View all text of Subpart 160.076 [§ 160.076-1 - § 160.076-39]
§ 160.076-29 - Production oversight.
(a) Production tests and inspections must be conducted in accordance with ANSI/CAN/UL 9595 (incorporated by reference, see § 160.076-5) or an alternative follow-up procedure accepted by the Commandant. The Commandant may prescribe additional production tests and inspections necessary to maintain quality control and to monitor compliance with the requirements of this subpart.
(b) Production oversight must be performed by the same laboratory that performs the approval tests unless the Commandant determines that the employees of an alternative laboratory have received training and have access to the same information as the inspectors of the laboratory that conducted the approval testing.
(c) In addition to responsibilities set out in part 159 of this chapter and the accepted Laboratory Follow-up Procedures, each manufacturer of an inflatable PFD and each recognized laboratory inspector shall comply with the following, as applicable:
(1) Manufacturer. Each manufacturer must—
(i) Perform all required tests and examinations on each PFD lot before any required inspector's tests and inspection of the lot;
(ii) Follow established procedures for maintaining quality control of the materials used, manufacturing operations, and the finished product;
(iii) Implement a continuing program of employee training and a program for maintaining production and test equipment;
(iv) Admit the inspector to any place in the factory where work is done on PFDs or component materials, and where parts or completed PFDs are stored;
(v) Have an inspector observe the production methods used in producing the first PFD lot and observe any revisions in production methods made thereafter; and
(vi) Allow the inspector to take samples of completed PFDs or of component materials for tests required by this subpart and for tests relating to the safety of the design.
(2) Recognized laboratory oversight. An inspector from a recognized laboratory shall oversee production in accordance with the MOU. During production oversight, the inspector shall not perform or supervise any production test or inspection unless—
(i) The manufacturer has a valid approval certificate; and
(ii) The inspector has first observed the manufacturer's production methods and any revisions to those methods.
(3) The inspector must perform or supervise testing and inspection of at least one in each five lots of PFDs produced.
(4) During each inspection, the inspector must check for compliance with the manufacturer's quality control procedures.
(d) PFD lots. A lot number must be assigned to each group of PFDs produced. Lots must be numbered serially. A new lot must be started whenever any change in materials or a revision to a production method is made, and whenever any substantial discontinuity in the production process occurs. Changes in lots of component materials must be treated as changes in materials. The lot number assigned, along with the approval number, must enable the PFD manufacturer, by referring to the records required by this subpart, to determine the supplier of the components used in the PFD and the component supplier's identifying information for the component lot.
(e) Samples. For the tests, examinations, and inspections required by § 160.076-31, inspectors and manufacturers shall select samples as provided in this paragraph.
(1) Samples shall be selected at random from a lot in which all PFDs or materials in the lot are available for selection. Except as provided in § 160.076-31(c), samples must be selected from completed PFDs.
(2) Different samples must be selected for the manufacturer's and inspector's tests, except, if the total production for any five consecutive lots does not exceed 250 PFDs, the manufacturer's and inspector's tests may be run on the same sample(s) at the same time.
(f) Facilities and equipment—(1) General. The manufacturer must provide the test equipment and facilities necessary for performing production tests, examinations, and inspections, unless Commandant has accepted testing at a location other than the manufacturer's facility.
(2) Calibration. The manufacturer must have the calibration of all test equipment checked at least every six months by a weights and measures agency or the equipment manufacturer, distributor, or dealer.
(3) Facilities. The manufacturer must provide a suitable place and the necessary equipment for the inspector to use in conducting or supervising tests. For the final lot inspection, the manufacturer must provide a suitable working environment and a smooth-top table for the inspector's use.