Quality_Assurance_Annex_GEN_II.doc

Quality Assurance Annex

1.0 Security Requirements.

1.1 The contractor shall be responsible for safeguarding all Government equipment, information and property provided for contractor use.

1.2 Neither the contractor nor any of its subcontractor providers shall disclose or cause to disseminate any information concerning operations of military activities and or sensitive performance requirements. Such action(s) could result in violation of the contract and possible legal actions.

1.3 All inquiries, comments or complaints arising from any matter observed, experienced, or learned of as a result of or in connection with the performance of this contract, the resolution of which may require the dissemination of official information, shall be directed to the Contracting Officer Representative (COR) and the Contracting Officer (KO).

1.4 The contractor shall only conduct business with designated Government personnel listed as Points of Contact (POCs). Names of authorized personnel shall be provided to the contractor by the Government, in writing, and updated as necessary throughout the contract period.

1.5 U.S. Government records, copies of original results and reports, verified original data, corrected data, and corrected supporting final reports are maintained by the contractor, but remain the property of the U.S. Government. These files/results must be surrendered to the COR when requested.

2.0 General Information.

2.1 Contracting Officer Representative. The COR monitors all technical aspects of the contract and assists in contract administration. A letter of designation issued to the COR, a copy of which is sent to the contractor, states the responsibilities and limitations of the COR, especially with regard to changes in cost or price, estimates or changes in delivery dates. The COR is not authorized to change any of the terms and conditions of the resulting contract.

2.2 Organizational Conflict of Interest (OCI). The Defense Logistics Agency Troop Support (DLA TS) may use contractor and subcontractor personnel associated with the Project Manager to perform work in support of the this contract; these personnel will have access to or participate in the review of proprietary or source selection information (e.g., cost or pricing information, budget information or analyses, specifications or work statements, etc.) or perform evaluation services (Quality Assurance audits) which may create a current or subsequent OCI as defined in Federal Acquisition Regulation (FAR) Subpart 9.5. The KO will affect the appropriate remedy for any verified violation of OCI.

DISTRIBUTION STATEMENT C. Authorized distribution is to U.S. Government Agencies and their Contractors for official use or for administrative and operational use as determined on 18 July 2019. Other requests for this document shall be referred to DLA Troop Support, FQSE, 700 Robbins Avenue, Philadelphia, PA 19111-5092.

3.0 First Article Test and Production Lot Acceptance Testing.

3.1 First Article Testing (FAT), Production Lot Acceptance Testing (LAT), and conformance inspections shall be conducted per contract, Purchase Description (PD), and contractor internal requirements. Tests, inspections, and procedures used are subject to Government review and approval. Any Certificate of Conformance (CoC) provided shall contain the applicable test data, traceability to materials, and procedures that verify the outcome contained in the certification. All articles shall be produced in accordance with an approved FAT and Production Process Package (PPP). The Government reserves the right to suspend or revoke production authorization for non-compliance with the contract requirements.

3.2 Failure Analysis and Corrective Action Report (FACAR). For each failure that occurs during FAT, LAT or conformance inspection the contractor shall conduct failure analysis and provide a FACAR response to the KO, Defense Contract Management Agency (DCMA) (Quality Assurance Representative (QAR) and Administrative Contracting Officer (ACO)) and DLA TS no later than (NLT) ten (10) working days after notification of failure. Upon receipt of the FACAR, the KO will determine whether to approve the FACAR within ten (10) working days from receipt.

3.3 FACAR content will include the date of failure, design code, lot number and size, detailed failure description, detailed failure analysis, including testing, to identify the root cause for the failure, failure history, any proposed changes/modification to approved design, corrective action plan and validation plan to assess the effectiveness of the corrective action and proposed disposition of the failed item and lot, and containment actions. Containment will address all suspect products and traceability analysis thereof, including end items in plant and already delivered to the Government as well as material work in process, at receiving, or in transit. The FACAR shall identify why the defect was not detected, impact to similar product or processes, and the process controls in place or planned to prevent the problem from recurring. The FACAR shall include documented evidence that rejected items will not get back into the supply system, General Services Administration (GSA) and other venues in which Soldiers/Units may buy replacements using individual or unit funds.

3.3.1 A production authorization remains in effect and acceptance may continue unless:

3.3.1.1 The contractor fails any single LAT. The KO will notify DCMA that acceptance shall be withheld, upon the recommendation of DLA TS. The contractor shall segregate the material of the lot in question from all other production lots in process, conduct a failure analysis, and provide a FACAR to the KO NLT ten (10) working days after notification of failure. The KO and COR will determine within ten (10) working days of receipt of the FACAR if is technically acceptable. If not found to be technically acceptable, the contractor will have ten (10) working days from notification of non-acceptance to resubmit the FACAR. The KO will notify the contractor of Government acceptance of the FACAR and if production under a previously approved FAT configuration may resume or if the contractor must conduct a new FAT. If a new FAT is required, the contractor shall submit the required samples for testing (at the contractor’s expense), as directed by the KO, for the issuance of a new FAT Approval Letter. The FAT Report remains the property of the Government. Schedule delays as a result of product failure to fully satisfy the Government's requirements as documented in the KO's correspondence, with the contractor, is the responsibility of the contractor. Cost to retest FAT products will be borne by the contractor.

3.3.1.2 The contractor fails LAT requirements on two (2) consecutive lots. Consecutive lots are defined by production dates and not testing dates. Should this occur, the Government will withhold acceptance and may immediately cease all production (Stop Acceptance) from the contractor. The contractor will segregate the material of the lot in question from all other ongoing production lots, conduct an analysis, and submit a FACAR to the COR NLT ten (10) working days after notification of failure. The FACAR and subsequent Government decision shall follow the same provisions outlined in the section above.

3.3.1.3 A pattern of negative trending or failure is demonstrated outside of the two (2) failed consecutive lots rule stated above. This could include statistically significant shifts in performance, whether improvement or degradation. Should this occur, the Government will withhold acceptance and may immediately cease all production (Stop Acceptance) from the contractor. The contractor will segregate the material of the lot in question from all other ongoing production lots, conduct an analysis, and submit a FACAR to the KO NLT ten (10) working days after notification of failure. The FACAR and subsequent Government decision shall follow the same provisions outlined in the section above. Schedule delays due to the provisions of a pattern of negative trending or failure are the sole liability of the contractor.

3.3.1.4 A contractor not in production with an approved First Article design for more than a period of 180 consecutive days. When multiple designs have been approved over the course of the contract, each design production time will be self contained. Non-production under this stipulation will result in automatic revocation of the FAT approval.

Additionally, when a lot fails LAT and is subsequently rejected, that lot is rejected in total and no component parts may be used in the production of any other lot, or any other Government contract. Failed lots shall not be delivered and products failed shall not be commingled with other lots. The Government shall have the right to revoke acceptance of any and all items that may contain the root cause failure mode, and to require the contractor to replace all affected units at the contractor’s expense, including transportation costs. Failures occurring during Government testing are also subject to this requirement.

Address for FAT/LAT submission. Samples selected by the Government shall be submitted with a DD Form 1222 for evaluation to the following address:

CONTACT INFORMATION

DODACC: W81C5M

U.S. Army Aberdeen Test Center

Building 358

400 Colleran Road

Aberdeen Proving Ground, MD 21005

410-278-1384

DSN: 298-1384

matthew.a.page4.civ@mail.mil

5.0

Quality Management System (QMS). The contractor shall have a QMS that follows the requirements of FAR 52.246-11 contained in this contract. As such, the contractor shall establish, document, implement and maintain a quality management system and continually improve its effectiveness in accordance with the requirements of International Organization for Standardization (ISO) 9001:2008 or higher level QMS industry standard. The contractor shall monitor, assess, and audit quality and reliability at all subcontractor and supplier facilities during the period of performance of this contract. 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 maintain a calibration system in accordance with American National Standards Institute (ANSI)/ISO/American Society for Quality (ASQ) Q10012-2003 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.

5.1 Quality Audits. The Government reserves the right to audit the contractor’s QMS for all products/processes related to the contract. These audits may be of the QMS, a particular process, or the product. A Pre-Production Readiness Review (PRR) audit is required prior to full rate production. Passing the PRR audit results is required in order to receive written authorization from the Government to proceed to full production.

5.2 Subcontractor and Supplier Management. The contractor shall be responsible for work performed by their subcontractors and suppliers including any inspections and tests. The contractor shall ensure that all contract requirements governing the performance of the product are effectively communicated to all subcontractors and suppliers. Subcontractors and suppliers of key/critical components or processes shall be identified including names and contact information for key personnel. The contractor shall maintain documented evidence that the subcontractors and suppliers meet all criteria related to the contract’s materials and processes, including ISO 9001:2008 compliant QMS. The Government reserves the right to, in coordination with the contractor, review/audit any subcontractors and suppliers of key/critical components. These reviews and audits by the Government will not relieve the contractor of responsibility for their subcontractors.

5.3 Quality Manual. The contractor shall plan for achieving customer satisfaction and assure that the product meets contractual and internal requirements. As required by ISO 9001:2008, the contractor shall establish and maintain a Quality Manual. The contractor shall submit the Quality Manual for Government approval within ten (10) working days of contract award or Contracting Officer request, whichever is first. Copies should be submitted to DLA TS Quality Assurance, the Contracting Officer, and cognizant DCMA. The Quality Manual must include: the scope of the QMS, the documented procedures established for the QMS, and a description of the interaction between the processes of the QMS. All procedures describing the activities needed to implement the system shall be submitted in their entirety. In conjunction with the Quality Manual the contractor shall provide a cross-walk matrix that demonstrates that their Quality Manual is compliant with and or equivalent to the requirements of ISO 9001:2008. The Quality Manual and the cross-walk matrix shall be submitted in electronic format Microsoft Word; electronic mail is the preferred method of delivery.

5.4 Production Process Package (PPP). A PPP shall be prepared by the contractor, validated by DCMA, and submitted for Government approval. The PPP submission shall be prepared in conjunction with the First Article build, and is required ten (10) working days after FAT submission (based on DCMA signed date on DD1222). Copies should be submitted to DLA TS Quality Assurance, the KO, and cognizant DCMA. The PPP must be approved by the KO prior to issuance of the FAT Approval Letter. The PPP is to be design specific and should supplement, not replace, the Quality Manual.

5.4.1 The PPP shall include detailed product information, to include at a minimum:

1. Design #

2. Technical data package (if not approved prior to FAT submission)

3. Raw materials

4. Raw material suppliers

5. FAT component material test data/certifications (to include Berry Amendment compliance certification for all applicable materials)

5.4.2 The PPP shall also include detailed process information, to include at a minimum:

1. Process Flow Chart (to include all steps and sequence in the manufacturing process)

2. Control Plan, to follow steps in process flow chart, including:

a) Process/operation number and description

b) Machinery/equipment/tools

c) Product/process characteristic to be controlled

d) Specification/tolerance

e) Reference drawing/criteria

f) Evaluation/measurement method

g) Sample size and frequency

h) Control method

i) Reaction plan

j) All work instructions shall be provided and referenced in either the Process Flow Chart or Control Plan.

5.4.3 The PPP must be submitted in electronic format. All internal documentation must state the controlled document revision used for the PPP under consideration.

5.5 Quality – Limited Life Material. The contractor shall ensure that shelf life, cure date, date of manufacture, and expiration date are provided to the Government for all limited life materials, and shall be recorded on the Certificate of conformance. Limited life materials shall have a minimum of 95% shelf life remaining unless otherwise approved in writing by Government. If rubber materials are used in the manufacturing process, the contractor shall provide test reports with each shipment to ensure remaining shelf life meets the Government requirement. Test reports shall show actual values as observed in testing along with the remaining shelf-life.

5.6 Configuration Management.

5.6.1 Configuration Management. The contractor shall establish a configuration management program that addresses all new and/or modified hardware, firmware, software and documentation resulting from this contract. The contractor, at no additional cost to the Government, shall correct all non-conformances. The contractor shall use configuration control to manage proposed changes beginning with the submission of the FAT item(s). Configuration control shall be used to document the impact of proposed changes and to update configuration documentation. Following acceptance of the First Article Unit(s), the contractor shall not alter the design in form, fit, or function without prior approval from the KO.

5.6.2 Configuration Status Accounting (CSA). All baselines, ECPs, deviations and waivers shall be documented in the contractor’s configuration status accounting database.

5.6.3 Engineering Change Request (ECR). The contractor shall prepare ECRs for any process or product changes proposed after FAT/PPP approval and submit them to the Government for concurrence. An ECR can be an Engineering Change Proposal (ECP), a Request for Waiver (RFW), or a Request for Deviation (RFD). An ECP is a permanent change to a configuration item. A RFD is a temporary change to a configuration before production. A RFW is a temporary change to a configuration after production. ECR (select type of change requested: ECP, RFW or RFD) submissions must be on PM SPE Form 1 (see Exhibit 1). The Government will approve or disapprove a submitted ECR with any modifications to the agreed to product or process; the contractor shall not implement any changes nor make modifications prior to Government approval of the ECR. The Government will decide as to the need for a new FAT based upon the proposed changes. Cost for a new FAT will be borne by the contractor.

5.6.4 Identification and Traceability. Reference ISO 9001:2008 Clause 7.5.3 – Identification and Traceability is a requirement under this contract. Lot numbering is applicable. The contractor shall maintain traceability records for all component parts used to manufacture the end item product. All component part lot identification shall be traceable through to the end item product's lot number and contract number. Subcontractor's component part lot information shall enable traceability to the raw materials used in the component part. Each product lot shall consist of only one product variant (size, color, etc). A product lot can be made from multiple lots of ballistic material, where a lot of ballistic material is defined as an individual roll of ballistic material. However, in the case where any additional ballistic material is left over from the production run, that material may only be used in the next consecutive product lot. Records shall be maintained and readily available for Government review and audit verification. For end item products identified with individual serial numbers, the traceability requirements listed above shall be traceable via the individual serial number. The contractor shall ensure that every end item is durably marked in such a fashion as to be traceable from production through to the ballistic test records for that lot. The contractor shall ensure that the serial number is indelible after exposure to mechanically stripping or by the use of a solvent and as specified in the PD. The contractor shall ensure that solvents, fuels and other liquids do not diminish the serial number markings.

5.6.5 Production Data. The following information determined during production shall be made a matter of record and shall be furnished on request to the KO. This data shall be identified with the serial number/lot number of the product. Data generated during inspection or other protocols per quality system/Quality Manual/PPP; shall include, but is not limited to the items below:

5.6.5.1 Dimensional measurements (weight, thickness, etc)

5.6.5.2 Supplier lot information and traceability for all component parts identified in the technical data package. This shall include material compliance forms signed by the contractor, each subcontractor or material supplier supported by independent test data (Material Test Report). Contractor shall ensure that Material Test Reports exist to support each compliance form per lot. A copy of the manufacturer’s material test report for each lot is required with shipment of material stating to which specification the material was made. These reports shall include the following information:

1. Signature and title of authorized test facility

2. Signature and title of authorized prime contractor quality personnel

3. Applicable specification and revision

4. Quality statement compliance to applicable specification/contract requirement

5.6.5.3 Operational, ownership and environmental test data generated by the contractor on the end items.

5.6.5.4 Ballistic performance test data generated under all first article, lot acceptance, conformance, and validation testing.

5.6.5.5 Traceability Information (see paragraph 5.6.4 for description of traceability information)

6.0 Safety. The contractor shall certify that the safety inherent in the design and fabrication of the product provided for FAT is achieved in accordance with Federal and Industry standards and regulations. The contractor shall implement a System Safety Program that applies to the applicable safety design requirements and management controls. The contractor shall ensure early hazard identification, evaluation, and elimination or control to preclude injury or death to user/operators or maintainers of product.

7.0 Management/Meetings/Reporting.

7.1 Program Manager. The contractor shall assign a Program Manager (PM) who shall serve as primary POC between the Government and contractor and shall be fully responsible for the coordination of all contractor activities related to the contract to include, but not limited to cost, schedule, technical performance, data management, etc. This person shall have the authority to commit the contractor to specific courses of action and accept direction from the KO or their authorized representative(s). This person shall be responsible for coordinating all meetings between the Government and the contractor. This person shall be responsible for taking the minutes from each meeting and distributing those minutes via e-mail to the entire Integrated Product Team (IPT) and attendees NLT two working days from the meeting. The PM shall be responsible for bringing to the KO’s attention any conflicts in the contractor's interpretation of the contract requirements (first by telephone, e-mail and followed in writing) or problems that could adversely affect the contractor's ability to meet the stated quality, cost, or production/delivery and master schedule requirements.

7.2 Post Award Conference/Periodic Progress Meetings. The contractor shall attend any post award conference convened by the contracting activity or contract administration office in accordance with FAR Subpart 42.5. The KO, COR, DCMA-QAR and other Government personnel, as appropriate, may meet periodically with the contractor to review the contractor's performance. At these meetings the contracting officer will apprise the contractor of how the Government views the contractor's performance and the contractor will apprise the Government of problems, if any, being experienced. Appropriate action shall be taken to resolve outstanding issues. These meetings shall be at no additional cost to the Government.

7.2.3 The contractor shall coordinate, schedule and conduct a Post Award Conference (PAC) with the Government at the contractor’s facility. The Government anticipates this conference to be conducted within 20 calendar days of contract award. The purpose of the conference shall be discussion of project orientation, transfer of background information, to provide a mutual understanding of the technical requirements/contractual requirements, and the QA provisions of the contract. The contractor shall ensure that all personnel, and subcontractors, required for an adequate discussion of the contract effort be in attendance. Scheduling of the post award conference shall not change the delivery schedule of the contract. The contractor shall be prepared to:

7.2.3.1 Conduct a review of the system requirements to ensure that they have been completely and properly identified and that there is a mutual understanding of the system requirements between the Government and the contractor.

7.2.3.2 Conduct a preliminary review of the design concept to verify its capability to meet the PD.

7.2.3.3 Make available to Government representative(s) the documentation for production planning, manufacturing methods and controls, material and manpower resource allocation, production engineering, quality control and assurance program, production management organization, and controls over major subcontractors.

7.2.3.4 Review and clarify all contract requirements: the Contract Data Requirements Lists (CDRLs), data deliverables, and verification/provisioning conference dates.

7.2.3.5 Review the overall tasks and schedule required to execute the contract within the schedule constraints set forth by the Government. The contractor shall keep an up to date Gantt chart tracking tasks, including baseline and actual schedule progress. It shall be supplied to the Government upon request.

7.2.3.5 Document the post award meeting minutes and distribute those minutes via e-mail to the entire PAC attendees NLT a week from the PAC.

7.3 Pre-Production Readiness Review/Audit. The PRR shall be conducted six (6) calendar days after receipt of final FAT and Inspection Report, and Government approval. The purpose of this review will be to verify that all lessons learned during FAT have been incorporated into the design and technical data before full-scale production. During the PRR/Audit the contractor shall declare their production readiness, documentation readiness level and provide briefings to Government in support their declaration. The contractor shall present to the Government as part of their presentation internal audits records (i.e. internal reports of their QMS, Configuration Management System and internal Audits of their subcontractor and their readiness level for production). The Government will provide written approval or disapproval five (5) calendar days after PRR/Audit. The contractor shall not proceed to full rate production until written approval from the Government declaring passing results. The Government will be responsible for agenda (see Exhibit 2) and minutes.

7.3.1 Contractor shall declare their production readiness, documentation readiness level in briefings to the Government in support of their production readiness declaration. The contractor shall present to the Government as part of their presentation internal audits records (i.e. internal reports of their QMS, Purchase Orders, Configuration Management System and Internal Audits of their subcontractor and their readiness level for production).

7.3.2 Prior to the PRR, the contractor shall conduct Configuration Management audits (functional configuration audit and physical configuration audit); the contractor shall ensure that all internal audits and the final product baseline is completed; internal audit results shall support the contractor self-assessment. In addition, the contractor’s quality assurance team shall review their internal system, production material release, or project-specific documentation. This review shall ensure that documentation is in place to support authorization for production; the results of all audits shall be presented to the Government five (5) working days prior to the PRR.

8.0 Place of Performance. The work to be performed and places of performance under this contract will be identified by the contractor per FAR 52.215-6 Place of Performance (October 1997). Any request for changes to the identified place of performance shall be submitted to the KO for review and approval. The contractor shall identify the new location and the verification data used to certify the new location, production capacity, floor plans, and management review/transition plans for startup at the requested location. Changes in production location may also result in a need to conduct a new FAT; these costs shall be borne by the contractor.

INSPECTION AND ACCEPTANCE

1.0

POINT OF INSPECTION

1.1 Inspection and Acceptance shall be accomplished at the contractor’s place of performance identified in this contract by the appropriate DCMA QAR. The Government will inspect the contractor’s production quantities as specified in this contract. All production quantities submitted after approval of the First Article shall be produced using the same materials, processes, procedures, equipment and facilities that resulted in the manufacture of the acceptable First Article. This includes all raw materials and/or sub-components. Any change in the production of the approved First Article must be reported in writing to the KO and the Contracting COR for determination if a new FAT is required. The cost of such testing will be borne by the contractor.

1.2 The Government reserves the right to require full or modified FAT to be accomplished or re-accomplished when it is deemed that there is evidence of potential degradation or failure of specific contractor designs prior to institution of stop work procedures as described in the FAT Approval Letter. The cost of such testing will be borne by the contractor.

1.3 Use of Contractor's Inspection Equipment. The contractor shall make available gauges, measuring, and testing devices for use by the Government when required to determine conformance with contract requirements. If requested by the Government, the contractor shall make available personnel for operation of such devices and for verification of their accuracy and condition.

1.4 Source Inspection Required. The contractor shall provide measurements and certificates of conformance for all material properties identified in the performance requirements by specific test methods.

1.5 Changes in Contractor Status. The contractor shall provide notification to the KO within twenty-four hours of a detected change in contract status; contract status is defined as any manufacturing/production process, production facility change, subcontractor default, component, subcomponent, material failure etc. Even when there is a subcontractor failure and or any other cause, the prime contractor shall not implement engineering or product changes without the explicit approval of the KO.

2.0

QUALITY ASSURANCE.

Product failures during the early life are a main determinant of customer perception of product quality and thus have a direct bearing on the volume procured. Early life failures are caused by latent defects; therefore the contractor must implement product assurance to eliminate and minimize these defects toward attaining the customer’s perception of good quality and resultant reliability in the field. The contractor shall have a QMS that follows the requirements of FAR 52.246-11 contained in this contract. As such, the contractor shall establish, document, implement and maintain a QMS and continually improve its effectiveness in accordance with the requirements of ISO 9001:2008. The contractor shall monitor, assess, and audit quality and reliability at all sub-contractor and supplier 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 maintain a calibration system in accordance with ANSI/ISO/ASQ Q10012-2003 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 third party certification of conformance to ISO 9001:2008 and ISO 10012:2003 within ten (10) working days of contract award.

3.0 BERRY AMENDMENT COMPLIANCE. The contractor shall ensure that all products provided are in compliance with the “Berry Amendment”, in that all applicable components of the item are to be “grown, reprocessed, reused, or produced in the United States”. All component part shall be identifiable and traceable throughout the supply chain and compliance with the “Berry Amendment”. Reference DFAR Clause 252.225-7012 Preference for Certain Domestic Commodities (January 2007).

SPECIAL CONTRACT REQUIREMENTS

1.0 CRITICAL SAFETY ITEM DESIGNATION. "Critical Safety Items (CSIs) are parts whose failure would cause loss of life, permanent disability or major injury, loss of a system, or significant equipment damage." The Lightweight Advanced Combat Helmet is considered a CSI.

1.1 CSI designation means the DCMA will engage in continuous in-plant audit surveillance and product examination of critical and major characteristics in accordance with a zero-based statistically valid sampling plan of 0.40% Quality Release Level (QRL) during the period of performance of this contract. The 0.40 QRL is equivalent to ANSI/ASQ Z1.4 zero based sampling approach. The Acceptance Quality Limit of 4.0% is established for minor defects in accordance with ANSI/ASQ Z1.4 General Inspection Level II. Any lots submitted to DCMA for inspection and acceptance shall be subject to the AQLs above: critical and major characteristics: zero defect, minor characteristics: 4.0% AQL.

1.2 Contractor shall not proceed with production prior to PRR approval and without DCMA oversight of the production processes for CSI designated personal protective equipment.

1.3 No Lot shall be released from the contractor’s plant prior to receipt of approval of passing, Government conducted ballistic test reports by DLA TS and acceptance from the appropriate DCMA QAR.

2.0 WITHHOLDING OF MATERIAL REVIEW BOARD (MRB) AUTHORITY – CRITICAL SAFETY ITEMS. The item being acquired is a critical safety item. Material Review Board (MRB) authority is hereby withheld as outlined below.

2.1 MRB authority is defined as disposition of nonconforming material whose non-conformance affects adherence to internal specifications or end item requirements. Non-conforming material can be any item, part, supplies, or product containing one or more non-conformities. Any disposition under MRB other than scrap requires Government authorization. Government authorization will be on a case by case basis unless so stated, and must come from the KO on this contract.

2.2 Scrap is when material that is nonconforming to internal specifications or end item requirements is dispositioned not to be reintroduced into any product under Department Of Defense (DOD) contract. Authority to scrap is allowed.

2.3 Use-as-is is disposition of material with one or more non-conformances affecting internal specifications or end item requirements to be used for its intended purpose in its existing condition. Authority to use-as-is is withheld without Government authorization.

2.4 Repair is a procedure which reduces but not completely eliminates a nonconformance. The characteristic after repair still does not completely allow adherence to internal specifications or end item requirements. Authority to repair is withheld without Government authorization.

2.5 Rework is a procedure applied to a nonconformance that will completely eliminate it and result in a characteristic that completely allows adherence to internal specifications and end item requirements. Authority to rework is withheld without Government authorization.

3.0 Ballistic Testing Requirements: All ballistic testing for FAT or LAT will be conducted at Aberdeen Test Center (ATC). DLA TS will provide the appropriate test report distribution lists to ATC.

EXHIBIT 1

PM SPE Form 1: ENGINEERING CHANGE REQUEST (ECR)

EXHIBIT 1

PM SPE Form 1: ENGINEERING CHANGE REQUEST (ECR)

EXHIBIT 1

PM SPE Form 1: ENGINEERING CHANGE REQUEST (ECR)

EXHIBIT 2

Pre-Production Readiness Review/Audit

Introduction

Contractor welcome, review of agenda, assessment schedule and orientation to the facility;

Opening Remarks

a. Introduction of assessment team and contractor personnel;

b. Briefing to contractor describing objectives and expectations for the PRR;

c. Contractor overview and discussion of the results of their self-assessment;

· Results and Findings of Internal PRR

· Results and Findings of subcontractor PRRs

Contract Overview

Contractor must declare their production and documentation readiness level and provide a briefings to support their declaration

· Production Capability

1. Facility Capability/Controls

2. Identification of Manufacturing Personnel

3. Manufacturing Management Personnel

4. Facility capabilities/controls

Open Risk Management/Mitigation Discussion

Delivery Schedule Review

Verification of Subcontractor Awards

a. Purchase Order Review and Verification of Requirements Flow-down

b. Test contract verification/Material verification

Configuration Management

Verification of Production Documentation/Materials

a. Drawings

b. Purchase descriptions

c. Work Instruction

d. Supply Chain Analysis

· Material availability

· Material proven and validated

· Material special handling requirements

contractor Subject Matter Experts (SMEs)

Private meeting of assessment team to record and discuss observations

Out-briefing by assessment team to contractor

EXHIBIT 3

Product Manager Soldier Protective Equipment

ISO 9001:2008 Crosswalk

Company:

Contracting Officer:

Solicitation Number:

Contract Number:

PM SPE Reviewer: MACROBUTTON AcceptAllChangesInDoc Date: Click here to enter a date.

EXHIBIT 3

Product Manager Soldier Protective Equipment

ISO 9001:2008 Crosswalk This ISO 9001:2008 crosswalk matrix is intended as a clarification map for a contractor’s Quality Management System (QMS). All Soldier Personal Protective Equipment (PPE) are Critical Safety Items, therefore, the contracts for PPE incorporate FAR Clause 52.246.11 Higher Level Contract Quality and delineates ISO 9001:2008 as the standard for compliance. Contractors are not required to be ISO certified at this time, however, they must be ISO 9001:2008 compliant. The definition of compliance is that they must meet all the standard requirements with exception of 3rd party registration. The contractor needs to demonstrate how they meet and maintain an ISO 9001:2008 Quality Management System. The Product Manager Soldier Protective Equipment (PM SPE) Quality Assurance (QA) and Defense Contract Management Agency (DCMA) will evaluate, audit, and monitor the contractor’s QMS to ensure compliance. The crosswalk matrix must be completed and submitted to PM SPE QA for evaluation prior to the initial audit.

1. First column: ISO Standard clauses

2. Second column: Company Quality Management System – The contractor shall populate this column by referencing their appropriate company document equivalent to requirement

3. Third column: Compliance Statement – If the contractor is not certified, explain how your process is in compliance with the standard

4. All Procedures required by ISO 9001:2008 shall be submitted as attachments to the Crosswalk Matrix and three (3) samples of supporting documents/records as they pertain to the Procedures.

Example: ISO 9001:2008 requires a Corrective Action Procedure. The crosswalk shall describe it, the Procedure shall be an attachment to the crosswalk and examples of a Customer driven Corrective Action, an Internal Corrective Action and a Supplier Corrective Action would be supporting documents/records pertinent to the procedure.

Remember, compliance and certification are not the same thing, but they require the same effort and management involvement. Early ISO developed the phrase that is still relevant today, “Say what you do, do what you say, and prove it.”

EXHIBIT 3

Product Manager Soldier Protective Equipment

ISO 9001:2008 Crosswalk

Introduction (title only)

ISO 9001:2008 Crosswalk

ISO 9001:2008 Crosswalk

ISO 9001:2008 Crosswalk

Compliance Statement

ISO 9001:2008 Crosswalk

Compliance Statement

Submitting Activity

a. Typed Name (First, Middle Initial, Last)

b. TITLE

c. DIGITAL SIGNATURE

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