Proactive Quality Strategy

1. Proactive Quality Strategy “A goal without a plan is just a wish.” Thomas A. Crane 612 Orr’s Camp Road Hendersonville, NC 28792 Phone: 828-696-9528 t_crane_nc@bellsouth.net http://www.cranesinhvl.info/ThomasCrane/ Thomas A. Crane – 2009 Proactive Quality Strategy 1

2. Proactive Quality Strategy Robust Quality Management System Any proactive quality strategy must be supported by a robust quality management system (QMS). Whether it is based on ISO 9000, TL9000, QS9000, TS16949, TQM, TPS or any other standard, a robust Quality Management System (QMS) will consist of some basic key elements. • Well defined quality goals and objectives, communicated to all levels of personnel, and with defined metrics that are reviewed to determine the effectiveness of the QMS. • Quality goals and objectives that are measureable and based on customer requirements, regulatory requirements and internal company requirements. • Corrective/Preventive action system that provides real root cause analysis and methods for evaluating corrective/preventive action’s effectiveness. • An effective method of auditing the QMS at all levels of the organization to determine effectiveness. • Management review of effectiveness of QMS and supporting appropriate actions needed for continuous improvement. These basic elements are the foundation for the rest of the Quality Management System. Without a strong commitment to these basics, the QMS will not be effective. Management Commitment A proactive quality strategy is a management focus on a philosophy that supports activities that lead to long term results, even at the expense of short term financial goals. This management philosophy is one of the foundational principles in the Toyota Production System. Management must communicate this philosophy to all levels of the organization, and support it with their actions. Management must stay focused on the business initiatives that bring continuous improvement and real change to the organization. They have to provide the working environment that enables every employee to participate. This means helping every employee understand their role and how they affect the business. The success of any business depends on the people that do the work. True success requires a balanced focus by management on the key drivers of the business; Safety, Quality, Service, Productivity, and Cost. Successfully managing each of these key drivers is a major task in itself, but lost focus on any one of them can negate the positive effects gained in the others. There is a plethora of tools available to accomplish managing these key drivers, such as Lean, Six Sigma, CTQ flowdown ( or QFD), TPS, TQM, etc. A proactive quality strategy will employ a variety of tools making sure the right tools are used for the right job and provide training for all levels of personnel so that the tools are used properly. Thomas A. Crane – 2009 Proactive Quality Strategy 2

3. Revise CTQ Flowdown Proactive Quality Strategy Identify What to Measure Measure & Control Drive Improvement • Effective Quality Management System • Quality Management Tracking • COQ (Warranty, Scrap, Concessions) • Internal & External PPM • Voice of the Customer Findings • CAR & Excursion Tracking • CTQ Flowdown Tracking • Quality improvement tracking • Change Management • Project Tracking • Quality Measurement System • (internal SPQ and Defect tracking) • Monitor Capability (Z scores) • Auto e-mail warnings • Tracking defects (internal and warranty) • Supplier Tools (SPQ, CARs) • Zscore data & Alarms (SPQ) • Delivered PPM and CAR Closure • Rejected Material Management • PM Tracking • Enables TPM • Tool/Equipment PM Triggers • Auto e-mail PM Violations • Best Practice Database • Translation to all areas and all plants • CAR’s • Submit Failure Details • Analysis & Corrective Action • Formal Closure (validation of effectiveness) • Customer Feedback • CTQ Flowdown • Quality Functional Deployment (QFD) • Identify customer’s CTQ’s (VOC). • Translate customer CTQ’s to product-performance CTQ’s. • Identify Low level Red X’s that impact Parts/Process CTQs • Prioritize the Red X’s • Assign current control levels • L1 – mistake proof • L2 – early warning • L3 – operator dependent • L4 – no quality plan • Quality and Process Improvement • Project Management • Clear project goals • Verifiable benefits • Timeline with resource allocation and well defined deliverables • Quality Focused Events • Leverage Lean/Sigma kaizen • Shift to L1/L2 Controls • Improve Z-score • Mistake proofing in design of product and processes Thomas A. Crane – 2009 Proactive Quality Strategy 3

4. Proactive Quality Strategy Identify What to Measure • CTQ Flowdown • Quality Functional Deployment (QFD) • Identify customer’s CTQ’s (VOC) • Translate customer CTQ’s to product-performance CTQ’s • Identify Low level Red X’s that impact Parts/Process CTQs • Prioritize the Red X’s • Assign current control levels • L1 – mistake proof • L2 – early warning • L3 – operator dependent • L4 – no quality plan Marketing – Technology – Quality - Manufacturing CTQ flowdown is a form of Quality Functional Deployment (QFD). It is a process for making sure that the Voice of the Customer is reflected in the design and manufacturing of products. CTQ flowdown begins with the voice of the customer and the design process. Understanding the customer needs and expectations (captured and documented) is the first step. Translating those needs and expectations into product design and easy to understand specifications is the next step. Producing products that meet the design specifications and therefore meet the customer needs and expectations is the final result. A robust Product Design Rationalization process is crucial. Technology design reviews with Quality and Manufacturing are essential for successful CTQ flowdown. L1 and L2 control levels are desired for each CTQ L1 – Mistake Proof (product, part, and/or process designed to ensure the CTQ is met without operator intervention) L2 – Early Warning (SPC is used to monitor part dimensions and/or process parameters to maintain control of CTQ within specification limits. Data can be reviewed for continuous improvement opportunities.) L3 – Operator Dependent (When L1 or L2 control level is too costly or improvement project is a lower priority, then L3 is acceptable if proper safeguards are in place. Clear control plans for process setup and operation, first piece and in-process inspections with data recorded, and frequent quality audits of procedures and records are needed for L3 control level to be effective. L4 – no quality plan (For a true CTQ, this level is never acceptable.) Thomas A. Crane – 2009 Proactive Quality Strategy 4

5. Proactive Quality Strategy Measure & Control Quality Management Tacking Quality metrics are essential to track and trend overall quality issues. They provide the data needed for effective root cause analysis. The quality metrics form the input for much of the continuous improvement projects and help drive true customer satisfaction. Quality Improvement Tracking Effective project management is essential for successful and timely continuous improvement. Change Management provides the structure to review projects to make sure they are viable with realistic objectives and deliverables. Project tracking, with milestone reporting on deliverables, can keep project on track or identify when gap closing measures are needed. Quality Measurement Systems Well defined systems (preferably automated) for data collection are essential for process and product control, accuracy in quality metrics, trend monitoring and identification of continuous improvement opportunities. Supplier Tools Parts and products supplied by vendors need to be subjected to the same metrics as internal parts and products. Use of SPC, defect tracking, and part level (as well as vendor level) PPM are part of evaluating the vendor performance. OTD and promises kept are as important as part quality in evaluating vendor performance, as well as the vendor’s responsiveness to CARs PM Tracking Preventive maintenance on equipment, tooling and facilities are not always linked to the Quality Management System but is essential to the sustaining of both quality and productivity. (ref. ISO 9001 section 6.3 and TPM) Best Practice Database Best practices should be documented and shared with all areas and all plants to drive consistency and to leverage the corporate knowledge base. • Effective Quality Management System • Quality Management Tracking • COQ (Warranty, Scrap, Concessions) • Internal & External PPM • Voice of the Customer Findings • CAR & Excursion Tracking • CTQ Flowdown Tracking • Quality improvement tracking • Change Management • Project Tracking • Quality Measurement System • (internal SPQ and Defect tracking) • Monitor Capability (Z scores) • Auto e-mail warnings • Tracking defects (internal and warranty) • Supplier Tools (SPQ, CARs) • Zscore data & Alarms (SPQ) • Delivered PPM and CAR Closure • Rejected Material Management • PM Tracking • Enables TPM • Tool/Equipment PM Triggers • Auto e-mail PM Violations • Best Practice Database • Translation to all areas and all plants Thomas A. Crane – 2009 Proactive Quality Strategy 5

6. Proactive Quality Strategy Drive Continuous Improvement Continuous Improvement Continuous improvement is driven by many things within an organization and should always be linked to customer satisfaction. Improvements in safety, quality, service, productivity,and cost all have positive affects on the customer. Real improvements solve root causes of problems with sustainable, measurable and effective results. A robust corrective/preventive action system is one of the essential tools needed to drive improvements. An effective CAR system provides the structure for detailed root cause analysis, tracking of issues to closure and evaluation of the effectiveness of actions taken. Another essential tool used to drive continuous improvement is Project management. An effective Project Management system will drive successful completion of projects with identifiable benefits. Projects to improve safety, quality, service, productivity, or cost need to have clearly defined goals with measurable benefits that affect the bottom line. A business with a proactive quality strategy incorporates a quality focus in all activities. With well defined CTQ flowdown, all continuous improvement projects, lean kaizen events, and six sigma projects, will incorporate a focus on improving the control level of CTQs. Lean activities designed to eliminate non-value added steps or waste from processes, will incorporate awareness of CTQ control levels to insure they are not altered. CTQ controls are included in the value stream maps for the process. Six Sigma projects designed to improve the quality of value added steps by reducing variation, can help improve the control levels of CTQs to level 1 or level 2. This business wide quality focus will drive the VOC through design and manufacturing with the result of improved customer satisfaction. • CAR’s • Submit Failure Details • Analysis & Corrective Action • Formal Closure (validation of effectiveness) • Customer Feedback • Quality and Process Improvement Project Management • Clear project goals • Verifiable benefits • Timeline with resource allocation and well defineddeliverables • Quality Focused Events • Leverage Lean/Sigma kaizen • Shift to L1/L2 Controls • Improve Z-score • Mistake proofing in design of product and processes Thomas A. Crane – 2009 Proactive Quality Strategy 6

7. Proactive Quality Strategy Continuous Improvement Cycle Six Sigma Lean Define Kaizen Scope Process Improvement Eliminate Waste Measure Standard Work Value Stream Map Control Improve Analyze Try Storming Time & Motion Study CTQ Flowdown 5S VOC/Design Sort Customer Satisfaction Sustainable Improvement Through Self Discipline CTQ Control Level Design Verification Straighten Sustain Design Reviews Design Validation Standardize Sweep Thomas A. Crane – 2009 Proactive Quality Strategy 7