Critical characteristic on manufacturing operations test procedure

#1
Regarding to 42 CFR 84.41 Approval of Respiratory Protective Devices, Subpart E-Quality Control,
(f) Each item manufactured shall be 100 percent inspected for defects in all critical characteristics and all defective items shall be rejected.

The questions is;
1. Does it mean to oblige us to put the critical characteristics on the manufacturing operations?
If yes, when it found one defects on the sampling, the whole entire lot will be rejected. Right?

2. Is there any other way to choose if there is found one defects to not rejected the whole lot?

Ref:
*Single Sampling Plan for Normal Inspection, ANSI/ASQ Standard Z1.4-2003 (R2013)
*AQL (Normal Inspections)

Thank you.
 
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