Aligned with QAF-058 Allergen Master Hazard Analysis and QAP-033 Allergen Management. Configure users, program basis, and the nine facility allergens below.
Users & Tab Access
Select an employee from the approved Employee List, then assign username, role, and tabs. Users cannot be created without an employee.
Choose Role = User, then check which tabs this person can open.
Approved Employee List
Read-only from shared_apps_data/employee_list/records. Manage employees in the Employee List shared app.
Program basis (QAF-058 / QAP-033)
Allergen Master List
Nine facility allergens per QAF-058. Edit risk level, control method, and notes for each allergen.
Shared catalogs (employees, production lines) are read-only from shared_apps_data. Allergen matrices, logs, users, and program setup save to sharedAllergenControlData/main. Matrix values: X = contains, N/A = not applicable, blank = none.
Document cleaning, inspection, line clearance, and swab/validation when required.
Deviation + CAPA
Wrong label, cross-contact, failed cleaning, or wrong ingredient must be escalated.
Raw Material Allergen Matrix
QAF-058 Sheet: Raw Material — mark X = contains, N/A = not applicable, blank = none.
Finished Products Allergen Matrix
QAF-058 Sheet: Finished Products
Production Line Allergen Matrix
QAF-058 Sheet: Process Allergens. Line names load read-only from shared_apps_data/production_lines/records; allergen assignments (X / N/A) save to sharedAllergenControlData/main.
Company GMP Policy, hand washing, personal hygiene, and employee training effectively prevent allergen cross-contact. Employee hand washing is monitored.
Label Verification
Changeover Cleaning / Validation
Allergen Rework Control
Allergen Records
Annual Allergen Review
Review program once per year or after formula/label/process changes (QAP-033).
Master List
Verify all facility allergens and ingredient profiles are current.
Labels
Confirm label approvals match ingredients and allergen declarations.
Sanitation Validation
Review changeover cleaning and swab/validation evidence.
Training + CAPA
Verify allergen training and repeat deviations/CAPAs.