Living Magazine English Living Magazine 2017 | Page 24

The
Quality Assurance
Process
What is
Quality Assurance?
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 dōTERRA standards, such as
CPTG Certified Pure Therapeutic Grade ® .
However, there are also legal require-
ments 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. 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
dōTERRA because our internal use
oils are labeled as dietary supplements.
24 / EUROPE LIVING MAGAZINE
There are three branches of QA at dōTERRA:
QA Inspectors, QA Engineers, and Document Control Specialists.
QA Inspectors QA Engineers Document Control
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 inspec-
tions 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. This highly technical group has a
scientific education and extensive QA
experience. 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: specifica-
tions, formulas, Standard Operating
Procedures (SOPs), batch records,
label approvals, master manufactur-
ing 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.
What is QA’s role in CPTG ® ?
Early in the process, Research and
Development, Quality Control (QC),
and Strategic Sourcing work with
QA to carefully develop and define
the testing criteria for each oil and
blend. The result of this definition is
documented in a specification created
and routed for review by Document
Control. This document is used by our
QC laboratories to determine which
tests are needed and to evaluate if
the oil passes or fails. This specifica-
tion is also used by the QA Inspectors
to evaluate the raw and the finished
good oils. Finally, the specification is
used by the QA Engineers when they
review the entire file that includes
the production, QC testing, and QA
inspection records to determine if the
product meets our standards and can
be released for sale.
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 an Independent Product
Consultant reports a quality issue
with one of our products, a QA Engi-
neer 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 certifica-
tion 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.
What does this mean to you?
Great quality lives in the details. Our constant checks, documentation, and reviews
mean that we care about the details that make our oils world class. This passionate
commitment means that you can use the oils and all of our products to benefit your
family with confidence. Know that we are working tirelessly to check every detail,
bringing you only the very best products. You can confidently share the products
with people you love, knowing that we are constantly striving to improve our products
and processes. Commitment to continuous improvement means longevity. Our
Quality Assurance group works to ensure that the fabulous products you enjoy will
continue to be the best for years to come.
doterra.com / 25