Tuesday, July 25, 2017

Quality: Control, Assurance, and Verification

When I was in my late teens and twenties, my dad transitioned from being on the manufacturing floor to being a six-sigma certified quality control manager for a very large and well known manufacturer in the film industry.  I went into software engineering as a programmer, but additionally trained in time and quality management using the same principles that the manufacturing industry had been using for decades. I was working for a Fortune 500 communications company.   My dad and I had many talks about quality control, quality assurance, and verification.  Below, I will be sharing a bit about quality measures and how they apply to botanical products, specifically essential oils.

Quality control:  In the auto industry, a windshield must be the right size (length, width, thickness), have the proper curvature, have glare protection, safety glass, and a host of other features in order to be safe and suitable for use in a motor vehicle.  All of these features are measurable and are called "metrics".  Each metric has a range.  For example, if the glass thickness must be 12mm, it may have a range of "acceptable" if it is between 11.995mm and 12.005mm to be usable.  If a particular windshield is 12.1mm in thickness, it is rejected and not used in a vehicle.  Controlling these metrics and rejecting those pieces which fall outside these metrics is done by people on the manufacturing floor, if a piece fails, it is rejected, if more than three pieces fail in a group of ten, manufacturing stops and the equipments is recalibrated so that there is as little waste as possible.  Safety of the end user is at stake, all the pieces of the vehicle must be correct within the specified ranges.

Quality assurance: It is not enough for the people who are manufacturing an item to say that it is correct, a separate testing group must double check.  In the software world, a programmer makes sure that his programs "works" on its own and in conjunction with the software from the rest of his team.  But, the "testing group" takes the software and assures that every single requirement is met. Several hundred requirements for a piece of software are written down before the software is designed or written.  For each requirement, the testing group writes a test to assure that the software meets the requirement.  While this may or may not find all the "bugs", it acts as an internal audit of the product answering the question: Does it do what it says it does?

Quality verification:  To verify something is to declare it as true.  In the banking industry, Federal regulators will visit a financial institution for several weeks as outside, independent auditors to assess whether or not the bank is following it's own procedures.  These auditors are "third-party", they have no incentive to falsely represent their findings, they exist for the purpose of "keeping the bank honest". Although banks have self-checking systems (internal auditors who constantly assure that procedures are written and followed), they are not independent.  Outside, independent verification is needed.  Without this step, the consumer must blindly trust that the institution is doing what it says it does.  The independent regulator can say "I am not an employee or owner or stockholder, I have checked that they do what they say, here is my report, here is my signature, you can trust them because you can trust me because I have no reason to lie."  A report verifying the findings of the independent auditor is made public every year, reassuring the consumer that the bank is above board.


How does all of this apply to botanical products, particularly essential oils?

Briefly, essential oils are extracted by one of three processes: cold pressing, steam or water distillation, or CO2 extraction.  The quality of the plant matter is important. Soil quality, water quality, altitude, farming methods, pest control methods, etc., all play a part in the quality of an essential oil, or any botanical product.  Each batch of distilled essential oil varies from other batches due to the factors listed above, that is there are slight (and sometimes not so slight) chemical variations between batches of essential oils.  Many vintage and professional aromatherapists seek out unique distillations for specific therapeutic needs.   Some very large retailers blend various batches together so that over the years, their product is chemically standardized, that is, they allow for almost no variation in chemical constituent levels in their final product from bottling to bottling.


Let's say that a retailer has purchased a barrel of essential oil from a distiller.  The distiller provides the retailer with a batch specific analysis of the chemical constituents.  The retailer then runs some basic tests, perhaps blends this batch with other batches, and retests until these test results fall within the acceptable ranges set by the retailer.  Retailer bottles and labels the product for sale.  This is quality control.

A quality inspector for the retailer randomly chooses a bottle, checks the label, the cap, the weight, opens it and smells it, perhaps they check some of the metrics that quality control says that it meets.  This is quality assurance.

So far, all of the quality control and assurance has been "in house".  The quality control group is sometimes given a fancy name, such as Purity Certifiers, but their job is still vested in the company, the company's interest, and they will test to the company's standards or desires. 


Now, before releasing this lot to the public, the conscientious retailer sends one to three bottles to an independent lab.  This lab specializes in essential oils.  Not only does the independent lab verify that the metrics set by the retailer are met, they check whether this product falls within industry standards, they check this essential oil is authentic, that no synthetics have been added, that it is pure. They give their report back to the retailer detailing the unique chemical makeup of this batch of essential oils. This is called third-party testing or verification.  

The ethical retailer makes the independent report available to the consumer.  The consumer may then look at the report and decide to purchase that product from that retailer because they trust the independent lab and they appreciate the properties of the product based on the unique chemical composition represented in the report.  Ideally, there will be subtle differences in chemical composition between batches of essential oils as this reflects the variability between growing seasons and conditions.  To the consumer, this final testing is a more accurate reflection of their purchase than any report which was done at distillation or during any step of the in-house quality control process.


How should this affect consumer choices?  Consumers should demand quality.  Quality should be verified by a third-party.  A savvy consumer will purchase from reputable companies who not only have strict internal quality control, but also those who release reports from third-party labs testifying to the authenticity of their product.  It only takes a few minutes to reach out to a retailer and ask them for their third-party test results.  Ask today!