updatedclauses.docx

Below are the updated clauses as a result of the questions and answers in the amendment 0003.

L-26 Local Clauses EPA-L-19-102 EPA'S GOALS FOR SUBCONTRACTING WITH SMALL BUSINESSES

(a) In accordance with FAR 52.219-9, Alternate II, the Contracting Officer is requesting all Large Businesses which submit an offer under a negotiated Request for Proposal (RFP) that is expected to result in a contract which will exceed $700,000 ($1,500,000 for construction) and have subcontracting possibilities provide a subcontracting plan with their initial proposal.

(b) In reviewing offeror's subcontracting plans submitted in accordance with the clauses entitled "Utilization of Small Business Concerns" (FAR 52.219-8) and "Small Business Subcontracting Plan" (FAR 52.219-9), EPA will use its own goals as negotiated with SBA as an Agency guideline. EPA's Socio-Economic subcontracting goal currently totals 55.0% of available subcontract dollars. These goals currently breakout as follows:

Dollars Awarded Percent of Subcontract Awards to Small Businesses 55.0% Awards to Small Disadvantaged Businesses 5.0% Awards to Woman-Owned Businesses 5.0% Awards to HUB Zone Businesses 3.0% Awards to Service Disabled Veteran 3.0%

(c) These goals are not intended to be mandatory; however, offerors are encouraged to keep these goals in mind when developing their subcontracting plan. Please note that goals must be proposed as a percentage of total dollars being subcontracted.

L-27 Local Clauses EPA-L-36-101 PROPOSAL INSTRUCTIONS

(a) Proposal Instructions

(1) The offeror's response is to be submitted in two volumes. The technical proposal is to be separate from the price proposal. Responses are subject to the following requirements and limitations:

I. Technical Proposal: Page limit of 90 double-sided pages.

II. Price Proposal: No page limit.

(2) Offerors shall include a cover letter with their proposal. The cover letter shall include, but is not limited to, the following:

(i) The solicitation number;

(ii) The name, address, telephone numbers, facsimile numbers, and electronic addresses of the offeror;

(iii) Names, titles, telephone numbers, facsimile numbers, and electronic addresses of persons authorized to negotiate with the Government on the offeror's behalf in connection with this Solicitation;

(iv) Name, title, and signature of person authorized to sign the proposal. Proposals signed by an agent shall be accompanied by evidence of that agent’s authority;

(v) Name, title, and signature of principals of the firm;

(vi) The name, address, telephone number, facsimile number, and electronic address of the individual in the offeror's organization to be contacted, if necessary, during evaluation of the proposal;

(vii) The complete formal name and address of the offeror's organization and/or other participants to be used in any resulting contract. Provide Dun and Bradstreet LTD DUNS number for each organization and new entity if one is being created;

(viii) The name, address, telephone numbers, facsimile numbers, and electronic addresses of representatives of the Government agency having administrative cognizance over the offeror, offeror team arrangement (as defined at FAR 9.601), or parent company, as applicable (such as contract administration within the meaning of FAR 42.3, Contract Administration Office Functions); and

(ix) A statement that the offeror grants to the EPA or its authorized representatives, the right to examine, for purposes of verifying the information submitted, those books, records, documents, and other supporting data that will permit adequate evaluation; and this right may be exercised in connection with any such reviews deemed necessary by the Government.

(3) Notwithstanding any other provision or clause in this solicitation to the contrary, proposals shall be submitted via the FedConnect® web portal (www.fedconnect.net). In order to submit proposals, offerors must register in FedConnect® at www.fedconnect.net, see main page of FedConnect® website for registration instructions. For assistance in registering or for other FedConnect® technical questions please call the FedConnect® Help Desk at (800) 899-6665 or email at support@fedconnect.net

(i) For those mailed through the U. S. Postal Service - U.S. Environmental Protection Agency Attn: Donna Reinhart 26 West Martin Luther King Drive Mailstop: W124A Cincinnati, OH 45268-0001

(ii) For those sent by Courier or Hand Carried - U.S. Environmental Protection Agency Attn: Donna Reinhart 26 West Martin Luther King Drive Mailstop: W124A Cincinnati, OH 45268-0001

(iii) NOTE: There must be an annotation on the face of the package which shows the RFP number and the closing date.

(b) Volume-Specific Instructions:

(1) Technical Proposal Instructions

Offerors shall submit one (1) printed technical proposal that will serve as the official copy, one (1) CD submission of the Technical Proposal, and one (1) electronic submission at the FedConnect® website.

CD-ROM shall contain an electronic copy of the information submitted in the hard copy volume. The CD-ROM is provided for evaluation convenience only. The hard copy volume constitutes the official Offer and proposal. In the event of a conflict, the hard copy material takes precedence over the CD-ROM text or the FedConnect version.

Technical evaluation of proposals will be based on the Technical Evaluation Criteria in provision M, Local Clauses EPA-M-15-101 “EVALUATION FACTORS FOR CONTRACT AWARD”.

FAXED OR E-MAILED COPIES WILL NOT BE ACCEPTED

1) In order that EPA may evaluate technical proposals in accordance with Technical Evaluation Criteria, offerors must address the following in their technical proposal.

The technical proposal shall be limited to 45 double-sided typewritten pages on standard 8½ x 11-inch paper, using no less than 12-point character size and no less than one inch all around margins. 10-point font is acceptable for non-text items such as tables, graphics, and exhibits. A piece of paper that has printing on both sides (double-sided) counts as two pages. A foldout page counts as two pages. These instructions equate to 90 single-sided typewritten pages.

The offeror is strongly urged to be as succinct, clear, and concise as possible in writing the technical submission and adhering to the page limitation. Any proposal pages that are exceeding the page limitation will not be evaluated.

Exclusions: The following items are excluded from the page limitation:

i. Transmittal letters, cover pages, table of contents, and dividers.

ii. The offeror’s Quality Management Plan (QMP), Sample Quality Assurance Project Plan (QAPP), letters of commitment without rate information, and resumes of the key personnel, shall be submitted as separate, tabbed attachments to the technical proposal and shall not count toward the page limitation.

2) The term “offeror” as used in the technical proposal instructions and the technical evaluation criteria shall mean the prime contractor and any proposed subcontractors and consultants.

3) The offeror’s technical proposal must be prepared as a separate part of the total proposal package, and shall be specific and sufficiently detailed to allow a complete evaluation of the method of satisfying the requirements set forth in the RFP. All cost or pricing details shall be omitted from the technical proposal.

4) The technical proposal shall comprehensively address each of the criteria described in the Technical Evaluation Criteria in provision M, Local Clauses EPA-M-15-101 “EVALUATION FACTORS FOR CONTRACT AWARD”, and shall be prepared in exactly the same order using the same numbering system for all criteria and subcriteria, including all material that is to be evaluated under the appropriate criterion and subcriterion. Resumes and consultant letters of commitment, referenced in more than one criterion, need only be attached once as an appendix or attachment.

5) The technical proposal shall include page numbers on all pages, including attachments.

6) It is mandatory that the offeror include, in both its cost and technical proposals, a clear explanation of how the individuals or categories proposed correspond to the Labor Categories included in the price proposal instructions. If proposal costing is not done based on specific individuals that are clearly named in both the cost and technical proposals, it is the offeror’s responsibility to demonstrate clearly in the proposal that the method of pricing accurately reflects the costs of using the individuals cited technically to an extent consistent with the level of effort usage proposed for personnel being technically evaluated.

7) The following instructions apply to the Technical Evaluation Criteria as set forth in Section M, Evaluation Factors for Contract Award. For this solicitation, all evaluation factors other than cost or price when combined are significantly more important than cost or price. The offeror shall comprehensively address each of the technical evaluation criteria in their technical proposal. Only information included under the individual criterion/subcriterion, or specifically referenced under the individual criterion/subcriterion, will be considered for evaluation of that particular criterion/subcriterion.

(i) The technical proposal shall include the offeror’s responses to the criteria/factors listed as:

I. TECHNICAL KNOWLEDGE AND EXPERIENCE

This criterion is established to evaluate the offeror’s collective team (prime, subcontractors and consultants) technical knowledge and experience of the drinking water regulatory process. The offeror’s knowledge and experience are crucial to performing the technical requirements of the contract that will result from this solicitation, so the offeror’s response to this criterion will be a significant factor in EPA’s evaluation. These two elements are separately identified and discussed below to assist the offeror in understanding the information that should be included in proposals to effectively address each element. However, EPA will only assign one evaluation rating for this criterion based on the offeror’s response to each element. The elements will not be given separate ratings.

The offeror shall address the following two elements: 1.) prepare a brief narrative that demonstrates knowledge and understanding of the agency’s drinking water regulatory process, 2.) provide examples of recently supported contract efforts that demonstrates relevant experience supporting the drinking water regulatory process.

1. Offeror’s Knowledge and Understanding of EPA’s National Drinking Water Regulatory Process

The offeror shall submit a narrative that describes the process used by EPA to identify contaminants for potential drinking water regulations, and develop, review, and revise drinking water regulations. The narrative shall describe how the agency’s action plans (e.g., PFAS Action Plan, Federal Lead Action Plan) and other initiatives fit into the current drinking water rulemaking process. Demonstrate knowledge of EPA’s process for deriving maximum contaminant level goal (MCLG) including relative source contributions, as well as maximum contaminant level (MCL), action levels and treatment technique requirements. The narrative shall identify and describe statutory authority, regulatory elements and key data sources used in the process. In addition, the narrative shall identify and discuss obstacles and unique challenges that are inherent to the process. The narrative shall be clear, concise and logically organized and shall not exceed ten (10) single-spaced, one-sided pages.

2. Offeror’s Demonstrated Experience Supporting Drinking Water Regulatory Process

The offeror shall present experience in supporting the drinking water regulatory process and developing communication strategies. The offeror must demonstrate previous experience with drinking water rule-making by submitting summaries for up to five (5) projects completed in the last 5-years. Each narrative shall identify the appropriate relevant task area(s) outlined in Section 1 of the Performance Work Statement. The offeror’s experience does not have to be from prior EPA support efforts but must have clear relevance to the federal or state agency drinking water regulatory process. Individual project narratives shall not exceed three (3) single-spaced, one-sided-pages. If the offeror submits one project only 3 single sided pages shall be submitted, if an offeror submits 5 projects the maximum number of pages submitted would be 15 single sided pages. For each project, the offeror shall include the following:

1. Project Number (i.e., 1,2,3…)

2. Name of the federal or state agency

3. Contract title and number

4. Offeror’s role (prime or subcontractor)

5. Project number and title

6. Client point of contact (i.e., name, telephone number, and email address)

7. Project performance period, task order/work assignment type (firm fixed price, cost plus fixed fee, time and materials), and total value

8. Offeror’s team member(s) that performed the work

9. Labor resources required (labor category, professional levels, and number of labor hours)

10. Crosswalk of the tasks performed on the project with tasks in the PWS

II. QUALIFICATIONS AND AVAILABILITY OF KEY PERSONNEL

Responses to this criterion evaluate the qualifications (experience, expertise and education) and availability of the key personnel. It is noted that each Key Personnel position will be rated individually. The offeror shall submit a biographical narrative that clearly establishes the key personnel’s specific experience in performing in the positions outlined and, at a minimum, provide the individual’s resume and present the following items;

a. Name, Professional Level, and Job Title

b. Degree (s) held and corresponding field of study (e.g., BS in Civil Engineering).

c. Number of years of experience relevant to his/her proposed role.

d. Description of work relevant to his/her proposed role (requirements outlined*).

e. Professional Certifications, licenses.

* It is not enough to merely state that an individual worked on a project. EXPLAIN WHAT HE/SHE DID.

Note: For the resulting contract, EPA has designated the positions of Program Manager, Quality Assurance Manager, Senior Analyst, Senior Scientist, and Senior Engineer as Key Personnel. Individuals proposed as Key Personnel will be listed as such in the contract Section H clauses entitled “Key Personnel” and are subject to all requirements of that clause. Only current employees of the Prime contractor shall be proposed for key personnel positions and each must meet the P-level requirements outlined in the Definition of Labor Classification Categories. An individual can only hold one key personnel position on the contract. The individuals proposed in key personnel positions of Senior Analyst, Senior Scientist and Senior Engineer, will have a project oversight role, so the offeror must demonstrate the experience of the individual in this element. For the key personnel categories Senior Scientist and Senior Engineer up to two personnel may be proposed.

1. Program Manager (PL-4) Qualifications and Availability

a. Demonstrated Contracts Management Qualifications of the Proposed Program Manager

The offeror’s proposed Program Manager must demonstrate leadership and contract performance oversight gained through a minimum of ten (10) years of experience as a Program Manager (or an equivalent contract level management role). The Program Manager must demonstrate experience managing contracts similar in technical scope (analytical, science and engineering), size (labor hours, labor categories, with multiple subcontractors and consultants) and complexity (firm fixed price and time and materials (or cost-plus fixed fee); with requirements issued by task orders or work assignments). Demonstrate experience in planning and coordinating project activities at both task order and contract levels. Demonstrate experience in developing budgets and staffing plans, monitoring and reporting technical progress and resource expenditures at both task order and contract levels.

b. Estimated Availability of the Proposed Program Manager

The offeror shall indicate the percentage of time the Program Manager will be available for management and administration of the resulting contract over the 5-year performance period. The offeror shall base its estimate on the Program Manager’s current workload on existing and potential follow-on contracts and other order vehicles. The offeror shall also include any other factors and assumptions used in the estimate.

2. Quality Assurance (QA) Manager (PL-4) Qualifications* and Availability

a. Demonstrated Qualifications of the Proposed Quality Assurance Manager

The offeror’s proposed QA Manager (or equivalent title) shall demonstrate experience in overseeing and evaluating implementation of the organization’s quality system and reporting to senior management on the effectiveness of the quality system, including needs for improvement. Qualifications of the QA Manager include education, QA training, QA certifications, and QA experience relevant to implementing the QA needed to support the activities described in the PWS (e.g., development and implementation of QA Project Plans, SOPs, and checklists; technical and/or editorial review of documents; documentation of QA strategies and results in final reports; controlling of project databases; validation of models).

b. Availability of the Quality Proposed Assurance Manager The offeror shall indicate the percentage of time the QA Manager will be available to the resulting contract over the 5-year performance period. The offeror shall base its estimate on the QA Manager’s current workload on existing and potential follow-on contracts. The offeror shall also include any other factors and assumptions used to establish the percentage.

* It is not enough to merely state that an individual has QA experience for working on a project. EXPLAIN HOW THAT EXPERIENCE SUPPORTS MANAGING QA UNDER THE PWS SECTIONS.

3. Senior Analyst (PL-4) Qualifications and Availability

a. Demonstrated Technical Qualifications of the Proposed Senior Analyst

The offeror’s proposed Senior Analyst must demonstrate project oversight and have a broad range of analytical capability. The Senior Analyst must have demonstrated experience supporting regulatory development and implementation efforts for federal and/or state environmental programs. Demonstrate analytical capability in evaluating and interpreting the technical accuracy of environmental data from research, technical documents, data bases and information systems. Demonstrate experience in evaluating cost and economic benefits and assessing regulatory impacts. Demonstrate experience in supporting programmatic process improvement efforts, where technology or innovation was used to develop effective solutions to complex problems.

4. Senior Scientist (PL-4) Qualifications and Availability

a. Demonstrated Technical Qualifications of the Proposed Senior Scientist

The offeror’s proposed Senior Scientist must demonstrate experience in project oversight and have knowledge of scientific principles necessary to evaluate health effects and exposure pathways associated with contaminants in drinking water. Demonstrate experience in assessing risk from exposure to chemical, radiological and microbiological contaminants. Demonstrate knowledge and experience in the development and evaluation of analytical methods and performance criteria for treatment/concurrence and compliance monitoring.

b. Estimated Availability of the Proposed Senior Scientist The offeror shall indicate the percentage of time the proposed Senior Scientist will be available for the resulting contract over the 5-year performance period. The offeror shall base its estimate on the Senior Scientist’s current workload on existing and potential follow-on contracts. The offeror shall also include any other factors and assumptions used in the estimate.

5. Senior Engineer (PL-4) Qualifications and Availability

a. Demonstrated Technical Qualifications of the Proposed Senior Engineer

The offeror’s proposed Senior Engineer shall demonstrate experience in project oversight and have knowledge of engineering principles specific to assessing design and operation of public water systems. Demonstrate knowledge and experience in evaluating and recommending treatment technologies designed to reduce and remove contaminants from source water and drinking water supplies. Demonstrate experience in developing and/or using chemical, radiological, and microbiological models to evaluate contaminant occurrences/co-occurrences in source water, water treatment plants and distribution systems. Demonstrate knowledge and experience with best available technologies (BATs) and small systems compliance technologies (SSCTs) listing criteria. Demonstrate knowledge and experience with development of unit treatment costs for drinking water treatment technologies.

b. Estimated Availability of the Proposed Senior Engineer

The offeror shall indicate the percentage of time the proposed Senior Engineer will be available for the resulting contract over the 5-year performance period. The offeror shall base its estimate on the Senior Engineer’s current workload on existing and potential follow-on contracts. The offeror shall also include any other factors and assumptions used in the estimate.

III. QUALITY MANAGEMENT SYSTEM

This RFP requires submission of a customized QMP; one sample QAPP, and a demonstration of the offeror’s qualifications relevant to implementing the Quality Assurance (QA) and Quality Control (QC) strategies needed to support the activities described in the PWS. This information may be submitted as an attachment to the offeror’s proposal, and will not be included in the page count. These two elements are separately identified and discussed below to assist the offeror in understanding the information that should be included in proposals to effectively address each element. However, EPA will only assign one evaluation rating for this criterion based on the offeror’s response to each element. The elements will not be given separate ratings.

A. APPROPRIATENESS OF THE QUALITY MANAGEMENT PLAN (QMP) AND QUALITY ASSURANCE (QA) QUALIFICATIONS Quality Management Plan (QMP)

This element evaluates the adequacy of the offeror’s Quality Management Plan (QMP) to effectively manage the Quality Assurance (QA) activities of the contract, including the completeness and relevance of the offer’s QMP for meeting the QA requirements under the contract. See the provision in Section L of the RFP entitled “Instructions for the Preparation of Quality Management Plan (QMP) (EPA-L-46-101)” and the Section E clause entitled “Higher-Level Contract Quality Requirement (Government Specification)” (FAR 52.246-12)”. Additional information on EPA requirements for the QMP can be accessed at the following: https://www.epa.gov/quality. It is the intent of the Government to incorporate the awardee’s QMP in its entirety into any resultant contract.

A.1. Appropriateness of the Customized QMP

The offeror, as a separate and identifiable part of its technical proposal, shall demonstrate the appropriateness of its quality system as documented in a customized (contract) Quality Management Plan (QMP) that is tailored to the requirements in the proposed contract PWS and explains how the organization’s Quality System, including QA and QC strategies will support the PWS activities; the customized QMP shall comply with all requirements specified in EPA QA/R-2, EPA Requirements for Quality Management Plans and Table 1 of the Technical Proposal Instructions. The offeror also must complete and submit the crosswalk provided in Table 2 of the Technical Proposal Instructions to demonstrate compliance with this criterion.

The offeror’s QMP must include a statement of policy concerning the organization's commitment to implement a QA/QC program to ensure the collection, generation, analysis, or use of environmental data is of sufficient quality to meet the requirements of the proposed contract PWS. The offeror’s QMP must provide a unified organizational chart that encompasses the technical PWS activities, subcontractors (including consultants), and QA/QC personnel. The offeror’s organizational chart must show the lines of authority, responsibility, and communication, must be consistent with the organizational chart presented in the Program Management Plan, and must be supported by text that discusses these roles and responsibilities.

The offeror’s QMP must discuss the independence of the QA personnel who are proposed by the offeror; these include a corporate QA Manager (or equivalent) as well as any project- or task-designated QA personnel who will perform a QA/QC review of the procedures and major work products. The offeror’s QMP must include a detailed discussion of the flow-down of QA responsibilities from the Offeror to all subcontractors (including consultants and related team members). The offeror’s QMP must document the organization’s procedures for ensuring that all personnel performing technical or QA/QC-related work for the organization have the necessary skills to effectively accomplish their work.

A.2. Appropriateness of the Offeror’s Experience in Developing and Applying QA/QC Procedures

Each offeror, as a separate and identifiable part of its technical proposal, shall demonstrate the appropriateness of the type and degree of the organization’s experience in developing and applying QA/QC procedures to the activities needed for performance of the PWS.

B. Sample Quality Assurance Project Plan (QAPP)

For this element, the offeror, as a separate and identifiable part of its technical proposal shall submit a sample Quality Assurance Project Plan (QAPP) developed for subtasks 1.2 and 1.6 of the PWS. The sample QAPP should demonstrate that the offeror: (1) understands EPA’s requirements for the QAPP; and (2) is capable of preparing a QAPP that includes all required QAPP elements and that addresses these elements with specific details concerning how the offeror controls, defines, documents, and measures quality for technical activities similar to those that will be performed under the PWS for the proposed contract. The sample QAPP should describe specific procedures for all environmental information and data operations relevant to the sample project, including the use of primary and existing data, software and model development, and validation of the model for its intended use. The QAPP should consist of the elements as specified in EPA QA/R-5, EPA Requirements for Quality Assurance Project Plans. Additional information on this document can be accessed at https://www.epa.gov/quality/epa-qar-5-epa-requirements-quality-assurance-project-plans.

IV. PAST PERFORMANCE

This criterion is established to evaluate the offeror’s past performance. For the offeror and each subcontractor proposed for a subcontract in excess of $5,000,000, demonstrated performance on up to five (5) contracts and/or subcontracts completed in the last three years, and all contracts and subcontracts currently in process that are similar in nature (size, type, technical scope, and complexity) to this requirement. Areas of demonstrated performance may include: quality of product or service, schedule, cost control, management, and regulatory compliance.

The Government will consider the information provided by the references, and may also consider information obtained from other sources, when evaluating an offeror’s past performance. Attempts to obtain responses from references will generally not go beyond two telephone messages and/or written requests. Not all references identified by the offeror may be contacted.

V. RESOURCE MONITORING

This criterion is established to evaluate the offeror’s proposed process and system for managing resources under the contract that will result from this Solicitation. Under this criterion, EPA will evaluate offeror’s organizational structure, plan and approach for managing a contract with both firm-fixed priced and time and materials (labor hour) task orders and in some cases, firm-fixed priced and time and materials tasks within a task order. This contract type creates unique contracts management and administration challenges.

The offeror shall provide a brief narrative on the process and approach for managing a contract with firm fixed price and time and materials requirements. The narrative shall also address task order that include both firm fixed price and time and material tasks. The narrative shall discuss the offeror’s experience with such contract vehicles, and the anticipated challenges. The narrative shall also discuss the systems and/or automated tools that will be used for managing labor hours and expenditures. The narrative should provide information that clearly identifies the following aspects of the organizational structure: the roles and responsibilities of the Program Manager and other proposed personnel (if more than one individual is being proposed for a position, clearly convey each person’s role; the lines of authority (i.e., to whom each proposed person reports within the contractor’s structure) for proposed prime contractor staff and management and, if applicable, for each proposed subcontractor and consultant (lines of authority can be included in the discussion of roles and responsibilities or presented in a chart); and proposed staff levels.

The relative importance of the technical criteria are as follows:

(1) Criterion I “Technical Knowledge and Experience” is the highest level of importance followed in level of importance by;

(2) Criterion II “Demonstrated Qualifications and Availability of Key Personnel Subcriterion 1, 2, 3, 4, and 5 followed in level of importance by;

(3) Criterion III “Quality Management System”; followed in level of importance by;

(4) Criterion IV “Past Performance” followed in level of importance by;

(5) Criterion V “Resource Monitoring.”

(d) Evaluation rating method will be as follows:

In accordance with FAR 15.305(a) the EPA will use the following adjectival ratings in its evaluation of all technical criterion other than Past Performance:

Combined Technical/Risk Rating

EPA will use the following adjectival ratings in its evaluation of the past performance criterion:

Performance Confidence Assessment

TABLE 1

EPA QUALITY MANAGEMENT PLAN REQUIREMENTS FOR CONTRACTORS

This is a list of requirements for contractor Quality Management Plans (QMPs) that are submitted to the Quality Assurance Officer/Coordinators for review under RFP 68HE0C18R0081.

Required elements in this list are discussed in detail in EPA Requirements for Quality Management Plans (QA/R-2), as customized below to meet EPA needs under the RFP. Consult this resource for more information on the items below.

Note that all items below must be included in a QMP. If an item is not relevant, an explanation must be provided. Also note that the process may either be described or referenced in the QMP; however, all references should be readily accessible within the organization.

These RFP Technical Proposal Instructions include a separate Table 2 that provides a crosswalk between the QMP requirements and the contractor’s QMP. The contractor must 1) complete the Table 2 crosswalk by identifying the specific location in which its QMP addresses each OST QMP requirement, and 2) submit the crosswalk as part of its Technical Proposal. Failure to comply with the requirements identified below will negatively impact the rating of the submitted QMP.

Note also that, per QA/R-2 section 2.6, Quality Management Plan Submission and Approval, EPA approval of a Quality Management Plan will be valid for no more than “the length of the extramural agreement”.

MANAGEMENT AND ORGANIZATION (3.2)

QMPs that are not signed by the organization’s QA manager (or equivalent) when submitted with the offer will negatively impact the rating of the submitted QMP.

Note: Review during the proposal evaluation process does not constitute acceptance by EPA. Formal acceptance must occur before the QMP is included in the contract award

4. Includes statement of the organization’s QA policy, which includes:

a. The importance of QA and QC activities to the organization and why

b. General objectives/goals of the quality system

c. Policy for resource allocation for the quality system

5. Includes organizational chart

The organization chart must show communication/ coordination lines between the offeror’s QA manager or equivalent for this program and the offeror’s program/project management team. If the QA manager is supported by an independent team of QA/QC staff, the organization chart also must present the lines of communication between these staff, the QA manager, and the technical staff and managers.

d. Organization Chart identifies any other QA staff

8. Describes procedures to ensure QA staff members have access to appropriate levels of management

11. Identifies where internal coordination of QA and QC activities among organizational units is needed

12. Discusses how management assures quality system understanding and implementation in all programs

QUALITY SYSTEM COMPONENTS (3.3)

13. Includes description of quality system

14. Describes principal quality system components (e.g., quality system documentation, annual reviews and planning, training, systematic project planning, project-specific quality documentation, project and data assessments)

15. Description of each component includes responsibilities of management and staff

Offerors must identify and describe all proprietary tools (e.g., models, data, software) that will be used to generate work products that will be submitted to the EPA under this contract, and describe any limitations on the EPA’s ability to share these tools with stakeholders that wish to reproduce information disseminated by the EPA that is based on those work products.

18. Identifies review and approval procedures for these internal QMPs (if applicable)

QUALIFICATIONS AND TRAINING (3.4)

19. States policy regarding QA training for management and staff

21. Describes process for ensuring personnel maintain quality-related qualifications

22. Describes process for identifying the need for quality-related retraining based on changing requirements

23. Includes roles, responsibilities, and authorities in description of each of the above processes

PROCUREMENT OF ITEMS AND SERVICES (3.5)

24. Describes/references process for reviewing and approving all procurement documents

a. Review process ensures documents are complete and accurate

b. Review process ensures agreement clearly describes the item or service needed

c. Review process ensures agreement describes the associated technical and quality requirements

d. Review process ensures agreement describes the quality system elements for which the supplier is responsible

e. Review process ensures that the supplier’s conformance to the customer’s requirements will be verified

25. Describes/references process for reviewing and approving applicable responses to solicitations to ensure that they satisfy all technical and quality requirements

26. Describes/references process of ensuring procured items and services are acceptable, including the review of objective evidence of quality for applicable items and services

27. Includes roles, responsibilities, and authorities in description of each of the above processes

DOCUMENTS AND RECORDS (3.6)

28. Describes/references process for identifying quality-related documents and records (including electronic) requiring control

29. Describes/references process for preparing, reviewing, approving, issuing, using, authenticating, and revising documents and records

30. Describes/references process for ensuring that records and documents accurately reflect completed work

31. Describes/references process for maintaining documents and records, including transmittal, distribution, retention, access, preservation, traceability, retrieval, removal of obsolete documentation, and disposition

33. Describes/references process for establishing and implementing appropriate chain of custody and confidentiality procedures for evidentiary records

34. Includes roles, responsibilities, and authorities in description of each of the above processes

COMPUTER HARDWARE AND SOFTWARE (3.7)

35. Describes/references process for developing, installing, testing, using, maintaining, controlling, and documenting computer hardware and software used in environmental programs to ensure it meets technical and quality requirements and directives from management

36. Describes/references process for assessing and documenting the impact of changes to user requirements and/or the hardware and software on performance

37. Describes/references process for evaluating purchased hardware and software to ensure it meets user requirements and complies with applicable contractual requirements and standards

38. Describes/references process for ensuring that data and information produced from or collected by computers meet applicable requirements and standards

39. Includes roles, responsibilities, and authorities in description of each of the above processes

PLANNING (3.8)

a. Does process include identification and involvement of the project manager, sponsoring organization and responsible official, project personnel, stakeholders, scientific experts, etc. (e.g., all customers and suppliers)

b. Does process include description of the project goal, objectives, and questions and issues to be addressed

c. Does process include identification of project schedule, resources, milestones, and any applicable requirements

f. Does process include specification of needed QA and QC activities to assess the quality performance criteria

g. Does process include description of how, when, and where the data will be obtained (including existing data) and identification of any constraints on data collection

41. Describes/references process for developing, reviewing, approving, implementing, and revising QA Project Plans or equivalent planning documents

43. Includes roles, responsibilities, and authorities in description of each of the above processes.

IMPLEMENTATION OF WORK PROCESSES (3.9)

Note: For the purposes of this contract, the term ¿procedures¿ used throughout this section refers to standard operating procedures (SOPs)

44. Describes/references process for ensuring that work is performed according to planning and technical documents

45. Describes/references process for identifying operations needing procedures

46. Describes/references process for preparation, review, approval, revision, and withdrawal of these procedures

47. Describes policy for use of these procedures

48. Describes/references process for controlling and documenting the release, change, and use of planned procedures

a. Process includes description of necessary approvals

c. Process includes removal of obsolete documentation from work areas

d. Process includes verification that the changes are made as prescribed

49. Includes roles, responsibilities, and authorities in description of each of the above processes

ASSESSMENT AND RESPONSE (3.10)

1. Documented assessment of the QMP, determining whether it accurately reflects the current organization and the Quality System, including identification of past and planned changes and revisions to the QMP.

2. Documentation showing that the Quality System has been effectively implemented during the past year. This documentation needs to include a summary of the contractor’s assessments of its Quality System, including assessments conducted by the contractor of its organization and subcontractors, and by external organizations. The summary needs to include the following information for each assessment: (a) type of assessment performed, (b) organization and project that were the subject of the assessment, (c) who performed the assessment, (d) when the assessment was performed, and (e) general statement of the assessment results and any corrective actions.

51. Describes/references the process for planning,…