Celia Berry, CQA, CSSGB Supplier Quality Engineering Manager, Milton Roy Company (div. of United Technologies) BS, Massachusetts Institute of Technology MS, Northwestern University Materials Science and Engineering

Groundhog Day

Celia’s Groundhog Days Day 1: Motorola- Plastics and Die Casting Commodity Manager Day 2: C & D Technologies- Senior Supplier Quality Engineer Day 3: Milton Roy- Supplier Quality Engineering Manager

Supplier Quality Engineering- Responsibilities Supplier Evaluation Process Part Quality Improvement Supplier Development Part Approval Process

Starting Up an SQE Organization From Scratch Step 1: Obtain top management commitment and allocation of resources. Obtain support from Supply Chain Management, Engineering and IT. Step 2: Understand your product down to the component level (If on site, spend a day building product) Step 3: Work with supply chain management to understand the supplier base (80/20 rule for spend and quality issues) Step 4: Start building your organization

Starting Up an SQE Organization From Scratch Step 5: Perform internal audit of your company’s supplier management processes- supplier selection/certification, supplier performance metrics, verification of purchased product prior to use, control of non conforming material. Identify gaps. Step 6: Visit key suppliers- conduct audits Step 7: Develop strategy

SQE is not for the faint! This awesome job might require you to be Wonder Woman!

Building Your Organization Hire SQE’s with 1. Knowledge of quality philosophy, specifications, and tools 2. Technical with knowledge of a diversity of product and processes 3. Experience in auditing, helps to be certified (ASQ ) 4. Experience in problem solving and knowledge of problem solving tools 5. Analytical, detail oriented, organized and great writing and presentation skills 6. Hands on with good interpersonal skills

Supplier Evaluation 1. Who selects your suppliers? What is the criteria? How are results documented? 2. You may need to develop or revise the supplier evaluation process. 3. Supplier Audit Requirements ISO-9000, TS16949 (auto), AS9000 (aero), 10 CFR 50 Appendix B (NUPIC), ISO13485 (med devices), ISO (food), ISO (environment), Military specs, etc. Good References Quality Audits for Improved Performance- Dennis Arter ISO 9001: 2008 Explained- Charles Cianfrani, Joseph Tsiakais, John West CQA Primer- Quality Council of Indiana Supplier Management Handbook- ASQ, James Bossert editor

Part Quality Improvement 1. How is non-conforming material managed? What monitoring and measurement equipment does your company use? (quality lab capabilities) 2. Make sure a calibration system in place 3. Metrics: Data captured manually vs. software? Linked to MRP? Web based sharing with suppliers? (If not, you need IT help) 4. Set up system that links your Material Review Board team (workflows) 5. Hold MRB meetings regularly to disposition non-compliant material. (insure cross-functionality) 6. Identify Suppliers of Concern-perform analysis to determine systemic and specific issues

Part Quality Improvement Root Cause Analysis Problem solving tools: 5 Whys, Flow charts, check sheets, histogram, Pareto diagrams, fishbone diagrams, control charts, scatter diagrams, affinity diagrams, tree diagrams, process maps, etc. Material Analysis: microscopy, spectroscopy, thermal analysis, NDT Corrective Action Statistical Tools: to characterize, correct, and improve processes (Minitab) 8 D process (or equivalent)

Part Quality Improvement 3. Preventative Action (mistake proofing) Level 1: Prevent error from occurring Level 2: Catch error at time of occurrence Level 3: Catch error after occurrence Good References: The Certified Quality Engineer Handbook-Benbow, Berger, Elshennawy, and Walker Poka-Yoke- edited by NKS/Factory Magazine

Supplier Development PPM? Cp, Cpk? Six Sigma? 5S? Quality Control Plan? Control Charts? CTQ? Capability Study? FMEA? Gage R&R? Root Cause Analysis? Mistake Proofing? Does your supplier give you this look? If yes, you need to set up a supplier development program.

Supplier Development 1. Consult Supply Chain Mgt. to determine whether supplier is strategic. 2. Use supplier audit results to determine gaps 3. Hold a Supplier Day with key suppliers: communicate expectations; give quality tools overview 4. Hold one-on-one sessions with suppliers- quality performance review, root cause analysis/mistake proofing for specific issues. 5. Help supplier set up internal quality clinics to resolve issues.

Verification of Purchased Product Prior to Use Part Approval Process (aka PPAP for automotive) First Article Inspection Lab and Functional results Process Capability Studies Process Control Plan Gage Study FMEA- Failure Mode and Effects Analysis Reference: AIAG- Automotive Industries Action Group Need to set up a system for managing approvals, communicating results to suppliers and resolving non conformances/ issues (including deviations while engineering changes are in process)

Lessons Learned as a Woman in Quality Get a mentor Work for ethical companies that value Quality and people Become adept at program management and multitasking Learning is a lifelong endeavor Balance your life- SQE can be all consuming Mother Bethel AMEFun and ExerciseFamily