Celia Berry, CQA, CSSGB Supplier Quality Engineering Manager, Milton Roy Company (div. of United Technologies) BS, Massachusetts Institute of Technology.

Celia Berry, CQA, CSSGB

Supplier Quality Engineering Manager,

Milton Roy Company(div. of United Technologies)

BS, Massachusetts Institute of TechnologyMS, Northwestern University

Materials Science and Engineering

Groundhog Day

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 Developme

nt

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 Evaluation1. 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 RequirementsISO-9000, TS16949 (auto), AS9000 (aero), 10 CFR 50 Appendix B (NUPIC), ISO13485 (med devices), ISO 22000 (food), ISO 14001 (environment), Military specs, etc.

Good ReferencesQuality Audits for Improved Performance- Dennis

ArterISO 9001: 2008 Explained- Charles Cianfrani, Joseph

Tsiakais, John WestCQA Primer- Quality Council of IndianaSupplier Management Handbook- ASQ, James

Bossert editor

Part Quality Improvement1. 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 Improvement3. 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 Development1. 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