This is a collection of rules, procedure, and forms related to the management of nonconforming products in a form consistent with the FDA QSR.
Non-conforming product management required by FDA is closely related to CAPA,
FDA’s requirements are closely related to CAPA, and the necessity of reporting to the FDA must be determined.
List of Forms
The following forms are included with your purchase.
・MD-QMS-K12 Nonconforming Product Provision
・MD-QMS-F1201 Nonconforming Product Procedure
・MD-QMS-S1201 Nonconforming Product Report
・appendix-Acceptance tests and Non-Conforming Product Management
Table of Contents
Provision
1 Objective.
2 scope (of a document)
3 Definition of Terms
4 Person in charge of managing non-conforming products
5 Control of non-conforming products
6 Evaluation of non-conforming products
7 Determination of the severity of nonconformity
8 Investigation and Notification
9 Measures for non-conforming products
9.1 Measures to be taken for non-conforming products prior to delivery
9.2 Measures to be taken for non-conforming products found after delivery
9.2.1 Measures to be taken for non-conforming products found after delivery
9.2.2 Detection of nonconforming products through customer complaints
9.2.3 Determination of need for recovery (renovation)
9.2.4 Issue of Notification
10 Records of actions taken for nonconforming products
11 Processing of returned non-conforming products
12 Corrective and preventive action required
13 Determine need for SCAR and issue SCAR
14 Non-conforming product data analysis and reporting
15 reference
16 by-laws
Procedure
1 Objective.
2 scope (of a document)
3 Definition of Terms
4 Roles and Responsibilities
5 Discovery and reporting of nonconforming products
6 Evaluation of non-conforming products ・Development of measures
7 Notification to the person/organization responsible for the nonconforming product
8 Determination of need for collection (repair) and issuance of notification
9 Determination of whether or not an investigation is necessary
10 Performing a survey
11 Treatment of nonconforming products
11.1 Return of nonconforming product to supplier and issuance of SCAR
11.2 Actions to remove nonconformities found (rework, etc.)
11.3 special recruitment
11.4 Disposal, etc.
12 Corrective and preventive action requests
13 Data analysis of non-conforming products
14 form
15 reference
16 by-laws