13485cert

QC is Dead: Muda vs. Kaizen

In Consulting, International Standard, ISO, Kaizen, Lean Manufacturing, Medical Device, QA, QC, Quality, Quality Management Systems on November 10, 2010 at 12:57 am

         I thought it might be fitting to explain the title of my blog. Quality Control (QC) is not really dead. The concept is just old and tired. QA, or Quality Assurance, is the politically correct acronym of the twenty-first century. QC is no longer the focus of the Quality Department. In fact, progressive companies do not even have departments. Inspection is now the responsibility of manufacturing personnel, while the quality function is the responsible for monitoring, measuring, data analysis, and improvement of processes and product. The purpose of the broader range of activities is to ensure that Quality Management Systems remain effective and companies continue to satisfy customers.

            For those of you who are not already enlightened, ISO certification is the process for verifying that companies have an effective Quality Management System. Registration bodies audit Quality Systems to verify conformity to an international standard that can guide them to building a more successful business. This standard is divided into eight sections. The first three sections are boilerplate (i.e. – purpose, scope and definitions). The fourth section is about documentation of the Quality Management System. The fifth section defines the requirements for Management Responsibilities. The sixth section is about resource management of both human resources and equipment (i.e. – HR, training, maintenance, and work environment). The seventh section is the longest section. It is titled “Product Realization.” This section includes everything but the kitchen sink. In this section, the standard includes all of the following functions: customer service, R&D, purchasing, manufacturing, process control, installation, service and calibration. The eighth section is where the standard finally addresses QC and QA. Specifically, 8.2.4 Monitoring and Measurement of Product, is QC. Everything else in section eight is in the realm of QA.

            For those of you that have not already been indoctrinated into the world of Lean Manufacturing, QC is something very bad—almost evil. QC is muda. QA, however, is a value-added activity. QA projects are Kaizen events. These focused projects are exciting. The projects educate and recharge our tired work force. Kaizen events transform a shift of clock watchers into an elite Delta Force waging guerilla war upon the wastes of twentieth century industrialization.

            In the modernized organization, QC is now fully integrated into the job duties of manufacturing. If a company is unfortunate enough to still have silos, the Quality Department oversees the QC function by reviewing paperwork. Often this consists of a checklist that gets no more than 15 minutes of scrutiny. If all the documents on the checklist are complete, signed and dated—product will ship. Some companies have had the foresight to automate this double-check and replaced the QA clerk with a mobile barcode reading device and a fork truck driver.

            The primary role of QA today is to identify problems before they bite us in the ass and to recommend corrective actions to top management. Hourly inspectors of the QC era have been replaced by salaried quality engineers that wield tremendous influence over operational decisions. I am a consultant that trains this new generation of employees responsible for quality. If you happen to see anyone in your organization reverting back to the old ways, please remind them to follow the yellow brick road.

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  1. Rob,
    Had no idea, that these changes are now part of the mainstream. I always like to get refreshed so appreciate your passing this along. Technology and integration makes the job automated and changes the function certainly, thus the people managing.
    Writing about this or perhaps most any topic is maybe what you should do as well. You are a very good writer, so impressed!
    Peggy
    Mercury

    • Hi Peggy,

      It’s fantastic to hear from you after years have gone by. I guess my efforts to catch-up with people on LinkedIn are paying off. Your comments on my blog are very much appreciated. I’ll do my best to live up to them.

      Rob

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