§ 29.41 - Quality control plans; contents.

(a) Each quality control plan shall contain provisions for the management of quality, including: (1) Requirements for the production of quality data and the use of quality control records; (2) control of engineering drawings, documentations, and changes; (3) control and calibration of measuring and test equipment; (4) control of purchased material to include incoming inspection; (5) lot identification, control of processes, manufacturing, fabrication, and assembly work conducted in the applicant's plant; (6) audit or final inspection of the completed product; and (7) the organizational structure necessary to carry out these provisions.

(b) Each provision for final inspection in the quality control plan shall include a procedure for the selection of a sample of the end product and the functional components thereof for testing, in accordance with procedures set forth in Military Standard MIL-STD-105D, “Sampling Procedures and Tables for Inspection by Attributes,” or Military Standard MIL-STD-414, “Sampling Procedures and Tables for Inspection by Variables for Percent Defective,” or an approved equivalent sampling procedure, or an approved combination of sampling procedures. Military Standard MIL-STD-105D, “Sampling Procedures and Tables for Inspection by Attributes,” and Military Standard MIL-STD-414, “Sampling Procedures and Tables for Inspection by Variables for Percent Defective” are hereby incorporated by reference and made a part hereof. These documents are available for examination at Approval and Certification Center, Box 201 B Industrial Park Road, Dallas Pike, Triadelphia, W. Va. 26059 and may be purchased from the Superintendent of Documents, U.S. Government Printing Office, Washington, DC 20402.

(c) The sampling procedure shall include a list of the characteristics to be tested by the applicant or his agent.

(d) The characteristics listed in accordance with paragraph (c) of this section shall be classified according to the potential effect of such defect and grouped in to the following classes:

(1) Critical. A defect that judgment and experience indicate is likely to result in hazardous or unsafe conditions for individuals using, maintaining, or depending upon the product; or a defect that judgment and experience indicate is likely to prevent performance of the function of the end product.

(2) Major. A defect, other than critical that is likely to result in failure, or to reduce materially the usability of the unit or product for its intended purpose.

(3) Minor. A defect that is not likely to materially reduce the utility of the instrument for its intended purpose, or a defect that is a departure from established standards and has little bearing on the effective use or operation of the instrument.

(e) The quality control inspection test method to be used by the applicant or his agent for each characteristic required to be tested shall be described in detail.

(f) Each item manufactured shall be 100 percent inspected for defects in all critical characteristics and all defective items shall be rejected.

(g) The Acceptable Quality Level (AQL) for each major or minor defect so classified by the applicant shall be:

(1) Major—1.0 percent;

(2) Minor—4.0 percent.

(h) Except as provided in paragraph (i) of this section, inspection level II as described in MIL-STD-105D, or inspection level IV as described in MIL-STD-414, shall be used for major and minor characteristics and 100 percent inspection for critical characteristics.

(i) Subject to the approval of MSHA, where the quality control plan provisions for raw material, processes, manufacturing, and fabrication inspection are adequate to ensure control of finished article quality, destructive testing may be conducted at a lower level of inspection than that specified in paragraph (h) of this section.