【FDA CFR 820 QSR Compliance】Identification Provision and Procedure

¥400

【FDA CFR 820 QSR Compliance】Identification Provision and Procedure

【FDA CFR 820 QSR Compliance】Identification Provision and Procedure

¥400

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During QSR inspections, the identification method at all stages of the manufacturing process, from individual parts to the finished product, is questioned.

List of Forms
The following forms are included with your purchase.
・MD-QMS-K60 Identification Provision
・MD-QMS-S6001 Identification Procedure


Table of Contents

Provision 

1. Objective.
2 scope (of a document)
3 Definition of Terms
4 identification
4.1 identification procedure
4.2 Identification details
4.3 serial number system
4.4 Identification
4.5 Identification by color control
4.6 Isolation and identification of non-conforming products, returned products, and process deviations
5 reference
6 by-laws


Procedure

1 Objective.
2 scope (of a document)
3 Definition of Terms
4 Roles and Responsibilities
5 Identification of goods
5.1 Identification of parts
5.2 Identification of semi-finished products
5.3 Product Identification
5.4 Identification of products after packaging and packing
5.5 Identification of returned products
5.6 Identification of repaired items returned by customers
5.7 Identification of service parts
6 State Identification
6.1 Identification by color control
6.2 Identification of conditions in incoming inspections
6.2.1 Identification of products prior to inspection
6.2.2 Identification of products after inspection
6.3 Identification before and after shipment determination
6.4 Identification during installation and incidental services
6.5 Identification of nonconforming products
6.6 Identification of process deviations
6.7 Identification of equipment, measuring instruments, jigs and tools with abnormalities
7 reference
8 by-laws