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1、key elements for effective root cause analysis & problem solvingpresented by:cathy fisherquality improvement strategieswhat we will discuss. . . what are problems how problems are communicated: crei statement types of problems and problem solving methods process view of problems isolating proble

2、ms 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 mo

3、st out of root cause analysis investigationsvisual 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

4、be” is specifiedwhere 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 generatedcommunication of problemscrei problem state

5、menta 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 signif

6、icant is the problem from a performance and/or cost standpointconcern 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

7、 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 documentevidence demonstrates requirement

8、 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 observedimpacthow big is the problem?how much does it cost?is the customer affected?is it affecting fu

9、lfillment of organizational goals?refer to effect and severity ranking on fmea for performance impactalso consider cost impactin the case of auditing findings: typically, auditors do not cite impact as this could be viewed as subjectiveimpact should be determined by auditee upon their review of the

10、audit findingutilizing 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 sta

11、tement of “requirement” critical success factor to effective problem solving is consistent and complete communication of problem conditionproblem categoriesand problem solving approachestypes of problems simple, cause known; “just do it” issues complex, cause unknown; need to dig deeper issues somet

12、imes 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 rem

13、edy) 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 impacttroubleshooting“dig deeper” issues sometimes referred to as chronic long-term and/or complex issues cause is not re

14、adily 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 s

15、ystem 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 risksteps in disciplined problem solving1. establish team2. operational problem definition3. containment & interi

16、m actions, (if needed)4. root cause analysis, (process & system)5. plan & implement solutions6. results of solutions7. verification, (including independent)8. closure & congratulate the teamproblem type considerationsjust do itreflects product or process controls established when plannin

17、g the processmanagement decision to “live with” such conditions based on acceptable level of riskshould be routinely evaluated for cost and impactcan only be eliminated by applying disciplined problem solving to understand true root cause in order to improve process dig deeper unanticipated conditio

18、ns 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 solutionsa note about fire-fighting!fire-fighting

19、 is essentially un-prescribed actions taken on a process without understanding the relation of causal factors and process outputfire-fighting is dangerous as these actions tend not to be specifically focused to a particular causethe resulting impact of fire-fighting is typically not known ahead of t

20、imetherefore, chaos is introduced into the processa very high-risk approach to problem solving!problem type considerationsproblem typeprocess of originmethodconsidera-tionsjust do itknowntroubleshooting; reworkseen before; can live with impact when problem recursdig deeperunknownroot cause analysisd

21、ata-driven investigation to determine actual factors causing problem conditionunknownfire-fightingtaking action possibly on wrong process; not using data to confirm root causeprioritize problemsmost organizations should only be actively working on 3-5 disciplined problem solving efforts, (dig deeper

22、 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 resourcesmanagement i

23、s responsible for establishing the priorityprocess view of problemsthe 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

24、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 thei

25、r outputscomponents of processprocess 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 & practiceswhat are the process f

26、actors?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 viewsystem processes = policies, objective

27、s & practices (how an organization does business)planning processes apply system to fulfill customer requirementsproducing processes to accomplish plansproducts/services = output of producing processesmain functions of problem solvingdefine gap between “what is” and “what should be”identify proc

28、ess of origin from which gap is originatingstudy the process of origin to determine which process factor(s) are causing the gapanalyze the relationship between process causal factors and system factors to identify root causegetting to the process of origin where was the problem found? where is the f

29、irst 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 stratificati

30、on 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”

31、demonstrates this idea of problem convergenceuse data to determinewhat is the problem? define the problem condition such that anyone could recognize it; basis for data collection about the problemwhere is the problem occurring? which processes, customers; also, where on the output is the problem con

32、dition 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 proble

33、mshow big is the problem? how much output is affected?narrows the problem focus to isolate the problem to its process of origindata is collected to demonstrate answers to these questionsapplying is/is not analysis clarify aspect what question needs to be answered to obtain a better understanding of

34、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

35、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 timecomponents of problems operational definition bas

36、is 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 inc

37、lude 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 causesystem r

38、oot cause = management systempolicy/practice contributing to actual root causeactual root cause = previous process factorscontributing to process root cause, (planning)direct process cause = at process of origin defect/detection cause = product leveldig! how deep? management decides on depth of root

39、 cause investigation through the establishment of smart goals for each problem solving effort.problem 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 go

40、als to organizational objectives/targets provided to team by managementeffective problem solving is based on smart goals: specific measurable agreed upon by team as attainable relevant to organization and results-oriented timing definedroot cause analysis systematic investigation of a process to ide

41、ntify 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 causeprocess cause what fac

42、tor 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 pr

43、ocess factor causes to “weaknesses” in management systems policies/practices4/8/2007disciplined problem solvingprocessroot cause analysisidentify process from which problem originatedreview data from operational definition, containment and interim actionidentify potential causes contributing to the

44、problemdevelop plan to test if potential cause actually leads to problemconduct test and collect dataanalyze data from testdoes potential cause directly lead to problem condition?select other potential causescan cause be controlled or eliminated?identify possible actions to monitor process for probl

45、em conditionidentify possible actions for either controlling or eliminating causenoyesnoyesidentify management policies related to process from which problem originated4/8/2007disciplined problem solvingsystemroot cause analysisreview existing policies for existing controlsdo current policies define

46、 controls to prevent the cause of the problem?identify possible management policy controls to address causeinvestigate if these controls are in placeidentify other processes affected by these policiescontrols working?identify how these controls and/or policies can be changed analyze why controls are

47、 not working at the process where problem originatednoyesnoyesroot cause analysis levelslevel(deep)root causeconsiderationtoolsother(wide)productdefect/detection causecondition of controls to detect problemcontrol barrier analysiswhat other products have similar controls?processdirect process cause,

48、 (trigger at process of originfactors at process of origin triggering problem, (5ms)fishbone, (cause & effect)what processes have similar trigger cause?planactual root cause, (led to trigger cause)linkage to planning processes that trigger cause5 why with hypothesis testingwhat other processes a

49、ffected?system“weakness” in mgt. policies or practiceslinkage of mgt. system to actual causesystem cause analysisother affected mgt. policiescontrol barrier analysis(defect/detection root cause) how did the problem escape the process and/or organization? was the problem anticipated in advance? were

50、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 def

51、ect/detection root causecontrol barrier analysis worksheetresults of control barrier analysismay recognize missing controls or controls not working as plannedinterim actions represent solutions to addressing these concerns but should not be accepted as the permanent solutionwhen the results of this

52、analysis uncover additional problems, refer these to the team champion for direction on addressingteams main focus at this point is to implement some type of control to protect downstream processes from continuing to experience the problemsolutions based on this level of “root cause investigation” m

53、ainly are reactive in nature; they only improve our ability to detect the problem condition but dont 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 o

54、utput 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

55、 is knowncause & effect diagram apply to problems process of origin gap is head of fish major cause categories 5ms potential causes brainstormed are process factors existing at the problems process of origin define potential causes specifically when confirmed, these will be known as direct proce

56、ss/trigger causesfishbone diagramfishbone 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 o

57、rigin 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

58、hypothesis test to evaluate each potential cause at the process of origindirect process root cause investigation plan & resultsprocess of origin:problem understanding tools(especially useful in identifying system causes) task analysis reviews process in detail; helpful for operator dependent pro

59、cess 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 worksheetchange analysis worksheetactual root cause explains why trigger cause/condition exists

60、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 proble

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