by Warren Ha
Published by Manufacturing Engineering
Quality Assurance (QA) is more than just a process or department that ensures products meet customers’ requirements. It is a philosophy, a mindset shared between the corner office and the shop floor to achieve excellence. Quality standards must be enmeshed into the fabric of a company’s culture. Striving to achieve zero defects involves the commitment of resources, cutting-edge technology, and continuous fine-tuning.
“Striving to achieve zero defects involves the commitment 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 empoyees and implementing processes like Statistical Process Control (SPC) methodology and lean initiatives is one small step in the right direction.
QA is not just a process that occurs at the end of production. Employees 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 necessary 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 proactively 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 it’s 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 accomplishing 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 confidentiality of electronic records. It should limit access to authorized individuals only, and provisions should be included for periodically checking, 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 corrective 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 supplier 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 and opportunities for new business, and demonstrating your capability to manufacture a quality product will help you win new business.