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Transportation Technology Center, Inc., a subsidiary of the Association of American Railroads 27th Annual 2015 Quality Auditors and Industry Conference © TTCI/AAR, 1/10/2012. filename, p1 Larry Strouse Railroad Safety Specialist (HM) Federal Railroad Administration 3:00 to 3:30 p.m. Root Cause Analysis

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Transportation Technology Center, Inc., a subsidiary of the Association of American Railroads

27th Annual 2015 Quality Auditors and Industry Conference © TTCI/AAR, 1/10/2012. filename, p1

Larry Strouse

Railroad Safety Specialist

(HM)

Federal Railroad

Administration 3:00 to 3:30 p.m.

Root Cause Analysis

2/19/2015

FRA – Office of Railroad Safety

Moving America Forward

F E D E R A L R A I L R O A D A D M I N I S T R A T I O N

2/19/2015

FRA – Office of Railroad Safety

Moving America Forward

F E D E R A L R A I L R O A D A D M I N I S T R A T I O N

The Art (and Science) of

Root Cause Analysis

2/19/2015

FRA – Office of Railroad Safety

Moving America Forward

Overview

• Definitions

• Regulatory Requirements

• Root Cause – Origins

• Root Cause – Mistakes Made

• Root Cause – What FRA Is Looking For

• Tools

• CSB Investigation

• Case Study

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49 CFR 179.7(a) Each tank car facility shall have an AAR approved quality assurance program (QAP) that —

(1) Ensures the finished product (tank car) conforms to the applicable specifications and regulations;

(2) Has the means to detect any nonconformance in the manufacturing, repair, inspection, testing, and qualification / maintenance program of the product;

(3) Prevents nonconformances from recurring.

Regulatory Requirements

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49 CFR 179.7(b) At a minimum, the quality assurance program must have the following elements . . .

(b)(7) Procedures for correction of nonconformances. 49 CFR 180.509 The qualification and maintenance program must maintain the design level of reliability and safety.

Regulatory Requirements

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Federal tank car quality assurance regulations apply to:

Regulatory Requirements

• Design • Manufacture • Fabrication • Inspection • Testing • Repair • Maintenance • Marking • Representation

• Management • Engineering • Procurement • Construction • Inspection • Quality Control • Qualification • Maintenance • Ownership

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Federal tank car quality assurance regulations apply to:

• Incoming / Receiving Inspection (Verification)

• In-Process Inspection (Verification)

• Final Inspection (Verification)

• Post-Release / In-Service Activity

Regulatory Requirements

We must identify True Root Causes

to develop and implement

Effective Corrective Actions !!!

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"The most basic cause (or causes) that can reasonably be identified that management has control to fix and, when fixed, will prevent (or significantly reduce the likelihood of) the problem’s recurrence.“Paradies

M-1003 Chapter 7.2.6.10 - The root cause is the cause that, if eliminated, will result in the non-conformance never recurring.”

There may be multiple Root Causes for one problem!!!

Definitions – Root Cause

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Chapter 7 - Nonconformance Elimination Process Step 3:

• Clear Nonconformance Description(s)

• Nonconformance Disposition(s)

• Root Cause Analysis

• Corrective Action(s) Taken to Eliminate Root Cause(s) and Identify Responsible Personnel

• Follow-Up Plan(s) to Ensure Corrective Action(s) Are Effective and Permanent.

Definitions – Root Cause (Analysis)

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Most Problems Can Be Tracked Back To: • Process / Procedure Deficiencies

• Process / Procedure Deviations

• Human Factors

Root Cause – Origins

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Unclear Nonconformance Description(s) Poor: Bottom outlet valve leaks Better: Bottom outlet valve to tank saddle connection leaks about 1 pint per minute.

Root Cause – Mistakes Made

Spur of the Moment Nonconformance Disposition(s) Poor: Tightened valve mounting bolts. Better #1: Offloaded car, removed valve, checked for gasket, reapplied valve, sent car out. Better #2: Offloaded car, notified car & valve owner, filed OTMA-1, sent car to shop for analysis.

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Moving America Forward 13

Limited Root Cause Analysis Poor: Valve technician didn’t reference valve drawing to rebuild valve so we fired him. Better #1: Different valve drawings in existence; revised procedure to reference correct drawing. Better #2: Leak test procedure doesn’t apply to this valve arrangement; revised procedure. Better #3: Inexperienced manager approved procedures; experienced manager now approves. Better #4: Top management reviews manager job descriptions for qualifications and QAP responsibilities.

Root Cause – Mistakes Made

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Limited Corrective Action(s) Effectiveness Poor: Supervisor trained valve technician so no more problem. Better #1: SME trains and tests valve technician, management conducts regular process audits. Better #2: Valve Process Improvement Teams reporting to VP - Operations. Better #3: Sales involves customers to monitor nonconformance (7.1s / OTMAs / 5800s). Better #4: Engineering works with customers to improve their Qualification & Maintenance Program.

Root Cause – Mistakes Made

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Moving America Forward 15

Limited Corrective Action(s) - Schedule and Personnel Poor: Valve technician will be trained so no more problems. Better #1: Supervisor will train technician so no more problems. Better #2: SME will train valve technicians by (date). Better #3: SME will train and test valve technicians by (date) and audit performance quarterly or more frequently if problems continue.

Root Cause – Mistakes Made

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Short-Term Follow-Up Plans Poor: Supervisor performed process audit, no findings. No repeat audits. Better #1: QA manager develops audit schedule, SMEs perform process audits. Better #2: Regular management process audit reviews. Better #3: Top management monitors nonconform- ance (rework, complaints, 7.1s / OTMAs / 5800s). Better #4: Management compensation plans include nonconformance & continuous improvement metrics.

Root Cause – Mistakes Made

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Deeper Dives – Peel the Onion!!!

First, look at the process, not the people!

• Not “we fired the employee so it won’t happen again”

• Not “the employee wasn’t trained so we trained the employee”

• Not “if the employee doesn’t remember how to do the job he can ask the supervisor for the procedure”

Root Cause - What FRA is Looking For

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5 Whys • May require more than 5 • Multiple iterations for combined failure modes

Tools

TapRoot® • Reactive - multiple interviews and linked events • Discovers missing and broken barriers

Failure Mode and Effects Analysis (FMEA) • Multiple interviews and expertise • Pre-release design & process activity plus revisions

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Reliability Analysis • “Weibull” • Competing failure modes and mechanisms

Tools

Ishikawa Diagram • Cause and Effect Diagram (Fishbone) • Requires knowing the “ribs”

Fault-Tree Analysis • Combines Fishbone and FMEA • Pre-release activity with revision

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CSB Investigation – Heat Exchanger

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Case Study – Leaking Bottom Outlet Valve

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Valve Design

Case Study Considerations

Gaskets

Fasteners

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Procedures

Case Study Considerations

Process

Personnel

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Who Is This?

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Who Is Ms. Barra?

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Federal regulations require that the finished product conforms to customer requirements, AAR specifications, and Federal regulations.

Summary

Federal regulations require “deep dive” procedures for corrective actions that prevent recurrence.

Federal regulations require that the QAP detect any nonconformance in manufacturing, qualification, and maintenance of tank cars.

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