Biomedical Engineering Reference
In-Depth Information
SOP No. QAS-025.00 Effective date: mm/dd/yyyy
Approved by:
Subject: Random Sampling
44.1 PurPose
The purpose of this SOP is to describe the measures taken by the ABC Pharmaceutical Company
management to use random sampling plan and statistical technique for sampling of raw and packag-
ing material, and in-process and finished product.
44.2 resPonsibility
The QAI is responsible for following the procedure and the QA manager is responsible for the SOP
compliance.
44.3 Procedure
To ensure that the sample selected from a lot is representative of that particular lot, it is essential to
select it in a manner such that each part has an equal chance of being selected regardless of its quality
or ease or difficulty of obtaining it.
1. If the lot is in one container: Select parts proportionally from all areas of the container.
Take sample from the top, middle, bottom, and sides in approximately equal proportions.
2. If the lot is in several containers: Refer to the table given below to determine the mini-
mum numbers of containers from which the samples are to be selected.
total number of
containers
number of containers from
Which sample should be taken
1-5
All
6-10
5
11-50
7
51-100
10
101-250
15
Over 250
20
3. The table will show the number of containers to be opened.
4. Assign number to all the units (containers) in a lot to uniquely identify each unit.
Tables of random numbers are useful in obtaining random samples when containers in the lot are
identified separately.
44.3.1
i inStructionS for u Sing t aBle of r andom n umBerS
1. Containers in a lot must be numbered or placed in rows so that numerical positions can
be established.
2. Select any point in the table of random numbers. (This can be accomplished by putting
a pencil at random on a digit in the table.)
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