Document Type Definitions

Location-Level Documents

  
3rd Party Audit (Primary) This document shows each of the points that were reviewed by an independently performed audit. Third-Party audits assess conformity of manufacturing facilities to ensure that they meet or exceed standards and to identify steps to continually improve processes to supply safe and consistent quality products. This is more extensive than the certificate which displays only the final score.
3rd Party Audit Certificate This document shows the final score for a facility of the audit performed by an independent agency.
3rd Party Audit Corrective Action Plan This document shows each of the points that were reviewed by an independently performed audit. If the audit report shows deficiencies, this document includes what actions the facility will take (or has taken) against any deficiencies found by the auditor.
Allergen Control Policy This document outlines the allergen control plan (ACP) in place that specifies the systematic method for identifying and controlling allergens. If processing, this would include from the incoming ingredients to the final packaged product in the facility.
Bioterrorism Letter This document represents the companies specific plan for Bioterrorism Preparedness and Response.
CA Transparency Act This document discloses what efforts a supplier is taking to ensure their supply chain is free of human rights violations as per the California Transparency in Supply Chains Act, also known as Senate Bill 657. This law impacts companies that do business in the state of California.
CTPAT This document shows the findings of the C-TPAT audit for the supplier facility. The Customs-Trade Partnership Against Terrorism (C-TPAT) is a voluntary supply-chain security program led by U.S. Customs and Border Protection (CBP) focused on improving the security of private companies' supply chains with respect to terrorism.
Environmental Policy This document states the supplier's commitment to the laws, regulations, and other policy mechanisms concerning environmental issues.
Ethical Code of Conduct This document clarifies an organization's mission, values, and principles, linking them with standards of professional conduct.
FDA Registration This document confirms the facility has completed the FDA site registration requirements per the Public Health and Bioterrorism Preparedness and Response Act of 2002 and FSMA 2011 (Food Safety Modernization Act).
Food Defense Plan Statement This document represents the facilities plan to address intentional adulteration (IA) vulnerabilities and mitigation strategies for those vulnerabilities.
GFSI Audit Report This document shows each of the points that were reviewed in the Global Food Safety Initiative (GFSI) audit performed by an independent agency for the GSFI approved schemes including SQF, BRC, IFS, FSSC, GLOBALG.A.P. and BAP and CanadaGAP. This is more extensive than the certificate which displays only the final score.
GFSI Certificate This document shows the final score of the Global Food Safety Initiative (GFSI) audit.
HACCP Plan (Facility) This document outlines the facilities HACCP plan (Hazard Analysis and Critical Control Points).
HARPC Food Safety Plan (Facility) This document describes the Hazard Analysis and Risk-Based Preventive Controls (HARPC) plan for the facility as required by the United States FSMA.
Insurance Supplier document to certify the insurance coverages and limits in place for the supplier.
Letter of Guarantee This document guarantees that the supplied items are not adulterated or misbranded within the meaning of the Federal Food, Drug, and Cosmetic Act.
NDA This document specifies a legal contract between at least two parties that outlines confidential material, knowledge, or information that the parties wish to share with one another for certain purposes, but wish to restrict access to or by third parties. Non-disclosure agreement (NDA) is also known as a confidentiality agreement (CA), confidential disclosure agreement (CDA), proprietary information agreement (PIA), or secrecy agreement (SA).
Organizational Chart This document shows the leadership structure of the organization and the roles, responsibilities, and relationships between individuals. This is typically represented as an illustrated organizational chart (often called organization chart, org chart, organigram(me), or organogram).
Recall Plan This document outlines the facility recall program which includes a written action plan that is carefully constructed, tested, and evaluated to ensure efficiency.
Recall/Emergency/Contact List This document lists the supplier company contacts who should be contacted in case of an emergency situation or recall. At minimum, this should include name, title, office phone, and mobile number for each individual.
Supplier Approval Program Statement This document outlines the company program to approve suppliers.
Supplier Questionnaire TraceGains Standard Online Form - collects facility level information to assist customers in the supplier approval process and for creating and maintaining food safety plans. TraceGains works with an ongoing customer advisory panel to ensure standard forms are current with ongoing requirements and regulatory changes.
Sustainability (Level 1) TraceGains Standard Online Form - collects basic sustainability and social responsibility information for customer evaluations. Sustainability is responsibility for the impact that the organization exerts on its surroundings, in business, environmental, and social terms. TraceGains works with an ongoing customer advisory panel to ensure standard forms are current with ongoing requirements and regulatory changes.
Sustainability (Level 2) TraceGains Standard Online Form - form to collect more detailed sustainability and social responsibility information for customer evaluations. Sustainability is the responsibility for the impact that the organization exerts on its surroundings, in business, environmental and, social terms. TraceGains works with an ongoing customer advisory panel to ensure standard forms are current with ongoing requirements and regulatory changes.
W-9 The W-9 form provides key U.S. tax information a customer needs if supplier is an independent contractor.

Item-Level Documents

  

Allergens

 TraceGains Standard Online Form - collects allergen information for the supplied item and its manufacturing facility. TraceGains works with an ongoing customer advisory panel to ensure standard forms are current with ongoing requirements and regulatory changes.
Animal Testing Statement This document allows customer to understand if the item has had or will have animal testing conducted, or if any of its individual ingredients/raw material components have been tested on animals.
BSE - TSE This document allows customer to understand any relevant risk in regards to Transmissible Spongiform Encephalopathy (TSE) and Bovine Spongiform Encephalopathy (BSE).
California Prop. 65 This document gives customers the information they need to satisfy the requirements of the Safe Drinking Water and Toxic Enforcement Act of 1986, also known as Proposition 65. The law requires businesses to provide warnings to Californians (and others doing business in the State of California) about significant exposures to chemicals that are known to cause cancer, birth defects, or other reproductive harm. The State of California publishes a list of all chemicals of concern. The document should declare any chemicals in the product present on the list and the amounts in which they are present.
CoA Sample This document is a Certificate of Analysis (COA), which states the identity, purity, and/or microbiological state of a product. It shows that the supplier completed the required testing and that the results meet the product specifications. This document also provides an example of the COA format for this supplier item for customer reference purposes.
Country of Origin TraceGains Standard Online Form - collects the Manufacturing Country of Origin of the supplied item and the Country of Origin for each raw material component in the item. The Manufacturing Country of Origin is the country where the final product is produced, which is reported on the finished good’s package label for import/export purposes. Country of Origin for the raw material components is the originating source country of each component used in the creation of the finished good. TraceGains works with an ongoing customer advisory panel to ensure standard forms are current with ongoing requirements and regulatory changes.
Dietary Supplement Questionnaire TraceGains Standard Online Form - collects item information for dietary supplement customers. TraceGains works with an ongoing customer advisory panel to ensure standard forms are current with ongoing requirements and regulatory changes.
EtO Statement This document allows customer to understand if Ethylene Oxide is used in the processing of the item.
Food Contact Packaging Certificate of Compliance This document certifies that all packaging materials used in the manufacture of this item meet local regulatory requirements and the customer's receiving location regulatory requirements for articles intended for use in contact with food.
FSVP Assessment Form TraceGains Standard Online Form - collects facility and product/ingredient information to support the Foreign Supplier Verification Program (FSVP) rule. The FSVP requires impacted companies to document specific verification steps to satisfy regulations and meet foreign-supplied shipment information requirements. TraceGains works with an ongoing customer advisory panel to ensure standard forms are current with ongoing requirements and regulatory changes.
Gluten A gluten-free certificate provides assurance that a product or facility meets established standards for gluten-free production. A gluten statement allows buyers to better understand if uncertified items are suitable for use in gluten-free products. 
GMO A non-GMO certificate provides assurance that a product of facility meets non-GMO standards. A GMO statement allows buyers to better understand if uncertified items are suitable for use in non-GMO products. 
GRAS/NDI/ODI Statement This document communicates the item's legal status for use in dietary supplements in regards to Generally Recognized as Safe (GRAS), whether it is a New Dietary Ingredient (NDI), or an Old Dietary Ingredient (ODI) “grandfathered” per DSHEA, the Dietary Supplement Health and Education Act of 1994, also known as Pre-DSHEA ingredients.
HACCP This document describes the HACCP (Hazard analysis and critical control points) system used, along with any applicable details to illustrate that the system is implemented and operational.
HACCP Process Flow Diagram This document is an illustrated flow diagram that shows every aspect or activity of an item's manufacturing process in the order that they occur. It should be in a simple format that is able to be interpreted clearly.
Halal A halal certificate provides assurance that a product or facility complies with Islamic dietary laws and principles. A halal statement allows buyers to better understand if uncertified items are suitable for use in halal products. 
HARPC Food Safety Plan (Item) This document describes the Hazard Analysis and Risk-Based Preventive Controls (HARPC) plan for the item as required by the United States FSMA.
Heavy Metal This document allows customer to understand any heavy metal content, including all regulatory guidance or references used.
Ingredient Statement This document declares all ingredients listed on label in descending order by weight.
Irradiation Status Statement This document allows customer to understand if irradiation is used in the processing of the item.
Item Questionnaire TraceGains Standard Online Form - collects facility level item risk information to assist customers in the item approval process and for creating and maintaining food safety plans. TraceGains works with an ongoing customer advisory panel to ensure standard forms are current with ongoing requirements and regulatory changes.
Kosher A kosher certificate provides assurance that a product or facility adheres to the requirements of Jewish dietary laws and principles. A kosher statement allows buyers to better understand if uncertified items are suitable for use in kosher products. 
Label Claims This document specifies all applicable claims that customer can make for the item including health claims, nutrient content claims, free-of claims, structure/function claims, etc., including an attached certificate or other applicable supporting documentation.
Label Guidance This document outlines consumer label requirements for products containing the item such as logos, patent numbers, halal marks, trademarks, ingredient naming specifications, etc.
Label Sample This document illustrates an example of the item label that the customer should expect to see upon receipt of the item. It is often a clear photo or scanned copy of the label.
Lot Code This document explains the lot code system used for the item and gives examples of the code breakdown for customer to easily interpret.
Melamine This document declares if the item contains melamine.
National Bioengineered Food Disclosure Standard (Simplified) National Bioengineered Food Disclosure Standard (Simplified)
Natural This document specifies if the item meets applicable "Natural" labeling regulations, including applicable regulatory guidance.
No Animal Ingredient Statement This document declares if the item is of animal origin or if it contains ingredients of animal origin. If so, the document identifies all animal sources for the item.
Nutrition TraceGains Standard Online Form - collects nutritional information for the item, defaulted to collect data per 100 grams, but can also collect "per serving."
Organic An organic certificate provides assurance that a product or facility complies with established organic standards. An organic statement allows buyers to better understand if uncertified items are suitable for use in organic products. 
Pesticide This document allows customer to understand applicable pesticide monitoring programs and testing standards for the item to ensure acceptable safety, including regulatory guidance or references used.
Phthalate Esters Letter This document declares if the item contains any Phthalate esters.
Product Specification Sheet This document summarizes the technical characteristics (attributes) and other key properties of the item. This can also be referred to as a product information datasheet.
Residual Statement This document allows customer to understand if any organic solvents are added or used in any form during the manufacture, storage, or packaging of the item. Residual Solvents are organic volatile chemicals used in the manufacture of a material or component, which may not have been completely removed during the manufacturing process.
Safety Data Sheet (SDS) This document (formerly known as MSDS) provides useful information on chemicals, describing hazards the chemical presents, and giving information on handling, storage, and emergency measures in case of an accident. This document must follow the standard format as required by The Hazard Communication Standard (HCS) (29 CFR 1910.1200(g)).
Sewage Statement This document states that the item has not been produced with the use of sewage sludge as a part of the production process.
Shelf Life This document states the shelf life of the item at a given temperature and storage condition. If more than one condition is applicable, it will list all shelf life specs that apply (i.e. frozen, refrigerated, ambient).
Suitability Requirements TraceGains Standard Online Form - collects the item suitability type information (kosher, Halal, Organic, etc.) for the supplied item. TraceGains works with an ongoing customer advisory panel to ensure standard forms are current with ongoing requirements and regulatory changes.
Vegan/Vegetarian Statement This document allows customers to understand if the item is considered acceptable for consumption for a Vegan or Vegetarian diet. Vegan: doesn't contain any ingredient of animal origin or animal derivatives (meat, fowl or fish including crustaceans, mollusks, dairy, egg and bee products), including additives and processing aids such as animal derived enzymes, glycerides or bone char used in sugar manufacturing. Vegetarian: doesn't contain meats of animal origin (bovine, porcine, fowl or fish including crustaceans and mollusks) including additives and processing aids such as animal derived enzymes, glycerides or bone char used in sugar manufacturing. However, may contain ingredients of animal origin like dairy, egg and bee products (e.g. honey, bees wax). Not Suitable: contains meat(s) of animal origin (bovine, porcine, fowl or fish including crustaceans and mollusks), including additives and processing aids.
WADA/NSF/NFL Statement This document communicates if the item is impacted by the World Anti-Doping Agency Prohibited List or other established sport-banned ingredients lists and specifies any third-party testing or certification in regards to safe use for athletes.
   

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