en. Page 1 of 14 (CONTROLLED) TECDIA CEBU Inc. REFERENCE MANUAL ROOT CAUSE ANALYSIS TOOLS AND METHODS RM-EM-001 Revision 01 L INTRODUCTION ‘The company aims to improve its abilty to satisfy its customer by continuously and contiwally improve its business and production processes. It aims to achieve small incremental changes in the process from time fo time in order to improve process elfciency and product ually. Series of actviles is conducted and elective methods are determined to identily ‘opportunities to streamline the processes and reduce waste generation. ‘One of the activities that drive improvement in the company is root cause analysis conduction. Problems encountered once solved becomes opportunties. Root cause analysis happers in the planning stage of Plan-Do-Check-Act (POCA) cycle which mainly focuses on defining the problem, analysis of problem state, identfication of its root cause and planning for ‘countermeasures. This activity consumes 60% of the entice problem management. Different manufacturing groups procedures citferent products and implement different activities for improvement or methods of ‘solving the problom. Thus, there can be variation of problem tools used in the entire company but the approach of solving the problem is similar and following the universal principle of managing problems in the production and business process is unifermly followed, OBJECTIVE © To identity common root cause analysis used in the organization to mitigate non-confermance occurrence. @ Touse correct root cause analysis tools appropriately to the non-conformance occurrence. © To implement effective and efficient root cause analysis using common approach implemented in the organization. Prepared By Prepared Date ‘Approval By ‘Approval Date | Effective Date (Chuckle Randot Yeap ositaroa Me Rafael Eleloro ositare2 sri- DIA Page 2014 Il, RESPONSIBILITY cops In-charge ‘Any engineering or ualty assurance personnel in coordination with Education and Reference Manual Update an Content Education/information | Immediate Head of any employees conducting root cause analysis IV. RESOURCES Outsourced Training: Practical and Simplified Root Cause Analysis Training \V, RELATED DOCUMENTS. Handling Request for Investigation GL-Ew-007 VI. DEFINITION OF TERMS AND ACRONYMS Root cause analysis (RCA) is a comprehensive problem solving process for conducting an investigation into a correctly identited incident, problem, concem or non-conformity. Tool: used to carry out root cause analysis. Method : a particular form of procedure for accomplishing or approaching root cause analysis isa systematic order. VIL CONTENT OUTLINE A. Problem Analysis Root Cause Analysis Tools and Techniques ©. Other Related Concepts Vill, REFERENCE CONTENT A. Problem Analysis Problem occurs in the organization when the current state does not meet what is expected based on the customer ‘and company requirements. Root cause of these incidents isthe Underlying cause ofthe problem which f adequately addressed will prevent a recurrence of that problem. It is specifc, idenifable, controlable and can be resolved. ‘These are not obvious and not observable. Frequently only problem symptoms of effects are observable. Root cause {is mainly is @ factor that cause a nonconformance and should be permanently eliminated through process improvement and effective cause analysis. Root cause analysis has been used successfully to better analyze exactly what is happening in a process and figure out how to prevent recurrences and eliminate problems at source. It defines all the major and minor causation factors, and then datermines the one thal, ifeliminated, would prevent a future nanconfermance or recurrence, 8. Root Cause Anaivsis Tools and Techni Root Cause Analysis (RCA) tools helps the employee facilitated a structured team to indentfy root cause of an event that resulted in an undesired outcome and develop correctve actions. The purpose of root cause analysis to find ‘out what happened, why it appened, and determine what changes need to be made. Doe. No. RM-EM-001 REFERENCE MANUAL TITLE: Rev. No. 1 ROOT CAUSE ANALYSIS TOOLS AND METHODS. Effective Date | 13-Juno-22Cc DIA Page 2014 Root Cause Analysis Tools © Change Analysis: a six-step process analysis showing when and what existed before, during and after the change, Itanewers the 4Ws (what, when, where, wna) and 1H (how) of the change occurrence. It's ‘generally used when: “when problem is obscure (unclear, unusual) effective for single-problem occurrence focus ison things that have changed comparison of trouble-free process with occurrence to identiycitferences is necessary differences are evaluated forts contrbution to problem occurrence EXAMPLE: CHANGE ANALYSIS. Steps: “mandate 3 6 @ Pareto Analysis: A statistical approach to problem solving that uses database of problems to identify the number of pre-defined causal factors that have accurred in process or system. It uses the Pareto Principle (also known as the 80/20 rule) the idea that by doing 20% of the work one can generate 80% ofthe beneft of doing the entre job. Generally Pareto analysis is ideal to: direct resources towards the most common cause % dotermine where you should start your analysis, EXAMPLE 1: PARETO ANALYSIS (Top 5 Product No Good Results) Pareto Chart EXAMPLE 2: PARETO ANALYSIS (Customer Satisfaction Study) Doe. No. RM-EM-001 REFERENCE MANUAL TITLE: Rev. No. o1 ROOT CAUSE ANALYSIS TOOLS AND METHODS Effective Date | 13-June-22Cc DIA Page 14 Study of Customer Satisfaction ers 80% of the {The raph even approx 20a] ceasane fer leaving ae ropor=bl ‘Quantity or Gost eres Number of Custor ra J Ao ef Reason orLesving —[24e#Csee4] © Eaiture Mode Effect Analysis: stopby-stp approach for dentiyng al possible failures in a design, a ‘Manufacturing or assembly process, ora product or sevice. itis also a systematic, proactive method for evaluating a process to idently whore and how it might fal and to assess the relative impact of diferent alures, in order to dently the parts o! the process that are ‘most in need of change. ‘This mainly used in the design of engineered systems rather than root cause analysis, Failure modes (what coutd go wrong?) are means the ways, oF modes, in which something might fa Flues causes (why would the fare happen?) are any errs o defects, especelly ones that affect the customer, and can be polanial of actual. Effects (what would be the consequences of each failure?) analysis raters to studying the consequences of those falures. Failures aro prioritized according to how serious their consequences are, how froquonly they occur and how easily they can be detected. The purpose of he FMEA is to take actons to eliminate or reduce failures, starting with the highestprinty ones Failure modes and effects analysis also documents current knowledge and actions about the risks of failures, for use in continuous improvement, FMEA is used during design to prevent failures, Later its used for contro, before and during ongoing operation of the process. Ideally, FMEA begins during the tarllst conceptual stages of design and continues throughout the Ie of the procuct or service. ‘To summarize, FMEA identifies component, subjectively lists all the possible failures that could happen, {and then make assessment of the consequences of each failure. Relative score is given to how crtical {he failure mode isto the operability of the system or component, WHEN TO USE FMEA: “When a process, product or service is being designed or redesigned, after quality function deployment. \When an existing process, product or service is being appled ina new way. Before developing control plans for a new or modified arocess. \When improvement goals are planned for an existing process, product or service, When analyzing failures of an existing process, product or service. Periageally thoughout the life ofthe process, product or service. sues Doe. No. RM-EM-001 REFERENCE MANUAL TITLE: Rev. No. o1 ROOT CAUSE ANALYSIS TOOLS AND METHODS Effective Date | 13-June-22- DIA Doe, No. Rev. No. Effective Date Page 5 of 14 © Scatter Diagram: a graph in which the values of two variables are plotted along two axes, the pattem of the resuting points revealing any correlation present. tis also called as scatter plot, X-Y graph ‘The scatter diagram graphs pairs of numerical data, with one variable on each axis, to look for @ relationship between them, Ifthe variables are correlated, the points wil fall along a Ine or curve. The Deiter the correlation, the tighter the points will hug the lin. ‘+ Here are some examples of situations in which might you use a scatter diagram: Variable A isthe temperature of a reaction after 15 minutes. Variable B measures the color ofthe product. You suspect higher temperature makes the product darker. Plot, temperature and color on a scatter diagram, ‘© Variable A is the number of employees trained on new sofware, and variable B is the rhumbers of eals tothe computer nlp ne. You suspect that more training reduces the number of calls. Plot numer of people trained versus number of call. To test for autocorrelation of a measurement being monitored on a control char, plot this pair of variables: Variable Ais the measurement ata given time. Variable Bis the same Measurement, but atthe previous time, Ifthe scatter diagram shows correlation, do another diagram whore varable B isthe measurement two times proviously. Koop inoreasing the separation between the two times unt the seater lagram shows no correlation ‘+ Even ifthe scatter diagram shows a relationship, do not assume that one variable caused the other. Botn may be influenced by a third varabl. ‘+ When the data are plotted, the more the diagram resembles a straight line, the stronger the relationship, ‘+ Ifa fine i not clear, statistics (N and Q) determine whether there is reasonable certainty that a relationship exists I the statics say that no relationship exist, the pattem could have occurred by random chance. ‘+ Ifthe scatter diagram shows no relationship between the variables, consider whether the data might be stralifed ‘+ Ifthe diagram shows no relationship, consider whether the independent (x-axis) variable has been varied widely. Sometimes a relationship isnot apparent because the data don't cover a wide ‘enough range. ‘+ Think creatively about how to use scatter diagrams to discover a roat cause. ‘+ Drawing a scatter diagram isthe first step in looking fora relationship between variables. F SCATTER DIAGRAM: RM-EM-001 REFERENCE MANUAL TITLE: ” ROOT CAUSE ANALYSIS TOOLS AND METHODS. 13-June-22- DIA Page 4 Doe, No. Rev. No. Effective Date aking a scatter hagram and drawing ane or curve I the primary investigation to assess the typeof telatorshp betwoen the variables. The knowledge gained rom the seater diagram can be vsed fr fuer analy of te gata, nmoat ofthe cases he agar are nota smplea Bou (a) There fe cule complcaled dogroms and Its ailal choose. @ proper material modal for Tepresentng tne eigal dat, Tne sates gram ges an icicaton of te appropiate model which Should be used for further anljis wth he help of method of east squares igre (2) shows tht the poms nthe seater eiagram are ‘ling rom te ‘op le corner tse igh, Thins atonal Frere erindrect. The pants ae nthe neighborhood ofa cetan ne eal the regression ne {As ong as the scaltred points show closeness to a salt ne of some director, we draw a straight tne to fepreert the cape daa, But wen the pos do pote arcu a aig in, we dona ew the regresion Ine Figure (¢) shows thal the plated ports have a tendency fo fal fom tt to ight hy the form ofa curve, Ths @@ relation caled neninea or curvinear, Figure (2) shows the pons whieh apperety donot folow any pater. i Xiakes smal vale, Yay take a small r large val, “hore seems to be no sympay between Nand Y', Such a dagrm suggests that thre fe no Ilstorhip ben the two vaabies WHEN TO USE SCATTER DIAGRAM “When you have paired numerical dat. “+ When your dependent variable may have mutple values for each value of your independent variable wen tying to determine wheter the two variables ar related, suchas When trying to identity potential root causes of protlems, * After brainstorming causes and effects using afishbone diagram, to determine objectively whether a paricular cause and effect are related ‘+ When determining whether two effects that appears lobe related both occur withthe ‘When testing for autocorrelation before constructing @ contal chart © Histogram: are graphs of a distribution of data designed to show centering, dispersion (spread), and shape (relative requency) ofthe data. Histograms can provide a visual display of large amounts of data that are diffcult to understand in a tabular, or spreadsheet form. Ths allows the inspection of the data for its underying distribution (e.g., normal distribution}, outlers, skewness, etc. ‘They are used to understand how the oulput ofa process relates to customer expectations (targets and specifications), and help answer the question: “Is the process capable of mesting customer requirements? ‘The histogram tool is a common tool for understanding data and the characteristics of data. Knowing how to correctly read a histogram graph can grealy assist process improvement efforts. Because of & histograms common use it also makes an excellent graphic for representing data during presentations, In histogram analysis, before drawing any conclusions from your histogram satisfy yourself that the process was operating normally during the time period being studied. If any unusual events affected the Drocess during the time period of the histogram, your analysis ofthe histogram shape probably cannot be generalized to all ime periods. Other is analyzing the meaning of your histagram’s shape provide signficant impact on the analysis RM-EM-001 REFERENCE MANUAL TITLE: 1 ROOT CAUSE ANALYSIS TOOLS AND METHODS. 13-June-22Page 7 of 14 Absolute Frequencies Histogram of Height 7 50) 23 oo e 6 8 mM mM class itarvale WHEN TO USE HISTOGRAM. s+ When the data are numerical % Whon you want to see the shape of the data’s distribution, especially when determining whether the output ofa process is stributed approximately normaly. \When analyzing whether a process can meet the customer's requirements, \When analyzing what the output from a suppliers process looks like. \When seeing whether a process change has occurred from one time period to another. \When determining whether the outputs of two or more processes are diferent. ‘When you wish to communicate the distrbution of data quickly and easly to others, seus 1, Root Cause Analysis Methods Oc wpping (Cause-Effect Diagram) + Five Why (5-WHY) Analysis: Most simplistic root cause analysis process and involves repeatedly asking “why” al least five times or untl you can no longer answer the question Five is an arbitrary figure; the theory is that ater asking why “ve times" you wil probably artve at the root cause. It shows logical relationship of each response to the one that preceded EXAMPLE 1: SWHY ANALYSIS (Responsivity No Good) Doe. No. RM-EM-001 REFERENCE MANUAL TITLE: Rev. No. 1 ROOT CAUSE ANALYSIS TOOLS AND METHODS. Effective Date | 13-Juno-22Cc DIA Doe, No. Rev. No. Effective Date RM-EM-001 oI 13-June-22 Page 8 of 14 ‘Eebedane cnt ane be rte Based on the flow, the root cause is therefore, small sleeve ciameter Is the cause of responsivity no good. Thus, the corrective action 's that there Is a need to ullize or fabricate enlargement iool to be used in widening the diameter ofthe sleeve. ishbone Analysis (Ishikawa Diagram): Its used a pre-defined lst of causal factors and arranged based on pre-defined categories: Manpower, Methods, Machinery and Environment WHEN TO USE FISHBONE ANALYSIS: “Each categorical method has its own lst of causal factors. Used for mult-faceted problems or long, complex causal factor chains. Aer reviewing the list of each category, oblained the factors most likely caused the problem. EXAMPLE: FISHBONE ANALYSIS REFERENCE MANUAL TITLE: ROOT CAUSE ANALYSIS TOOLS AND METHODS.Page 9 of 14 Cc DIA \4 YO _ Case S\ _—<« Equipment J cause / SJ caer Z y Sf PS causes 7 | easuement Levan Y | ~~ LCase? S EET] posed nema Tree Diagram: same approach with Ishikawa Diagram and is used a pre-defined Ist of causal factors and arranged based on predefined categories: Manpower, Methods, Machinery, Materials end Environment WHEN TO USE TREE DIAGRAM Causes are listed as branches to the right ofthe problem. Continue to clay causes, drawing additional branches to the right “Repeat until each branch reaches its logical end, REFERENCE MANUAL TITLE: Doe, No. RM-EM-001 ROOT CAUSE ANALYSIS TOOLS AND METHODS. Rev. No. oI Effective Date | 13-Juno-22oe DIA Page 10014 EXAMPLE: TREE DIAGRAM fee Deere echonclsress ph Teperure Senge eines Surge curentronbe Pigopfsendrdsanele Saecue ower supe ‘heeknotperiomes echiesauipmenties ed Baredbeamsatnuton| (monitor tow Power Preoppstonderdsomle = (hetknotsertomed incnedishied === cptcalans tot eneredopersor ee pert faes ofolow Sondbrprocesire ‘Bape at obser ealgrmert ‘pesteion a ‘laveiofipcotis a ‘reumurterartoouerat shies performed Festal uy roca —i LL] stanecarsrst tens Doe, No. RM-EM.001 REFERENCE MANUAL TITLE: Rev. No. o1 ROOT CAUSE ANALYSIS TOOLS AND METHODS Effective Date | 13-June-22Cc DIA Page 11 oF 14 © Process Mapping & Flow Chart Analysis: It uses flowchart as graphical presentation of process. WHEN TO USE PROCESS MAPPING AND FLOW CHART: Useful toa to understand what's going on in the process, % Help to track down which spectfic process might the problem occurs, EXAMPLE: PROCESS MAPPING ‘Sener ecing 1 Se | Commer i Cominn | Stra © Fault Tree Analysis: It uses a general conclusion to determine specific causes of a system failure. ‘The fault tree analysis (FTA) was frst introduced by Bell Laboratories and is one of the most widely used methods in system relabilty, maintainabilty and safety analysis. Its a deductive procedure used to determine the various combinations of hardware and software failures and human errors that could ‘cause undesired events (referred to as top events) atthe system level ‘The deductive analysis begins with a general conclusion, then attempts to determine the specific causes of the conclusion by constructing a logic diagram callod a fault tree. Ths is also known as taking a top- ‘down approach. Tha main purpose of the fault tree analysis isto help identy potential causes of system failures before the failures actualy occur. It can also be used to evaluate the probabil of the top event using analytical of statistical methods. These calculations involve system quantitative reliability and maintainability information, such as failure probabiliy, failure rate and repair rate. After completing an FTA, one can focus his or her efforts on improving system safety and relabilty. FAULT TREE ANALYSIS LOGIC DIAGRAM ‘The basic symbols used in an FTA logic diagram are called logic gates and are similar tothe symbols used by electronic circuit designers. Two kinds of gates, “and” and "or," are described in Table 1. Doe. No. RM-EM-001 REFERENCE MANUAL TITLE: Rev. No. 1 ROOT CAUSE ANALYSIS TOOLS AND METHODS. Effective Date | 13-Juno-22Page 12 0f 14 indicates the x cutout occurs | a italthema | 4-9 [7 F F events are dapat T . F = F The or gate opt pat | Out T a : indicates the id ‘output occurs if atleast one sp T I/F oftheingut | 8 S vents present. F F F If apart or another factor is functioning corect, the state is ‘rue (TI the part or other factor is mattunctoning, the tate {false (F1. When a logic statement is tue, itis assignad Boolean logic value of one. When a logic statement i false, {ts assigned a Boolgan gic value of aro ‘The partial FTA logic diagram in Figure 1 uses the “and” and "or" gates’ symbols to analyze hazard to the patient, Inputs to the "or gale atthe top identify the four reasons ths fallure can occur. One of the reasons, electrical shock, is than broken down because it results from simultaneously grounding the patient and creating @ pathway to a current source (an ‘and” gate). The analysis continues on, using the ‘same technique, untl the lowest levels such as operator error or open ground pin are identified Doe. No. RM-EM-001 REFERENCE MANUAL TITLE: Rev. No. o1 ROOT CAUSE ANALYSIS TOOLS AND METHODS Effective Date | 13-June-22Page 13 of 14 EGE Fault Tree Depicting The Root Causes of Hazard to Patients During Surgery Hazard to patient Electrical shock ea ism aime atient grounded current source acon Pal a table ci ameciod equipment ‘Vig aortic Via balloon pressure catheter catheter Operator | Openground | Operator pin ‘error Aortic pressure Conductive transducer path along bation eatherer When you perform an FTA, you systematically determine what happens to the system when the status fof a part or another factor changes. In some applications, the minimum criterion for success is that no Single fallure can cause injury or an undetected loss of contral over the process, In others, where ‘extreme hazards exist of when high value product is belng processed, the criteria may be increased to ‘equite toleration of multiple failures. Doe. No. RM-EM-001 REFERENCE MANUAL TITLE: Rev. No. o1 ROOT CAUSE ANALYSIS TOOLS AND METHODS Effective Date | 13-June-22- DIA Page 4 4 c. OTHER FAULT TREE CONSTRUCTION To do a comprehensive FTA, fllow these steps: 4. Define the fault condition, and write down the top level failure, 2, Using technical information and professional judgments, determine the possible reasons for the fallure to occur. Remember, these are level two elements because they fall just below the top level {allure in the ee. 3. Continue to break down each element with additional gates to lower levels. Consider the felatonships between the elements to help you decide whether fo use an "and" or an “ar logic gat. 4. Finalize and review the complete ciagram. The chain can only be terminated ina basic faut: human, hardware or sofware, 5. If possible, evaluate the prababilly of occurence for each of the lowest level elements and calculate the statistical probabllies from the bottom up. RELATED CONCEPTS Root cause analysis requires the problem solvers to look beyond the solution to the Immediate problem and Lunderstand the fundamental or underlying causes of the situaion and put them right, thereby preventing re- ‘occurrence of the same issue. © 20 (Eight Disciplines) - is not an RCA too! but problem solving approach. Some customer provided this format for their CFRs (Customer Feedback Request) and CARRS (Corrective Action Report and Request). © Experimentationnvestigation Analysis - it is part of RCA activities wherein the product/process!materals subjected of series of experimentation to possibly identify the root cause. © Failure Analysis - itis an analysis on the component level or the physical analysis of the fallure. On this approach, falure analysis capabilites setup and machine are needed such as SEM, C-SAM, XRAY and ete © DMAIC (Design Measure Analyze Improve Control) — itis an approach used to possibly eliminate or decrease current top falure made. Iis'a progressive type of activites which aim to improve the quality 88 well asthe process, 1% REVISION SUMMARY Ree eae PreparedBy | Avproveay | Peaive of Company Name from Cebu Microelectronics, Ine. to ” Senna TRweaant REFERENCE NANOAL TLE Rov Net ROOT CAUSE ANALYSIS TOOLS AND METHODS Effective Date 13-June-22