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Draft Section C – JBADS RFP as of 31 August 2016 Section C - Descriptions and Specifications PERFORMANCE WORK STATEMENT

PERFORMANCE WORK STATEMENT

Joint Biological Agent Decontamination System (JBADS)

C.1. SCOPE. This Performance Work Statement (PWS) defines the Contractor activities in support of the Engineering and Manufacturing Development (EMD) phase of the Joint Biological Agent Decontamination System (JBADS) program. There are contract Options for Full Rate Production (FRP) and Contractor Logistics Support (CLS) to fulfill Sustainment and Operational Mission Support requirements.

C.2. BACKGROUND. The JBADS is an Acquisition Category (ACAT) III joint program with participation from the United States Air Force. The Joint Program Executive Office for Chemical and Biological Defense (JPEO-CBD) is the Milestone Decision Authority (MDA). The Joint Project Manager for Protection (JPM P) manages the effort and the JBADS Product Management Office (PMO) executes the program.

The goal of JBADS is to provide the United States (U.S.) Air Force Air Mobility Command (AMC) with the ability to thoroughly decontaminate a U.S. Transportation Command (TRANSCOM) C-130 (H/J/J-30) model aircraft from biological warfare agents, to allow unrestricted use through the employment of hot, humid air (170 degrees F +/-5 degrees and 90% +/- 5% relative humidity).

The JBADS program will enter the acquisition cycle at Milestone (MS) B and immediately begin execution of EMD phase activities. The JBADS program is able to enter at MS B due to the JBADS Joint Capability Technology Demonstration (JCTD) that was conducted in 2014-2015. The JCTD demonstrated a log-6 decontamination capability, using hot, humid air. The JCTD system was composed of an Aircraft Enclosure (AE) and Aircraft Decontamination Units (ADUs), the latter comprised of blowers, heaters, humidifiers and chillers connected to the AE via ducting.

At the conclusion of the JCTD desired improvements to the JBADS system were identified as follows:

· Aircraft Enclosure must allow for quick and safe ingress/egress. [Note: The JCTD system structure was built in a conformal fashion around and above the aircraft.]

· Provide ability for sequential and potentially sustained decontamination operations.

· Elimination of the escape of the hot humid air outside of the AE.

Following completion of the JCTD the Government initiated improvements to the AE design. The Government’s modified AE design is provided in Attachment XX; to date the Government has not built or verified functionality of the JBADS using this modified AE design.

C.2.1 Overview. During the base period of this contract, the contractor will provide a production representative JBADS that will be built and verified during the EMD phase. This production representative JBADS will undergo Operational Assessment (OA) and Initial Operational Test and Evaluation (IOT&E). The JBADS will consist of an AE, ADUs, a Control Module and Control Software. The JBADS under this contract must have the capacity to enable aircraft to enter and exit (allow for 5 feet clearance on all sides of the aircraft), provide heat (170 degrees F +/- 5 degrees), and humidity (90% relative humidity +/- 5%) during decontamination, provide adequate control to ensure no condensation forms within the AE or on the Aircraft surfaces, and provide real-time monitoring. (The Contractor may utilize the Government’s modified AE design, or may propose improvements to the Government’s modified AE design, or propose a unique/new AE design of their own.)

A Start of Work Meeting will be held after contract award. In conjunction with the Start of Work Meeting and prior to fabricating the initial JBADS for verification testing and OA, the JBADS will undergo a Critical Design Review (CDR) to establish the initial product baseline. The detailed specifications and technical data for JBADS materials will remain under Contractor control but Class 1 changes to materials will require Government approval starting with CDR and continuing throughout the life cycle of JBADS. Upon completion of verification testing, the Contractor shall support and attend a combined System Verification Review (SVR)/Production Readiness Review (PRR) to verify the production baseline.

During the first option period of this contract, the contractor will provide four (4) Full Rate Production JBADS that will encapsulate a C-130J and provide heat and humidity to decontaminate the aircraft in accordance with the JBADS Performance Specification (PSPEC) Version X.X (Attachment XXX). In addition, the contractor will retrofit the production representative JBADS from the EMD phase.

If the option for FRP is exercised, the Contractor shall fabricate the four (4) FRP systems, based on the product description delivered to the Government at the conclusion of the EMD phase, and shall collaboratively conduct a Physical Configuration Audit (PCA) on these systems. Performance requirements for FRP, including updated details of the first article and conformance inspections, will be included in the JBADS PSPEC that will be updated following the Physical Configuration Audit (PCA).

During Option periods X through X, the contractor will provide sustainment CLS that will enable storage and storage maintenance (to include a yearly health and availability inspection), and conduct a bi-annual Full System Exercise. Option periods X through X will also encompass CLS that facilitates the world-wide deployment of the JBADS.

C.3. APPLICABLE DOCUMENTS. The following documents specified form a part of this PWS to the extent specified herein. The most recent revision of the referenced document at the time of contract shall be used unless otherwise specified. In the event of conflict between the applicable documents and this PWS, the PWS shall take precedence. All second tier and below references cited in mandatory compliance documents shall be considered as guidance only. Nothing in this document, however, supersedes applicable laws and regulations unless a specific exemption has been obtained.

C.3.1. Military Standards and Specifications.

MIL-PRF-32216Evaluation of Manuals and Preparation of Supplemental Data
MIL-STD-129Military Marking for Shipment and Storage
MIL-STD-130Identification Marking of U.S. Military Property
MIL-STD-882Standard Practice for System Safety
MIL-STD-1472Human Engineering
MIL-STD-2073-1DoD Standard Practice for Military Packaging

C.3.2. Federal Standard - Mandatory.

Not applicable

C.3.3. Handbooks - Guidance Only.

MIL-HDBK-61A Configuration Management Guidance

MIL-HDBK-470 Designing and Developing Maintainable Products and Systems

MIL-HDBK-781 Reliability Test Methods, Plans, and Environments for Engineering Development, Qualification, and Production

MIL-HDBK-881Work Breakdown Structures For Defense Materiel Items
MIL-HDBK-2155Failure Reporting, Analysis and Corrective Action Taken

C.3.4. Other Government Documents. Unless otherwise stated, the following documents may be obtained from http://www.documentservices.dla.mil.

DoDI 5000.02 Operation of the Defense Acquisition System, dated January 2015

C.3.5. Non-Government Documents.

ASME Y14.34 Associated Lists

ASME Y14.100 Engineering Drawing Practices

(Copies of ASME documents are available from www.asme.org)

ASTM D3951 Standard Practice for Commercial Packaging

(Copies of ASTM documents are available from www.astm.org)

EIA-649 National Consensus Standard for Configuration Management

(EIA documents are available from www.eia.org.)

C.3.6. Forms.

(Department of Defense (DD) and Secretary of Defense (SD) Forms are available from the DoD Forms Management Program http://dtic.mil/whs/directives/infomgt/forms/index.htm)

DD Form 254 Contract Security Classification Specification, DoD

Standard Form 368 Product Quality Deficiency Report

C.4. REQUIREMENTS. The contractor, as an independent contractor and not as an agent of the Government, shall determine the resources necessary (e.g., materials, equipment, personnel, and facilities) to perform the tasks described herein. The Contractor shall fabricate, package, deliver, prepare associated documentation and deliverables, and provide management, technical and field service support to include training for the JBADS program in accordance with (IAW) the quantities, packaging and delivery schedule requirements identified in Section B, the JBADS PSPEC (Attachment X) and the individual task/delivery orders. In addition, the Contractor shall support and participate in technical reviews and audits including CDR, SVR/PRR, PCA, and MRAs IAW with this PWS, and shall prepare and deliver data in accordance with Section B and the Contract Data Requirements List (CDRL). The Government has the unilateral right to exercise contract options for FRP and Sustainment CLS.

C.4.1. ENGINEERING AND MANUFACTURING DEVELOPMENT

C.4.1.1. Program and Data Management.

C.4.1.1.1. Program Management. The Contractor shall establish and maintain program management practices throughout the period of performance. Program management practices shall provide visibility into the Contractors’ organization and techniques used in managing the program, specifically subcontractor and data management. Documentation shall be readily available to Government representative(s) during planned visits. The Contractor shall provide quarterly Progress, Status and Management Reports to indicate the progress of the support effort and the status of the program as it applies to the Contractor’s product, assigned tasks, reports, costs, and inform the Government of existing or potential problems. The Progress, Status, and Management Report shall be submitted using a Government approved Work Breakdown Structure (WBS) indenture level.

(CDRL A0001) DI-MGMT-80227, Contractor’s Progress, Status and Management Report

C.4.1.1.2. Subcontractor Management. The Contractor is responsible for performance of requirements delineated in this PWS, and shall institute appropriate management actions relative to subcontractor performance including Certificates of Compliance at a minimum, which shall be provided to the Government.

(CDRL A0002) DI-MISC-81356A, Certificate of Compliance

C.4.1.1.3. Data Management. The Contractor, in developing information that will be furnished to the Government, shall make the maximum use of existing data and technical information to minimize data redundancy and eliminate duplication of effort. The Government reserves the right to review all data associated with and developed for the JBADS.

C.4.1.1.3.1. Technical Proposal. The Contractor's Technical Proposal, as negotiated and accepted by the Government, shall be incorporated by reference into the resultant contract. Information contained in the Offeror's proposal regarding organization, staffing, manning levels, and experience or education qualifications of personnel that are to be utilized in performance of this contract shall also be incorporated into the resultant contract. Any changes in these arrangements are to be submitted to the contracting officer in advance for approval.

C.4.1.1.3.2. Schedule Planning. The Contractor shall develop and maintain an accurate schedule of program events and recommended program activities, including review and evaluation techniques that provide for the timely execution of training, field support and commercial products to execute the Government’s test schedule while at the same time satisfying all requirements in a cost effective manner. The program schedule shall include all significant events, and a Program Milestone Chart shall depict major tasks, shipping/deployment dates, technical reviews and test events from start to completion of the contract. The Contractor shall notify the Government in writing of any anticipated or projected work stoppages or delays that will impact schedules.

(CDRL A0003) DI-MGMT-81861, Program Schedule

The Government’s general schedule for the JBADS program is displayed in Attachment X.

C.4.1.1.3.3. Contract Work Breakdown Structure. The Contractor shall maintain the Contract Work Breakdown Structure (CWBS) and dictionary using MIL-HDBK-881 for guidance only. The CWBS shall provide the basis for further extension by the Contractor to lower levels during the performance of the contract. The Contractor shall extend the CWBS to the appropriate level required to provide adequate internal management, surveillance, and performance measurement, regardless of the reporting level stipulated in the contract for Government visibility. The Contractor shall use the CWBS as the primary framework for contract planning, budgeting, and reporting of the cost, schedule and technical performance status to the Government. The Contractor shall update the CWBS during the execution of the contract.

(CDRL A0004) DI-MGMT-81334D, Contract Work Breakdown Structure (CWBS)

C.4.1.1.3.4. Assignment of Responsibility and Authority. The Contractor shall identify the organizational elements responsible for the conduct of the activities delineated in this PWS. Responsibilities shall be assigned and clear lines of authority defined for determining and controlling the resources necessary to satisfy each element of this PWS. The following roles shall be considered Key Personnel. The Contractor shall designate in writing the appointment of personnel to accomplish these responsibilities. The Contractor shall notify the Government within ten (10) days of any changes regarding authority, responsibility, or key personnel changes made by the Contractor during the period of performance. Note: It is acceptable that a single individual may fill multiple personnel roles.

a. Program Manager. The Contractor shall designate a Program Manager (PM) who shall possess sufficient corporate authority to manage, direct, execute and control all elements of the contract. The PM shall serve as the primary point of contact between the Contractor and the Government, and be responsible for the coordination of all Contractor activities related to the contract such as configuration management and quality control/assurance elements.

b. Test Manager. The Contractor shall designate a Test Manager who shall possess sufficient authority to manage, direct, execute and control all test elements of the contract.

C.4.1.2. Government Furnished Property.

C.4.1.2.1. Government Furnished Equipment. The Government will provide the Contractor a list of available Government Furnished Equipment (GFE) within 60 days of award. Items will be provided to the contractor within 60 days of receipt of contractor's written request to the Program Office. Proposals shall list required delivery date of Government Furnished Property (GFP) to meet proposed delivery schedules. The Contractor shall provide for accountability, security and storage for the GFP provided. The Contractor shall inspect and inventory all GFP received and identify and report any discrepancies/deficiencies to include associated costs (materials, labor and test (if applicable) for repair or replacement of the GFP to like new conditions. The Government will forward an accountability agreement to the Contractor for signature on an annual basis.

(CDRL A0005) DI-MGMT-80389B, Receipt of Government Materiel Report

C.4.1.2.2. Government Furnished Information. The Government will furnish the Government Furnished Information (GFI) identified in the contract including deployment scenarios, Concept of Operations (CONOPS), AE drawings upon written request from the Contractor to the Program Office. The Contractor shall notify the Government of any deficiencies in the GFI received.

(CDRL A0006) DI-MGMT-80596, Government Furnished Information Deficiency Report

C.4.1.3. Meetings, Formal Reviews, Conferences, and Audits.

C.4.1.3.1. Contractor Responsibilities. The Contractor shall attend and support the meetings, formal reviews, conferences, and audits (hereinafter called "reviews"). The reviews shall be conducted at a time and place mutually agreed to or via teleconference and/or virtual collaborations. All such reviews shall be included in the program schedule and may be held concurrently with test events and/or other reviews with the Government’s approval. The Contractor shall provide the Government with conference presentation materials at least two weeks prior to each review, unless specified otherwise in the detailed section pertaining to each review. The Government reserves the right to cancel or postpone any review or to require any review to be scheduled at critical points during the period of performance. Action item documentation, assignment of responsibility for completion and due dates shall be determined prior to adjournment of all reviews. The Contractor shall provide written responses to action items assigned during the review, within the time allowed, following each review.

(CDRL A0007) DI-ADMN-81373, Presentation Material

C.4.1.3.2. Start of Work Meeting. The Contractor shall participate in a Start of Work Meeting at a place mutually agreed to within 30 calendar days after Contract Award. The Start of Work Meeting shall include the potential for virtual attendance so that all personnel need not attend in person, although the key personnel supporting the contract are expected to attend in person. The purpose of the Start of Work Meeting is for the Contractor to review and demonstrate to the Government the management and quality procedures, review of technical processes, and to establish milestone schedule dates for critical program activities. The Contractor shall introduce and review the assignment of key personnel and program implementation processes.

C.4.1.3.3. In-Process Review. In-Process Reviews (IPR) will be held on a quarterly basis or as needed basis if problems arise, at a date and location (e.g., in person or by telecom and DCO) mutually agreed upon. The Contractor may assume one review will be held at Aberdeen Proving Ground, MD each year. The Government reserves the right to cancel any review or to require any review to be scheduled during the period of performance. The Contractor’s progress, management, technical support services (if any), administrative, assurance of compliance with contract requirements, program status, funding, problem identification and resolutions shall be agenda items. Actual versus expected performance of each area shall be addressed. The Contractor shall prepare presentation materials providing an overview of all agenda items.

C.4.1.4. Systems Engineering.

C.4.1.4.1. Systems Engineering. The Contractor shall establish and maintain an effective systems engineering program throughout the development, production, and operations and support phase activities under the contract.

C.4.1.4.2. Systems Engineering IPT. The Contractor shall participate as required in the Systems Engineering (SE) IPT.

(CDRL A0008) DI-ADMN-81505 Report, Record of Meeting/Minutes (SE IPT)

C.4.1.4.3. Technical Reviews. Technical reviews will be conducted in accordance with the Department of Defense Instruction (DoDI) 5000.02, Operation of the Defense Acquisition System and the Defense Acquisition Guidebook to include the following:

C.4.1.4.3.1. Critical Design Review. The Contractor shall participate in a Critical Design Review (CDR) to be held in conjunction with the Start of Work Meeting and have all studies, estimates, analyses, designs, and reports available for the Government to review at least 20 days prior to the CDR. The final design, which becomes the initial product baseline upon successful completion of the CDR, shall include “build-to” specifications for hardware (product, process, material specifications, engineering drawings, Safety Data Sheets (SDS), and other related data). The Contractor shall provide a detailed review of the hardware design for the JBADS and all data items required by the contract. The Contractor shall provide traceability that demonstrates the product design and configuration established at CDR fulfills the performance requirements of the JBADS, and present the methods used to verify and validate the performance. The Contractor shall present the results of internal analyses conducted on product composition and system hardware for Government assessment to ensure a thoroughly detailed analysis of the complete end-to-end system to satisfy the established requirements. Topics the Contractor shall cover at the CDR shall include, but not be limited to the following:

a. Detailed evaluation of Aircraft Enclosure (AE) Design/composition, Fabrication, Quality Testing, Specifications, and Drawings

b. Detailed evaluation of Aircraft Decontamination Unit (ADU) Electrical/Mechanical Design

c. Testing results and documents.

d. Detailed Reliability, Availability and Maintainability Analysis.

e. Environment, Safety, and Occupational Health (ESOH) Analysis.

f. Packaging/Handling/Storage/Transportation.

g. Transportability.

h. Quality and Producibility, including identification of high cost, high risk and long lead components.

i. Diminishing Manufacturing Sources and Material Shortages (DMSMS).

j. Open Systems Design, as relevant.

k. Summary review of overall system performance versus Performance Specifications.

C.4.1.4.3.2. System Verification Review/ Production Readiness Review. The Contractor shall participate in the SVR / PRR at a time and place mutually agreed to in order to formally evaluate the Contractor's production readiness, identify existing or projected manufacturing problems, and areas of risk. The Contractor shall present a summary of, and make all studies, estimates, analyses, designs, audits, test results, and reports available for the Government to review at least 20 days prior to the SVR/PRR. The SVR/PRR is a multi-disciplined product and process assessment to ensure that the JBADS can proceed into FRP within cost, schedule, risk, and other system constraints. It also establishes and verifies final product performance. The review dates shall be Contractor-proposed, Government-approved, and incorporated into the program schedule. The agenda of the SVR/PRR shall include, as applicable, at least the following considerations:

a. A review of the Contractor’s production plans to include cost and schedule considerations to fulfill FRP requirements under the respective Contract Option.

b. A status review of previously recommended actions to reduce cost, manufacturing risk, and sustainment concerns.

c. The identity of open production concerns which require additional direction/effort to minimize risk to the production program.

d. Identification and status of long lead items for production, if any.

e. Identify all relevant testing that has been conducted.

f. Clear identification of system configuration as tested.

g. Requirements verification – review of the traceability between requirements and system verification results.

h. Specific review of system’s capabilities against KPP.

i. Specific review of all “Not Met” or “Met with Exception” results.

j. Identify any outstanding discrepancies found as a result of testing.

k. Recommended plan of action for unmet/untested requirements.

C.4.1.4.4. Manufacturing Readiness Assessment. The Contractor shall participate in a MRA during the EMD phase. The Contractor shall demonstrate the ability to attain a minimum Manufacturing Readiness Level (MRL) of 8 at the conclusion of EMD in support of Milestone C. The manufacturer will be assessed for manufacturing readiness in accordance with the MRA Handbook by an independent Government sponsored team. Completion of questionnaires and site visits to each of the primary manufacturing facilities by Government Representatives will be required in order for manufacturing readiness and risks to be assessed.

(CDRL A0009) MRA Questionnaire Response

C4.1.4.4.1 Manufacturing Maturation Plan. In conjunction with the program/project office, the Contractor shall prepare a Manufacturing Maturation Plan (MMP) that covers all manufacturing risk areas identified during the MRA. The MMP will be delivered in conjunction with the results of the assessment of manufacturing readiness. The following outline for a MMP includes the most essential items in planning for the maturity of a specific element of assessment found to be below its target MRL:

a.Title
b.Statement of the problem
c.Describe the element of assessment and its maturity status
d.Describe how this element of assessment would be used in the system
e.Show areas where manufacturing readiness falls short of target MRL including key factors and driving issues
f.Assess type and significance of risk to cost, schedule or performance
g.Solution options
h.Benefits of using the preferred approach
i.Fall-back options and the consequences of each option
j.Maturation plan with schedule and funding breakout
k.Key activities for the preferred approach
l.Preparations for using an alternative approach
m.The latest time that an alternative approach can be chosen
n.Status of funding to execute the manufacturing plan
o.Specific actions to be taken (what will be done and by whom)
p.Prototypes or test articles to be built
q.Tests to be run
r.Describe how the test environment relates to the manufacturing environment
s.Threshold performance to be met
t.MRL to be achieved and when it will be achieved

(CDRL A0010) DI-MISC-80508B, Technical Report-Study/Services (Manufacturing Readiness Assessment/Manufacturing Maturation Plan (MMP)

C.4.1.4.5. Reliability, Availability, and Maintainability Program. The Contractor shall maintain a comprehensive Reliability, Availability, and Maintainability (RAM) program for equipment and components under contract to ensure the RAM standards set forth in the performance specification are being met. The design shall be monitored throughout the entire period of performance to identify and assess any changes, which would impact reliability, availability or maintainability. The Contractor shall develop reliability analysis and predictions, as required, to ensure compliance with the performance specification. The program shall encompass all aspects of reliability with respect to design selection and integration of components, assemblies, subassemblies, subsystems, the associated predictions, and the results of testing throughout the EMD phase of the program. If it is determined that an item is expendable, an analysis shall be performed at the next higher indenture level. The Contractor shall maintain and make available to the Government all reliability and maintainability data on any vendor or subcontractor supplied item and shall inform the Government of any part or component, which will degrade system RAM requirements. The RAM program shall minimally include the following tasks:

C.4.1.4.5.1. Procedures and Controls. The Contractor shall maintain procedures and controls, which ensure products, obtained from suppliers, vendors and subcontractors meet RAM requirements. The Contractor shall also establish, implement, and maintain documented procedures, which detect and/or preclude the use of substandard or counterfeit parts in the production process, and impose similar requirements on subcontractors and component vendors.

C.4.1.4.5.2. Failure Reporting, Analysis, and Corrective Action System. The Contractor shall develop a closed loop failure reporting system, procedures for analysis of failures to determine the root cause, and documentation for recording corrective actions taken. The Failure Reporting, Analysis, and Corrective Action System (FRACAS) shall include uniform failure reporting, failure analysis reports and corrective actions IAW with the CDRL. All failures shall be subject to these requirements throughout testing under the contract. The Contractor shall administer a single FRACAS database to encompass in-house (testing) failure reporting, which shall be transferred to the Government upon conclusion of the period of performance. All failures shall be reported to the Government for review IAW with the CDRL. System operating time (Elapsed Time, where applicable) shall be identified for each failure occurrence and included in the FRACAS data structure. The Contractor shall assess the failure data for the identification of trends (five (5) or more failures of the same root cause) and identify those trends in the failure summary and analysis report. Each FRACAS report shall, at a minimum, identify the root cause, and detail the remedial action taken including parts replaced. The Government reserves the right to conduct a Failure Review Board throughout the contracted period of performance. The Contractor is encouraged to use MIL-HDBK-2155 as guidance.

(CDRL A0011), Failure Reporting, Analysis, and Corrective Action System database (CDRL A0012) DI-SESS-81315B, Failure Analysis and Corrective Action Report (FACAR)

C.4.1.4.6. Quality Management System. The Contractor's quality management system shall ensure product conformation to specification and configuration management requirements. The Contractor shall have implemented, documented, and have previously demonstrated the ability to maintain the quality management system to be used on the contract. The Contractor shall make available all quality management documentation for the Government to review upon request, especially during the MRAs. The Contractor's plan for the quality management system shall address the following elements:

a. Management Responsibility. Define, document, and implement a quality policy.

b. Quality System. Establish, document, and maintain a quality system, which includes a quality manual, system procedures, and quality planning.

c. Contract Review. Establish and maintain documented procedures for contract review.

d. Design Control. Establish and maintain documented procedures to control and verify product conformance to specified requirements.

e. Document and Data Control. Establish and maintain documented procedures to control all documents and data (including hard copy and electronic media) including such documents as standards and drawings.

f. Purchasing. Establish and maintain documented procedures to ensure that purchased product, associated documents and data conform to requirements. Sub-contractors are to be evaluated and selected on their ability to meet subcontract requirements and type and extent of control exercised by the supplier over subcontractors is to be defined.

g. Control of Government Furnished Equipment and/or Information. Establish and maintain documented procedures for the control of verification, storage and maintenance of GFE/GFI provided for contract related activities.

h. Product Identification and Traceability. Where appropriate, establish and maintain documented procedures for identifying products throughout all stages of production, delivery, use in support of the contract and disposal.

i. Inspection and Testing. Establish and maintain documented procedures for inspection and testing activities, in order to verify that the specified requirements for all products are met.

j. Inspection and Test Results. Ensure that the inspection and test status of the product are identified and maintained throughout the production, and use of the product. Ensure that only products that pass the required inspections and tests are dispatched or used throughout the period of performance.

k. Control of Non-Conforming Product. Establish and maintain documented procedures to ensure that all products that do not conform to specified requirements are prevented from unintended use or installation.

l. Corrective and Preventive Action. Establish and maintain documented procedures for implementing corrective action in the handling of Government complaints, product non-conformities, and the application of controls to ensure corrective action is taken and that it is effective. Preventive action procedures will detect, analyze, and eliminate potential causes of non-conformities.

m. Handling, Storage, Packaging, Preservation and Delivery. Establish and maintain documented procedures to prevent damage or deterioration of products.

n. Control of Quality Records. Establish and maintain documented procedures for identification, collection, indexing, access, filing, storage, maintenance and disposition of quality records. Quality records shall be maintained to demonstrate conformance to specified requirements and the effective operation of the quality system.

o. Internal Quality Audits. Establish and maintain documented procedures for planning and implementing internal quality audits to verify whether quality activities and related results comply with planned arrangements and to determine the effectiveness of the quality system.

p. Training. Establish and maintain documented procedures for identifying training needs and provide for the training of all personnel performing activities affecting quality of products or supplies produced under this contract. Appropriate records of training shall be maintained.

(CDRL A0013) DI-QCIC-81722, Quality Program Plan (QPP)

C.4.1.4.7. Open Systems Design. The Contractor shall consider using an open systems approach as the ADU design strategy to: (1) choose commercially supported specifications and standards for selected system interfaces (external, internal, functional and physical), products, practices, and tools; and (2) build open system architectures as the primary foundation in developing the proposed system and its elements. Open systems is a system design philosophy that uses widely-accepted, industry-approved interface standards that will allow technological upgrades in system components to be easily inserted in the future. To the extent that open systems design is used, the Contractor shall identify the means for ensuring conformance to open systems standards and profiles throughout the development process and provide evidence that the process being used to manage the open systems approach supports open system benefits such as portability, interoperability, technology insertion, vendor independence, reusability, scalability, and commercial product based maintainability. To the extent open systems design is used, the Contractor shall address how use of open systems design impacts corrosion prevention and control requirements on hardware components and if such causes the system to not meet the specified service life, maintenance ratio, safety or other requirements how this will be corrected.

C.4.1.4.8. Producibility. The Contractor shall apply and implement effective producibility principles throughout the EMD phase to ensure that the JBADS production units can be manufactured using the anticipated production facilities, equipment, materials, manpower, and processes. The producibility planning effort shall also maximize the ease of production control, quality control, tooling, and inspection. The Contractor shall report on the progress of this effort during the CDR and SVR/PRR and make any data created available to the Government upon request.

C.4.1.5. Environment, Safety, and Occupational Health.

C.4.1.5.1 System Safety. The Contractor shall identify and evaluate environmental, safety, and health hazards, define risk levels, and establish a program that manages the probability and severity of all hazards associated with development, use, and disposal of the system in accordance with MIL-STD-882. Risks will be evaluated by the Government in accordance with MIL-STD-882 and accepted as appropriate prior to exposing people, equipment, or the environment to known system related ESOH risks. The Contractor shall identify all explosive safety risks as such in the system safety documentation.

C.4.1.5.1.1. Safety Assessment. The Contractor shall perform and document a Safety Assessment to identify all safety features of the system design and to identify all hazards that may be present in the JBADS including specific procedural controls and precautions that should be followed.

C.4.1.5.1.2. Safety Assessment Report. The Contractor shall provide a Safety Assessment Report (SAR) that documents the Safety Assessment and clearly identifies risks of the JBADS. The SAR shall include a signed statement that all identified hazards have been eliminated or their associated risks controlled to acceptable levels and that the JBADS is ready to test, field and operate.

(CDRL A0014) DI-SAFT-80102B, Safety Assessment Report (SAR)

C.4.1.5.1.3. Safety Data Sheets (SDS). The Contractor shall make all SDS for the JBADS available for Government review.

C.4.1.5.2. Environmental Considerations. The Contractor shall provide information on the potential for adverse environmental impacts from the manufacturing, operation, maintenance, and disposal of the JBADS. This information will be used to assist the Government in making a preliminary National Environmental Policy Act (NEPA) decision and in the preparation of formal NEPA documents to support test events. Such environmental impacts include air, soil, wetlands, water, flora, fauna, endangered species, emissions and toxic waste resulting from system maintenance, operation, and disposal.

(CDRL A0015) DI-MISC-80508B, Technical Report, Study/Services

C.4.1.6. Configuration Management.

C.4.1.6.1. Configuration Management Process. The Contractor shall maintain a Configuration Management (CM) process for the control of all documentation, media, materials, deliverables, components, elements, items, parts and external system interfaces representing or comprising the JBADS. The principles contained in EIA-649, National Consensus Standard for Configuration Management, and MIL-HDBK-61A, Configuration Management Guidance, should be used for guidance. The Contractor shall designate a CM representative to serve as a primary point of contact to the Government for all CM matters. The Contractor's representative shall be responsible for any subcontractor's CM efforts. The contractor shall notify the Government of any changes at the contractor's facility, which affect the execution of the Contractor's CM Plan. The Government will review and approve the Contractor's CM plan. The CM Plan shall be updated as per the CDRL to reflect changes in system engineering, logistic supportability or acquisition strategy concepts.

(CDRL A0016) DI-CMAN-80858B, Contractor's Configuration Management Plan

C.4.1.6.1.1. Configuration Identification (CI). In coordination with the Government’s lead Systems Engineer, the Contractor shall develop methods to uniquely identify Configuration Items (CIs) and associated documentation, such as specifications, drawings, manuals, plans, procedures, instructions, software media, and other configuration- related documents.

C.4.1.6.1.2. Configuration Status Accounting. The Contractor shall establish and maintain a Configuration Status Accounting (CSA) database, which represents the configuration of the JBADS delivered under contract. All baselines, changes and planned systems upgrades shall be documented in the Contractor’s CSA database. The Contractor’s CSA database shall permit acceptance of commercial product information; however, if requirements to report data outside of the Contractor’s CSA database or format exist, the information may be delivered as a supplement to prevent disruption to their existing system. The Contractor’s CSA database shall reconcile any differences between the supplier information and Contractor practices to provide the Government with clear accountability of product information. Additionally, the CSA database shall provide a reliable source of configuration information to support JBADS activities, including program management, systems engineering, logistics support, and modification/maintenance actions. The Contractor’s CSA database shall be capable of providing CSA data in a digital format.

(CDRL A0017) DI-SESS-81253C, Configuration Status Accounting Information

C.4.1.6.2. Baseline Management. The Contractor shall be responsible for maintaining the currency and accuracy of the established baseline to ensure form, fit, and function of the JBADS delivered under contract. The Contractor shall establish definitive processes, which identify how the baseline will be monitored/managed/maintained. These processes shall be defined in the contractor's CM plan and made available for Government review.

C.4.1.6.2.1. Product Baseline. The product baseline is the approved technical documentation that describes the configuration of CI during the production, fielding/deployment and operational support phases of its life cycle. The product baseline shall prescribe; (1) all necessary physical form, fit, and functional characteristics of a CI; (2) the selected functional characteristics designated for production acceptance testing and; (3) the production acceptance test requirements. The Contractor shall establish the initial product baseline at the CDR. The Contractor shall establish the final product baseline by the successful completion and Government acceptance of the PCA. No changes shall be made to this baseline without following the Engineering Change Proposal (ECP) process.

C.4.1.6.2.2. Allocated Baseline. The allocated baseline is the approved performance oriented documentation, for a CI to be developed, which shall describe the functional and interface characteristics that are allocated from those of the higher level CI and the verification required to demonstrate achievement of those specified characteristics which shall include; (1) essential CI functional characteristics; (2) external and internal interface requirements for each CI; (3) physical characteristics necessary to ensure compatibility with associated systems and CI’s; (4) constraints on the design of a CI, including GFE employed, component standardization, ILS requirements and Computer Resources Life Cycle Management Plan requirements.

The allocated baseline shall be established after successful completion of the overall system CDR with all associated documentation. No changes shall be made to this baseline without prior government approval.

C.4.1.6.2.3. Functional Baseline. The JBADS Performance Specification, which is developed and maintained by the Government, establishes the functional baseline.

C.4.1.6.3. Configuration Control. The Contractor shall implement configuration control methods and procedures, which maintain the integrity and traceability of an established baseline. Changes to established baselines shall only be made after Government approval of ECPs and Request for Deviations (RFDs) via the Configuration Control Board (CCB) process. Sufficient supporting data to evaluate the proposed change, such as drawings, supplemental drawings, sketches, specifications, or manufacturer’s data sheets, shall be submitted with ECP’s and RFD’s. Changes shall be identified to the affected assembly serial number, or if not part of an assembly, to the affected equipment serial number. The Contractor’s configuration control process shall be available for Government review. The Contractor shall submit all configuration control documentation in a digital format, which must be approved by the Government. Configuration control will begin after the initial product baseline is established, at the conclusion of CDR and after any applicable corrective action plans have been implemented.

C.4.1.6.3.1. Engineering Release System. The Contractor shall maintain an engineering release system and shall use the system to issue configuration documentation to functional activities (e.g. manufacturing, logistics, quality control, engineering, and test and evaluation) and to authorize the use of configuration documentation associated with an approved configuration. The contractor shall maintain current and historical engineering release information for all configuration documentation for the JBADS. The Contractor shall submit an Engineering Release Record (ERR) to release new or revised configuration documentation to the Government for approval. The Contractor shall ensure all Government approved ERR information and documentation is reflected in the Configuration Status Accounting (CSA) database.

(CDRL A0018) DI-CMAN-80463C, Engineering Release Record (ERR)

C.4.1.6.3.2. Engineering Change Proposals. ECPs shall be submitted by the Contractor, and shall be limited to those, which are necessary or offer significant benefit to the Government. MIL-HDBK-61A provides guidance concerning the classification of ECPs. Class I ECPs shall be submitted for approval by a Government CCB when changes are required to: (a) Correct deficiencies; (b) Add or modify interface or interoperability requirements; (c) Make a significant and measurable effectiveness change in the operational capabilities or logistics supportability of the system; (d) Affect substantial life cycle costs/savings; and (e) Prevent slippage in an approved production schedule. Class II ECPs shall be submitted by the Contractor to the Acquisition Contracting Officer (ACO) for approval for those engineering changes, which impact none of the factors listed above. As a minimum, Class I ECP’s shall contain the following information: (a) Date prepared; (b) Originator; (c) ECP Classification; (d) ECP Number; (e) Reason/need for change; (f) System designation (nomenclature, model, P/N); (g) Name of part (or lowest assembly) affected to include part numbers; (h) Baselines affected (to include drawings, specifications, CAGE, revision level, etc.); (i) Title of change; (j) Description of change; (k) Effect on interfaces (Interchangeability and Interoperability); (l) Total costs/savings w/ breakout; (m) Retrofit information; (n) Ozone Depleting Substances; (o) Impact on any engineering disciplines (such as quality, environmental, safety, health, reliability, maintainability, etc.); (p) Justification for change; (q) Priority of change; (r) Impacts to any logistics support elements (such as software, manuals, spares, tools, etc.) being utilized by Government personnel in support of the product; and (s) Alternatives evaluated or considered.

(CDRL A0019) DI-CMAN-80639C, Engineering Change Proposal (ECP)

C.4.1.6.3.3. Notices of Revision. The Contractor shall generate and submit Notices of Revision (NOR) concurrently with ECPs when technical documentation controlled by another Contractor or Government agency requires changes following approval of an ECP. As a minimum, the NOR shall contain the following information: (a) Date; (b) CAGE code; (c) NOR number; (d) Document number; (e) Title of document; (f) Revision letter (current and new), related ECP number; (g) Configuration item (or system) to which ECP applies; and (h) Description of revision.

(CDRL A0020) DI-CMAN-80642C, Notice of Revision (NOR)

C.4.1.6.3.4. Requests for Deviation. The Contractor shall process RFD from current approved configuration documentation. Authorized deviations are a temporary departure from the requirements and do not constitute a change in an approved baseline. Submission of recurring deviations is discouraged and shall be minimized. Where it is determined that a change should be permanent, the Contractor shall process an ECP. MIL-HDBK-61A provides guidance concerning the classification of RFDs. As a minimum, the RFD shall contain the following information: (a) Date prepared; (b) Originator; (c) RFD Classification (critical, major or minor); (d) Designation for deviation (model/type, CAGE code, system designation, and deviation number); (e) Class of deviation; (f) Part Number affected; (g) Cost/Price data; (h) Effectivity; (i) Description of deviation; (j) Need for deviation; (k) Effect on delivery schedule; (l) Recommended corrective action; and (m) Alternatives evaluated.

(CDRL A0021) DI-CMAN-80640C, Request for Deviation (RFD)

C.4.1.6.3.5. Notification of Changes to Commercial Equipment/Software. The Contractor shall submit notification to the Government when changes occur to commercial equipment or software, which is being procured or fabricated by the Contractor off-the-shelf, and the Government does not control the developer’s design. The Contractor shall submit a change notice to the Government implementing any Class II ECPs and the Government will concur in the classification designation of the ECP.

(CDRL A0022) DI-MISC-80508B, Technical Report - Study/Services

C.4.1.7 Engineering Drawings.

C.4.1.7.1. Commercial Drawings/Models. The Contractor shall provide commercial drawings/models to the Government for commercial item(s) approved for use in the design and not covered by Government or nationally recognized industry association specifications and standards. The Contractor shall provide evidence that the part complies with the requirements of the applicable part documentation. Existing test data (such as supplier originated objective evidence of compliance or Government/Industry Data Exchange Program (GIDEP) reports) shall be used to the maximum extent practicable.

(CDRL A0023) DI-SESS-81003D, Commercial Drawings/Models and Associated Lists

C.4.1.8. Item Unique Identification. The Contractor shall implement specific Item Unique Identification (IUID) marking, as defined in MIL-STD-130 and DFARS clauses 252.211-7003, 252.211-7007 for items delivered under the contract, as applicable. For all commercial contracts, the contractor shall comply with DFARS clauses, 252.245-7001, 252.245-7002, 252.245-7003, 252.245-7004 and 252.246-7006. The IUID marking shall be incorporated into existing data plates when possible. Bar Coding and the two-dimensional (2D) IUID data matrix shall be readable by optical scanning devices and be accompanied by the corresponding human readable markings when practical. All 2D data matrix shall be permanently affixed and have the ability to withstand and perform within the same environmental conditions as the JBADS. All spare parts, secondary repairable and consumable that exceed $5,000, when purchased separately, shall also be marked and registered with the IUID prior to delivery to the Government.

C.4.1.9. Diminishing Manufacturing Sources and Material Shortages. The Contractor shall identify the parts planned to be used as well as those used in the JBADS at all levels.

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