SOP Development Package: Defect Action Levels (DAL) Control
Regulatory Reference: 21 CFR § 117.110
Development of a standardized documentation and training package to support food safety compliance with FDA’s cGMP requirements regarding natural or unavoidable defects. This package ensures quality control systems are in place to identify, reduce, and document the handling of defect levels in food products in alignment with FDA’s DAL guidance.
Deliverables
1. Program Document
- • Overview of DAL requirements and defect types
- • Regulatory references and enforcement risks
- • Integration with HACCP or QA systems
2. Policies
- • Defect Control Policy
- • Supplier Verification & Raw Material Inspection Policy
- • Finished Product Hold and Disposition Policy
3. Standard Operating Procedures (SOPs)
- • Incoming Raw Material Inspection for Natural Defects
- • Finished Product Visual Inspection and Sampling
- • Reject and Rework Procedures for Non-Conforming Batches
- • Recordkeeping and Trending of Defect Incidents
- • QA Verification Procedures (e.g., sample size, frequency, escalation)
4. Forms for Records
- • Raw Material Inspection Log
- • Finished Product Defect Check Sheet
- • Defect Disposition Record
- • QA Trend Analysis Log
- • Hold/Release Authorization Form
5. Training Materials
- • Slide deck and handouts: "Understanding Defect Action Levels & FDA Standards"
- • SOP walkthrough videos/presentation
- • Knowledge check quiz with answer key
- • Training acknowledgment and attendance sheets
Fees and Subscriptions
Per Unit Pricing
| Service Component | Price (USD) |
|---|---|
| SOP Development – Per Food Category | $150/category |
| Policy Customization – Defect Control | +$200 |
| Record Form Customization – Per Facility | +$100 |
| Translation (English to 1 language) | +$300 |
| Annual Update & Compliance Subscription | +$450/year |
Bundle Package Options
| Bundle Name | Inclusions | Price (USD) |
|---|---|---|
| Basic Defect Control Kit | 2 SOPs, 2 forms, 1 policy, basic training module | $700 |
| QA Monitoring Package | 4 SOPs, 3 forms, 2 policies, training module, 1 inspection checklist | $1,250 |
| Full DAL Compliance Set | 6 SOPs, 5 forms, 3 policies, complete training set, integration guidance | $1,900 |
| Advanced Quality Suite | 10 SOPs, 8 forms, 4 policies, full training, supplier QA add-on, mock audit | $2,850 |
Optional Add-Ons: Remote QA gap audit, DAL trend dashboard, FSMA/SQF audit alignment module, product-specific SOPs.