70C TOOLS en eee SF Scatter Dia. Check Sheet > chert Wo PCL LU LU Eee 7 QC tools for process improvement are systematic and scientific methods for Problem Solving and they are used for Product and Process Improvement. 7 QC tools Is a systematic and scientific method for the Problem Solving Technique. — Itis used to solve 90% of shop floor problems very easily and it improves our workplace. From Where did the 7 QC Tools come? — Primarily Kaoru Ishikawa introduced the 7 QC Tools. — Ishikawa has known for the “Democratizing (Visual Alds/Symbois) Statistics”. — Good visual aids make statistical and quality control more comprehensive. — Dr. Kaoru Ishikawa was a professor at the engineering college at Tokyo UniversityFrom Where did the 7 QC Tools come? — Primarily Kaoru Ishikawa introduced the 7 QC Tools. — Ishikawa has known for the “Democratizing (Visual Aids/Symbols) Statistics". Good visual aids make statistical and quality control more comprehensive. — Dr. Kaoru Ishikawa was a professor at the engineering college at Tokyo University. Why we use The 7 QC Tools for Process Improvement? — The 7 QC tools for Process Improvement is a set of graphical techniques identified as being most helpful in troubleshooting issues related to quality. — Itis @ fundamental concept to improve the process and product quality. = Itis used to examine the production sequence, identify the key issues, control fluctuations of product quality, and give solutions to avoid future defects. = This facilitates the organization to resolve the basic problems. = These 7 QC tools are easy to understand and implement and they do not need complex analytical/ statistical competence, hence itis simple yet powerful. Benefits: + it encourages the way of problem-solving and improvement. “+ They are very simple to use but itis very powerful. “+ It is @ scientific approach for problem-solving. + We can get an 80% result by applying 20% of the effort. + Each tool has its own specialty for problem solving and analysis. + ILis very easy to understand, communicate and use by the shop floor operator. The 7 QC Tools: 1. Flow Charts 2. Cause and Effect Diagram (Fishbone or Ishikawa) 3. Checksheet 4. Histogram 5. Pareto Chart 6. Scatter Diagram 7.Control ChartFlow Chart in 7 QC Tools = 1118. diagrammatic representation that Illustrates the sequence of operations to be performed to (eet the desired result and it is also known as Process Flow Diagram. + Flow Charts a dlagrammatic representation that illustrates the sequence of operations to be performed to get the desired result. —-AS per Wikipedia, It is a type of diagram that represents an algorithm, workflow or sequence of operation. = The flowchart shows the steps as boxes of various kinds, and their order by connecting the boxes with arrows. —Itis used in analyzing, designing, documenting or managing a workflow or program in various fields. Dr. Edwards Deming's statement: “Draw a flowchart for whatever you do, Until you do, you do not, know what you are doing, You just have a job" Use of Process Flow Diagram: = Planning a new project = Documenting a process + Managing workflow = Also used for auditing purposes. Milestones: +1960: The American National Symbols Institute (ANSI) set standards for Flow Charts and their symbols in the 1960s. +1970: The International Organizations for Standardization (|SO) adopted the ANS! symbols. +1985: The current standard was revised in 1985.Guideline for Flow Chart making: — The process needs to start from top to down, from left to right. — The graph size needs to be the same and the start symbol only appears once, but the end symbol can use more. — There is only one arrow path graph for the same path. — The line should avoid the cross, if need crossed should be used across the graph. Flow chart Symbols: (a) Oval = This is used for Start and End activity or we can say beginning or end of a program. = inthis symbol generally “start’ or “End” word used or other phrases used such as ‘submit inquiry” ot "receive product". (b) Flowline / Arrow line = The flowline or arrow line shows the order of operation. — Arrow line used to indicate line coming from one symbol and ending at another (c) Diamond — Diamond is used for decision-making purposes. —For yes/no or true/false activity, we use a diamond. (d) Rectangle + We use a rectangle for change value, shape, or location of date. — For different symbol, their use, and example refer belaw picture.Flow chart Symbols Oval ED} Hlowline/Arrow line GD | Diamond aD Rectangle =D (e) Parallelogram — The parallelogram is used for input and output data. tis also used for entering data or displaying results. (£) Single document graph = It is used to display a single document in any process,(g) Multiple documents graph It fs used to cisplay muitiple documents in any process, (h) Delay Activity — The Delay shape represents a waiting period where no activity is done. — For different symbol, their use, and example refer below picture. Flow chart Symbols Parallelogram GD | Single document == Multiple documents GUND Delay Ss Different Types of Flowcha! 1. Macro 2M 3. Micro 4. Matrix Flowchart The examples of different flowcharts are mentioned in the below pictures. (@) Macro and Mini FlowChartMacro & Mini Flow Chart Macro Flow chart Ger Mini Flow chart Start ‘Alarm Rings Jp — 2104 tO a wit snooze I Button Climb out from Bed(b) Matrix Matrix Flow Chart aese nh wth Prati) — Improve process understanding — Provide a tool for training sider —+Define and analyze processes in an easy way problem areas and improvement opportunitiesCause and Effect Diagram in 7 QC Tools — It isa representation that represents the meaningful relationship between an effect and its causes. -Itis a very good tool for root cause analysis and a part of Z Basic Quality Control Tools, — Dr. Kaoru Ishikawa developed it in 1943 while consulting for Kawasaki steelworks in Kawasaki Shipyards so Dr. Joseph M. Juran named it as "ishikawa’ — This dlagram is also known as a "Fishbone" because it looks like the bone of fish. FISH BONE DIAGRAM OR CAUSE & EFFECT DIAGRAM [cause |} [ertect POL rece eee <—FWhen we can use the Fishbone or Ishikawa: + When identifying possible causes for an issue (trouble) = To identity all of the contributing root causes likely to be causing an issue (trouble) — Especially when a team’s thinking patterns are different —- This tool is very helpful during a Six Sigma Project Four Steps for Constructing Fishbone Diagram — Four Steps are mentioned below: 1. State the undesirable effect or problem. 2. Identify the main cause groups 3. Arrange causes and sub-causes as relevant 4, Identify potential root cause(s) Step 1. State the undesirable effect or problem —-First of all, we will mention the undesirable effect or problem and draw the backbone and a line. Then define a problem statement (effect), + Write it at the center-right of the chart or whiteboard. Draw a box around it and draw a horizontal arrow running to I. — For better understanding, we are taking one example for root cause analysis for this we will prepare the backbone and line as mentioned in the below picture.STEP |. STATE THE UNDESIRABLE EFFECT OR PROBLEM [enue] | [Ettoct PC EL Step 2. Identify the main cause groups — Inthe second step, we brainstorm the major categories of causes that are related to the problem. — For the manufacturing industry, it is "6M" ‘= In Manufacturing Industry "6M" stands for, -+ Man/People ~» Machine ~+ Material ~+ Method ~» Measurement ~» Mother Nature / EnvironmentSTEP 2. IDENTIFY THE MAIN CAUSE GROUPS ieee eel ol [_Man/Peeple | ' nixunjbhoraniy3.com = For marketing Industry "6M" is replaced by "gP" -» Product (or service) ~» Price Promotion Place Process People (personnel) Physical evidence ~» Performance = For Service Industry “= Now we are taking an example of the poor mileage of cars to understand the concept of root cause analysis for this we are taking 6M then we will remove irrelevant "MI from "6M". Step 3. Arrange causes and sub-causes as relevant —- Now we ate moving forward by taking the problem of poor mileage in the car. — Write the categories of causes as branches from the main arrow — Brainstorm all the possible origins of the problem. — Ask: Why does this happen?” As each idea Is given, the facilitator writes It as @ branch from the appropriate category. — Study all probable causes which are related to poor mileage of the car as mentioned below + Carburator adjustment + Underinflated tire -» Poor maintenance -» Poor driving habit No awareness + Improper lubrication + Wrong fuel mixture + Engine oil grade is not proper ~» Gear shifting is not in sequence ~ Wrong gear shifting ~ Drive too fastSTEP 3. ARRANGEMENT OF CAUSES AND SUB-CAUSES = —=\ = ‘eis vase er | [mamianty Cay eet —— a were! [ome ma hater ated Step 4. Identify potential root cause(s): — Again ask ‘why does this happen?” about each cause. = Write all the things with the main branch and sub-branch. — Continue to ask “Why” and generate deeper levels of problem. — After validation of all probability, we will get the reason for poor gas mileage in the car is poor ‘maintenance of the car which you can easily understand from the below exemple.STEP 4. IDENTIFY POTENTIAL ROOT CAUSE(S): Benefits of Fishbone or Ishikawa: —+Helps to determine the root cause — Increase Process Knowledge = Encourage group participation + A good 1001 for brainstorming = Identifies areas for collecting date Check Sheet in 7 QC Tools = Iisa systematic method of collecting, recording and presenting the relevant data in a simple ‘manner for analysis of the process and It Is also known as a "Tally Sheet’, — It can collect qualitative and quantitive data also. —Itis one of the most popular tools of 7 QC Tools for process improvement. Different Types: — Dr. Kaoru Ishikawa identified five different types which are mentioned below. 1. Process performance, 2. Defect item, 3. Defect location, 4. Task conformation (Related to traceability) etc... 5. Defect cause5 Types of Check Sheet Process DefectItem Defect Defect Cause Task Performance CheckSheet Location ‘Conformation Steps for Making a Check Sheet in 7 QC Tools: = The five steps are mentioned below. 1. Establish what information is needed. 2. Determine SW and 2H. 3. Construction. 4. Testing. 5. Take the final approval for Use.5 - Steps for making a Check sheet Step 1. Establish what information is needed — Define what information is needed? = Sometimes this is known as record form, data form, etc.Step 2. Determine 5W 2H: — Why is the data needed? + What type of information collection is required? + Where the data should be collected from? (Plant/machine/place) + Who has to collect the data? (Operator/ supervisor/manager) — When will the information be collected? (Every hour/ at the time of receipt) —+ How the data should be measured? (Instrument/clock) — How much data is essential? Step 3. Construction of the Sheet: + Checksheet has three types of information. [Title [2] Source information + Name of the project/ problem theme. ~» Location of data collection. ~» Date and/or time. ~» Name of the person recording data. [3] Content information ~» Column/Raw with defect/event name. ~» Then Column/Raw to record frequency. ~+ And Column/Raw to record total.Step 4. Testing of Sheet: + Test the Sheet with at least three different collectors. + Reconfirm that the columns/ rows are relevant and required. + Check if the Sheet is easy to record and use. “+ Make changes based on the feedback. Step 5. Final approval for using this sheet: “+ Explain the use of this sheet to the data collector. + Ensure that the data collector understands the reason for which the data is being collected. = Collect data. + Standardize its use to assure consistency. Examples: + For a better understanding refer below picture. “+ In this example, we have mentioned the day-wise count of the defect and at the end of the weekCheck Sheet ajar tones + The example of the defect collection tally sheet is mentioned below. In this example, we have counted the frequency of various defects at the time of checking the product in ongoing production.Tally Sheet & Tally Mark = Tally Mark fo Defect lame Frequency Fubberpecting HTT HT 11 Blister SeC Laat in ett “atu un wine ae Fold Ply mu sag nikunjbhoranjyp.com Cordsaperation JH | Rough Surface SAT AT 1 fubberseparaion Jaf 11 Benefits: + By using this we can make data gathering simple, systematic, easy and effective ~ We can save time and get easily data collection in regular Manufacturing Process — Itis used for monitoring process performance — We can use this for different purposes like counting, tracking, etc. — Itis also very helpful for traceabilityHistogram in 7 QC Tools — Its a type of bar chart representing the frequency distribution of the data from a process. — Only one parameter can be used for constructing this chart. —+ tis a frequency distribution tool of the Basic 7 QC Tools for the process improvement. — The parameter must be variable data, ie., measured on a continuous scale. (eg. weight, time, temperature, dimensions, speed, etc.) + This tool is used in the DMAIC Methodology of Six Sigma Project Key Concept of Histogram in 7 QC Tools: = The Key Concept is: ~» Data always have a variation ~ Variation has Pattern ~» Pattems can be seen easily when summarized pictorially Steps for construction of Histogram: Seven Steps are mentioned below: 1. Data Collection 2. Compute the Range 3. Determine the numbers of intervals, 4. Determine the interval width, 5. Summarize the record 6. Construct the Graph 7. Analyze the pattern of the chart[01] Data Collection: — For better analysis and forecasting of process collect at least 100 record points. —- Here we take an example of 150 record points for making a chart. Step 1: Collection of Data 796 | 366 | 362 | 367 | 32 | 909 | 277 | 332 | 307 | 305 soa _| 280 | x19 | 293 | a8 | asa | 2aa | a28 | 03 | 393 26 | 25 | 117 | 37a [| 290 | 277 | 290 | ran | soe | 336 335_| a9 [| s12 | aoa | 357 | 302 | sue | 360 | 209 | 201 aca [oan [saa | 302 | 95 | an | 345 | 360 | 301 | 302 soa | 246 | sao | 335 | 297 | ain | asa | 922 | 374 | 300 aco | 0 | 297 [vas [i ses | asa | a7a | st7 | 30s [aaa aa |357_| 333 [oa fang [ato Poaua] aa aso | ans, zs | sae | aa | oe | aaa | aie | ava | ao | ae | sar ua | 207 | a6 | 305 | 2a | ais | 205 | ace | aie | as ace | sea | a6 | 308 | 50 | 223 | a00 | 220 | 352 | 260 200 | 209 | a2 | av | 205 | a7a | ava | 207 | 203 | 202 as2_| 253 | 404 | a76 | 406 | 258 | 265 | 204 | 295 | 274 z7_| 6 | 205 | 957 | 25 | 20 | 422 | 226 | 255 | 277 ae_| 280 | 257 | 205 | 266 | 205 | 26a | a6 | 275 | a16 [02] Compute the Range: — Largest Value = 442 Smallest Value = 204 Range of Values = 442-204 = 238[03] Determine the No. of intervals required: = This step is for determining the no. of intervals required. [04] Determine the interval width: = Step 4 is for determining the width of intervals to construct. Step 3: Determine the no. of . Step 4: Determine Intervals Width Intervals required Data Points | Interval Imerat Range 238 ‘wiath Number of — ~~49 Less than 50 507 intervals 501099 6t010 nikunjbhoraniya.com Round up to (25) [05] Summarize the record: = InStep 5 we will summarize the date es per the interval and count the frequency of data as per range value for construction of the graph.[06] Construct the Graph: — Now we will construct the graph by mentioning the Title, = ¥-axis/Vertical axis = interval width, X-axis/Horizontal axis = interval width, Graph -Trendiine and Legend (if applicable). ‘Step 5: Summarize the data count | 3 | 5 | 7 | 27 36 | 29 e[3]32 Rang [200 to |226to|251 to [276 to value | 225 | 250 | 275 | 300 301 te as | 375 326 te |351 to | 376 to | 401 to |426to aoa | a2s | 450 ‘Step 6: Construct the Graph nikunjb! Histogr No. of Counts (Frequency) Machine Temperature Reading Temperature oraniya.comFive Important Parameters in Histogram: + Title + Y-axis/Vertical axis = Interval width + Xaxis/Horizontal axis = Interval width + Graph- Trendline + Legend (if applicable) + Fora better understanding of these 5 parameters study below chart: Important Nomenclature of Histogram Interval with nikunibhor: ae Temperature Weanls]Morinontal ane = Interval width[07] Analyze the Graph pattern: = Interpretation of the Graph ~ Central Tendency ~» Process Variation ~ Histogram Shape ~+ Process Capability (Comparison with the specification) Types of Histogram Patterns = Various types of Histogram based on patterns are mentioned below = [A] Normal Distribution: ~» Bell Shaped Curve “A peak in the middle = IB] Skewed Distributi + A peak is off-center either right or left ~ Analysis of very pure products is skewed ie. product cannot be more than 100%. ~» The range is not set properly for operationTypes of Histogram Based on Pattern A. Normal Distribution B. Skewed Distribution [0] Double-Peaked / 8-modal: » Two Bell Shaped distributions. » Maybe a combination of records of two processes or two shifts. = [D] Multi Peaked / Multi-modal: + Maybe readings of several processes are plotted on the same graph. + Range selection is not proper.Types of Histogram Based on Pattern C. Double Peaked or Bi-model D. Multi Peaked or Multi-Mode! F alld + Borderline doubt for inspection and take it as ok. + Instrument error. = IE] Edge Peaked: = [Fl Truncated or Heart-cut: » The supplier might mix apart within spec and out of spec. limit. + 100% of Incoming inspection and screening of mixed parts. Types of Histogram Based on Pattern E. Edge Peaked F. Truncated or Heart-cut r Fi Benefits: Summarize Large data set Graphically Confirms measurements to Specification — Excellent problem forecasting tool in the process — Assist to decision making in the ongoing processPareto Chart in 7 QC Tools — It was invented by Mr. Vilfredo Pareto and it is a combination of a bar graph and a line graph. It helps us to prioritization. — Inthis diagram the order of the largest number of occurrences by item or by classes and the cumulative sum total are available. — The bar graph shows the number of defects in descending order and the line graph shows the cumulative percentage of the defect. = Itis the most popular prioritization tool out of 7 OC Tools for Process Improvement. History: — vilftedo Pareto was an ttallan engineer, sociologist, economist, political scientist, and philosopher. + He shows an observation that is: “80% of the land in taly was owned by about 20% of the population. — He introduced the concept of efficiency and helped to develop the field of | = The Pareto principle was named after him. —+He also contributed to the fields of sociology and mathematics. Pareto Principle in 7 QC Tools: = Itis also known as the 80/20 rule, the law of the vital few or the principle of factor sparsity + 80% of the Problems come from 20% of the causes. + 80% of the Output comes from 20% of the Input. = IL Distinguishes between Vital Few from Trivial Many. + 80% of the Results come from 20% of the effortPareto Principle nikunjbhoraniya.com Five Steps for Making a Pareto Chart: 1, Select the problem. 2.Collection of data. 3. Sort data & calculate the cumulative percentage. 4, Draw the axes, bars, cumulative percentage line, and labeling, 5. Identify Priority and plan further action. Step 1. Select the Problem: “+ Select the problem for investigation “+ Determine the data collection method and period of collection. “+ Design a separate Check Sheet if necessary + Eg: Defect analysis.Step 2. Collection of data: “+ The second step is data collection for the graph after the selection of the problem Step 3. Sort data & calculate the cumulative percentage: — The third step is to sort out data and find the cumulative percentage. “+ Refer the below picture for better understanding and clarification Step 2:Collect Data _|[ Step 3: Sort Data And Calculate Cumulative % | [Sr No| Defect Name] No of Defect |<: no Defect Name No of Defect| Cumulative Defect Cumulative Defect %Step 4. Draw the axes, bars, curnulative percentage line, and labeling: — Now, we have to draw the axes, bars, cumulative percentage line and give ttle and labeling to the chart — See the below picture in which all the above things are mentioned. Pareto Chart for Defect Analy: = saan 1 Primary focus J on this Defect ne ge, cow gu mon Sa saws a 4 sane =f =| ner ] oe ‘ eves Name of the Defects Step 5: Identify Priority and plan further action: + Now we analyze the chart and identify Vital Few problems from the Trivi principle and plan further action: = Let's say in our example we are taking defect D, €, F, and defect A for further action because the contribution of these defects is almost around 81%. itis as per 80:20 Rule. + itis not mandatory to take defects up to 80% we can take only the first two defects which contribute around 65% problem. Many by using 80:20— Now we will take action on these defects by finding the root cause with the help of any root cause analysis method (Le. Cause and Effect Diagram or 5 Why analysis) of defect generation and implement preventive action on it. Benefits: We can easily distinguish between Vital Few and Trivial Many. = It displays the relative importance of causes of the problem. = Ithelps the team to focus on those causes that will have the greatest Impact when solved, By using 20% of resources we can solve 80% of problems. — We can easily understand the impact of the defect on our production = Itis very easy for analysis by this tool and also this tool is very useful sigma, QCC, and 70¢ Tools. ‘the various project of six Scatter Diagram in 7 QC Tools — Scatter Diagram is used to study and identify the possible relationship between two variables. —Itis also used to validate the relation between cause and effects and itis also known as the validation tool. —-Scatter Chart in 7 OC Tools is a graph in which the values of two variables are plotted along two axes of the graph, the pattem of the resulting points will say the correlation, We use this chart to find out the relation between cause and its effect by using cause and effect diagram. — This tool ts commonly used in the analyze phase in the Six Sigma Methodology. Examples of the relation between two variables: = Weight and Height of a man. — Hardness and carbon content in the product. = Visual Inspection mistakes and Illumination levels. = Child's height and Father's height. — Curing Temperature and Curing Time. — Advertising and sales. Steps for Making a Scatter Graph: 1. Data Collection 2. Choose Independent and Dependent variables. 3. Construct the Graph and add the titles & trend line, 4. Interpret the GraphStep 1. Data Collection: Now we are taking one example to understand how to make a chart? — Inthis example, we are taking 50 readings of different curing temperatures on different curing time for a product manufactured on the thermosetting press. we want to find out the relation between curing time and curing temperature. —-We have to find is any correlation is present or not between curing temperature and curing time. — If we have more data sample then it will give a more precise result. Data Collection for Validation Curing] Curing Tine Curng | Curing Tine 5% HTempertue (‘| (Second) |S" [Temperature(C)| (Second) maz e200 ZF 32 2 [220 [ar [26 32, sma zm za |Z 5 am| eT ream || Zz 35 s [a2 33 | 30 | _228 3a Sle rm || a= 3a a San || EZ 33 =| 208 a [as | 2 30 es 23 10_| 210 a [3s | 245, 2 [210 a [36 | 245, 2 za sea | a7 | 205 2 13 | 208 a5__[ 38 | 247 21 aa_[ 204 [39 | 237 26 [208 a [a0 240 2 36_[_205 aa | 235 30, | roe mar |Z 2 aa[ 218 a7 [aa [2a 28 a9 [219 asf [2a 27 20_[ 319 asf as | 26 26 za | 201 a5 [46 | 23 3 Z| 202 tee 5 a | ae 38 rz 78 can |Z 38 2a | 28 2 pas | 28 37 25 | 28 a. [so | 29 2Step 2. Choose Independent and Dependent Variables: = The dependent variable is usually plotted along the vertical axis Le. In Y-axis and its called a measured parameter. — The independent variable is usually plotted along the horizontal axis control parameter, — In this case, we are taking heating temperature as an independent variable on the x-axis and curing time is dependent on heating temp. so we mentioned it on the y-axis. in X-axis and itis called a Step 3. Construct the Graph and add the titles & trend line: — Now based on recorded data construct a graph and add a suitable title, horizontal axis name, vertical axis name, and make trend line. 2 nikunjbhoraniya.com Heating temperatureStep 4. Interpret the Graph — We will interpret the chart based on the trend line. Types of Correlation in Scatter Diagram in 7 QC Tools: — There are many different types of correlation found between the Independent and Dependent. variables which are mentioned below with pictorial representation. Mainly three relations available between two variables we can say that Strong, Moderate and No Relation. —-A strong positive correlation means it's a clearly visible upward trend from left to right, a strong negative correlation means itis a clearly visible downward trend from left to right. eg. In positive relation, as the vaiue of x increases, the value of y will also increase we can say that the slope of the straight line drawn along the data points will go up and the pattern will resemble the straight line. For example, in the summer season the temperature increase, icecream sales will also increase, — Anegative correlation, as the value of x increases, the value of y will decrease and the slope of a straight line dravin along the data points will go down, —-For example, in the summer season the temperature increase, the sales of winter coats decrease. A weak correlation means itis less clear that the relation is either positive or negative? —-No correlation means neither positive nor negative relation and indicates the independent variable does not affect the dependent variable. — Examples of correlation: ~» (1) Strong Positive + (2) Moderate Positive + (3) Weak Positiveje Co-relation between two variable » (4). Strong Negative + (5). Moderate Negative » (0). Weak Negative + (7). Random Pattern Random & Negative Co-relation between two variable nikunjbhordfiya.com STRONG NEWATIVE [NODERATE NUEATIVE WHAK NGATIVE RANDOM PATTERN Benefits of Scatter Diagram: —It is beneficial to confirm a hypothesis (assumption) between two variables that are related or not. + Provide both visual and statistical means to test the strength of a potential relationship. Its @ very good validation tool. — Used for proving the relation between cause and effect — Plotting the diagram is relatively simple. Limitation: — It does not show you the quantitative measure of the relationship between the variable. = This chart does not show you the relationship for more than two variables ata time,Control Chart in 7 QC Tools “+ Itis a statistical tool used to differentiate between process variation resulting from a common cause & special cause. + The Control Chart in 7 QC Tools is a type of run chart used for studying the process variation over time. — This is classified as per recorded data is variable or attribute. — In our business, any process is going to vary, from raw material receipt to customer support. —+Machines have wear, tear, and matfunction and tear after a long run. — Control charts measure variation and show itto you graphically and we can easily say that itis, within an acceptable limit or not? —+ Many processes can be tracked by this graph like defects, production time, inventory on hand, cost per unit and other metrics. Also, we can use this graph to measure nonmanufacturing processes like billing errors, missed ‘eppointments, customer support calls bill payment dues, days between billing and payment, expenses, on-time delivery failure, unplanned absences, etc History: = Iwas invented by Dr. Walter A. Shewhart working for Bell Labs in the 1920s. — So this is called “Shewhart Control Charts". — The compeny's engineers had been seeking to improve the reliability of their telephony transmission systems. = Because amplifiers and other equipment had to be buried underground, there was a stronger business needs to reduce the frequency of failures and repairs. + By 1920, the engineers had already realized the importance of reducing variation in the ‘manufacturing operation.Principles of variatio: —+ Every process has variation + More the variation, the more loss to the Organization. “+ Two types of causes are responsible for the variation. (1) Common cause (2) Special cause Action depends on the type of caust [1] Common Cause: "Common cause is fluctuation caused by unknown factors resulting in a steady but random distribution of output around the average of the data” + eg. the rubbing effect of matting part like gears, bearings, etc... [2] Special Cause: + "Special cause is caused by known factors that result in a non-random distribution of output" “+e. machine breakdown, accident, etc... ‘Types of data: — There are two types - Attribute and Variable [1] Attribute: ~» Attribute data that can be counted or can glve an answer In GO/No Go, OK/Not OK or Pass/Fall ~» €g, aesthetic look of product ok or not ok [2] Variable: ~+ Variable data can be measured. ~+ e.g, Weight, Height, Length, Hardness, Diameter, AngleTypes of the Control Chart: — There are many types of control charts are available in Statistical Process Contiol. + The classification depends on the below parameters. ~» Nature of recorded data type such as variable or attribute ~» The number of samples is available in each subgroup or we can say subgroup size. ~» Focus on defects (occurrence) or defectives (pieces or units) ~» The subgroup size is equal or not? — For better understanding refer below picture whi classification. is very easy to understand with the help of n_of Control Chart Classifice:Steps for making Control Chart: — Here we take an example of the most common (X-Bar, R chart) To understand this example we are taking variable date and subgroup size-5 as per the classification mentioned above —We can easily construct (X-Bar, R chart) in simple 8 steps which are mentioned below: 1. Collect the data, 2. Calculate the subgroup average. 8, Determine the overall average. 4, Calculate the range, ‘5. Compute the average of the range. 6. Calculate the control limit 7. Plot the data in the graph. 6. Interpret the Graph. Step 1: Collect the data: Record the readings and stratify it into subgroups as per our sampling plan and record itin the Check Sheet. Step 2: Calculate the subgroup average: — In the second step, we find the individual sub group's average os per the formula mentioned in theStep 3: Determine the overall average X-double bar: —Here we find the overall average by using all sub group's individual average. Step 1: Data Collection Step 3: Calculate Overall Average n lm XD4X20x34X40XS, Where n = Nos. of Sample in one Subgroup. seme tg |e | oo | me | os = Xi+ ¥2+ ¥: ur y= Sek z wfaw | a | o | oe 35.64+29.2+22.2+39.2438.8 3 ~ {uw fu | a 5 + | #2 |# | | *| | ~23 | [Where k= Nos. of subgroupsin test. nikunjbhoraniya.com Step 2: Calculate the Subgroup Average Y= 47432+44435+20 Y1-35.6 5 Step 4: Calculate the subgroup Range (R): — In the fourth step, we find the individual sub group's range as per the mentioned formula.Step 5: Calculate the Average Range (R-bar): — Here we find out the average range of all individual subgroups range. Step 4- Calculate Range of Subgroup Step 5: Calculate R-Bar Samples xa | x2 | x3 | xa | x5 Sub-groups: 1 a7 | 32 | a4 | 35 | 20 2 a9 | 37 | 31 | 25 | 34 3 29 | aa | as | aa | a0 4 28 | 29 | a2 | 59 | 38 5 22 | 20 | ao | as | 57 YR = Maximum value - Minimum value ¥ Ry=47-20 -27 Step 6: Calculate the control limit R1+R2+R3+R4+R5 k R 27+18+33+314+35 5 R=288 pete eee seers et nikunjbhoraniya.com —Inthis step, we find the limit of the X-bar and R chart with the below-mentioned formula.In this step, we find the limit of the X-bar and R chart with the below-mentioned formul Step 6: Calculate Control Limits * Conmat tint fr X]<¥0" | Posteo Limits for X-Bar Chart 2) Contral line =" ») Upper eontrottimit = UCLe =X + A2R ) Lower controllimit = CLs =X - ALR — Different Constants value are mentioned in below pictures which is very Important for the Graph: = The source of this constant valueis the AIAG-SPC_ handbook.Constant values for Control Chart fomptes incest) gp a2 E D3 pa 2 sub groupe 2 aize_| 1.880 ° 3.267 | 2660 3 1.693 | 1023 © 2874 | 1.772 4 2.059_| 0.729 © 2282 | 1.457 5 2.326 | 0577 © 2.114 | 1.280 6 2534 | 0.483 © 2.006 | 1.184 7 2.704 | 0419 =e 0.076 | 1.924 | 1.109 8 2.807 | 0373 0.136 | 1.864 | 1.054 9 2970 | 0337 0.184 | 1.816 | 1010 10 3.078 | 0308 “Ge 0.223 | 1.777 | 0975 Step 7: Plot of the data: = Vertical axis: X-Bar and R values. — Horizontal axis: subgroup number. — Draw the central line: X-double bar and R-bar —- Draw all control limits UCL & LCL. —+ Plot the X-Bar and R values and join the points. — Write necessary items like the name of the operation, product, size of the subgroup, work conditions, shift, etc. = IA] Example of X Bar and R Chart:Example of X-bar & R-chart eee eee ikonybhoraniye.com|* Aare NUMBER (NO OF SUB OXOUP) ‘SAMPLE NUMBER (NO OF SUB GROUP) Step 8: Interpret the Graph: [A] Process stability: + Look at the pattem of variation. It should be random and not a systematic pattem. ~ Look for the presence of special causes. + For detailed information, go through these 8 rules of special cause identification[B] Process capability: + Compare with specification and establish Process Capability e.g. are our processes capable enough to achieve customer's specifications? Benefits: + This chart gives information about the common causes and special causes. “+ It also helps in determining whether the Process is capable or not & stable or not? so, we can get the information about the behavior of the process. “+ It helps in predicting operation performance. + It makes possible to implement substantial Quality Improvement. Cost of Quality vs Cost of Poor Quality | COQ.vs COPQ What is the Cost of Poor Quality (COPQ)? —Itis the cost related to providing poor quality products or services. in easy words, we can say that itis the total financial losses incurred by the company due to doing the wrong things. —-COPQ Is the cost that would disappear if in smooth operating conditions. — It is a refinement of the concept of COQ, + COPQis the hidden cost because most of the organizations do not have a proper method of the ‘assessment of COP and hence they do not know how much money they can earn by reducing cora. Examples: = Repair = Rework —+ Scrap Warranty failure — Wastes of ManufacturingWhat is the Cost of Quality (COO)? C00 is the cost of achieving Quality Products or Services + COQ = Costs of Achieving Good Quality + COPQ + Most of the people think that higher quality requires higher costs, which Is due to buy better materials or machines or by hiring more labor but this is not true in actual. + Itis a methodology that allows an organization to determine that its resources are used for activities that prevent poor quality Examples: > Training and motivational activity = Vendor evaluation, vendor development — Process Capability Study of machines + Calibration of measuring devices and equipment = Incoming material inspection = Stage inspection — Final inspection, etcClassification: = = Ly a fa = oa = | 3 = a = =| [A] Prevention Cost: — Prevention Is incurred to prevent or avold problems related to products or services. = This is associated with the design, implementation, and maintenance of the QMS. = They are planned and incurred before the actual operation, and they could include it. Examples: 111 Planning ~ This is related to the creation of plans for quality, reliability, operations, production, and inspection [2] Training and development of the workforce [3] Product or service requirements ~ The establishment of specifications for incoming materials, processes, and finished goods [4] Assurance ~ The creation, and maintenance of the system that assures the defect-free output after each operation until the end.(B] Appraisal Costs: — An appraisal is associated with measuring and monitoring activities. = This is associated with the suppliers’ and customers’ evaluation of purchased materials, processes, goods, and services to ensure that they conform to specifications. Examples: [1] Verification: ~ Itis related to checking of incoming material, process setup, and finished good output as per agreed specifications [2] Audits: + The audit is the confirmation that the quality system is functioning correctly [3] Supplier assessment related to the assessment and approval of suppliers. [4] Test and inspection of purchased materials [5] Acceptance testing [6] Inspection 7] Testing and inspection of equipment, etc. {C] Internal failure: — Internal failure is related to the remedy of defects discovered before the product or service is delivered to the customer. = This occurs when the resuits of work fall to meet the agreed specttications and are detected before they are dispatched to the customer. Examples: [1 Rework: ~» If a product or service is not made or supply right the first time, then we try to correct it instead of ‘scrap it. The cost related to do this activity is called rework. This includes additional labor hours/ ‘machine hours for correct work and (wherever rectification requires material) sometimes additional ‘material and process, too. [21 Rejection or Scrap: ~» Consider another case where a finished good or service hasrit been made right the first time and also it is not reworkable or repairable. in such a case, we have no other choice apart from scrap it. ~~» In simple language, the scrap is defective product or material that cannot be repaired, used or sold [al waste: ~» The waste is the performance of unnecessary work or holding of stack as a result of errors, poor organization, or communication. [4] Failure analysis ~» Failure activity is required to establish the causes of an internal failure.(D] External failure: — Extemal failure is incurred to remedy defects discovered by customers. — This occurs when products that fail to reach design quality standards are not detected until after transfer to the customer. Examples: [1] Warranty repairs and replacement: ~ ifthe product falls during the warranty petiod, an attempt is made to repair it and make it functional. If the product is not repairable then we have to replace it with the one. It's @ loss of the organization. [2] Compiaints: ~All work and costs associated with handling and servicing customers’ complaints, ~» Returns - handling and investigation of rejected or recalled products, including transport charges. COPQ Calculation: = Now" we will take one example of COPQ calculation in a tire manufacturing company you can apply the same concept for any organization. For better understanding refer the below picture in which the various costs mentioned related to various COPQ activity.Example of COPQ Calculation COPQ Calculation Cost for Failure or loss Amount _| % COPQ IScrap due to defect $3,250.00 | 133% |Rework & Repair $45,000.00 | 18.42% [Warrenty Failure $56,500.00 | 23.13% IMaterial Waste during Production | $38,550.00 | 15.78% [Total $143,300.00 | 58.66% Cost of appraisal Amount | %COPQ lincorming inspection $22,500.00 | 9.21% linprocess Inspection $35,250.00 | 14.43% lPre Dispatch inspection $28,000.00 | 11.46% [Total $85,750.00 | 35.10% Cost of Prevention Amount % COPQ Performance testing destructive $15,250.00 | 6.24% [Total $15,250.00 | 6.24% Grand Total $244,300.00 the help of COPQ analysis, we can prioritize the major cost spending area with the help of the Pareto Chart. Then we can find the root cause by Cause and Effect Diagram behind the cost spending ‘and we can improve our efficiency and effectiveness.Key Points To Minimize COPQ: 1. Traceability 2. Nonconformity and Corrective Action 3, Machine and Instrument Maintenance 4. intemal Audit ‘5. Change Management 6. Customer Complaints Management 7. Supplier improvement Program ©. Training and Empowerment of Employees [1] Traceability: — If we want to reduce the COPQ then traceability is one of the most important parameters that we have to maintain for our product and process. = Without proper traceability, the organization faces problems like delays, defects, and recalls, etc. —It possible then itis better to implement the Poka-Voke System within traceability from production to delivery. So we can easily view and access details on production location, time of production, warehouse, labeling and packaging. and delivery related information.[2] Nonconformity and Corrective Actio1 + Implement strong correction action for each and every nonconformities without any delay. + The nonconformities may be in any form like production deviations, errors in specifications, or customer complaints, etc. Record and maintain all action was taken on nonconformities like containment action taken, rework, replacement, discounts, or recall, etc. — We can use below standard methodologies for root cause and corrective action: ~» 8D Problem Solving Method 5S Methodology ~» Swhy ~» Cause and Effect Analysis ~+ FMEA, etc. [3] Machine and Instrument Maintenance: — Various maintenance processes of vario. conformity of our products continuously. + Maintenance activity also reduces the losses and minimizes the failure So it maintains a smooth process flow. instruments and machines will help us to give [4] Internal Audit: = Internal audit is important for organizations to keep a record of non-conformities and corrective actions. = This helps us to identify loopholes in our system which can be eliminated from the system. = We can implement various audits like factory audits, process aucits, facility audits, QMS audits, and health & safety audits, which helps in boosting the performance of the organization. [5] Change Management: — Change management is also very important for the organization it can be any change related to technology, culture, operation, system, process, etc. — Successful change management depends on strong leadership and clear policies of the organization. — Also, we have clear visibility into the whole process, including change history, data on the changes. made, the status of change made, and departments or areas affected, etc.[6] Customer Complaints Management: — Effective customer complains handing without any delay help us to satisfy our customer so we have a happy customer. — The happy customer gives us repetitive bust line, —Also, ensure that the same compliant will not repeat twice. 8 and it will ncrease our top line as well bottom [7] Supplier Improvement Program: — The supplier's improvement program automatically improves our products. —Ithelps us reduce our COPQ by maintaining smooth process flow and elimination all Wastes of Manufacturing and Supply chain. [8] Training and Empowerment of Employees: — The training and empowerment of employees also reduce COP of our organization. — By providing periodic awareness sessions, training sessions, and evaluation for the same upgrade the knowledge of the employees and it boosts the performances. —-We can evaluate the effectiveness of the training by test, questionnaires, and by giving the practical tasks. —-We can also apply the same forall stakeholders.Step 6: Interpreting the results: — You must have variance in the parts and in the appraisers to calculate the above numbers. + We have to check TV to decide that our measurement system is applicable or not? % AV = 100(AV/TV) = 100(0.235/0.9285) = 25.3% % GRR = 100(GRR/TV) = 100(0.319/0.9285) = 34.37% '% PV = 100(PV/TV) = 100(0.872/0.9285) = 93.9% + The number that most people focus on first is the % GRR. — The following guidelines can be used to determine if the measurement system is acceptable, conditionally acceptable or not acceptable. = Green: GRR %< 10% of TV (Measurement system is acceptable) = Yellow: GRR % = 10-30% of TV (Conditionally acceptable based on the application) = Red: GRR % > 30% of TV (Measurement system needs improvement)FMEA | What is FMEA (Failure Mode and Effects Analysis)? FMEA | What is FMEA (Failure Mode and Effects Analysis)? What is FMEA (Failure Mode and Effects Analysis)? +"FMEA (Failure Mode and Effects Analysis) is an Analytical Technique that combines the technology and Experience of People in identifying predictable failure modes of a Product or Process and pianning for its eimination." > FMEA can be expiained as a group of activities intended to: 1. Recognize and evaluate the potential failure of a product or process and its eftects. 2. Identify actions that could eliminate or reduce the chance of potential failures. 3. Document the Process. — Fallure move and effects analysis is a rigorous step-by-step process, to identiying all possible failures in a design, manufacturing, assembly process, product or service.\ FMEA drives systematic thinking about a product or process by asking and attempting to answer three basic questions: 1. What coula go wrong (failure) wth a system or process? 2. How bad can it get (risks), something goes wrong (als)? 3. What can be done (corrective action) to prevent things from going wrong (failures)? “> FMEA attempts to Identify and prioritize potential process or system failures and the failure is rated on three criteri 1. The impact of a failure ~ Severity 2. The frequency of the causes of ine failure — Occurrence 8. How easy is it to detect the cause of failure - Detection = Itis an Analyiical Technique that combines the technology and Experience of People in identifying predictable fallure modes of @ Product or Process and planning for its elimination. — Itwas made from two different words as mentioned below: + Failure modes" means the ways, or modes, in which something might fai. = Failures are any errors or defects, especially ones that affect the customer and can be potential or actual, + “Effects analysis” refers to studying the consequences of those failures.History of FMEA (Failure Mode and Effects Analysis): — Procedures for conducting FMEA were described in US Armed Forces Military procedures document MIL-P-1629 in (1949) — By the early 19605, contractors for the U.S National Aeronautics and Space Administration (NASA) were using variations of FMEA under a variety of names. — NASA programs using Failure Mode and Effects Analysis variants included Apollo, Viking, Voyager, Magellan, Galileo, and Skylab. oe= The civil aviation incustry was an early adopter of Failure Mode and Effects Analysis, with the Society for Automotive Engineers (SAE) publishing ARP926 in 1967. INTERNATIONAL. —+ During the 1970s, the use of FMEA and related techniques spread to other industries. In 1971 NASA prepared a report for ihe U.S Geological Survey recommending the use of Failure Mode and Effecis Analysis in the assessment of offshore petroleum expioration, = The automotive industry began to use it by the mic-1970s. + The Ford Motor Company introduced Falure Mode and Effects Analysis to the automotive industry for safety and regulatory consideration, r — In 1993, the Automotive Industry Action Group (AIAG) first published a Failure Mode and Effects Analysis siandard for the automotive. | AIAG 2a Insight. Expertise. Results.— Failure Mode and Effects Analysis manual is now latest available in its fourth edition eee Ly aire ae ea aa Fourth Edition — The SAE tirst published related standard J1739 In 1994. — This standard is also now in its fourth editionChanges in FMEA Manual in 4th Edition: —+ An improved format, easier to read. + Better examples to improve utility. = Reinforces need for management support — Strengthens linkage between DFMEA / PFMEA. — Ranking tables better reflect real-world use. = Introduces alternative methods in use. — Suggests better means than RPN to assess risk. —+ Recommends threshold RPN values to initiate the required action When to do Failure Mode and Effects Analysis? = Itis a live document = Throughout the product development cycle. the FMEA is changed and updated as appropriate when ihe product and process changed > These changes can introduce new failure modes. — We can begin as soon as a project is selected for a certain Process, System or Design.» Review and/or updating of the FMEA: — FMEA Should be revised as improvement or changes made to a process. — A new product, process or service Is being initiated (at the beginning of the cyc'e). — When an existing process, product or service Is being applied in a new way. = Before developing control plans for a new or modified process. — When improvement goals are planned for an existing process, product or service. — Changes are made to the operating conditions the product, process or service. — When analyzing failures of an existing process, product or service. — When the product design is changed the process is impacted and vice-versa. — Periocically throughout the Ife of the process, product or service = New regulations are instituted — Customer feedback indicates problems in the product or process. » Who does an FMEA (Failure Mode and Effects Analysis)? — This is a Team Process. — Team sizes may vary, but the recommenced size Is approximately 5 to 7 members — Depending upon the type of FMEA being done, members may come trom. ‘* Research and Development + Manufacturing ‘Testing & Validation « Human Resources Maintenance Supplier « Quaity Department « hlarketing & Sales ete» Four Common Classes of FMEA: ‘* System FMEA — Focuses on how interactions among systems might fal ‘= Design FMEA — Focuses on how product design might fal = Process FMEA — Focuses on how processes that make the product might fail. © Equipment FMEA — Focuses on how machinery that performs processes might fail Benefits of FMEA (Failure Mode and Effects Analysis): —+ Improve product or process quailty, reliabilty, and cost-effectiveness. —rItincreases customer satisfaction — Decrease inhouse defects and line stoppage issues — Early identification and elimination of potential faiure modes related to product or process = Ithelps to prioritize product or process deficiencies = FMEA improves engineering and organization knowledge: + Itemphasizes problem prevention rather than detecton = IIs an important too! for risk assessment and actions taken for reducing the risk — FMEA Is a catalyst for teamwork and idea exchange between functions MSA | Measurement System Analysis | Tutorial | Examples What is MSA? —+ The full name is a Measurement System Analysis. —A measurement system measures the quantification (data, number, or reading) of particular characteristics of any object. It also includes a combination of gages, fixtures, software, and personnel required to measure the characteristics of any object. — For better understanding, we are taking an example if wwe want to measure the weight of the product then the combination of operator, weighing scale, and our product is the whole measurement system. — Let us take another example if the weight of the product is automaticelly measured on a conveyer belt and recording in software in this example measurement system includes the product, software, and conveyer. —+MSA is a Statistical Tool that is used to determine if this system is capable or not?Basics of Measurement System Analysis: In our daily life, we are using more and more data for analysis so data has more value and day by day itis increasing. —This data use for decision making. If the collected data has an error due to measurement system, error then there may be a chance of wrong decision making. To avoid this problem MSA can help us to build a strong system for our data-based decision- making process. We use various measuring instruments & gauges to judge the dimensional quality of incoming, In- Process and Finished Production parts. — These gauges and instruments have to be Precise and Accurate to give results of a higher confidence level. — To build this confidence, we have to calibrate these gauges/instruments periodically to achieve ‘Accuracy and Precision. ‘a measuring process are due to the below factors: ~» Personnel -» Tools, Equipment, Gauges, Instrument, Fixtures, etc -» Product to be measured -» Environmental (e.g. temperature, humidity, etc.) ‘= Below measuring instrument has a definite numerical scale to measure the numerical dimensions of the component. 4g, Vernier, Micrometer, Dial indicator, Height Gauges... Vernier: Range: 0 - 200 mm L.C: 0.02mm; 0.01mm, — Micrometer : Range: 0-25; 25 - 50 L.C:0.01mm; 0.001mm = "Resolution’ is the ability to detect small changes. = "Sensitivity’ is the smallest amount of difference in a quantity that will change an instrument's, reading. —E.g. ameasuring tape have a resolution, but not sensitivity and an analytical balance have both resolution and sensitivity = While selecting equipment, the following basic points need to be considered: ~» Range, -» Least Count, -» Accuracy and other relevant factors shall be considered. = If we have a tolerance of 0.100 of a component, we should use the instrument with a Least Count of 0.010 mm. (which means the least count of the instrument should be 1/10th the tolerance range.)Terminologies used in Measurement System Analysis: = There are certain terminologies that should be understood for better use of Gauges and Instruments which is mentioned below Precision and Accuracy = Bias, Linearity,and Stability = Repeatability and Reproducibility Terminologies used in MSAWhy MSA is required? — Its required to understand the impact of these measurement systems on your operations. It is extremely important in the Continuous Improvement of the process. + We must measure to know where we are. — For measurements to be effective, they must be timely, acourate, and precise. — Many of our customers, both internal and external, rely on our measurements. We can get a Good Quality Product, The Measurement System Analysis includes: + The SWIPE is included and the full name is mentioned below 1. Standard 2. Work Piece 3. Instrument 4, Personnel / Procedure to use equipment 5. EnvironmentSWIPE in MSA nikunjbhoraniya.com = MSA deals with analyzing the effect of the Measurement system on the measured value. = ILemphasis on the effect due to equipment & personnel We test the system to determine the numerical values of its statistical properties and compare them to Accepted Standards The objective of MSA: To determine how much erroris in the measurement due to the measuring process itself and quantifies the variability added by this system. — Applicable to attribute data and variable data. — Itreduces the likelihood of passing a bad part or rejecting a good part. = Types of MSA Study: ~» Variable GR&R Study ~+ Attribute GRR StudyFMEA | What is FMEA (Failure Mode and Effects Analysis)? FMEA | What is FMEA (Failure Mode and Effects Analysis)? What is FMEA (Failure Mode and Effects Analysis)? +"FMEA (Failure Mode and Effects Analysis) is an Analytical Technique that combines the technology and Experience of People in identifying predictable failure modes of a Product or Process and pianning for its eimination." > FMEA can be expiained as a group of activities intended to: 1. Recognize and evaluate the potential failure of a product or process and its eftects. 2. Identify actions that could eliminate or reduce the chance of potential failures. 3. Document the Process. — Fallure move and effects analysis is a rigorous step-by-step process, to identiying all possible failures in a design, manufacturing, assembly process, product or service.\ FMEA drives systematic thinking about a product or process by asking and attempting to answer three basic questions: 1. What coula go wrong (failure) wth a system or process? 2. How bad can it get (risks), something goes wrong (als)? 3. What can be done (corrective action) to prevent things from going wrong (failures)? “> FMEA attempts to Identify and prioritize potential process or system failures and the failure is rated on three criteri 1. The impact of a failure ~ Severity 2. The frequency of the causes of ine failure — Occurrence 8. How easy is it to detect the cause of failure - Detection = Itis an Analyiical Technique that combines the technology and Experience of People in identifying predictable fallure modes of @ Product or Process and planning for its elimination. — Itwas made from two different words as mentioned below: + Failure modes" means the ways, or modes, in which something might fai. = Failures are any errors or defects, especially ones that affect the customer and can be potential or actual, + “Effects analysis” refers to studying the consequences of those failures.History of FMEA (Failure Mode and Effects Analysis): — Procedures for conducting FMEA were described in US Armed Forces Military procedures document MIL-P-1629 in (1949) — By the early 19605, contractors for the U.S National Aeronautics and Space Administration (NASA) were using variations of FMEA under a variety of names. — NASA programs using Failure Mode and Effects Analysis variants included Apollo, Viking, Voyager, Magellan, Galileo, and Skylab. oe= The civil aviation incustry was an early adopter of Failure Mode and Effects Analysis, with the Society for Automotive Engineers (SAE) publishing ARP926 in 1967. INTERNATIONAL. —+ During the 1970s, the use of FMEA and related techniques spread to other industries. In 1971 NASA prepared a report for ihe U.S Geological Survey recommending the use of Failure Mode and Effecis Analysis in the assessment of offshore petroleum expioration, = The automotive industry began to use it by the mic-1970s. + The Ford Motor Company introduced Falure Mode and Effects Analysis to the automotive industry for safety and regulatory consideration, r — In 1993, the Automotive Industry Action Group (AIAG) first published a Failure Mode and Effects Analysis siandard for the automotive. | AIAG 2a Insight. Expertise. Results.— Failure Mode and Effects Analysis manual is now latest available in its fourth edition eee Ly aire ae ea aa Fourth Edition — The SAE tirst published related standard J1739 In 1994. — This standard is also now in its fourth editionChanges in FMEA Manual in 4th Edition: —+ An improved format, easier to read. + Better examples to improve utility. = Reinforces need for management support — Strengthens linkage between DFMEA / PFMEA. — Ranking tables better reflect real-world use. = Introduces alternative methods in use. — Suggests better means than RPN to assess risk. —+ Recommends threshold RPN values to initiate the required action When to do Failure Mode and Effects Analysis? = Itis a live document = Throughout the product development cycle. the FMEA is changed and updated as appropriate when ihe product and process changed > These changes can introduce new failure modes. — We can begin as soon as a project is selected for a certain Process, System or Design.» Review and/or updating of the FMEA: — FMEA Should be revised as improvement or changes made to a process. — A new product, process or service Is being initiated (at the beginning of the cyc'e). — When an existing process, product or service Is being applied in a new way. = Before developing control plans for a new or modified process. — When improvement goals are planned for an existing process, product or service. — Changes are made to the operating conditions the product, process or service. — When analyzing failures of an existing process, product or service. — When the product design is changed the process is impacted and vice-versa. — Periocically throughout the Ife of the process, product or service = New regulations are instituted — Customer feedback indicates problems in the product or process. » Who does an FMEA (Failure Mode and Effects Analysis)? — This is a Team Process. — Team sizes may vary, but the recommenced size Is approximately 5 to 7 members — Depending upon the type of FMEA being done, members may come trom. ‘* Research and Development + Manufacturing ‘Testing & Validation « Human Resources Maintenance Supplier « Quaity Department « hlarketing & Sales ete» Four Common Classes of FMEA: ‘* System FMEA — Focuses on how interactions among systems might fal ‘= Design FMEA — Focuses on how product design might fal = Process FMEA — Focuses on how processes that make the product might fail. © Equipment FMEA — Focuses on how machinery that performs processes might fail Benefits of FMEA (Failure Mode and Effects Analysis): —+ Improve product or process quailty, reliabilty, and cost-effectiveness. —rItincreases customer satisfaction — Decrease inhouse defects and line stoppage issues — Early identification and elimination of potential faiure modes related to product or process = Ithelps to prioritize product or process deficiencies = FMEA improves engineering and organization knowledge: + Itemphasizes problem prevention rather than detecton = IIs an important too! for risk assessment and actions taken for reducing the risk — FMEA Is a catalyst for teamwork and idea exchange between functions MSA | Measurement System Analysis | Tutorial | Examples What is MSA? —+ The full name is a Measurement System Analysis. —A measurement system measures the quantification (data, number, or reading) of particular characteristics of any object. It also includes a combination of gages, fixtures, software, and personnel required to measure the characteristics of any object. — For better understanding, we are taking an example if wwe want to measure the weight of the product then the combination of operator, weighing scale, and our product is the whole measurement system. — Let us take another example if the weight of the product is automaticelly measured on a conveyer belt and recording in software in this example measurement system includes the product, software, and conveyer. —+MSA is a Statistical Tool that is used to determine if this system is capable or not?Basics of Measurement System Analysis: In our daily life, we are using more and more data for analysis so data has more value and day by day itis increasing. —This data use for decision making. If the collected data has an error due to measurement system, error then there may be a chance of wrong decision making. To avoid this problem MSA can help us to build a strong system for our data-based decision- making process. We use various measuring instruments & gauges to judge the dimensional quality of incoming, In- Process and Finished Production parts. — These gauges and instruments have to be Precise and Accurate to give results of a higher confidence level. — To build this confidence, we have to calibrate these gauges/instruments periodically to achieve ‘Accuracy and Precision. ‘a measuring process are due to the below factors: ~» Personnel -» Tools, Equipment, Gauges, Instrument, Fixtures, etc -» Product to be measured -» Environmental (e.g. temperature, humidity, etc.) ‘= Below measuring instrument has a definite numerical scale to measure the numerical dimensions of the component. 4g, Vernier, Micrometer, Dial indicator, Height Gauges... Vernier: Range: 0 - 200 mm L.C: 0.02mm; 0.01mm, — Micrometer : Range: 0-25; 25 - 50 L.C:0.01mm; 0.001mm = "Resolution’ is the ability to detect small changes. = "Sensitivity’ is the smallest amount of difference in a quantity that will change an instrument's, reading. —E.g. ameasuring tape have a resolution, but not sensitivity and an analytical balance have both resolution and sensitivity = While selecting equipment, the following basic points need to be considered: ~» Range, -» Least Count, -» Accuracy and other relevant factors shall be considered. = If we have a tolerance of 0.100 of a component, we should use the instrument with a Least Count of 0.010 mm. (which means the least count of the instrument should be 1/10th the tolerance range.)Terminologies used in Measurement System Analysis: = There are certain terminologies that should be understood for better use of Gauges and Instruments which is mentioned below Precision and Accuracy = Bias, Linearity,and Stability = Repeatability and Reproducibility Terminologies used in MSAWhy MSA is required? — Its required to understand the impact of these measurement systems on your operations. It is extremely important in the Continuous Improvement of the process. + We must measure to know where we are. — For measurements to be effective, they must be timely, acourate, and precise. — Many of our customers, both internal and external, rely on our measurements. We can get a Good Quality Product, The Measurement System Analysis includes: + The SWIPE is included and the full name is mentioned below 1. Standard 2. Work Piece 3. Instrument 4, Personnel / Procedure to use equipment 5. EnvironmentSWIPE in MSA nikunjbhoraniya.com = MSA deals with analyzing the effect of the Measurement system on the measured value. = ILemphasis on the effect due to equipment & personnel We test the system to determine the numerical values of its statistical properties and compare them to Accepted Standards The objective of MSA: To determine how much erroris in the measurement due to the measuring process itself and quantifies the variability added by this system. — Applicable to attribute data and variable data. — Itreduces the likelihood of passing a bad part or rejecting a good part. = Types of MSA Study: ~» Variable GR&R Study ~+ Attribute GRR StudyPPAP | Production Part Approval Process | Excel Templates PPAP (Production Part Approval Process): — PPAP is the Production Part Approval Process. —Itis a very important tool for establishing confidence in product suppliers and their production processes” ISO 9001:2015 and LATE 16949:2016 is used to formally reduce risks prior to product or service release, in a team-oriented manner, using well-established tools and techniques. — Initially developed by AIAG (Automotive industry Action Group) in 1993 with input from the Big 3 - Ford, Chrysler, and GM —- AIAG's Ath edition effective June 1, 2006, is the most recent version of the PPAP. — PPAP has now spread to many different industries beyond the automotive and it provides evidence that all customer design record and specification requirements are properly understood by the organization. + To demonstrate that the manufacturing process has the potential to produce the product that, consistently meets all requirements during an actual production run at the quoted production rate.When is PPAP Required? — PAP is required at the time of new product development —Itis required at the time of Engineering change(s) = Tooling: transfer, replacement, refurbishment, or additional = Correction of discrepancy = Itis required at the time of Tooling inactive > one year, — Change to optional construction or material — Sub-supplier or material source change — Parts produced at a new or additional location Benefits of PPAP Submission: — PPAP helps to maintain design integrity = Identifies issues early for resolution — Reduces warranty charges and prevents the Cost of the Poor Quality — Assists with managing supplier changes — It prevents the use of unapproved and nonconforming parts — Identifies suppliers that need more development — Improves the overall Quality of the Product & customer satisfaction What is Run @ Rate in PPAP: — The purpose of a Run @ Rate is to verify the supplier's manufacturing process is capable of. producing components. — Successful Run @ Rate means it meets Your Company's Quality Requirements, at quoted tooling capacity, fora specified period of time. = Verification of the Run @ Rate will be at the Supplier Quality Engineer's (SQE) discretion. > The supplier will be notified of the need to perform a Run @ Rate as early in the process as possible. — And the number of components to be produced during the Run @ Rate should be sufficient to demonstrate process capability and will be predetermined by the Supplier Quality Engineer and the supplier. — The no. of components to be produced, it may vary as per the customers specific requirement. + Factors such as product complexity, shelf fe, storage, cost and single shift vs. multiple shift operations will be taken into considerationFive levels of PPAP Submissio: —-Level 1: Production Warrant and Appearance Approval Report (if applicable) — Level 2: Warrant, product samples and dimensional results submitted — Level 3: Production Warrant, product samples & complete supporting data submitted — Level 4: Warrant, and other requirements as defined by the customer — Level 5: Production Warrant, product samples and complete supporting data (review will be at the organization's location). PPAP Documents with Excel Templates: +The 16 Documents or Elements of PPAP are: 01. Design Records 02. Authorized Engineering Change Documents 03. Engineering Approval, if required 04, Design Failure Modes and Effects Analysis (OFMEA) (05. Process Flow Diagram (PFD) 06. Process Failure Modes and Effects Analysis (PFMEA) 07. Control Plan 08. Measurement System Analysis (MSA) (09, Dimensional Results 10. Records of Material / Performance Test Results 11. Initial Process Studies 112. Qualified Laboratory Documentation ‘13. Appearance Approval Report (AAR) 14, Sample Production Parts 115. Master Sample 16. Checking Aids 17. Customer-Specific Requirements 18. Part Submission Warrant (PSW)= Note: For each level, full APQP is required as per the customer's requirement. The PPAP level simply indicates which elements you submit, and which you retain at your site. [1] Design Records or Drawing: — A design record is a copy of the drawing either itis given by the customer with the purchase order (PO) or developed by the supplier. — If the supplier is responsible for designing this is a released drawing in the supplier's release system. @! = =] Solid Edge ikunjbhoraniya.com. 5:[2] Authorized Engineering Change Documents: + Authorized Engineering Change Documents is a document that shows ¢ detailed description of the change. Usually, this document is called “Engineering Change Notice (ECN)*, but it may be covered by the customer PO or any other engineering authorization, [3] Engineering Approval, if required: — Engineering approval is usually the trial taken with production parts and takes an approval for Production plant from the customer. +A temporary deviation’ is an example of engineering approval [4] Design Failure Modes and Effects Analysis (DEMEA): A copy of the Design Failure Mode and Effect Analysis (OFMEA), reviewed and signed-off by supplier and customer. — Design maker is responsible for (DFMEA) [5] Process Flow Diagram (PFD): A copy of the PFO, indicating all steps end sequences of operation, including incoming components to the final part, dispatched. tis also known as a flow chart. nikut[6] Process Failure Modes and Effects Analysis (PFMEA): — Accopy of the PFMEA reviewed and signed-off by the supplier and customer. — The PFMEA follows the Flow Chart’s steps, and indicate “what could go wrong" during the operation and assembly of each component till product dispatched [7] Control Plan: — A copy of the Control Pian reviewed and signectoff by supplier and customer. = The Control Pian follows the PFMEA steps and provides more details on how the “potential issues” are checked in the incoming quality, assembly process or during inspections of finished products until the dispatched final product. ‘CONTROL PAN Te a Co ease | ten aoe = i ie <= —— een = ae mao[8] Measurement System Analysis (MSA): — Measurement System Analysis (MSA) usually contains the Gage R&R Study for critical or high impact characteristics. —Itgives confirmation that the measurement system (an instrument and appraiser) is able to measure these characteristics of the product. Measurement System Analysis (MSA) Study fee: Mikunjbhoraniya.cOm sewsrence ann:[9] Dimensional Results: = Alist of every dimension noted on the ballooned drawing. = This list shovis the product characteristic, specification, the measurement results and the assessment showing if this dimension is “ok” or “not ok [10] Records of Material / Performance Test Results: — A summary of every test performed on the part. — This summary is usually on a form of DVP&R (Design Verification Plan and Report), which lists each individual test when it was performed, the specification, results and the assessment pass/fail. = The DVP&R shall be reviewed and signed off by both customers and suppliers, = Inaddition, this section ists all material certifications (steel, plastics, plating etc.),as specified on the print [11] Initial Process Studies: — Usually this section shows all Statistical Process Control (SPC) Charts affecting the most critical characteristics. = The intent is to demonstrate that critical processes have stable variability and that is running near the intended nominal value. = It's also known as the Process Capability Study.[12] Qualified Laboratory Documentation: — Copy of all laboratory certifications of the laboratories that performed the tests reported. — Also required all calibration certificates of all Measuring instruments and Testing Equipment [13] Appearance Approval Report (AAR): — A copy of the AAR (Appearance Approval Report) form signed by the customer. — Applicable for components effecting appearance only and required by the customer. "APPEARANCE APPROVAL REPORT ERENCE VALUATION. ER AATON[14] Sample Production Parts: A sample from the same lot of initial production run. — The PPAP package usually shows a picture of the sample and where itis kept. [15] Master Sample: A sample signed off by customer and sup inspections. after the defined interval master sample should be replaced and approved by the customer periodically. that usually is used to train operators on subjective [16] Checking Aids: When there are special tools for checking parts, this section shows a picture of the tool and calibration records, including a dimensional report of the tool. [17] Customer-Specific Requirements: — Each customer may have specific requirements to be included in the PAP. —+In general, it should be the length, width, height, weight, GSM, or any technical value depends on the product. [18] Part Submission Warrant (PSW): — This is the form that summarizes the whole PPAP package. — This form shows the reason for submission (design change, annual revalidation, etc.) and the level of documents submitted to the customer. — There is a section that asks for “results meeting all drawing and specification requirements: yes/no’ refers to the whole package.PPAP Approval Status: [a] Approved: ~» The part meets all the customer's requirements. ~» The supplier is authorized to ship production quantities of the part. IB] Interim Approved: ~» Permits shipment of the part on a limited time or piece quantity basis. IC] Rejected: ~» The part does not meet the customer's requirements.Quality (\ » PSTN Quality Assurance vs Quality Control | QA vs QC = The difference between similar-looking two different words Quality Assurance and Quality Control are mentioned below in fve different categories. — Quality Assurance is Prevention Control = Quality Control is Detection Contra What is Assurance? — Assurance means giving a positive declaration on a product which gives confidence for the outcome — It gives a surety that the product will work without any problems as per the expectations or requests.What is Quality Assurance? — Quality Assurance is focused on preventing defect. = ILensures that the methods, techniques, and processes are designed for the projects are implemented correctly. — Its @ proactive approach and is prevention control, What is Control? — Control is to check or verify the actual results of the product or process by comparing with the defined standards or spectfication. What is Quality Control = Quality Control is focused on identifying a defect or mitch match of the specification as compared toa defined specification — I ensures that the metnoas, techniques, and processes are designed in the project are rollowing correctly, = Itis @ reactive approach and is detection control. 4) Definition: = QA = Itis 2 set of activities which ensures the process for good output.” =ac: = It's a set of activities whien ensure the quailty of product eltner it's good or baa2) Focused on: = QA = Ils focused on the prevention of defects. = IIs a proactve approacn that means it works before procuct made. =ac = Ils focused on the identtfication of defects = Itis a reactive approach that means it works after a product made 3) Goa = QA — The goal of QA is to develop a robust process so that the defects will not generate. = ac — The goal of QC is to develop the product checking method so thal the defects do not pass to the customer. 4) Responsibility: = OA — Everyone from supplier to dispatch team (all team member) are responsible for that. =ac — Usually, a specific team is responsible for testing of product for defect before pass it to the customer, 5) Examples: = an — Process verification is an example of QA. —r It makes sure you are doing the right things, the right way = ac: — Product validation Product testing Is an exampie of QC.The Real Meaning of Quality What is Quality? | Meaningict! paaitty, | Eight = Quality is 2 degree of excellence = Quality is a Conformance to specification.1) Definition of Quality: — Fit for Purposes - A product or process is ft for purpose — Conformance fo Requirements - A product or process is conformance to requirements. — tis a Value for Performance — It means Freedom from defects — Meeting the requirements of the customers — Doing the right things at the right time 2) Quotes on Quality — "Quality is everyone's responsibly” - By Edward Deming — "Quality means do it right when no one is looking" - Henry Ford3) Dimensions of Quality: + Itis not only saying the product, process or service is ok or not ok but also it has eight different dimensions which are given below. > Eight imensions of Quality: 1. Performance 2. Feature 3. Rellabilly 4, Conformance 5. Durability ©. Sermceabilty 7. Aesthetics 8 Perceived Quality> [1] Performance: —+ Performance is the product wil perform as expected by the user and as specified by the manufacturer = If products do not do as buyers expect, users will be disappointed and frustrated — Poor performing products get negative reviews and lose sales and reputation — The performance of a product retiects on the proftablity or reputation of tne business > [2] Features: — What additional benefits will be adced to the product? — Some features will be present in all products. — For example, all cars have wheels, steering wheel, gears, windows, and seats but only some cars have assisted parking and Bluetooth, etc.> [3] Reliability: — Rellabilty is the ability of the product to consistently perform within specifications —s the product consistent? — Wilt perform well over its expected lifetime and perform consistently? — Usually, reliabilty may be closely related to the product's performance. — Many brands have developed trust with customers because of their product's reliability. — 8.9. Apple. Microson. Gooate. = So the reliability of the product is a major contributor to any brand or organization Dimensions of Quality E30 €=10 > [4] Conformance: — Does your product meet the specification which was given by the customer or mentioned In gesign?> [5] Dural — Durabilty is related to how long will the product perform and under what conditions? usualy, the durability of he product is closely retated to tne warranty. — Sometimes, the product's durability is mentioned in procurement contracts and specifications — How durabie is your product? — Will it fast long with daily use? > [6] Serviceability: — Serviceabiityis the abilty of the product that is easy to maintain and repair — Make sure customers are satisfied withthe products and services of the organization > [7] Aesthetics: — Aesthetics is the look of the product in simple language — Its related to a product's look, appearance or beauty e.g. Lamborghini — The aestnetic dimension of a product is playing a major role in an organization or brand's, Identity buildup.> [8] Perceived Quality: — Perception is a reality or how the customer thinks about a specific product is called perceived quality, — itis a perception or thinking about the brand e.g. Rolls Royce — What brand name is going to be used anc does this convey any perception? “Eight Dimensions of Qua SPC | Statistical Process Control | Quality Core Tool What is SPC (Statistical Process Control)? —+ SPC (Statistical Process Control) is a method for Quality control by measuring and monitoring the manufacturing process. — In this methodology, data is collected in the form of Attribute and Variable. — Also, we have to collect readings from the various machines and various product dimensions as per requirement. — This data is used for monitoring and controlling the process, — tis a tool to improve the Quality of the Product by reducing variation — SPC manual is published by the Automotive Industry Action Group (AIAG) which is used by almost all automotive industries for reference. + As per Dr. Shewart two sources of variation, (1) Chance variation and (2) Assignable variation or uncontrolled variation. = Then Dr. Deming gave a new name to (1) chance variation as Common Cause variation, and (2) assignable varlation as Special Cause variation.History of SPC: William A. Shewhert developed the control chart and the concept that a process could be in statistical control in 1924 at Bell Laboratories. The SPC was made very famous during World Wer Il and it was very much used by the military "Statistical Method from the Viewpoint of Quality Control” is a very famous book by William A. Shewhart — After that Japanese manufacturing companies picked up the SPC and they are using it nowadays also. Meaning of SPC: —Itis made from three different words, 1. Statistical 2. Process 3. Contiol (1] Statistical: — The statistical tool used to make a prediction of the operation. = Statistics is a science which deals with, a collection, summarization, analysis, and drawing information from the data, = There are many and simple methods available for data analysis if these are applied correctly then that can lead to the prediction of the process with @ high degree of accuracy. (2] Process: — It converts input resources into desired output products & services. — It involves a man (People), Machine/Tool, Material, Method, Environment and Management working together to produce desired output (End Product) [3] Control: Controlling process and comparing actual performance against set target then identifying when and what corrective actions are necessary to achieve the target.Why we Use SPC? —- Manufacturing companies today are facing ever-increasing competition. — At the same time, raw material costs and processing continue to increase. = So, for the industries, tis beneficial If they have good control over their operation. —- Companies must make an effort for Continuous Improvement in quality, efficiency and cost reduction. — Many companies still fllow inspection after production for detecting quality-elated issues. —-SPC helps the company to move towards prevention-based quality controls instead of detection based quality controls. — By monitoring the graph, we can easily predict the behavior of the process. —-We-can get Good Quality of Product — And we can smooth our production and prevent non-conforming output. Where to use SPC? —tt would be most beneficial to apply this tool to that area where unnecessary waste is generated. + Some of the examples of manufacturing waste are... rework, scrap and re-inspection time. = We can implement SPC for the critical characteristics of the design or operation. —-Cross-Funetional Team (CFT) identifies critical characteristics = Critical characteristics are mentioned in DFMEA or in PFMEA. Collecting and Recording Data for SPC — Data is collected in the form of measurements of a product dimension or product feature. Based on data (Variable or Attribute), it recorded and tracked on various types of graphs. = Its important that the correct type of chart is used to gain value and obtain useful information. = It can be collected in subgroups or as an individual. Selection of Control Chart: — The charts are selected based on different two factors (1) the datais attribute or variable? ~» (2) subgroup size. + The X-bar and R chartis one of the most widely used charts for variable type. — K-bar represents the average value of the variable x. — The X-bar chart displays the variations in the sample averages. — A Range chart shows the variations within the subgroup, — The difference between the highest anc lowest value is called Range. @ Reed this article for making an X‘bar and R chart in Simple 8 Steps. — The chart selection diagram is mentioned in the below picture.Selection of Control Chart Cont Chas Veale Data [_rernweoa | Ontecives Daf pe ese DE aca) aac a [een] (-Bar | sar $ char Equal Different Equal Different ramciat| [Faerun] [yas] [Senet | (Siam | [a ) | ppbat | Se a a i | i T T I I nikunjbhoraniyacom <=> o> (4 aa{1] Chart related to a variable type = The below HMR, X-bar -R, and X-bar-S charts are related to variable type. = HMR (Individual ~ Moving Range): used if your data is individual values + Xbar - R: used for recording data in subgroups of 9 or less = Xbar - S: used for sub-group size is greater than 8 [2] Chart related to attribute type = The below PnP, U, and C charts are related to attribute type. +P - used for recording the number of defective parts in different subgroup size —nP ~ the number of defective parts in equal subgroup size + U- used for the number of defects in different subgroup size + C - the number of defects in equal subgroup size Analyzing the Data in SPC: — If we can see all data points between UCL and LCL then the only common cause is present in the ‘see any points beyond the control limit then the special cause is available in the operation. — Allpoints should fall between the UCL & LCL in the graph. — Another name of Special cause is an outlier. — If there should be no special cause in the chart then we can say that the process is in statistical control and all point should fall between the UCL and LCL.Examples of common cause variation: — Wear and tear of machine and tool — Variations in properties of the material within specification + Seasonal changes in ambient temperature or humidity —+ Variability in operator-contvolled settings — Normal measurement variations Examples of special cause variation: — Special causes generally fall outside of the UCL or LCL. Failed controllers Improper equipment adjustments A change in the measurement system —Amean specification shift Machine malfunction — Product specifications do not match with the design specifications — Punch, drill, cutting tool or any instrument broken. —Inexperienced operator not familiar with the operation Instruction During SPC Study + When monitoring a process through charts, the inspector should verify that all points should fall between UCL and LCL. — If any special causes of variation are identified, then necessary action should be taken to determine the cause and implement corrective actions. = Thus the ongoing production can be controlled by implementing the corrective action. — Monitor 8 Different Chart Pattern for Special Cause available.