By clarifying the management method of acceptance, it is possible to standardize within the company.
By standardizing, you can smoothly respond to FDA inspections.

List of Forms
The following forms are included with your purchase.
・MD-QMS-K80 Acceptance Activities Provision
・MD-QMS-S8001 Acceptance Activities Procedure
・MD-QMS-F8001 Receiving Inspection and Testing Record Sheet

Table of Contents

Provision

1 Objective.
2 scope (of a document)
3 Definition of Terms
4 Type of Inspection
5 Method of Inspection
6 Inspection method for each inspection type
7 check procedure
7.1 In-process inspection
7.2 Product Inspection
7.3 inspection protocol
7.4 Forms to record inspection results
7.5 judgment
7.6 Disposal of defective products (non-conforming products) and rejected lots
7.7 record
7.8 Processing of inspection data
8 Inspection Management
8.1 Management of Inspection Standards
8.2 Management of Inspection Performers
8.3 Management of limit samples
8.4 Management of measuring instruments
9 sampling plan
10 reference
11 by-laws

Procedure

1 Objective.
2 scope (of a document)
3 Definition of Terms
4 Roles and Responsibilities
5 In-process inspection (interim inspection)
5.1 Creation of in-process inspection procedures
5.2 Conduct in-process inspections
5.3 Periodic reporting of in-process inspections
6 Product inspection (final inspection)
6.1 Preparation of product inspection procedures
6.2 Conduct product inspections
6.3 Periodic reporting of product inspections
7 Management of Inspection Standards
8 Management of limit samples
9 Record keeping
10 Management of inspectors
11 Management of measuring instruments
12 Data Analysis
13 form
14 reference
15 by-laws