What type of sampling methods may manufacturers use to obtain a “statistically significant” sample of lenses?
A. FDA does not limit manufacturers to any specific sampling plan; however, you should use a valid statistical sampling plan. FDA has recognized the standards below. You may use either of these standards or an equivalent standard. ANSI/ASQC Z1.4/1993, Sampling Procedures and Tables for Inspection by Attributes American National Standard Institute (ANSI) http://www.ansi.org American Society for Quality (formerly America Society for Quality Control (ASQC) http://www.asq.org ISO 2859-1/1999, Sampling Procedures for Inspection by Attributes — Part 1: Sampling Schemes Indexed by Acceptance Quality Limit (AQL) for Lot-by-Lot Inspection International Organization for Standardization (ISO) http://www.iso.ch CDRH supplemental information for these standards is available at www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfm or directly at http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/ cfStandards/Detail.CFM?STANDARD__IDENTIFICATION_NO=1595 and http://www.accessdata.fda.gov/sc
