Quality Thinking

Understanding quality assurance and quality control

One of the most misused expressions these days is the term “quality assurance.” There are people who obviously don’t have the faintest idea what the terminology means, but feel it sounds impressive when they say, “We have quality assured…” Unfortunately, when they continue with their explanation, it becomes easy to see that they don’t know what it means, since they are actually saying: “We have let others check this after we did it.” That, guys, is quality control – not quality assurance.

In Norway, some of today’s politicians are among the most frequent misusers of this expression. They don’t understand what quality means. However, they do understand that quality is something good.

For example, politicians recently decided that universities needed to go through a “quality reform,” where the students are now supposed to finish their Bachelor’s, Master’s and Ph.D. degrees much more quickly than before. The new speed in the program has made it possible to omit many classes and still obtain the degree. This way, we can educate more people.

Unfortunately, this is actually a “quantity reform” rather than a “quality reform.” My husband, a professor in geochemistry, claims that a Master’s now is equivalent to a Bachelor’s of the good old days. Then again, it seems that older people (i.e. 50 plus) have always claimed that everything was better when they were young.

Quality assurance versus quality control

What we do see today in our society is that, although real quality assurance is not performed more often than it was before, the quality control is a bit more visible.

Quality assurance is defined in ISO 9000:2000 as the “part of quality management focused on providing confidence that quality requirements will be fulfilled.”

It is defined by the FDA glossary as
“[1] The planned, systematic activities necessary to ensure that a component, module, or system conforms to established technical requirements
[2] All actions that are taken to ensure that a development organization delivers products that meet performance requirements and adhere to standards and procedures
[3] The policy, procedures, and systematic actions established in an enterprise for the purpose of providing and maintaining some degree of confidence in data integrity and accuracy throughout the life cycle of the data, which includes input, update, manipulation and output
[4] The actions, planned and performed, to provide confidence that all systems and components that influence the quality of the product are working as expected individually and collectively.”

In clear terms, the expression “quality assurance” means to have plans and procedures for what we want to do and for how to do it correctly.

Quality control is defined in ISO 9000:2000 as the “part of quality management focused on fulfilling quality requirements.”

In clear terms, the expression “quality control” means to check that whatever we have done according to our preplanned procedures (stated in the quality assurance) actually fulfills the requirements that we have set.

Those who have worked in the pharmaceutical industry and in other industries that have to comply with quality standards understand this distinction. We plan what to do in our quality system (quality policy, quality manual, procedures, and plans), and we control what we have done by comparing the result with the pre-defined result stated in our procedures.

So, why is this terminology so difficult for politicians and others to understand? Quality assurance is unfortunately not something you can learn in a short course and then understand, at least from my personal experience. It takes time to start thinking in a quality way. It seems to me that some sort of analytical, systematic and logical mind is needed, as well as a relatively long process of working through the subject. Only then is it possible to get “quality thinking” under the skin and start acting accordingly.

In the meantime, we can continue our quality-assured work, and continue to try to influence the people with whom we interact to use the correct term for what they are doing: quality assurance is not the same as quality control!

Siri Segalstad is Principal, Segalstad Consulting AS and author of International IT Regulations and Compliance (Wiley, 2008). She may be reached at [email protected].