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                            Subpart 46.1 - General
        
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FAC Number: 2024-03 Effective Date: 02/23/2024
PartPart 1Part 2Part 3Part 4Part 5Part 6Part 7Part 8Part 9Part 10Part 11Part 12Part 13Part 14Part 15Part 16Part 17Part 18Part 19Part 20Part 21Part 22Part 23Part 24Part 25Part 26Part 27Part 28Part 29Part 30Part 31Part 32Part 33Part 34Part 35Part 36Part 37Part 38Part 39Part 40Part 41Part 42Part 43Part 44Part 45Part 46Part 47Part 48Part 49Part 50Part 51Part 52Part 53
Subpart46.046.146.246.346.446.546.646.746.8
Section46.10146.10246.10346.10446.105
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Subpart 46.1 - GeneralSubpart 46.1 - General    **Parent topic:**  Part 46 - Quality Assurance46.101 Definitions.       As used in this part-          *Acceptance* means the act of an authorized representative of the Government by which the Government, for itself or as agent of another, assumes ownership of existing identified supplies tendered or approves specific services rendered as partial or complete performance of the contract.          *Conditional acceptance* means acceptance of supplies or services that do not conform to contract quality requirements, or are otherwise incomplete, that the contractor is required to correct or otherwise complete by a specified date.          *Contract quality requirements* means the technical requirements in the contract relating to the quality of the product or service and those contract clauses prescribing inspection, and other quality controls incumbent on the contractor, to assure that the product or service conforms to the contractual requirements.          "Counterfeit item" means an unlawful or unauthorized reproduction, substitution, or alteration that has been knowingly mismarked, misidentified, or otherwise misrepresented to be an authentic, unmodified item from the original manufacturer, or a source with the express written authority of the original manufacturer or current design activity, including an authorized aftermarket manufacturer. Unlawful or unauthorized substitution includes used items represented as new, or the false identification of grade, serial number, lot number, date code, or performance characteristics.          *Critical item* means an item, the failure of which is likely to result in hazardous or unsafe conditions for individuals using, maintaining, or depending upon the item; or is likely to prevent performance of a vital agency mission.          *Critical nonconformance* means a nonconformance that is likely to result in hazardous or unsafe conditions for individuals using, maintaining, or depending upon the supplies or services; or is likely to prevent performance of a vital agency mission.          *Design activity* means an organization, Government or contractor, that has responsibility for the design and configuration of an item, including the preparation or maintenance of design documents. Design activity could be the original organization, or an organization to which design responsibility has been transferred.          *Government contract quality assurance* means the various functions, including inspection, performed by the Government to determine whether a contractor has fulfilled the contract obligations pertaining to quality and quantity.          *Major nonconformance* means a nonconformance, other than critical, that is likely to result in failure of the supplies or services, or to materially reduce the usability of the supplies or services for their intended purpose.          *Minor nonconformance* means a nonconformance that is not likely to materially reduce the usability of the supplies or services for their intended purpose, or is a departure from established standards having little bearing on the effective use or operation of the supplies or services.          *Off-the-shelf item* means an item produced and placed in stock by a contractor, or stocked by a distributor, before receiving orders or contracts for its sale. The item may be commercial or produced to military or Federal specifications or description.          *Patent defect* means any defect which exists at the time of acceptance and is not a latent defect.          *Subcontractor* (see  44.101).          *Suspect counterfeit item* means an item for which credible evidence (including but not limited to, visual inspection or testing) provides reasonable doubt that the item is authentic.          *Testing* means that element of inspection that determines the properties or elements, including functional operation of supplies or their components, by the application of established scientific principles and procedures.46.102 Policy.       Agencies shall ensure that-                                       (a) Contracts include inspection and other quality requirements, including warranty clauses when appropriate, that are determined necessary to protect the Government’s interest;                                          (b) Supplies or services (including commercial services) tendered by contractors meet contract requirements;                                          (c) Government contract quality assurance is conducted before acceptance (except as otherwise provided in this part), by or under the direction of Government personnel;                                          (d) No contract precludes the Government from performing inspection;                                          (e) Nonconforming supplies or services are rejected, except as otherwise provided in  46.407;                                          (f) Contracts for commercial products rely on a contractor’s existing quality assurance system as a substitute for compliance with Government inspection and testing before tender for acceptance unless customary market practices for the commercial product being acquired permit in-process inspection (  41 U.S.C. 3307). Any in-process inspection by the Government shall be conducted in a manner consistent with commercial practice; and                                          (g) The quality assurance and acceptance services of other agencies are used when this will be effective, economical, or otherwise in the Government’s interest (see  42.002 and  subpart  42.2.46.103 Contracting office responsibilities.       Contracting offices are responsible for-                                       (a) 						            Receiving from the activity responsible for technical requirements any specifications for inspection, testing, and other contract quality requirements essential to ensure the integrity of the supplies or services (the activity responsible for technical requirements is responsible for prescribing contract quality requirements, such as inspection and testing requirements or, for service contracts, a quality assurance surveillance plan);                                          (b) 						            Including in solicitations and contracts the appropriate requirements for the contractor’s control of quality for the supplies or services to be acquired;                                          (c) 						            Issuing any necessary instructions to the cognizant contract administration office and acting on recommendations submitted by that office (see  42.301 and  46.104(f));                                          (d) 						            When contract administration is retained (see  42.201), verifying that the contractor fulfills the contract quality requirements; and                                          (e) 						            Ensuring that nonconformances are identified, and establishing the significance of a nonconformance when considering the acceptability of supplies or services which do not meet contract requirements.46.104 Contract administration office responsibilities.       When a contract is assigned for administration to the contract administration office cognizant of the contractor’s plant, that office, unless specified otherwise, shall-                                       (a) 						            Develop and apply efficient procedures for performing Government contract quality assurance actions under the contract in accordance with the written direction of the contracting office;                                          (b) 						            Perform all actions necessary to verify whether the supplies or services conform to contract quality requirements;                                          (c) 						            Maintain, as part of the performance records of the contract, suitable records reflecting-                                                         (1) 								                The nature of Government contract quality assurance actions, including, when appropriate, the number of observations made and the number and type of defects; and                                                            (2) 								                Decisions regarding the acceptability of the products, the processes, and the requirements, as well as action to correct defects.                                                                             (d) 						            Implement any specific written instructions from the contracting office;                                          (e) 						            Report to the contracting office any defects observed in design or technical requirements, including contract quality requirements; and                                          (f) 						            Recommend any changes necessary to the contract, specifications, instructions, or other requirements that will provide more effective operations or eliminate unnecessary costs (see  46.103(c)).46.105 Contractor responsibilities.       (a) 						            The contractor is responsible for carrying out its obligations under the contract by-                                                         (1) 								                Controlling the quality of supplies or services;                                                            (2) 								                Tendering to the Government for acceptance only those supplies or services that conform to contract requirements;                                                            (3) 								                Ensuring that vendors or suppliers of raw materials, parts, components, subassemblies, etc., have an acceptable quality control system; and                                                            (4) 								                Maintaining substantiating evidence, when required by the contract, that the supplies or services conform to contract quality requirements, and furnishing such information to the Government as required.                                                                             (b) 						            The contractor may be required to provide and maintain an inspection system or program for the control of quality that is acceptable to the Government (see  46.202).                                          (c) 						            The control of quality by the contractor may relate to, but is not limited to-                                                         (1) 								                Manufacturing processes, to ensure that the product is produced to, and meets, the contract’s technical requirements;                                                            (2) 								                Drawings, specifications, and engineering changes, to ensure that manufacturing methods and operations meet the contract’s technical requirements;                                                            (3) 								                Testing and examination, to ensure that practices and equipment provide the means for optimum evaluation of the characteristics subject to inspection;                                                            (4) 								                Reliability and maintainability assessment (life, endurance, and continued readiness);                                                            (5) 								                Fabrication and delivery of products, to ensure that only conforming products are tendered to the Government;                                                            (6) 								                Technical documentation, including drawings, specifications, handbooks, manuals, and other technical publications;                                                            (7) 								                Preservation, packaging, packing, and marking; and                                                            (8) 								                Procedures and processes for services to ensure that services meet contract performance requirements.                                                                             (d) 						            The contractor is responsible for performing all inspections and test required by the contract except those specifically reserved for performance by the Government (see  46.201(c)).
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