Biomedical Engineering Reference
In-Depth Information
SOP No. QCS-015.00 Effective date: mm/dd/yyyy
Approved by:
15.3.4 f iniShed P roductS
i. Finished products are sampled by the QA inspector as per the sampling quantity specified
in the finished products sampling procedure (sufficient for testing only).
ii. The QA inspector will hand over the sample to the QC supervisor (material receiving).
iii. The QC supervisor (material receiving) makes sure that the materials are entered in the mate-
rials receiving register. The samples will be kept under the custody of the QC manager.
iv. The QC supervisor (finished products) will then hand over the materials for testing.
v. The sample will be under safe custody until the analysis is completed.
vi. After completion of the test, the leftover quantity is preserved in a file sample room for the
period of shelf-life plus one year.
15.4 reason for revision
First time issued for your company, affiliates, and contract manufacturers.
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