Key Elements for Effective Root Cause Analysis & Problem Solving Presented by: Cathy Fisher Quality...

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Key Elements for Effective Root Cause Analysis & Problem Solving Presented by: Cathy Fisher Quality Improvement Strategies

Transcript of Key Elements for Effective Root Cause Analysis & Problem Solving Presented by: Cathy Fisher Quality...

Page 1: Key Elements for Effective Root Cause Analysis & Problem Solving Presented by: Cathy Fisher Quality Improvement Strategies.

Key Elements for Effective Root Cause Analysis &

Problem Solving

Presented by:

Cathy Fisher

Quality Improvement Strategies

Page 2: Key Elements for Effective Root Cause Analysis & Problem Solving Presented by: Cathy Fisher Quality Improvement Strategies.

What we will discuss. . .• What are problems• How problems are communicated: CREI statement• Types of problems and problem solving methods• Process View of problems• Isolating problems to their process of origin; establishing

context for Root Cause Analysis• Levels of Root Cause investigation• Data collection/analysis tools to apply at each level of

Root Cause investigation• Confirming root causes before applying solutions• Three possible solutions to each root cause• Getting the most out of Root Cause Analysis

investigations

Page 3: Key Elements for Effective Root Cause Analysis & Problem Solving Presented by: Cathy Fisher Quality Improvement Strategies.

Visual Definition of Problem

• Gap between current condition, (what is), and the desired performance level, (what must be, should be or could be)

• This gap can exist in a process, product or system

• A problem can only be considered to be valid if “what should be” is specified

Page 4: Key Elements for Effective Root Cause Analysis & Problem Solving Presented by: Cathy Fisher Quality Improvement Strategies.

Where do “gaps” arise?• Customer complaint• Nonconforming output

of a process• Out of control process• Management systems

not being followed• Safety incidents• Environmental

“releases”• Goals not being

achieved• Can be actual,

potential or generated

Page 5: Key Elements for Effective Root Cause Analysis & Problem Solving Presented by: Cathy Fisher Quality Improvement Strategies.

Communication of Problems

Page 6: Key Elements for Effective Root Cause Analysis & Problem Solving Presented by: Cathy Fisher Quality Improvement Strategies.

CREI Problem StatementA tool for communicating the gap:• Concern: what is wrong; statement of

nonconformity• Requirement: what should be;

documented requirement or reference to• Evidence: data demonstrating that

something is wrong; objective evidence observed that supports statement of nonconformity

• (Impact): how significant is the problem from a performance and/or cost standpoint

Page 7: Key Elements for Effective Root Cause Analysis & Problem Solving Presented by: Cathy Fisher Quality Improvement Strategies.

Concern

• What is wrong?• What is different than

what should be?• May be recognized as a

symptom, (effect), or as a failure condition, (failure mode)

• Define in terms of requirement, (language of organization)

Page 8: Key Elements for Effective Root Cause Analysis & Problem Solving Presented by: Cathy Fisher Quality Improvement Strategies.

Requirement• What should be• Must be defined and valid• Can be found in

procedures, policies, drawings, specifications, etc.

• #1 reason problems are not effectively solved is that Requirement is not clearly known or defined

• Reference where Requirement can be found

• State as defined in Requirement document

Page 9: Key Elements for Effective Root Cause Analysis & Problem Solving Presented by: Cathy Fisher Quality Improvement Strategies.

Evidence• Demonstrates

requirement is not being fulfilled

• Data initially gathered associated with problem

• Objective evidence collected while auditing process or system

• Must be verifiable• Can be tangible, a

statement of admission or observed

Page 10: Key Elements for Effective Root Cause Analysis & Problem Solving Presented by: Cathy Fisher Quality Improvement Strategies.

Impact• How big is the problem?• How much does it cost?• Is the customer affected?• Is it affecting fulfillment of

organizational goals?• Refer to effect and severity

ranking on FMEA for performance impact

• Also consider cost impact• In the case of auditing findings:

typically, auditors do not cite Impact as this could be viewed as subjective

• Impact should be determined by auditee upon their review of the audit finding

Page 11: Key Elements for Effective Root Cause Analysis & Problem Solving Presented by: Cathy Fisher Quality Improvement Strategies.

Utilizing CREI Format• Incorporate these fields on problem solving and

nonconformance report formats to prompt complete recording of information re: problems

• May require some investigation to identify necessary information for completing CREI statement, especially location and actual statement of “Requirement”

• Critical success factor to effective problem solving is consistent and complete communication of problem condition

Page 12: Key Elements for Effective Root Cause Analysis & Problem Solving Presented by: Cathy Fisher Quality Improvement Strategies.

Problem Categoriesand Problem Solving Approaches

Page 13: Key Elements for Effective Root Cause Analysis & Problem Solving Presented by: Cathy Fisher Quality Improvement Strategies.

Types of Problems

• Simple, cause known; “Just do it” issues

• Complex, cause unknown; need to dig deeper issues

• Sometimes the financial impact of a problem dictates how it will be classified

Page 14: Key Elements for Effective Root Cause Analysis & Problem Solving Presented by: Cathy Fisher Quality Improvement Strategies.

“Just Do It” Issues• Typically isolated, sporadic incidents• Are easily fixed; apparent cause tends to be

known• Often recognized during process planning

and reflected in PFMEA• Addressed through troubleshooting,

(diagnosis and remedy) and reaction plans on control plans, (control of nonconformity)

• Can be fixed by process owner; addressed at process level

• Occurrence should be monitored ongoing for cost and impact

Page 15: Key Elements for Effective Root Cause Analysis & Problem Solving Presented by: Cathy Fisher Quality Improvement Strategies.

TroubleshootingRecognize

problem condition

Communicate problem condition to process owner

Diagnose problem condition

Decide on appropriate action

Implement remedy

Observe results of remedy

Record condition and remedy

Periodically review records of

conditions for trends

Page 16: Key Elements for Effective Root Cause Analysis & Problem Solving Presented by: Cathy Fisher Quality Improvement Strategies.

“Dig Deeper” Issues• Sometimes referred to as Chronic• Long-term and/or complex issues• Cause is not readily apparent, unknown• Require in-depth investigation to identify root cause• Addressed through root cause analysis,

disciplined problem solving and improvement process

• Source of problem typically unknown• Cross-functional participation needed to solve• Effective resolution requires both process and system

solution consideration• Require management intervention via resource

commitment• When available data re: problem is limited, may be

handled as “Just do it” based on impact and/or risk

Page 17: Key Elements for Effective Root Cause Analysis & Problem Solving Presented by: Cathy Fisher Quality Improvement Strategies.

Steps in Disciplined Problem Solving

1. Establish Team2. Operational Problem Definition3. Containment & Interim Actions, (if

needed)4. Root Cause Analysis, (process &

system)5. Plan & Implement Solutions6. Results of Solutions7. Verification, (including independent)8. Closure & Congratulate the Team

Page 18: Key Elements for Effective Root Cause Analysis & Problem Solving Presented by: Cathy Fisher Quality Improvement Strategies.

Problem Type ConsiderationsJust Do It

• Reflects product or process controls established when planning the process

• Management decision to “live with” such conditions based on acceptable level of risk

• Should be routinely evaluated for cost and impact

• Can only be eliminated by applying disciplined problem solving to understand true root cause in order to improve process

Dig Deeper• Unanticipated

conditions which occur• May also be anticipated

issues for which actual level of risk is now determined to be unacceptable

• Require concentrated investigation to understand source of problem and process factors leading to problem condition to allow appropriate solutions

Page 19: Key Elements for Effective Root Cause Analysis & Problem Solving Presented by: Cathy Fisher Quality Improvement Strategies.

A Note about Fire-fighting!

• Fire-fighting is essentially un-prescribed actions taken on a process without understanding the relation of causal factors and process output

• Fire-fighting is dangerous as these actions tend not to be specifically focused to a particular cause

• The resulting impact of fire-fighting is typically not known ahead of time

• Therefore, chaos is introduced into the process

• A very high-risk approach to problem solving!

Page 20: Key Elements for Effective Root Cause Analysis & Problem Solving Presented by: Cathy Fisher Quality Improvement Strategies.

Problem Type ConsiderationsProblem

TypeProcess of

OriginMethod Considera-

tions

Just do it Known Troubleshooting; rework

Seen before; can live with impact when problem

recurs

Dig Deeper Unknown Root cause analysis

Data-driven investigation to

determine actual factors causing

problem condition

Unknown Fire-fighting Taking action possibly on wrong process; not using

data to confirm root cause

Page 21: Key Elements for Effective Root Cause Analysis & Problem Solving Presented by: Cathy Fisher Quality Improvement Strategies.

Prioritize Problems• Most organizations should

only be actively working on 3-5 disciplined problem solving efforts, (Dig Deeper issues), at a time to balance the use of resources and get the most effective solutions; (no one person should be working on more than 2 Dig Deeper teams at any given time)

• Impact portion of CREI statement facilitates prioritization of problems for allocation of problem solving resources

• Management is responsible for establishing the priority

Page 22: Key Elements for Effective Root Cause Analysis & Problem Solving Presented by: Cathy Fisher Quality Improvement Strategies.

Process View of Problems

Page 23: Key Elements for Effective Root Cause Analysis & Problem Solving Presented by: Cathy Fisher Quality Improvement Strategies.

The Secret to Solving Problems

• The source of every problem is a process: typically the gap is found in the output of the process

• The cause of every problem is one or more process factors not behaving as they should

• Understanding the relationship between process factors and process outputs is important to effective problem solving

• Data about the process and the problem is required to gain enough understanding to effectively solve any problem

• The result of any problem solving effort is increased knowledge about processes and their outputs

Page 24: Key Elements for Effective Root Cause Analysis & Problem Solving Presented by: Cathy Fisher Quality Improvement Strategies.

Components of Process

Process steps(Methods)

Input

(Materials)

Actual Output

(Desired outcome:targets, goals, specs)

Equipment(selection,

Maintenance, etc.)

People(training, skills)

Environment(space, layout, etc.)

Evaluation(plan, gages, etc.)

Management Policies & Practices

Page 25: Key Elements for Effective Root Cause Analysis & Problem Solving Presented by: Cathy Fisher Quality Improvement Strategies.

What are the Process Factors?

Processes are mainly influenced by:

• Man• Material• Machine• Methods• Mother Nature,

(environment)

Other factors which influence processes include:

• Measurement• Management System,

(policies including SOPs, targets, operational decisions)

• Money• Other?

Page 26: Key Elements for Effective Root Cause Analysis & Problem Solving Presented by: Cathy Fisher Quality Improvement Strategies.

Process View

System Processes = Policies, Objectives & Practices (how an organization does business)

Planning Processes apply System to fulfill customer requirements

Producing Processes to accomplish Plans

Products/Services = output of producing Processes

Page 27: Key Elements for Effective Root Cause Analysis & Problem Solving Presented by: Cathy Fisher Quality Improvement Strategies.

Main Functions of Problem Solving

• Define Gap between “what is” and “what should be”

• Identify process of origin from which gap is originating

• Study the process of origin to determine which process factor(s) are causing the gap

• Analyze the relationship between process causal factors and system factors to identify root cause

Page 28: Key Elements for Effective Root Cause Analysis & Problem Solving Presented by: Cathy Fisher Quality Improvement Strategies.

Getting to the Process of Origin

• Where was the problem found?• Where is the first process the problem

condition could occur?• Go to these and any processes in between

to collect data recognizing where the problem is actually first observed; this is the process of origin!

• Use a process flow diagram to make this investigation visual.

Page 29: Key Elements for Effective Root Cause Analysis & Problem Solving Presented by: Cathy Fisher Quality Improvement Strategies.

Select Process tomap

Identify output ofprocess

Identify whoreceives output andtheir requirements

Identify inputsneeded for processand who supplies

these

Identify last step ofprocess which

creates that output

Identify firstprocess step and

trigger input

Brainstorm processsteps which occurbetween first and

last identifiedprocess steps

Combinebrainstormed

process steps forduplication/similar

ideas

Clarify any processstep ideas which

are unclear

Sequence processsteps between firstand last process

step to reflectcurrent process

flow

Review flowchartfor correct structure

(use 8 pointchecklist)

Review processmap with process

owners foraccuracy

Revise processmap based onfeedback from

process owners

Analyze processmap to identifyimprovementopportunities

Assess feasibility ofand establish goals

for potentialimprovements

Establish plan forimplementingimprovements

Update processmap to reflectimprovements

Measure impact ofimplementedimprovements

11/1/2002Prepared by: C. Fisher

Process Mapping Process

Page 30: Key Elements for Effective Root Cause Analysis & Problem Solving Presented by: Cathy Fisher Quality Improvement Strategies.

Is/Is Not Analysis

• Also known as Stratification Analysis• Provides further detail about the problem so a

complete operational definition of the problem can be formulated.

• Used at this stage as well as in applying interim/containment actions and implementing/verifying permanent actions.

• “Splitting the dictionary” or “20 questions to the answer” demonstrates this idea of problem convergence

Page 31: Key Elements for Effective Root Cause Analysis & Problem Solving Presented by: Cathy Fisher Quality Improvement Strategies.

Use Data to determine• What is the problem? – define the problem condition such

that anyone could recognize it; basis for data collection about the problem

• Where is the problem occurring? – which processes, customers; also, where on the output is the problem condition observed?

• Who knows about the problem? – who initially identified the problem? Who else has seen this problem? Who is involved in the process steps reflected in the process flow?

• When did the problem begin? – timeline associated with when the problem was seen; can be applied even for ongoing problems

• How big is the problem? – how much output is affected?• Narrows the problem focus to isolate the problem to its

process of origin• Data is collected to demonstrate answers to these

questions

Page 32: Key Elements for Effective Root Cause Analysis & Problem Solving Presented by: Cathy Fisher Quality Improvement Strategies.

Is/Is Not Analysis Worksheet

Focus Aspect Data to Collect

Where to Collect

How to Collect

Results – IS

Results – IS NOT

Comments

What? Problem condition

Refer to requirement

Where? Geographically See process

flow Where? On output Concentration

diagram Refer to

problem condition

When? First seen Refer to

timeline Seen before? Days, shifts,

time

Who? Identified

problem Interview

Involved in related processes

Interview Refer to process flow

Customers How Quantity Containment

Page 33: Key Elements for Effective Root Cause Analysis & Problem Solving Presented by: Cathy Fisher Quality Improvement Strategies.

Applying Is/Is Not Analysis• Clarify aspect – what question needs to be answered to

obtain a better understanding of the problem• Identify what data to collect that would assist in

answering the question• Determine where that data can be obtained• Decide how to go about collecting the data; what

tools/methods to apply• Go collect the data• Review and analyze the data to draw a conclusion re:

questions being posed• This is an important step in Root Cause Analysis as the

results of this investigation provide a context for the root cause investigation

• By conducting Is/Is Not Analysis, it is also possible to determine if further investigation can take place at this time

Page 34: Key Elements for Effective Root Cause Analysis & Problem Solving Presented by: Cathy Fisher Quality Improvement Strategies.

Components of Problem’s Operational Definition

• Basis for root cause investigation• More detailed version of CREI statement based on

what was learned from Is/Is Not• Indicate process from which problem

originated/generated• Indicate direction of problem related to

requirement• Define extent of problem• Possibly isolates problem to a certain timeframe• Include refined information re: impact • Problem statement must be clear, concise and

understandable by anyone

Page 35: Key Elements for Effective Root Cause Analysis & Problem Solving Presented by: Cathy Fisher Quality Improvement Strategies.

A Root Cause is. . .

A process factor which directly defines the reason for the problem when it is present and is having an influence on

the process and its output.

Page 36: Key Elements for Effective Root Cause Analysis & Problem Solving Presented by: Cathy Fisher Quality Improvement Strategies.

4 Levels of Root Cause

System Root Cause = management systempolicy/practice contributing to Actual Root Cause

Actual Root Cause = previous process factorscontributing to Process Root Cause, (planning)

Direct Process Cause = at Process of Origin

Defect/Detection Cause = Product level

Page 37: Key Elements for Effective Root Cause Analysis & Problem Solving Presented by: Cathy Fisher Quality Improvement Strategies.

Dig! How Deep?

• Management decides on depth of root cause investigation through the establishment of SMART goals for each problem solving effort.

Page 38: Key Elements for Effective Root Cause Analysis & Problem Solving Presented by: Cathy Fisher Quality Improvement Strategies.

Problem Solving Goals• Define problem’s

boundaries/depth of solutions

• Identify right people to solve problem

• Establish measures of end results

• Develop plan of how to accomplish the goal

• Tie problem solving goals to organizational objectives/targets

• Provided to team by Management

Effective Problem Solving is based on

SMART Goals:

• Specific• Measurable• Agreed upon by team as

attainable• Relevant to organization

and results-oriented• Timing defined

Page 39: Key Elements for Effective Root Cause Analysis & Problem Solving Presented by: Cathy Fisher Quality Improvement Strategies.

Root Cause Analysis• Systematic investigation

of a process to identify the root cause of the gap, and take corrective action to eliminate the gap and keep it from occurring again in the future

• A structured investigation that aims to identify the true cause of a problem, and the actions necessary to eliminate it.

Page 40: Key Elements for Effective Root Cause Analysis & Problem Solving Presented by: Cathy Fisher Quality Improvement Strategies.

Process Cause vs. System CauseProcess Cause

• What factor of the process of origin is triggering the undesirable output

• What other processes and their factors are causing the trigger?

• Relates product output, (symptom), to process parameters, (causes)

System Cause• Addresses how the

management system allowed the process to become out of control

• Relates process factor causes to “weaknesses” in management systems policies/practices

Page 41: Key Elements for Effective Root Cause Analysis & Problem Solving Presented by: Cathy Fisher Quality Improvement Strategies.

4/8/2007Disciplined Problem

Solving

ProcessRoot Cause Analysis Identify process

from which problem originated

Review data from operational definition,

containment and interim action

Identify potential causes

contributing to the problem

Develop plan to test if potential cause actually

leads to problem

Conduct test and collect data

Analyze data from test

Does potential cause directly

lead to problem condition?

Select other potential causes

Can cause be controlled or eliminated?

Identify possible actions to monitor

process for problem condition

Identify possible actions for either

controlling or eliminating cause

No

Yes

No

Yes

Page 42: Key Elements for Effective Root Cause Analysis & Problem Solving Presented by: Cathy Fisher Quality Improvement Strategies.

Identify management

policies related to process from

which problem originated4/8/2007

Disciplined Problem Solving

SystemRoot Cause Analysis

Review existing policies for existing

controls

Do current policies define controls to

prevent the cause of the problem?

Identify possible management

policy controls to address cause

Investigate if these controls are in

place

Identify other processes affected by these policies

Controls working?

Identify how these controls and/or policies can be

changed

Analyze why controls are not working at the process where

problem originated

No

Yes

No

Yes

Page 43: Key Elements for Effective Root Cause Analysis & Problem Solving Presented by: Cathy Fisher Quality Improvement Strategies.

Root Cause Analysis LevelsLevel(Deep)

Root Cause Consideration Tools Other

(Wide)

Product Defect/Detection cause

Condition of controls to

detect problem

Control Barrier

Analysis

What other products have similar controls?

Process Direct process cause, (trigger at process of origin

Factors at process of

origin triggering problem, (5Ms)

Fishbone, (cause &

effect)

What processes have similar trigger cause?

Plan Actual root cause, (led to trigger

cause)

Linkage to planning

processes that trigger cause

5 Why with Hypothesis

testing

What other processes affected?

System “weakness” in mgt. policies or

practices

Linkage of mgt. system to

actual cause

System Cause

Analysis

Other affected mgt. policies

Page 44: Key Elements for Effective Root Cause Analysis & Problem Solving Presented by: Cathy Fisher Quality Improvement Strategies.

Control Barrier Analysis(Defect/Detection Root Cause)

• How did the problem escape the process and/or organization?

• Was the problem anticipated in advance?

• Were controls defined to recognize and contain the problem?

• At which process are the planned controls applied?

• Were the planned controls in place?

• Were the planned controls working?

• What is the capability of these controls?

• Assists in identifying appropriate interim actions as well as identifying the defect/detection root cause

Page 45: Key Elements for Effective Root Cause Analysis & Problem Solving Presented by: Cathy Fisher Quality Improvement Strategies.

Process Condition Control Status Capability Observations Actions

Other Opportunities:

Control Barrier Analysis Worksheet

Page 46: Key Elements for Effective Root Cause Analysis & Problem Solving Presented by: Cathy Fisher Quality Improvement Strategies.

Results of Control Barrier Analysis• May recognize missing controls or controls not working as

planned• Interim actions represent solutions to addressing these

concerns but should not be accepted as the permanent solution

• When the results of this analysis uncover additional problems, refer these to the team champion for direction on addressing

• Team’s main focus at this point is to implement some type of control to protect downstream processes from continuing to experience the problem

• Solutions based on this level of “root cause investigation” mainly are reactive in nature; they only improve our ability to detect the problem condition but don’t typically do anything about addressing the root cause!

Page 47: Key Elements for Effective Root Cause Analysis & Problem Solving Presented by: Cathy Fisher Quality Improvement Strategies.

Direct Process Cause

• Relates one or more factors of the affected process, (process of origin), not “behaving” as required to obtain the desired output result at that process

• Use Cause & Effect diagram, (fishbone technique)

• Direct process causes, (trigger causes), are the starting point for identifying root cause

• Some action may be required to address the direct process/trigger cause but actions should not be taken until actual root cause is known

Page 48: Key Elements for Effective Root Cause Analysis & Problem Solving Presented by: Cathy Fisher Quality Improvement Strategies.

Cause & Effect Diagram

• Apply to problem’s process of origin

• Gap is head of fish• Major cause categories

– 5M’s• Potential causes

brainstormed are process factors existing at the problem’s process of origin

• Define potential causes specifically

• When confirmed, these will be known as direct process/trigger causes

Page 49: Key Elements for Effective Root Cause Analysis & Problem Solving Presented by: Cathy Fisher Quality Improvement Strategies.

Gap:

Material Man

Method MachineMother Nature

PROCESS:

Fishbone Diagram

Page 50: Key Elements for Effective Root Cause Analysis & Problem Solving Presented by: Cathy Fisher Quality Improvement Strategies.

Fishbone Process• Involve personnel from process of origin in

brainstorming of potential causes at the process of origin triggering the problem

• Develop a sketch/list of the process factors, (man, material, machines, methods, mother nature), related to the process of origin

• After brainstorming, review each identified cause to establish:– If the cause is actually a factor at the process of origin– If the cause makes sense based on the operational definition

of the problem• Prioritize remaining causes as to their possible

contribution to the problem condition• Develop hypothesis test to evaluate each potential

cause at the process of origin

Page 51: Key Elements for Effective Root Cause Analysis & Problem Solving Presented by: Cathy Fisher Quality Improvement Strategies.

Process of Origin: Potential Causes

Related to

process?

Feasible based on

operational definition?

Priority to

confirm

Method of confirmation

Results of confirmation

Confirmed causes to investigate via 5 Why Analysis:

Direct Process Root Cause Investigation Plan & Results

Process of Origin:

Page 52: Key Elements for Effective Root Cause Analysis & Problem Solving Presented by: Cathy Fisher Quality Improvement Strategies.

Problem Understanding Tools(especially useful in identifying system causes)

• Task Analysis – reviews process in detail; helpful for operator dependent process

• Change Analysis – identifies differences; extension of Is/Is Not analysis; expands on application of timeline

• Both these tools must be applied with a location context, (process of origin)

Page 53: Key Elements for Effective Root Cause Analysis & Problem Solving Presented by: Cathy Fisher Quality Improvement Strategies.

Steps Who Required Actions Component Tools Remarks/Questions

Task Analysis Worksheet

Page 54: Key Elements for Effective Root Cause Analysis & Problem Solving Presented by: Cathy Fisher Quality Improvement Strategies.

Change Factor Difference/Change Effect Questions to AnswerWhat (conditions,

activity, equipment)When (occurrence, status, schedule)Where (physical

location, environmental

conditions, steps of procedure)

How (work practice, omission, extraneous

action, out of sequence, poor

procedure)

Who (personnel involved, supervision)

Change Analysis Worksheet

Page 55: Key Elements for Effective Root Cause Analysis & Problem Solving Presented by: Cathy Fisher Quality Improvement Strategies.

Actual Root Cause• Explains why trigger cause/condition exists at

the process of origin of the problem• Typically found in previous “planning” processes• Many problems have multiple causes• Usually only one over-riding cause that when

addressed, can significantly reduce the problems impact on the organization

• Very complex problems may have interacting causes but these are typically viewed as isolated problems that only repeat infrequently, (often managed as Just Do It), until resources allow necessary time to discover interaction through data collection, analysis and experimentation

Page 56: Key Elements for Effective Root Cause Analysis & Problem Solving Presented by: Cathy Fisher Quality Improvement Strategies.

5 Why Analysis

• Ask “Why does this happen?” for each identified process cause from Cause & Effect diagram

• Differentiates between process, (direct) cause and underlying root cause

• Each level of causes identified in 5 Why analysis must also be confirmed via testing in order to verify root cause

• Deeper levels of 5 Why Analysis which get into Planning processes will require interview-type data collection

Page 57: Key Elements for Effective Root Cause Analysis & Problem Solving Presented by: Cathy Fisher Quality Improvement Strategies.

5 Why Analysis Worksheet

Process of Origin

Cause

Plan/Data to confirm

Results 2nd level

Cause

Plan/Data to confirm

Results 3rd level

Cause

Plan/Data to confirm

Results 4th level

Cause

Plan/data to confirm

Page 58: Key Elements for Effective Root Cause Analysis & Problem Solving Presented by: Cathy Fisher Quality Improvement Strategies.

Test Potential Root Causes

• Validating cause “guesses” by collecting and analyzing data

• Test under controlled conditions

• Turn the problem on and off by manipulating the suspected cause

Page 59: Key Elements for Effective Root Cause Analysis & Problem Solving Presented by: Cathy Fisher Quality Improvement Strategies.

Hypothesis Testing

• Design hypothesis and select methods for testing hypothesis - state how potential cause could result in described problem; decide what data to collect that would prove potential cause; establish acceptable risk of decision outcome; determine sample size; develop action plan for study

• Prepare to test hypothesis - organize and prepare materials required to conduct study; collect data during study

• Analyze results of test - analyze data using appropriate statistical tools, (t, F, Chi-squared tests)

• Interpret results - conclusions from study; does data establish potential cause as reason for problem?

Page 60: Key Elements for Effective Root Cause Analysis & Problem Solving Presented by: Cathy Fisher Quality Improvement Strategies.

Root Cause Analysis Plan• Identify causes to be investigated• What data supports each cause?• Can cause be introduced and removed to

confirm presence/absence of problem?• What tests will be performed to confirm root

cause?• What is the statistical confidence of these

tests? (i.e. how much data is needed?)• Results of tests recorded and analyzed with

conclusions drawn

Page 61: Key Elements for Effective Root Cause Analysis & Problem Solving Presented by: Cathy Fisher Quality Improvement Strategies.

System Causes

• What in the system allowed this problem/cause to occur

• Identifies why the process root causes occurred based on current management policies/practices

• Often not readily measurable• Data obtained through interview• By identifying system causes, systemic

improvement can be made in order to prevent recurrence of problem in other similar processes

• Typically addressed once process root causes of problem are known and confirmed

Page 62: Key Elements for Effective Root Cause Analysis & Problem Solving Presented by: Cathy Fisher Quality Improvement Strategies.

System Cause Analysis Worksheet Operational Definition: Process of origin cause: Process root cause: Which management system process is the process root cause related to? Who is responsible for this management system process? What documentation/policies are available describing actions and controls for this management system process? Does this documentation/policy recognize the possibility for this problem to occur? Are there any current management system controls in place to prevent or detect this problem? Has this management system process been associated with previous problems? What other processes within the organization are driven by this management system process? Possible Management System Level Solutions: 1) Create new policy 2) Change existing policy 3) Reinforce/re-apply current policy

Page 63: Key Elements for Effective Root Cause Analysis & Problem Solving Presented by: Cathy Fisher Quality Improvement Strategies.

Problem Solutions

• There are always at least 3 possible solutions related to each level of cause

• Therefore, at least 12 possible solutions could be identified for a problem investigation if all levels of cause are investigated!

• Management provides solution selection criteria as basis for evaluating possible solutions

Possible Solutions Matrix

Root Cause(s)

Confirmed Eliminate Control Detect Gap

Defect: Direct: Actual: System:

Page 64: Key Elements for Effective Root Cause Analysis & Problem Solving Presented by: Cathy Fisher Quality Improvement Strategies.

3 Possible Solutions• Eliminate root cause – preventive control; often

referred to as error-proofing; eliminates causal factor leading to problem condition

• Control root cause – process detective control; implement actions to monitor cause condition so action can be taken on process factor before problem occurs

• “Do nothing” – reactive control; continue monitoring for problem condition; defect detection solution; may be required when root cause can’t be eliminated or controlled economically or technically; this solution may include accepting interim action as permanent solution

Page 65: Key Elements for Effective Root Cause Analysis & Problem Solving Presented by: Cathy Fisher Quality Improvement Strategies.

Solution Selection

• Allow brainstorming of possible solutions at all levels of confirmed causes and the 3 possible categories of solutions

• Then apply solution selection criteria provided by management to evaluate each possible solution as well as refine the brainstormed ideas

• Have data available re: actual costs associated with problem, (initial impact, revised impact based on data collection/analysis, anticipated future impact if no action is taken)

Page 66: Key Elements for Effective Root Cause Analysis & Problem Solving Presented by: Cathy Fisher Quality Improvement Strategies.

CRITERIA MATRIX

SOLUTIONS

A B C D E n* CRITERIA

1

MUSTS 2

3

4

n*

1

WANTS 2

3

4

n*

RATING TOTALS

* reflects any number of variables that are appropriate to include in the analysis.

Page 67: Key Elements for Effective Root Cause Analysis & Problem Solving Presented by: Cathy Fisher Quality Improvement Strategies.

Implementing Solutions

• Actions to eliminate and control causes require change

• Change management tools should be applied when implementing solutions

Change Management Tools

• FMEA• Risk assessment• Resource planning• Contingency planning• Training• Evaluation• Verification

Page 68: Key Elements for Effective Root Cause Analysis & Problem Solving Presented by: Cathy Fisher Quality Improvement Strategies.

Brainstorm possible solutions for each confirmed

root cause

Establish solution selection criteria

Evaluate possible solutions vs.

solution criteria

Develop action plan to implement selected solutions

Evaluate solution risks and impact

on other processes

Develop contingency plan

for solutions

Establish solution effectiveness

measures

Trial plan for solution

implementation

Evaluate trial plan results

Revise solution implementation

plan as necessary

Permanent solution

implementation

Evaluate results of permanent

solution

Remove interim actions

Team verification of solution vs.

goals

Independent verification of

problem solving effort

Finalize problem solving report,

lessons learned

Team celebration and disbanding of problem solving

team

4/8/2007

Plan, Implement & Verify Solutions

Page 69: Key Elements for Effective Root Cause Analysis & Problem Solving Presented by: Cathy Fisher Quality Improvement Strategies.

Other Opportunities

• Identified typically while collecting data for Is/Is Not Analysis, Root Cause investigation/confirmation, solution evaluation

• Record these other problems/opportunities• Share these problems/opportunities with team champion

to get direction on how to address: (change scope of current problem solving effort to include; management assigns another team to address)

• Don’t allow these other opportunities to distract from the focus of the problem solving effort

• These Other Opportunities become the “Bonus” of an effective problem solving effort

Page 70: Key Elements for Effective Root Cause Analysis & Problem Solving Presented by: Cathy Fisher Quality Improvement Strategies.

A Key Outcome of Every Problem Solving/Root Cause Investigation. . .

Expansion of Knowledge

Page 71: Key Elements for Effective Root Cause Analysis & Problem Solving Presented by: Cathy Fisher Quality Improvement Strategies.

Failure Modes & Effects Analysis(FMEA) – A Tool for Cataloging Problems

Process

Function

Requirements

Potential Failure Modes

Potential Failure Effects

Potential Failure Causes

Current Product & Process Controls

Process of origin

Technical definition of

problem

Symptom Process factors = root

causes

Interim actions

Page 72: Key Elements for Effective Root Cause Analysis & Problem Solving Presented by: Cathy Fisher Quality Improvement Strategies.

Management’s RoleSystem

• Establish problem solving culture

• Provide problem solving process

• Ensure training of all personnel in problem solving process and related tools

• Prioritize/categorize problems based on magnitude/risk

• Audit/review effectiveness of problem solving system

Each Problem• Appoint Team Champion• Define SMART goals for

problem solving effort• Provide resources and time

to support problem solving team

• Establish solution selection criteria

• Authorize Team Plan as contract for problem solving effort

• Periodically review progress of problem solving teams

Page 73: Key Elements for Effective Root Cause Analysis & Problem Solving Presented by: Cathy Fisher Quality Improvement Strategies.

Problem Solving Culture• Problem solving is a value-added

process• Problem solving supports improvement

of every aspect of the business• Time should be dedicated to problem

solving on a daily basis• Everyone in the organization is involved

in problem solving• Use problem solving survey to measure

effectiveness of problem solving system

Page 74: Key Elements for Effective Root Cause Analysis & Problem Solving Presented by: Cathy Fisher Quality Improvement Strategies.

Comments on Effective Problem Solving Culture “Culture is the result of behavioral change over time.” Many organizations struggle with effectively implementing problem solving for several reasons:

1. problem solving is not viewed as a value-adding process 2. process ownership for problem solving is not defined beyond

someone to manage the administrative aspects, (i.e. tracking of status, accounting for open issues, etc.)

3. time is not specifically nor continually allocated for problem solving; instead, it is an activity that is done “when required”; in fact, problem solving should be an ongoing process if an organization is committed to continual improvement

4. expectations of the outcomes from problem solving efforts are not clearly defined nor connected with organizational goals, (quality objectives); in some cases, when expectations are defined, these may be unrealistic

5. more value is placed on “tribal knowledge” rather than data driven analysis and results, (ISO 9001:2000 quality management principle “fact based approach to decision-making”)

6. ownership of problems are parsed out to individuals instead of viewing each problem solving effort as an opportunity to increase organizational knowledge and therefore involving the entire organization in the problem solving effort with the core team being the drivers of the effort

To effectively solve problems, organizations must recognize problem solving as a valid process contributing significant value in terms of continual improvement and increase in knowledge. When ISO 9001:2000 specifies “determining and managing the work environment”, this includes establishing a culture which supports the success of the organization, which is clearly a management responsibility. Culture by default is NOT a “managed work environment”. One means of understanding current problem solving culture and therefore closing the gap in the desired culture, is the application of the AIAG Effective Problem Solving Process Survey found in CQI-10. The management team can use this tool to assess the current state of problem

Page 75: Key Elements for Effective Root Cause Analysis & Problem Solving Presented by: Cathy Fisher Quality Improvement Strategies.

Quality Improvement Strategies Problem Solving Survey – Short Version

This tool can be used to evaluate your organization’s problem solving system. The survey can be administered to any employee to gain an overall understanding of perceptions regarding this key process within your business. Continual improvement of the problem solving process can be measured based on conglomerate results of this survey, (can be re-administered repeatedly to evaluate progress). Each response scored 3 or 5 should have related evidence indicated to support. Scoring: 1 = no evidence currently exists to demonstrate this 3 = evidence exists to demonstrate this, but improvement potential

exists 5 = this aspect of our problem solving system is “world class”, (i.e.

would want others to benchmark ours) NA = not applicable; unable to respond

Culture: Question Score Evidence/Observations

1 Is problem solving viewed as a value-added process in your organization?

2 Are problem solving behaviors/expectations defined and communicated?

3 Are resources, (e.g. time), allocated specifically in support of problem solving?

4 Is problem solving used throughout the organization in all areas and at all levels?

5 Are the top 3-5 problem solving efforts known by all employees throughout the organization?

Page 76: Key Elements for Effective Root Cause Analysis & Problem Solving Presented by: Cathy Fisher Quality Improvement Strategies.

For Further Information, you are welcome to contact

Cathy Fisher

Quality Improvement Strategies

(704) 575-4496

[email protected]