What’s it all about?

Quality Management (QM) = A set of principles, guidelines,and methods by which Managers (= Administration) operatea business or institution, in order to be ethical, efficient, meetregulations, and provide a quality product.

Quality Assurance (QA) = Operating principles, strategiesand methods which assure that the technological processesin place are ethical, efficient, meet regulations, and provide aquality product. The emphasis is on process.

Quality Control (QC) = Processes put in place to guaranteethe accuracy of data or the quality of the product. Theemphasis is on product.

Quality Management/Assurance/ Control

QM/QA/QC

First: Quality Management

It’s about instituting practices in your class, business, lab,clinic, software or web development which assure theuser/customer that your product or analysis meets thestandards you claim for it.

It’s also about compliance with legally-adopted standardsor regulations!

Without QM/QA/QC your lab (or business) can lose itsclients, or in some cases its certification.

What are some values you would apply if you were amanager of a lab, a classroom, or a business?

How would you institutionalize those values?

How would you assess whether you’re successful?

For a company which produces a tangible product (stereo,car, blue jeans) would the quality of the product or thequality of the institutional processes be more important?

Why?

There are many different approaches to Quality Management.Here are several:

• Total Quality Management (TQM): http://home.att.net/~iso9k1/tqm/tqm.html

• ISO 9000: www.iso.org

•Lean: http://en.wikipedia.org/wiki/Lean_manufacturing

• Baldrige: www.quality.nist.gov

• Six Sigma: www.6sigma.us/six-sigma.phphttp://en.wikipedia.org/wiki/Six_Sigma

• QMII: www.aworldofquality.com/content/

Quality Assurance/ Control: QA/QC

What are some reasons you’d want your data to be accurate, or yourproduct to be within specs?

• It’s good science/good business!

• It ‘s ethical – someone’s life or health may depend on it.

• The law may require It – e.g. EPA, ISO, etc.

• You can keep your job.

• Other people may be making decisions based on your data.

Some institutes and associations for Quality Assurance – (there are many more!)

QA in health care: http://www.ncqa.org/index.htmQA in IT/software: http://www.qaiworldwide.org (Mozilla, Linux, etc. have their own QA associations.) Twin Cities QA Assoc http://www.tcqaa.org/index.htmQA in labs and clinics:http://www.sqa.org/newsite/public/pubhome.aspQA in organic food: http://www.qai-inc.com/0_0_0_0.phpAmerican Society for Quality: www.asq.org

Quality Assurance/ Control

Some basic principles of QM/QA/QC:

• Quality is achieved throughout the life-cycle of a process, NOTjust in one or two steps, or in testing.

• This means that QM/QA/QC should be a consideration in thedesign and adoption of processes, not just in their testing.

• Like a system of ethics, QM/QA/QC should pervade theinstitution.

• QM/QA/QC is everybody’s responsibility, not just the P.I., C.E.O.or quality assurance manager. All employees should be remindedof this regularly!

Quality Assurance/ Control

Quality Management -- e.g. TQM, Baldrige, etc.All aspects of a business or institution. Focus is on management,

administration, assessment of goals, etc.

Quality AssuranceEmphasis is on all aspects of a process, from

design to completion. E.g. includes instrumentcalibration, etc.

Quality ControlSampling a product or analyses to

control quality

Quality Assurance/ Control