**DAAN-09-06**

**Critical Safety Items**

(September 2016)

CONDITIONS FOR EVALUATION AND ACCEPTANCE OF OFFERS FOR CRITICAL SAFETY ITEMS

 (a) Definitions.

"Actual manufacturer" means an individual, activity, or organization that performs the physical fabrication processes that produce the deliverable part or other items of supply for the Government. The actual manufacturer must produce the part in-house. The actual manufacturer may or may not be the design control activity. 

"Approved source" means a prime contractor or the actual manufacturer(s) cited in the procurement item description (PID). It does not include design control activities with no manufacturing capability.

"Critical safety item" (CSI) means a part, assembly, installation, or production system with one or more critical characteristics that, if not conforming to the design data or quality requirements, would result in an unsafe condition that could cause loss of, or serious damage to, the end item or major components, loss of control, or serious injury or death to personnel. 

"Design control activity" means a contractor or Government activity having responsibility for the design of a given part, and for the preparation and currency of engineering drawings and other technical data for that part. The design control activity may or may not be the actual manufacturer.

"Exact product" and "alternate product" are defined in the provision at DLAD 52.217-9002 or Procurement Note L04, Conditions for Evaluation and Acceptance of Offers for Part Numbered Items. 

"Prime contractor" means a contractor having responsibility for design control and/or delivery of a system/equipment such as aircraft, engines, ships, tanks, vehicles, guns and missiles, ground communications and electronics systems, and test equipment.

"Rebranding" means remarking, re-labeling, repackaging, or otherwise obscuring the marking of the approved source cited in the PID (i.e., the prime contractor or actual manufacturer).

(b) The item being acquired is a critical safety item (CSI). Given their vital importance and the catastrophic consequences that can result if they fail, procurement of these items requires the highest standards of oversight and verification. 

(c) This clause applies only to offers of "exact product." Offers of "alternate product" will be evaluated in accordance with the clause at DLAD 52.217-9002 or Procurement Note M06. Offerors of Government surplus material must comply with the requirements in the clause at DLAD 52.211-9000 or Procurement Note C04 in addition to this clause, and surplus offers will be evaluated in accordance with the provision at DLAD 52.211-9003 or Procurement Note M05. 

(d) If the Offeror is the prospective awardee and is not currently an approved source cited in the procurement item description (PID) on the schedule page of this solicitation, the Offeror will be requested by the Contracting Officer to provide documented evidence prior to award sufficient to establish that the item being offered is (or will be) the exact item cited in the PID and is (or will be) manufactured by an approved source cited in the PID, modified (if necessary) to conform to any additional requirements set forth in the PID, and is (or will be) manufactured by or under the direction of an approved source cited in the PID. Additionally, if the Offeror manufactures the offered item for an approved source cited in the PID, evidence of approval and acceptance by the approved source will be required. Evidence must include the following at a minimum, plus whatever additional evidence the Contracting Officer determines necessary to sufficiently establish the identity of the item and its manufacturing source:

(1) If offered item(s) are "not in stock" or "not yet manufactured" --

(i) A copy of Offeror's Request for Quotation to approved source cited in PID; and

(ii) An original, hard copy of quotation received by Offeror from approved source cited in PID; or other verifiable documentation of quotation. (If Offeror is unable to provide this documentation to the Contracting Officer prior to award, it must be provided to the Quality Assurance Representative (QAR) for examination at time of source inspection.)

(iii) For offers of surplus material, a completed 52.211-9000 or Procurement Note C04 with supporting documentation. 

(2) If offered item(s) are "shipped" or "in stock" --

(i) A copy of invoice on approved source's letterhead. (Invoice must identify exact item cited in PID and a quantity sufficient to satisfy the solicitation requirement.); or 

(ii) A copy of packing slip which accompanied shipment from approved source to Offeror. (Packing slip must identify exact item cited in PID and a quantity sufficient to satisfy the solicitation requirement; or

(iii) For offers of surplus material, a completed 52.211-9000 or Procurement Note C04 with supporting documentation; and

(iv) Inventory control records to establish that items Offeror proposes to furnish under current order are still in Offeror's stock. (This documentation is mandatory and must be provided to Quality Assurance Representative (QAR) for examination at time of source inspection. Documentation may be provided to Contracting Officer prior to award, at Offeror's discretion.)

(3) If Offeror is an authorized dealer/distributor, or manufactures the item for an approved source --

(i) An authorized dealer/distributorship agreement, licensee agreement, or other type of agreement. (The agreement must specifically identify the exact item, or otherwise ensure that the Offeror is authorized by the approved source to manufacture or distribute the exact item being acquired. If the agreement covers a general product line or is otherwise not product-specific, the Offeror must also furnish additional documentation to address the exact item being acquired (see above).); or 

(ii) Letter from an approved source cited in the PID, specifically identifying Offeror as authorized to distribute or manufacture the exact item cited in the PID for that approved source; or 

(iii) Other verifiable information (e.g., listing of authorized dealers on official Web page of an approved source) to establish the Offeror's authority to manufacturer or distribute the exact item cited in the PID for an approved source cited in the PID. 

(4) When the PID specifies a revision number --

(i) Documentation establishing that the offered item was (or will be) made in accordance with the revision cited in the PID. (This requirement is considered to have been met when documentation provided by Offeror to satisfy other portions of this clause or solicitation already establishes that offered item was (or will be) made to the revision cited in the PID); or

(ii) Documentation identifying the revision offered and the differences between the revision offered and the revision cited in the PID. 

(e) By the submission of this offer, the Offeror represents that -- 

(1) The item(s) to be provided to the Government --

(i) Is (or will be) in full compliance with all requirements specified in the solicitation; and 

(ii) Is not (or will not be) --

(A) A factory second; 

(B) Changed, mutilated, or rebranded; 

(C) A manufacturer's overrun; 

(D) A rejected item; or 

(E) Government surplus material (unless Offeror has complied with clause at DLAD 52.211-9000 or Procurement Note C04, Government Surplus Material). 

(2) In the event of item failure, Offeror will have access to, and will provide to the Government upon request, all information necessary to trace the item back through the manufacturing process. 

(3) Any documentation provided by Offeror will correspond to the exact item(s) that will be furnished to the Government; or Offeror will obtain updated documentation and provide it to the Government (if, for example, Offeror sells item(s) to another Buyer before award or before tender for acceptance). 

(f) Failure to provide adequate documentation within the timeframe requested by the Contracting Officer may result in rejection of the offer.

CHANGES IN CONTRACTOR STATUS, ITEM ACQUIRED, AND/OR MANUFACTURING PROCESS/FACILITY

(a) Since the item being acquired is a critical safety item, the Contractor shall immediately provide notification and documentation of the changes to the Contracting Officer when any changes occur in the Contractor’s business status or relationship with the approved source(s) after award of this contract (such as, for example, inability to obtain manufacturing process information; or changes in status as authorized dealer/distributor, or in terms of licensing arrangement), 

(b) The Contractor shall immediately provide to the Contracting Officer notification (and documentation, if available) of any of the following changes the Contractor becomes aware of:

(1) Later revisions to drawings, specifications or standards that differ from the revision cited in the procurement item description (PID) in the contract;

(2) Changes in the manufacturing process;

(3) A change in the approved source’s manufacturing location; or

(4) A transfer of manufacturing facilities by the approved source since last manufacture.

WITHHOLDING OF MATERIEL REVIEW BOARD (MRB) AUTHORITY 

The item being acquired is a critical safety item. Notwithstanding any other term or condition included in this contract/agreement, Materiel Review Board (MRB) authority is hereby withheld. 

(End of Notice)

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