Gummy Packing Quality Jeopardy

Systems/SOPs

100

This system is set in place to ensure all CLs and quality checks are in specification/range

Proficy

200

This standard shows all GCAS numbers and what materials associates with it including substitutions 

FPP

300

This system manages inventory consumption during production for reconciliation purposes

MCT

400

This standardized operating procedure includes the defect flow chart and action steps with classified defect

PKG-SOP04383

500

This standardized operating procedure states all gummy packing quality procedures

PKG-SOP04371 Gummy Packing Lines Quality Control Operations

Quality Defects

100

This system allows P&G personnel to input materials into this database that does not align with specifications and causes unplanned downtime due to defected material

COM - Complaint on Material

200

This standard assists with defect classification

QAC 

300

This physical location is where gummies place their defected material

Behind line 9 or top of gummy tunnel

400

This step must be taken when campaign length exceeds campaign length duration. 

Stop production and product contact clean immediately. 

500

This time frame is the validated campaign length for Gummy Packing Lines 

96 hours.

Start-up/Quality Checks

100

This start up check ensures the weight of our gummies meets our specifications

Average Gummy Weight

200

This hourly check ensures the seal is sealed completely around the mouth of the bottle and no burn marks are present

 Area 4 Attributes

300

This timeframe is allotted to complete quality inspections without entering a memo

30 minutes

400

Corrugate must be marked with this term while performing start up checks at the casepacker. 

Test

500

Last Clean/Sanitization date must be entered in this format in QIMS. 

HH:MM; MM/DD/YYYY format. 

Hourlys

100

This sample must be taken during bulk batch changes. 

micro sample. 

200

This inspection requires "x" amount of bottles in Area 3 during hourlys. 

12

300

Area 4 consists of "x" bottles when performing hourly inspections. 

63. 

400

This must be performed prior to taking samples. 

Hourly inspections. 

500

This constitutes as a major defect for container label per the QAC

Count, UPC barcode or brandcode is missing, illegible or incorrect on one or both sides of container. 

Wild Card

100

This logbook entry shows pit stop/RLS was performed. 

"E" or non-product contact cleaning

200

This action must be taken when QIMS is not readily available. 

perform back up paperwork.

300

This vault is where all GMP and Non GMP documents are stored. 

Veeva

400

This SOP shows the "Do's" and the "Don'ts" when making GDP corrections

SOP02945

500

This must be done in Proficy when production line is under validation, APD (Authorized Planned Deviation), ATS (Authorized Temporary Standard) or an EO (Experimental Order). 

Mark "Yes" and enter applicable memo. Ensure ATS/APD include expiration date. If "No" then mark "NA" in appropriate inspection.