M67854-13-R-1040_OI_RFP.pdf

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OCULAR INTERRUPTION (OI) SYSTEM
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M67854-13-R-1040
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MARCORSYSCOM, PG-13, IWS

ATTN: LAWRENCE.HUBBARD@USMC.MIL

2200 LESTER ST

QUANTICO VA 22134-6050

703-432-4959

703--432-5712

UNDER DPAS (15 CFR 700)

11. DELIVERY FOR FOB

RFQ

SEE SCHEDULE

14. METHOD OF SOLICITATION

IFB RFP

CODE

SEE ADDENDUM

BLOCK IS MARKED

DESTINATION UNLESS

12. DISCOUNT TERMS

(No Collect Calls)

13b. RATING

13a. THIS CONTRACT IS A RATED ORDER

X

CODE

M67854-13-R-1040 10-Apr-2013

b. TELEPHONE NUMBER

(703) 432-3577

8. OFFER DUE DATE/LOCAL TIME

01:00 PM 24 May 2013

5. SOLICITATION NUMBER 6. SOLICITATION ISSUE DATE

AUTHORIZED FOR LOCAL REPRODUCTION

PREVIOUS EDITION IS NOT USABLE

STANDARD FORM 1449 (REV 3/2005)

Prescribed by GSA

FAR (48 CFR) 53.212

(TYPE OR PRINT)

(SIGNATURE OF CONTRACTING OFFICER) 31c. DATE SIGNED

ADDENDA X ARE

26. TOTAL AWARD AMOUNT (For Gov t. Use Only )

22. UNIT 23. UNIT PRICE 24. AMOUNT21. QUANTITY

CODE 10. THIS ACQUISITION IS

UNRESTRICTED

FAX: NAICS:

TEL:

CODE 18a. PAYMENT WILL BE MADE BYOFFEROR

SUCH ADDRESS IN OFFER

17b. CHECK IF REMITTANCE IS DIFFERENT AND PUT

BELOW IS CHECKED

TEL.

M67854

SIZE STD:

9. ISSUED BY

FACILITY

CODE

17a.CONTRACTOR/

18b. SUBMIT INVOICES TO ADDRESS SHOWN IN BLOCK 18a. UNLESS BLOCK

15. DELIVER TO CODE 16. ADMINISTERED BY

SEE SCHEDULE

7. FOR SOLICITATION

INFORMATION CALL:

a. NAME

LAWRENCE HUBBARD

2. CONTRACT NO. 3. AWARD/EFFECTIVE DATE 4. ORDER NUMBER

(TYPE OR PRINT)

30b. NAME AND TITLE OF SIGNER 30c. DATE SIGNED 31b. NAME OF CONTRACTING OFFICER

30a. SIGNATURE OF OFFEROR/CONTRACTOR 31a.UNITED STATES OF AMERICA

27a. SOLICITATION INCORPORATES BY REFERENCE FAR 52.212-1. 52.212-4. FAR 52.212-3. 52.212-5 ARE ATTACHED.X

25. ACCOUNTING AND APPROPRIATION DATA

1. REQUISITION NUMBER

19. ITEM NO. 20. SCHEDULE OF SUPPLIES/ SERVICES

SEE SCHEDULE

333314

TO ISSUING OFFICE. CONTRACTOR AGREES TO FURNISH AND DELIVER ALL ITEMS

SET FORTH OR OTHERWISE IDENTIFIED ABOVE AND ON ANY ADDITIONAL SHEETS

SUBJECT TO THE TERMS AND CONDITIONS SPECIFIED HEREIN.

SB

HUBZONE SB

SET ASIDE: 100 % FOR

OFFEROR TO COMPLETE BLOCKS 12, 17, 23, 24, AND 30

SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL ITEMS

ARE NOT ATTACHED

27b. CONTRACT/PURCHASE ORDER INCORPORATES BY REFERENCE FAR 52.212-4. FAR 52.212-5 IS ATTACHED. ADDENDA ARE ARE NOT ATTACHED

TEL: EMAIL:

COPIES

(BLOCK 5), INCLUDING ANY ADDITIONS OR CHANGES WHICH ARE

SET FORTH HEREIN, IS ACCEPTED AS TO ITEMS:

.OFFER DATED YOUR OFFER ON SOLICITATION

28. CONTRACTOR IS REQUIRED TO SIGN THIS DOCUMENT AND RETURN 29. AWARD OF CONTRACT: REFERENCE

8(A)

SVC-DISABLED VET-OWNED SB

EMERGING SB

X

X

32g. E-MAIL OF AUTHORIZED GOVERNMENT REPRESENTATIVE

SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL ITEMS

(CONTINUED)

SEE SCHEDULE

19. ITEM NO. 20. SCHEDULE OF SUPPLIES/ SERVICES 21. QUANTITY 22. UNIT 24. AMOUNT

PAGE 2 OF

23. UNIT PRICE

ACCEPTED, AND CONFORMS TO THE CONTRACT, EXCEPT AS NOTED: ______________________________________________________

32a. QUANTITY IN COLUMN 21 HAS BEEN

RECEIVED INSPECTED

32b. SIGNATURE OF AUTHORIZED GOVERNMENT

REPRESENTATIVE

32c. DATE 32d. PRINTED NAME AND TITLE OF AUTHORIZED GOVERNMENT

REPRESENTATIVE

32e. MAILING ADDRESS OF AUTHORIZED GOVERNMENT REPRESENTATIVE 32f . TELEPHONE NUMBER OF AUTHORIZED GOVERNMENT REPRESENTATIVE

37. CHECK NUMBER

FINALPARTIALCOMPLETE

36. PAYMENT35. AMOUNT VERIFIED

CORRECT FOR

34. VOUCHER NUMBER

FINAL

33. SHIP NUMBER

PARTIAL

38. S/R ACCOUNT NUMBER 39. S/R VOUCHER NUMBER 40. PAID BY

41a. I CERTIFY THIS ACCOUNT IS CORRECT AND PROPER FOR PAYMENT

41b. SIGNATURE AND TITLE OF CERTIFYING OFFICER 41c. DATE

42a. RECEIVED BY (Print)

42b. RECEIVED AT (Location)

42c. DATE REC'D (YY/MM/DD) 42d. TOTAL CONTAINERS

STANDARD FORM 1449 (REV 3/2005) BACK

Prescribed by GSA

FAR (48 CFR) 53.212

AUTHORIZED FOR LOCAL REPRODUCTION

PREVIOUS EDITION IS NOT USABLE

M67854-13-R-1040

Section SF 1449 - CONTINUATION SHEET

ITEM NO SUPPLIES/SERVICES MAX

QUANTITY

UNIT UNIT PRICE MAX AMOUNT

1001 5 Each Ocular Interruption (OI System)

FFP

OI System in accordance with performance specification which includes hard case

(transportation case), soft carrying pouch, cables, commercial manual and pistol grip with sighting device and rail offset.

FOB: Destination

MAX

NET AMT

UNIT UNIT PRICE MAX AMOUNT

1002 UNDEFINED

Contract Data Requirements List (CDRL)

Technical Data

See each SubCLIN for Priced or Not Separately Priced (NSP).

UNIT UNIT PRICE MAX AMOUNT

100201 UNDEFINED

CDRL A001

Contractor's Progress, Status and Management Report

NSP

UNIT UNIT PRICE MAX AMOUNT

100202 UNDEFINED

CDRL A002

Integrated Master Schedule

UNIT UNIT PRICE MAX AMOUNT

100203 UNDEFINED

CDRL A003

Conference Agenda/Presentation Material

UNIT UNIT PRICE MAX AMOUNT

100204 UNDEFINED

CDRL A004

Conference Minutes

UNIT UNIT PRICE MAX AMOUNT

100205 UNDEFINED

CDRL B002

Safety Assessment Report (SAR)

UNIT UNIT PRICE MAX AMOUNT

1002AA UNDEFINED Each

CDRL C009

FFP

Commercial Drawings/Models and Associated Lists (PRICED)

UNIT UNIT PRICE MAX AMOUNT

1002AB UNDEFINED Each

CDRL C010

FFP

Product Drawings/Models and Associated Lists (PRICED)

UNIT UNIT PRICE MAX AMOUNT

2001 20 Each Ocular Interruption (OI System)

FFP

OI System in accordance with Performance Specification which Includes hard case (transportation case), soft carrying Pouch, cables, Government approved commercial manual and pistol grip with sighting device and rail offset.

UNIT UNIT PRICE MAX AMOUNT

2002 UNDEFINED

Contract Data Requirements List (CDRL)

Technical Data

UNIT UNIT PRICE MAX AMOUNT

200201 UNDEFINED

CDRL A005

Technical Report/Study Services (PRR)

UNIT UNIT PRICE MAX AMOUNT

200202 UNDEFINED

CDRL B001

Failure Summary and Analysis Report

UNIT UNIT PRICE MAX AMOUNT

200203 UNDEFINED

CDRL B003

Test Plan

UNIT UNIT PRICE MAX AMOUNT

200204 UNDEFINED

CDRL B004

Test Procedure (IAT)

UNIT UNIT PRICE MAX AMOUNT

200205 UNDEFINED

CDRL B005

Test/Inspection Report (IAT)

UNIT UNIT PRICE MAX AMOUNT

200206 UNDEFINED

CDRL B006

Technical Report/Study Services (BTC)

UNIT UNIT PRICE MAX AMOUNT

200207 UNDEFINED

CDRL C001

Contractor's Configuration Management Plan

UNIT UNIT PRICE MAX AMOUNT

200208 UNDEFINED

CDRL C002

Configuration Status Accounting Information

UNIT UNIT PRICE MAX AMOUNT

200209 UNDEFINED

CDRL C003

Configuration Audit Summary Report (Physical)

UNIT UNIT PRICE MAX AMOUNT

200210 UNDEFINED

CDRL C004

Configuration Audit Plan (Physical)

UNIT UNIT PRICE MAX AMOUNT

200211 UNDEFINED

CDRL C005

Engineering Change Proposal (ECP)

UNIT UNIT PRICE MAX AMOUNT

200212 UNDEFINED

CDRL C006

Request For Deviation (RFD)

UNIT UNIT PRICE MAX AMOUNT

200213 UNDEFINED

CDRL C007

Notice of Revision (NOR)

UNIT UNIT PRICE MAX AMOUNT

200214 UNDEFINED

CDRL C008

Technical Report - Study/Services (C/N)

UNIT UNIT PRICE MAX AMOUNT

200215 UNDEFINED

CDRL D001

Logistics Management Information (LMI) Data (Provisioning Plan)

UNIT UNIT PRICE MAX AMOUNT

200216 UNDEFINED

CDRL D002

Logistics Management Information (LMI) Data Product (PTD)

UNIT UNIT PRICE MAX AMOUNT

200217 UNDEFINED

CDRL D003

Logistics Management Information (LMI) Data Product

UNIT UNIT PRICE MAX AMOUNT

200218 UNDEFINED

CDRL D004

Commercial Off-the-Shelf (COTS) Manuals and Associated Supplimental Data

UNIT UNIT PRICE MAX AMOUNT

200219 UNDEFINED

CDRL E001

Instruction Performance Requirements Document

UNIT UNIT PRICE MAX AMOUNT

200220 UNDEFINED

CDRL E002

Course Conduct Information Package

UNIT UNIT PRICE MAX AMOUNT

2003 1 Lot Spare Parts

FFP

Spare Parts

UNIT UNIT PRICE MAX AMOUNT

3001 UNDEFINED Each Ocular Interruption (OI System)

FFP

OI System in accordance with performance specification Includes hard case

(transportation case), soft carrying pouch, cables, Government approved

UNIT UNIT PRICE MAX AMOUNT

3002 UNDEFINED Lot Spare Parts

FFP

UNIT UNIT PRICE MAX AMOUNT

4001 UNDEFINED Each Ocular Interruption (OI System)

FFP

OI System in accordance with performance specification Includes hard case

(transportation case), soft carrying pouch, cables, Government approved

UNIT UNIT PRICE MAX AMOUNT

4002 UNDEFINED Lot Spare Parts

FFP

UNIT UNIT PRICE MAX AMOUNT

5001 UNDEFINED Each Ocular Interruption (OI System)

FFP

OI System in accordance with performance specification Includes hard case

(transportation case), soft carrying pouch, cables, Government approved

UNIT UNIT PRICE MAX AMOUNT

5002 UNDEFINED Lot Spare Parts

FFP

UNIT UNIT PRICE MAX AMOUNT

6002 UNDEFINED Lot Travel

Not exceed $5,000 and in accordance with FAR 31.205-46 and the Joint Travel

Regulation. All travel shall be preapproved by the Contracting Officer's

Representative.

MINIMUM & MAXIMUM LIMITATIONS

B.1 Fair Opportunity Ordering Procedures

Marine Corps Systems Command intends to award multiple, firm-fixed-priced, Indefinite Delivery, Indefinite

Quantity (IDIQ) contracts. These contracts will be awarded for the purpose of procuring test articles for product verification testing. The results of that testing will help the Government determine the best value awardee for all future Delivery Orders. Based upon the test results and the evaluation factors below, the Government will down-select to one (1) awardee for Delivery Order 0002 and all future delivery orders.

Upon contract award, each awardee will receive issuance of Delivery Order 0001 for procurement of the minimum contract order quantity of five (5) production representative Ocular Interruption (OI) Systems, which will be subjected to testing in accordance with the awarded performance specification. Upon completion of all performance testing, each awardee will receive a fair opportunity for award of Delivery Order 0002, which will be issued on a best value basis. The Government will utilize best value tradeoff considering technical performance, production schedule, and price. The Government reserves the right to issue Delivery Order 0002 without discussions.

Specific to award of Delivery Order 0002: In accordance with FAR 15.101-1, the Government will use a best value tradeoff process in evaluating for a down-select to one awardee for Delivery Order 0002 and all future delivery orders, using the following factors, listed in descending order of importance:

B.2.1 Factor 1: Technical Performance. Performance meets or exceeds functional baseline and meets the safety design requirements of the OPNAVINST 5100.27B/MCO 5104.1C.

B.2.2 Factor 2: Schedule. Production quantity and schedule will take into consideration the original proposal as submitted or revised prior to award of the basic IDIQ contract and any discussions held.

B.2.3 Factor 3: Price. The IDIQ FFP will be utilized for best value determination, subject to any discussions held.

All non-priced factors, when combined, are significantly more important than price.

It is the Government’s intent that issuance of Delivery Order 0002 will complete the source selection down-select to one (1) awardee, who will receive all future OI Delivery Orders, not to exceed the maximum contract limitation of

$49,000,000.00.

B.2 Minimum Contract/Order Requirement

The Government is obligated to purchase and the contractor is obligated to provide all products and work as required for the minimum amount covered by this contract. The guaranteed minimum contract purchase is five (5) OI

Systems from CLIN 1001. The minimum for the remaining CLINs is zero.

The minimum contract/order requirement will be fulfilled to by the issuance of Delivery Order (DO) 0001 to each awardee. It is the Government’s intent that ONLY one (1) awardee will receive additional delivery order awards beyond issuance of DO 0001.

B.3 Maximum Contract/Order Limitation – While each awarded IDIQ contract will have a maximum contract/order limitation of $49,000,000.00, upon source selection down-select, ONLY one (1) contract may receive orders up to, but not exceeding the maximum contract/order limitation.

The Government’s current Acquisition Objective is 1,848. This number is subject to change due to Government requirements.

B.4 Ordering Agency

The agency authorized to place Delivery Orders against this contract is:

Commander

Marine Corps Systems Command

2200 Lester Street

Quantico, VA 22134

B.5 Ordering Period

Delivery Orders will be placed against this contract, within a period of five (5) years after the effective date of the contract, by the Government using a Standard Form 1449 format.

B.6 Expediting Contract Closeout

(1) As part of the negotiated fixed price or total estimated amount of this contract, both the Government and the

Contractor, have agreed to waive any entitlement that otherwise may accrue to either party in any residual dollar amount of $500 or less at the time of final contract closeout. The term “residual dollar amount” shall include all money that would otherwise be owed to either party at the end of the contract except that, amounts connected in any way with taxation, allegations of fraud and/or antitrust violations shall be excluded. For purposes of determining residual dollar amounts, offsets of money owed by one party against money that would otherwise be paid by that party may be considered to the extent permitted by law.

(2) This agreement to waive entitlement to residual dollar amounts has been considered by both parties. It is agreed that the administrative costs for either party associated with collecting such small amounts could exceed the amount to be recovered.

STATEMENT OF WORK

1 SCOPE. This Statement of Work (SOW) defines the tasks and deliverables required of the contractor for the procurement and delivery of an Ocular Interruption (OI) System. This system will incorporate engineering controls to automatically adjust the output to prevent exposures exceeding the Maximum Permissible Exposure. This includes all associated program management, engineering, and logistic activities to ensure that delivery schedules, performance requirements, and supportability of the OI System are accomplished as set forth in the contract. This procurement will be pursued as a Commercial/Non-Developmental Item (C/NDI) purchase as defined in FAR Part

2.101. The contractor is responsible for providing all the specified materials, services, and necessary support documentation needed to complete the tasks identified in this SOW.

The delivery of the initial systems will be used to verify the contractor’s system performance against the requirements of the OI performance specification (PSPEC) through verification testing. The verification test results will be used to down-select to one contractor for the remaining delivery orders of the contract.

2 APPLICABLE DOCUMENTS. The following documents form a part of this SOW to the extent specified herein. The most recent revision of the referenced documents at the time of contract award shall be used unless otherwise specified. In the event of conflict between the applicable documents and this SOW, the SOW shall take precedence. Nothing in this document, however, supersedes applicable laws and regulations unless a specific exemption has been obtained.

2.1 Military Standards and Specifications - Mandatory Compliance.

OI-PRF-0001 Ocular Interruption Performance Specification

MIL-PRF-29612 Training Data Products

MIL-PRF-32216 Evaluation of Commercial off the Shelf Manuals and Preparation of

Supplemental Data

MIL-STD-38784 Manuals Technical Style and Format Requirements

GEIA-STD-0007 Logistics Product Data

MIL-STD-129 Military Marking for Shipment and Storage

MIL-STD-130 Identification Marking of U.S. Military Property

MIL-STD-1425 Safety Design Requirements for Military lasers and associated support equipment

MIL-STD-2073-1 DoD Standard Practice for Military Packaging

2.2 Military Standards and Specifications - Guidance Only.

Not Applicable.

2.3 Federal Standard - Mandatory.

21 CFR Part 1040 Performance Standards for Light-emitting Products

2.4 Drawings.

Not Applicable.

2.5 Handbooks - Guidance Only.

MIL-HDBK-61A Configuration Management Guidance

MIL-HDBK-454 General Guidelines for Electronic Equipment

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

MIL-HDBK-502 Acquisition Logistics

2.6 Other Government Documents.

DOD-4160.21-M Defense Material Disposition Manual

DODI 6055.15 DoD Laser Protection Program

SECNAVINST 5100.14 Military Exempt Lasers

OPNAVINST 5100.27B/

MCO 5104.1C Navy Laser Hazard Control Program

OPNAVINST 4410.2A/ Joint Regulation Governing the Use and

MCO 4400.120 Application of Uniform Source Maintenance and Recoverability Codes

FDA Laser Guidance on the Department of

Notice-No. 52 Defense Exemption from the FDA Performance Standard for Laser Products;

Guidance for Industry and FDA

2.7 Non-Government Documents.

ASME Y14.34 Associated Lists

ASME Y14.100 Engineering Drawing Practices

ASTM D4169-09 Standard Practice for Performance Testing of Shipping Containers and Systems

ASTM D3951 Standard Practice for Commercial Packaging

EIA-649 National Consensus Standard for Configuration Management

NAS 411 Hazardous Materials Management Program

3 REQUIREMENTS. The contractor(s) shall perform all tasks required and delineated in this SOW and the

PSPEC OI-PRF-0001. This includes the manufacturing, delivery, preparation of associated documentation, provide logistics and technical support, field service support during operational testing, training, develop technical manuals and deliver OI systems in the quantity specified in the contract. The contractor(s) shall provide all materials, equipment, personnel, and facilities necessary to manufacture and deliver the types and quantities of deliverables specified by the contract.

3.1 Program and Data Management.

3.1.1 Program Management. The contractor shall establish and maintain program management practices throughout the period of performance. Program management practices shall provide visibility into the contractor’s organization and techniques used in managing the program. Documentation shall be readily available to Government representative(s) during visits.

A001 Contractor’s Progress, Status and Management Report

3.1.2 Subcontractor Management. The contractor is responsible for performance of requirements delineated in this SOW, and shall institute appropriate management actions relative to subcontractor performance. Requirements that are contractually specified shall apply to subcontractor performance; however, the contractor shall be accountable for compliance of its subcontractors and is responsible for ensuring all delivered products comply with the contract requirements.

3.1.3 Data Management. The contractor shall establish a single, centralized system for management of all data required under this contract. The contractor, in developing information that will be furnished to the Government, shall make the maximum use of existing data and technical information. Any electronic databases or applications used to store, track, share, transmit or display information pertaining to this contract shall be web-based.

Government use of any data management system shall not require installation of client software on Government computer systems (with the exception of Internet Explorer and Microsoft Office). Specific data management functions shall include schedule control for deliverables, maintenance of deliverables, approval of deliverable format, and distribution and delivery of data products. The system shall include facilities for storage of all data developed or utilized for this contract, and shall provide access to data by the Government. The contractor shall ensure all data is centrally available for Government review to ensure continuity of the system fabrication and supporting documentation. The Government reserves the right to review all data associated with and developed for the OI System.

3.1.3.1 Schedule Planning. The contractor shall maintain an accurate schedule of program events and recommended program schedules, including technical reviews and evaluation techniques, which provide for the earliest delivery schedule while at the same time satisfying all requirements in a cost effective manner. The program schedule shall include all significant events and major tasks.

A002 Integrated Master Schedule

3.1.3.2 Assignment of Responsibility and Authority. The contractor shall identify the organizational elements responsible for the conduct of the activities delineated in this SOW. Responsibilities shall be assigned and clear lines of authority defined for determining and controlling the resources necessary to satisfy each element of this

SOW. The contractor shall appoint all persons filling these billets. At a minimum, the following billets shall be identified:

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.

b. Systems Engineer. The contractor shall designate a Systems Engineer who shall possess sufficient authority to manage, direct, execute, and control all testing and engineering elements of the contract.

c. Integrated Logistics Support (ILS) Manager. The contractor shall designate an ILS Manager who shall possess sufficient authority to manage, direct, execute, and control all ILS elements of the contract.

3.2 Meetings, Formal Reviews, Conferences, and Audits.

3.2.1 Contractor Responsibilities. The contractor shall plan, host, attend, coordinate, support and conduct meetings, formal reviews, conferences, and audits (hereinafter called "reviews"). The reviews shall be conducted at

Government and/or contractor facilities. Reviews requiring demonstration and/or examination of equipment shall be conducted at the contractor's facility. All such reviews shall be included in the program schedule and shall only be held concurrently with the Government’s approval. The contractor shall prepare agendas, conference presentation materials, and provide minutes and reports following each review. The Government reserves the right to cancel any review or require a 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. A summary of all action items, responsible parties, and estimated completion dates shall be included with the minutes.

A003 Conference Agenda/Presentation Material

A004 Conference Minutes

3.2.1.1 Post Award Conference. The contractor shall host a Post Award Conference (PAC) at the contractor's facility. Dates for the PAC shall be provided to the Government for coordination and approval. The purpose of the

PAC is for the contractor to demonstrate understanding of the contractual terms and conditions and its execution.

The PAC also serves to review and demonstrate to the Government the management procedures, provide any progress assessments, review of technical and other specialty area status, and to establish schedule dates for near term critical reviews/actions. The contractor shall present management, key personnel, and program implementation processes.

3.2.1.2 In-Process Review. In-Process Reviews (IPR) will be held on a quarterly or as needed basis, at a date and location mutually agreed upon. The contractor’s progress, management, technical support services (if any), integrated logistics support, assurance of compliance with contract requirements, program status, funding, problem identification and resolution 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.

3.2.1.3 Production Readiness Review. The Production Readiness Review (PRR) shall be performed to formally evaluate the contractor’s production readiness, identify existing or projected manufacturing problems, and any areas of risk.

The contractor shall show that system design has included key production factors (e.g. minimum time, manufacturing simplicity/flexibility, resource availability) necessary to assure the system can be acquired on schedule. An initial

PRR shall be conducted at the contractor’s facility. At the Government’s discretion, follow-on PRR may be held at the contractor’s facility to resolve problems and assure smooth transition into production. The review dates shall be contractor-proposed, Government-approved, and incorporated into the program schedule.

The agenda of the PRR shall include at least the following considerations:

a. A review of Program Management, Engineering/Product Design, Production Engineering and Planning, Production Facilities Readiness, Materials and Purchased Parts, Industrial Resources, and Quality

Assurance.

b. A review of the manufacturing program to include the overall manufacturing system and detailed factors such as manufacturing organization, responsibilities, facilities and equipment, manufacturing methods, and production flow.

c. A status review of all production efforts for cost and schedule considerations.

d. A status review of manufacturing technology and other previously recommended actions to reduce cost, manufacturing risk, and industrial base concerns.

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

f. A status review of production engineering efforts, tooling and test equipment demonstrations, and proofing of new materials, processes, methods, and special tooling.

g. A status of the High and Serious Risk Environment, Safety, and Occupational Health (ESOH) hazards from ESOH analyses performed including planned mitigations to reduce risk.

h. The status of long lead items for production, if any.

i. A review of the first pass yield, variability reduction efforts, and process qualification status.

The PRR exit criteria will be satisfied when all request for actions items have been closed. At the conclusion of each

PRR, the contractor shall provide a report documenting the results of the PRR.

A005 Technical Report/Study Services (PRR Report)

3.3 Producibility. The contractor shall maximize the ease of production control, quality control, tooling and inspection. The contractor shall report on the progress of this effort during the PRR and make any data created available to the Government upon request.

3.4 Reliability and Maintainability Program. The contractor shall maintain a comprehensive Reliability and

Maintainability (R&M) program to ensure the OI device meets the R&M standards set forth in the PSPEC. The design shall be monitored throughout the contracted Period of Performance (PoP) to identify and assess any issues that would impact reliability or maintainability. The program shall encompass all aspects of reliability with respect to design, selection of components, forecast, and testing. The contractor shall maintain and make available to the

Government all R&M data on any vendor or subcontractor supplied item and shall inform the Government of any part or component, which will degrade system R&M requirements. The R&M program shall at a minimum include the following tasks:

3.4.1 Procedures and Controls. The contractor shall maintain procedures and controls which ensure products obtained from suppliers, vendors, and subcontractors meet the overall reliability of the system as specified in the performance specification. Furthermore, the contractor shall:

a. 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.

b. Provide the Government with any special R&M program review scheduled with subcontractors so

Government representatives will attend at their discretion.

3.4.2 Failure Reporting, Analysis, and Corrective Action System (FRACAS). The contractor shall develop a closed loop failure reporting system, procedures for analysis of failures to determine the root cause, trends, and documentation for recording corrective actions taken. The FRACAS shall include uniform failure reporting, failure analysis reports, and corrective actions. All failures shall be subject to these requirements throughout the testing period including production, integration, and acceptance testing, and during the post-production support period (to include warranty as applicable). The contractor should use MIL-HDBK-470 as guidance.

3.4.2.1 FRACAS Reports. Each FRACAS report shall, at a minimum, identify the root cause of the identified failure; detail the remedial action taken to correct the failure and the approval to do so from Quality Assurance; list the serial number, production lot number, and system operational hours (elapsed time meter readings) of the affected unit; and indicate on which production lot the corrective actions will be implemented. In the event a failed item is returned subject to a Product Quality Deficiency Report (PQDR), traceability of the PQDR shall be integrated into the FRACAS report.

3.4.2.2 FRACAS Database and Reporting. The contractor shall create and maintain a single FRACAS database to encompass in-factory (testing) and in-field (post-production) failure reporting; the FRACAS database shall be transferred to the Government upon conclusion of the PoP. All failures shall be categorized as in-field or in-factory failures and reported to the Government for review. The contractor shall assess the failure data for the identification of trends (five or more failures of the same type) and identify those trends in the report.

3.4.2.3 FRACAS Resolution. The Government will review completed FRACAS reports and provide either acceptance or requirements for resolution, as applicable. The Government reserves the right to conduct a Failure

Review Board (FRB) throughout the contracted PoP. The Government reserves the right to halt acceptance of product as it deems necessary to review and resolve failures.

B001 Failure Summary and Analysis Report

3.4.3 Quality Management System. The contractor's quality management system shall ensure product conformation to contractual requirements. The contractor shall employ ISO 9001:2008 or an equivalent Quality

Management System (QMS) to meet Government Quality Management requirements. The contractor shall make available all quality management documentation for the Government to review upon request. The Contractor shall provide access to their QMS system to facilitate review. Access shall be enabled for authorized Government personnel.

3.5 Environment, Safety, and Occupational Health.

3.5.1 Hazardous Materials Management Program and Pollution Prevention. The contractor shall implement a Hazardous Materials Management Program (HMMP) and Pollution Prevention (P2) in accordance with NAS 411.

The contractor shall avoid the use of toxic chemicals, hazardous materials, and ozone depleting substances (ODS) in the design, operational support and disposal of the OI System where possible. The HMMP shall establish a process to manage all requirements for asbestos, radioactive materials, cadmium, hexavalent chromium, and extremely toxic or hazardous materials in design, production, operation, and support. In some cases, the only acceptable management process may be total elimination of the material. The use of Class I or Class II Ozone Depleting

Chemicals (ODCs) is prohibited in the design or operational support of the system without specific written approval of the Procuring Contracting Officer (PCO). More information on chemicals and hazardous materials to be avoided can be obtained from the Environmental Protection Agency (EPA).

3.5.2 Material Safety Data Sheets. The contractor shall make available Material Safety Data Sheets (MSDS) to the Government for review.

3.5.3 Environmental Considerations. The contractor shall provide information on the potential for any adverse environmental impacts from the manufacturing, operation, maintenance, and disposal of the OI System. 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, which include Categorical Exclusion

(CATEX), Environmental Assessment (EA), and Environmental Impact Statement (EIS). Such environmental impacts include air, soil, wetlands, water, flora, fauna, endangered species, emissions and toxic waste resulting from development, maintenance (coatings and primers), operation, and disposal.

3.5.4 Environment, Safety, and Occupational Health Compliance Assessment. The contractor shall provide the

Government with an assessment of applicable Environment, Safety and Occupational Health (ESOH) laws and regulations, identifying any potential compliance issues.

B002 Safety Assessment Report (SAR)

3.5.5 Lasers. The contractor shall ensure proper design and disposal of all equipment and systems capable of producing laser radiation including laser fiber optics in accordance with DOD-4160.21-M, MIL-STD-1425 and

MIL-HDBK-454. The contractor shall verify that proper labeling is in place as required for the laser classification.

3.5.5.1 Laser Support. The contractor shall provide support for the Naval Laser Safety Review Board’s (LSRB) reviews. Laser products that are not fully compliant with 21 CFR Part 1040 shall be covered under a provisional military exemption letter issued by Marine Corps Systems Command (MARCORSYSCOM), per SECNAVINST

5100.14, for the initial systems delivered. For deliveries after system verification, a military exemption letter for production systems will be issued by the Product Manager Non-Lethal Systems (PdM NLS). The contractor shall verify compliance in accordance with 21 CFR Compliance Checklist and deliver the results along with justification statements explaining why non-compliant attributes cannot be made fully compliant prior to issuance of the military exemption letter. The contractor shall be in possession of the military exemption letter, prior to transferring any laser product not fully compliant with 21 CFR Part 1040 to MARCORSYSCOM. The contractor shall ensure that all Military Exempt laser systems have an appropriate disposal plan according to the guidelines set forth by DODI

6055.15, Food and Drug Administration (FDA) Laser Notice-No. 52, and OPNAVINST 5100.27B/MCO 5104.1C.

All systems must undergo a Laser Hazard Evaluation (LHE), and any changes requested by the LSRB shall be implemented prior to outdoor testing.

3.6 Testing/Verification.

3.6.1 Test Plan. The contractor shall prepare an overall Test Plan (TP) that encompasses all Initial Acceptance

Testing (IAT) and Conformance Testing (CT) identified in the OI PSPEC OI-PRF-0001. The TP shall be the top-level working document that ties all contractor and subcontracting test activities together. The following areas shall be emphasized in the TP:

a. Test event

b. Purpose of the test

c. Date of test start and end

d. Location of the test

e. Overall schedule of individual tests

f. Interoperability analysis/testing

The initial TP shall be provided prior to IAT. The Government reserves the right to review and approve the TP and all applicable updates. Once it has been approved, the TP shall be used both to conduct IAT and to support CT.

B003 Test Plan

3.6.2 Contractor Support to Government Testing. The contractor shall support Government test efforts by providing on-site maintenance, training, logistics, and technical support for the period of the tests. Test support requirements will be tailored to the test being conducted. The contractor shall provide all required maintenance support, equipment, and spare parts needed to maintain the OI System during each test.

3.6.3 Reporting Test Results. The contractor shall certify by signature on the recorded data sheets to indicate the validity of the test results. The Government shall be notified of any failure to achieve the allocated threshold. Any failure shall be followed up in writing in the form of a FRACAS report in accordance with 3.4.2.1. FRACAS reports regarding test failures shall include a time-phased projection of when the threshold will be achieved.

3.6.4 Initial Acceptance Test. The contractor shall develop and implement IAT procedures to demonstrate the adequacy and suitability of the contractor's production processes and procedures for achieving the requirements in the PSPEC. The results of the test shall demonstrate the manufacturing and production techniques employed are adequate to meet established requirements. The Government reserves the right to witness IAT events at its discretion.

B004 Test Procedure (IAT)

B005 Test/Inspection Report (IAT)

3.6.4.1 Non-conformances during IAT. In the event the test articles fail to meet requirements as described in the

PSPEC, the contractor shall submit plans for the corrective action or disposition to the Government for approval.

Minor non-conformances, as described in 3.6.6, may be corrected during the testing, with Government approval.

3.6.5 Conformance Testing. The contractor shall conduct CT using the procedures developed for IAT.

Conformance testing shall be conducted on a number of samples taken from each production lot, per the PSPEC.

The Government reserves the right to witness CT events at its discretion.

3.6.5.1 Non-conformances during CT. In the event the test articles fail to meet requirements as described in the

PSPEC, the contractor shall submit a FRACAS report, per 3.4.2.1, to the Government for approval prior to the shipment of the failing production lot.

3.6.6 Classification of Non-conformances. A major non-conformance is defined as a non-conformance that affects any of the following:

a. Cost

b. Health or safety

c. Performance or function

d. Interchangeability, reliability, or maintainability

e. Effective use or operation

f. Weight or appearance

Non-conformances not affecting any factor listed above will be considered minor.

3.7 Power.

3.7.1 Battery Technical Characteristics. The contractor shall provide Battery Technical Characteristics (BTC) to the Government.

B006 Technical Report/Study Services (BTC)

3.8 Configuration Management Process. The contractor shall maintain a Configuration Management (CM) process for the control of all requirements, documentation, hardware, software, and external system interface configuration documentation, media, and parts representing or comprising the OI System. The principles contained in EIA-649, and MIL-HDBK-61A, should be used for guidance. The contractor's CM process shall consist of CM planning, configuration identification, configuration control, configuration status accounting, configuration verification and audits and data management including tools. 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 shall review and approve the contractor's CM plan. The CM Plan shall be reviewed at least annually, and updated to reflect changes in system engineering, logistics, or acquisition strategy concepts.

C001 Contractor's Configuration Management Plan

3.8.1 Configuration Status Accounting. The contractor shall establish and maintain a Configuration Status

Accounting (CSA) database, which represents the configuration of the OI System. All baselines, changes and planned system upgrades shall be documented in the contractor’s CSA database. 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 OI System 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 compatible with United States Marine Corps (USMC) CSA automated information system, Joint Configuration Management Information System (JCMIS).

C002 Configuration Status Accounting Information

3.8.1.1 Configuration Status Accounting Serialized Tracking. The contractor shall use the CSA database to record the serial numbers and computer software name and version for primary components of the OI device delivered to the Government. The contractor shall maintain the information that allows traceability of vendor assigned serial numbers/nomenclatures to the USMC OI device Serial Number, computer software name and version or Item Unique Identification (IUID). The contractor’s CSA database shall include the following data elements:

a. USMC Serial Number, computer software name and version or IUID

b. Vendor Part Number/CAGE

c. Vendor Serial Number

d. Serialized Part Nomenclature

e. Date of Report

3.8.1.2 Configuration Status Accounting Modification Tracking. The contractor shall utilize the CSA database to record completed field modifications or retrofit actions as a result of approved Engineering Change Proposals

(ECPs) for each Configuration Items/Software Configuration Items (CI/SCI). The contractor shall maintain the information that allows visibility of completed actions to the OI device serial numbers, computer software name and version, or IUID. The contractor’s CSA database shall include at least the following data elements:

a. Serial Number, computer software name and version or IUID

b. ECP/Modification Instruction (MI) Number

c. Date Installed

d. Unit Identification Code (UIC)

3.8.1.3 Configuration Identification (CID). The contractor shall establish a database that records and maintains configuration baselines. The database shall record documents, hardware, computer software, and drawings that have been approved and placed under Government configuration control and new CID/SCIs, which are planned for inclusion in future baseline updates. As a minimum, CID data shall identify the current approved baseline by:

a. Document number and Document type

b. CAGE

c. Revision Level

d. Nomenclature

e. Drawing size

f. Indentured breakdown of parts, which display a “parent to child” relationship, to include quantity. The breakdown shall only pertain to CID documents under Government configuration control.

g. Computer software version number

3.8.2 Physical Configuration Audit. The Physical Configuration Audit (PCA) shall be performed to verify the OI

System and its Configuration Items (CIs) are accurate, complete, compatible, and that the CI has achieved the performance and functional characteristics defined in the baseline. The Government and the contractor shall conduct the PCA jointly at the contractors facility, at a mutually agreed to time, with the Government chairing the audit. The

PCA shall verify the drawings reflect the "as-built" to “as-designed” configuration of all newly developed or modified portions of the system; accurate form, fit or function information is provided on control drawings for

C/NDI; and confirm the drawings accurately represent the "as-built" production configuration. The PCA shall be conducted concurrent with hardware fabrication and assembly of the first production system. The contractor shall develop a configuration audit plan and provide the system to be audited, facilities, personnel, documentation

(including drawings) and other support as may be required. The contractor shall participate and assist the

Government in the development of the PCA, using the guidelines contained in Section 8 of MIL-HDBK-61A. The contractor shall document the results of the PCA after each audit and shall correct all audit discrepancies documented in the configuration audit summary reports. In the event the Government finds evidence the drawings and/or documents do not adequately represent the equipment, production shall cease until all discrepancies are resolved and the Government approves the configuration audit summary report. The product baseline will be established upon completion of the PCA and resolution of audit discrepancies.

C003 Configuration Audit Summary Report (Physical)

C004 Configuration Audit Plan (Physical)

3.8.3 Baseline Management. The contractor shall be responsible for maintaining the currency and accuracy of the established baseline to ensure form, fit, function, and interface of the OI device. The contractor shall establish definitive processes, which identify how the baseline will be managed and maintained.

3.8.3.1 Product Baseline. The product baseline is the approved technical documentation that describes the configuration of a CI during the production, fielding/deployment and operational support phases of its life cycle.

The product baseline shall prescribe; (1) all necessary physical or 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 product baseline at the PCA. No changes shall be made to this baseline without following the ECP process in accordance with 3.8.4.1.

3.8.3.2 Functional Baseline. The approved configuration documentation describing a system’s or top-level CIs performance (functional, interoperability, and interface characteristics) and the verification required to demonstrate the achievement of those specified characteristics is referred to as the functional baseline. The functional baseline shall be established and managed at contract award and shall be maintained throughout the PoP. No changes shall be made to this baseline without prior Government approval.

3.8.4 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 ECP and Requests for Deviation (RFD). Sufficient supporting data to evaluate the proposed change, such as drawings, supplemental drawings, sketches, specifications, or manufacturer’s data sheets, shall be submitted with ECPs and RFDs. 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.

3.8.4.1 Engineering Change Proposals. The ECP shall be submitted for all changes which affect Government established baselines. The opportunity to submit ECPs shall extend through contract finalization. In addition, ECPs shall be submitted at the request of the Government. 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.

ECPs shall be submitted by the contractor to the PCO for classification determination. At the Government’s discretion, classification determination may be delegated to the local Defense Contract Management Agency

(DCMA) representative. Those engineering changes which impact none of the factors listed below will be considered Class II. Class I ECPs shall be submitted to the PCO when changes:

a. Increase cost

b. Correct deficiencies;

c. Add or modify interface or interoperability requirements;

d. Make a significant and measurable effectiveness change in the operational capabilities or logistics supportability of the system;

e. Effect substantial life cycle costs/savings; and

f. Prevent slippage in an approved production schedule

As a minimum, Class I ECPs 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

s. Alternatives evaluated or considered

C005 Engineering Change Proposal (ECP)

3.8.4.2 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 Engineering Change Proposal.

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

m. Alternatives evaluated

Each RFD submission to Government shall be in digital format of DD Form 1694 or an acceptable contractor format

(e.g., MS Word or Adobe Portable Document Format [PDF]).

C006 Request for Deviation (RFD)

3.8.4.3 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. At 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

h. Description of revision

C007 Notice of Revision (NOR)

3.8.4.4 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…

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