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Compliance Plan Guidance Document
For Inputs Used in Organic Crop and Livestock Production
Introduction
The following outline provides guidance on the essential components needed to create and maintain a Compliance Plan for input manufacturers of products used in organic production. This is intended to be a guidance document for input manufacturers and not every facility will require all components.
Inputs for use in organic production must meet the requirements of the USDA National Organic Program (NOP) regulations, 7 CFR Part 205. Companies supplying organic producers with fertilizers and soil amendments need to maintain all the records necessary to document compliance to the NOP. Third-party reviewers, including certification agents, are implementing comprehensive due diligence in approving not only high-nitrogen liquid fertilizers but all inputs for use in organic production.
In addition to formal regulations, the NOP issued a policy on December 14, 2009, titled “Approval of Liquid Fertilizers for use in Organic Production”, which states that manufacturers seeking approval of products for use in organic production must:
1. Maintain complete records sufficient to demonstrate compliance with the NOP regulations.
2. Submit complete documentation describing all ingredients (active and inactive), manufacturing processes, process control information, testing, and other information as required by the material evaluation program.
The following guidance will serve as an aid to manufacturers seeking to develop an organic compliance plan. Once a plan is developed, it can be used to provide information as requested by a materials evaluation program and aid in on-site inspections.
Part I: General information
A. Company Information
1. Contacts (including title of each contact, addresses, telephone numbers, fax numbers, and email addresses of personnel authorized to handle confidential, public or other information)
2. Legal structure and ownership of the company
3. Co-packer or contract manufacturer information, if appropriate
4. Brief description of the business and the procedures in place for compliance to the National Organic Program and other organic regulations if applicable
5. Procedures for training staff about organic regulations
B. Product General information
1. Timing of manufacture (seasonal, continuous, intermittent, etc)
2. Other non-organic products produced in the same facility, if any
3. Location of facility (ies)
4. Facility contact personnel, titles
Part II: Raw Ingredients
A. List of all Incoming Raw Ingredients, including:
1. Sources
2. Analysis
3. Storage Location
4. Reviews by Independent Third-Party Auditors, if applicable
Part III: Manufacturing Process
US organic regulations require that the final input be non-synthetic or on the National List of Allowed Synthetics Section 205.601. To understand whether your process uses or creates synthetic ingredients or inputs, the following information is needed:
A. Facility map – locations of all facilities relevant to manufacture of your product
B. Equipment list – all equipment used in handling and manufacturing your product
C. Production Process Description
1. Production Flow chart – all steps from initial ingredients until there is a final product ready for storage or shipping
2. Written Description of the Manufacturing Process - including ingredient amounts and processing aids, sequence and duration of events, temperatures, and processes such as digestion, fermentation, extraction, or any chemical reactions, etc.
3. Typical yields – the quantities you produce in a specified period of time. Consider this from a third party’s point of view. What is understandable and able to be confirmed during a single site visit? Be prepared to explain discrepancies in the results or anticipated losses during the manufacturing of the final product.
4. Batch capacity – What will one batch produce, and how often is a batch completed.
5. Sampling performed (testing performed, labs used, frequency of testing, etc.) – Tests related to your quality control.
6. Process Validation by Third-Party Audit - Any outside confirmation of aspects of your process. (ISO accreditation, OMRI, WSDA or other outside inspection)
D. Compliance Control Points (CCPs)
1. Pest control – Where necessary, what system do you provide to prevent pests from contaminating your system (thus your product)
2. Contamination prevention – How do you prevent prohibited materials in any quantity from being added to your products? Examples: Clean out systems between production of other products, Lockout systems to prevent unintentional addition of other ingredients, Sanitation systems where necessary (with removal of prohibited sanitizers where necessary), and segregation systems to prevent contamination which might occur from the manufacture of non-compliant products.
3. Employee training – describe training to assure that employees follow the control system
4. Split operations: If the facility produces products for both organic and non-organic use, describe steps taken to prevent commingling of ingredients or products.
E. Storage facilities/capacity – a description of your facilities for storing both the ingredients to manufacture your product and the final product. Also include the facilities used if there is storage used intermediate to the process of manufacture (e.g. storage of blended ingredients used in manufacture of product). Capacities available and alternate uses should be noted.
Part IV: Finished Goods
A. A list of all products manufactured in this facility, including any conventional products as well as those allowed for organic use. The list should provide:
1. Copy of all labels
2. MSDSs, if applicable
Part V: Documentation
A. Inventory Management
1. Raw Ingredients
a. Receipts, Purchase Orders, Bills of Lading
b. MSDSs, if applicable
c. Spec sheets, if applicable
d. Make sure to obtain “current” information from the ingredient supplier – suppliers can change their own formulations, placing the compliance of a final product at risk.
e. Live organism listing including species and quantity, if applicable
f. NOP compliance documentation
i. Organic certifications for applicable inputs
ii. Disclosure of any presence or use of Genetic Engineering, Sewage Sludge or Irradiation.
g. Sampling records/analyses – Results of any and all analyses for quality control and to meet compliance requirements i.e.; Heavy metal tests, nutrient analyses, contamination tests, etc.
2. Storage Location and Quantities of All Inventory Items
3. Production - Volume in-volume out record (Yield estimates & records.) Both your anticipated results and your actual results.
4. Work in Process records
5. Finished goods
a. MSDS, if applicable
b. Spec sheets, if applicable
c. Sampling records/analyses – the tests you use to assure the quality of your final product
6. Sales and Shipping Records
B. Lot Tracking Records
1. Raw Ingredients
2. Work in Process (WIP)
3. Finished Goods
4. Flow charts for Lot Tracking (Lot tracking pathways)
5. Description of lot numbering system, or other tracking system
C. Standard Operating Procedures (SOPs) (These are optional and may be helpful for various manufacturing operations)
1. General Recordkeeping / Document Flow
2. Purchasing
3. Documenting receipt of incoming ingredients
4. Lab testing of incoming ingredients
5. Ingredient storage
a. Lot Number Assignments
b. Segregation of allowed vs. prohibited materials
6. Equipment Cleaning / Purging
7. In-Process Storage
8. Staging and Batch Mixing
9. Packaging
10. Storage of final product
11. Order Processing
12. Shipping
13. Pest Control
14. Training and Safety Protocols
D. Formulas
1. Confidential Statement of Formula - recipes that include quantities and quality specifications significant to the quality of the Final product
E. Registrations and Certifications
1. Other entities which license, inspect, or otherwise regulate the facilities used for the manufacture of this product
a. Other certification for organic input compliance, or certificates for compliance of ingredients
b. Non-governmental third party inspection/audit results/reports (quality systems, ISO, HACCP, etc.)
c. State or other government licenses, registrations, inspection reports, etc.
F. Other Documentation
1. Sanitation Logs
2. Pest Control Logs
3. Personnel Training Logs
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