10 www.sme.org/manufacturingengineering | December 2011

QualityScan

Quality Assurance (QA) is more than just a process or department that ensures products meet customers requirements. It is a philos-ophy, a mindset shared between the corner office and the shop floor to achieve excellence. Quality standards must be enmeshed into the fabric of

a companys culture. Striving to achieve zero defects involves the commit-

ment of resources, cutting-edge technology, and continuous fine-tuning.

Companies that transcend the ordinary have at their core a quality-

assurance mindset that inspires client loyalty. Quality inhabits everything

that is done: from design, to manufacturing, to shipping, to the way

customer service calls are handled to achieve the long-term goals of

the company. Management sets the tone by investing in the resources,

equipment, and personnel necessary to exceed customer expectations, and

every employee understands that quality is critical to his or her success.

Achieving six sigma should be on the minds of all your employees and

implementing processes like statistical process control (SPC) methodolo-

gies and lean initiatives is one small step in the right direction.

QA is not just a process that occurs at the end of production. Employ-

ees company-wide are empowered to act immediately during the entire

production process to proactively resolve situations as they occur, or even

before they occur. QA personnel are vital to the production process. They

spot trends as they occur and take corrective action, and make the neces-

sary decisions to ensure standards are constantly met, quality products are

produced, and your process continually improves.

QA tools and equipment ensure that data are error-free and analyzed to

indicate when a process is out of control or out of specification or trending

toward either. Such data analysis tools enable employees to react proac-

tively versus reactively to situations that occur, eliminating downtime.

Cutting-edge technology also enables the use of historical data. Previously

recorded data are a predictor of future data; they let you know when its

necessary to invest in new equipment to maintain your quality standards.

One key component in QA is the ability to centralize information and

collect real-time information for continuous improvement. This information

can be shared from the production floor to upper management and, with

the proper security in place, to your suppliers. One means of accomplish-

ing this is through a native SQL database system. Every QA system should

comply with government security regulations, specifically FDA 21 CFR Part

11. The system should be designed to ensure the authenticity, integrity,

and confidentially of electronic records. It should limit access to authorized

individuals only, and provisions should be included for periodically check-

ing, recalling, or revising the user ID and passwords to cover events such

as password aging, including safeguards to prevent unauthorized use.

A QA system should also include Automotive Industry Action Group

(AIAG)Compliant Measurement Systems Analysis. Gage repeatability and

reproducibility (R&R) should be a standard feature in the QA system allowing

two or three operators to conduct up to a three-trial repeatability analysis.

Users should also have the ability to create repeatability range charts, part

operator average charts and part by operator plots from your Gage R&R data.

A QA system must also provide ID fields for traceability such as lot

number, machine number, department number, employee number, etc.

Note fields should also be included to trace assignable causes and cor-

rective actions. A query function is helpful to allow filtering of spreadsheet

data in order to see the parameter for which you want matching results.

To consistently deliver superior products to your customers and exceed

their expectations, you must have data on your products instantly available

to them, albeit it in an audit, or an on-site inspection. You can also have

the information readily accessible so your customers can view the QA data

in real-time, therefore connecting the links for supply chain quality. To

guarantee meeting your standards, data related to the products delivered

to you by your suppliers must be captured. If inconsistencies occur, this

must be immediately communicated to them so that any future defects are

detected before the product reaches your dock.

When executed well, QA enables you to manage suppliers, reduce

downtime, eliminate scrap, minimize rework, and use your employees time

more efficiently, saving money. The quality data collected also enables you

to make educated decisions about opportunities for new business, and

demonstrating your capability to manufacture a quality product will help

you win new business. ME

Warren HaPresidentZontecWeb site: www.zontec-spc.com

Striving to achieve zero defects involves the commitment of resources, cutting-edge technology, and continuous fine-tuning.

QA: The Heart of Your Business