Intelux

Electronics Private Ltd

Presentation-

Root Cause Analysis
By

Mr. Sandip Tambe Quality Assurance Intelux Electronics Pvt. Ltd

Scope
‡ To Understand ISO 9001 requirements on cause non conformities, cause identification, correction & corrective action. ‡ To Apply these requirements in generating non conformities, planning & implementing corrective actions. ‡ To Review non conformities, correction,causes & corrective action reporting for correctness. ‡ Improve effectiveness of QMS by effective implementation of corrective actions

founder of Toyota .Kilchiro Toyoda.if the company can uncover its cause and work to prevent it across the corporation´ .³Every Problem is an opportunity´ ³Every defect is treasure .

‡ ISO 900 Requirements Vis-à-vis Root Cause Analysis ..

What is a Nonconformance ? ISO 9000:2000.6.2 ³Non ± Fulfillment of a Requirement´ ‡ Objective evidence exists showing that: ‡ ‡ ‡ ‡ Type of NC A requirement not been addressed (intent) Practice differs from the defined system(implementation) The practice is not effective (effectiveness) ‡ Correction: Action to eliminate a detected non conformity . 3.

Defect and Non conformity ‡ Defect ± Non fulfillment of requirement related to an intended or specified use Product quality characteristics ‡ Non conformity : Non fulfillment of requirement Business or production process .

Corrective x Preventive action ‡ Preventive Action ± ‡ Corrective Action ± ‡ Action to eliminate the ‡ Action to eliminate cause of a potential cause of detected non non conformity conformity or other undesirable situation .

2 Documented Procedure Identification of Non conformity Identification of cause Elimination of cause Plan and implementation of corrective action ‡ Review of effectiveness ‡ Maintain record .2.5.ISO 9001 Requirement ‡ Internal Audit ± 8.2 ‡ Documented Procedure ‡ Audit Planning ‡ Roles of Auditor & Auditee ‡ Correction &Corrective Action ‡ Records of Results of Audit ‡ ‡ ‡ ‡ ‡ ‡ Corrective Action ± 8.

Traceable. Concise . Objective. ‡ Non conformance must be. Factual.Nonconformity Report No set rules. Precise. however all have these two parts: ‡ The requirement ( What was supposed to do ) ‡ The evidence ( What actually is ) ‡ ‡ Different organizations have different formats ‡ Use the format chosen by your client or firm.

Examples of NCs & CAs ‡ Scenario: ‡ Production. Clause 6. requires that all personnel entering W4 must wear nylon caps. ‡ 4 out of 18 operators seen not wearing nylon caps. . ‡ WI4-01.Lens Department W-4 ‡ Morning Shift. Instruction clearly displayed at the entrance. Caps were available at the entrance area.

4. cl. Auditor :Yogita . NONCONFORMITY REPORT Incident ‡ ‡ ‡ ‡ ‡ ‡ Area Problem Attribution Grading Reference to internal Requirement's).... Note ISO9001 Class No«««. Category: Major/Minor Deficiency: During the morning shift 4 out of 18 operators were not wearing nylon caps. if Necessary ‡ Sign Company Under Audit XYZ plc.W14-01. Number««« Area Under Review.Div. IRCA Quality Audit No««««. requires that all staff entering W-4 must wear nylon caps. Production..Lens. The Slandered requires that the organization must determine & manage the work environment needed to achieve product conformity.W-4«««««««.6. 6...

‡ Will the proposed action prevent recurrence of the non conformity? ‡ New operator .Corrective Action Proposed: ‡ The 4 concerned operators will be given a verbal warning to follow system.training .

health. environmental. but also why it happened. ‡ Simply stated RCA is a tool designed to help identify not only what & how an event occurred. reliability & production impacts.Quality Tools for Root Cause Analysis What is Root cause Analysis? ‡ A process designed for use in investigating & categorizing the root cause of events with safety. ‡ Should we apply in depth root cause analysis for each identified non conformity or problem ? . quality.

Major steps in RCA: ‡ Step1 ± Problem identification ‡ Steip2 ± Data collection ‡ Step3 ± Causal factor charting ‡ Step4 ±Root Cause Identification ‡ Step5 ± Corrective action Recommendations & Implementation .

Tools & Techniques: ‡ ‡ ‡ ‡ ‡ ‡ ‡ ‡ Brain Storming Data Collection Graphs & Charts Flow Charts (process Map) Pareto Analysis Histogram Cause & Effect Diagram Scatter Diagram .

Brain Storming ‡ Brain Storming is used to establish common method for a team to creatively & Efficiently generate high volume of ideas on any topic ‡ Brainstorming encourages of all the team members without the dominance of anyone team member ‡ Allows team members to build on each others creativity while staying focus on the joint mission .

. ‡ Definition ± Brain Storming is a team approach to generate creative in a short time brain storming plays an important role to build a cause & Effect diagram. ‡ Why Brain Storming? ‡ To identify the problem ‡ To identify critical causes ‡ To find the Solution ‡ To Prevent the problem .

Types of Brainstorming ‡ Free Wheeling: Spontaneous flow of ideas by all team members ‡ Round Robin: Team members take turns suggesting ideas ‡ Card Method: Team members write ideas on cards with no discussion .

‡ Thumb rule: 5-15 minutes works well . ‡ Create a certain amount of press Unstructured ‡ Group members simply give ideas as they come to mind ‡ Create more relaxed atmosphere ‡ Risks domination.Brain storming : Structured ‡ Every person in a group must give an idea as their turn ‡ Forces even shy people to participate.

Data Collection ‡ ³The Skill with which a company collects & uses data can make the difference between success & failure´ -Maasaki Imai .

improve or control objects. situations or phenomenon in the form of measurements. describe. . ‡ It is used to classify. situations or phenomenon.Data Collection ‡ Step1 : What is data? ‡ Data is information about a topic ‡ It is derived from objects.

How to measure the data ? Plan for the Data Collection Establish Data Collection Goals Develop operational Definitions & procedures/ measurement method ‡Write & pilot operational definitions ‡Develop & pilot data collection forms & Procedures ‡Establish a sampling ‡Data collection is the 1st step to Understanding the Variation the Customer Feels Ensure Data consistency & Stability Collect Data & Monitor Consistency ‡Clarity Purpose of data collection ‡Identify what data to collect ‡ Test & Validate measurement systems ‡Train data collectors ‡Pilot process & make Adjustments ‡Collect data ‡Monitor data accuracy & consistency .

.Types of Data: ‡ Data type is an important considerations because it can impact not only hoe you define your measures but also how you collect data & what you can learn from it.

Cycle time (measured in days. ‡ Can have almost any number value which can be measuring subdivided into finer & finer increments ‡ Can be broken down into increments ‡ Infinite no. etc. Defect/No Defect) Ordered categories( 1-5) E. hour.) Weight (measured in tons.etc. of Green Belts Trained Continuous Data (Variable Data) ‡ Continuous data is information that can be measured on a continuous & Scale.) . of incomplete applications ± No.‡ ‡ ‡ ‡ ‡ ‡ Discrete Data (Attribute data) Discrete data is information that can be categorized into a classification. No. Of values which can not be subdivided meaningfully. Binary (Yes/No.pounds.g. It is based on counts. minutes. Finite no.g. of possible values E.

So discrete data can be more expensive Discrete data can bury important information You can do many more potentially useful Analysis with continuous data versus discrete ‡ ‡ . e. City. Street). not sure) ‡ It is faster & easier to capture discrete data ‡ ‡ Cons: Requires to make more observations to get valid information. some statisticians note that continuous data can be accurate with a sample of just 200 items no matter how high the volume of the process. business VS home) ‡ Intangible factors can often be converted into measurable discreet characteristics. ±Location (State. bad. Effectiveness of ad (good. Customer type new or repeat.Pros & Cons ± Discrete Data Pros: ‡ Factors can be defined only as discrete data. E.g.g. Need to count more items to get accurate data.

any unit that contains one or more defects. a lost reservation ‡ Defective. Hence a car with any defects is just defective as a car with 15 defects ‡ Opportunity ± a chance to go right or wrong.Defects Based Measurement ‡ Unit.a failure tom meet a customer requirement or performance standard ± a leaky cranky case. a hotel statement etc.Key Concepts. Defect.a car.an items being processed. or the final product or service being delivered to the customer.Most product or services have multiple customer requirements. there can be several chances or opportunities to have a defect .

. ratios & comparisons among different groups of data. making it easy to spot trends. Purpose: ‡ Graphs & Charts are pictorial representation of the data.Graph .

‡ The more common types of graphs & charts are line graphs . ‡ To present the numerical Data in an easy to plot visual form..Bar charts & pie charts. .

time intervals etc. regions.Graph ‡ To present the numerical Data in an easy to plot visual form. . ‡ Pie Charts are used to show % or proportions of different components of a specific items. ‡ Line graphs used to depict change or variation over time ‡ Bar charts are used for comparing quantities between persons.

‡ Colour or shade the lines or bars to distinguish between different groups or classes. ‡ Provide appropriate title. . ‡ Decide the units & scale of items to be shown on X-axis & Y-axis.‡ Select the type of chart or graph most suitable for the type of data. ‡ Fill the information on the graph sheet. ‡ Join the required points to complete line or bars.

Example Response Time 97 100 % Complition 80 60 40 20 0 1 eek 43 eek 44 eek 45 eek 46 eek 47 95 100 92 95 95 100 96 96 94 .Line Graph .

Bar Graph .Example JSRV/SRV VOLUME Type Week 42 48 86 134 Week 43 75 60 135 Week 44 46 79 125 Week 45 76 75 151 WeeK 46 82 112 194 Week 47 63 68 131 SRV JSRV Total IN ARD U 6 4 W k4 W k 43 W k 44 W k4 W K 46 W k 47 .

Example WP 7 W P D E .Pie Chart .

Jul-09 Aug09 09 Rejected Mon h i SR R j Inspected Rejected M on h . of Items Inspected 414 39 5 2 38 562 499 822 438 1 23 2 32 26 31 31 1000 800 600 400 200 0 Jan09 Feb09 Mar09 Apr09 May09 Jun.Monthwise SRV Rej Month Month Jan-09 Feb-09 Mar-09 Apr-09 May-09 Jun-09 Jul-09 Aug-09 No.

Process Mapping ‡ Process mapping is technique used for marking work visible ‡ Process map shows who is doing what .when and for how long ‡ It also shows decision that are made .with whom . if any in the process . sequence of events and time delays.

Start Step1 Step 2A Step 2B Step3 Step2C Rework NO Good Yes End .Process flow diagram that visualizes how work is done.

Symbol Meaning Start or End of Process Activity or Process Decision or Inspection point Connector Direction of flow .

Process mapping Steps
1.Fix process start & end points 2.Brainstorms list of process steps. 3.Do first walk-through & interview 4.List key process steps on sticky notes 5.Discuss, review & modify 6.Do second walk-through & interview .Add inspection, rework, repair and scrap steps on sticky notes ‡ 8.Agree on ³as is´ process map. ‡ ‡ ‡ ‡ ‡ ‡ ‡

Processes Mapping ‡ ‡ ‡ ‡ ‡ ‡ ‡ ‡ ‡ ‡ ‡ ‡ ‡ Start And End Point Review problem statement Describe the process causing the problem Discuss measurable start & end points Agree & record Problem statement : Customer waits to long for modified drawings. Process: Drawing revision process. Ask: - what might the start point be? Ask: - what might the end point be?

Process Map - Analysis
Identify :  Process deliverables  Process output  Value added and non value added steps  Intermediate measures  Input and output for key process steps  Specific types of wastes in each step

       Loo at each process for Bottle necks Sources of delay Errors being fixed instead of being prevented Role ambiguity Duplications Unnecessary steps Cycle time Look at each decision for Authority ambiguity Are the decision needed for this point B.Process Mapping :analysis A.   .

Process Mapping :analysis C. Loo at each Rewor loop for    Possibly doing it in less time Possibility of eliminating step Trying to prevent D. Using Customer Point of View  Identify value added vs non value added steps .

What Is A Pareto Diagram? ‡ A diagram that shows 20% of the input(Xs) Of the problems with dependent process outputs(Ys) KEEP IN MINDPareto analysis is powerful tool when we use objective data & facts & not opinions. .

80% of the people own 20% of the country¶s wealth. ‡ Two fatal accidents deserve more attention than 100 cut fingers. ‡ .Solve the vital Few ‡ Remember« ‡ The most frequent or most costly events are not always the most important ‡ e.Pareto Analysis ‡ Vilfredo pareto was an Italian engineer in the 19th century who studied the number of people in various income classes & declared« ‡ .Get the biggest problem first ‡ .g. ‡ .20% of the people own 80% of the country¶s wealth. .

Collect Data 3.Using cumulative data. Calculate cumulative % in the next column 5. Calculate the cumulative in the next column 4.Identify the VITAL FEW ‡ Exercise Players Laxman Dravid Ganguli SS Das S Ramesh Zaheer Khan Sachin Mongia Runs 281 180 48 39 30 23 10 4 .Steps to Build a Pareto Chart ‡ ‡ ‡ ‡ ‡ ‡ ‡ ‡ 1. Draw bar chart based on data . draw cumulative curve 8. Draw a graph with scales on both axis 6. Arrange data in the descending order 2.

Players Scored Players Laxman Dravid Ganguli SS Das S Ramesh Zaheer Khan Sachin Harbhajan Mongia Runs 281 180 48 39 30 23 10 8 4 Cum 281 461 509 548 578 601 611 619 623 % 45 73 81 87 92 96 98 99 100 .

%r 100 120 20 40 60 80 0 La xm an Dr av id G an gu li SS Da s S R am es Za h he er K ha n Sa ch in Ha r ha ja n M on gi a % .

‡ In 1953.What is cause ‡ CAUSE = Reason or Factor contributing to the EFFECT CAUSE is happens. used the cause & effect diagram for the first time. Professor of the University of Tokyo. .Kaoru Ishikawa. ‡ A cause & effect diagram is also called a fish bone diagram since it looks like the skeleton of a fish.

Measurement Man Method Cause Effect Material Machine Environment ‡ If there are no clues to indicate the cause. Write a cause & effect diagram. ‡ Group them under 5M & E category ‡ Then by observation eliminate causes which do not contribute to the problem. ‡ List down the possible & probable causes by brain storming. .

Fishbone Diagram ‡ Arial Font Size 24 .

‡ Teams create cause & effect diagrams to get at the difficult to discover causes.‡ Cause & Effect Diagramming is brainstorming! ‡ It is very important to ask ³WHY´ over &over again. Good cause & Effect Diagramming is question & answer. .

1They fear ma ing mista es (1.1. Why .1.1.Why.1)They are criticized for mista es (1. Why People People resist change 1. )To err is human to forgive is not company policy 1.2) They are penalized for mista es (1.2 They fear ob loss Poor & declining participation I improvement programs .

Histogram ‡ It is graphic summary of variation in set of data ‡ Enables us to see patterns that are difficult to see in simple table of numbers .

Histogram ± Normal Distribution .

100% inspection. often means that part of the distribution has been removed through screening. y A truncated curve. . with one tail longer than the other. with the peak at or near the edge while trailing gently off to the other side. These efforts are usually costly and make good candidates for improvement efforts. or review.Histogram ± Normal Distribution y A skewed distribution.

Histogram ± double peaked y A double-peaked curve often means that the data actually reflects two distinct processes with different centers. . You will need to distinguish between the two processes to get a clear view of what is really happening in either individual process.

. with one tail longer than the other.Histogram ± Skewed Distribution y A skewed distribution.

y A truncated curve. These efforts are usually costly and make good candidates for improvement efforts. often means that part of the distribution has been removed through screening. or review. with the peak at or near the edge while trailing gently off to the other side. . 100% inspection.

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