Quality or Quality Assurance

Quality or Quality Assurance

Posted by Peggy Milz on Aug 30, 2019 10:41 am

This morning I have been reviewing and editing a document.  It is riddled with "Quality Assurance" and "QA."  I personally prefer to use "Quality", when referring to the Quality function/department of an organization.  However, the authors of this document prefer QA.  I am curious what others think about this and how you refer to the Quality function/department.  I did a quick Google search and found numerous links to resources about Quality Assurance vs. Quality Control, but not much about just Quality, so I thought I would reach out to the community of Quality professionals on myASQ to get your feedback.

Thanks in advance for taking time to share your thoughts and opinions.

Re: Quality or Quality Assurance

Posted by Sheena Gerstenberger on Aug 31, 2019 5:01 am

If the responsible group is listed as Quality rather than QA or QC, my first question as an auditor would be whether that would allow QC to complete those actions as well as QA. For a larger and older companies where the quality systems are expected to be more mature, it becomes less acceptable for QA and QC responsibilities to be handled by the same group of people. 

Personally, even with young or small companies, where these activities may be executed by the same people, I would suggest writing QA or QC under the assumption that eventually the two groups will be separate and you will have one less SOP to revise.

That all being said, I am in Pharmacueticals and the expectations for other industries may be less stringent. I hope this helps.


Re: Quality or Quality Assurance

Posted by Dawn Garcia on Aug 31, 2019 7:17 am

Great question Peggy. I would offer that the use of QA and QC within a Quality department or team is contextual to the type of organization. In smaller organizations, the roles are often managed by a core group of people in one department - sometimes by the same person. Using 'Quality' in that case makes sense. In larger, or more complex organizations, the focus and fund of knowledge, experience, and tools are different. Generally, I consider those in quality system and process design are in quality assurance roles, whereas those that are the measurement, auditing, and verification of final product or service features are in quality control. I hope that this is helpful. 


Re: Quality or Quality Assurance

Posted by Rajesh Babu on Aug 31, 2019 1:13 pm

i know of organizations which has " Quality Function" managed by a head and there are different roles or division within the function , for eg, compliance team, Quality control team, Quality Assurance team, etc , all of these have different purpose but fall under one roof /head.
When it comes to production floor quality, there are names like L1 quality team which basically takes care of Inspection of product/Service and L2 which takes care of the Assurance bit. this differentiation in name is just to recognize  the role and the responsibility else they are part of Quality team trying to establish superior customer experience 

Rajesh B

Re: Quality or Quality Assurance

Posted by Jeremiah Genest on Aug 31, 2019 5:31 pm

I tend to avoid even using broad terms like quality assurance or quality control in procedures. Those terms really only belong at the policy level. When you are down at the procedural and below level you want to be specific the exact role in the process. That way you can map competencies, experience and education to the role.

Re: Quality or Quality Assurance

Posted by Cyrus Parlan on Sep 1, 2019 4:22 am

In my opinion, Quality alone is a subjective term that doesn't describe an absolute functions but rather understood as a characteristic of product or service output. In most organisation, when someone mentioned Quality, all eyes are immediately with Quality Department who are perceived to be the last line of defence. They almost forgot that Quality is everyone's responsibility regardless of which department they are belongs to. Quality Assurance, however, is a functions that gives the organisation the necessary confidence that the product/service meet the planned result taking into account the regulatory and customer requirements. These are performed by independent person who are not involve on the execution and final delivery of product/services.

Re: Quality or Quality Assurance

Posted by Marvin Christensen on Sep 1, 2019 1:19 pm

As an old person who has been involved with the 'Quality' movement since 1987 and a QMS registered auditor for years, I have probably seen every version you can dream up.
It is my opinion that organizations should use the terminology that is part of the culture of the organization.  What makes sense to the work force to make sure they understand the job that needs to be done correctly.  It seems to me that too many people get hung up on a word and sort of miss the real point. The bottom line is to meet all requirements consistently while improving over time.
One discussion going on now is about using continuous or continual.  To me the term is not the main issue. Does the organization show improvement over time?  All organizations will have some hiccups and have a reversal of improvement. If they don't they are not pushing the limits for improvement.  SMART goals are not always achievable and people should learn and not make the same mistakes over and over. Then over time the data should show some improvement. As some people have said before "In God we trust, all others bring data."
My uses of the terms are as follows: (but I use the client's terminology when working with them)
Quality is the characteristics of a product, service or organization's output.
Quality Assurance are the processes in place to ensure quality.
Quality control is the actual monitoring, measurement, or gathering of information to ensure all the requirements are met. (The organization's, the customer's and statutory and regulatory.)
Quality System or Quality Management System is the overall use of processes to produce the product, service or organization's output.
I usually do not tell my clients there are 'quality processes' since I believe any process that is involved with making sure the organization is meeting requirements and promotes sustainability is all they need and just call it a process.  Why carve the organization up into many parts, such as: environmental, safety, financial, product, sales, accounting, etc.?  To me there should be one system and then various 'departments' to accomplish the different tasks needed to be successful.
Mickey Christensen

Quality or Quality Assurance

Posted by Harold Anyang Achiando on Sep 1, 2019 11:09 pm

What a great question. I personally have had the challenge where QA means more than one thing (including Qatar Academy,  and the country itself, Qatar). For a general unit that does both Quality Assurance and Quality Control, I would go for the Quality Unit as described in the FDA regulations. This solves the challenge and still remaining within the bounds of the responsibilities.

Re: Quality or Quality Assurance

Posted by Kelly Gau on Sep 3, 2019 7:59 am

There are many excellent responses here. I agree that "Quality" can be too vague, and should be everyone's responsibility. However, since it is not clear how this term is being used in the document, an argument could be made this could be the best option for this scenario. To avoid any misalignment of terms, an option is to include the term in the definitions to clarify the intent of the word. In general, I prefer to be as specific as possible (i.e. I would spell out QA, QC, etc.). However, I work in the biotech industry where specifics matter greatly, and roles don't typically overlap. But as long as there is no risk of confusion (terms are defined the same throughout all processes/procedures) there should be no issue with the proposed method. 

Re: Quality or Quality Assurance

Posted by Caroline Cook on Sep 3, 2019 8:58 am

I agree with the above post that it's important to do what makes sense within your own organizational culture. Others have also eluded to doing what makes sense within your company's unique regulatory environment (FDA, ISO, etc.). Then it's just a matter of using the terms consistently. Quality Control in laboratories means something very specific within the CAP and CLIA world. Also, our team has had to forego calling ourselves QA so as not to be confused with Software Quality Assurance. In our company, that's a separate team. We've ended up calling our team Quality Management. I also agree that the broader term of "Quality" should just be embedded within every process, but more specifically called out and defined in policy level documents. 

Re: Quality or Quality Assurance

Posted by Stephanie Thompson on Sep 4, 2019 3:06 pm

To me it's about the context. I tend to use the word Quality. The Quality Department to me encompasses the Quality Management System and is way bigger than QA or QC alone. With that being said, Quality Assurance and Quality Control are often critical components to a company's final output of a quality product or service. I try to understand the context and ask for clarity to understand an organizations culture better.  

Great question!

Re: Quality or Quality Assurance

Posted by Stephanie Thompson on Sep 4, 2019 3:09 pm

Dr. Deming said it best, "Quality is everyone's responsibility."

Re: Quality or Quality Assurance

Posted by Vladimir Simic on Sep 20, 2019 12:23 pm

I agree with colleagues who point out that the name itself is not important, but much more important what is being done and happening in the tk organizational part.
I would just like to point out the changes,  that I believe everyone is familiar with in detail, in the introduction of the term "role" in the new versions of ISO standards after 2015 and the term "acountability", which becomes crucial what is happening in that organizational part. I would also point out the facts that impose industry 4.0 and Quality 4.0 concepts, where more general terms will certainly have a much greater ability to apply and understand the various activities related to quality issues. I think there is no reason for the overall quality term to be acceptable.

Vladimir Simic

Re: Quality or Quality Assurance

Posted by Marvin Christensen on Sep 23, 2019 11:34 am

One other thing I did not include in the first reply I made  and that is the use of acronyms, especially in written documents but also in all communications.
I was working in a hospital and as I reviewed procedures for different departments I kept seeing "ADA" and usually without a definition.
Well, as I went around 'ADA' could mean: Americans with Disabilities Act, American Dental Association, American Dietary Association, American Diabetes Association, Age Discrimination Act, American Dairy Association, Anti-drug Antibody, and more.  The point is make sure people know what the terminology stands for so they can do the job correctly consistently.
Mickey Christensen