Archive for the ‘Consulting’ Category

How to Qualify a Supplier

In Consulting, Forward to MDA, International Standard, ISO, Medical Device, Purchasing, QA, QC, Quality, Quality Management Systems, Supplier Audit, Supplier Qualification, Supplier Quality on November 17, 2010 at 2:49 am

This blog has been moved to the following location, and the title has been changed: http://bit.ly/HowQualifyaSupplier.

This blog website and the blogs within it are gradually being transferred over to my new website: http://www.MedicalDeviceAcademy.com. The titles may change, and there may be minor revisions to the content as the blogs are reviewed and edited. There will be a subscription list created for the new blog site. If you would like to be added to the list for the new blog site, please email me directly at: rob@13485cert.com.


The Quality Police

In Consulting, International Standard, ISO, Medical Device, QA, QC, Quality, Quality Management Systems on November 11, 2010 at 12:24 am

            A few years ago I was in the process of resigning from my job as Director of Quality from ConforMIS. My boss at that time paid me a kind complement that provided me with a perspective that I had not had prior to that moment. I don’t remember the exact wording, but his basic message was: Quality Managers that work cooperatively with operations are rare and highly sought after. He described my approach to Quality as modern and progressive. Over time I have learned to articulate this as the difference between Quality Control (QC) and Quality Assurance (QA). The word “control” is the key difference between these two responsibilities. QC is responsible for verifying that product is “good.” Often this creates friction between manufacturing personnel and inspectors. It doesn’t help that the people often have the same title as our favorite FDA employees—the Inspectors.

            We might as well give the QC folks a uniform, a badge and a gun. They act like they are the Quality Police. Progressive companies have changed their organizational structure and integrated the Inspectors into the production lines. Now we have U-shaped cells instead of lines. Operators are now referred to as “team members,” and everyone takes a turn at inspection as a normal part of job rotations. This modern and progressive approach is difficult for “old school” Quality Managers to accept. They feel uncomfortable with this approach, because they remember when manufacturing didn’t care about Quality and would just “ship it.” Some of these managers are quite young. Unfortunately, these Quality Managers were taught methods for achieving quality that are thousands of years old.

            The 21st century is not “out of control.” We merely upgraded our risk controls. Once we relied upon the Inspectors. Now we rely on process validation, automation, and statistical analysis of process variable that are Critical to Quality (CTQ). Many people use rules of thumb to estimate the effectiveness of visual inspection. At best visual inspection is capable of catching 98% of the problems. Validation, automation and statistical analysis each have the capability of exceeding 98% effectiveness by themselves. When we combine each of these methods together, we improve the certainty of making good product to Sigma Quality levels of 5 and 6-sigma. At this level of quality, the importance of visual inspection begins to evaporate. It is in the context of a highly automated and robust process that modern Quality Managers are implementing “radical” changes. We don’t need the Inspectors. We need Quality Engineers that can help us implement the new risk controls.

            When I first started at ConforMIS, I was interviewing candidates for a new QA Associate. I used this title to differentiate it from QC Inspectors. One of the design engineers argued that we needed to hire an inspector that was more qualified at performing measurement of implants. I argued that we needed good suppliers to do this for us. We also needed to have strong supplier controls such as process validations, supplier audits, process risk management, and a physical presence on-site at the supplier. Being the hiring manager, I got my way (I’m also 6’6”).

            During the interview process, I asked each person to describe their role in their current position. One candidate actually described himself as the “Quality Police.” I stopped the interview immediately and showed him the door. Coincidentally, the design engineer thought this candidate was great. When I finally hired someone for the job, I made a point of telling him this story. The person I hired had no experience in the medical device industry and he knew little about measurement techniques. He was also the oldest candidate that interviewed for the job. What won him that job was that his mindset was the most modern and progressive of the people we interviewed. He may also be the first QA person in history to have the customer service department rave about him. I miss working with him, but I know a company in Massachusetts that is very lucky to have him.

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.

“What a Long Strange Trip It’s Been”

In Consulting, Medical Device on October 26, 2010 at 3:36 am

September 21, 2009 was the last time I was employed by a company. In the spring of 2009, I was afraid to start out on my own as a consulting in the middle of a deep recession. I had always lived by the saying, “You never quit a job until you have the next one already lined up.” Thanks to my wife’s encouragement, I took a leap of faith and finally quit my job. A year later, my consulting business is growing steadily and I’m having more fun than I ever did working for someone else. I worried about not having enough work, but instead I should have worried about having enough hours in my day. I thought I would start blogging in 2009 to find new customers. Now it’s 18 months later than I planned, but this is my first blog. I’m writing this because I love to write–not because I need more customers. I suspect this is the only good reason for me to start a blog.

Truckin by The Greatful Dead

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