Reducing Time to Market while ensuring Product Quality and Reliability to Gain Customer Preference and Meet Company Demands
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The requirement for getting products to market faster is rising, putting intense pressure on product development teams. This session will examine the following with the aim of reducing product development cycle times: • Using Lean methods to uncover what is slowing the organization down • Implementing lean product development solutions in a complex R&D environment • Leveraging Six Sigma DMAIC to hold the organization accountable to lean improvements and create early proof that the lean approaches are delivering results • Exploiting the Design for Six Sigma toolkit to institutional Lean Product Development principles such as set based design.
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Reducing Time to Market while ensuring Product Quality and Reliability to Gain Customer Preference and Meet Company Demands
- 1. Reducing Time to Market while ensuring Product Quality and Reliability to Gain Customer Preference and Meet Company Demands Sharon Rozzi Lean Six Sigma Master Black Belt January 15, 2009
- 2. Agenda 1. About Boston Scientific 2. Our Lean Six Sigma Strategy in R&D 3. Leading with Lean 4. Delivering results with Bef or e Af t er 100 80 60 Crit ical Y Six Sigma 40 20 0 -20 -40 Surface Plot of MktShare 1 3 5 7 9 11 13 15 17 19 21 23 Tim e 5. Institutionalizing Lean 20 with DFSS MktShare 10 14 0 13 12 1011 8 9 OLSupTot 2 100 200 6 7 KitPrAve 300
- 3. Boston Scientific is a global, Fortune 500 company focused on innovative medical devices and procedures Boston Scientific Corporation Profile General Facts: Product Innovation: • 13,818 Patents issued worldwide • Founded in 1979 with 38 employees and • $1.1 Billion invested in R&D (’07) $2 million in sales • $475 Million invested in 20 alliances/ • Now a global leader in cardiovascular acquisitions (’07) medicine and one of the world’s largest medical device companies Financials: • Portfolio of approx. 13,000 products, • $8.4 Billion Revenue (’07) many with market leading positions • 25% CAGR1 (’03-’07) • The TAXUS® drug-eluting coronary stent • $1.2 Billion Net Income2 (’07) was the most successfully launched • NYSE: BSX product in the history of the industry Demographics: • Added Cardiac Rhythm Management • 25,000 Employees Group through acquisition of Guidant • Dedicated marketing and sales force in Corporation in April 2006 more than 45 countries • Corporate HQ: Natick, MA • 37 manufacturing, distribution and • Regional HQs: Paris, Tokyo, Singapore technology centers worldwide • Website: www.bostonscientific.com 1. Compound Annual Growth Rate 2. Excluding acquisition, litigation, divestiture, restructuring, and other charges 3
- 4. Boston Scientific’s mission is to improve the quality of patient care and increase health care productivity Boston Scientific’s Mission Statement Boston Scientific’s mission is to improve the quality of patient care and the productivity of health care delivery through the development and advocacy of less-invasive medical devices and procedures. This is accomplished through the continuing refinement of existing products and procedures and the investigation and development of new technologies that can reduce risk, trauma, cost, procedure time and the need for aftercare. 4
- 5. Boston Scientific is advancing patient care across a broad range of medical specialties INTERVENTIONAL NEUROVASCULAR RADIOLOGY CARDIAC RHYTHM INTERVENTIONAL MANAGEMENT CARDIOLOGY ELECTROPHYSIOLOGY PAIN MANAGEMENT INTERVENTIONAL GASTROENTEROLOGY BRONCHOSCOPY ONCOLOGY GYNECOLOGY PERIPHERAL VASCULAR UROLOGY 5
- 6. 29 years of innovation have led to a broad and deep portfolio of more than 13,000 products Sampling of Boston Scientific’s Product Portfolio Stents Balloons Catheters / Guidewires Embolic Protection Ultrasound Imaging Pacemakers / ICDs Ablation Peripheral Dilatation Detachable Coils Neurostimulation Biopsy Systems Embolics Stone Retrieval Lithotripsy Systems Enteral Feeding 6
- 7. Agenda 1. About Boston Scientific 2. Our Lean Six Sigma Strategy in R&D 3. Leading with Lean 4. Delivering results with Bef or e Af t er 100 80 60 Crit ical Y Six Sigma 40 20 0 -20 -40 Surface Plot of MktShare 1 3 5 7 9 11 13 15 17 19 21 23 Tim e 5. Institutionalizing Lean 20 with DFSS MktShare 10 14 0 13 12 1011 8 9 OLSupTot 7 100 200 6 7 KitPrAve 300
- 8. Our Lean Six Sigma Strategy in R&D Our Mission: Boston Scientific’s mission is to improve the quality of patient care and the productivity of health care delivery through the development and advocacy of less-invasive medical devices and procedures. Goals: To be our customers’ first choice Strategy: Rapid delivery of Exceptional Products Tactics: • Lean Bef or e Af t er • Six Sigma DMAIC 100 80 60 Crit ical Y 40 20 0 -20 -40 1 3 5 7 9 11 13 15 17 19 21 23 Tim e • Design for Six Sigma Surface Plot of MktShare 20 10 MktShare 14 0 13 12 1011 8 9 OLSupTot 100 6 7 8 200 Boston Scientific Corporation Confidential KitPrAve 300
- 9. We believe Lean Six Sigma will help us serve our customers better and make us a marketplace leader Lean (Speed) Identify value, eliminate waste, Create flow, pull instead of push Cu t en s to em me r ov rR mp es sI po Moving toward es ns Leadership… oc Surface Plot of MktShare iv e Bef or e Af t er 100 80 Pr 60 Crit ical Y ne 40 20 20 0 10 -20 MktShare ss -40 14 1 3 5 7 9 11 13 15 17 19 21 23 0 13 12 Tim e 8 9 10 11 OLSupTot 100 7 200 6 KitPrAve 300 DMAIC DFSS Hold values: CostApAv: 1.35 TriedBr: 34.15 Six Sigma Capability Reduce variation, Designing new products with exceptional Shift performance capability for meeting customer needs 9
- 10. Agenda 1. About Boston Scientific 2. Our Lean Six Sigma Strategy in R&D 3. Leading with Lean 4. Delivering results with Bef or e Af t er 100 80 60 Crit ical Y Six Sigma 40 20 0 -20 -40 Surface Plot of MktShare 1 3 5 7 9 11 13 15 17 19 21 23 Tim e 5. Institutionalizing Lean 20 with DFSS MktShare 10 14 0 13 12 1011 8 9 OLSupTot 10 100 200 6 7 KitPrAve 300
- 11. Leading with Lean • Key Lean principles: – Specify Value – Identify the Value Stream – Make the value-creating steps Flow continuously – Let customers Pull value from the enterprise, rather than push – Drive to Perfection with continuous improvement Typical Original Lead Process Time Traditional Improvement Lean Improvement Value Added Non-Value Added 11
- 12. There is growing recognition that Lean can be applied to Quality Systems October 2008 Extending ‘Lean’ Principles to Quality Systems How Physio-Control, Osmetech and Kyphon Ues “Lean quality” to Beat Problems ADOPTING "LEAN" MANUFACTURING may be an option for some device firms as they cut costs during rough economic times, but the concept should be extended to their quality systems to prove truly effective, experts say. "Don’t make quality lean, but integrate quality throughout your lean process," says Linda Lovett, a consultant who implemented lean quality methods at Abbott Laboratories and Medtronic subsidiary Kyphon. Meanwhile, another Medtronic division, Physio-Control, is optimistic it will soon clear up its FDA compliance problems in part because it is adopting lean quality, and small manufacturer Osmetech says it now closes CAPAs quicker because of the technique. "By applying that tool, I’m able to have regularly scheduled meetings for CAPAs," says Bob Dicheck, VP of quality & regulatory for Osmetech. 12
- 13. Examples of Waste in Product Development Companies Waste Category Example Implication Defective Products • Drawing or code errors • Excessive changes, scrap • Work does not match customer needs • Rework, scrap, warranty Over Production • Working w/ incomplete requirements • Queue time drives lead-time • Not using standard parts and subs • No re-use of knowledge • Extra software features customer doesn’t want • Drives supply chain variation Excessive Inventories • Projects ≠ desired future business • Long lead-time, rework • Work-in-process exceeds capacity • Investment not realized • Partially done work Excessive Motion • Excessive engineering changes • Barriers to adding value • Requirements change impact design • Capacity consumed by rework • Moving info from one person/ group to another Excessive • Unnecessary items specified • Ineffective use of skills • Too may approvals required • No decision rules Processing • Too much “paperwork” • Drives rework and inflexibility Transportation • Excessive approvals and controls • Queue time, work-arounds • Process monuments • Batch processing, no flow • Task switching on multiple projects Waiting • Workload ≠ capacity • Project sits for next “event” • Excessive multi-tasking • Not cost effective • Delays due to reviews/ approvals/ testing/ • Inefficiencies built-in deployment/ staffing/ workload Lean helps us see what is slowing down product development Lean helps us see what is slowing down product development 13
- 14. Agenda 1. About Boston Scientific 2. Our Lean Six Sigma Strategy in R&D 3. Leading with Lean 4. Delivering results with Bef or e Af t er 100 80 60 Crit ical Y Six Sigma 40 20 0 -20 -40 Surface Plot of MktShare 1 3 5 7 9 11 13 15 17 19 21 23 Tim e 5. Institutionalizing Lean 20 with DFSS MktShare 10 14 0 13 12 1011 8 9 OLSupTot 14 100 200 6 7 KitPrAve 300
- 15. Delivering Results with Six Sigma • Implementing Lean Solutions is not enough • Cycle time to show better products getting out the door faster is too long • Need earlier feedback • Six Sigma DMAIC can … – Identify root cause of the waste 100 Bef or e Af t er that is slowing down product 80 development 60 Crit ical Y – Simultaneously improve speed 40 and quality 20 0 – Provide early feedback that the -20 lean approaches are working -40 – Create accountability 1 3 5 7 9 11 13 Tim e 15 17 19 21 23 15
- 16. Six Sigma DMAIC keeps Counter-balancing Measures Front and Center Improve Reduce Quality Cycle Time Reduce Effort Counter-Balancing Inputs Outputs Process • Quality • Cycle Time • Effort 16
- 17. Example: Reducing Rework 17
- 18. Example: Increasing Reuse 18
- 19. Other Examples of Six Sigma DMAIC Project Objectives we are driving in R&D Reduce Effort Reduce Cycle Time Increase Knowledge Capture and Reuse Increase Report Improve the Reduce Testing Cycle Time Utility on-boarding for earlier feedback process 19
- 20. Agenda 1. About Boston Scientific 2. Our Lean Six Sigma Strategy in R&D 3. Leading with Lean 4. Delivering results with Bef or e Af t er 100 80 60 Crit ical Y Six Sigma 40 20 0 -20 -40 Surface Plot of MktShare 1 3 5 7 9 11 13 15 17 19 21 23 Tim e 5. Institutionalizing Lean 20 with DFSS MktShare 10 14 0 13 12 1011 8 9 OLSupTot 20 100 200 6 7 KitPrAve 300
- 21. Defining Design for Six Sigma • Design for Six Sigma (DFSS) is a methodology for developing new products with exceptional capability for meeting customer needs. • DFSS is inherently anti-waste because it focuses on delivering customer value and preventing defects • DFSS supports the Lean Product Development System LSL USL 21
- 22. The Lean Product Development System System Designer Entrepreneurial Leadership Operational Responsibility- Set-based Value Stream based Concurrent to the Planning & Engineering Customer Control Expert Engineering Workforce The Lean Product Development System has little waste, and good The Lean Product Development System has little waste, and good flow of value-creating activities flow of value-creating activities 22
- 23. The Lean Product Development System is a Paradigm Shift From To • Highly structured PDP • Knowledge-based product development • Detailed task/ procedure • Detailed quality standards for the descriptions work product • Early component specification • Just-in-Time definition • Manager as administrator • Engineering expert/ mentor • Detailed project plans • Firm integration dates 23
- 24. The DFSS toolkit helps institutionalize the Lean Product Development System • Voice of Customer System Designer • KJ Analysis Entrepreneurial • House of Quality Leadership • Pugh Concept Selection • DFMEA • Capability Studies Operational Responsibility- Set-based • Factorial Concurrent Value Stream based to the Planning & Designed Engineering Customer Control Experiments • Response Surface Methodology • Measurement Expert Engineering System Analysis Workforce • Critical Parameter Management • Control Plans 24
- 25. Our Results with Lean Six Sigma in R&D • In 2008 we introduced COGNIS™ Cardiac Resynchronization Therapy Defibrillator (CRT-D) and TELIGEN™ Implantable Cardioverter Defibrillator (ICD) – The smallest, thinnest, high-energy CRT-D and ICD in the world – These full-featured devices were designed, built and tested with patient safety, quality and reliability in mind. Lean Cu sto nt me m er ve Re pro sp Im on Moving toward s s iv Leadership… es en oc es Pr s Six Sigma Capability DMAIC DFSS • 3-7% YOY Productivity Improvement 25
- 26. Summary • Lean is helping us see what is slowing down product development (the “waste”) • Six Sigma DMAIC is helping us identify root cause of the waste, and simultaneously improve speed and quality. It is also creating early proof that the lean approaches are delivering results. Bef or e Af t er 100 80 60 Crit ical Y 40 20 0 -20 -40 1 3 5 7 9 11 13 15 17 19 21 23 Tim e Surface Plot of MktShare • The Design for Six Sigma toolkit is helping us institutionalize a Lean Product Development system 20 10 MktShare 14 0 13 12 1011 8 9 OLSupTot 100 200 6 7 KitPrAve 300 26
Editor's Notes
- Narrative: Today I want to talk with you about how Boston Scientific is leverage Lean, Six Sigma DMAIC and DFSS to reduce Time to Market with new products while ensuring Product Quality and Reliability to Gain Customer Preference and Meet Company Demands. But first let me tell me you a little bit about Boston Scientific.
- Narrative: Here are some fast facts on Boston Scientific. (You can read from the slide on individual bullet points) Be sure to make the following points: We are a global company with a 29-year track record of innovation and success. We have been a pioneer in the medical device industry and continue to be a leading innovator with major internal and external R&D investments. We operate manufacturing facilities in the U.S., Ireland and Costa Rica and have direct marketing and sales operations in 45 countries. Our international presence helps us accelerate the time within which new products can be brought to market and gain access to worldwide technological developments that may be implemented across product lines. In 2004, we launched the most successful product in medical device history - the TAXUS drug eluting stent – which continues to lead the coronary stent market. In 2006, we acquired Guidant Corporation, which provided us with a leading Cardiac Rhythm Management (CRM) business, enhancing our diversification and creating market leadership in cardiovascular technology.
- Narrative: Boston Scientific was founded on the simple premise that less-invasive medicine could improve patient care. We have remained committed to our mission since our founding nearly three decades ago. Today we are a leading innovator of medical devices and technologies that improve patient lives.
- Narrative: Boston Scientific develops, manufactures and markets technologies that are used to treat a wide range of medical conditions throughout the body. We cater to a broad and diverse set of medical professionals including interventional cardiologists, electrophysiologists, gastroenterologists, oncologists, gynecologists and pain specialists. The medical specialty names used on this slide generally correspond either to Boston Scientific’s businesses or product franchises, which are explained in more detail in later slides.
- Narrative Boston Scientific pioneered the use of less-invasive medical devices to treat patients and we continue to develop medical technologies that save and improve lives. Many of our products are catheter-based and use the body’s venous system or other natural openings to gain access to the afflicted area. Our expansive product portfolio includes more than 13,000 products that treat a variety of medical conditions throughout the body. The diversity of our product portfolio allows us to provide a comprehensive range of treatment options. We continue to add to our product portfolio through internal development and strategic acquisition of proprietary and leading technologies. In recent years, we have begun to offer microelectronic devices such as neurostimulators and implantable cardiac defibrillators which are small electronic devices implanted in the body to deliver therapy.
- Narrative With that as background on Boston Scientific, let me tell you about how Lean Six Sigma plays into our R&D strategy to Reduce Time to Market while ensuring Product Quality and Reliability to Gain Customer Preference and Meet Company Demands
- Narrative Our mission I shared with you earlier, but it is at the foundation of our R&D strategy so I will restate it. Our goal is be our customer’s first choice. Success is doctors and patients insisting on Boston Scientific products. Our strategy is rapid delivery of exceptional products. In our business new products are the life blood of the company. Customers expect newer, better therapies are available at a steady cadence. Our tactics to achieve our goals include Lean, Six Sigma DMAIC, and DFSS. Let me tell you why…
- Narrative We believe Lean Six Sigma will help us serve our customers better and make us a marketplace leader We are not choosing amongst Lean, Six Sigma DMAIC and DFSS: we are doing all three. The value each of the three bring to R&D is what I will discuss in the remainder of this presentation Lean is fundamentally about speed. Lean is at the top of the triangle because we are leading with lean. What unites Lean and Six Sigma DMAIC is that they are about improving our processes, and in this case our R&D business processes What unites Six Sigma DMAIC and Design for Six Sigma is that they are about driving to an entitlement quality standard…Six Sigma capability What unites Design for Six Sigma and Lean is they are driving customer responsiveness… delivering solutions to customer needs fast The three methodologies working together are helping us serve our customer better and win in the marketplace
- Narrative Let me begin by talking about how we are leveraging Lean in R&D…
- Narrative We are leading with lean. By that I mean that the conversation starts here. Lean is fundamentally about speed. Speed is achieved not being fast and sloppy, but rather through the steps described here from the book “Lean Thinking” by Womack and Jones. Steps: Specify value (what in our business process creates customer value…in R&D these are the process steps that make new product more valuable to customers) Identify the Value stream (map the business process…highlight the value-creating steps and the non-value creating steps (the “waste”... Extra approval signatures on PDP deliverables, engineers context switching on 3-4-5 different PDP projects and having to recall where they left off and begin again) Make the value-creating steps flow continuously (through elimination or reduction of the “waste”). Elimination or reduction of the waste makes our business process fast, and allows us to move from a push to a customer pull strategy. We want to be developing product features in response to customer pull, rather than engineering push. The last principle of Lean is driving to perfection with continuous improvement….its about never being satisfied with our current performance and the way that work gets done.
- Narrative There is growing recognition that Lean can be applied to Quality Systems. What I mean by “Quality System” is the collective plans, activities, and events that are provided to ensure that a product, process, or service will satisfy given needs This is an except from a recent article in the Silver Sheet. “ The Silver Sheet” is a medical device industry publication which focuses on quality control, compliance and pre- and post-market issues affecting medical device manufacturers.
- Narrative In the lean methodology there are 7 standard forms of waste (non-value creating items or activities): Defects, Over Production, Excessive Inventories, Excessive Motion, Excessive Processing, Transportation and Waiting. These waste categories are very familiar in the factory floor environment, but they apply equally well to transactional business processes including product development. Listed here are examples of the 7 forms of waste in product development companies. Defects manifests itself as drawing or software code errors. Over production manifests itself as producing with incomplete customer requirements, or extra product features that customer don’t want. Excessive inventories manifest itself as lots of partially done work because the work in progress exceeds capacity. Excessive motion manifests itself as excessive engineer change requests. Excessive processing manifests itself as too many approval signatures Example of Transportation waste is task switching on multiple projects Example of waiting waste is delays due to workload exceed capacity. The waste in product development companies has serious consequences for R&D including low re-use of knowledge, lots of rework late in the development process, R&D scrap, long lead times. Lean has helped us see what is slowing down product development. It has created a language to talk about what is slowing us done and has given us solution strategies.
- Narrative Although we are leading with lean to help us see what is slowing down product development, lean thinking alone is not enough to reduce time to Market while ensuring Product Quality and Reliability to Gain Customer Preference and Meet Company Demands. Six Sigma is also proving to have a very power impact on R&D outcomes
- Narrative Implementing Lean Solutions is not enough. Any change management text book will tell you that to sustain any change initiative you have to produce early evidence that the new approaches are working. An inherent problem with a Lean only initiative in R&D is that cycle times to show better products are getting out the door faster is too long. Two-three years later when you have the proof, you have lost the organization already. To sustain the change initiative you need earlier feedback Six Sigma DMAIC process improvement methodology can provide that earlier feedback. Lean can help you articulate what the waste is, but it doesn’t reveal root cause. Six Sigma DMAIC is a very effective methodology for drilling down to root cause. Also, Six Sigma is inherently focused on counter-balancing measures so it is possible to simultaneously improve speed and quality Lastly, the Six Sigma DMAIC approach creates accountability to show that the lean solutions are working to produce a meaning business result
- Narrative Six Sigma DMAIC keeps Counter-balancing Measures Front and Center Every project charter has a primary measure (perhaps cycle time), but it also has counter balancing measures (e.g. quality, effort). Projects are established with Faster-Cheaper-Better goals at the start. This tension in the measures fuels creative solutions.
- Narrative Here is a very specific example of how we are leveraging Lean and Six Sigma. This picture is a simplification of a real project. Lean helped us articulate “rework” as a major source of waste in product development. I am not talking about the front end iterative experimenting that is inherent in good R&D work. Rather I am talking about late development stage rework when we thought the component was finished, and ready for system incorporation and we had to rework it. We used Six Sigma to set specific and aggressive goals for reducing rework in the Define phase. We set a counter-balancing metric that we had to have zero escaped defects. We also defined secondary measures of speed and effort. In the measure phase we mapped the process, reached back into history and measured our baseline performance, and begin to funnel the inputs to the process from the many to the few. In Analyze, we dispelled many myths about what was driving rework, and showed 1 critical input explained 70% of the variation in rework. This was the number of late, new requirements. In the improve phase, we improved the quality of the requirements gathering process so that we would have fewer late new requirements. We also worked to reduce our process cycle times so that we could create the work product just-in-time when requirements were known. In the control phase, we implemented the solutions, trained those affected, obtained process owner sign-off, and held ourselves accountable to the aggressive goal. This project summary is an example of how we are capturing our knowledge work from R&D process improvement. It is simplified example of an A3 report. Ready A3 Thinking for more information on this KM approach.
- Narrative Here is another example of how we are leveraging Lean and Six Sigma. Again, this picture is a simplification of a real project. A source of waste in product development is developing new assets, components or design elements when previously developed assets were available for use in the system. Here the critical output is reuse of non-new assets. Our counter-balancing measures were that 100% of customer needs described in the marketing specification needed to be met. Also, the cost to make assets re-useable had to be small. In the measure phase we mapped the process by which assets were created and reused. We measured our hististorical reuse baseline and confirmed we could improve substantially. In analyze we established root cause, one of which was the % of new assets planned for the product. When the % of new assets increased, the amount of reuse of non-new assets was diminished. In the simplest of terms, this was due to asset architecture. In the improve phase, we re-engineered the architecture to drive asset reuse. We also put in place chief engineer oversight to prevent engineer propensity to tweak assets that were already meeting customer needs. In Control, we held ourselves accountable to a meaning shift in reuse. We didn’t want to implement solutions and run. Accountability to the improvement is key. It fuels 120% commitment to the effort, and engineers feel good in the end about having made a meaningful difference to the business and to our customers.
- Narrative We have run dozens of Six Sigma DMAIC projects in R&D. I cited examples of reducing rework and increasing reuse. Here are other examples of Six Sigma DMAIC Project Objectives we are driving in R&D. Collectively these are greatly improving R&D outcomes and improving productivity.
- Narrative Last, but not least let me tell you how were are leveraging DFSS to institutionalize a lean product development system
- Narrative The Lean Product Development System is described in two key Lean PD books: Product Development for the Lean Enterprise by Michael Kennedy Lean Product and Process Development by Allen Ward The Lean Product Development system has little waste, and good flow of value-creating activities. There are 4 key elements of the Lean PD system: System Designer Entrepreneurial Leadership (Chief Engineer) Responsibility-based planning & control Expert engineering workforce Set-based concurrent engineering
- Narrative The Lean Product Development system is a major paradigm shift in product development
- Narrative The DFSS toolkit helps institutionalize the Lean Product Development System. In particular, it supports set-based concurrent engineering and an expert engineering workforce. Set-based concurrent engineering depends on have good product requirements so that all design sets are working to satisfy the same goal. The DFSS front end tools (VOC, KJ, HOQ) enable good requirements generation. DFMEA helps weed out weak design concepts early, and strengthen others. Designed Experiments and Capability studies help identify the best design at the integration date. DFSS supports an expert engineering workforce. For example, RSM creates a very strong, quantitative understanding of trade-offs in product development (e.g. I can increase strength, but ill have to trade off weight, for example).
- Narrative Our tactics of using Lean, Six Sigma DMAIC and DFSS in R&D are producing real results in our business.
- Narrative Boston Scientific is leveraging Lean, Six Sigma DMAIC and DFSS to reduce Time to Market with new products while ensuring Product Quality and Reliability to Gain Customer Preference and Meet Company Demands.