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

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

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

Communication of Problems

CREI Problem Statement A 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

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)

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

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

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

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

Problem Categories and Problem Solving Approaches

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

“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

Troubleshooting

“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

Steps in Disciplined Problem Solving 1. Establish Team 2. Operational Problem Definition 3. Containment & Interim Actions, (if needed) 4. Root Cause Analysis, (process & system) 5. Plan & Implement Solutions 6. Results of Solutions 7. Verification, (including independent) 8. Closure & Congratulate the Team

Problem Type Considerations Just 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

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!

Problem Type Considerations Process of Origin Method 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 Fire-fighting Taking action possibly on wrong process; not using data to confirm root cause

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

Process View of Problems

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

Components of Process Management Policies & Practices 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

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?

Process View Products/Services = output of producing Processes Producing Processes to accomplish Plans Planning Processes apply System to fulfill customer requirements System Processes = Policies, Objectives & Practices (how an organization does business)

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

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.

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

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

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

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

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.

4 Levels of Root Cause Defect/Detection Cause = Product level System Root Cause = management system policy/practice contributing to Actual Root Cause Actual Root Cause = previous process factors contributing to Process Root Cause, (planning) Direct Process Cause = at Process of Origin Defect/Detection Cause = Product level

Dig! How Deep? Management decides on depth of root cause investigation through the establishment of SMART goals for each problem solving effort.

Effective Problem Solving is based on 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

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.

Process Cause vs. System 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

Root Cause Analysis Levels (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

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

Control Barrier Analysis Worksheet

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!

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

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

Fishbone Diagram

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

Direct Process Root Cause Investigation Plan & Results Process of Origin:

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)

Task Analysis Worksheet

Change Analysis Worksheet

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

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

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

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?

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

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

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

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

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)

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

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

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

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

Management’s Role System 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

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

For Further Information, you are welcome to contact Cathy Fisher Quality Improvement Strategies (704) 575-4496 cathyf2@earthlink.net