OI_System__RFP_M67854-13-R-1040_Amendment_0001_dated_14_May_2013.pdf

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT

Except as provided herein, all terms and conditions of the document referenced in Item 9A or 10A, as heretofore changed, remains unchanged and in full force and effect.

15A. NAME AND TITLE OF SIGNER (Type or print)

30-105-04EXCEPTION TO SF 30

APPROVED BY OIRM 11-84

STANDARD FORM 30 (Rev. 10-83) Prescribed by GSA

FAR (48 CFR) 53.243

Questions and Answ ers for the Ocular Interruption System RFP.

Revised language in Request for Proposal, CLIN's 1001, 2001, 3001, 4001, 5001, and page 29, paragraph 3.6.1. of SOW.

Revised Performance Specif ication, see red line changes.

Extend submission due date. See updated SubSection L-3.1.1. Solicitation Due Date.

1. CONTRACT ID CODE PAGE OF PAGES

1 23

16A. NAME AND TITLE OF CONTRACTING OFFICER (Type or print)

16C. DATE SIGNED

BY 14-May-2013

16B. UNITED STATES OF AMERICA15C. DATE SIGNED15B. CONTRACTOR/OFFEROR

(Signature of Contracting Officer)(Signature of person authorized to sign)

8. NAME AND ADDRESS OF CONTRACTOR (No., Street, County, State and Zip Code) X M67854-13-R-1040

X 9B. DATED (SEE ITEM 11)

10-Apr-2013

10B. DATED (SEE ITEM 13)

9A. AMENDMENT OF SOLICITATION NO.

11. THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICITATIONS

X The above numbered solicitation is amended as set forth in Item 14. The hour and date specified for receipt of Offer X is extended, is not extended.

Offer must acknowledge receipt of this amendment prior to the hour and date specified in the solicitation or as amended by one of the following methods:

(a) By completing Items 8 and 15, and returning 1 copies of the amendment; (b) By acknowledging receipt of this amendment on each copy of the offer submitted;

or (c) By separate letter or telegram which includes a reference to the solicitation and amendment numbers. FAILURE OF YOUR ACKNOWLEDGMENT TO BE RECEIVED AT THE PLACE DESIGNATED FOR THE RECEIPT OF OFFERS PRIOR TO THE HOUR AND DATE SPECIFIED MAY RESULT IN REJECTION OF YOUR OFFER. If by virtue of this amendment you desire to change an offer already submitted, such change may be made by telegram or letter, provided each telegram or letter makes reference to the solicitation and this amendment, and is received prior to the opening hour and date specified.

12. ACCOUNTING AND APPROPRIATION DATA (If required)

13. THIS ITEM APPLIES ONLY TO MODIFICATIONS OF CONTRACTS/ORDERS.

IT MODIFIES THE CONTRACT/ORDER NO. AS DESCRIBED IN ITEM 14.

A. THIS CHANGE ORDER IS ISSUED PURSUANT TO: (Specify authority) THE CHANGES SET FORTH IN ITEM 14 ARE MADE IN THE

CONTRACT ORDER NO. IN ITEM 10A.

B. THE ABOVE NUMBERED CONTRACT/ORDER IS MODIFIED TO REFLECT THE ADMINISTRATIVE CHANGES (such as changes in paying office, appropriation date, etc.) SET FORTH IN ITEM 14, PURSUANT TO THE AUTHORITY OF FAR 43.103(B).

C. THIS SUPPLEMENTAL AGREEMENT IS ENTERED INTO PURSUANT TO AUTHORITY OF:

D. OTHER (Specify type of modification and authority)

E. IMPORTANT: Contractor is not, is required to sign this document and return copies to the issuing office.

14. DESCRIPTION OF AMENDMENT/MODIFICATION (Organized by UCF section headings, including solicitation/contract subject matter where feasible.)

10A. MOD. OF CONTRACT/ORDER NO.

2. AMENDMENT/MODIFICATION NO. 5. PROJECT NO.(If applicable)

6. ISSUED BY

3. EFFECTIVE DATE

14-May-2013

CODE

MARCORSYSCOM, PG-13, IWS

ATTN: LAWRENCE.HUBBARD@USMC.MIL

2200 LESTER ST

QUANTICO VA 22134-6050

M67854 7. ADMINISTERED BY (If other than item 6)

4. REQUISITION/PURCHASE REQ. NO.

CODE

See Item 6

FACILITY CODECODE

EMAIL:TEL:

M67854-13-R-1040

SECTION SF 30 BLOCK 14 CONTINUATION PAGE

SUMMARY OF CHANGES

SECTION SF 1449 - CONTINUATION SHEET

SOLICITATION/CONTRACT FORM

The required response date/time has changed from 24-May-2013 01:00 PM to 03-Jun-2013 01:00 PM.

SUPPLIES OR SERVICES AND PRICES

CLIN 1001

The CLIN extended description has changed from 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. to OI System in accordance with performance specification which includes hard case (transportation case), soft carrying pouch, cables, commercial manual and pistol grip with aiming capability..

CLIN 2001

The CLIN extended description has changed from 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. to 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 aiming capability..

CLIN 3001

specification Includes hard case (transportation case), soft carrying pouch, cables, Government approved commercial manual and pistol grip with sighting device and rail offset. to OI System in accordance with performance specification Includes hard case (transportation case), soft carrying pouch, cables, Government

CLIN 4001

specification Includes hard case (transportation case), soft carrying pouch, cables, Government approved commercial manual and pistol grip with sighting device and rail offset. to OI System in accordance with performance specification Includes hard case (transportation case), soft carrying pouch, cables, Government

CLIN 5001

specification Includes hard case (transportation case), soft carrying pouch, cables, Government approved commercial manual and pistol grip with sighting device and rail offset. to OI System in accordance with performance specification Includes hard case (transportation case), soft carrying pouch, cables, Government

The following have been modified:

ADDENDUM TO FAR 52.212-1

L–1 COMMUNICATION WITH THE CONTRACTING OFFICE

Solicitation information and amendments will be posted to the Federal Business Opportunities (FBO) website at www.fbo.gov. Offerors may ONLY e-mail written questions requesting clarification of the RFP to the Government via the Contract Specialists, Katy Hurd and Larry Hubbard, at: kathryn.hurd@usmc.mil and lawrence.hubbard@usmc.mil and copy Patsy D. Stefan at patsy.d.stefan@usmc.mil. The Government will answer questions received up 1:00 p.m. local time, 22 Apr 2013 and will provide responses to interested parties via an amendment to the solicitation. Questions received after this date may not be answered. All communication regarding this solicitation shall be addressed to the Contracting Office personnel identified in this paragraph.

L–2 CONFIDENTIAL INFORMATION

The Freedom of Information Act (FOIA) and its amendments have resulted in an increasing number of requests from outside the Government for copies of contract qualifications and proposals submitted to federal agencies. If an offeror’s submissions contain information that he/she believes should be withheld from such requestors under FOIA on the grounds that they contain “trade secrets and commercial or financial information” [5 USC§552(b)(4)], the offeror should mark its submissions in the following manner:

The following notice should be placed on the title page: “Some parts of this document, as identified on individual pages, are considered by the submitter to be privileged or confidential trade secrets or commercial or financial information not subject to mandatory disclosure under the Freedom of Information Act. Material considered privileged or confidential on such grounds is contained on page(s) _________________.”

Each individual item considered privileged or confidential under FOIA should be marked with the following notice:

“The data or information is considered confidential or privileged, and is not subject to mandatory disclosure under the Freedom of Information Act.”

L–3 SOLICITATION RESPONSE REQUIREMENTS

L–3.1 GENERAL

The Offeror shall submit documentation illustrating their approach for satisfying the requirements of this solicitation. Proposals must be clear, coherent, and prepared in sufficient detail for effective evaluation of the offeror’s proposal against the evaluation criteria. Also, this documentation shall cover all aspects of this solicitation and include the offeror’s approach for integration and program management activities. Proposals must clearly demonstrate how the offeror intends to accomplish the project and must include convincing rationale and substantiation of all claims. Unnecessarily elaborate brochures or other presentations beyond those sufficient to present a complete effective response to the solicitation are not desired.

The Offerors shall describe their proposals, through the use of graphs, charts, diagrams and/or narrative, in sufficient detail for the Government to understand and evaluate the nature of the approach. In its evaluation, the Government will consider the degree of substantiation of the proposed approaches in the proposal volumes and in response to any discussions if held.

Each proposal shall be sufficiently complete to demonstrate an understanding of and an ability to comply with all the requirements referenced in this solicitation. Clarity, completeness, and conciseness are essential and the quality of the proposal being indicative of the offeror’s capability to perform the solicitation requirements.

L–3.1.1 Submission Due Dates. Offers shall be received prior to 1:00 p.m. local time, 24 May 2013 03 Jun 2013.

mailto:kathryn.hurd@usmc.mil mailto:lawrence.hubbard@usmc.mil mailto:patsy.d.stefan@usmc.mil

L–3.1.2 Submission Address. The proposals and all copies shall be sent or hand-carried to the address and POC shown below:

COMMANDER

MARINE CORPS SYSTEMS COMMAND

ATTN: Patsy D. Stefan/Katy Hurd

2200 LESTER STREET

QUANTICO, VA 22134

RFP: M67854-13-R-1040

Telephone: 703-432-4958/4956/4959 L–3.1.3 Proposal Receipt. Upon receipt, all proposals are subject to the terms of DFARS Clause 252.227-7016 “Rights In Bid or Proposal Information.” After contract award, the unsuccessful Offerors will be required to return to the Government all information, data, drawings, specifications, etc., provided to the offerors by the Government.

L–3.2 PROPOSAL VOLUME REQUIREMENTS

The proposal shall be accompanied by a cover letter (letter of transmittal) prepared on the company’s letterhead stationery. The cover letter shall identify all enclosures being transmitted and shall be used only to transmit the proposal and shall include no other information. The first or title page shall be in accordance with FAR 52.215-1, paragraph (c)(2). Further descriptions of the volume requirements are located in Table L-1 below.

Table L-1. Volume Requirements Volume Section L

Reference Electronic Copy Paper Copies Page Limit

I. Technical Approach

L–3.3 5 Original plus 5 copies

Appendix A Product Specification

L-3.3.1 5 Original plus 5 copies

No Limit

Appendix B Integrated Master Schedule

L-3.3.2 5 Original plus 5 copies

No Limit

Appendix C Warranty Terms and Conditions

L-3.3.3 5 Original plus 5 copies

No Limit

Appendix D Provisioning Parts List

L-3.3.4 5 Original plus 5 copies

No Limit

Appendix E Commercial Manual

L-3.3.5 5 Original plus 5 copies

No Limit

II. Past Performance

L–3.4 1 Original plus 2 copy

III. Price L–3.5 2 Original plus 2 copy

No Limit

L–3.2.1 Page Limitations. The cover letter, title page, table of contents, table of figures, list of tables, glossary of abbreviations and acronyms do not count against page count limitations. Proposal contents that exceed the stated page limitations will be removed from the proposal by the Procuring Contracting Officer (PCO), prior to turning the proposal over to the Government evaluation teams, and will not be considered in the evaluation.

L–3.2.2 Format. Text shall be single-spaced, on 8½” x 11” paper (except as specifically noted), with a minimum one-inch margin all around. Pages shall be numbered consecutively. A page printed on both sides shall be counted as two pages. Submission as double-sided printing/copying on recycled paper is encouraged. Offerors may use 11” x 17” sized fold-out pages for tables, charts, graphs, or pictures that cannot be legibly presented on 8½” x 11” paper.

An 11” x 17” is a two-sheet equivalent (with regards to the page count limitations). Print shall be of a minimum 12-point font size or a maximum 10 characters per inch spacing. Bolding, underlining, and italics may be used to identify topic demarcations or points of emphasis. Graphic presentations, including tables, while not subject to the same font size and spacing requirements, shall have spacing and text that is easily readable and no smaller than 8-point font.

Each volume in the proposal shall include a copy of the cover letter, title page and table of contents. The table of contents shall list sections, subsections and page numbers. Each volume shall also contain a one-page executive summary briefly describing the overall technical approach and identifying subcontractor/teaming efforts, to include subcontractor/partner company name, address , cage code, and DUNS. Each volume shall also contain a glossary of all abbreviations and acronyms used. Each acronym used shall be spelled out in the text the first time it appears in each proposal volume.

In addition to the paper copies identified in Table L-1, the Offeror shall submit all proposal information in electronic format on a Compact Disc (CD) in the quantities identified in Table . Text and graphics portions of the electronic copies shall be in a format readable by Microsoft (MS) Word and Adobe PDF. Data submitted in spreadsheet format shall be readable by MS Excel. In case of conflict between the paper copy and the electronic copy of the proposals submitted, the paper copy shall take precedence.

Each volume shall be bound separately in hard side three-ring binders. CDs shall be “read-only” CDs formatted for Microsoft with one exception. One of the Volume III Price CDs shall be in read-or-write format with spreadsheets unlinked to any other spreadsheets or other files. The other copy may contain links, but only to documents and spreadsheets that have been submitted as part of the proposal. Offeror(s) are responsible for ensuring printed material accurately reflects the electronic data on the CD.

L–3.2.3 Restriction of Disclosure/Proprietary Information. If the Offeror wishes to restrict the disclosure or use of its proposal, use the legend permitted by FAR 52.215-1(e). Individual subcontractor/vendor proprietary information may be submitted via separate binders/CDs. The information contained in these binders/CDs must be referenced (by binder title, page and section number as appropriate) within the main proposal where the information would have been included if it were not subcontractor/vendor proprietary. The information in these separate binders/CDs is subject to all other requirements of the RFP and must be well-marked to clearly indicate any special handling instructions.

L–3.2.4 Cross Referencing. Each volume, other than the Price volume, shall be written to the greatest extent possible on a stand-alone basis so that its content may be evaluated with a minimum of cross-referencing to other volumes of the proposal. Cross-referencing within a proposal volume is permitted where its use would conserve space without impairing clarity. Hyper linking of cross-references is permissible. Information required for proposal evaluation, which is not found in its designated volume or cross-referenced, is assumed omitted from the proposal.

L–3.3 VOLUME I – TECHNICAL APPROACH

This volume shall be limited to 100 pages and shall address evaluation Factor 1 – Technical Understanding and Capability and Factor 2 –Management Capability, as per the solicitation. No cost or pricing information shall be included in this volume. The Technical Approach volume shall demonstrate an understanding of the Offeror’s ability to meet all of the requirements of this solicitation. The proposal should be sufficiently complete to demonstrate how the Offeror will comply with requirements throughout the performance period. Data previously submitted, or presumed to be known, i.e., descriptions of previous projects performed for the Government cannot be considered as a part of the proposal unless physically incorporated in the proposal.

The Offeror shall clearly describe in detail their proposed management and organization structure for the entire period of performance, to include the lines of authority, roles and responsibilities, subcontractor(s) and their design/development responsibilities. Description shall clearly show the proposed level of effort to support the entire period of performance outlined in this solicitation, inclusive of any subcontracting/teaming/consulting arrangements.

Clarity, completeness, and conciseness are essential. The Offeror shall demonstrate the ability, resources and experience required to perform the requirements, including the detailed procedures, plans, and methods to be used.

All information shall be presented in sufficient depth for the Government to make a comprehensive evaluation of the Offeror’s understanding of the solicitation requirements and of the Offeror’s capability for successful performance.

The proposal should demonstrate this understanding and capability in a concise, logical manner and should not contain superfluous material not directly related to this solicitation. The Government reserves the right to request certifications, test data, or any other documentation supporting the proposal claims, as deemed appropriate.

The proposal shall describe the automatic power-limiting subsystem that is responsible for preventing accidental exposure to irradiance levels above the maximum accessible irradiance as defined in the OI PSPEC. The proposal shall describe how the Nominal Ocular Hazard Distance (NOHD) zone of the OI device's glare source is monitored, and how the OI device glare source output is adjusted in response to a target entering the beam short of the NOHD.

The proposal shall outline the Minimum target size, range of detection, OI system response time, frequency of Intra- NOHD measurements/(monitoring), and how the OI device adjusts visible power output when a target is within the NOHD zone. This shall include the time it takes to detect a target and Intra-NOHD detection time shall be described and quantified.

L-3.3.1 Appendix A Product Specification. At a minimum, the Offeror’s product specification shall address all aspects referenced in the Government’s OI PSPEC. The level of performance offered shall become the threshold specification, should the Offeror be awarded the contract. A table matrix similar to the below Table L-2 shall be included as part of Appendix (A):

Table L-2. Performance Specification Matrix

MARCORSYSCOM OFFEROR

OI PSPEC

Reference

Title Threshold/Objective Specification Proposal Reference

3.1.2 Weight Shall not exceed 20

ounces/should not exceed 10 ounces

Insert Offeror’s product specification

Insert Proposal Volume, Page Number, and paragraph

L-3.3.2 Appendix B Integrated Master Schedule (IMS). The IMS shall contain a detailed schedule of delivery of the required systems and CDRL for Delivery Order 1 and projected rates of delivery for subsequent delivery orders.

Schedule should contain sufficient details of all efforts throughout the contract period.

L-3.3.3 Appendix C Warranty Terms and Conditions

Offeror shall provide their manufacturer/commercial warranty provisions, to include instructions on warranty coordination.

L-3.3.4 Appendix D Provision Parts List. The provisioning parts lists will be a recommended parts list that will contain all repair parts and spares that will be needed for the system. This will be considered recommended buy lists of parts and will not be any lower than can be accomplished by organizational maintenance within the Marine Corps.

L-3.3.5 Appendix E Commercial Manual. Commercial manuals shall be provided that show sufficient detail on use (to include mounting, boresighting, etc.), hazards, warnings, parts list and troubleshooting techniques for the system.

L–3.4 VOLUME II – PAST PERFORMANCE

This volume is limited to no more than ten (10) pages in length and shall address evaluation Factor 3 – Past Performance, as per the solicitation. Offerors are directed to provide the completed Past Performance Questionnaire, Sections I and II on no more than five of the Offeror’s most recently completed Federal Government and/or State contracts, not to exceed three years since completion for like or similar services to those to be provided under this solicitation. Offeror’s may submit the completed Past Performance Questionnaire, Sections I and II regarding current contract performance as long as a minimum of two year(s) of performance has been completed as of the closing date of this solicitation. The Offeror has both the duty and discretion to determine which of its prior contracts are most relevant to the currently described requirements. However, the Offeror should consider that the Government may give special attention to past performance relating to the United States Federal Government. If the Offeror is unable to provide five relevant contracts for past performance evaluation, a lesser number may be submitted.

The Offeror may also submit relevant contracts performed by subcontractors that will perform under this contract, however, this does not increase the number of past performance contracts to be submitted. Any submission(s) in excess of this stated limit of no more than five contracts will be excluded by the Government. If subcontractor contracts are submitted, the Offeror shall clearly indicate the percentage of work that the subcontractor(s) performed under each task/category of the effort throughout the course of the referenced contract.

If the Offeror possesses no relevant past performance, it should affirmatively state this fact in its proposal. Failure to submit the completed Past Performance Questionnaire, Sections I and II shall be considered certification (by signature on the proposal) that the Offeror has no past performance for like or similar items for the Government to evaluate.

The Government may use other information available from Government sources to evaluate an Offeror’s past performance. The Government reserves the right to limit or expand the number of references to contact and to contact references other than those provide by the Offeror.

Offerors, including any subcontractors, may submit the completed Past Performance Questionnaire, Sections I and II to the assessors (Government personnel that had experience with the Offeror/Subcontractor on a previous relevant contract) and request that they verify Sections I and II, complete the questionnaire, and email the completed questionnaire directly to kathryn.hurd@usmc.mil and lawrence.hubbard@usmc.mil and copy to patsy.d.stefan@usmc.mil.

L–3.5 VOLUME III – PRICE

There is no page limitation for the Volume III – Price, which shall address evaluation Factor 4 – Price, as per the solicitation. The Offeror agrees to hold the prices in its offer firm for 180 calendar days from the date specified for receipt of offers. The Offeror shall present sufficient detailed Price information, to assist the Government in conducting price analysis to determine the proposed price is fair and reasonable. The consistency of the proposal price data with the Offeror’s Technical Approach reflects on the Offeror’s understanding of the work required and the Offeror’s ability to perform according to the requirements of the contract. Any apparent inconsistency between the promised performance and price must be explained. The Offeror’s Price Proposal shall also identify: (a) any assumptions applied and the mathematical or other methods used in the estimate and (b) the nature and amount of any contingencies or adjustments included in the proposed price amounts. After proposal submission, the Government reserves the right to request more detailed price and/or cost information, as necessary.

The Offeror’s Price Volume III shall consist of the following:

a. Signed Standard Form 1449, titled Solicitation,/Contract/Order for Commercial Items, with blocks 17a, 17b, and 30a through 30c completed

b. Signed Standard Form 30, titled Amendment of Solicitation/Modification of Contract, if applicable.

c. Completed “Pricing Schedule,” to reflect the unit price for each line item detailed therein. Offerors are encouraged to submit their proposals based on the most favorable terms provided to the Offeror’s most valued customer, in order to reflect their best offer. The Government’s current Acquisition Objective is 1,848 OI Systems.

Offerors are also encouraged to propose economical price breaks for any line item, as appropriate. Each contract mailto:kathryn.hurd@usmc.mil mailto:lawrence.hubbard@usmc.mil mailto:patsy.d.stefan@usmc.mil line item numbers 3001, 4001, and 5001 shall be proposed with price breaks to allow ordering of quantities at least up to 1,848 OI Systems.

d. Completed Certifications and Representations. Offerors shall include all completed fill-in solicitation Federal Acquisition Regulation (FAR) and Defense Federal Acquisition Regulation Supplement (DFARS) provisions, as applicable.

The Government will view unrealistic proposals in terms of technical or schedule commitments, or lack of price information as indicative of a lack of understanding of the complexity and risk in the contract requirements.

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.v2.0. 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…