What Do QE’s Want? … and How to Provide It Scott Laman Teleflex Reading ASQ Section March 9, 2015

Teleflex Corporate HQ – Wayne, PA 12,000 global employees More than 130 countries Class I, II and III devices Vascular, Respiratory, Anesthesia, Urology, Dialysis, Surgical, Cardiac

Typical Medical Kit

Presentation Objectives Learn about factors for success in hiring, developing and retaining QE’s –Provide ideas to promote a culture of quality in which they can thrive –Avoid departmental and organizational pitfalls Obtain ideas for successful technical management –Quality tools –Statistical analyses

The Broad QE Field Supplier Manufacturing R&D Software CAPA Complaint Investigation Audit Continuous Improvement Lean Six Sigma …

Characteristics of QE’s Focus on facts and data Desire and want to demonstrate leadership Use project management Are organized and systematic Use quality and statistical tools Desire clear goals Tie work to higher-level objectives Appreciate learning and growth Want to be ethical

The QE Employee Life Cycle Recruit and hire Develop and train Satisfy and retain Lose via termination or attrition –Avoid this last step! –Leaving for another internal job OK

Recruiting and Hiring Needs Fit with the organization Clarity of initial opportunity Facts and data Walk the walk

Tool #RH1: Interview Questions QuestionAnswerRating Core Skill: Quality Thinking What is your philosophy with respect to Quality? What makes you a good Quality professional? Who was your most influential mentor in Quality? Core Skill: DOE Give me an example of your use of design of experiments. How was the experiment set up? What analysis did you do? How did the results benefit the company? Core Skill: Risk Management Tell me about a risk analysis that you did on a product. What techniques were used? How did the results help the company? If applicable, how did the analysis meet the requirements of ISO 14971? Core Skill: Sample Size Determination How do you determine sample sizes for product testing? Core Skill: Test Method Development Tell me about a test method that you developed or helped develop. How did you determine variation? Core Skill: Team Facilitation Give an example of a team you led and how it achieved positive results? How did you organize the team? What contributed most to keeping the team on track? Core Skill: Project Management What tools do you use to manage projects? Give an example of your completion of a successful project.

Tool #RH2: Pre-employment Testing Example is the Caliper test –Individual’s responses compared to the “typical” for the position –Report generated to ascertain “fit” Additional analysis –Statistical comparison between new hire and departmental data –Identify differences May be unimportant, or even positive May be a red flag

Caliper Test Case Study New Employee (NE) added to well- functioning department (WD) Data (1-100 scale): –Abstract reasoning: WD mean 90.3, NE 49 –Sociability: WD 45.2, NE 7 –Ego-strength/Resilience: WD 31.0, NE 86 –Idea orientation: WD 64.7, NE 99 Conclusion –Not a good fit! Lesson learned.

Tool #RH3: Mission/Vision/Values Mission: who we are –Promote the business and culture through … Vision: who we strive to be –Recognized as influential subject matter experts in … Values: how we do it –Strive for excellence while balancing …

Tool #RH4: SWOT Analysis Strengths Weaknesses Opportunities Threats

SWOT Analysis Example

Tool #RH5: SIPOC Diagram Suppliers Inputs Process Outputs Customers

SIPOC Diagram Example – Risk Mgmt.

QE Recruiting and Hiring Summary QE Need Interview Questions Pre- employment Testing Mission/ Vision/ Values SWOT AnalysisSIPOC Fit with the organization XXXX Clarity of initial opportunity XXXX Facts and data XX Walk the walk XXX

The QE Employee Life Cycle Recruit and hire Develop and train Satisfy and retain Lose via termination or attrition –Avoid this last step! –Leaving for another internal job OK

Developing and Training Needs Clarity of goals Individualized attention Feedback Mastery of the profession

Tool #DT1: Priority List Priority Activity/Project (Internal Customer) Project Requirement %ChaJebGuyJimDon Total Time % Additional Needs 1Project #1 (Bob Jones) Project #2 (Gary Toft) Project #3 (Shannon Hart) Project #4 (Joe Merijucky) Etc

Tool #DT2: Time Reporting Assign project numbers Report weekly to nearest 1/2 hour Analyze planned versus actual time –Make corrections as needed

Tool #DT3: Balanced Scorecard

Balanced Scorecard Example Balanced Scorecard Category MetricTarget Level 3Q2014 Actual Level YTD Actual Level Financial – Budget Management Actual vs. planned expenditures Under budgetary plan $5K over$10K under Customer – R&D, Sustaining Engineering and Packaging Support On-time Quality Engineering deliverables 90% min.98.0% (98/100) 98.8% (241/244) Document review turnaround time within 3 business days 90% min.98.0% (744/759) 98.7% (2503/2536) Internal Business Process – Training Non-delinquent training95% min.95%98% Learning and Growth – Personal Development Significant Development Plan item executed – each employee 100% (5/5)

Tool #DT4: Knowledge/Interest Survey List topics or areas of knowledge and interest to rate Have people rate on a 1-10 scale –No interest to very interested –No awareness to expert Analyze –Interest minus knowledge –Break data into quadrants: low/low, low/high, high/low, high/high

K/I Survey QE Topics TopicInterest 1 = no interest 10 = very interested Knowledge 1 = no awareness 10 = expert Quality Systems and Philosophy Regulatory Affairs Experiment Planning - DOE, Samples Sizes Risk Management Program Improvement Risk Management in Product Development (Initial Development of Risk Documents) Postmarket Risk Management (Risk Assessments, HHE, Complaint Trend Analysis) Test Method Development Complaint Management (as that department does) Complaint Investigation (as the testing lab does) Team Facilitation Reliability Analysis (e.g., Weibull, ALTA) Project Management People Management Information Management (Databases) Training and Teaching Statistical Analysis of Data Remediation (DHF, Tech Files) Other -

K/I Survey Numerical Results TopicAverage Interest Average Knowledge Interest - Knowledge Regulatory Affairs Test Method Development Reliability Analysis (e.g., Weibull, ALTA) Project Management Experiment Planning - DOE, Samples Sizes Statistical Analysis of Data Complaint Investigation (as our lab does) Risk Management Program Improvement People Management Team Facilitation Complaint Management (as that department does) Quality Systems and Philosophy Information Management (Databases) Remediation (DHF, Tech Files) Training and Teaching Risk Management in Product Development (Initial Development of Risk Documents) Postmarket Risk Management (Risk Assessments, HHE, Complaint Trend Analysis) Overall Average

K/I Survey Data by Quadrant

K/I Survey Next Steps by Quadrant A: Low interest/low knowledge –Is interest and knowledge in these areas key to our success? B: High interest/low knowledge –How can we develop more knowledge in this area?

K/I Survey Next Steps by Quadrant C: Low interest/high knowledge –How can we either develop interest or train others in these areas? D: High interest/high knowledge –How can we capitalize further and continuously improve in these areas?

Tool #DT5: Development Plans A subset of situational management –Accelerated learning for new employees –Specialized learning for experienced ASQ certification order by career track – ication/cert-career-tracks.pdf Special assignments for successor Special assignments for tech. leader

Example ASQ Certification Sequences For more detail, see the ASQ website. TechnicianEngineerManager CQICQTCQIA CQTCSSGBCQT CSSGBCCTCQPA CCTCSSBBCQA CRECBA/CHA/CPGP CQECMQ/OE

QE Developing and Training Summary QE NeedPriority List Time Reporting Balanced Scorecard Knowledge/ Interest Survey Development Plans Clarity of goals XXX Individualized attention XX Feedback XX Mastery of the profession XX

The QE Employee Life Cycle Recruit and hire Develop and train Satisfy and retain Lose via termination or attrition –Avoid this last step! –Leaving for another internal job OK

Satisfying and Retaining Needs Clarity of continuing opportunity Communication A purpose Sense of belonging

Tool #SR1: Career Path TitleManagement Equivalent Executive FellowVice President Senior FellowSr. Director FellowDirector Senior Principal Engineer - Quality & ReliabilitySr. Manager Principal Engineer - Quality & ReliabilityManager Staff Quality EngineerGroup Leader or Supervisor Senior Quality EngineerN/A Quality EngineerN/A Associate Quality EngineerN/A

Career Path Qualifications by Level TitleYrs. of Experience, TechnicalPreferred Education Executive Fellow20Ph.D. or M.D Senior Fellow20Ph.D. or M.D Fellow20Ph.D. or M.D Senior Principal15M. S or M.B.A Principal12M. S or M.B.A Staff10M. S or M.B.A Senior5 – 10Technical B.S or B.A Quality Engineer2 – 5Technical B.S or B.A Associate0 – 2Technical B.S or B.A

Career Path Certifications by Level TitlePreferred ASQ Certification Status Executive Fellow Broad or deep portfolio of Quality or other certifications (e.g., PMP, RAPS, etc.) Senior Fellow Fellow Senior Principal Multiple Quality (e.g., ASQ-CQE, CQA, CRE, CSSBB, CQM/OE, etc.) Principal Staff Specialized Quality (e.g., ASQ-CQE, CSSGB) Senior Quality Engineer Entry-level Quality (e.g., ASQ-CQIA, CQT) Associate

Tool #SR2: Organizational Structure Independence of the quality function Authority of the quality function Line management preferred to be … –Competent –Knowledgeable –Appreciative of quality

Example Organizational Structure

What About This?

Or This?

Tool #SR3: Hoshin-Kanri (X-Matrix) Company strategy Department strategy Department objectives Metrics or individual objectives

Example X-Matrix

This Year’s Version

Tool #SR4: Meetings One-on-one meetings –Weekly Department meetings –Bi-weekly Skip level –Quarterly High level/functional –Quarterly or as needed

QE Satisfying and Retaining Summary QE NeedCareer Path Organizational StructureHoshin-KanriMeetings Clarity of Continuing Opportunity XX Communication XX A Purpose XX Sense of Belonging XX

The QE Employee Life Cycle Recruit and hire Develop and train Satisfy and retain Lose via termination or attrition –Avoid this last step! –Leaving for another internal job OK

Attrition - Sometimes Unavoidable? Offer that couldn’t be refused –Salary –Bonus –Opportunity Need for a new location –Family situation Industry change Objectives and motivations change

Attrition – Unavoidable … or is it? Counter-offer –Salary –Bonus –Opportunity Work remotely Flexible work hours Sell why your organization is the best

Presentation Summary Learned about factors for success in hiring, developing and retaining QE’s –Provided ideas to promote a culture of quality in which they can thrive –Presented departmental and organizational pitfalls Shared ideas for successful technical management –Presented quality tools –Showed simple statistical analyses

THANK YOU FOR ATTENDING!