Product Recall Flowchart

Company Name

Page 11 of 11

Department

SOP No.+ Version No.

Product Recall

Supersedes: SOP No. Attachments: 1 (one page) Effective date:

8.

Attachment 1: Recall Decision Flow Chart

Customer complaint Internal Finding Any other source

Identification of a potential product non-compliance issue

Information to Quality Unit

Preliminary Recall Assessment

no

Response to customer and documentation of Findings

yes Convene Recall Committee 1. Technical Assessment 2. Medical Assessment 3. Documents for Recall

no

Recall Decision

yes Implementation

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