QS-108-F1

CAPA Initiation Form

Section B — Manufacturing

Original Document

Scanned document (image-only PDF)

Extracted Text

Searchable text extracted from PDF

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):