Utilizing Enterprise Quality Management to Optimize the Supply Chain and Gain Greater Visibility Into Processes Across the Business Ecosystem



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Overview, Goals, & Introductions

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Utilizing Enterprise Quality Management to Optimize the Supply Chain and Gain Greater Visibility Into Processes Across the Business Ecosystem Using Supplier Quality Management

Before We Begin If you experience technical problems, please contact GoToMeeting Technical Support at 800 263 6317 or +1 805 617 7000. All attendees are muted upon entry to the event Please use the question option to send questions at any time during the event. All attendees will receive a copy of today s webinar. 2

Today s Presenters Joe Humm Vice President, Global Sales Operations for Sparta Systems Dirk Dusharme Editor in Chief of Quality Digest 3

Why Is Quality Important to Your Business Ecosystem? INNOVATION Globalization Speed to Market Vendor Network EVOLVING MARKET CONSULTATIVE SALES Evolving Compliance Requirements Brand protection SHOPPER MARKETING Cost, Price & Margins Consistent Delivery 4

Quality Challenges within an Organization SUPPLY CHAIN INTERNAL INFRASTRUCTURE VALUE CHAIN No Quality Visibility Regulatory Bodies Tier 1 Suppliers EQMS Tier 2, 3 Suppliers & Supplier s Suppliers Contract Manufacturers & Packagers Brand Owner ERP Finance & Sales MES Manufacturing & Packaging Quality Management Master CAPA Master Change Control Master Deviations Master Investigation Distribution Retail Issue Resolution Cost: Consumers 1x 10x 100x 1000x 5

Example: Contract Spending Grouping and Rations DIRECT ENTERPRISE SALES & MKTG R&D MGT 32% 25% 22% 21% # Suppliers % of Costs Quality Transactions # Suppliers % of Costs # Suppliers % of Costs # Suppliers % of Costs Raw Materials 3K 9% 20K Services 18K 16% Creative 5K 6% Services 24K 12% Packaging 2K 6% Corp Svs10K2K 4% Marketing 5K 6% Corp Svs 11K 9% Contract Mfg. 4K 8% IT 100K3K 3% Promotion 15K 8% Transportation Total 5K 9K 23% 5% Energy 130K1K 1% Meetings 36K 5% Capital 2K 4% Telecom 1K 1% Travel 20K 3% 3 categories are under scrutiny by Regulatory Agencies Must be fully audited 6

The Challenge Raw Material Supplier Issues Impact Packaging Contract Manufacturers & Packagers Product shipped late Product damaged Manufacturing delays Scrap, delays in Mfg & shipping + Product out of spec Product mislabeled Shipped + wrong product = Issues Issue No visibility Issues Not Captured: Poor quality product delivered Inconsistent processes Poor information Reactive Environment Manufacturing Facility Manufacturing Facility Distributor Distribution delays Impact Issue not captured Dangerous product distributed Impact Issue not captured Poor quality product delivered Distributor Pharmacy (Out of Stock) Consumers Business Impact Overhead Costs Out of Stock Costs Organizational Impact Compliance & Litigation Market Impact Time = Money Poor Quality = Danger Poor Quality Affects Brand Reputation 7

Addressing the Challenge Better Visibility On Time Shipping Fewer Damaged Products Interactive Supplier Scorecard TrackWise Analytics Real-Time Consistent Accurate Manufacturing Quality Few Manufacturing Delays Fewer Shipping Delays Less Product Quarantined Less Waste/Rework Protected Supply Chain Raw Material Supplier Efficiency Packager Product In Spec Accurate Labeling Correct Product Shipped Fewer Damaged Products Supplier Quality Management Quality Processes Contract Manufacturers & Packagers Product In Spec Accurate Labeling Right Product Shipped Consistent Quality 8

Stratas Supplier Scorecard Accurate Data When you need it VP Procurement VP Manufacturing VP of QA Manufacturing Metrics PROCESS FLOW METRICS 8 Materials Waiting Time Quotient MWTQ Percent (%) Ratio of waiting time for materials to total manufacturing lead time (TML) 9 Line Efficiency LE Percent (%) Ratio of actual process throughput to the theoretical idea throughput based on the pace and cycle time at the bottleneck station. QUALITY METRICS 10 Scrap Rates SR Percent (%) Percentage of units starting as raw material that are lost as scrap from all steps in the process. 11 Rework Rates RR Percent (%) FINANCIAL METRICS 12 Cost per Part CPP $/unit Percentage of units starting as raw material that have to be reworked at least once in the process. Total cost per unit for raw materials, processing and indirect overhead. Net Effects Greater Transparency Better Accountability More Efficiencies 9

Stratas Protecting the Supply Chain from Supplier Issues Packagers Certified Trending Negative Manufacturer 1 Can you get to the data you need to protect your entire supply chain? Certified Suppliers Not Certified Manufacturer 2 Corporate Distributors Remediate Retail Certified Manufacturer 3 Contract Manufacturers SQM by Manufacturing Facility Industrial Internet Consumer 10

Meeting the Needs of the Organization Internal Teams Need to Increase Visibility PROCUREMENT QA MANUFACTURING IT QA Processes Risk/ Compliance Accuracy Speed Supplier Nonconformance Supplier Audits Supplier Onboarding Warning Letters/Decrees (483s) Recalls 11

The Challenge Technology Driving Efficiency & Accuracy Days or months to receive data TrackWise Analytics ACCURACY Lost or incomplete data at time of business decision TIME On Premise SQM Quality Processes Resulting in negative monetary impact Paper based Audits Manufacturing Process ISSUE VOLUME 12

Addressing the Challenge Technology Driving Efficiency & Accuracy TrackWise Analytics ACCURACY Complete data at time of business decision Via TIME On Premise SQM Quality Processes Resulting in positive monetary impact Electronic Audits One Click Electronic Upload Manufacturing Process ISSUE VOLUME 13

The Challenge Supplier Audits Suppliers and CMOs to Be Audited Supplier Audit Checklist Supplier qualification Risk Assessment Interim Check Critical Suppliers No Quality Visibility Prioritize Schedule Manage Cumbersome Resource Intensive Difficult to coordinate Supplier qualification Risk Assessment Interim Check Important Suppliers No Quality Visibility Execute Inconsistent Remediate Detached Supplier qualification Risk Assessment Interim Check General Suppliers No Quality Visibility 1. Online Assessment 2. Audit Execution 3. Observations & CAPAs Measure Inaccurate Decisions 14

Addressing the Challenge Supplier Audits Suppliers and CMOs to Be Audited Supplier Audit Checklist Supplier qualification Risk Assessment Interim Check Critical Suppliers Audit Planning Prioritize Schedule Manage Audit Execution Informed Systematic Efficient Execute Consistent Supplier qualification Risk Assessment Interim Check Important Suppliers Audit Management Remediate Measure and Inform Integrated Measure Accurate Decisions Supplier qualification Risk Assessment Interim Check General Suppliers 1. Online Assessment 2. Audit Execution 3. Observations & CAPAs Complete 15

The Challenge Product Non Conformance Paper based Management Slow Response Detached Product Damaged Notification Received Supplier Response Due Date Extension Product Damaged (Repeat Issue) Days or months to receive data Quarantine Issue Identified Notification SCAR Reviewed Action Item Extension Approved No Visibility Quality Processes Issue Missed Product Manufactured Product Shipped Poor Quality = Brand Reputation Poor Quality = Danger

The Solution Product Non Conformance e Electronic Record Management Efficient Response Connected TrackWise Analytics Product Damaged Notification Received Supplier Identification Root Cause CAPA Plan Effectiveness Check Efficient Response Electronic Record Management Quarantine Issue Identified Notification SCAR Reviewed CAPA Approved Action Item Reminders Visibility Quality Processes Product Manufactured Product Shipped On time Quality Safe

The Challenge Supplier Onboarding Poor Onboarding and subsequent management leading to: Less Compliance More Risk Onboarding x Supplier x Material o Raw Material x 1,000 s Higher Costs Material #1 Cert Material Certification Material #1 Received Improperly Filed PLM Cert Flagged Out of Date Inconsistent Processes Inefficient Management Poor Recordkeeping Supplier A Material #2 Cert Material Certification Material #2 No Cert Received PLM Supplier Flagged w/ Cert Manufacturing Facility 2 Product Manufactured Non Compliant Certs. = Danger Poor Recordkeeping = Brand Risk 18

The Solution Supplier Onboarding Automated onboarding and subsequent management leading to: Consistent Processes Efficient Management Electronic Recordkeeping Onboarding x Supplier x Material Raw Material x 1,000 s Product Manufactured Material #1 Cert Supplier A Material #2 Cert Supplier Onboarding Material #1 Certification Doc Posted Business Rules Safe Material Material #2 Received Systematic Efficient Delivered SQM Automated Processing Manufacturing Facility 2 Compliant Certs. = Quality Certification Doc Posted Business Rules Safe Material Received Systematic Efficient Delivered Sound Recordkeeping = Brand Protection 19

In Conclusion Fast and efficient management of information so you are working with complete and accurate data sets Single integrated quality and analytics platform to narrow in on your most important supplier related issues Reduction of risk by virtue of better supplier quality management (i.e., protect your downstream interests) Margin and profit protection as a result of improved operations and a quality consumer experience 20

Building a Culture of Quality 21

Quality s Defining Moment 1950 Deming Prediction after Lecture Within 5 years, if Japanese manufacturers faithfully follow the principles I ve shared, Japan will be economically competitive and consumers worldwide will clamor for Japan s products Actual Outcome 18 Months: Quality of Goods Productivity 5 Year Prediction: Beat by 1 year

What Did A Statistician Teach the Japanese about Quality, Management and Business? Suggested Fallacy Results to Cause Profits should not drive actions Actions should drive profits Independent Goals All businesses are an ecosystem Sales are a result of quality, usefulness, inter departmental cooperation Best Efforts Working harder, or giving more doesn t work People need decisions, direction, knowledge and training Suggested Assertion A Better Way Quality in everything the organization does must be the #1 priority Old Attitude vs. New Organizations must always stay committed to the continuous improvement journey Quality Impact on Profits Quality must be viewed as a driver of profits and not an inhibitor No Defects Product defects must be prevented as they are expensive to manage and fix

Case Study #1: RCA Pennywise, Pound Foolish Context Mid 80 s Worldwide Leader Electronics Organization was focused on innovation and thought leadership Chairman of RCA maintained an apartment near the R&D facility Recommendation: Don t work backwards from profits and margins. Focus on Event research, innovation, quality, consumer needs and execution. The profits will Chairman leaves RCA follow Firm finds a new way, in which they will maximize profits To increase margins, the firm begins to substitute existing parts for cheaper parts (costs ; profits ) Deming Philosophy: Look Forward, Not Backwards.. Outcome Sharp increase in the # of televisions failing during the warranty period Warranty costs (paperwork, personnel, process management) escalated (~25% or more of manufacturing costs) Fixing the televisions became prohibitively expensive. The cost of repairs equated to the original manufacturing costs Televisions accumulated in warehouses and all had to be written off How many RCA customers were lost in the process? How many customers were gained by Sony as they rose in the 80s as the electronics leader?

Case Study #2: ITT Context In 1961 ITT had sales of $756.6M and earnings of $29M when the new CEO took over In 1977 when the CEO stepped down, sales were $16.7B and earnings were $562M In the 16 years of business, ITT bought, sold and merged more than 350 businesses into their core across 80 countries ITT became the 9 th largest industrial company on the Fortune 500 list The business was managed to one simple philosophy: 15% improvement in profit every year Recommendation: Build a sustainable business with repeatable, and scalable processes that focus on quality and continuous improvement Deming Philosophy: Arbitrary goals sales goals don t work, arbitrary shipment goals will fail and morale will suffer. Shortcuts to reach business goals will mount, snowball and impact margins Event in the long run ITT acknowledges operational and structural issues in the late 70s ITT acknowledges subsidiary problems and begins to sell them off ITT experiences a spectacular collapse and shrinks to a fraction of its original size Shareholder value is lost ITT s brand is eroded Competitors gain market share Outcome

Case Study #3: 1980 s Ford vs. GM vs. Toyota Context In 1980, Ford, GM and Chrysler were on the brink of collapse Chrysler was grabbing headlines with its flirtation with bankruptcy & federal loan guarantees In 1983 a quiet revolution was beginning at Ford as they recognized the biggest complaint at the time with American made automobiles was quality Recommendation: Real profits are generated by loyal customers not just satisfied customers. Satisfied customers will try or change brands based on price. Loyal customers brag about the goods and services they are receiving Deming Philosophy: Deming s philosophy Event calls for organizations to produce products and services that help people live better. Providing those goods and services is the raison d etre of an organization. By providing ever improving services management and products, (i.e., Deming an organization believed management develops and quality loyal were customers synonymous) Ford requested that Edwards Deming come to their headquarters to teach seminars on quality To the management team s surprise, Deming did not talk about quality, but rather spoke about Ford s Chairman committed to implement Deming s philosophy throughout the company as a means to change its culture. Outcome In 1986 Ford emerged as the darling of the automotive industry For the first time, Ford s earnings exceeded that of Chrysler and GMs (and actually exceeded their combined earnings) Earnings again exceeded GM s and Chrysler s in 1987, which resulted in profit sharing of $2,000/employee in 1987 and $3,700 in 1988

So what is quality? Quality is NOT: Preference Technology or Features Backup Systems or Overdesign Quality is: Understanding the CoPQ Recognizing the cost of the lack of quality Understanding the consequences of better quality in the marketplace Uniformity Clear specifications Consistent manufactured output Pride of Workmanship Happy employees means more productivity and better quality