〝Measures shall be established to assure that conditions adverse to quality, such as failures…….,are promptly identified and corrected. In the case of significant conditions adverse to quality, the measures shall assure that the cause of the condition is determined and corrective action taken to preclude repetition.〞
二、10CFR50附錄B第五條「作業程序書」:
〝Activities affecting quality shall be prescribed by documented instructions, procedures, or drawings, of a type appropriate to the circumstances and shall be accomplished in accordance with these instructions, procedures, or drawiongs.〞
SOP 161(自我查證技術指引):