SAE EIA-584-2015由SAE - SAE International 发布于 2015-07-01,并于 2016-06-30 实施。
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PURPOSE Conventional attribute sampling plans based upon nonzero acceptance numbers are no longer desirable. In addition@ emphasis is now placed on the quality level that is received by the customer. This relates directly to the Lot Tolerance Percent Defective (LTPD) value or the Limiting Quality Protection of MIL-STD-105. Measuring quality levels in percent nonconforming@ although not incorrect@ has been replaced with quality levels measured in parts per million (PPM). As a result@ this standard addresses the need for sampling plans that can augment MIL-STD-105@ are based upon a zero acceptance number@ and address quality (nonconformance) levels in the parts per million range. This document does not address minor nonconformances@ which are defined as nonconformances that are not likely to reduce materially the usability of the unit of product for its intended purpose. APPLICATION The sampling plans based upon a zero acceptance number designated in this standard are applicable@ but not limited@ to inspection of the following: a. End items. b. Components and raw material. These plans are for use with a continuing series of lots@ and not for isolated lots. With a continuing series of lots@ consult Table 2 if it is desired to use the Average Outgoing Quality curves of Appendix A@ and consult Table 1 for the resulting consumer's risk for a given sample quantity. At the discretion of the responsible authority@ certain characteristics may require 100% inspection. INSPECTION Inspection is the process of measuring@ examining@ testing@ or otherwise comparing the unit of product with the requirements. INSPECTION BY ATTRIBUTES Inspection by attributes is inspection whereby either the unit of product is classified simply as nonconforming or conforming@ or else the number of nonconformances in the unit of product is counted and compared to a given requirement or set of requirements. UNIT OF PRODUCT The unit of product is the item inspected in order to determine its classification as nonconforming or conforming or to count the number of nonconformances. It may be a single article@ a pair@ a set@ a length@ an area@ an operation@ a volume@ a component of an end product@ or the end product itself. The unit of product may or may not be the same as the unit of purchase@ supply@ production@ or shipment. NONCONFORMANCE A nonconforming unit is one that is likely to result in failure@ or to reduce materially the usability of the unit of product for its intended purpose.
2.7 非均质性药品不同部分的性质和质量有所差异的同一批药品。2.8 正常非均质性药品正常理化属性可呈现为非均质性但不改变其性质和质量的一批药品(如:混悬液及低温下可析出部分结晶而复温后能恢复原来状态的液体药品)。2.9 异常非均质性药品生产或者贮运过程中因未按正常工作程序操作等因素造成非均质性的同一批药品。2.10 最终样品由不同单元样品汇集制成的供检验或查处物证等之用的样品。...
2.3.2由正常检验转换为加严检验的条件在正常检验过程中,连续检验十批(不包括两次交验复检批)中,有五批以上被判定不合格(拒收)时,品管部可以申请改用加严检验。2.3.3由加严检验转换为正常检验的条件在加严检验过程中,连续检验十批均判定合格(允收)时,品管部可以改用正常检验方。...
c.根据单位产品编号的最大位数(如 A1,最大为三位数),查出所在行的连续列数字(如 A2 所点数为第 48 行、第 10、11 和 12 列,其数字为 245),则编号与该数相同的那一份单位产品,即为一件应抽取的样品。d.继续查下一行的相同连续列数字(如按A3、即第49 行的第10、11 和12列的数字,为608)。该数字所代表的单位产品为另一件应抽取的样品。e.依次按A4所述方法查下去。...
c.根据单位产品编号的最大位数(如 A1,最大为三位数),查出所在行的连续列数字(如 A2 所点数为第 48 行、第 10、 11 和 12 列,其数字为 245),则编号与该数相同的那一份单位产品,即为一件应抽取的样品。d.继续查下一行的相同连续列数字(如按A3、即第49 行的第10、 11 和12列的数字,为608)。该数字所代表的单位产品为另一件应抽取的样品。e.依次按A4所述方法查下去。...
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