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1、Key Elements for Effective Root Cause Analysis 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 caus
2、e 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
3、 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 Problem
4、s,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
5、 (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
6、,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,
7、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
8、 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ranking on FMEA for performance impact Also consider cost impact In the case of auditing findings: typically, auditors do not cite Impact as this could be viewed as subjective Impact should be determined by
9、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,
10、especially location and actual statement of “Requirement” Critical success factor to effective problem solving is consistent and complete communication of problem condition,Problem Categoriesand Problem Solving Approaches,Types of Problems,Simple, cause known; “Just do it” issues Complex, cause unkn
11、own; 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 throug
12、h 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-ter
13、m 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
14、 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 Pro
15、blem Definition 3. Containment (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
16、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 output
17、s 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,What are the Process Fa
18、ctors?,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,System Processes = Policies, Object
19、ives 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
20、 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; ba
21、sis 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 r
22、eflected 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 d
23、emonstrate 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 abo
24、ut 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
25、/Is Not Analysis, it is also possible to determine if further investigation can take place at this time,Components of Problems 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 proble
26、m 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 whi
27、ch 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,Dig! How Deep?,Management decides on depth of root cause investigation through the establishment of SMART goals for each problem solving effort.,Problem
28、Solving Goals,Define problems 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 b
29、ased 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 oc
30、curring 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,Process Cause What factor of the process of origin is triggering the undesirable output What other processes and their f
31、actors 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
32、Levels,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
33、 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 cont
34、rols 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 Teams main focus at this point
35、 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 dont typically do anything abou
36、t 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 helpful for operator dependent process Change Analysis identifies differences; extensio
37、n 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
38、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 tha
39、t 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 decide what data to collect that would
40、 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 statis
41、tical 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
42、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 proces
43、s 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
44、 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 s
45、election 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 condi
46、tion 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 cant be eliminated or controlled economically or technically; this solution may include accepting i
47、nterim 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 brainst
48、ormed 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 b
49、e 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
50、 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) Dont allow these other opportunities to distract from the focus