When Key Characteristics (KCs) or Critical Items (CIs) are specified on the drawing or contract, the Seller shall utilize Statistical Process Control (SPC) methods to collect and analyze KC data and take action to reduce variation. Documented practices and procedures for variability reduction shall be established and maintained. When key characteristics are not specified, the Seller is encouraged to assess the design package and independently identify additional KCs or CIs to improve product quality and reduce costs. The evaluation should include process-related characteristics and associated risks that may affect impact variation to fit, form, function, safety, and producibility.
The Seller shall determine the appropriate management level, based on the risk assessment, for each design feature for each KC or CI and document them in a quality control plan or variation management strategy. Typical elements of a quality control plan or variation management strategy will include:
QC215 - Key Characteristics & Critical Items
Effective: 12/1/2020