QS-108-F1
CAPA Initiation Form
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Corrective And Preventative Action (CAPA) Assignment Form: QS-108-F1 CCR No. CC-21-0412 Revision: 2 CAPA Number (assigned by Document Control after the rest of this form is completed) Revision # CAPA — Title / Description Gummies final release testing/evaluation reoccurring Aw failures CAPA Source / Reference (i.e. RPT #, DEV #, INV#, etc.) Event Dates CAPA CAPA 06/21/24 Open Date Due Date CAPA- Owner (i.e. Assigned to) Gabriel Dominguez CAPA Plan /Comments LI N/A J_1. Standardized Water Activity Testing in production. 2. Feasibility of loosening final aW packaging specs. 3. Process adjustments downstream off transfer belt traying gummies, adding extra verification check on level/amount of gummies per tray. 4. Dehydration room monitoring and standardization. Title / Name Signature Date Completed By: Gummy Manager/Gabriel Dominguez Assignment Accepted By: 1 N/A if same as completed by Approved By (Quality):