QAS-007 - Quality Operations Procedures for Pharmaceutical, API, and Biotechnology - page 243

26.4 attachment forms

abc Pharmaceutical comPany

LEVEL 3

SOP No.:

Issued on:

Revision No.:

Initiator name:

ANNEXURE I

ACCEPTANCE PLAN A—DOUBLE SAMPLING

NORMAL INSPECTION MIL. ANSI/ASQC Z1.4

ACCEPTANCE QUALITY LEVEL

Critical
AQL 0.0%

Major
AQL 1.0%

Minor
AQL 2.5%

Sample Size
Letter

Sample
Size

Cumulative
Sample Size Sample Acc. Rej. Acc. Rej. Acc. Rej.

L First 125 125 0 1 2 5 5 9

Second 125 250 0 1 6 7 12 13

M First 200 400 0 1 3 7 7 11

Second 200 400 0 1 8 9 18 19

N First 315 315 0 1 5 9 11 16

Second 315 630 0 1 12 13 26 27

Names :
Acc. : Acceptance number
Rej. : Rejection number
* If acceptance number exceeded on the first sample, inspect another sample.
* If rejection number exceeded on the first sample, no second sample is taken.