Code of Federal Regulations (alpha)

CFR /  Title 21  /  Part 158  /  Sec. 158.3 Definitions.

For the purposes of this part the following definitions shall apply:

(a) Lot. A collection of primary containers or units of the same size, type and style manufactured or packed under similar conditions and handled as a single unit of trade.

(b) Lot size. The number of primary containers or units (pounds when in bulk) in the lot.

(c) Sample size. The total number of sample units drawn for examination from a lot.

(d) Sample unit. A container, a portion of the contents of a container, or a composite mixture of product from small containers that is sufficient for the examination or testing as a single unit.

(e) Defective. Any sample unit shall be regarded as defective when the sample unit does not meet the criteria set forth in the standards.

(f) Acceptance number. The maximum number of defective sample units permitted in the sample in order to consider the lot as meeting the specified requirements. The following acceptance numbers shall apply: ------------------------------------------------------------------------

Size container

Lot size (primary container) ---------------------

n \1\ c \2\------------------------------------------------------------------------

net weight equal to or less than 1 kg (2.2 lb)------------------------------------------------------------------------4,800 or less..................................... 13 24,801 to 24,000................................... 21 324,001 to 48,000.................................. 29 448,001 to 84,000.................................. 48 684,001 to 144,000................................. 84 9

144,001 to 240,000................................ 126 13Over 240,000...................................... 200 19------------------------------------------------------------------------

net weight greater than 1 kg (2.2 lb)------------------------------------------------------------------------

Number of Pounds20,000 or less.................................... 13 2More than 20,000 to 100,000....................... 21 3More than 100,000 to 200,000...................... 29 4More than 200,000 to 400,000...................... 48 6More than 400,000 to 600,000...................... 84 9More than 600,000 to 1,000,000.................... 126 13More than 1,000,000............................... 200 19------------------------------------------------------------------------\1\ n=number of sample units.\2\ c=acceptance number.

(g) Acceptable quality level (AQL). The maximum percent of defective sample units permitted in a lot that will be accepted approximately 95 percent of the time. [42 FR 14461, Mar. 15, 1977]