Leadership Keys to Success to Improve Human Performance Steven A. Greer Procter & Gamble
Learning Objectives In this session you will learn: 5 keys to success to improve HP New ideas for managing change Leadership mindset change required Tools for improving investigations of HP
Acknowledgements Ginette Collazo, Consultant P&G Cayey Plant Lori Carlson, P&G FDA San Juan District Talsico International Marilee Adams, Ph.D. Inquiry Institute Kelly Allan Deming Institute Wallace Torres Amgen Martin VanTrieste Amgen
Quality Our Consumers, Customers, Regulators and Employees trust everywhere, every time. P&G Quality Promise 4
The Good Sample of penicillin mould presented by Alexander Fleming to Douglas Macleod, 1935. Digital image. Wikipedia. Science Museum London / Science and Society Picture Library. n.d. Web 19 Mar 2017 <https://en.wikipedia.org/wiki/penicillin> Viagra. Digital image. Sunset Pharmacy. n.d. Web 19 Mar 2017 <http://sunsetpharmacyllc.com/
The Bad FDA 483 Citation Your Quality Unit failed to conduct a thorough assessment and establish adequate corrective and preventative actions on investigations generated due to human performance. 6
Kelly Allan PDA/FDA 2016 7
ROI: The And Equation P&G Cayey Plant Case Study 8
Initial Status Cost: $550K/mo 50% Q Alerts & OOS Human Error Service Impact: 5%
Analysis 6 month evaluation Established focus areas Procedures Human Factors Engineering Individual Performance 8% C4a (Not used) 7% C5a (Work place layout) 77% 15% C4b (Misleading/Confusing) C4c (Wrong/Incomplete) 50% 29% 14% C5b (Work Environment) C5c (Workload) C5d (Intolerant System) 55% 45% C9a (Slip Lapse) C9b (Mistake)
Human Performance Action Plans Leadership on the Floor Simplification Documentation Workplace Layout Focused Automation Work Process Improvement
Human Alerts and OOS % Human Q Alerts % Human OOS 60% 60% 50% 40% 30% 20% 10% 50% 70% 40% Reduction in 30% 20% Human Errors 10% 0% 11/12 12/13 13/14 14/15 0% 11/12 12/13 13/14 14/15
Business Results 25 $14M Inventory Savings 100% Reduction in Past Due Investigations Human Q Alerts - P30M (Jan 2013 - Jun 2015) 20 15 10 5 $20M+ MOE Savings & Improved Productivity 0 16 pt Increase in Corporate Survey Almost Perfect Customer Service Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec Jan Feb Mar Apr May Jun
5 Keys to Improve Human Performance Build Human Performance Mastery Lead Differently Investigate Differently CAPA Differently Robust Review Process 14
Key #1: Build HP Mastery 15
BLUE RED YELLOW ORANGE GREEN BLUE PURPLE RED PURPLE YELLOW RED BLUE ORANGE BLUE YELLOW RED RED GREEN ORANGE BLUE 16
BLUE RED YELLOW ORANGE GREEN BLUE PURPLE RED PURPLE YELLOW RED BLUE ORANGE BLUE YELLOW RED RED GREEN ORANGE BLUE 17
Human Error Rate Read a single number wrong 2 10,000 Read a clear 5 letter word wrong 3 10,000 Read a checklist wrong 1 1,000 Perform the wrong visual inspection 3 1,000 Record information wrong 1 100 Read an unclear 5 letter word wrong 3 100 Fail to notice wrong position of valves 5 10 Fail to act after 1 min in emergency 9 10 Dr. David J. Smith, Reliability and Maintainability and Risk 18
Kelly Allan PDA/FDA 2016 19
A bad system will beat a good person every time Edwards Deming 20
Checklists 21
SOPs are the single leading cause of confusion 22
SOPs Source: Talsico International
Martin VanTrieste PDA/FDA 2016 24
Standards & Specs Page 1 Page 2 25
Work Processes 26
Managing Change Normal routine 1 2 3 4 New step New Procedure 1 2 3 4 5 Routine stored in the lower part of brain 1 2 3 4 New step stored in higher part of brain Must interrupt existing routine to include the new step Source: Talsico International
Triggers 1. Sound Fastest response Not dependent on field of vision 2. Motion or change in pattern or location 3. Color Can t see color in dim light or peripheral vision 7% color blind 4. Shape 5. Text Source: Talsico International
Key #2: Lead Differently 29
Work as Done vs Work as Imagined How managers believe work is being done (rules) GAP Every-day work: How work IS being done Slide: Terry Fairbanks, adapted from Ivan Pupulidy
Change How We Think About Failure James Dyson. Digital image. Jae-ha Kim. n.d. Web 19 Mar 2017 <http://www.jaehakim.com/travel/go-away-with/go-away-with-james-dyson/> 31
Blame Cycle Source: Ginette Collazo
Mindset Shift Former Paradigm Human Error = Employee Problem Whose Fault is It and Why did They Fail? New Paradigm Human Error = Leadership Problem What are the Causes and What Do I Need to Do Differently?
Copyright Inquiry Institute 2017 www.inquiryinstitute.com
Emotional Intelligence Increase Self-Awareness Assessments Coaching
Key #3: Investigate Differently 36
Windows of Opportunity Window of opportunity. Digital image. Ann Bernard. 3 Jun 2013 Web 19 Mar 2017 <http://annbernard.biz/2013/06/the-relationship-window-of-opportunity/> 37
FDA Investigation Operations Manual During the evaluation of the Quality System it is important to determine if top management makes science-based decisions and acts promptly to identify, investigate, correct, and prevent manufacturing problems likely to, or have led to, product quality problems. 38
Key #3: Investigate Differently HE Investigate technical problem not HP Real Root Cause is not identified IA/CA/PA Ineffective HE Human Performance as a Root Cause Wrong problem is addressed 5 ERRORS Root cause analysis for human error events rarely gets to the real issues. Ginette Collazo
Ginette Collazo
Interviews Interviews are not about asking questions they are about stimulating memories and collecting the best possible information Mark Paradies, System Improvements
Who Investigates? Dedicated Investigators Skills Certification Experience Reward Structure New Investigator Watch-out Limited knowledge of possible causes Experienced Investigator Watch-outs No knowledge of human performance Focus on favorite causes Sherlock Holmes. Digital image. Spy Hollywood. n.d. Web 19 Mar 2017 <http://spyhollywood.com/for-sherlock-holmes-everything-is-elementary/>
Investigate Differently Summary Avoid Looking for One Root Cause Structured Investigation Process Seek to Understand Why the Steps Made Sense Maintaining Trust is Key Evaluate How You Staff Investigations Strengthen How You Qualify Investigators
Key #4: CAPA Differently Minimize the Normal Human Error CAPAs Discipline the Employee Re-train the Employee Modify the Procedure Avoid the Easy Fix versus the Real Solution Escalate to Leadership When Necessary (Q Council) 44
Key #5: Robust Review Process DMS: Quality Alert Investigation & CAPA Weekly Investigation Leadership Reviews Monthly CAPA Effectiveness Checks Monthly Root Cause & CAPA Theme Reviews
Investigation/CAPA Board 46
5 Keys to Improve Human Performance Build Human Performance Mastery Lead Differently Investigate Differently CAPA Differently Robust Review Process 47
Call to Action What was your key takeaway from this session? How can you apply these concepts? Call to Action. Digital image. Preston D. Lee. n.d. Web 19 Mar 2017 <http://millo.co/the-death-of-the-call-to-action-in-design> 48
Learning Objectives In this session you will learn: 5 keys to success to improve HP New ideas for managing change Leadership mindset change required Tools for improving investigations of HP
Questions? Steven A. Greer P&G, Corporate QA External Engagement Leader Phone: (513) 477-5379 Email: greer.sa@pg.com LinkedIn and Twitter: SteveAGreer