by the QAPP.
• Providtag suMrient resources in the budget and schedule to cover Vie quaHy assuranceplanning effort, as wel as al required audfts, inspections and reviews, to ensure vafdty andummjidllllllCtt tO COnfrBCt I
• Providfcig suflkaent resources in the budget and schedule for the appropriate peer, technical,and other reviews.
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• Working with the project team in the development of an effective, workable quality assuranceplan.
The Project QAP will be reviewed and approved as shown in Table 1-1. Revisions, except forinconsequential editorial corrections, will receive the same review and approval as the originaldocument. Analytical measurements will not be initiated until the QAPP has been approved.
3.4 General Contents
Each QAPP will adopt approaches, or reference SOPs, designed to first prevent and, failing that, todetect quality problems during planning, implementation, and assessment of technical work.
The QAPP should define the methods by which processes and methodologies will be controlled anddocumented to permit evaluation and improvement. Similarly, documentation of decisions,exceptions, and changes should be required, as it provides evidence of validity and defensibility.
The QAPP should address:
CJ • The client's processes and logistical needs to avoid interfering with the client's other projects,and to identify and take advantage of synergies and opportunities to add value to the client'sprojects.
• Administrative excellence — each project plan should include provisions for ensuring thatcontracts, reporting, and billing activities are consistently accurate, responsive and timely,promoting the clients confidence in ENSR.
• The project schedule and budget constraints and provisions to ensure compliance;
• Revision of SOPs or analytical protocols as necessary to accommodate project requirementsand circumstances, and to eliminate inappropriate or irrelevant date collection.
Each QAPP should provide:
• An explanation of the scope of the plan (i.e., the project or specific tasks to which the planapplies)
• Reference to related documents (e.g., Contract, Health & Safety Plan)
• An explanation of the client's requirements, including (as applicable):
0 Deliverables;
0 Budget;
n Schedule of work, including provision for changes in scope;
VJ _n\SWhttn page 3-3
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a Process reporting and other communication;
0 Invoice fonnat. schedule, routing, and other requirement
D Approach to changes in the scope of work or technical objectives (induing dentnoUfkatiun. aulhnri/Hlhin, and payment);
• The prcfecfs task structure;
• Project otgancabon and reaponsMttes;
• Subconfcactor responsMttes. requiionionts, end quaity control provisions;
• Criteria and procedures far quatty assessment, and far douunmOig corrective action.
QAPPs for moMuroment piugiams should include specific provisions pertaining to data quaRty.
Detned objective of ttie measurement program Cndudng contractual and regutakxyreojuiiui INN to);
Spec*: data quaRy objectives to be met;
Any applcatfe SOPs, analytical procedures, or other method descnptions that explain howttte woik is to be peribnned.
Held and laboratory equipment specifications;
Data vaidaBon procedures and acceptance criteria; and
Corrective action in the event of deviation.
QAPPs should provide for continual assessment and adjustment of project operations to
• bi MOVB responsiveness to dent needs;
• Accelerate resuts or reduce cycle time; and
• Improve the effectiveness of resources art staff.
Hams and processes that do not meet the project requirements wrii be identified and corrected
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3.6 Revision Process
In cases where the Project QAPP has been submitted as part of the Proposal process, the QAPPwill be revised to incorporate specific requirements of the final negotiated contract, as well asadditional information that might become available after contract award. The QAPP should berevised (or modified by addenda) to reflect changes in scope and/or procedures throughout theproject life.
Revisions, except for inconsequential editorial corrections, will receive the same review and approvalas the original document.
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4.0 PERSONNEL QUALJRCAT1ONS AND TRA1MNG
4.1
ENSR and is subcontractors should ensure that personnel working on ENSR projects have the), and experience commensurate with their job responsMtes. Personnel wrii be
required to demonstrate pmfidency in performance of their assigned work inttaiy and periodfcaiy
Pen\>miaiKje evaluation criteria emphasize those elements of perfonnance that most drecflyoonMwte to dent satisfaction. inducing:
• ThiioliMns, oomptotoieas. and cost;
• RaJaMBy and conttttoncy,
• CfanTyandpnKa»ioninrBceMngand>ransmaBngconimunicaBons;
• Proactive rather tan reactive management; and
• Teamwork
• Piujed Managers wfl ensure that project personnel have the tiducatioii, bdiiiiiy, andtaMM^ ___ |LLJL ..... •. — ..ft.. .. Mk rt. „ t, ZjtK ma-njLn.ii n a i Ml n ••ice oonvnonAuaB vMDi VMMT joo responsBanes.
aro nntpon<riMft f1*1 yftn^|r^*ijp|u pflreonnol Iff oMtMn ftrtmr educationand tor ensuring that personnel receive training before their responsMBes are expanded IP
• Resource Managers are responsible tor conducting periodic perbrrnance appraisals of thepersonnel lepwting to them.
The Project Manager demonstrates proactive management before a project begins. Not only docfent expectations precede the project, but so also do the estimates of scope, cost, and schedule.
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The ability to correctly scope, budget, schedule, and staff a project are so vital to the clientssatisfaction with a project that all other criteria must be viewed within that context. The qualificationcriteria may include but are not limited to:
• Communication and interpersonal skills;
• Ability to manage pro-actively to position projects for quality achievement;
• Skill and expertise in project-task analysis, estimating, and budgeting;
• Expertise in resource scheduling and leveling;
• Expertise in the client's processes, billing systems, and capital/cash flow requirements;
• Expertise in subcontractor and vendor selection and qualifications;
• Expertise in the environmental project requirements, methods, standards, and processes;
• Skill in anticipating and avoiding problems;
• Demonstrated ability in leadership and mentoring; and
• Education and training in project management and the appropriate technical disciplines.
W . •4.3.2 Qualification of Project Personnel
The qualification criteria may include but are not limited to:
• Communication and interpersonal skills;
• Effectiveness as a team member;
• Expertise in the project requirements, methods, standards, and processes relevant to theassignment;
• Demonstrated ability to carry out an assignment on-schedule and within budget, and producethe expected work product;
• Skill in anticipating and avoiding problems;
• Education and training in the appropriate technical discipline(s).
4.4 Training, Indoctrination, and Performance Proficiency
Training will be conducted as necessary to qualify personnel for the tasks they are to perform. Theextent of the training will be commensurate with the scope, complexity, and nature of the work.
, '; Training will emphasize correct completion of work, an understanding of the basis of quality
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requirements, docurnuiiluliuii roouiuiiionts, and the appropriate response to non-mji Jmnanyproducts or processes. Proficiency wal be demonsliated periodtealy to ensure odoojufltoperformance. Performance criteria wl be derived from project and/or dent reojuiuinents.
45 QuaMcatlon and Training Records
Quoifc noon and training records wl be maintained for the Company's use as appropriate. Healthand safety taHng records and unsatisfactory health and safety pertonnance test results w« befolninod in permanent corporate records.
The curriculum of the heeflh and safety training is listed in the ENSJiHejlth_angJ5aJetyJ rjDaranOverview (Section TV This is a forty-hour course designed to fuffil the requirements of 29 CFR1910.120. Each employee working at a hazardous waste site must receive this forty-hour trainingprior to that work, and must receive an eight-hour refresher annuaiy. Further, employees involved inthe management of hazardous waata sie work must receive eight hours of manager training. Theseprogram are deteied in the EHSR Health and Safety Program Overview (Section 71.
The I looMi and Safety Manager maintains permanent records of health safety training courseattendance for employees who have completed the required curriculum.
ndMdtBfe education and training obtained prior to joining ENSR. Addteonal training or educationQblainad<>ihtheasaiglanceoftheENSR'sContirManQEducatk)nan^Devoloomoot Proarani is also documented in the permanent indMdual personnel records. Thesecorporate records are maintained by the Human Resource Departmenfs Regional Representatives.
DucuiiieiteBon of other cntegories of training, such as vendor-provided software instruction, may beletnevabto through purchase order or project number systems. However, this manual does notrequire that these records be maintained for corporate quaifications.
ENSFTs Project Management Training Program Manual is outfned in !§We4J,
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Table 4-1Project Management Training Program Outline
1 Core Concept*
2 Project Scope Planning
3 Work Breakdown Structures
4 Project Financial Processes
5 Cost and Effort Estimating and Pricing
6 Duration Estimating and Scheduling
7 Risk Management
8 Client and Team Communication
9 Project Controls and Change Management
10 Project Documentation and Record Keeping
11 Project Close-Out
4.6 Performance Evaluation
Personnel will be required to demonstrate proficiency in the performance of their assigned workinitially and periodically thereafter. Resource Managers will conduct periodic performance appraisalsto evaluate each employee's performance against a set of objective criteria, and to establish andperiodically review each employee's performance improvement and career path objectives. Inconducting appraisals, Resource Managers will solicit input from each employee's project manager)and co-workers, as appropriate. Results of the performance appraisals will be documented forconsideration in merit reviews, disciplinary action, or training plans.
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5.0 SUBCONTRACTOR QUALITY ASSURANCE
5.1
ENSR Projects may subcontract services far some tasks. Examples of such subcontracted servicesinclude drBng and excavation, construction, caHxation. computer-related services, and sampleanalyses. The purpose of subcontractor quafity assurance is to provide assurance that work ispertonned to a known and predctabte standard.
&2
Approval and signature authority is designated and updated by the President, ENSR CER. Authorityto approve contracts is assigned to the three Regional Subcontracts Administrators. Terms andcomfbons that require negotiation are assigned to the ST. Subcontract Adrnrtstrator (Acton).
• The Proposal Manager wl determine which, if any. portions of the work scope bengproposed wl be subuafractsd. identify o jaified subconfcadcys. ar
^
Tne Project Manager wl be responsUe lor the quaftyrfsubccrtracted services. Tte projectmanager wlftnafae precise subcontract work scope spedficafions and estabish subcontractagreements. working wM) the appropriate ReojonalSiMKar*actsAdrramstrator or the Seniorf^ li n i-ini. ii 11*11oUUCUlUUCB
The Project Manager wl oversee the subcontractors, monitor the ojuafity of UWMT work, keepthem on schedule and on budget, and ensure that the sutrontactort invoices are timely and
Each subcui*acl agreement must be approved by a Sut)uji at Administrator and by theapproonate ine manaoar in accordance with ENSR^ Signature Aporoval Poicv.
RBgjonalSuboootoxtiAdii*faliatorewl provide support and assistance to projectmanagers wlhin their respective regions by helping themidentyifiJaobtain proposals, bids and supporting documentation from prospective subcontractois;negotiate and document favorable subcontract agreements; and adhere to ENSRsubcontracting pofcy and procedures.
The Senior Subconfracts Administrator wl provide support and assistance to projectmanagers in identifying quaffied si fccmrti actors; obtaining proposals,documentation from prospective subcontractors; negotiating and documenting favorablesubcontract ogrooinonts; and adhering to ENSR subomiU acting pofcy and procedures.
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• The Senior Subcontracts Administrator will oversee ENSR's subcontracting activities andprovide recommendations to ENSR management regarding subcontracting policy andprocedures.
• The Senior Subcontracts Administrator will implement a system of qualifying subcontractorsfor basic ordering agreement (BOA) status, will maintain an up-to-date list of qualified BOAsubcontractors, and will periodically re-qualify and renegotiate each BOA.
5.3 Subcontracting Procedure Summary
Subcontracted services shall be governed by subcontract agreements approved by the ENSR SeniorSubcontracts Administrator. Each subcontract agreement also shall be approved by linemanagement in accordance with the ENSR Signature Approval Policy. Each subcontract should beinitiated by submitting a completed Subcontract Request Form to the Senior SubcontractsAdministrator or the appropriate Regional Subcontract Administrator. An overview of ENSR'ssubcontracting process is depicted in Figure 5-1.
5.4 Subcontractor Selection
The Proposal Manager and Project Manager are responsible for correctly identifying the technicalscope of work and defining the technical capabilities required of subcontractors. Initially, theProposal and, later, the QAPP and subcontract agreement clearly outline the scope of work andtechnical requirements. Subcontractor selection should be based on a set of objective criteria suchas the following:
• Technical capability and competence to perform the specific scope of services required. Thhtshould be demonstrated objectively with descriptions of relevant project experience, and ofapplicable facilities and equipment,
• Committed equipment and resources;
• Financial stability is confirmed through published financial reports and financial report services(e.g.. Dun & Bradstreet, TRW),
• Committed equipment and resources;
• Financial stability is confirmed through published financial reports and financial report services(e.g., Dun & Bradstreet, TRW),
• Qualifications of Personnel - Subcontractor personnel must have a level of experience andeducation commensurate with their responsibilities. Technicians and analysts who perform
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measurements, anatyses^cr evaluuttoits, of whouuuiffc iisfcUTnentsor equpiHont musthavedeniiunsliatedproidency at the specific procedures to i»Mch they are assigned
Hours 5-1BtSfffc Subcontracting
QuaBy Assurance Program - Subconto actors must implement a duuumei«Bd quaByauuanu) ptuymin appfopriate for the puaMy iiipaut of thor role in ENSR projects; andsafsfying the intont of this manual and the project requirements. DnVngcr constructionconfcactois may meet this requirement by providing iMritenoomn ient to comply with Iheappfcabte provisions of B4SR* QAPP.
When the work wfl invi ure to chemical orHeath and Safety Prognphysical hazards, the subcadractor must have a heath andsafety pmyiaiii that ensures theaness of assigned personnei (inchring capaMay to use respiratory protection), and in al
v»ih ENSf s I toaHh and Safety Pofcaesand Procedures. Dnlngor(anstnxttonujibtt(JDfS nay nieettnis requirement by prcvk^^comply with ENSFTs project Health and Safety plan.
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Before contracts are accepted, the selected subcontractors should be reviewed against criteria fororganizational conflicts of interest. Other criteria may also be developed that reflect added value toENSR's clients such as compatibility of methods or systems with ENSR or client invoicing.
5.5 Subcontract Specifications for Analytical Services
Technical specifications for analytical services are required to tailor the services to the project-specific data quality objectives. The specifications should include, by reference, the ENSR QAPPand the ENSR Health and Safety Plan, as applicable. The following should be specified, at aminimum:
• the exact sample preparation and analysis procedures to be followed (included or specificallycited),
• quality assurance and quality control procedures, including quantity or frequency and methodif not detailed In the cited methods(s) (e.g., reagent blanks, method blanks, laboratoryduplicates, matrix spikes or overspikes, surrogates, internal standards, recovery standards,check standards, and instrument calibration),
• data reduction and reporting format,
• limits of acceptability for quality control checks (if not stated in cited method(s)),
• deliverabtes - an itemization of the required contents of data packages, to ensure that thepackages are complete enough to permit validation by ENSR.
The project QAPP will describe any special conditions that apply, such as environmental controls orrequirements of the facilities, mobile or stationary, that might affect data quality. Items that mayrequire specification include:
• ventilation, • voltage control, • dust levels• temperature, • reagent purity, • incubators,• humidity, • air and water supply, • laboratory hoods, and• lighting, • refrigerators, • glove boxes.
Special facility and equipment considerations for the analyses of mixed-waste samples will bedetailed, if applicable.
If applicable, the Project QAPP will provide for the monitoring and inspection of subcontractorprocedures, service manuals, maintenance procedures, and service agreements used to maintainperformance standards.
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54 SubumUaOur SOUK* Srtirtion. Oniirirrtinn. and Approval Process
As appropriate, and as required by ENSffs dent contract, new subcontracts vrii be subject tocornpetittve bid by three or more companies. Companies that have been approved by ENSFTsquoMcoBon process, and contraclBd through a Basic Order Agreement, nroy be sotoctod vvfthout theuse of ouiifMiUtivu bid process.
During the competitive bid process and the quaMcation fbr BOA contracts, the Senior SubcontractsAdmtoisimtoi wl request satisfactory documentation in the fafiowing general areas:
• A superior I tooth and Safarty program, as doniunaUutod by a superior OOWBT) rate for EMRcompared to industry averages, and a superior (tower) rate of OSHA reportable incidents
• SatofoctaryreuraiKe tor general corntr
negotiation of terra art coridM^
• Evidence of prior experience wortdng successfuly on B4SR projects and demonstrating theabove.
tn ight of dent and corporate goals for cost control, reduction of rework, and documented.iMhniiiihi decMona. the BOA subcomractore have sioriilkant advantages far ENSR and its cfents.
roiowing acceptance of BOA status, the qunUcnbon must be updiflod and supjed to approval processafter 3 years. If the heaMn and A«iJuly. technical, or contractual performance of the sitioniiliauluf hasdeteriorated, the cunfractor wfl be aftowed probation status for one year to regain approval or beterminntod torn the program. Records are retained in active storage for three years and transferred topermanent stompe, These records include the information required by the HeaRh and Safetyojuesflonraire, and ojuaBy audtts performed. For specific types of stfcuui'ihaciuis. nckxfi'iytabmatoiies. driers, and riggers, deficiency findngs for technical quaHy are recorded. The firstdeficiency resute in a warning, the second involves penalties under the terms and condttons of thecontact and a third is cause to remove the subcontractor from BOA stato and luture work vriftENSR.In such a case a subcontractor may be given subsequent opporluralies to work win ENSR on apratoct-by-project basis, rather than through a BOA, only if they can demonskate that they have
ents.
For some large contacts, eapecialy federal government oarfracts. teaniing agrccnionts arewMi strategic teaming partners early in the proposal pnxess. Teaming agnxirrionts can take two forms:
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1) where ENSR is proposing to be the prime contractor and ENSR's teaming partner will serve as asubcontractor to ENSR, and
2) where ENSR is proposing to serve as a subcontractor to another firm, who is proposing to be theprime contractor.
The remainder of this section will address only the first of these cases.
Teaming partners are subcontractors who are engaged early in the proposal process because theybring qualifications considered necessary to a successful proposal effort For example, in bidding on amonitoring program, ENSR might engage a teaming partner who has specialized expertise orequipment required to successfully perform some measurement that is key to the program. Thisarrangement requires a specific kind of subcontract agreement contingent on contract award aridnegotiated early enough in the proposal process to allow the teaming partner to participate in trieproposal effort.
The teaming process begins with the identification of a strategic need and prospective partner. TheENSR Proposal Manager or Senior Subcontracts Administrator will contact the candidate firm andpropose a teaming relationship. If the two firms agree in principle, the ENSR Proposal Manager orSenior Subcontracts Administrator will forward a generic teaming agreement to the firm'srepresentative for review. The Senior Subcontracts administrator will then negotiate with theprospective teaming partner to finalize the agreement.
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6.0 PROCUREMENT QUALITY ASSURANCE
11
This section presents an overview of the quality control provisions h ENSRTs procurement processfar equipment and suppies.
Procurement practices lor services are dbcussed in Section 5. Subuuntactor QuaBy Assurance.
Appendbt A dacusses pnxurement procedures associated with design, construction, and uperalion ofenvfconniunCif technology.
i far accurately aotectiitg and specifying jams or seivfces to bepmJiased, far cmuJtoUng the appropriate requisition and/or purdiase order documentation, and forprompty inspecting defvered terns to verify their operabflty and confannance to the purchase order.In procurement of tons other than compuiora. computer peripherafa. and software, the requisitkyiermay be responsible far assigning a purchase order number and placing the order with the vendor.
The ENSR Purchasing Department b responstote for maintaining the Purchasing Poicies andProcedures. The ENSR Purchasing Department, or delegated purchasing authority, is responsUefar executtng the purchase orolers far computers, conputer peripherals, or software. The ENSRPurchasing Department may execute purchase orders for other items as appropriate. For computers,computer peripherals, and sofhuare. the ENSR Purchasing Department is responsfcte foraotocting avendor and obtaining defray of the items.
6L3 Review of Procurement Documents
Procurement documents (purchase requBtlions, specrfications, purchase orders) record the primaryquaBy criteria far procured items and services.
The Project Manager should review the procurement documents and changes, prior to anypurchase, to ensure that the documents include adequate specifications, nsquremenls. performancestandards, and quafty criteria If this review is delegated, it w> be performed by personnel whohave an adequate understandng of the analytical and technical requirements and the purpose of theprocured items.
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6.4 Receipt Inspection and Verification of Computers and Computer Peripherals
Upon delivery of purchased computers and/or computer peripherals, the Purchasing Department willinspect the delivered items to ensure that they conform to the specifications in the porocurementdocuments. The Purchasing Department will ensure that any nonconforming items are returned,replaced, or refunded.
The Purchasing Department will arrange with the IS Department to have each newly deliveredcomputer configured to user's specifications and installed at the user's location. Should defects ornonconformities become apparent during the set-up and installation process, they will be reportedpromptly to the Purchasing Department. Again, the Purchasing Department will make arrangementswith the vendor for correction or replacement of defective, deficient, or nonconforming computers,components, or peripherals.
6.5 Receipt Inspection and Verification of Measuring and Test Equipment
Upon delivery of purchased items, the delegated purchasing representative and/or the requisitionerinspects them for conformance to the specifications on the purchase order, with respect to quantity,model or part number, and other observable features.
The requisitioner is responsible for performing functional tests to assure that procured instrumentsand equipment are in operating condition and satisfy performance specifications. Failures should bebrought to the attention of the Purchasing Department immediately. The deficient or nonconformingitems should be segregated immediately, restricted from use, and clearly tagged until returned tovendor, or until corrective action and acceptable performance have been demonstrated.
The Purchasing Department will contact the vendor of any instrument or equipment that failsincoming inspection or functional testing and obtain replacement or refunds as appropriate.
6.6 Receipt Inspection and Verification of Supplies
The recipient of supplies confirms receipt by verifying items and quantities, marking anydiscrepancies on the receiving report of requisition, signing the receiving report or requisition, andreturning the form to the Purchasing Representative.
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«J
When data quafty is at risk, variations in hardware or software may produce unpredictable errors indata. The cost of re-vaUating the data or resamping is significant Therefore, ndrvidualpreferences for operating systems, or non-standard software. wl be dfecouraged throughout thecompany and denied when data quaBy may be chaiongod. ENSR Puicriasiny Representatives wBimplement corporate pofcies through the selection of specffied computer equpnient and software.
Section 7. Computer Hardware and Software Conliguiation Control, presents ENSR pofcy and
6L8 CuHSlmcuuH Related Procurement QuaMy Assurance
Major equipment construction materials, or safety related items are si Mijoct to project-basedconstruction procurement quaity assurance programs. Programmatic controls are instituted toprovide assurance that materials, equipment, and oomponenrts are specBed to appfcabte rationalstandards, regulations, and project requirements.
Fordes^nated quafty categories. ENSR representatives may choose to verity manufacturingprocesses, verify test resuts. or arrange for independent verification that the quaaty of products orprocesses meets quaBy requirements. These vendor audte and inspections may be included in thevendor selection process and continue through the Me of a project
Receipt inspection wfl be conducted for specified items or materials in acoxdance wflh the program.When appropriate, non-destructtve testing or destructive samplng may be reojiared fcr instatedcomponents or materials (e.g.. radtography of piping welds, or test bonngs for concrete strength).
Appendb: A dtocusses procurement procedures associated with design, construction, and operationof environmental technology.
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7.0 COMPUTER HARDWARE AND SOFTWARE CONFIGURATION CONTROL
7.1 Purpose
The purpose of controlling software and the hardware configuration is to facilitate efficient andreliable interchange of information within ENSR's computer network, and to maintain dataconsistency, comparability, and retrievability.
Compatibility of hardware and software:
• supports a work group benefit by facilitating file sharing;
• promotes communication among all offices;
• reduces rework;
• reduces the requirements to validate new software;
• reduces time and cost of training;
*Hlr • promotes a unified corporate image; and
• supports retrieval and re-use.
As a client focused company, ENSR will achieve the above-listed benefits for its clients by limitinghardware and software to approved items. Other hardware and software will be used if requested bya client or otherwise required for a specific project.
7.2 Scope and Applicability
This section applies to the procurement and use of computer hardware and software for ENSRprojects. Due to the rapid evolution of computer hardware and software products, only basicguidelines are presented here.
7.3 Responsibilities
The Project Manager is responsible for ensuring that the project complies with the provisions of thissecton
The ENSR Information Systems Department (IS) is responsible for maintaining the standard forconfiguration of the ENSR computer network.
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The ENSR PuichOBJUQ Department is responsfcto forprocunng computers and ensuring that theyare configured in accordance wih ENSR's standards and furnished wflh software that compies withthis manual
7A Commercial Software and Hardware
Commercial uses, such as word processing, spreadsheet appBcaMiuns, presentation authoring, ande-mafl, must moot the folowvig
• tie corporator 1st of stj)c<)rtedsortaareAianjware;cr
• a dent request far support of a specifc software/hardware;
and in eflher case,
• reojuiromonto for transfaraMtty and compaBbBty to supported aoftxaro.
If an unsupported soflware product is obtained to match a oBent request, oonwrsion software wl beobtained g necessary to maintain the ink to the company standard. For projects that useunsupported software, the QAPP (see Section 3. Project Quafty Assurance Planning) shouldaddress the methods by which oornpatibity with ENSRs staridard configuralion wl be achieved inorder to meet the recjuheiiients of this section and Section 8. Document Control and Records
V f1.9
Software used for spedabed purposes such as numerical modelng. data visuafzation andMerpretatton, and geoapanal Information systems (CIS), and data management shal be used inaccordance with the developer's guidance.
Computer components and software Ritegrated into analytical or test equipment, moniors, andcommunications equipment that are caferated for a specific purpose do not require further testing ofthe supporting software, unless:
• ttie scope of the MJAworo use changes; or
t are made to the hardware/software configuration.
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Section: 7Date: August 2003Revision: 0
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7.6 Experimental and Beta-Test Software
ENSR or its subcontracted laboratories or vendors may develop or use new software to supportanalytical projects. Such projects might include experimental design or analysis, modeling, or datamanagement. When such software and hardware configurations are developed, they should bedeveloped to meet current standards, such as the IEEE Standard for Software Quality AssurancePlans (ANSI/IEEE Standard 730-1989). New applications shall be tested to specific acceptancecriteria before they are used for ENSR projects. It should not be assumed that beta-test softwarehas been tested adequately to be applied to analytical work, even though it might appear acceptablefor non-technical applications.
As a minimum, algorithms and equations used for modeling or other analyses must be submitted toSenior Review and approval. All software must be completely documented as to its purpose andapplicability, limitations, and testing (See ENSR SOP 1006. Qualification and Documentation ofComputer Programs).
7.7 Notification Requirements
Immediate notification of the Project Manager and the Quality Program Manager, within onebusiness day, is required for discovery of a software design error that could affect data quality. Theimpact of design error will be assessed and the client immediately informed of the error anddeviation. Similarly, viruses that may affect data quality will be addressed by the Project Managerand the Quality Program Manager, as well ad the ENSR Information Services (IS) Department.
7.8 Individual Accountability
All computers providing files to ENSR from ENSR employees should be operating with adequatevirus protection. Telecommuting employees are required to meet requirements for commercialgrade software and compatibility. Corporate software licenses should extend coverage to suchemployees.
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Sedan: 8Date August 2003Revision: 0
&0 RECORDS MANAGEMENT
8.1
The purpose of records management is to provide orderly. timely and accurate documentation of thecorrect performance of ENSR*s contract commitments. That documentation supports successfulsutxrattats to regulatory agencies, provides significant defense in litigation, and also provides arepository of successful projects, which serves as a valuable information source for new projects.
12
This records retention pofcy shal be consistently and routinely appied across the company.Effective iiiplemontoUon of this poBcy can occur only if al ENSR offices uffizp a recordsmanagement system that is:
• consistent with the pofcy* objectives;
• appied across the
• routinely practiced as a part of normal business operations.
Records management is a critical concern because of the possbttty of Kgation involving bothENSR artdfor dents that retain us as their consultants and expert witnesses. A proper defense ofENSR interests, and our dents' Merest, can be developed only if there is rapid access to projectand corporate Bes that are wei organized and purged of extraneous materials.
The fciowlng records management system meets the oaraiel requirements of accessMfty forpi eject or proposal use and anticipation of itigious dfecovery.
Speciic contracts governing ENSR projects may contain records rotoiition requiremenls. Whenountiactual requjrements are more rigorous than ENSR*s requireiiients. they wl supercede theit ii mmin mn nmt iMmi !• aiaini • ••n««» ^if ift*^ — g*»JiiN»> nmt M%^ CT IOD ry..-..-_J— fT^ftnMjIjx.. ^ rT>i_r_i_ J —cunespormig provisions or HNS secuun ana me trioK Kecoras Ketenoon ocnoouo.
hiyteiiientaflon should occur win each new project
8J
A Trecowr is defined as a document in any form (e.g., hard copy, rniooflm, or letmvabte data storedon magnetic or optical medn). originated or used in the performance of work. Inactive and/or
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u
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Date: August 2003Revision: 0
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semiactive records are records that are no longer needed for frequent reference, but must beretained to meet legal, contractual, or other business requirements. Paper documents are thosedocuments that exist primarily on paper. Although a paper document or parts of it may exist in theform of electronic files, its paper form is the primary record (e.g., a signed letter). The "record copy"of a paper document is defined as the original document, or a first generation copy in the case ofoutgoing paper communications. The record copy of all paper documents will be retained followingthese guidelines.
8.4 Responsibilities
ENSR Corporate Counsel together with his/her divisional or local designee, has overall responsibilityfor maintaining the Records Retention Schedule, which identifies ENSR records and their retentionperiods. The Corporate Counsel and/or his/her designee(s) will monitor legal records retentionrequirements and update the ENSR Records Retention Schedule as appropriate.
Managers are responsible for notifying the Corporate Counsel, or his/her local designee, if additionalcategories or any revisions to the ENSR Retention Schedule are required.
Project Managers are responsible for implementing the provisions of this section and/or theapplicable contractual records retention requirements on their projects. This includes organizing andaccumulating project records during the life of the project, preparing the records for off-site storageafter project closure, and authorizing destruction of the records after the appropriate retention timehas elapsed.
The IS Department is responsible for providing continual back-up of electronic records stored onnetwork servers, and for maintaining off-site archives of inactive network server contents.
8.5 Records Retention Schedule
Records are maintained to meet statutory, regulatory, contractual, and historical requirements. Theretention schedule provides the recommended retention period for various kinds of records to satisfylegal, tax, and internal administrative/management requirements.
8.6 Privileged and Confidential Files
Final project reports of a Privileged and Confidential nature must be kept in a secured (locked) area.Access is limited and checkout procedures must be strictly monitored by the local Client ServiceCenter manager or their designee.
Page 8-2
8August 2003
0
Work-product flee (those fles generated by the project team members, and indue** al figures,plans, laboratory reports, appendices, correspondence, and relevant electronic mecfa such as floppydbfcs) am mantained by the members of the MMdual project team in their dices and are kept inlocked fle cabinets. Each fle is labeled frivieged and Confidential'Onoe the project work iscompleted, the lies become inactive and are turned over to the records manager for a retentionperiod spociiod in ENSITs corporate record retention poicy.
Etecbonic mai has been determined to be a cotporate forum which may be accessed duringHgaflon. Dototod fites can be recovered from archived sources. To avoid an inappropriate blendingof ojuafly records and standard communication, significant or confidential materials should not bejnrnrnnminrl in otoi Ironic mni Private or personal e-mail wfl not be guaranteed to remain private or
S.7 UttgaOon
If a project becomes part of a Mgabon, Corporate Counsel or fas/nor designee wfl issue specificmliucUuns reganfing the associated i&tim&ii. The offoctod fites wfl bo mavitavied in a contioicid
Al subsequent work may become a part of the newly estebished bgafion" fite.
The folowing are a few measures that have been used by the Cfient Service Centers to ensurei of the records management system.
reduce volume by sepamttng project records as you work, oiyanuing the Has by project and
eJninnte dupicotos of drafts, laboratory data, field reports, correspondence, matnos;
dasfcoy nonessenfal hand oiBton notes, or comments written on work-product:
heap only active project fles in your inrmedtote possession. Review records perioolcaly, andfor those over 1 year old. mate anangements to have them inventoried and sent to off-sitearchival storage. Remember tut tie network servers are archived weekly so there is no needto keep older, inactive utocfcuiic fles readty accessiite.
dototoal draft versions retained on etedronic meola and oanst*into ai final documents inthe appropriate location on the appropriate network drive.
always update the project description in QM for coinpanv-wkte access during proposal
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Quality Program Manual
In larger offices, a centralized storage area may require a dedicated records manager. The primaryrole of the records manager includes:
• proper daily management of paper project and proposal files;
• understanding of personal and corporate responsibility; and
• adherence to legal retention requirements.
8.9 General Preparation of Paper Records for Off-Site (Long-term) Storage
Procedures for preparing paper records for off-site storage are provided on the intranet atintranet.ensr.com/records.
In peparation for off-site storage, the following items should be removed from project record sets:
• newspapers and magazines;
• copies of ENSR policies, instructions, and procedures manuals;
• drafts of correspondence, reports, etc.;U• vendor catalogs; and
• duplicate working files held by individual project team members.
Additionally, records volume can be reduced as follows:
• remove bulky fasteners;
• use light-weight folders, remove hanging folders;
• remove binders that are not essential to identification;
• remove department/job site equipment and supplies; and
• remove Corporate or departmental operating procedures as these are not normallystored as project records.
Page 8-4MnaMpprawd200aCtapin.doc
9
9.0 REVIEW
9,1
ENSR includes sovoral forms of review in is work and service doivory processes to ensure theconsistency and quatty of ENSRs technical work, project management, and documents. Thepofties and procedures tited in the blowing three bullets are incorporated herein by reference.
• Project performance reviews are performed to ensure that projects are being managedeffectively to achieve the dents and ENSR* objectives. ENSR's Project PerfomianceReview Poicv can be found in ENSR Poicv Document AP-14.
• Senior reviews are performed to ensure tie Mowing:
O understandkig and satisfaction of dent requirements;
O clarity of resuts and the moons by which they were obtained: and
O interpretation of data or requbBrnents is siJijoctod to a quatted second opinion from adMerent perspective to ensure objectivity.
ENSRs senior review procedures are dotaiod in ENSR SOP 1003. Senior Review.
• Reviews of numerical analyses are performed to ensure that the purpose, logic, andcorrectness of calculations are verified and documented. Er4SRfe numerical analysis reviewprocedures are described in ENSR SOP 1005. Numerical Analysis and Peer Review.
• AudWngbdbcussed in Section 10.
An essential purpose of the review process is the early initiation of review activKes in eart project tot the project's progress from the proposal stage through performance and to avoid last-minute
ig dncuUes that may crento oonlfcts among review, defvery schedule, and quaity
The project/piugrain or proposal manager has the prirnaryresponsfca^ far providkig sufficientbudget and ensuring that the appropriate reviews occur and are dmunenAed for each project
CSC managers are responsMe far ensuring that project reviews are scheduled and carried out inaccordance wtti ENSR poicy.
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Ultimately the Regional Presidents and President are responsible for ensuring that ENSR policy isconsistently followed.
The project or proposal manager is responsible for
• determining what needs to be reviewed;
• obtaining reviewer(s);
• keeping the Reviewers) informed; and
• seeing that the reviews are performed, and that any issues raised are property resolved.
9.3 Scope and Applicability
ENSR's review policies apply to all projects, project deliverables or proposals generated by ENSR.All ENSR documents (design, analyses, reports, or proposals) generated for external distributionshall incorporate the review processes described here, as applicable. This policy is a company,requirement without exception. To minimize ENSR and personal liability, final letter proposals andreports are included in this requirement. If the deliverable is a draft work plan or if the finaldeliverable to the client is a draft, this requirement also applies.
Senior review requirements are not applied for the following cases:
• if the project/proposal is a small, fast-turnaround effort involving less than $5,000 for projects;or $10,000 for proposals; and
• if the deliverable is a letter proposal or letter report.
The second signature on the deliverable (required by ENSR's dual signature policy, which in given inSection 4 of the Project Performance Review Policy), is the minimum required documentation tosignify conformance to these review requirements.
9.4 Policy
All ENSR documents (design, analyses, reports, or proposals) generated for external distributionshall incorporate the review processes described here, as applicable. This policy is a companyrequirement without exception. To minimize ENSR and personal liability, final letter proposals andreports are included in this requirement. If the deliverable is a draft work plan or if the finaldeliverable to the client is a draft, this requirement also applies.
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Sedan: 10Date Amust2Q03ftewion. 0
10.0 QUALITY ASSURANCE AUDITING AND CORRECTIVE ACTION
10.1
QuaKy assurance audMng refers to the formal assessment of conformance to the quaBtyassuranra/quairy confroi program and the effectiveness of it Specific audR procedures, schedulesand corrective action processes are determined on a project-specific basis and are described in theappropriate QuaBty Assurance Project Plans. This section dbcusses general provisions that must
to project-specific ohms.
112
The Quatty Program Manager is responsMe for maintaining these standardguidefnes and for ensuring that audits are conducted in a consistent manner.
Quatty Assurance Audtors (who may be a Quality Assurance Officer, the QualityManager, or a technical person assigned to audit a specific activity) are
responsMe for the scheduling, planning and conduct of audits and for reportingresults and issuing corrective action requests.
Project Managers are responsMe for determining and budgeting the appropriatelevel of quatty assurance auditing for their projects, win the advice of the QualityProgram Manager. The project manager also is responsMe for assigningresponsMtty within the project organization for correction of deficiencies and forresponding to corrective action requests.
113
QuaMy assurance audtors should have, at a minimum, the (blowing quaffications:
• Independence - Uninvotved in the project work being audted and independent ofthe project organization.
• Education - Bachelor's or higher degree in science or engineering; preferably, butnot necessariry. in chemistry, environmental engineering, environmental science ora related science.
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• Experience - Two to five years' professional experience in chemistry, engineering,or in the environmental field, in which skill in the design, implementation and/orcritical evaluation of methods and procedures has been demonstrated.
10.4 Project Audits
A project audit addresses all aspects of the project quality assurance plan, this quality assurancemanual, and SOPs. Project audits cover both project-specific and general considerations. A projectaudit may or may not include a laboratory audit (Section 10.5).
10.5 Laboratory Audits
Audits of subcontract laboratories are conducted by qualified analytical chemists who areexperienced In evaluating laboratory procedures. Laboratory audits take two forms - performanceaudits and systems audits. Performance audits involve submittal of blind spikes to the laboratory forassessment of analytical accuracy. Systems audits consist of a thorough review of projectprocedures and documentation to confirm that work was performed in accordance with the projectQA Plan and the laboratory's QA program and that adequate documentation exists to satisfy theproject requirements.
10.6 Audit Reporting and Corrective Action
Each audit is documented in a written audit report addressed to the project manager. Audit reportsshould not contain significant findings that have not been addressed in post-audit debriefings orotherwise discussed with the responsible manager.
Each audit report should summarize the scope of the audit, the audit findings and recommendedcorrective action. The audit report is first issued in draft to the ENSR project manager to solicitcomments and/or rebuttals. After discussion to clarify findings and corrective actionrecommendations, the audit report should be finalized and filed. The auditor should work with theproject manager and project team to develop a corrective action plan addressing each of thefindings. Subsequent audits should assess implementation of the corrective action plan and itseffectiveness.
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Sadat AppendbcAAugust 2003
APPENDIX ADESIGN, CONSTRUCTION. AND OPERATION OF ENVIRONMENTAL TECHNOLOGY
A-1 Planning and QAPP Preparation
A-2 Development of Engineering and Design Tasks and Schedules
A-3 Technical Specifications
A-4 Dovotopmont and Control of Drawfciga and Dialing Rtes
A-5 Construction and Field Operations Pn
A-6 Configuration Management
Page A-1
Section: Appendix ADate: August 2003Revision: 0
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A.1 Planning and QAPP Preparation
A.1.1 Planning
Design, construction, and operation of environmental technology projects will be planned. ProjectPlans will specifically address items below, in addition to other requirements described in the QualityProgram Manual (QPM).
• objectives, standards, and criteria for technical performance and regulatory compliance;
• critical or safety-related systems and the acceptance criteria for those systems and theircomponents;
• specific environmental technology components to be designed, built, and operated;
• acceptance criteria for each completed system;
• requirements for selection, acquisition, transfer, or storage of equipment, components, or\ ^ materials;
• reporting and notification requirements;
• technical reviews, audits, and other QA/QC actions; and
• predictive quality assurance reviews or safety-related activities, especially pre-operationaltesting and operational readiness reviews.
A.1.2 Engineering Design Control/Configuration Control
Design controls maintain active links among design and acceptance criteria, materials selection,purchasing, field changes, pre-operational testing, and operating procedures. Whether those linksare maintained using work group software or administrative procedures, each project will incorporateconfiguration controls during the planning stage. This appendix discusses requirements for technicalspecifications, drawings, procedures, and field work. References to configuration control are madethroughout this appendix.
A.1.3 Regulatory Standards
Environmental technology projects may be subject to extensive contract specifications or regulatorystandards. For example, regulation may include:
\JPageA-2
Sedan AppendbcAAugu
ents for (iiaWy Assurance F*
Operations (Eirvhonmeitoi Protection Agency. Interim. August 1994); and
HUREG 1293. QuaBy Assurance guidance for Low Level Radnactive Waste DisposalFadMy. (U.S. Nuclear Regulatory Radoective Waste Disposal Facaty. (U.S. NuclearReguMory Commission).
n * hl«MMMAM* .J FBI !••• • • ••« •• --- • W\m •!!••• T» »fc^ ••iff ITiii. aA Ja»uevwopineni of engneenng ano uesign lasm ana scneouws
Key issues in design development include dent requirements, task breakdown, schedule, technicalspecification, and drawJny and design development The purpose of each is to estahish or ensurespedftc ctaractoristfcs in the project even though rBspcrafc*ties for each rriay vary over time,function, staff, vendor, or contract personnel assignments. Work and task breakdowns arecombined with schedufng and tracking procedures to provide feedback and controls that consolidateand integrate work. In each project, the tasking and scheduling functions may be centralized, orthey may be dMributed and Jntegialod through work group software. The purpose is constantensure that at characteristics required for quaity are incorporated in ttie project and throughout theHe of the project.
A-22
The Project Engineering Manager is responsfcte for the engineering and design task schedule, andfor changes to the schedule due to changes in scope, design criteria, or other factors.
The Project Manager reviews and approves the schedule and its revisions to ensure that cient
Av3.1 Purpose
Technical specifications estabfah the specific characteristics that must be ncorporated in a designas it pertains to function arid to predk^ and actual oper Technical specificationsmay also be appied to operating procedures. Fuly integrating technical specifications becomes
PageA-3
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Quality Program Manual
increasingly challenging when the project demonstrates an experimental technology or hasespecially complex or hazardous processes.
For example, if a design calls for a component to be able to operate at pressures up to 2500 psig,the Purchase Order for that component must incorporate that requirement as a technicalspecification. Months later, the operating procedure must specify that pressure in the system thathas that component shall not be operated above 2500 psig. The maintenance procedure for thecomponent's seal replacement two years later must also comply with that technical requirement. Thepurchasing agent re-ordering seals for the next maintenance cycle must also comply with thattechnical specification.
A.3.2 Responsibilities
The Project Engineering Manager establishes a policy that identifies contract requirements, includingquality requirements, for incorporation into technical specifications. Responsible engineering staffprepare specifications in accordance with the policy and procedures. The Engineering Manageroversees the review and follow-up of revisions or additions to the technical specifications.
The procedure for technical specifications should incorporate reviews, communication, anddocumentation of any specific requirements that may be associated with the following:
• agreement of customer needs expressed during planning with technical specifications formaterials, items, and services, including delivery documentation requirements;
• ability of components and systems to perform under expected conditions of use;
• ability of components and systems to safely respond to unexpected conditions (such asaccidents and equipment failures), including consideration of redundant systems or othersafeguards;
• acceptance/rejection criteria for components and systems;
• any constraints of cost or schedule that apply;
• compliance with regulatory requirements, national standards and codes, and organizationalengineering practices;
• considerations of unintended uses and misuses;
• effective coordination and interfacing of organizations participating in the design process;
• production of verified, reviewed, and approved design outputs in a timely manner; and
• safety, reliability, serviceability, and maintainability requirements.
PageA-4
AppendbtAAUBU
The procedure required for a project may be Imfed to oomplanoe wttt a specific software reportformat or database ertryform. The Project Manager and Project Engineering Manager wl approvethe project procedure. Cooroliation wih and consensus from the denfs opetaUon andHMJnsttnance orgajriuilIuM may be appfcabte.
A^4 DevMOptnent and Coirtrol of rxvwinQjs and Drawing nMe
AA1 Purpose
Cut Auftjig dovotoprnont and revision of drawings 1) ensures the compteBon of as-buit and as-modMted drawings, 2) reduces the cost of safety and compliance for the cfient by spocMicaMyrequesting as-bult. as-mcdWed drawings as a matter of scope, and 3) requires each projectgenerating delated engineering drawings to provide and Mow an SOP for the control of accuracyand quaHy of those drawings.
AA2 Peer Review. Approval, and Verification or Audtt
Engineering drawings and process flow dtegrams should be developed subject to technical peerreview or senior review and approval As-buit and as-modified drawings should be subject toindependent verification, on a perfedk: basts, as a part of review.
Unto of measure should be according to dfent requests. If rot otherwise speeded, the rationalstandards wl apply, such as ASTM. ASME. ANSI, or IEEE
Standards of the ste-spedfc country may be appiod for work performed outside the U.S.
AJ5
When ENSR is constructing and operating a project on its own behalf, the project shal institute aconfguration management program or procedure at the beginning of a project When ENSR isconstructing or operating a project far others, the Project Manager srnuld address the scope of
tfon management requested by the dfent
Section: Appendix ADate: August 2003Revision: 0
Quality Program Manual
The common problems associated with engineering technical specifications, drawings, construction,and operations are failures caused by incorrect, inconvenient or insufficient information.
As-built conditions and later modifications may not be known or understood by operations ormaintenance. Failure to document the judgment used for a design basis may encourageundocumented changes by an unknowing and uninformed reviewer or maintenance worker.
The QPM addresses document control and records management policy, which apply. However, theactive and continuing control of design and operational data is more complex. This on-going qualityassurance function usually is referred to as configuration control or engineering managementcontrols, and must operate continually throughout the 30- to 50-year lifecycle of a project.
• The applicable criteria, discussed in Technical Specifications, are markers for establishing aconfiguration management program.
• Approved calculations, design justifications, parts/components data, which direct or fulfill thetechnical specifications must be traceable and retrievable.
• The requirements for drawing control are a part of the program, but so are other media.Process flow diagrams, indicating the chemistry, should be considered equally withengineering drawings as significant controlled documents.
• Field changes made during construction, procedure changes adopted during test and startup,and maintenance re-fits are also incorporated for configuration control.
To the extent possible, configuration control should be designed into the initial project as automaticfeatures, rather than considered a back-end activity. CADD programs (which can generate materialslists that are accessed by purchasing) have made some initial progress in contributing toconfiguration management. However, they do not provide the comprehensive, tight integration of alllifecycle uses.
PageA-6
AppendbcB
ENSR's CorporateStandard Operating Procedures
W.200S
Senior Review Date: October 1999
Revision Number: DRAFT
Author: Scott Whittemore
Discipline: All
1.0 PURPOSE AND APPLICABILITY
This document describes ENSR's procedures for senior review of project deliverables. Thepurpose of senior review is to ensure that project deliverables are correct, complete,consistent with project objectives, and readily retrievable.
The senior reviewer is an experienced individual with recognized insight about the clientand/or the work being performed. The senior reviewer may be an account manager,department manager, senior program manager, or other similarly qualified person.
T his procedure applies to all deliverables for ENSR projects larger than $5,000 contractvalue, and to ENSR proposals greater in value than $10,000. This procedure does not applyto letter proposals and letter reports.
Fteview and control procedures for engineering drawings are provided in SOP 1004.
2.0 RESPONSIBILITIES
2.1
2.2
The project manager is responsible for ensuring that this procedure is followed on hisor her projects, and that the project's schedule and budget are sufficient toaccommodate the reviews.
The task manager preparing the project deliverable is responsible for providing the!review materials to the assigned reviewer, obtaining a review in accordance with thisprocedure, incorporating the reviewer's recommendations, and reconciling anydisagreements with the reviewer.
The assigned senior reviewer is responsible for conducting the senior review withinthe allocated budget and schedule, completing the review documentation (if any),and assisting the project manager, lead author, or task manager in the process ofresolving any issues raised.
3.0 REQUIRED MATERIALS
• Materials as specified in project-specific plans.
2.3
mw97\SOPs\1 OOJ> Page 1 of 5 Revision 2
4.0 METHOD
4.1 Review of Proposals, Plans and Reports
4.1.1 The senior reviewer may attend internal kickoff and other significant progressmeetings. At these meetings, the senior reviewer should independentlydetermine whether the client's needs are being met and that proper steps arebeing taken to produce a quality product. The senior reviewer should be onthe communication distribution list for the project/proposal.
4.1.2 The senior reviewer should be provided with drafts of all client-deliverablematerials as early as possible.
4.1.3 In the senior review, the reviewer should detect and note any:
• inconsistencies between the project direction or methodologies and theclient/project objectives;
• disagreement with interpretations, conclusions, recommendations orprocedures;
• obscurity of rationale for interpretations, conclusions orrecommendations;
• passages that are unclear, imprecise or misleading;
• material that is poorly organized or difficult to follow;
• inadequate or inappropriate citation of references.
The written findings of the review are returned to the originator in one or both of thefollowing forms:
• a marked-up copy of the draft; and/or
• the completed Senior Review Record (Figure 1), which might be requiredon some projects.
The final responsibility for product quality rests with the project manager.
n-w97\SOPs\1005 Page 2 of 5 Revisicn: 2
j;OPNUMBER:;1-..-.• *V> -A ~ »>
4.2 Review of Numerical Analyses
4.2.1 Senior review of numerical analyses shall be performed to ensure thai:appropriate methods were used and to detect miscalculations, data entryerrors, and documentation deficiencies.
4.2.2 All numerical analysis and review is performed and documented inaccordance with ENSR SOP 1005. The calculations and review records arefiled in the project file.
4.3 Drawings/lllustrations/lmages/Animations
4.3.1 Drawings, images or animations that have been created to depict projectdata, interpretations of project data, remedial construction objectives, etc.,shall.undergo senior review to ensure that:
• the purpose and intent of each graphic is clear;
• interpretations are valid and defensible;
• graphics do not contradict corresponding text discussions or tabulateddata;
• recognized industry standard symbology and terminology are used (e.gi.,AGI, ANSI, USGS);
• all symbology is explained in a key as part of the graphic;
• visual quality of the graphic (size, resolution, color, etc.) is commensuratewith its purpose.
Detailed procedures for engineering drawings are given in ENSR SOP 100^.
5.0 REFERENCES
• ENSR SOP 1005. Numerical Analysis and Peer Review• ENSR SOP 1006. Qualification and Documentation of Computer Programs• ENSR SOP 1004. Control and Review of Drawings
rnw? ASOPsV 005 Page 3 of 5 Revision 2
rlENR
Figure 1. Senior Review Record
EMSR. Senior Review Record
ReviewRequested by:.
Reviewer:
. For (Client):.
Date:
Title of Document Reviewed:
Section(s) Reviewed:
ENSFJ Document Number _ Document Type: DDraft/Final Report DProposaJ Dottier
[3 Reviewer has had advance communication sufficient tounderstand the Client's needs and property scheduleths review.
i3 Dijcument satisfies Clients requirements.
G Pioject methodology is consistent with identifiedobjectives and project plans and procedures.
G Piocedures, numerical analyses, conclusions andrecommendations are presented dearly and professionally.
Q All data and references forming the basis forconclusions anil recommendations are presented or died.
Q All appropriate quality assurance, induding audits,technical reviews and data validation, has beenperformed and documented.
Q Numerical analyses have been documented, andcomputer programs have been qualified anddocumented, ir accordance with ENSR procedures.
Q Document conforms to the ENSR Corporate Style templates.
REVIEWER'S COMMENTS
Reviewer's SignatureAUTHOR'S RESPONSE FINAL RESOLUTION
Author's SignatureAuthor's Signature Date
DISTRIBUTION:
Reviewer's Signature Date
mw;!7\SOPs»1005 Page 4 of 5 Revision 2
SO?
Control and Review of Drawings Date: September, 1995
Revision Number: 0
Author: Scott Whittemore
Discipline:
1.0 PURPOSE AND APPLICABILITY
This document describes ENSR's procedures for ensuring that all manually drawn orcomputer generated technical drawings for ENSR projects are correct, comparable with non-IENSR drawings, and consistent with project objectives. The purpose of the documentationis to facilitate review and reconstruction of the information depicted in the drawings.
For the purpose of this SOP, a drawing is any graphical depiction of project technical orschedule data or engineering specifications. Computer-generated drawings include thosoproduced by illustration, desktop publishing, GIS, CADD, Data Visualization, or projectmanagement software.
2.0 RESPONSIBILITIES
JM The responsibility for implementation of this procedure on each project rests with theindividual creating or revising a drawing.
2.2 The project manager is responsible for ensuring that the project files are complete,and that appropriate drawings/revisions and reviews are accommodated in theproject's schedule and budget.
2.3 The reviewer is responsible for verifying that the drawing is accurate, traceable to thedata it depicts, and consistent with project objectives.
3.0 REQUIRED MATERIALS
None.
4.0 METHOD
4.1 Drawings and drawing revisions will be labeled with:
• A unique name and/or identification number (in the case of computer-generated drawings, this should be the name of the computer file containingthe drawing);
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• The applicable project number;• An explanation of the purpose of the drawing and the information it depicts;• The revision number and date;• A key that explains the symbology and terminology used (if appropriate).
Slides and photographs will be labeled with a. unique identification number that isreadily traceable to:
• The electronic file containing the image (if appropriate);• The applicable project number;• An explanation of the purpose of the drawing and the information it depicts;• The revision number and date;• A key that explains the symbology and terminology used (if appropriate).
4.2 Technical drawings that contain a title block (CADD) will conform to client/project orENSR style requirements.
4.3 Drawings will use standard symbology and recognized drafting standards, asapplicable. Symbology and terminology will be explained in a key on each drawing.The standards used in each drawing should be identified in the key. In the case ofcomputer-generated drawings, the standards used will be identified in theappropriate layer of the drawing file.
4.4 Engineering drawings depicting engineering designs and/or specifications will besigned and dated by the originator and checked, signed, and dated by a reviewer. Inaddition to this review, some drawings will require the stamp of a registeredprofessional engineer (P.E.).
4.5 Drawings to be included in ENSR work products will be approved for issue by theproject manager or designee.
4.6 Review and Revision
4.6.1 Drawings will be reviewed by a qualified individual other than the originator toensure that:
• Depicted data interpretations are documented adequately to demonstratethat they are valid and defensible;
• Drawings do not contradict corresponding text discussions or tabulateddata;
• Recognized industry standard symbology and terminology are used (e.c|.,ANSI, USGS);
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• Symbology and terminology are explained in a key as part of theillustration;
• Engineering drawing title blocks have the necessary approvals (sign-offs)prior to release, and include the lalest revision number;
4.6.2 The originator will provide the reviewer with a clean copy (review print) of tl-eillustration, along with related data tabulations and text discussions. Thereviewer notes remarks and recommendations in ink on the review print,signs and dates the marked-up review print and returns it to the originator.
4.6.3 If the reviewer recommends revisions, the reviewer and originator wi1' workcollaboratively to resolve any disagreements.
4.6.4 After determining that the drawing is acceptable, the reviewer will sign anddate a final review print.
4.6.5 Revisions are subject to the same review and approval cycles as initialdrawings.
5.0 QUALITY CONTROL
The review and revision portions of the method define the quality control requirements fortiis procedure.
6.0 DOCUMENTATION
€.1 The master drawing is filed in a central drawing file or in the project file.
6.2 The marked-up, signed and dated review prints should be filed in the project file.
6.3 Drawings will be prepared in, or converted to, file formats that are compatible withclient- and/or ENSR-standard software applications to ensure retrievability.
6.4 Electronic files will be stored and backed up on reliable media such as diskettes,tapes, optical media, or other reliable storage media. Primary and back-up files willbe maintained on distinctly separate storage media. The data storage structure,showing the relevant directory and subdirectory names, should be documented in theproject file.
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61.5 Diskettes used for storage of project data and drawings will be labeled clearly anc!conspicuously with the project name and number, the file names, and the file revisiondates. If the diskette label cannot accommodate a complete list of file names anddates, it should contain a clear summary.
7.0 REFERENCES
None.
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EN9R
Numerical Analysis and PeerReview
Date: September, 1995
Revision Number: 2
Author: Scott Whittemore
Discipline:
I
1.0 PURPOSE AND APPLICABILITY
This document describes ENSR's procedures for ensuring that calculations supportingENISR project results are correct, consistent with project objectives, legible, and readilyretrievable. The purpose of the documentation is to permit peer review and to facilitatereconstruction of the logic by which conclusions were developed.
Tiis procedure applies to calculations performed in support of engineering design,engineering estimates, risk assessments, and any other calculations that directly affect thedata, conclusions or recommendations that ENSR will include in its work product.
2.0 RESPONSIBILITIES
2.1 The project manager is responsible for ensuring that this procedure is followed on hisor her projects (as applicable), that the project files are complete, and that theproject's schedule and budget are sufficient to accommodate the appropriatecalculations and reviews.
2.2 The responsibility for implementation of this procedure on each project rests with theindividual performing the calculations.
2.3 The reviewer is responsible for verifying that the calculations and computer outputare correct (i.e., correctly follow the appropriate procedure), thoroughly documented,and consistent with project objectives.
3.0 REQUIRED MATERIALS
• • ENSR Calculation Title Page (or equivalent)• • ENSR Calculation Work Sheets (or equivalent)
4.0 METHOD
4.1 Manual Calculations
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4.1.1 All calculations will be documented in legible, reproducible records. Therecords will be complete enough to permit logical reconstruction by a qualifiedperson other than the originator.
4.1.24.1.3 Calculations will be maintained in working project files during the course of
the project, and will be placed in the Central Files following completion of theproject. Calculations should be filed together and indexed in each project tile.
4.1.44.1.5 Each calculation will be assigned an unique identification number, containing
the project number and (if appropriate) task number, to permit unambiguousreferencing in other calculations and documents.
4.1.64.1.7 An index sheet should be maintained lor all calculations in each project.4.1.84.1.9 Each calculation record should contain the following information:4.1.104.1.11 Each page of a calculation should contain:
• Project number• Calculation Number• Page Number• Date• Statement of the calculation's purpose (if there is no title page)• Brief description of method (if there is no title page)• All calculation steps, with units clearly indicated• Clear citation of any related computer output, lookup tables or other
references• Assumptions and justifications not contained on the calculation title page,
or pertaining to specific steps in the calculation• Signatures of originator and reviewer (if there is no title page)
4.1.12 Each calculation should have a title page containing:
• Client name• Project name and number• Calculation name and number• Total number of pages in the calculation• Date• Basic assumptions and justifications that pertain to the calculation as a
whole
4.1.13 If a series of related or dependent calculations are performed for a project,the complete record of the calculation series should have a cover pagecontaining:
• Statement of purpose for the series
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• Brief description of method• Basic assumptions and justifications that pertain to the calculation series;
as a whole
4.2 Computer Programs (Including Spreadsheets)
Documentation and qualification procedures for ENSR-written computer programsare detailed in ENSR SOP No. 1006.
4.3 Computer Program Output
4.3.1 Computer Models and Compiled Programs
All final computer program output used in a given project will be retained inhard copy in the project files. The output will be bound and assigned anunique reference number or title.
Each program output record should contain the following, as applicable:
• Name and revision date of program used• Input parameters• Date the output was generated
A copy of the data file will be retained, on diskette or other appropriatestorage media, in the project file and/or in the department's central files. Theoutput record will provide the name of the data file, along with appropriatepathnames indicating the directory and subdirectory(ies) in which the file canbe found.
4.3.2 Spreadsheets
All final spreadsheet output used in a given project will be retained in hardcopy in the project files.
Each spreadsheet output record will identify the spreadsheet name andversion and the date the output was generated.
A copy of the spreadsheet file will be retained, on diskette or otherappropriate storage media, in the project file and/or in the department'scentral files. The output record will provide the name of the spreadsheet file,along with appropriate pathnames indicating the directory andsubdirectory(ies) in which the file can be found.
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4.4 Review and Revisions
4.4.1 All calculations and computer output, and all revisions, will be reviewed by aperson other than the originator.
4.4.2 Review consists of a thorough check of calculations and/or computer outputfor the following:
• Correctness of calculation• Appropriateness of method• Appropriateness of assumptions• Completeness of calculations• Completeness of references• Completeness of record• Appropriateness of input parameters
4.4.3 If the reviewer recommends changes, the reviewer and originator will workcollaboratively to resolve any disagreements.
4.4.4 After determining that the calculation, computer output or revision isacceptable, the reviewer will sign and date the cover page and/or the firstpage of the computer output.
5.0 QUALITY CONTROL
The review and revision portions of the method define the quality control requirements forIhis procedure.
6.0 DOCUMENTATION
13.1 6.1 The original reviewed calculation record and/or computer program output will beretained in the project file. Calculations should be filed together and indexed in eiEichproject file.
6.2 6.2 A photocopy of the final, reviewed hand calculations should be retained in theproject file along with the original.
B.3 6.3 Computer program records will be retained in the associated project files and inthe central program documentation files for the affected program.
6.4 6.4 Data or spreadsheet files will be retained, on diskette or other appropriatestorage media, in the project file and/or in the: department's central files. The output
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record will provide the name of the data or spreadsheet file, along with appropriatepathnames indicating the directory and subdiroctory(ies) in which the file can befound.
7.0 REFERENCES
ENSR SOP 1006, Qualification and Documentation of Computer ProgramsENSR SOP 1004, Control and Review of Drawings
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Qualification and Documentationof Computer Programs
Date: September, 1995
Revision Number: 3
Author: Scott Whittemore
Discipline:
1.0 PURPOSE AND APPLICABILITY
1.1 This document describes ENSR's procedures and systematic approach to the testingand approval of computer programs (or their revisions) for general use, and fordocumentation of the applicability, limitations and operating procedures for eachprogram.
1.2 This procedure applies to any ENSR-written program that is used to calculate,interpret, and/or graphically depict ENSR project technical data, schedule data orengineering specifications.
1.3 For the purpose of this SOP:
• A compiled program is defined as a program written in a programming languagesuch as Fortran or Basic, or in an application shell such as dBase(r) or FoxPro [r).
• Spreadsheets and macros are also considered programs, but are not compiledprograms.
2.0 RESPONSIBILITIES
2.1 The responsibility for implementation of this procedure on each project rests with tieindividual performing the qualification and/or documentation of the computerprogram.
2.2 The individual using a computer program to generate material for an ENSR workproduct is responsible for ensuring that the program is appropriate for the use, thatits applicability and user instructions are documented, and that it is used inaccordance with the documented instructions.
:2.3 The project manager is responsible for ensuring that the project files are complete,and that appropriate computer program qualification and documentation tasks areaccommodated in the project's schedule and budget.
2.4 The project manager is responsible for the qualification, documentation and properuse of any program that is created or modified for a specific project.
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3.0 REQUIRED MATERIALS
• ENSR Program Qualification Record (or equivalent)• ENSR Compiled Program Qualification Record (or equivalent)
4.0 METHOD
4.1 Computer program versions accompanied by the following documents areconsidered qualified for use on ENSR projects:
• User instructions• Qualification record
4.2 Each qualified program version will be assigned a unique name, version number andrevision date.
4.3 The user instructions will:
For compiled Programs:
• Describe the theory behind the program;• Describe the program's applicability and limitations, and the assumptions on
which its design is based;• List input data requirements, including input file format requirements;• Describe hardware and software compatibilities, including memory requirements;• Indicate the program version's compatibility with earlier program versions (if
appropriate);• Provide general instructions for operating the program; and• Describe the output the program will provide, and any options in that regard.
For other programs:
• Describe the program's applicability and limitations, and the assumptions onwhich its design is based;
• List input data requirements;• Describe hardware and software compatibilities; and• Provide general instructions for operating the program.
4.4 The qualification record must document that Ihe computer program operates asintended and as described in the user instructions.
4.4.1 The compiled program qualification record (Figure 1 or equivalent) will becompleted for each compiled program. The program qualification record
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(Figure 2 or equivalent) will be completed for programs that are not compiledprograms as defined in 1.2.
4.4.2 The qualification record is completed as the result of testing of the programversion using a representative data set, and comparing the output to resultsobtained with the same data set using a different accepted method (e.g.another previously qualified program or documented hand calculations).
4.4.3 If the test described in 4.4.2 compares program output to hand calculations,the hand calculations must be documented and reviewed in accordance withENSRSOPNo. 1005.
4.4.4 The program output and the comparison standard (e.g. hand calculation) ateattached to the qualification record as supporting documentation.
4.4.5 The qualification procedure for a new version of a compiled program willdetermine the new version's compatibility with earlier versions (backwardcompatibility). The qualification record will clearly indicate the nature andextent of compatibility.
4.5 Program Revisions
4.5.1 Programs used for ENSR projects will be password-protected fromunauthorized revision whenever possible.
4.5.2 Revisions of an existing program will be made in a copy of the program,leaving the original intact.
4.5.3 Each revision of a program will undergo the qualification procedure describedin 4.4. The user instructions and qualification record must be updated for thenew version before it is qualified for use on an ENSR project.
4.5.4 Project-specific versions of a program are subject to the same qualificationand documentation requirements. The purpose and limitations of the project-specific version must be clearly documented.
5.0 QUALITY CONTROL
The documentation generated as a result of this procedure is subject to Senior Review inaccordance with ENSR's Senior Review policy.
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6.0 DOCUMENTATION
6.1 The qualification record and user instructions for each computer program will bemaintained in the central file. Project-specific program qualification records will bemaintained in the project file.
6.2 In addition to hard-copy supporting documentation, electronic "READ.ME" files willbe stored with the primary and back-up files for compiled programs. The"READ.ME" files will contain, at a minimum, a brief description of the program, itspurpose and its applicability.
6.3 Programs will be maintained in file formats that are compatible with client- and/orENSR-standard software applications to ensure retrievability. Electronic files will fc>3stored and backed up on reliable media. Primary and back-up files will be maintainedon distinctly separate storage media.
7.0 REFERENCES
« ENSR SOP 2005, Numerical Analysis and Peer Review.« ENSR Senior Review Policy.
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