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ETM 591 Quality Engineering Spring 2014 Daniel Yoon

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1 ETM 591 Quality Engineering Spring 2014 Daniel Yoon
Quality Company Interview Mr. Andrew Lockwood – Kenco Logistic Services, LLC. (Stryker Medical) ETM 591 Quality Engineering Spring 2014 Daniel Yoon

2 Background (Interviewee)
Mr. Andrew Lockwood Interviewed on April 12th~15th ( ) Mercer University B.S.E. & M.S.E. Industrial Engineering Awards Louie D. Newton Award Outstanding Graduate in Industrial Engineering Bear Award for Campus Involvement Who’s Who Among American College Students Work experience Process Development and Technology Transfer Engineer at Chattem Inc. Project Leader at Kenco Logistic Services LLC. (Current) Stryker Medical group

3 Background (Company) Kenco Logistic Services Stryker
Started in 1950 – Chattanooga, TN. Member of the Kenco Family of Companies. One of the largest privately held third-party logistics providers (3PL). Over 100 facilities and warehouses in 25 different states and also in Canada Stryker A medical technology company Reconstructive, neurotechnology, spine, and various surgical products. Customers over 100 countries around the world

4 Corporate Philosophy 1 Does your company's mission statement mention quality? No, not specifically, but allow me to clarify. Our Mission Statement is: To enhance the value of Stryker and their end customers by consistently improving our service, promoting a positive work environment, and serving as ethical stewards for both Kenco and Stryker. Does your company's mission statement mention customer service? Yes, see Mission statement above. Customer service is essential to our survival.

5 Corporate Philosophy 2 Does the company have a separate quality mission statement? Yes. While Kenco is a large company, my account deals with the Stryker Medical group specifically, so our mission, goals, and objectives are tied to their overall logistics objectives. In our industry, quality is a must. Therefore, we have a separate “Network Quality Plan” which states: The Kenco Logistic Services-Stryker Distribution Network strives for Operational Excellence through the continual monitoring and focused improvement of our quality management system. Our Kenco Quality Management System (KQMS) is aimed at building a culture of servitude, engagement, and accountability to ensure we consistently meet or exceed Stryker’s expectations specific to product handling, storage, and delivery.

6 Corporate Philosophy 3 Does the company have a written quality plan? If so, where is it located? Yes, our quality plan is printed and posted on each location as well as posted on our network intranet for quick access. In your organization, who is responsible for quality? Everyone is responsible for quality, but our quality coordinator directly manages the quality activity within the network. Each person is encouraged to submit quality improvement suggestions and corrective/preventative action requests when they think of them.

7 Corporate Philosophy 4 What are some job titles that relate to quality in your company? What is the educational background for these positions? Quality Supervisor and Quality Coordinator. Most of the time, the educational background is more of a general business background with some work/field experience in the quality areas. How does your organization define quality? In general, we define quality by what our customer dictates as “quality” to us. Within our account, we offer “white glove service” or an expectation of what a product delivery experience would be like at a hospital. Our customers are both the hospitals buying the products and the sales reps directly selling them, so we must be sure that we’re engaging the quality needs of both parties.

8 Corporate Philosophy 5 How do you train/educate your employees concerning quality issues? We hold monthly training calls for updates to our central quality documents (SOPs, etc.) and we aim to over communicate any quality issues that need to be addressed on the spot. How do your customers influence your quality program? They define it! If our delivery service is subpar and fails to meet expectations, our perceived “quality” as a third-party logistics provider (3PL) is diminished.

9 Corporate Philosophy 6 Has your company ever applied for or earned a national quality award or certification? (Baldrige Award, ISO 9000, CMMI, Other?) We’re compliant with ISO 9001:2008 and ISO 13485:2003 standards, but we like to hang our hat on the fact that we were rated in the Top 10 3PL Providers in the country by Inbound Logistics. We’re also a Certified Women’s Business Enterprise and top 100 Great Supply Chain Partners. There’s also some talk about going after a Shingo Prize in the future.

10 Corporate Philosophy 7 Do government regulations have a large impact on your quality procedures? They do based on what governing bodies are in charge over our industry. In our field (medical devices), the FDA does provide some rules and oversight that impact quality procedures, but not to the effect that they would in a manufacturing environment.

11 Quality Methodology 1 Do you routinely collect data on the quality of your product or process? Do you use statistics to analyze the data collected? Do we collect data? We collect so much data, we often times are overwhelmed with the magnitude of it all. We do use control charts and regression as needed, but often times, simple measures will do the trick. Putting the data into the right statistic or chart can sometimes make or break our projects. Do you use control charts? If so, what processes are charted? Yes. We control chart quite a few metrics, including our inventory count accuracy, return on invested capital (ROIC), and other quality metrics.

12 Quality Methodology 2 What kind of quality reporting techniques do you use? Who generates the reports? Who sees the reports? We have multiple systems that produce reports, ranging from our Warehouse and Transportation Management Systems to Excel spreadsheet based on databases pulling data with SQL. At every level, our employees read and interpret reports based on data in order to perform their jobs. What kind of quality/process control software do you use? (Excel, generic SPC, proprietary, etc) At my previous employer I used Minitab and loved it. Now I just use a SPC Add-In for Excel. It has most of the same functionality. In all honesty though, Pivot Tables (in MS Excel) take me a long way in my day-to-day projects now.

13 Quality Methodology 3 How do you monitor incoming materials and/or your suppliers? Our Transportation Management System called TMW allows us to view inbound and outbound shipments along with plan future routes. Do you use acceptance sampling methods? If so, what standards are they based on? Who designs the plan? Yes. Often times, we’ve collected so much data in the past the question isn’t “do we have enough?” but rather “when do I need to cut-off this data set?” Usually 30+ points will do though but more is better based on what we’re looking at. The project manager will often design the plan.

14 Quality Methodology 4 What percentage of your product is scrapped or reworked? < 1%...but again, we’re not in manufacturing…we just transport, store, and deliver. Has your organization ever issued a product recall? If so, please identify the product and the date of the recall. Not directly, but we’ve executed pickups for a recall. Check into this recall for more:

15 Quality Methodology 5 Does your organization follow Six Sigma or Lean Sigma quality methodologies for process improvement? We are all about Six Sigma and Lean. Our company is basically driven by those concepts, but we also view them as just “tools” to do the job…not the end all, be all. I’m about 60% through my first black belt project right now. Are employees encouraged to obtain quality credentials such as Certified Quality Engineer or Six Sigma Black Belt? Yes! I was hired into the Kenco organization as a Green Belt, but am in the midst of pursuing my black belt right now. My current projected project savings are about $1.4M for a logistics/transportation model change to our current account.

16 References Kenco Logistic Services, "About Us." Kenco Family. 18 Apr < Stryker, "About Us." Stryker. 18 Apr <

17 Authorization Do you give Dr. Burtner permission to publish your interview responses on her course website? Absolutely! I’m always willing to help or provide material for any of her courses.

18 Appendix A Kenco - Lean Six Sigma philosophy drives operational excellence Kenco adopted Lean Six Sigma as its primary continuous improvement philosophy. Our emphasis is on gaining process and product knowledge with critical Lean thinking while reducing variability and non-value added activities. “Lean Thinkers” within Kenco focus on enhancing customer value through the reduction of cost, cycle time, waste and defect rates. Our Lean philosophy results in the generation of growth and breakthrough improvements for our customers. Kenco’s continuous improvement philosophy is perfectly aligned with the Operational Excellence initiatives that have been instilled in our culture. Our vision of Operational Excellence is to leverage our most valued asset, our people, by bringing them together with the right processes and systems to ensure the highest level of execution possible for our customers. Our ability to achieve Operational Excellence is driven through five key initiatives: Safety & Security, Quality, Communication, Bench Strength and Financial Management.

19 Appendix B1 ISO 9001:2008 specifies requirements for a quality management system where an organization needs to demonstrate its ability to consistently provide product that meets customer and applicable statutory and regulatory requirements, and aims to enhance customer satisfaction through the effective application of the system, including processes for continual improvement of the system and the assurance of conformity to customer and applicable statutory and regulatory requirements. All requirements of ISO 9001:2008 are generic and are intended to be applicable to all organizations, regardless of type, size and product provided. Where any requirement(s) of ISO 9001:2008 cannot be applied due to the nature of an organization and its product, this can be considered for exclusion. Where exclusions are made, claims of conformity to ISO 9001:2008 are not acceptable unless these exclusions are limited to requirements within Clause 7, and such exclusions do not affect the organization's ability, or responsibility, to provide product that meets customer and applicable statutory and regulatory requirements.

20 Appendix B2 ISO 13485:2003 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer requirements and regulatory requirements applicable to medical devices and related services. The primary objective of ISO 13485:2003 is to facilitate harmonized medical device regulatory requirements for quality management systems. As a result, it includes some particular requirements for medical devices and excludes some of the requirements of ISO 9001 that are not appropriate as regulatory requirements. Because of these exclusions, organizations whose quality management systems conform to this International Standard cannot claim conformity to ISO 9001 unless their quality management systems conform to all the requirements of ISO 9001. All requirements of ISO 13485:2003 are specific to organizations providing medical devices, regardless of the type or size of the organization. If regulatory requirements permit exclusions of design and development controls, this can be used as a justification for their exclusion from the quality management system. These regulations can provide alternative arrangements that are to be addressed in the quality management system. It is the responsibility of the organization to ensure that claims of conformity with ISO 13485:2003 reflect exclusion of design and development controls. If any requirement(s) in Clause 7 of ISO 13485:2003 is(are) not applicable due to the nature of the medical device(s) for which the quality management system is applied, the organization does not need to include such a requirement(s) in its quality management system. The processes required by ISO 13485:2003, which are applicable to the medical device(s), but which are not performed by the organization, are the responsibility of the organization and are accounted for in the organization's quality management system.


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