2_ECH_SOW_-_7.13.16.pdf

SECTION C

SECTION C - DESCRIPTIONS AND SPECIFICATIONS

1 SCOPE. This Statement of Work (SOW) sets forth the work efforts required to fabricate, produce and prepare associated documentation, and deliver the ECH in accordance with the ECH Purchase Description, First Article Test (FAT) Plan, and Lot Acceptance Test (LAT) Plan. The contractor is responsible for providing all specific material, services and necessary support documentation needed to complete the tasks identified in this SOW. The Enhanced Combat Helmet is a Critical Safety Item (CSI) and has been given a criticality designation of

"A" IAW FAR 42.1105

2 APPLICABLE DOCUMENTS. The following documents form a part of this SOW to the extent specified herein. All parties shall use the most recent revision of the referenced document at the time of contracting unless specified otherwise. All Government document issue dates are those listed in the Department of Defense Index of Specifications and Standards (DoDISS). In the event of conflict between the applicable documents and this SOW, the SOW shall take precedence. While the Government has made every effort to ensure the below lists are complete, the SOW may reference documents not included below. Contractors shall meet all specified requirements cited in this SOW regardless whether an applicable document appears below.

2.1 Military Standards and Specifications - Mandatory Compliance.

MIL-STD-129P Military Marking for Shipment and Storage

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

MIL-STD-882E Standard Practice for System Safety

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.

FED-STD-313 w/CN #1 Material Safety Data, Transportation Data and Disposal Data for

Hazardous Materials Furnished to Government Activities

2.4 Drawings.

ECH Drawing Package

NVD Mount Drawing Package

Helmet Pad Drawing

2.5 Handbooks - Guidance Only.

MIL-HDBK-61 Configuration Management Guidance

MIL-HDBK-512 Parts Management

2.6 Non-Government Documents.

ASME Y14.34 Associated Lists

ASME Y14.100 Engineering Drawing Practices

ASTM D-3951 Standard Practice for Commercial Packaging

ASTM D4169-01e1 Standard Practice for Performance Testing of Shipping Containers and

Systems

EIA-649 National Consensus Standard for Configuration Management

NAS 411 Hazardous Materials Management Program

3. REQUIREMENTS. The contractor shall perform all tasks required and delineated in this SOW to fabricate, produce and prepare associated documentation, and deliver the ECH in accordance with the ECH Purchase Description (PD) and as specified in each delivery order.

NOTE: Note 1 contained in Drawing 2-1-2566 - HELMET PADS incorporated as Attachment J.9 to this contract, is hereby clarified to read as follows: “1. WORKMANSHIP, CONSTRUCTION AND QUALITY ASSURANCE PROVISIONS SHALL CONFORM TO GL-PD-09-04.” GL-PD-09-04 is the Enhanced Combat Helmet Purchase Description.

The contractor shall provide all materials, equipment, hard tooling, personnel, and facilities necessary to manufacture, fabricate, integrate, produce, and deliver the types and quantities of deliverables specified by the contract.

The contractor shall design, fabricate, and produce the hardware to attach the NVD bracket to the helmet shell (see PD paragraph 3.7). The Contractor shall provide detailed NVD mount hardware drawings that enable the Government to reprocure these items in a competitive environment. The Contractor shall install the bracket on the shell with the hardware before shipment.

3.1 Program and Data Management.

3.1.1 Program Management. The Contractor shall designate a single individual to serve as the primary point of contact (POC) between the Government and Contractor, who shall be responsible for coordinating all Contractor activities related to this contract. This individual shall have the authority to commit the Contractor to specific courses of action and accept direction from the Contracting Officer or the Contracting Officer's authorized representatives. This individual shall coordinate all meetings between the Government and Contractor; shall immediately bring any conflicts in the Contractor's interpretation of the contract requirements to the Contracting Officer's attention (first by telephone verbal notification, to be followed by written notification); and shall bring to the Contracting Officer's attention any problems that could adversely affect the Contractor's ability to meet the contract quality, cost, production schedule, delivery schedule, or other performance requirements. The Contractor shall submit monthly Progress, Status and Management Reports.

Contractor’s Progress, Status and Management Report – CDRL A001

3.1.2 Subcontractor Management. The Contractor is responsible for performing requirements delineated in this SOW and shall institute appropriate management actions for subcontractor performance. Contractually specified requirements shall apply to subcontractor performance; however, the Contractor shall be accountable for subcontractor compliance and is ultimately responsible for ensuring all deliverable 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 Government reserves the right to review all data associated with and developed for the ECH. Security of data generated under this contract shall comply with ECH Security Classification Guide provided as Attachment J.2 and the DD 254, Contract Security Classification Specification provided as Attachment J.3 to this contract.

3.1.4 Security Requirements. This contract will require the contractor to have a Secret Facility Clearance and will require certain contractors to obtain and maintain classified access eligibility. The contractor shall have a valid Secret Facility Clearance prior to classified performance. The prime contractor and all sub-contractors (through the prime contractor) shall adhere to all aspects of DoD Directive 5220.22-M. All personnel identified to perform on this contract shall maintain compliance with Department of Defense, Department of the Navy, and Marine Corps Information and Personnel Security Policy to include completed background investigations (as required) prior to classified performance. This contract shall include a DoD Contract Security Classification Specification (DD Form

254) as an attachment. The contractor shall notify the Government (written notice) within twenty-four hours of any contractor personnel added or removed from the contract that have been granted classified access, issued a Common Access Card and/or MarCorSysCom Building access.

3.2 Government Furnished Property/Government Furnished Information.

3.2.1 Government Furnished Information. The Government will provide the Government Furnished

Information (GFI) identified below to the contractor:

ECH Purchase Description with Drawing Package ECH Quick Reference Guide (TM-12030A-QRG) NVD Mount Drawing Package Helmet Pad Drawing

3.2.2 Government Furnished Property. The Government will provide the Government Furnished Materiel

(GFM) identified below to the contractor for packing with each ECH delivered against Marine Corps CLINs:

Helmet Covers

The contractor shall provide for accountability, security, and storage for the GFM/GFI provided. The contractor shall inspect and inventory all GFM/GFI received and identify and report any discrepancies/deficiencies to include associated costs (materials, labor, and test (if applicable)) for repair of the GFM/GFI to like new conditions.

Receipt of Government Materiel Report – CDRL A002

3.3 Meetings, Formal Reviews, Conferences, and Audits.

3.3.1 Post Award Conference. The Contractor shall host a Post Award Conference (PAC) at its facility no later than 30 days after contract award. The PAC is for the Contractor to demonstrate its production, quality control, and management procedures for producing the ECH. All areas of the contract will be reviewed to ensure a complete understanding of requirements and responsibilities. The Contractor shall ensure its key operations and management personnel attend the PAC. The Contractor shall provide a meeting agenda before the conference starts and provide meeting minutes for Government approval no later than ten calendar days after the conference ends.

Conference Agenda - CDRL A003 Conference Minutes – CDRL A004

3.3.2 In-Process Reviews (IPRs). These reviews will be held no more than quarterly at dates and locations mutually agreed upon by the Government and the Contractor. The meetings generally are anticipated to be held only when production to meet delivery orders issued under the contract is in process. Issues such as ensuring compliance with contract requirements, problem identification and resolution, and actual versus expected manufacturing performance would be the types of issues that might necessitate face-to-face meetings. The Contractor shall provide meeting minutes for Government approval within 10 calendar days after IPR completion.

Conference Agenda - CDRL A003 Conference Minutes – CDRL A004

3.5 Environment, Safety, and Occupational Health.

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

3.5.1.1 Safety Assessment. The contractor shall perform and document a Safety Assessment to identify all safety features of the hardware and system design and to identify procedural and hardware related hazards that may be present in the ECH including specific procedural controls and precautions that should be followed. In addition, the contractor shall make recommendations applicable to hazards at the interface of the ECH with other system(s).

3.5.1.2 Health Hazard Assessment. The contractor shall perform and document a Health Hazard Assessment (HHA) to identify health hazards, evaluate proposed hazardous materials, and propose protective measures to reduce the associated risk to a level acceptable by the Government. The HHA shall include the minimum hazard probability and severity reporting thresholds and any selected hazards, hazardous areas, hazardous materials, or other specific items to be examined or excluded.

3.5.1.3 Health Hazard Assessment Report. The contractor shall provide a Health Hazard Assessment Report (HHAR) to the Government.

Health Hazard Assessment Report (HHAR) – CDRL A005

3.5.3 Material Safety Data Sheets. The contractor shall provide all Material Safety Data Sheets (MSDS) to the Government for review (a) at Post Award Conference and (b) anytime thereafter if their helmet material in support of the ECH product baseline changes. A copy of the MSDS is required in accordance with FED-STD-313E.

MSDS, Material Safety Data Sheets – CDRL A006

3.5.4 Environmental Considerations. The contractor shall provide information on the potential for any adverse environmental impacts from the manufacturing, operation, maintenance, and disposal of the ECH. 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, disposal, etc.

Technical Report, Study/Services (Environmental Considerations) – CDRL A007

3.6 Configuration Management Process. The contractor shall maintain a configuration management (CM) process for the control of all ECH configuration documentation, media, and parts representing or comprising the ECH. The principles contained in EIA-649 and MIL-HDBK-61 may be used for guidance. The contractor's CM process shall consist of configuration identification, configuration control, configuration status accounting, and configuration audits. The contractor shall notify the Government of any changes at the contractor's facility, which affect the contractor's established CM process. The Government’s CM plan will be made available as Attachment J.7 to the contract to aid the contractor in their CM process.

3.6.1 Configuration Identification. At the Post Award Conference, the contractor shall propose Configuration Items (CIs) to be managed by the Government and those to be managed by the contractor at a lower level/tier. For those CIs that have been identified for Government control, the contractor shall provide form, fit, function, and interface documentation necessary for configuration status accounting. The contractor shall establish management practices for those lower level/tier CIs.

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

Configuration Status Accounting Information – CDRL A008

3.6.2 Configuration Management Meetings/Audits.

3.6.2.1 Physical Configuration Audit. Physical Configuration Audit(s) (PCA) shall be performed to verify the ECH and its configuration items (CIs) (e.g. helmet shell, suspension hook disks, attaching hardware, edging, and pad suspension and retention systems) are accurate, complete, compatible, and that the particular CI has achieved the performance and functional characteristics defined in the functional configuration baseline. System level audit(s) shall be conducted to baseline CIs. Results of the contractor’s audits on subcontractors shall be consolidated by the contractor for use in configuration management of the ECH and its CIs. The Government and the contractor shall conduct the system-level PCA jointly, at a place mutually agreed upon prior to conclusion of first article testing, with the Government chairing the audit. The contractor shall plan, organize, chair, and conduct audits on sub-contractors, with the Government serving in a support capacity if required, prior to submission of the baselined CIs. The PCA shall verify the drawings reflect the "as-built" configuration of all newly developed or modified portions of the system; accurate form, fit, function information is provided on control drawings for all CIs;

and confirm the drawings accurately represent the "as-built" production configuration. As part of the configuration management plan/process, the contractor shall provide an approach and proposed schedule for conducting the PCA and identification of the CIs to be audited at first article production. The contractor shall participate and assist the Government in the development of the PCA, using the guidelines contained in MIL-HDBK-61A, section 8. 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, the Government reserves the right to request revisions until all discrepancies are corrected 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.

Configuration Audit Summary Report (Physical Configuration Audit) – CDRL A009

3.6.3 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 ECH. The contractor shall establish definitive processes which identify how the baseline will be managed/maintained. These processes shall be defined in the contractor's configuration management plan and made available for Government review.

3.6.3.1 Product Baseline. The contractor shall establish the product baseline by the successful completion and Government acceptance of the Configuration Audit Summary Report (Physical Configuration Audit) or other documentation, which describes all the necessary functional and physical characteristics of the ECH and its associated CIs (e.g. helmet shell, suspension hook disks, attaching hardware, edging, pad suspension and retention systems) to include all verifications required to demonstrate the ECH and its CIs meet all required performance parameters. The contractor shall make changes to the product baseline only through the Engineering Change Proposal (ECP) process.

3.6.3.2 Functional Baseline. The ECH Purchase Description and associated government furnished drawings establish the functional baseline. Government approval shall be required prior to making changes to the functional baseline.

3.6.4 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 ECPs and Requests for Variation (RFV) within the Multi-User Engineering Change Proposal Automated Review System (MEARS) (http://mears.army.mil/Home.aspx) for the approval process. Sufficient supporting data to evaluate the proposed change, such as drawings, supplemental drawings, sketches, specifications, or manufacturer's data sheets, shall be submitted with 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. The contractor shall submit all configuration control documentation to the ECH PCO in a digital format specified by the Government. At a minimum, documents submitted shall have a cover letter stating the purpose of the document;

also, the cover letter shall identify the base document and its associated attachments with titles, page numbers, and dates. Within the attachments ensure the title and page numbers are applied preferably in a footer to the attachment.

3.6.4.1 Engineering Change Proposals. ECPs shall be submitted by the contractor. MIL-HDBK-61 provides guidance concerning the classification of ECP’s. After the product baseline is established, all ECPs shall be submitted and processed in accordance with the ECH CM Plan incorporated as Attachment J.7 to this contract. The Government will review each ECP upon receipt and notify the contractor in writing of approval/disapproval. For Class I ECPs, approval of the ECP grants the contractor the authority to proceed to testing only. Based on the test results obtained, the Government will decide whether or not to proceed with permanent implementation of the change. The contractor will be notified of this decision via separate formal correspondence.

Engineering Change Proposal (ECP) – CDRL A010

3.6.4.1.1 ECP Required Data. The contractor will be required to fill out a DD Form 1692/1, Aug 96 Blocks 1-36 and submit to the Government for review if there are no costs to the Government associated with the change. If there are costs to the Government associated with the change, the contractor will be required to fill out Block 51 columns a-e with funding required for the engineering change. Block 51 column f will be reserved for the Government to estimate costs outside the contract (i.e. government lab testing, additional GFE, etc.). These ECPs, to include supporting documentation, will be submitted to the Government PCO as a PDF until such time as the contractor can input the ECP data into the Multi-user Engineering Change Proposal Automated Review System (MEARS) (http://mears.army.mil/Home.aspx) for the approval process. Until contractor access to MEARS can be established, the Government will return the approved ECP’s as a PDF for the contractor’s status accounting. After MEARS implementation, the contractor will be notified via the software system of the approved ECPs. The Government will provide MEARS training to the contractor.

Engineering Change Proposal (ECP) – CDRL A010

3.6.4.1.2 ECP Cost Responsibility. The contractor will be required to fund all ECP implementation up to its contractual responsibilities established in the Functional Baseline, Product Baselines, and this statement of work. It is the contractor’s responsibility to resource the manufacturing of test items and testing required for ECP approval at commercial testing facilities. Commercial testing facilities must meet the minimum criteria outlined in the Lot Acceptance Test (LAT) Plan, provided as Attachment J.6 to this contract. If the Government requires testing at a Government test facility, specifically Aberdeen Test Center (ATC), the Government will assume the cost of the testing via separate agreement with the test facility. If an ECP is directed by the Government, the Government will assume all funding of the ECP documented in the ECP block 51.

3.6.4.2 Requests for Variance. The contractor shall process Requests for Variance (RFV) from current approved configuration documentation. Authorized variances are a necessary temporary departure from the specified baseline requirements and do not constitute a change in the approved baseline. Submission of recurring variations is discouraged and shall be minimized. Where it is determined that a change should be permanent, the contractor shall process an ECP. EIA-649 Configuration Management for DoD provides guidance concerning the classification and processing of RFVs.

3.6.4.2.1 RFV Required Data. The contractor will be required to populate a DD Form 1694, Mar 2016 (EG); the contractor shall fill out Blocks 1-25 and submit to the Government for review. If there are costs to the Government associated with the variance, the contractor will be required to provide the specified cost information as an attachment to the DD Form 1694. Block 19 will be reserved for the Government to estimate costs outside the contract (i.e. government lab testing, additional GFE, etc.). These RFVs, to include supporting documentation, will be submitted to the Government PCO as a PDF until such time as the contractor can input the RFV data into the Multi-user Engineering Change Proposal Automated Review System (MEARS) (http://mears.army.mil/Home.aspx) for the approval process. Until contractor access to MEARS can be established, the Government will return the approved RFVs as a PDF for the contractor’s status accounting. After MEARS implementation, the contractor will be notified via the software system of the approved ECPs. The Government will provide MEARS training to the contractor.

Request for Variance (RFV) – CDRL A011

3.6.4.2.2 RFV Cost Responsibility. The contractor will be required to fund all RFV implementation up to its contractual responsibilities established in the Functional Baseline, Product Baselines, and this statement of work. It is the contractor’s responsibility to resource the manufacturing of test items and qualification testing (if required) at commercial testing facilities. Commercial testing facilities must meet the minimum criteria outlined in the Lot Acceptance Test (LAT) Plan, provided as Attachment J.6 to this contract. If the Government requires testing at a Government test facility, specifically Aberdeen Test Center (ATC), the Government will assume the cost of the testing via separate agreement with the test facility. If an RFV is directed by the Government, the Government will assume all funding of the RFV documented in the ECP block 19 if deemed fair and reasonable.

3.6.4.3 Notices of Revision. The contractor shall generate and submit Notices of Revision (NOR) concurrently with ECPs as well as any supporting documentation (i.e. drawings) when technical documentation controlled by another contractor or Government agency requires changes following approval of an ECP.

Notice of Revision (NOR) – CDRL A012

3.7 Engineering Data Package.

3.7.1 Engineering Data Package (EDP). The contractor shall develop and maintain a complete EDP of the current FAT design and submit it to the Government for use in the Configuration Management Process. This process may require the revision and update of existing documentation, and/or development of new documentation to meet the requirements of the EDP. A revised EDP shall be developed to document any design change and shall reflect all changes resulting from Government approved ECPs. The EDP will be approved and baselined at the end of the PCA and shall be submitted to the Government. After the final EDP has been submitted to the Government all changes to the EDP shall follow the Configuration Management Process. The Contractor shall produce all products in accordance with an approved FAT and EDP.

Drawings, lists, and indices for configuration control shall document the design, construction, and manufacturing of the helmet. The EDP shall detail the necessary design, manufacturing, assembly, test/inspection, and configuration details of the helmet’s materials, parts, subassemblies, and assemblies. The Items required are as follows:

3.7.1.1 Interface Control Drawings/Models. Interface control drawings/models shall be developed for the following items: helmet shell and the edging subassembly. These drawings/models shall include dimensioning to fully define the items. The helmet shell/edging drawings/models shall include the edging, finish, and labels and include dimensioning for both the inside and outside surfaces. Each helmet shell drawing/model shall correspond to a separate size helmet shell. The drawings/models shall be used to define the helmet interfaces with other ancillary helmet components such as NVG brackets, sensors, etc. Product drawings/models shall conform to ASME Y14.100 and ASME Y14.34. Drawings/models shall be delivered in an agreed upon file extension that is capable of being viewed by the Government.

Product Drawings/Models and Associated Lists – CDRL A013

3.7.1.2 Bill of Material Index. A Bill of Materials (BOM) and Drawings shall be supplied documenting all materials and components used in the construction of the helmet. It shall be submitted to the Government to identify Configuration Items for CM and shall contain any required back-up documentation. Each item in the BOM shall reference an internal or external drawing, specification, specification/data sheet, or similar item, or supplier part number that describes the properties, characteristics, etc. of the material or component. All documents and drawings shall be version controlled. The BOM shall contain the supplier of the material or component. The BOM shall also include control drawings for all commercial-off-the-shelf (COTS) items that do not conform to recognized Government or industry specifications. All materials or components with a shelf life shall be noted along with the specific shelf life. There shall be a BOM for each size helmet. The lay up or orientation of materials to include ballistic materials shall be shown in the Drawings. Drawings shall conform to ASME Y14.100 and ASME Y14.34.

3.7.1.2 Process Flow Chart. The manufacturing process shall be documented in a Process Flow Chart, submitted to the Government. The Flow Chart shall include all steps, critical inspection points, and sequence of the manufacturing process.

3.7.1.3 Control Plan. A Control Plan (CP) shall be supplied documenting all processes used in the construction of the helmet. For each manufacturing step, the critical processing parameters shall be documented in a Control Plan (CP). The Government shall determine which processes are critical based on discussions with the contractor.

Documentation of critical processes shall include but is not limited to:

Process/operation number and description Machinery/equipment/tooling Product/process characteristic to be controlled Specification/tolerances Reference drawing/criteria Evaluation/measurement method Sample size and frequency Control method Reaction plan

For example, in a molding process, clamping tonnage, dwell time, and mold temperature may be considered items to document in the Control Plan. Tolerances of each parameter shall also be included in the Control Plan.

Control Plan – CDRL A014

3.8 Item Unique Identification. The contractor shall implement specific Item Unique Identification (IUID) marking, as defined in MIL-STD-130N and DFARS clause 252.211-7003. The contractor shall use Construct #2 which includes enterprise identifier; original Part/Identification Number (PIN), lot or batch number; a serial number unique within the product identified and; National Stock Number. When using Construct #2, the contractor shall assure their serialization protocols provide globally unique combinations of serial number with original part, lot, or batch number assignments. The IUID marking shall be incorporated into the ECH data plate. Bar coding and the two-dimensional (2D) IUID data matrix shall be machine-readable with common optical scanning devices and be accompanied by the corresponding human readable markings when practical. All 2D data matrices shall be permanently affixed and have the ability to withstand and perform within the same environmental conditions as the

ECH.

Data Elements for Physical and Virtual Marking Report – CDRL A015

3.9 Testing/Verification. The Government plans to conduct several stages of testing to ensure ECH ability to meet the requirements of the PD, as follows:

3.9.1 First Article Test. The Government has developed a First Article Test (FAT) Event Design Plan through which testing shall demonstrate the adequacy and suitability of the contractor's production processes and procedures for achieving the requirements in the PD. The results of the test shall demonstrate that the manufacturing and production techniques employed do not negatively impact established requirements. The Contractor shall be responsible for costs associated with additional helmets that may be required for FAT. Additional helmet requirements will be determined in accordance with the FAT Event Design Plan, Attachment J.5 and the DOT&E Protocol provided as Attachment J.12 to this contract. No contractor support will be required for the FAT. The outcome of FAT will be briefed to the Milestone Decision Authority (MDA) who will then issue a production decision. This decision will be formally communicated to the contractor in an FAT approval letter as described below:

3.9.1.1 Conditional FAT Approval. A letter notifying the contractor of conditional FAT approval and conditional authorization to begin production may be sent to the contractor if the FAT results contain requirements that have been met with exceptions and contain any failures of a nature that may be considered waiverable for a specified time period. Requirements that have been met with exceptions during FAT and any failures noted during FAT not relating to mandatory source items (i.e. workmanship issues on the ECH, labeling issues, etc.) shall be corrected prior to the start of production. For failures noted relating specifically to mandatory source item quality issues, the contractor shall submit waivers addressing those items and must receive approval of those waivers prior to beginning production. The Government will provide the contractor a letter detailing specific findings during FAT.

After receipt of this letter of findings, the contractor shall submit a FACAR which must be approved by the Government prior to the contractor beginning production. Corrections on items relating to mandatory source item quality issues for which waivers were requested and granted shall be implemented prior to start of production.

Verification that all discrepancies have been resolved will be provided through increased Government inspection prior to the first shipment.

3.9.1.2 Failure Letter. A FAT Failure Letter will be sent to the contractor if any of the FAT requirements are not met. The contractor will have to submit a FACAR to be approved by the Government. Production will not proceed until the requirements have been re-tested at the discretion of the Government Program Office.

3.9.1.3 First Article Test Methods. The Government will conduct FAT after contract options award in accordance with FAR 52.209-4 First Article Approval – Government Testing (clause is included in full text in Section I of this contract), the ECH PD, and the FAT Plan (Attachment J.5). In-process manufacturing certifications of compliance shall be submitted by the contractor.

Certificate of Compliance – CDRL A016

3.9.2 Confirmation Testing. After approval of FAT, any changes below the product baseline shall require a confirmation test. Additionally any changes envisioned in equipment/tooling (hardware or software) replacement or modifications, equipment additions, and changes in equipment location will require confirmation testing. The Government will determine if additional testing is required and what that additional testing will encompass based on the scope of the change. Contractors shall notify the Government in writing in advance of any planned changes.

3.9.3 Lot Acceptance Test. The Government has developed and the contractor shall implement Lot Acceptance Testing (LAT) procedures to demonstrate the adequacy and suitability of the contractor's production processes and procedures for achieving the performance inherent in the design. The results of the test shall demonstrate the system meets all requirements identified in the PD. LAT shall be conducted in accordance (IAW) with the LAT Plan provided as Attachment J.6 to this contract. The Contractor shall be responsible for costs associated with additional helmets and testing that may be required for LAT. Additional helmet requirements will be determined in accordance with the LAT Plan and DOT&E Protocol provided as Attachments J.6 and J.12 to this contract. Any non-destructive tests the contractor elects to retain internally, IAW the LAT Plan, will be conducted at the contractor facility by the contractor, with DCMA surveillance. The contractor shall be responsible for conducting the destructive portions of LAT at any of the independent commercial laboratories and a contractor-selected facility IAW the LAT Plan for any ECH. ATC or MCOTEA is required to witness testing conducted at any independent commercial laboratory; however, the contractor will not bear any of the additional costs of having an ATC or MCOTEA witness present at commercial test facilities. These additional costs will be the Government’s responsibility and will be accounted for independent of this contract. The Government will be solely responsible for costs associated with testing at ATC. Non-destructive testing on each lot presented for LAT will be completed prior to submitting a lot for destructive testing. If a lot has met the required performance parameters for non-destructive testing as described in the ECH PD and LAT Plan, it will then be submitted for destructive testing. If the DCMA representative concurs with the Government’s technical recommendation for lot approval, he or she will then provide the contractor with notification of acceptance of the lot and authorize release of shipment via the Wide Area Workflow (WAWF) documentation process. Formal technical recommendation for approval and DCMA concurrence is required prior to shipment. The contractor may be present during LAT. The finished helmet shall conform to the quality of product established by this specification. Utmost care shall be taken during fabrication to ensure quality workmanship and safety of the service person using the item. Deviations in acceptable manufacturing procedures and/or quality of materials being used shall immediately be reported to the PCO. Except as otherwise specified herein, repairs are not allowed to be made to the helmet.

3.9.3.1 Lot Acceptance Testing Methods. The contractor shall conduct LAT in accordance with the ECH PD and the LAT Plan. Should the Marine Corps elect to conduct the destructive portion of the LAT, the contractor shall provide the required non-destructive verification outlined in the PD to the PCO.

3.9.2.2 Nonconformance of First Article and Lot Acceptance Test. In the event the FAT or LAT articles fail to meet requirements as described in the PD, FAT Plan or LAT Plan, the Government will return the article(s) to the contractor, who shall submit plans for the corrective action or disposition to the Government for approval.

Disposition will depend on the nature of the failures and the discussion contained in the FACAR. The Government will determine the nature and extent of further testing based on the information contained in and discussion on the FACAR. For Padding Layer Material (suspension pad water absorbency) failures only, the Government may authorize the contractor to conduct one retest of the failed suspension pad. If a retest is authorized, the contractor shall bear all costs associated with retesting. The contractor shall document results of the test and the retest in the test report and submit to the Government for review and approval. If the retest results in a failure, the Government shall be notified immediately and a FACAR shall be prepared for submission to the Government.

A sample form including the elements referenced above is included as Attachment J.10 to this contract. Contractor format for the FACAR is acceptable; however, the contractor shall also include a discussion of the following elements in the form to assure that all actions are completed and verified appropriately:

a. Problem Description - A detailed, specific description of the problem including how many items were initially found that contain the problem, when was the problem discovered, where was the problem discovered, and how the problem discovered.

b. Containment Actions – Detail the quantity of suspect product at the Vendors facility including the method of quarantine, quarantine identification, method of certification against the problem and certification identification (example: If product is screened and bad product is removed, good product is re-packaged and the package has a green “certified” label adhered to it). Specify the quantity of suspect product in transit including method of notification to the recipient, a proposed method of certification against the problem (return authorization, Vendor to go on-site and rework or screen product, etc.), and a method of certification identification. Detail the quantity of suspect product in the Customer’s possession including return authorization and details of quarantine and certification upon receipt back into the Vendor’s facility, or details of arrangements made for quarantine and certification at the Customer’s facility.

c. Root Cause Analysis – An explanation of why the failure happened (the root cause) and an explanation of why the failure was not detected.

d. Root Cause Verification – An explanation of what actions were taken to assure the true root cause of the failure was found, i.e. could not be something else. Explain in detail what actions were taken to assure the TRUE Root Cause was found.

e. Corrective Actions / Verification of the Actions – Discuss each corrective action individually as it relates to the root cause. Also discuss how each corrective action relates to non-detection of the problem. With respect to occurrence of the problem, list each action individually and include the date of implementation and provide detail for each Action as to how it was proven that the action taken eliminated the problem. With respect to the non-detection of the problem, list each Action individually and include the date of implementation and provide detail for each Action of how it was proven that the action taken eliminated the problem of non-detection. Lastly list if Poke- Yoke’s were implemented for this problem and provide details. If none implemented, explain why not.

f. Standardization and Control – Provide details regarding updates of documents such as Process Control Plans, Process Flow Diagrams, Visual Aids, Work Instructions, Operating Procedures, Training Methods / Records, and Preventive Maintenance Plans.

g. Verification of Corrective Actions – Describe the method(s) used to verify the corrective actions taken are effective and will remain effective in the long term. Provide the number of trials with corrections in place, measurements, inspections, etc. including data on the number inspected vs. number of subject defects found, etc.

Failure Analysis Corrective Action Report (FACAR) – CDRL A017

3.9.3 Component Level Testing. The contractor shall implement component level testing procedures to demonstrate compoent performance prior to assembly into helmets. Testing results shall demonstrate that components meet all requirements listed in the ECH PD. Testing procedures shall be in accordance with the Lot Acceptance Test (LAT) Plan for Enhanced Combat Helmet Marine Corps, provided as Attachment J.6 to this contract. Once a component lot is tested and approved, items from that lot may be used in the assembly of helmets or delivered as spare parts. All ballistic testing shall be conducted at a government certified or National Institute of Justice certified lab.

The following shall be tested as part of Component Level Testing.

Retention System:

- Retention System (type and quality or retention system)

- Marking of Retention Systems

- Hardware 9mm Resistance to Penetration

- Static Pull

Pad Suspension System

- Marking of Pad Suspension Systems

- Blunt Impact

- Pad Water Absorbency

Certificates of Compliance will be provided to the Government upon request to document the results of testing. The Government reserves the right to inspect or test additional components to verify validity of the certification. In the event of a failure during component level testing the Government shall be notified immediately and a FACAR shall be prepared for submission to the Government. Contents of the FACAR are outlined in paragraph 3.9.2.2.

Disposition will depend on the nature of the failures and the discussion contained in the FACAR. The Government will determine the nature and extent of further testing based on the information contained in and discussion on the FACAR. Note that for some failures there may be no further testing and the items remain failed and not accepted.

For Padding Layer Material (suspension pad water absorbency) failures only, the Government may authorize the contractor to conduct one retest of the failed suspension pad. If a retest is authorized, the contractor shall bear all costs associated with retesting. The contractor shall document results of the test and the retest in the test report and submit to the Government for review and approval. If the retest results in a failure, the Government shall be notified immediately and a FACAR shall be prepared for submission to the Government.

Test/Inspection Report (Lot Acceptance Testing) – CDRL A018

3.9.4 Quality Management System. The Contractor shall have a Quality Management System (QMS) that meets the requirements of Quality stated in FAR 52.246-11, Higher Level Contract Quality Requirement to ensure product conformance to contractual requirements. The contractor shall have implemented, documented, and have previously demonstrated the ability to maintain the quality management system to be used on the contract. The Contractor shall monitor, assess, and audit raw material quality, product performance, and reliability at all Subcontractor and supplier products and facilities. All requirements of the contract apply to Subcontractors and suppliers. The Government reserves the right to audit products and processes, as well as the QMS, at any stage of contract performance. The contractor shall make available all quality management documentation for the Government to review upon request.

The Contractor and Subcontractor shall maintain a calibration system in accordance with ANSI/NCSL Z540.3-2006 or equivalent to ensure that all test/inspection, measurement, and diagnostic equipment to include all accessories and ancillary equipment are properly calibrated and identified by appropriate labeling.

The Contractor shall provide certification of conformance or equivalence to ISO 9001:2008 and ANSI/NCSL Z540.3-2006 within ten (10) working days of contract award unless this requirement is met during the proposal phase of the contract. Certificates of Conformance (CoCs) and supporting test data, for all components/material performance as stated in the Purchase Description, shall be provided to DCMA at the time FAT and LAT samples are present for Inspection and Acceptance. The contractor shall ensure that all CoCs and supporting test results are attached to the DD1222.

The Contractor's plan for the quality management system shall address the following elements:

a. Management Responsibility. Procedures to define, document, and implement a policy for quality.

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

c. Contract Review. Procedures to establish and maintain documented procedures for contract review.

d. Design Control. Procedures to establish and maintain documented procedures to control and verify design of the product to ensure conformance to specified requirements.

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

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

g. Control of Government-Supplied Product. Procedures to establish and maintain documented procedures for the control of verification, storage and maintenance of Government-supplied product provided for incorporation into the supplies or for related activities.

h. Product Identification and Tractability. Where appropriate, procedures to establish and maintain documented procedures for identifying the product from receipt and during all stages of production, delivery, and installation.

i. Process Control. Procedures to identify and plan the production, installation, and servicing processes, which directly affect quality and to ensure these processes are carried out under controlled conditions.

j. Inspection and Testing. Procedures to establish and maintain documented procedures for inspection and testing activities, in order to verify that the specified requirements for the product are met.

k. Control of Inspection, Measuring and Test Equipment. Procedures to establish and maintain documented procedures to control, calibrate and maintain inspection, measuring and test equipment, (including test software) used by the Contactor to demonstrate the conformance of product to the specified requirements.

l. Inspection and Test Results. Procedures to ensure that the inspection and test status of the product are identified and maintained throughout the production, installation, and servicing of the product. And, to ensure that only products that passed the required inspections and tests (or released under an authorized concession) are dispatched, used, or installed.

m. Control of Non-Conforming Product. Procedures to establish and maintain documented procedures to ensure that product that does not conform to specified requirements is prevented from unintended use or installation.

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

o. Handling, Storage, Packaging, Preservation and Delivery. Procedures to establish and maintain documented procedures to prevent damage or deterioration of product.

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

q. Internal Quality Audits. Procedures to establish and maintain documented procedures for planning and…