Unplanned Deviation Initiation Form blackmaca 062024

Original Document

Scanned document (image-only PDF)

Extracted Text

Searchable text extracted from PDF

Unplanned Deviation Initiation Form 
 
 Form: C-201-F1l CCR No. CC-23-0469 Revision: 1 
 
 Deviation # 
 
 Section I — Unplanned Deviation Information 
 
 Deviation Overview (Completed by the Initiator) 
 Initiator’s Name: Gabriel Dominguez Department: Gummy Department 
 Observer’s Name: N/A Department: |N/A 
 Deviation Title 
 (Short description) Release product at 0.6790 water activity 
 Description of the Deviation: (Include details like who, what, when, where, and why associated with the deviation. As
 applicable include sequence of events, background information, cross references to protocols, etc. Include details like
 room numbers, lot numbers, material names and numbers, product names and numbers, etc.)
 Most recent specification for water activity release of Black Maca Gummies is 0.62 to 0.66 Aw.
 
 For Black Maca Gummies SGM00551 Batch 240516 the result is 0.6790 aw. 
 
 Drying below 0.75 Aw is for organoleptic purposes only and not required to limit growth of microbial organisms. These gummies were
 assessed organoleptically by Patrick Wilson and deemed acceptable. 
 
 Deviation Details (Completed by the Initiator) 
 Date & Time (if known) deviation occurred: 
 
 Date / Time deviation initiated: 06/20/24 2:30pm 
 LI N/A Reason for a delay between date of occurrence and initiation if greater than 2 business days
 Packaging Samples to lab for final release testing/evaluation. 
 
 Deviation Type: Specify what was deviated from: (procedure number,
 M Deviation from Procedure specification, standard, equipment function, etc.)
 L) Non-conforming material/product/result/data Water activity release specifications
 L) Deviation within facility/services/environment 
 L) Deviation from regulations 
 L] Adverse trend detected 
 L) Other, Specify: 
 
 
 

 
 Unplanned Deviation Initiation Form 
 
 Form: C-201-F1l CCR No. CC-23-0469 Revision: 1 
 
 Deviation # 
 
 What may be affected by the deviation? (Completed by the Initiator) 
 Item Detail 
 L] Equipment ID 
 
 Process/Specification 
 Product (SKU/Name/Batch#) Black Maca Gummies SGM00551 Batch 240516 
 L] Material (tem#/R#) 
 LI Standard 
 L] Other 
 
 Discuss potential impact of this deviation including process, products, materials, etc.
 (Note: Impact may change after investigation 1s completed) 
 Product samples of Black Maca texture are a bit softer with a heavy sheen. Possible that too much R#51254 oil & R#51226 polishing
 was added in the demolding process interfering with the dehydration process. 
 
 Initial Action(s) Taken (Completed by the Initiator) 
 Notifications (check all that apply) Quarantine / Tag Out / Hold
 L] QA LI QC Lab L] Executive LIN/A 
 L) QC Inspectors WR&D Management L Yes (explain below) 
 L] QC Doc Control W Prod. Management 1 Other (specify below) | 1 No (explain below)
 Describe immediate action taken to correct the deviation or nonconformance and to provide detail for boxes above.
 
 Production has noticed recently that gummies left in our drying rooms at ambient temperature will increase in water activity over time
 in seasons of high humidity. This lot of Black Maca was Wa tested five different times ranging from 0.71 to 0.63. Production has
 recently started targeting the lower to middle ranges of our Wa specifications before release. Also, releasing a max of three carts in the
 production area at a time to limit the time each cart is allowed to stay in ambient temperatures.
 
 Deviation Assignment (Completed by the Initiator and/or Quality) 
 A L s e s a i d g n I e nv d e t s o t igator Role Gabarbireile l DomiDominguez Deviation 06/20/24
 Due Date 
 Approval Signatures 
 Name Title Signature Date 
 
 ( C In o i m t p ia l t e o t r) e d By: Gabriel Dominguez Gummy Manager 
 
 Assignment Accepted By: 
 (/ N/A if same as completed by 
 Approved By: 
 (Quality)