【FDA CFR 820 QSR Compliance】SCAR Provision, Procedure, and Forms

¥500

【FDA CFR 820 QSR Compliance】SCAR Provision, Procedure, and Forms

【FDA CFR 820 QSR Compliance】SCAR Provision, Procedure, and Forms

¥500

Quantity

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SCAR (Supplier Corrective Action Request) procedure in a form consistent with the FDA QSR.
(Supplier Corrective Action Request (SCAR) procedure form in accordance with the FDA QSR.

List of Forms
The following forms are included with your purchase.
・MD-QMS-K50 SCAR Provision
・MD-QMS-S5001 SCAR Procedure
・MD-QMS-F5001 Survey Request Form
・MD-QMS-F5002 SCAR Form
・MD-QMS-F5003 SCAR List


Table of Contents

Provision

1. purpose
2. scope of application
3. definition of terms
4. sources of information on SCAR
5. criteria for issuing SCAR
6. issuance of scar
6.1. Request for Survey of Suppliers
6.2. Issuance of SCAR to Suppliers
6.3 Follow-up of SCAR
7. SCAR Data Analysis and Reporting
8. reference
9. supplementary provision


 

Procedure

1. purpose
2. scope of application
3. Definition of Terms
4. Roles and responsibilities
5. survey request to suppliers
5.1 Issuance of Survey Request Form
5.2. sending survey requests to suppliers
5.3. receiving survey request form responses from suppliers
5.4 Confirmation of survey responses
6. issuance of SCAR
6.1. issuing SCAR
6.2. sending SCAR to the supplier
6.3 Follow-up of SCAR
6.4. Receipt of SCAR response from the Supplier
6.5. reviewing the contents of the SCAR and approving its completion
7. SCAR file and SCAR list
8. SCAR Data Analysis and Reporting 9.
9. forms
10. reference
11. supplementary provision