What Do QE’s Want? … and How to Provide It

Scott LamanTeleflex

Reading ASQ SectionMarch 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 QuestionsQuestion Answer Rating

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

StrengthsQuality System ExperienceManufacturing Background

Statistical TechniquesReliability Engineering

Complete Understanding of RiskYears of Working ExperienceDevelop Good Relationships

Good Reputation – Considered ValuableWillingness and Motivation to Learn

Design Control ExperienceRespected

Multi-TaskingAuditing Skills

FlexibilityAvailability

ThreatsChanging Organizational Structures

Changing Priorities and ScopesUnclear Roles in Overlapping or Interconnected Processes

Inadequate Planning by Other GroupsNoncompliance per FDA, BSI

QE&RM Potentially not Fully Integrated into D&D PlanningIncomplete Remediation Activities

Spontaneous, Urgent Requests (e.g., HHE’s, Tech Files, Audits)SAP Implementation Challenges

Quality System Needs for New AcquisitionsDifferent Quality Systems (Teleflex, Arrow, VN)

OpportunitiesIncrease Statistical Knowledge

Lead Implementation of Best PracticesAcquisitions

Give Statistics Knowledge to Other EngineersMentoring

Develop New ProcessesCareer Path for Technical and Managerial Positions

Learning from Regulatory AuthoritiesReliability, Electronics, Software Projects

Regulatory ProjectsSupply Line Quality/Certified Supplier

ReorganizationTest Method Development

Lean Six SigmaSoftware Quality

WeaknessesCurrent Headcount versus Demands and Priorities

Regulatory ExpertiseAlignment and Integration with Other Business Units

MissionPromote the Vascular business and

culture through value-added leadership in design assurance, risk management, continuous improvement, statistics,

quality, and reliability.

Tool #RH5: SIPOC Diagram

• Suppliers

• Inputs

• Process

• Outputs

• Customers

SIPOC Diagram Example – Risk Mgmt.

Suppliers Inputs Process Outputs Customers Requirements

Step 1:Plan Risk

Management Activities

Step 2:Publish the Risk

Management Plan

Step 3:Conduct Risk

Analyses

Step 4:Publish the Risk

Management Report

Step 5:Maintain the

Risk Management File

Regulatory Agencies

Guidances and Regulations Risk Management

FileRegulatory Agencies Compliance

Product UsersFeedback, complaints,

data for reliability analysis

Products Patients, physicians, nurses

High quality, safety, ease of use, clear

instructions

Management with Executive

Responsibility

Resources, top-level vision, key

decisions

Management with Executive

Responsibility

Customer satisfaction,

business success

QE Recruiting and Hiring Summary

QE NeedInterview Questions

Pre- employment

Testing

Mission/Vision/Values

SWOT Analysis SIPOC

         

Fit with the organization X X X X         Clarity of initial opportunity X X X X         Facts and data X X         Walk the walk X X X

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

PriorityActivity/Project

(Internal Customer)Project

Requirement % Cha Jeb Guy Jim DonTotal

Time %Additional

Needs

1 Project #1 (Bob Jones) 100 5 5 10 20 35 100 0

2 Project #2 (Gary Toft) 20     15   5 20 0

3 Project #3 (Shannon Hart) 45   10   10   45 0

4 Project #4 (Joe Merijucky) 20   10       10 10

5 Etc. 25     5 20   25 0

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

Learning and Growth

Internal Business Process

Customer

Financial

Balanced Scorecard ExampleBalanced Scorecard

CategoryMetric Target

Level3Q2014 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 training 95% min. 95% 98%

         

Learning and Growth – Personal Development

Significant Development Plan item executed – each employee

100% (5/5) 100% (5/5) 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 TopicsTopic Interest

1 = no interest10 = very interested

Knowledge1 = no awareness10 = 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 ResultsTopic Average

InterestAverage Knowledge

Interest - Knowledge

Regulatory Affairs 5.50 3.00 2.50Test Method Development 8.50 6.17 2.33Reliability Analysis (e.g., Weibull, ALTA) 7.33 5.00 2.33Project Management 7.67 6.00 1.67Experiment Planning - DOE, Samples Sizes 8.17 6.83 1.33Statistical Analysis of Data 8.67 7.67 1.00Complaint Investigation (as our lab does) 4.83 3.83 1.00Risk Management Program Improvement 6.50 5.83 0.67People Management 5.17 4.50 0.67Team Facilitation 6.67 6.17 0.50Complaint Management (as that department does) 4.17 3.67 0.50Quality Systems and Philosophy 7.33 7.00 0.33Information Management (Databases) 6.17 6.00 0.17Remediation (DHF, Tech Files) 6.17 6.00 0.17Training and Teaching 6.83 7.00 -0.17Risk Management in Product Development (Initial Development of Risk Documents)

7.00 7.67 -0.67Postmarket Risk Management (Risk Assessments, HHE, Complaint Trend Analysis)

5.50 6.67 -1.17Overall Average 6.60 5.82 0.78

K/I Survey Data by Quadrant

QE & RM Interest / Knowledge Matrix

2.00

3.00

4.00

5.00

6.00

7.00

8.00

4.00 5.00 6.00 7.00 8.00 9.00

Average Interest, 1-10 Scale

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2

3

4

5

7,8

6

9

1013

11

12

14

15

16

17

A B

C D

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– http://cert.asq.org/certification/resource/pdf/

certification/cert-career-tracks.pdf

• Special assignments for successor

• Special assignments for tech. leader

Example ASQ Certification Sequences

• For more detail, see the ASQ website.

Technician Engineer Manager

CQI CQT CQIA

CQT CSSGB CQT

CSSGB CCT CQPA

CCT CSSBB CQA

CRE CBA/CHA/CPGP

CQE CMQ/OE

QE Developing and Training Summary

QE Need Priority ListTime

ReportingBalanced Scorecard

Knowledge/ Interest Survey

Development Plans

         

Clarity of goals X X X 

Individualized attention X X 

Feedback X X 

Mastery of the profession X X

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

Title Management Equivalent

Executive Fellow Vice President

Senior Fellow Sr. Director

Fellow Director

Senior Principal Engineer - Quality & Reliability Sr. Manager

Principal Engineer - Quality & Reliability Manager

Staff Quality Engineer Group Leader or Supervisor

Senior Quality Engineer N/A

Quality Engineer N/A

Associate Quality Engineer N/A

Career Path Qualifications by Level

Title Yrs. of Experience, Technical Preferred Education

Executive Fellow 20 Ph.D. or M.D

Senior Fellow 20 Ph.D. or M.D

Fellow 20 Ph.D. or M.D

Senior Principal 15 M. S or M.B.A

Principal 12 M. S or M.B.A

Staff 10 M. S or M.B.A

Senior 5 – 10 Technical B.S or B.A

Quality Engineer 2 – 5 Technical B.S or B.A

Associate 0 – 2 Technical B.S or B.A

Career Path Certifications by Level

Title Preferred ASQ Certification Status

Executive FellowBroad 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 EngineerEntry-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-Matrix3

Send Tom Givens to a risk management conference and provide increased responsibilities.

2Implement Lean Six Sigma in one manufacturing plant.

1Commercialize Product X by June 30, 2014 at the expected quality levels.

Tom

Jane

Kati

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John

1 Strong new product pipelineComments:

2 World class manufacturing

3 Attract, develop, and retain talented employees

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RESOURCES

1. Expect to add 2 new QE's in 2015

POLICYBENEFITTARGET

Metrics

Department Objective

Department Strategy

Company or Business Unit

Strategy

This Year’s Version

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Stra

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Name - Title

Name - Title

Name - Title

Name - Title

Name - Title

Moderate relationship - Gray

Relatively low relationship - White

Objective

Objective

Objective

Objective

Objective

Strong relationship - Black

LEGEND

Vascular Quality Engineering and Risk Management 2015

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V. SPECIFIC QE STRATEGIES

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POLICYBENEFITTARGET

IV.Development

Planning

III.People

II.Department Objectives

I.Vascular Objectives

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 Need Career PathOrganizational

Structure Hoshin-Kanri Meetings

         

Clarity of Continuing Opportunity X X 

Communication X X 

A Purpose X X 

Sense of Belonging X X

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!