Attachment 0001 - Quality Assurance Program.pdf

CUI / / SP-Procure / /

Section J Attachment 0001 Quality Clauses

1. QUALITY ASSURANCE PROGRAM

The Contractor shall have a Quality Assurance Program (QAP) in compliance with ISO 9001:2015 or an alternate plan approved by the Government. The Contractor shall have a quality program that encompasses all technical and manufacturing aspects of production. All supplies and services under this contract shall be controlled by the Contractor at all points necessary to assure compliance with contractual requirements. The Contractor shall make objective evidence of quality conformance readily available to PM CCS.

The Contractor shall maintain and implement the QAP and all quality assurance provisions incorporated at the time of award.

Changes to this program will not be implemented without the written permission of the Government. The Contractor’s quality management system shall ensure product conformance to contractual requirements. The Contractor shall ensure they have an implemented, documented, demonstrated ability to maintain the quality management system to be used on the contract. The Contractor shall make available all quality management documentation for the Government to review upon request.

2. CONTROL OF SUPPLIERS

The Contractor shall establish a supplier network that shall ensure timely delivery of material and parts throughout production to meet the requirements of the XM919 IAM, XM922 SCT and Sub-Caliber Tracer Cartridge . The Contractor shall maintain control of the quality of all suppliers throughout production. The control techniques shall be defined to incoming inspection, source inspection, and monitoring supplier selection, evaluation, and rating techniques. The Contractor must inform potential suppliers that the Government reserves the right to inspect their facilities and processes.

3. GOVERNMENT ACCESS TO FACILITIES

The Contractor shall provide the Government access to prime and subcontractor facilities so that regulatory surveys, inspection, and investigations can be conducted.

4. GOVERNMENT RIGHT TO AUDIT

At any time during this contract effort the Government reserves the right to independently audit or examine the Contractors and any subcontractors quality management system and records for compliance to all contractual quality requirements. The Contractor shall ensure the necessary provisions are placed in all subcontractor / vendor purchase orders / contracts to grant the Government access to perform these audits. The Contractor shall provide personnel and facilities to support the above audits.

5. AMMUNITION DATA CARDS (ADC)

Detailed requirements and guidance for the preparation of Ammunition Data Cards (ADCs) and Ammunition Lot Numbers are contained in MIL-STD-1168C, (DI-MISC-80043) and the Worldwide Ammunition-data Repository Program (WARP) online user's manual. Detailed requirements for obtaining and using a manufacturer's identification symbol, which is an integral component of the ammunition lot number, can be found in MIL-STD-1168C and the WARP user’s manual.

Information provided in paragraphs 6.7 through 6.16 of MIL-STD-1168C shall be considered mandatory requirements where all instances of the term "should" are considered to be replaced with the word "shall."

(a) The Contractor shall develop and submit ADCs in accordance with the requirements of this addendum, MIL-STD-1168C, and the user's manual located on the WARP database. The WARP application is accessed through the Munitions History Program (MHP) website. The ADC requirement is a flow-down requirement that applies to Contractors and their suppliers, vendors or subcontractors.

(b) The Contractor shall prepare an ADC for each lot of item(s) being produced under this contract, regardless of whether or not those lots are accepted or rejected by the Government. The ADC shall comply with MIL-STD-1168C and WARP requirements.

(c) Unless otherwise authorized by the Procuring Contracting Officer, the Contractor shall include, in the components sections on the ADC representing the deliverable item, as a minimum; all assemblies, sub-assemblies, components, explosives, and propellants listed below for the item being procured.

End Item Component Listing:

Drawing Number Nomenclature

(d) The component items identified below are from paragraph (c) above and will require their own component ADC in addition to being listed on the end item ADC. The component ADCs shall also comply with MIL-STD-1168C and WARP requirements.

Drawing Number from paragraph (c) above , components as follows:

Component Drawing Number Nomenclature

Drawing Number from paragraph (c) above , components as follows:

Component Drawing Number Nomenclature

Drawing Number from paragraph (c) above , components as follows:

Component Drawing Number Nomenclature

(e) Lot numbers shall be in accordance with MIL-STD-1168C lot number convention and the technical data package requirements. Lot numbers shall be used for all ammunition end items and their major components, including inert, dummy, or non-energetic items and components. When not required by Technical Data Package (TDP) and not considered an end item or major component, the component lot number may be constructed through Contractor lot number convention.

(f) The flowdown of the requirement for component ADCs generated via WARP is highly encouraged for other items not identified in paragraph (d) above when the prime Contractor is purchasing components, assemblies, and subassemblies from subcontractors or vendors.

(g) All component RFV / ECPs shall be listed on the ADC for the deliverable item, as well as on the component ADC, when that component is identified in paragraph (d) above. The WARP user's manual provides information on the level of detail required.

(h) A sample ADC shall be developed and submitted to the WARP system thirty (30) days prior to First Article testing or thirty (30) days prior to production in the event a first article is not required. The WARP ADC program will not allow the submission of additional ADCs until such time as the sample ADC has been approved in the system.

6. FIRST ARTICLE TEST (CONTRACTOR TESTING)

a. The first article shall be examined and tested in accordance with contract requirements, the item specification(s), Quality Assurance Provisions (QAPs) and all drawings listed in the Technical Data Package (TDP).

b. The first article shall be representative of items to be manufactured using the same processes and procedures and at the same facility as contract production. All parts and materials, including packaging and packing, shall be obtained from the same source of supply as will be used during regular production. All components, subassemblies, and assemblies in the first article sample shall have been produced by the Contractor (including subcontractors) using the technical data package applicable to this procurement.

c. The first article shall be inspected and tested by the Contractor for all requirements of the drawing(s), the QAPs, and specification(s) referenced thereon, except for:

(1) Inspections and tests contained in material specifications provided that the required inspection and tests have been performed previously and certificates of conformance are submitted with the First Article Test Report.

(2) Inspections and tests for Military Standard (MS) components and parts provided that inspection and tests have been performed previously and certifications for the components and parts are submitted with the First Article Test Report.

(3) Corrosion resistance tests over ten (10) days in length provided that a test specimen or sample representing the same process has successfully passed the same test within thirty (30) days prior to processing the first article, and results of the tests are submitted with the First Article Test Report.

(4) Life cycle tests over ten (10) days in length provided that the same or similar items manufactured using the same processes have successfully passed the same test within one (1) year prior to processing the first article and results of the tests are submitted with the First Article Test Report.

(5) One-time qualification tests, which are defined as a one-time on the drawing(s), provided that the same or similar item manufactured using the same processes has successfully passed the tests, and results of the test are on file at the Contractor's facility and certifications are submitted with the First Article Test Report.

d. Those inspections which are of a destructive nature shall be performed upon additional sample parts selected from the same lot(s) or batch(es) from which the first article was selected.

e. A First Article Test Report shall be compiled by the Contractor documenting the results of all inspections and tests (including supplier's and vendor's inspection records and certifications, when applicable). The First Article Test Report shall include actual inspection and test results to include all measurements, recorded test data, and certifications (if applicable) keyed to each drawing, specification and QAP requirement and identified by each individual QAP characteristic, drawing / specification characteristic and unlisted characteristic. Evidence of the QAR's verification will be provided. One copy of the First Article Test Report will be copy furnished to the Procurement Contract Officer (PCO).

f. Notwithstanding the provisions for waiver of first article, an additional first article sample or portion thereof, may be ordered by the PCO in writing when (i) a major change is made to the technical data, (ii) whenever there is a lapse in production for a period in excess of ninety (90) days, or (iii) whenever a change occurs in place of performance, manufacturing process, material used, drawing, specification or source of supply. When conditions (i), (ii), or (iii) above occurs, the Contractor shall notify the PCO so that a determination can be made concerning the need for the additional first article sample or portion thereof, and instructions provided concerning the submission, inspection, and notification of results.

Costs of the additional first article testing resulting from any of the causes listed herein that were instituted by the Contractor and not due to changes directed by the Government shall be borne by the Contractor.

7. MEASUREMENT SYSTEM EVALUATION (MSE)

(a) Definitions. This paragraph defines specific terms utilized throughout the rest of the addendum and in the accompanying Contract Data Requirements List (CDRL) and Data Item Description (DID) (DI-QCIC-81960). This aids in clarifying the MSE requirements to Government and Contractor personnel.

(1) Acceptance Inspection Equipment (AIE). All equipment (includes AAIE defined below), special and standard, including dimensional gages, measuring equipment, test fixtures, electronic and physical test equipment, and other test equipment used for examination and test of a product to determine conformance to the Technical Data Package (TDP) which may include drawings and specifications (e.g., Detail, Performance, Weapon Specifications, and Quality Assurance Provisions (QAPs)).

(2) Automated Acceptance Inspection Equipment (AAIE). AIE in which the inspection and acceptance determination of the product is performed, in whole or in part, in an automatic manner.

(3) Contractor Inspection Equipment. Government-approved equipment utilized by the Contractor to perform examination and tests to assure conformance to contract requirements.

(4) Commercial Inspection Equipment. Industry-developed inspection equipment of universal application, without limitations to a specific part or item, which is advertised or cataloged as available to the trade or to the public on an unrestricted basis at an established price. Examples follow:

(i) Standard Test Equipment. Multi-usage equipment that is specific to a function rather than to an item. It includes such items as hardness testers, tensile strength testers, meters, weighing devices, standard gear testers, ohmmeters, voltmeters, and oscilloscopes.

(ii) Standard Measuring Equipment (SME). Multipurpose equipment and standards used for performing measurements. It includes such items as micrometers, rulers, tapes, height gages, and protractors, etc. Standards include visual inspection equipment such as scratch and dig standards, surface finish comparator, color standards (FED-STD-595), etc.

(5) Nondestructive Testing (NDT). The development and application of technical methods to examine materials or components in ways that do not impair future usefulness and serviceability in order to detect, locate, measure and evaluate flaws; to assess integrity, properties and composition; and to measure geometrical characteristics. NDT includes Radiography / Radioscopic, Ultrasonic, Eddy Current, Magnetic Particle, and Liquid Penetrant.

(6) Measurement System Analysis (MSA). Per ASTM E2782 (Standard Guide for MSA), paragraph 3.1.7, MSA is any of a number of specialized methods useful for studying a measurement system and its properties.

(b) Scope. This addendum establishes requirements for design, supply, performance, and maintenance of AIE used for product inspection and acceptance. In addition, this addendum establishes requirements for the preparation, submission, and approval of AIE documentation.

(c) AIE. The Contractor shall provide all AIE necessary to ensure conformance of components and end-items to contract requirements. AIE shall include inspection, measuring, and test equipment whether Government furnished or Contractor furnished (including commercially acquired) along with the necessary specifications and procedures for their use (see ISO 10012, paragraph 6.2.1). The AIE shall not create or conceal defects on the product being inspected. All AIE documentation shall contain sufficient information to permit evaluation of the AIE’s ability to test, verify, and / or measure the applicable characteristics or parameters (see DI-QCIC-81960).

(d) AIE Designs & Government Furnished Gages. AIE designs are of two types – Government designs (see d.1) and Contractor designs (see d.2). When applicable, Government designs or Government furnished gages are designated in the TDP / contract; responsibility for all other AIE is assigned to the Contractor. The designs, associated inspection procedures, and theory of operation shall have the level of detail to demonstrate capability of the proposed AIE to perform the required inspection.

(1) Government AIE Designs. Government AIE designs may consist of detailed drawings necessary for the fabrication and use of the AIE. Unless otherwise specified, the Contractor may submit alternate or modified Contractor designs of Government AIE designs.

(2) Contractor AIE Designs. Contractor AIE design drawings shall meet the requirements of ASME Y14.100, ASME Y14.5 and ASME Y14.43 and may include commercial inspection equipment. [“Commercial inspection equipment” is defined as shown in paragraph a.4 above. It shall be fully described by catalog listings or other means which provide sufficient information to permit identification and evaluation by the Government and may include illustrations and engineering data.] Designs shall be submitted for any special fixture(s) to be used. Unless otherwise specified, Gage Tolerancing Policy shall be in accordance with ASME Y14.43, “Absolute Tolerancing (Pessimistic Tolerancing).”

(3) Visual Inspection. Visual inspection standards used for the acceptance / rejection of product shall be submitted for approval.

(e) AIE Package Submittals. The Contractor shall prepare the AIE package submittal in accordance with (DI-QCIC-81960) in the applicable Contract Data Requirements List (CDRL – DD Form 1423). In addition, the Contractor shall adhere to the following requirements:

(1) Designs for Approval. Contractor designs and / or the submission for the use of Government designs shall be approved by the Government. Partial submission of AIE designs is permissible in order to expedite the approval process; however, the response date for design review will be based on the date of the final complete submission of designs.

(2) Correspondence in English. The Contractor shall ensure all AIE correspondence and documentation are submitted in English.

(3) Units of Measurement. The units of measurement within the AIE package submittal shall be consistent with the requirements of the TDP.

(4) AIE Flow Down. The Contractor shall flow down AIE requirements to subcontractors at any tier who are performing acceptance inspections.

(f) Characteristics for Inspection. AIE documentation for Critical, Special, and Major characteristic inspections shall be submitted to the Government for approval in accordance with (IAW) the CDRL (DI-QCIC-81960). AIE for Minor characteristic inspections shall be submitted to the Government for approval IAW CDRL (DI-QCIC-81960) and as required below:

☐ (1) Listed Minor (characteristics displayed on specifications and / or drawings

☐ (2) Government selected list (as attached or as provided herein)

☒ (3) Not submitted

(g) Automated Acceptance Inspection Equipment. The AAIE shall accept only conforming material. All characteristics requiring AAIE per the TDP shall utilize inspection equipment with a minimum demonstrated reliability of 99.8% at a 90% confidence level to detect non-conforming material unless otherwise specified below.

(1) Reliability of 99.8% at a 90% Confidence Level for Critical / Special Characteristics

(2) Reliability of 99.0% at a 90% Confidence Level for Major Characteristics

(3) For inspection of major and minor characteristics where Contractor utilizes AAIE when it is not required by the TDP, the AAIE package shall be submitted to the Government for approval. If the Minor characteristic is not listed in paragraph f.2 or not required for submittal in paragraph f.3, then the AAIE requirements (e.g., verification, calibration, prove-out, etc.) of the inspection shall still be performed.

(4) All AAIE packages submitted to the Government for approval shall be in accordance with MIL-A-70625 (Automated Acceptance Inspection Equipment Design, Testing and Approval of). Furthermore, the Contractor shall be responsible for producing the acceptance and rejection verification standards / masters representative of the characteristics the AAIE is designed to inspect. The verification standards and frequency of use require Government approval prior to use. When verification standards are used for the VL-VII “sampling plan” per MIL-STD-1916 paragraph 4.4, verification standards and frequency of use shall require Government approval prior to use.

(5) If the AAIE accepts a critical characteristic “reject” standard the Contractor shall notify the Government and act in accordance with paragraph f of the Critical Characteristic Control Addendum. In addition, if the AAIE accepts a major and / or minor characteristic “reject” standard the Contractor shall act in accordance with paragraph 8.3 of ISO 10012 or paragraph

5.2.3 of ANSI / NCSL Z540.3.

(6) All AAIE shall be required to pass a Government-approved Acceptance (Prove-Out) Test. The Contractor shall conduct this test per the approved test plan and shall submit a test analysis report for approval. See applicable CDRL (DI-QCIC-

81960). This test shall be performed at the Contractor’s facilities who’s manufacturing system has had the AAIE fully integrated and calibrated as per paragraph (j) of this addendum. The Contractor shall allow Government personnel access to this facility and unobstructed monitoring of this test.

(7) The Contractor shall notify the Government prior to a modification and / or relocation of the Government-approved AAIE. The modified AAIE designs shall be submitted for approval. The modified and / or relocated AAIE shall require submission of the acceptance test plan (prove-out) and results for review and approval prior to use. The modified and / or relocated AAIE shall be in accordance with paragraphs (g)(1) – (g)(6).

(h) Measurement System Analysis (MSA). The Contractor is responsible to ensure all AIE is, at a minimum, stable, repeatable, and reproducible for all characteristics. Refer to ASTM E2782 and / or AIAG MSA for guidance. The Contractor shall provide objective evidence, including the MSA assessment plan, associated data, and analysis, which demonstrates the AIE is, at a minimum, stable, repeatable, and reproducible for the following characteristics (MSA CDRL):

SPECIFICATION PARAGRAPH NO. DRAWING CHARACTERISTIC

Approval of submitted MSA(s) must be granted before the corresponding AIE can be used or continue to be used for acceptance of product. If at any time following approval of the AIE and MSA the AIE is disapproved, then the MSA shall be disapproved. After the resubmitted AIE is approved, the MSA shall be conducted on the approved AIE and resubmitted for approval.

(i) Robust AIE System. The Contractor shall ensure the AIE and its use is not negatively affected by any manufacturing / inspection environmental stimuli including, at a minimum, production rate, noise, temperature, humidity, and vibration.

(j) AIE Calibration and Verification. The calibration system shall be in accordance with ISO 10012 or ANSI / NCSL Z540.3. All AIE shall be subjected to scheduled calibration intervals to ensure that the equipment will accept only conforming product and reject all non-conforming product for the duration of the approved calibration period. AIE shall be subjected to periodic verification to ensure that the equipment will continue to accept and reject product with the same consistency as it did at the time of its previous calibration.

(k) Nondestructive Testing (NDT). Contractor shall submit detailed plans for qualifying and certifying NDT personnel and plans for qualification and ongoing use of NDT methods used for inspecting product. If re-qualification of NDT personnel and / or NDT methods is required, then the applicable plans shall be submitted.

(1) Personnel performing NDT examinations shall be qualified and certified in accordance with the standard practices prescribed by NAS 410 (NAS Certification & Qualification of NDT Personnel), ANSI / ASNT-CP-189 (ASNT Standard for Qualification and Certification of NDT Personnel), or SNT-TC-1A (Recommended Practice for Personnel Qualification and Certification in NDT), and additional procedures that may be identified by the Government. Acceptance of product using NDT shall be performed by personnel at a level of qualification consistent with that defined in the applicable standard.

(2) The NDT method(s) shall be applied in accordance with ASTM E 543 (Standard Specification for Agencies Performing Nondestructive Testing) and the current nationally recognized standard practices appropriate to the NDT method(s) employed, such as ASTM E-1742 (Standard Practice for Radiographic Examination) and SAE-AMS-STD-2154 (Inspection, Ultrasonic, Wrought Metals, Process For). Each application technique shall identify the standard(s) utilized. Non-destructive testing includes, at a minimum, the following types of testing: Radiography / Radioscopic, Ultrasonic, Eddy Current, Magnetic Particle, and Liquid Penetrant.

(l) Contractor Alternate Inspection Method(s), Modifications and / or Relocation of AIE (Non-Automated) After Government Approval. If the Contractor proposes an alternate inspection method and / or modifies the AIE design(s) affecting hardware, software, or procedures after Government approval the intended change(s) shall be submitted to and approved by the Government prior to implementation. If an AIE is relocated and the relocation risks the integrity of the inspection system, notify the Government to determine information needed to assess impact to AIE. See CDRL (DI-QCIC- 81960).

(m) Responsibility for AIE Package Submittal. The Contractor shall submit the AIE design documentation package within contractual timeframes per CDRL (DI-QCIC-81960). The Government will provide approval or disapproval within the timeframe specified in the CDRL. Disapproval of the AIE package will require re-submittal and subsequent Government review in accordance with the CDRL requirements. The AIE package and any required prove-outs must be approved prior to First Article (FA) (if required) or production start-up if FA is not required.

(n) Government’s Right to Disapprove AIE. The Government reserves the right to revoke approval of any AIE that is not satisfying the required acceptance criteria at any time during the performance of this contract. See CDRL (DI-QCIC-81960).

(o) Navy Furnished Gages. When gages are listed in paragraph o.9 below, the Navy Special Interface Gage (NSIG) Requirement paragraphs o.1 – o.8 shall be satisfied.

(1) The NSIG(s) are provided for verification of selected interface dimensions and do not constitute sole acceptance criteria of production items or relieve the Contractor of meeting all drawing / specification requirements under the contract.

(2) The Contractor is responsible for contacting the Naval Surface Warfare Center (NSWC), Corona Division at least forty-five (45) days prior to FAT (if required) or production, for the delivery of NSIG(s).

(3) NSIG(s) will be forwarded to the Contractor for joint use by the Government and the Contractor. Government furnished NSIG(s) shall not be used by the Contractor(s) or subcontractor(s) as in-process or working gage(s).

(4) For production items that fail to be accepted by the applicable NSIG(s), an alternate inspection method may be submitted for approval.

(5) The Contractor may substitute Contractor designed and built AIE for the NSIG(s) noted in paragraph (o.9) below.

However, the designs require Government (Navy) approval and the Contractor AIE hardware requires Government (Navy) certification. AIE designs shall be submitted in accordance with CDRL (DI-QCIC-81960).

(6) The Government (Navy) shall not be responsible for discrepancies or delays in production items resulting through misuse, damage or excessive wear to the NSIG(s).

(7) Calibration and repair of the NSIG(s) shall only be performed as authorized by the NSWC Corona Division. Repair is at no cost to the Contractor unless repair is required due to damage to the gages resulting from Contractor fault or negligence.

Damaged, worn, or otherwise unserviceable NSIG(s) shall be brought to the immediate attention of the CAO and NSWC Corona Division. The Contractor shall not make any adjustments, alterations or add permanent markings to NSIG(s) hardware unless specified by the NSIG operating instructions or authorized by the NSWC Corona Division.

(8) Within forty-five (45) calendar days after final acceptance of all production items, the NSIG(s) shall be shipped to NSWC Corona Division, ATTN: Receiving Officer, Bldg 575, Gage Laboratory, 1999 Fourth St., Norco, CA 92860-1915. The following shipping and marking specifications are applicable:

(i) Shipping, MIL-STD-2073, "DOD Standard Practice for Military Packaging"

(ii) Marking, MIL-STD-129, "Marking for Shipment and Storage".

(9) The following NSIG(s) shall be provided and are mandatory for use except as noted by paragraph (o.5) above.

DRAWING REV CHARACTERISTIC NSIG # QTY DIMENSIONS WEIGHT VALUE

N / A

8. ACCEPTANCE AND DESCRIPTION DATA SHEETS, MIL-STD 1171A (FOR PROPELLANTS AND EXPLOSIVES)

(a) The Contractor shall prepare Acceptance and Description Sheets in accordance with MIL-STD-1171A as reinstated by Notice 2 when mandated by the Contract Data Requirements List (CDRL). The Worldwide Ammunition-data Repository Program (WARP) shall be utilized to store the data sheets required by MIL-STD- 1171A. The Army Electronic Product Support (AEPS) network located at https: / / mhpwarp.redstone.army.mil must be used to gain access to WARP.

(b) The requirements of MIL-STD 1171A as reinstated by Notice 2 specified in the CDRL is a flow-down requirement that applies to Contractors and their suppliers, vendors or subcontractors.

(c) The Contractor is responsible for on-screen entry of the data sheets into the appropriate Acceptance and Description Sheet module located in the WARP system.

(d) The presence of the Contractor’s typed signature has the same legal effect and consequences of a handwritten signature.

The signatory of the data sheets has the authority to sign for the Contractor and certifies the information contained on the data sheets is truthful and accurate as evidenced by release of the typed signature.

9. CRITICAL CHARACTERISTICS (SIX SIGMA)

a. The Contractor’s processes shall be designed with the objective of preventing the creation or occurrence of nonconforming critical characteristics (see paragraphs d & e). The Contractor shall establish, document and maintain a product specific, Critical Characteristics Control (CCC) Plan that shall be submitted to and approved by the Procuring Contracting Officer (PCO) IAW DD Form 1423 and (DI-MGMT-81986). The CCC Plan shall include or reference all procedures, work and handling instructions and process controls relating to any critical characteristics. Mistake Proofing techniques of the material handling and inspection systems shall be a part of the CCC Plan. Guidance for developing this plan and submitting Critical Plans of Action (CPOA) (paragraph g) can be found at https: / / ac.ccdc.army.mil / organizations / QESA / .

b. The Contractor shall assure its critical processes are robust in design, capable and under control, with the objective of not generating any critical non-conformances. The Contractor shall calculate, document, clearly identify, and have a schedule that routinely assess the reliability and effectiveness of its critical processes to prevent generating critical non-conformances as identified in the CCC Plan.

c. An inspection and verification system shall be employed that will verify the robustness of all critical processes.

The Contractor shall calculate, document, clearly identify, and have a schedule that routinely assess the reliability and effectiveness of its inspection and verification system to detect and prevent critical non-conformance escapes as identified in the CCC Plan. The Government expects that a Contractor will allow zero critical escapes. To demonstrate its critical escape risk the Contractor will utilize the non-conformance escape risk goal provided below.

(1) Unless otherwise specified immediately below, the calculated critical non-conformance escape risk is 1 in a million (.000001) items delivered. Or: Alternate calculated Critical Non-conformance Escape risk (fill-in -1-): Unless otherwise approved by the PCO, the non-conformance escape risk is the sum of the individual characteristic escape rates. The probability of escape for a single characteristic shall be calculated by multiplying the non-conformance rate(s) entering the inspection system(s) by the error rate of the inspection system(s). These escape rates are then summed and shall not exceed the tolerable critical non-conformance escape risk.

(2) Within forty-five (45) days after award, the Contractor can elect to submit a phased-in approach on how the nonconformance escape risk will be achieved over a period of time not to exceed 180 days from the date of first article approval, or from initiation of production when first article is not required. Submission will require approval by the https://mhpwarp.redstone.army.mil/

Government and is subject to a technical review and analysis. Allowance for a phased-in approach will then become a part of the contract. Disapproval of the Contractor’s submission does not relieve the Contractor of its obligation to comply with the terms of this addendum.

(3) Based on the maximum error rate defined for the inspection system, the Contractor shall develop a test procedure to demonstrate the error rate. As part of the test plan the Contractor shall include sufficient test quantities to assure 90% statistical confidence in the resultant rates unless otherwise approved by the PCO. Once established, the Contractor shall have a documented schedule to routinely monitor the non-conformance and inspection system error rates to assure they do not exceed the maximum rates allotted.

d. As a result of previous practices, the Government’s technical data may refer to “Critical I”, “Critical II”, and “Special” characteristics. The use of the term "critical characteristics" within this addendum includes Critical I, Critical II and Special characteristics and the use of the term "critical nonconformances" includes those nonconformances pertaining to Critical I, Critical II and Special characteristics. Unless otherwise stated in Section C, these characteristics shall be subject to all requirements of this addendum.

e. In addition to critical characteristics defined in the Government’s technical data (drawings, specifications, etc.), the Contractor shall also identify and document in their Contractor developed technical data all known material, component, subassembly and assembly characteristics whose non-conformances would likely result in hazardous or unsafe conditions for individuals using, maintaining or depending upon the product. All additional critical characteristics identified by the Contractor shall comply with the critical characteristic requirements of the technical data package, supplemented herein. The Critical Item Characteristic List (CICL) review process shall be included in the CCC Plan. The Contractor's additional critical characteristics shall be classified in accordance with guidance located at https: / / ac.ccdc.army.mil / organizations / QESA / and shall be submitted to and approved by the PCO prior to production (DI-SAFT-80970A).

f. In the event that a critical non-conformance is found anywhere in the production process, the Contractor, as part of its CCC Plan, shall have procedures in place to ensure:

(1) The non-conformance is positively identified and segregated to ensure that nonconforming product does not inadvertently remain in or reenter the production process. This control shall be accomplished without affecting or impairing subsequent non-conformance analysis. Final disposition of non-conforming product shall be documented and audited for traceability.

(2) The operation that produced the non-conforming component or assembly and any other operations incorporating suspect components or assemblies are immediately stopped. (See para h. for exceptions)

(3) The Government (PCO) is immediately notified of the critical non-conformance (electronic mail) (DI-SAFT-80970A).

(4) Any suspect material is identified, segregated and suspended from any further processing and shipment.

(5) An investigation is conducted to determine the root cause of the non-conformance and the required corrective actions. An evaluation shall also be conducted with regard to suspect material to ensure that no additional critical non-conformances are present. A report of this investigation shall be submitted to the Government (DISAFT- 80970A). The use of the Data Item Description (DID) report shall not delay notification to the Government as required in f(3) above.

(6) A request to restart manufacturing or to use any suspect material associated with the critical nonconformance is submitted to the Government (DI-SAFT-80970A). Restart of production shall not occur until authorized by the PCO, unless previously addressed in the approved CCC Plan. The Government will respond to a restart request within three (3) working days. All objective evidence of the investigations to date shall be available for review at the time of restart. Suspect material shall not be used without PCO approval.

(7) The procuring activity reserves the right to refuse acceptance of any suspect material until the root cause or reasonably likely cause of the critical non-conformance has been identified, corrective action has been fully implemented and sufficient evidence has been provided to exclude non-conforming material from the conforming population.

g. The Contractor may develop alternative plans and provisions, collectively referred to as a CPOA, relative to Government or Contractor identified critical characteristics. All CPOAs are independent and shall be evaluated by the Government for this contract. The CPOA and any subsequent revisions submitted IAW DD Form 1423 and (DI-MGMT-81996) require PCO approval prior to implementation. Unless otherwise specified at time of approval, Contractor shall review and evaluate CPOAs for currency and process improvements at least on an annual basis and submit results to the PCO. Unless otherwise approved by the PCO, each critical characteristic shall require a separate CPOA. If the CPOA includes other documents by reference they shall be submitted upon request. Guidance for the development of a CPOA can be found in the referenced guidance located at paragraph a of this addendum.

h. The Contractor may continue production with an approved CPOA provided that the critical non-conformance is consistent with the failure mode(s) and rates established in the CPOA. Failure to meet all CPOA requirements will require the Contractor to revert back to paragraph f requirements.

i. If a critical non-conformance is discovered beyond its designated inspection point and prior to Government acceptance the Contractor shall take actions specified in paragraph f above. If a critical non-conformance is discovered after Government acceptance the Government has the right to invoke the requirements of paragraph f with respect to the Contractor’s remaining production under this contract.

10. REWORK AND REPAIR OF NONCONFORMING MATERIAL

a. Rework and Repair are defined as follows:

(1) Rework - The reprocessing of nonconforming material to make it conform completely to the drawings, specifications or contract requirements.

(2) Repair - The reprocessing of nonconforming material in accordance with approved written procedures and operations to reduce, but not completely eliminate, the nonconformance. The purpose of repair is to bring nonconforming material into a usable condition. Repair is distinguished from rework in that the item after repair still does not completely conform to all of the applicable drawings, specifications or contract requirements.

b. Rework procedures along with the associated inspection procedures shall be documented by the Contractor and submitted to the Government Quality Assurance Representative (QAR) for review prior to implementation. Rework procedures are subject to the QAR's disapproval.

c. Repair procedures shall be documented by the Contractor and submitted on a Request for Variance, DD Form 1694, to the Contracting Officer for review and written approval prior to implementation.

d. Whenever the Contractor submits a repair or rework procedure for Government review, the submission shall also include a description of the cause for the nonconformances and a description of the action taken or to be taken to prevent recurrence.

e. The rework or repair procedure shall also contain a provision for re-inspection which will take precedence over the Technical Data Package requirements and shall in addition, provide the Government assurance that the reworked or repaired items have met reprocessing requirements.

11. USE OF MIL-STD 1916

a. The Government will not accept lots whose samples submitted for acceptance contain non-conformances unless appropriately documented and approved by the Procurement Contract Officer. The Contractor shall use MIL-STD 1916, DOD Preferred Methods of Acceptance of Product. The Verification Level (VL) shall be:

VL IV for major characteristics and

VL II for minor characteristics.

b. MIL-STD HDBK-1916 provides guidance on the use of MIL-STD 1916. This handbook is not contractually binding.