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Quality assurance (QA) is often referred to as the “police” of the manufacturing world, because some of our duties in QA make us seem like police officers. We enforce doTERRA standards, such as CPTG Certified Pure Therapeutic Grade®. However, there are also legal requirements that we enforce throughout each stage of sourcing and bottling our oils. All of our products, whether they are foods, cosmetics, or dietary supplements, have regulatory requirements in each country where they are sold. These requirements influence and sometimes dictate the labeling, sourcing, and manufacturing processes that result in the end product. For example, the United States 21 CFR 111 (the section of the Code of Federal Regulations that governs dietary supplements), lists duties for quality. In brief, QA has the responsibility to review and approve items such as ingredient, component, and finished good specifications; procedures; manufacturing records; and equipment. This applies to doTERRA because our internal use oils are labeled as dietary supplements.
Part of our responsibility in QA is to enforce standards and government regulations.
QA Inspectors
Since nothing enters or leaves the building without QA approval, you will find a QA Inspector in every process. QA Inspectors inspect every component of every batch. Before an incoming shipment can be moved into our warehouse, our QA Inspectors examine each batch of oil, labels, caps, bottles, boxes, etc. The QA Inspector then labels a raw material or component that passes as approved. QA Inspectors inspect the filling line at the start of every run, perform inspections at set intervals during the run, keep samples of every batch, verify production records, and inspect each lot of finished goods. The samples collected ensure that we have a history of the oil’s appearance, odor, and taste for future reference.
QA Engineers
This highly technical group has a scientific education and extensive QA experience. They sign that each product meets our standards and they serve as a second set of eyes to verify our QA Inspectors have checked each detailed step in the process. They review and approve testing and changes to our equipment with our manufacturing engineers. If a Wellness Advocate reports a quality issue with one of our products, a QA Engineer investigates the complaint to continuously improve our products and processes, developing new procedures as needed. The QA Engineers also conduct internal and supplier audits, and help us maintain our third party NSF cGMP (Good Manufacturing Practices) certification. This certification requires a third party to audit our manufacturing facility every six months. As a QA team, we chose to pursue this certification because audit by a third party creates a culture of accountability. It is designed to keep us focused on meeting and exceeding our own quality standards. QA Engineers carefully review inspection records created by QA Inspectors to confirm that a product is ready to be released.
Document Control
We create several hundred document files, totaling thousands of individual documents per week that must be housed and updated in an organized, easily retrievable fashion. Sample document types include: specifications, formulas, Standard Operating Procedures (SOPs), batch records, label approvals, master manufacturing records, audits, investigations, maintenance and cleaning records, and equipment and room use logs. Just as it would not be possible for electricians, framers, and plumbers to build a house without a blueprint, all of the departments from sourcing to the chemists who come together to create, manufacture, and approve a finished oil need a set of “blueprints.” These specifications provide order and predictability to help ensure the desired outcome. Document control gathers all of the required information in one place, obtains approvals, and then releases the specification to all affected departments. Everyone has the same standard when producing, inspecting, and testing the oils. Document Control manages the processes needed to ensure that we have "laws" that govern the definition of our standards.