In the interest of "Continuous Improvement", I'm considering the potential of breaking our formal Quality effort into two focused areas -- QUALITY SYSTEMS, which focuses primarily on implementation and maintenance of systems which support the overall quality improvement effort, and QUALITY CONTROL, which focuses a team on the actual on-the-floor activity defined by the System. I'd invite any insights as to what others have experienced or ideas which I might consider in this effort.

How does Quality Assurance play into your scheme?

Our system has a seperate QC and QA manager. The QC Manager/dept is responsible for acceptance and rejection of product. In ISO/QS terms section 4.10. While QA is responsible for the entire system, and has direct authority for Document and data control, internal audit system, and management review.

I do not think it is necessary to keep the two seperate in a small company.

I agree with you Christian. I'm just ferreting out distinctions.

I never really looked at there being a major difference between "Quality Assurance" and "Quality Control." I suppose that what I'm considering might be construed as dividing up between a Quality System that systems are in place to "Assure" quality and one that "Controls" the process so that the ouput is quality product. In most cases, it seems that many companies use the terms interchangeably. In any event, I value the continued input of this forum to help me ferret out the best direction for our company.

Christian, thanks for your input. You've raised my curiosity: in your company, you describe two separate departments, which is what I'm considering. Could you elaborate a little on what type of interaction the two departments have -- how are the areas of responsibility defined and what are they? What type of working relationship is there between the two department managers? Do both managers report to Top Management?

sorry for the belated response, both managers report to top management, (although in many cases I have seen QC report to QA, since QC deals with a subset of the entire QA system. The two managers have the same relationship that exists between production and QA. In fact in our company I believe the title QA manager will cease to exist, and modern quality journals see this as a trend for the future. Is it really accurate to call someone with responsibility for many systems a "quality" manager? The quality manager in our comapny is someone who is versed in everything from HR to purchasing, contract review to final inspection and everything in between. Sounds more like a CEO, plant manager, or General manager eh? Those are the skills the modern "Quality Manager" will need. The QC manager on the other hand deals only with acceptance or rejection of product (in process and final). He is responsible for testing for the physical property characteristics that the customer requires.

Our company is organized in exactly this way. There is a "Manager of Quality Engineering" and a "Manager of Quality Systems". The QE Mngr has quality engineers working for them that are assigned to specific teams. The QS Mngr has internal auditors. As QS9000 compliance becomes reality, the need to reorganize in this fashion makes sense due to the increased resources needed to maintain the QS9000 monster. The two Quality Mngrs both report equally to top management and give monthly reviews (using policy deployment)on PPM (QE mngr) and internal audit issues/findings (QS Mngr).

Blast from the Past - Any contemporary comments?

Quality Control + Quality Assurance = Quality Management System

I have had a lot of debates over this, during my years in Quality, and I'm sure I will again.
IMHO (in a simple form)

Quality Control = The measurment of our system and in its simplest form is the compliance to our agreed internal product standards or specifications either in process or post process.

Quality Asssurance = The compliance to a set standards (International, National or Company driven)

QMS = The tool that controls how we manage these control methods

I gave a rendering of Phil Crosby's description of QC, QA, and QM and added what I felt that the ISO Standards tried to accomplish (see link).

QC vs QA Phil Crosby.ppt (http://elsmar.com/Forums/attachment.php?attachmentid=496)

I have been in a number of environments where the Quality Management or Business Management do not inter-relate the QC and QA elements of QM and it is disasterous! Just my two cents worth!

Doug

Quality Control + Quality Assurance = Quality Management System

I agree with this comment.
FYI -
According to Cem Kaner (testing guru):

Quality Assurance - Assures quality
Quality Control - Enforces standards

I agree with this comment.
FYI -
According to Cem Kaner (testing guru):

Quality Assurance - Assures quality
Quality Control - Enforces standards

I'm getting dizzy. Won't enforcing standards assure quality?

I actuality, it doesn't make any difference for the functions. The best thing to do is eliminate the picky details and just call it "Quality". We have accounting, purchasing, etc. Why split hairs over doing things that encompass "all of the above" activities. (except for maybe government contracts;) )

As I'm reading through Cem Kaner's book, Testing Computer Software (which should be fairly universally applicable), he describes the QC group as, "QC Inspectors can refuse to ship the product until procedures are followed, standards met, and designated problems are fixed"

In comparison, he describes the QA group as, "...involved at all stages of development. It must set standards, introduce review procedures, and educate people into better ways to design and develop products. The big payoff from Quality Assurance is that it helps the company prevent defects. It also does testing but this is just one part of its job".

How's the dizziness factor now???

In my oppinion:

Quality Control + Quality Assurance + Quality Management = Quality Management System

Quality Management= Activity of assing resources, responsabilities, ...

I don't have any particular basis for this, but I always thought:

QC is more reactive and physical:whip:;
the brute-force style of controling quality by inspection & destruction of bad parts.
QA is proactive & intellictual :read:;
designing in quality to begin with, SPC to ensure that quality problems are detected before they actually become problem, etc.Tim

Quality Management= Activity of assing resources, responsabilities, ...

Once again we are in agreement:D

QC is more reactive and physical:whip:;
the brute-force style of controling quality by inspection & destruction of bad parts.
QA is proactive & intellictual :read:;
designing in quality to begin with, SPC to ensure that quality problems are detected before they actually become problem, etc.[/LIST]Tim
I agree and so does the author of that book. QA includes preventative methods and QC has the power to stop everything, if needed.

Good feedback, everyone! Thanks, everyone. I know this is kinda an old topic, but I wanted to resurrect the discussion for contemporary comments. The definitions have evolved somewhat since I got into quality in the 1980's (way back when...)...

In my oppinion:

Quality Control + Quality Assurance + Quality Management = Quality Management System

...

Hair on the back of my neck is standing straight up. Please Mr. ISO remove the word Quality from Management System and substitute Business.

Worst mistake ever made. Relegated all us quality true believers to the ghetto. Fosters an attitude of "we got ISO", and the QA Manager takes care of quality stuff so we get on with the things that really matter (business)

9K2K made a small move in a good direction with more responsibility for executives, but I think most companies still fob it all off on a low level person (like me). Registrars are still too afraid to spend most of their audit time with the top dog.

The Business Management System gets exactly the Quality level it is set up for, no more, no less.

Quality is a result or output of the business system. It is passive.

Any attempt to make Quality a verb or activity or department results in the frustration that all of us suffer from each day. You can't push on a rope. You can't expect a person who has essentially no control over the "real" system to have a meaningful impact on the result.

The QA Manager can't make quality. QC can try to stop shipment, but the business system has lots of avenues to get around even this if they want.

A mature business incorporates quality, ethics, safety, the environment and so on into the day to day culture, not as an afterthought.

I look for ISO 9000:2020 Business Management System

c'mon, c'mon, I dare ya! We may even see a measurable result from that one!

Rant ends.

My company has this defined into Regulatory Affairs & Quality Assurance Group. One Directing Officer with two managers. Regulatory Affairs specifically dealing with quality systems work & compliance efforts.