> ### Subpart 46.4- Government Contract Quality Assurance

> ## 46.401 General.

> (a) Government contract quality assurance shall be performed at such times (including any stage of manufacture or performance of services) and places (including subcontractors' plants) as may be necessary to determine that the supplies or services conform to contract requirements. Quality assurance surveillance plans should be prepared in conjunction with the preparation of the statement of work. The plans should specify-
> (1) All work requiring surveillance; and
> (2) The method of surveillance.
> (b) Each contract shall designate the place or places where the Government reserves the right to perform quality assurance.
> (c) If the contract provides for performance of Government quality assurance at source, the place or places of performance may not be changed without the authorization of the contracting officer.
> (d) If a contract provides for delivery and acceptance at destination and the Government inspects the supplies at a place other than destination, the supplies shall not ordinarily be reinspected at destination, but should be examined for quantity, damage in transit, and possible substitution or fraud.
> (e) Government inspection shall be performed by or under the direction or supervision of Government personnel.
> (f) Government inspection shall be documented on an inspection or receiving report form or commercial shipping document/packing list, under agency procedures (see Subpart 46.6).
> (g) Agencies may prescribe the use of inspection approval or disapproval stamps to identify and control supplies and material that have been inspected for conformance with contract quality requirements.

> ## 46.402 Government contract quality assurance at source.

> Agencies shall perform contract quality assurance, including inspection, at source if-

> (a) Performance at any other place would require uneconomical disassembly or destructive testing;
> (b) Considerable loss would result from the manufacture and shipment of unacceptable supplies, or from the delay in making necessary corrections;
> (c) Special required instruments, gauges, or facilities are available only at source;
> (d) Performance at any other place would destroy or require the replacement of costly special packing and packaging;
> (e) Government inspection during contract performance is essential; or
> (f) It is determined for other reasons to be in the Government's interest.

> ## 46.403 Government contract quality assurance at destination.

> (a) Government contract quality assurance that can be performed at destination is normally limited to inspection of the supplies or services. Inspection shall be performed at destination under the following circumstances-
> (1) Supplies are purchased off-the-shelf and require no technical inspection;
> (2) Necessary testing equipment is located only at destination;
> (3) Perishable subsistence supplies purchased within the United States, except that those supplies destined for overseas shipment will normally be inspected for condition and quantity at points of embarkation;
> (4) Brand name products purchased for authorized resale through commissaries or similar facilities (however, supplies destined for direct overseas shipment may be accepted by the contracting officer or an authorized representative on the basis of a tally sheet evidencing receipt of shipment signed by the port transportation officer or other designated official at the transshipment point);
> (5) The products being purchased are processed under direct control of the National Institutes of Health or the Food and Drug Administration of the Department of Health and Human Services;
> (6) The contract is for services performed at destination; or
> (7) It is determined for other reasons to be in the Government's interest.
> (b) Overseas inspection of supplies shipped from the United States shall not be required except in unusual circumstances, and then only when the contracting officer determines in advance that inspection can be performed or makes necessary arrangements for its performance.

> ## 46.404 Government contract quality assurance for acquisitions at or below the simplified acquisition threshold.

> (a) In determining the type and extent of Government contract quality assurance to be required for contracts at or below the simplified acquisition threshold, the contracting officer shall consider the criticality of application of the supplies or services, the amount of possible losses, and the likelihood of uncontested replacement of defective work (see 46.202-2).
> (b) When the conditions in 46.202-2(b) apply, the following policies shall govern:
> (1) Unless a special situation exists, the Government shall inspect contracts at or below the simplified acquisition threshold at destination and only for type and kind; quantity; damage; operability (if readily determinable); and preservation, packaging, packing, and marking, if applicable.
> (2) Special situations may require more detailed quality assurance and the use of a standard inspection or higher-level contract quality requirement. These situations include those listed in 46.402 and contracts for items having critical applications.
> (3) Detailed Government inspection may be limited to those characteristics that are special or likely to cause harm to personnel or property. When repetitive purchases of the same item are made from the same manufacturer with a history of defect-free work, Government inspection may be reduced to a periodic check of occasional purchases.

> ## 46.405 Subcontracts.

> (a) Government contract quality assurance on subcontracted supplies or services shall be performed only when required in the Government's interest. The primary purpose is to assist the contract administration office cognizant of the prime contractor's plant in determining the conformance of subcontracted supplies or services with contract requirements or to satisfy one or more of the factors included in (b) of this section. It does not relieve the prime contractor of any responsibilities under the contract. When appropriate, the prime contractor shall be requested to arrange for timely Government access to the subcontractor facility.
> (b) The Government shall perform quality assurance at the subcontract level when-
> (1) The item is to be shipped from the subcontractor's plant to the using activity and inspection at source is required;
> (2) The conditions for quality assurance at source are applicable (see 46.402);
> (3) The contract specifies that certain quality assurance functions, which can be performed only at the subcontractor's plant, are to be performed by the Government; or
> (4) It is otherwise required by the contract or determined to be in the Government's interest.
> (c) Supplies or services for which certificates, records, reports, or similar evidence of quality are available at the prime contractor's plant shall not be inspected at the subcontractor's plant, except occasionally to verify this evidence or when required under (b) of this section.
> (d) All oral and written statements and contract terms and conditions relating to Government quality assurance actions at the subcontract level shall be worded so as not to-
> (1) Affect the contractual relationship between the prime contractor and the Government, or between the prime contractor and the subcontractor;
> (2) Establish a contractual relationship between the Government and the subcontractor; or
> (3) Constitute a waiver of the Government's right to accept or reject the supplies or services.

> ## 46.406 Foreign governments.

> Government contract quality assurance performed for foreign governments or international agencies shall be administered according to the foreign policy and security objectives of the United States. Such support shall be furnished only when consistent with or required by legislation, executive orders, or agency policies concerning mutual international programs.

> ## 46.407 Nonconforming supplies or services.

> (a) The contracting officer should reject supplies or services not conforming in all respects to contract requirements (see 46.102). In those instances where deviation from this policy is found to be in the Government's interest, such supplies or services may be accepted only as authorized in this section.
> (b) The contracting officer ordinarily must give the contractor an opportunity to correct or replace nonconforming supplies or services when this can be accomplished within the required delivery schedule. Unless the contract specifies otherwise (as may be the case in some cost-reimbursement contracts), correction or replacement must without additional cost to the Government. Paragraph (e)(2) of the clause at 52.246-2, Inspection of Supplies-Fixed-Price, reserves to the Government the right to charge the contractor the cost of Government reinspection and retests because of prior rejection.
> (c)(1) In situations not covered by paragraph (b) of this section, the contracting officer ordinarily must reject supplies or services when the nonconformance is critical or major or the supplies or services are otherwise incomplete. However, there may be circumstances (e.g., reasons of economy or urgency) when the contracting officer determines acceptance or conditional acceptance of supplies or services is in the best interest of the Government. The contracting officer must make this determination based upon-
> (i) Advice of the technical activity that the item is safe to use and will perform its intended purpose;
> (ii) Information regarding the nature and extent of the nonconformance or otherwise incomplete supplies or services;
> (iii) A request from the contractor for acceptance of the nonconforming or otherwise incomplete supplies or services (if feasible);
> (iv) A recommendation for acceptance, conditional acceptance, or rejection, with supporting rationale; and
> (v) The contract adjustment considered appropriate, including any adjustment offered by the contractor.
> (2) The cognizant contract administration office, or other Government activity directly involved, must furnish this data to the contracting officer in writing, except that in urgent cases it may be furnished orally and later confirmed in writing. Before making a decision to accept, the contracting officer must obtain the concurrence of the activity responsible for the technical requirements of the contract and, where health factors are involved, of the responsible health official of the agency concerned.
> (d) If the nonconformance is minor, the cognizant contract administration office may make the determination to accept or reject, except where this authority is withheld by the contracting office of the contracting activity. To assist in making this determination, the contract administration office may establish a joint contractor-contract administrative office review group. Acceptance of supplies and services with critical or major nonconformances is outside the scope of the review group.
> (e) The contracting officer must discourage the repeated tender of nonconforming supplies or services, including those with only minor nonconformances, by appropriate action, such as rejection and documenting the contractor's performance record.
> (f) When supplies or services are accepted with critical or major nonconformances as authorized in paragraph (c) of this section, the contracting officer must modify the contract to provide for an equitable price reduction or other consideration. In the case of conditional acceptance, amounts withheld from payments generally should be at least sufficient to cover the estimated cost and related profit to correct deficiencies and complete unfinished work. The contracting officer must document in the contract file the basis for the amounts withheld. For services, the contracting officer can consider identifying the value of the individual work requirements or tasks (subdivisions) that may be subject to price or fee reduction. This value may be used to determine an equitable adjustment for nonconforming services. However, when supplies or services involving minor nonconformances are accepted, the contract need not be modified unless it appears that the savings to the contractor in fabricating the nonconforming supplies or performing the nonconforming services will exceed the cost to the Government of processing the modification.
> (g) Notices of rejection must include the reasons for rejection and be furnished promptly to the contractor. Promptness in giving this notice is essential because, if timely nature of rejection is not furnished, acceptance may in certain cases be implied as a matter of law. The notice must be in writing if-
> (1) The supplies or services have been rejected at a place other than the contractor's plant;
> (2) The contractor persists in offering nonconforming supplies or services for acceptance; or
> (3) Delivery or performance was late without excusable cause.

> ## 46.408 Single-agency assignments of Government contract quality assurance.

> (a) Government-wide responsibility for quality assurance support for acquisitions of certain commodities is assigned as follows:
> (1) For drugs, biologics, and other medical supplies-the Food and Drug Administration;
> (2) For food, except seafood-the Department of Agriculture.
> (3) For seafood-the National Marine Fisheries Service of the Department of Commerce.
> (b) Agencies requiring quality assurance support for acquiring these supplies should request the support directly from the cognizant office.