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C orrective  A nd  P reventive  A ctions C.A. are intended to determine the cause of nonconformance's that have been detec...
CAPA  - DMAIC
<ul><li>Define  –  Helps priorities a problem by using the following  matrix template .  Put together a team of qualified ...
<ul><li>Measure – to understand the current state of the process you need to collect reliable data on process, speed, qual...
CAPA  - DM A IC <ul><li>Analysis  –  to pinpoint & verify causes affecting the KPIV & KPOV connected to project. </li></ul...
CAPA  - DMA I C <ul><li>Improve  –  implement tested solutions to problems found in Analysis. </li></ul><ul><li>Key Steps:...
CAPA  - DMAI C <ul><li>Control – in order to complete project work & hand off improvements to process owners one must impl...
Design For Six Sigma  (DFSS) <ul><li>DMADV – Define Measure Analyze Design Verify -  strives to generate a new process whe...
DEFINE  - This step is virtually identical to the DMAIC process. It focuses on identifying the size and scope of the oppor...
VALIDATE  - Since DMADVI is a (from-the-ground-up) process, small-scale experiments make the most sense for two reasons: F...
Pareto Charts A Pareto charts are use to graphically ranks defects from largest to smallest, which can help you prioritize...
Cause & Effect ( Fish Bone )
5 M ’ s  –  Root Causes
Hypothesis Testing Sample  1 & 2
ANOVA ANOVA  –  Analysis Of Variance  –  is used to compare 3 or more samples to each other to see if any of the sample me...
ANOVA  (continue) Step 4:  Construct ANOVA table Stat>ANOVA>One way Input:  Response=Response, Factor=material,  √   = sto...
ANOVA  (continue) Step 5.  Recheck the assumption made in Step 2 using Residuals Plot. a ) Are the means independent?  Sho...
ANOVA  (continue)
8D   –  Problem Solving  D0:  The Planning Phase : Plan for solving the problem and determine the prerequisites. D1:  Use ...
CAPA  –  Rubric - Identification <ul><li>Identification – is where the Event is broken down into detail by collecting data...
CAPA  –  Rubric - Evaluation <ul><li>Evaluation  –  breaks down identification further by collecting more data </li></ul><...
CAPA  –  Rubric - Investigation <ul><li>Investigation  –  Create a Problem Statement by reviewing how the requirement / ex...
CAPA  –  Rubric - Investigation <ul><li>Root Cause Analysis: </li></ul><ul><li>Determine and document possible causes thor...
CAPA  –  Rubric - Resolution <ul><li>Resolution  –  is the plan used to resolve the impacted items. </li></ul><ul><li>The ...
CAPA  –  Rubric - Implementation <ul><li>Implementation - is the process of carrying out corrective and preventive actions...
CAPA  –  Rubric - Effectiveness <ul><li>Effectiveness -  identifies specific criteria to verify the elimination or reducti...
Continuous Lean Improvement Continuous Lean Improvement is a principle taught to employees on how to think lean while perf...
Continuous Lean Improvement <ul><li>Current Status: </li></ul><ul><li>Before any improvements are made one must define whe...
Process Map  <ul><li>Values of Process Mapping ( video ): </li></ul><ul><li>Graphical illustration of the process </li></u...
Identify Waste <ul><li>Layout ( Transportation ) </li></ul><ul><li>Waiting </li></ul><ul><li>Incapable process </li></ul><...
Improvement  –   Process Map  Process Map of Sensor Isolator Burn In
Value Stream Maps Value Stream Mapping is a tool used to identify and prioritize based on problems & opportunities and the...
Improvement  –  Value Stream Maps CT = Cycle Time PT = Process Time CO =
Total Lead Time Lead time - (also called cycle time, process cycle time, process lead time) The time from when a work item...
Process Cycle Efficiency (PCE) PCE – indicates how efficiently the process is converting work-in-process into exist/comple...
Reasons for using SPC are to 1) Establish a measurement baseline, 2) Detect special cause variation, 3) Ensure process sta...
<ul><li>2 grouped of charts (I, mR -  few data points  &  , R -  Subgroups ) are generally shown:  </li></ul><ul><li>I ( i...
, R chart (Xbar & R, Average + Range)  Stat>Control Charts> * Subgroup >  R Plots averages of  subgroups  (Xbar) on one ch...
The tests below relate to  “ zones ”  which mark off the standard deviation from the mean.  Zone  “ C ”  is  +  1 std. dev...
Process Capability  –  Cpk, Cp Process Capability answers:  ● How well are we doing?  ● Are the process improvements makin...
Process  is  consider  Capable  when it’s output variability is able to stay within customer specifications.  Process  mus...
Below is an example of two suppliers supplying part that meet specifications 600mm  + 2mm.  Using the stat>quality>tool>ca...
In my last job my manager asked me to determine the process capability for our department to see if we are reaching a goal...
6 sigma Process Capability   (see previous page) To find the process capability and refer to a 6 sigma process.  Do the fo...
FMEA - Failure Mode Effects & Analysis <ul><li>FEMA  –  is a Potential Problem Analysis (PPA) process for uncovering & dea...
Elements of FMEA
<ul><li>SEVERITY of the effect: </li></ul><ul><ul><li>As it applies to the effects on the local system, next level, and en...
FMEA  –  1 st  Why
FMEA  –  2 nd  Why
Determining  Sample Size <ul><li>α  is the risk of finding a difference when there really isn’t one (usually set at 5%) </...
Design of Experiments (DOE) DOE is a systematic approach to investigation of a system or process. A series of structured t...
Lean Manufacturing ( Video ) <ul><li>The goal of Lean Manufacturing is to: </li></ul><ul><li>To optimize the manufacturing...
Project  –  Apply Lean Concepts & 5S to Refurbishing Pumps. <ul><li>Identify and eliminate Waste </li></ul><ul><ul><li>5S ...
<ul><li>W hy are we in business  –  to satisfy a demand & make a profit </li></ul><ul><li>W hy would we make more profit u...
5S  3 Key Elements
5S  Sort  (Def. & Implementation) <ul><li>Definition: </li></ul><ul><li>Sort refers to the practice of going through all t...
<ul><li>Area selected is Pumps Refurbish & Tear Down </li></ul><ul><li>Questions to ask to prevent confusion & wasted effo...
<ul><li>Upon identifying items not belonging to the area fill out a Red Tag & place on item.  </li></ul><ul><li>5 day  Loc...
<ul><li>Take before and after pictures of application areas.  Ex.  Disassembly, Cleaning, Discard Area, Bin Stacking, Asse...
5S  Sort  (Imp. Template)
5S  Set In Order  (Def.) “ Set In Order” is a means to arrange needed items in the area and to identify or label them so t...
<ul><li>Steps Taken for Implementing Sort: </li></ul><ul><li>Select team members: </li></ul><ul><ul><li>John Salvetierra, ...
<ul><li>Take before and after process time. </li></ul><ul><li>Look for ways to make the work place more visually instructi...
<ul><li>Video sample of Set In Order </li></ul>Before  After 5S  Set In Order  (Sample)
Before 5S  Set In Order  (Sample)
5S  Set In Order  (Sample)
5S  Shine  (Def.) <ul><li>To have a work place  “ Shine ”  one must remove dirt & debris, inspect & clean equipment, and e...
<ul><li>Steps Taken for Implementing Shine: </li></ul><ul><li>Select team members: </li></ul><ul><ul><li>Mark Renolet, Jef...
 
5S Create a Standard for common areas.
5S  Audit Forms Sort Set in Order Shine Standardized Sustain
5S  Seeing The Benefits <ul><li>One of the surest ways to identify these benefits is to establish and track specific metri...
6 Sigma <ul><li>Is broken into 3 major topics: </li></ul><ul><ul><li>A Statistical term & business metric (Process Capabil...
Design For Manufacturability (DFM) DFM – is the process and practice of designing products so it can be produced efficient...
Design For Manufacturability (DFM) <ul><li>Factory Design Considerations: </li></ul><ul><li>Cycle & Takt Time </li></ul><u...
Design Controls For Med. Devices <ul><li>What is Design Controls FDA 21 CFR PART 820.3: </li></ul><ul><li>Design & Develop...
21 CFR Part 820 cGMP  cGMP are set forth in the QMS regulations.  The requirements used to govern the methods used the fac...
21 CFR Part 820 820.5 Quality System  –  maintain a quality system appropriate for medical device mfg.. 820.20 Mgmt. Resp....
21 CFR Part 820 820.72  –   Inspection, measuring, & test equip.  –  each mfg. Shall ensure all equip. is suitable for its...
21 CFR Part 820 820.140 - Handling – Each mfg. shall establish & maintain procedures to ensure that mix-ups, damages, dete...
21 CFR Part 820 820.200 – Servicing – Where servicing is required Each mfg. shall establish & maintain instructions & proc...
ISO 13485 - 5 Principal Elements <ul><li>Quality Management System : </li></ul><ul><li>Documentation requirements </li></u...
ISO 13485 - 5 Principal Elements <ul><li>Measurement, Analysis, & Improvements  : </li></ul><ul><li>Monitoring & Measuring...
Verification & Validation for Medical Devices <ul><li>Regulations & Standards for V & V: </li></ul><ul><li>FDA Design Cont...
Verification & Validation for Medical Devices <ul><li>Key Tasks in V & V </li></ul><ul><li>Establish product requirements ...
Verification & Validation for Medical Devices <ul><li>Key Concepts for V & V: </li></ul><ul><li>Well-written requirements ...
Process Validation
Risk Management
SolidWorks -  Sample
Gage R & R <ul><li>Define:  Involves evaluating the Reliability & Repeatability of a measurement system.  </li></ul><ul><l...
 
Decision Rules
Kaizen <ul><li>Define:  Is used for intensive project where emp. Are pulled off their regular job. </li></ul><ul><li>Team ...
Kaizen Example Layouts, Screw to long, Screw loose, Process redundant, creating to many failures, paint, cosmetic
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  1. 1. C orrective A nd P reventive A ctions C.A. are intended to determine the cause of nonconformance's that have been detected and to find a solution, while P.A. is a plan to stop the problem from happening again in the future. Several tools were develop to help structure and document the necessary steps to apply CAPA. The tools I am most familiar with are DMAIC (Define, Measure, Analyze, Improve, Control), Rubric, and 8D. DMAIC is a tool I learned to used during Black Belt training. DMAIC is a process one goes through to state the problem ( D efine ), applying Metrics & collecting data to find the various causes ( M easure ), taking the data and applying different techniques to investigate and examine the data to find the root cause ( A nalyze ), finding and applying the solution ( I mprove ), then apply the necessary steps to either monitor or prevent the problem from reoccurring ( C ontrol ). Rubric is a tool I learned while at Abbott Diagnostic. Basically they break down the CAPA steps into 6 levels called 1) Identificatio n , 2) Evaluatio n , 3) Resolutio n , 4) Investigatio n , 5) Implementation, and 6) Effectiveness. 8D is a quality tool that provides scientific facts to details of problems and solutions and presents a guideline to get to the root of the problem & verification the solution actually works.
  2. 2. CAPA - DMAIC
  3. 3. <ul><li>Define – Helps priorities a problem by using the following matrix template . Put together a team of qualified individuals to develop a problem statement that have the following characteristics: </li></ul><ul><li>Problem exist – seen, magnitude, impact to customers </li></ul><ul><li>Important to customers (VOC) </li></ul><ul><li>Financially beneficial </li></ul><ul><li>Problem statement focuses on symptoms not solutions. </li></ul><ul><li>Identify key stakeholders. </li></ul><ul><li>Stipulate goal statement by identifying key output metrics to be improved. </li></ul><ul><ul><li>Show targeted completion dates & milestones . </li></ul></ul><ul><li>Verify Project Scope by achieving project objectives within planned timeframe. </li></ul><ul><ul><li>List key process output variables such as time, quality, cost metrics. </li></ul></ul>CAPA - D MAIC
  4. 4. <ul><li>Measure – to understand the current state of the process you need to collect reliable data on process, speed, quality, failures, costs, capability, SPC, etc. to expose the underlying cause of problems. </li></ul><ul><li>Key Steps: </li></ul><ul><li>Create & validate a value stream map to confirm current process. </li></ul><ul><li>Identify key process outputs & inputs (KPOV & KPIV) variables relevant to project. </li></ul><ul><li>Create a data collection plan and a data analysis plan to verify what kind of tools can be used for the type of data collected. </li></ul><ul><li>Collect data to establish baseline. </li></ul><ul><li>Calculate lead times and process capability. </li></ul><ul><li>Use Measurement System Analysis to make sure your data is valid. use one of the following analysis: Bias, Stability, Kappa, Gage R&R , & Discrimination. </li></ul>CAPA - D M AIC
  5. 5. CAPA - DM A IC <ul><li>Analysis – to pinpoint & verify causes affecting the KPIV & KPOV connected to project. </li></ul><ul><li>Key Steps: </li></ul><ul><li>Identify value-add and non-value-add using value stream mapping. </li></ul><ul><li>Calculate Process Cycle Efficiency (PCE) to find how much improvement is needed. </li></ul><ul><li>Analyze process flow by identifying bottlenecks, constraints, fallout & rework points. </li></ul><ul><li>Analyze data collected in Measure. </li></ul><ul><li>Generate hypothesis to explain potential causes using, C&E (fishbone), FMEA . </li></ul><ul><li>Zeroing in on the problem using 5 W ’ s, 5 M ’ s, Pareto, Hypothesis testing (Ha & Ho). </li></ul><ul><li>Collect additional data to verify root causes using Ha & Ho, ANOVA , Scatter plots. </li></ul>
  6. 6. CAPA - DMA I C <ul><li>Improve – implement tested solutions to problems found in Analysis. </li></ul><ul><li>Key Steps: </li></ul><ul><li>Develop potential solutions by using the caused-and-effect relationship (from Analysis) to identify a wide range of potential solutions. </li></ul><ul><li>Evaluate, select, & prioritize best solutions. </li></ul><ul><li>Develop “ To Be ” value stream map by revising the existing VSM to reflect what the process will look like after the changes are executed. </li></ul><ul><li>Develop & implement pilot solutions. </li></ul><ul><li>Confirm achievement of project goals. </li></ul><ul><li>Confirm improvements by reviewing metrics of controls and capability. </li></ul>
  7. 7. CAPA - DMAI C <ul><li>Control – in order to complete project work & hand off improvements to process owners one must implement metrics or monitoring system to make sure process problems do not return. </li></ul><ul><li>Steps: </li></ul><ul><li>Develop supporting methods and documentation to sustain full-scale implementation. </li></ul><ul><li>Lock in performance gains my using mistake-proofing measures to prevent people from performing old process steps. </li></ul><ul><li>Monitor implementation using metrics. </li></ul><ul><li>Develop Process Control Plan and hand it to process owner. </li></ul><ul><li>Audit the results by confirming measures of improvements and assign dollar figures were appropriate. </li></ul><ul><li>Finalize project by document ideas about where company could apply the methods and lessons learned from this project. Hold Control Gate Review and go over achievements. </li></ul><ul><li>Document improve processes, process maps, mistake proofing process controls, increase performance and quality. </li></ul>
  8. 8. Design For Six Sigma (DFSS) <ul><li>DMADV – Define Measure Analyze Design Verify - strives to generate a new process where none existed, or where an existing process is deemed to be inadequate and in need of replacement. DFSS aims to create a process performance of around 4.5 sigma or better with the end in mind of optimally building the efficiencies of Six Sigma methodology into the process before implementation; traditional Six Sigma seeks for continuous improvement after a process already exists. </li></ul><ul><li>DFSS seeks to avoid manufacturing/service process problems by using advanced Voice of the Customer techniques and proper systems engineering techniques to avoid process problems at the outset (i.e., fire prevention). When combined, these methods obtain the proper needs of the customer, and derive engineering system parameter requirements that increase product and service effectiveness in the eyes of the customer. </li></ul><ul><li>DFSS is an approach and attitude towards delivering new products and services with a high performance as measured by customer critical to quality metrics. Some of the main tools include QFD - Quality Function Deployment, FMEA, DOE, & simulation techniques . DFSS methodologies are about a wider, deeper and more integrated approach to commercial design, which involves everyone in the process as well as the customer to deliver a better product/service and final implementation </li></ul>
  9. 9. DEFINE - This step is virtually identical to the DMAIC process. It focuses on identifying the size and scope of the opportunity, while making sure that DMADV is the best fit for the situation. It's also about building the most effective, efficient team with clearly defined goals supported with a well-thought out project plan. MEASURE - While this step in the DMAIC process measures the performance of the current process, DMADV focuses on measuring (and quantifying) the expectations and requirements of customers. The team is building a a product/service profile against which design alternatives will be compared. The Six Sigma targets set in this step will define the success or failure of the DFSS project. ANALYZE - This step combines the practicality of turning customer requirements into product/service functions with the creativity of generating and testing new concepts to fulfill those functions. The team must also create a design of a new production process along with its capabilities. A number of iterations are usually needed to get these process concepts up to Six Sigma level performance, even on paper. This is the step of small-scale experiments with very rapid PDCA cycles. DESIGN - The team (torture tests) the most promising product/service design(s) by developing detailed production plans and their likely failure modes. Based on more realistic picture of process capability, the team must make tradeoffs between product/service features and functions and the level of reliability that production processes can consistently deliver. This is also where process control plans are designed and built right into the proposed production process. Design For Six Sigma (DFSS)
  10. 10. VALIDATE - Since DMADVI is a (from-the-ground-up) process, small-scale experiments make the most sense for two reasons: First, pilot implementations minimize both the cost and the risk of trying something entirely new. Secondly, the PDCA cycle can be turned very quickly, making it possible to dramatically accelerate the team's learning curve. Once performance gaps have been uncovered and root causes eliminated, the team must design the quality management and production control systems needed to move to full-scale implementation. Finally, the team must create a transition schedule to the full-product production/service delivery. Design For Six Sigma (DFSS)
  11. 11. Pareto Charts A Pareto charts are use to graphically ranks defects from largest to smallest, which can help you prioritize quality problems and focus improvement efforts on areas where the largest gains can be made. Stat>Quality Tools>Pareto chart . This chart illustrates the number and type of causes for late Sales Orders (Black Belt).
  12. 12. Cause & Effect ( Fish Bone )
  13. 13. 5 M ’ s – Root Causes
  14. 14. Hypothesis Testing Sample 1 & 2
  15. 15. ANOVA ANOVA – Analysis Of Variance – is used to compare 3 or more samples to each other to see if any of the sample means is statistically different from the others. It is used to analyze the relationships between several categorical inputs (KPIVs or factors ) & one continuous output (KPOV). The samples (Values describing the factors) are referred to as levels or treatments . One-Way is used with a 1 factor & several levels. Two-Way is used with 2 factors & several levels. ANOVA.doc : Step 1: State Practical Problem: Is the mean response (KPOV) the same for the 4 different materials ANOVA Material. mpj (1 factor – material & 4 levels of material). Step 2: Assumptions – a ) The means are independent (randomize) & adequate sample sizes. b ) Data collected must be normal ( residuals plots). c ) Population variances are equal across all factor levels. Using the data from equal variance. mpj test for equal variance by Stat>ANOVA>test . Reponse = Response, Factor = Material, Confidence = 95. The graph illustrates the variances are relatively equal & balanced. Dots represents overall mean. P value above .05 & therefore can use a One-Way ANOVA. If not equal , use Stat>ANOVA>General linear Step 3: State Hypotheses Ho: μ 1 = μ 2 = μ 3 = μ 4 Ha: μ 1 ≠ μ 2 ≠ μ 3 ≠ μ 4
  16. 16. ANOVA (continue) Step 4: Construct ANOVA table Stat>ANOVA>One way Input: Response=Response, Factor=material, √ = store residuals & store fits
  17. 17. ANOVA (continue) Step 5. Recheck the assumption made in Step 2 using Residuals Plot. a ) Are the means independent? Should display no trend or repeated pattern. This shows pattern & violates assumption b ) Is the data normal? Points should hug the diagonal line and they don’t. Histograms (bell shape) provide a visual check for normality. In this case it does not. c ) A re the variance equal cross all factor levels? Equal # of points should be on each side of the 0 line & they aren’t. b c b a Step 6: The P-value of 0.747 (on previous page) > .05 & F<S indicates the Ho is true where μ 1 = μ 2 = μ 3 are equal. Step 7: But the Assumption for the residuals do not hold and therefore cannot draw a reliable conclusion from the analysis.
  18. 18. ANOVA (continue)
  19. 19. 8D – Problem Solving D0: The Planning Phase : Plan for solving the problem and determine the prerequisites. D1: Use a Team : Establish a team of people with product/process knowledge. D2: Define and describe the Problem : Specify the problem by identifying in quantifiable terms the who, what, where, when, why, how and how many (5W’s, 2H) for the problem. D3: Developing Interim Containment Plan Implement and verify Interim Actions : Define and implement containment actions to isolate the problem from any customer. D4: Determine and Identify and Verify Root Causes and escape points : Identify all potential causes that could explain why the problem occurred. Also identify why the problem has not been noticed at the time it occurred. All causes shall be verified or proved, not determined by fuzzy brainstorming. D5: Choose and verify Permanent Corrective Actions (PCAs) for root cause and Escape point : Through pre-production programs quantitatively confirm that the selected corrective actions will resolve the problem for the customer. D6: Implement and validate PCAs : Define and Implement the best corrective actions. D7: Prevent recurrence : Modify the management systems, operation systems, practices and procedures to prevent recurrence of this and all similar problems. D8: Congratulate your Team : Recognize the collective efforts of the team. The team needs to be formally thanked by the organization. [ 1 ] [ 2 ]
  20. 20. CAPA – Rubric - Identification <ul><li>Identification – is where the Event is broken down into detail by collecting data describing the Event. </li></ul><ul><li>The following questions are asked and answered: </li></ul><ul><li>What object or item is involved (e.g. name, batch #, Line, Lot #, description of item) </li></ul><ul><li>What is the event/problem or malfunction? </li></ul><ul><li>Where is the event/problem observed (geographically describe). </li></ul><ul><li>When did the event/problem occur (date, time) </li></ul><ul><li>What documents #’s, name, revision, & revision date are associate with problem. </li></ul><ul><li>Note *: </li></ul><ul><li>This does not include assignment of blame, cause, or offer a solution. It also verifies initial timing was or was not met (discovering the problem or event and notifying supervisor). </li></ul>
  21. 21. CAPA – Rubric - Evaluation <ul><li>Evaluation – breaks down identification further by collecting more data </li></ul><ul><li>The following questions are asked: </li></ul><ul><li>Identifies additional items impacted by the event (i.e., by date range, lot #, asset #, location, p/n, line) and how each item was impacted. Or why no additional items were impacted. </li></ul><ul><li>Documents whether or not all items impacted by the event were contained, not contained, or justified why containment was not necessary. </li></ul><ul><li>Document impact level and justification for the level. Include Frequency and Severity. </li></ul><ul><li>Documents an investigation or justifies why no investigation is needed. </li></ul>
  22. 22. CAPA – Rubric - Investigation <ul><li>Investigation – Create a Problem Statement by reviewing how the requirement / expected result for the event/problem was not met by answering the following: </li></ul><ul><li>What object or item is involved (name, description, batch #, line #)? </li></ul><ul><li>What is the problem or malfunction? </li></ul><ul><li>Where is the problem observed? </li></ul><ul><li>When did the problem occur? </li></ul><ul><li>Collect / Analyze Data: </li></ul><ul><li>Collect background information to understand problem more clearly </li></ul><ul><li>Doc. the 5M ’ s (man, machine, material, method, mother nature). </li></ul><ul><li>Collect evidence of data that supports impact level. </li></ul><ul><li>Doc. historical details by examining other data sources (CAPA, audits) related to event. </li></ul>
  23. 23. CAPA – Rubric - Investigation <ul><li>Root Cause Analysis: </li></ul><ul><li>Determine and document possible causes thoroughly using tools (fish bone, pareto, DOE, etc.). </li></ul><ul><li>Narrow causes to find root by testing and providing supporting evidence that documents justification to eliminate or retain cause. </li></ul><ul><li>Provide a clear, concise statement of the identified cause once root cause had been identified. </li></ul><ul><li>Once causes have been identified, evaluate and describe where else the event/problem may occur for the following: </li></ul><ul><ul><li>Supply Chain, similar products/processes/equipment, quality systems related to the event/problem. </li></ul></ul>
  24. 24. CAPA – Rubric - Resolution <ul><li>Resolution – is the plan used to resolve the impacted items. </li></ul><ul><li>The following steps are performed to address all impacted items. </li></ul><ul><li>Doc. all impacted item and disposition items for destruction, rework, continue use, return to supplier. </li></ul><ul><li>Doc. with justification if no corrective action is necessary for impacted items. </li></ul><ul><li>Identify all impacted items that will be corrected. </li></ul><ul><li>List actions taken to correct impacted items & how it will remedy the nonconformance. </li></ul><ul><li>List criteria that will be used to confirm correction was successful. </li></ul><ul><li>Who/what functional area will perform the correction. </li></ul><ul><li>When will correction be completed (due date). </li></ul>
  25. 25. CAPA – Rubric - Implementation <ul><li>Implementation - is the process of carrying out corrective and preventive actions. The list below shows what actions should be preformed to document and improve effectiveness. </li></ul><ul><li>Perform pilot of corrective action to make sure corrective action is successful and does not effect any other parts/products/process. </li></ul><ul><li>List process needed to prevent/mitigate recurrence/occurrence. </li></ul><ul><li>Identify how this action addresses the identified cause. </li></ul><ul><li>Identify functional area that will be performing the procedure to prevent recurrence? </li></ul><ul><li>When and where will the action be implemented? </li></ul><ul><li>Address any concerns that the preventive measure does not create any adverse consequences. </li></ul><ul><li>List any interim actions or modes of control that were applied pending implementation of corrective and preventive action if applicable. </li></ul>
  26. 26. CAPA – Rubric - Effectiveness <ul><li>Effectiveness - identifies specific criteria to verify the elimination or reduction of causes with the steps listed below: </li></ul><ul><li>List methods of data collection (batch record review, complaints, ER, etc.). </li></ul><ul><li>Methods of analysis with evaluation criterion </li></ul><ul><li>Minimum sample size (i.e., lot, assets, etc.) & duration with justification. </li></ul><ul><li>Consider if the action created adverse consequences. </li></ul><ul><li>If no effectiveness plan was required provide justification. </li></ul>
  27. 27. Continuous Lean Improvement Continuous Lean Improvement is a principle taught to employees on how to think lean while performing their assigned duties. It teaches what waste is and ways to reduce or eliminate it. Reducing Takt time or improving quality are means of how to make improvements. Companies usually run using either a Push or Pull type of production or a combination of the two. Pushed Production is based on forecast and extra quantities and inventory and can lead to waste and can cause many problems if customer decides they no longer need product. Pull Production is based on customer orders and the amount they need - no extra quantities, no inventory (reduce waste). One Piece Pull - balanced work & material flow - (no waiting, material is not backing up at anyone particular station). One Piece Pull and Pull Production is what a company should strive for.
  28. 28. Continuous Lean Improvement <ul><li>Current Status: </li></ul><ul><li>Before any improvements are made one must define where they are currently by invoking and studying various metrics that can provide data to determine if the process is in Control, Capable, Normal, and within the assigned cycle time . This should be done at each station. If any of these parameters are not within spec., improvements should be made in these areas to eliminate problems. </li></ul><ul><li>Steps Toward Improvement: </li></ul><ul><li>Create a Value Stream Map (VSM). This map will identify value-added and non-value-added items. It’s basically a detail flow chart in conjunction with the amount of time taken for each steps needed to produce a part. </li></ul><ul><li>Calculate the total Lead Time. </li></ul><ul><li>Calculate Process Cycle Efficiency. </li></ul><ul><li>Locate and quantify the time traps and capacity constraints. </li></ul><ul><li>Compute the Workstation Turnover Times. </li></ul><ul><li>Identify the concepts and tools for improving flow in an area: </li></ul><ul><ul><li>Production Smoothing, Just-In-Time, Setup Reduction, Total Productive Maint. </li></ul></ul>
  29. 29. Process Map <ul><li>Values of Process Mapping ( video ): </li></ul><ul><li>Graphical illustration of the process </li></ul><ul><li>Identify all Value and Non-Value-Added process steps </li></ul><ul><li>KPIV, KPOV, data collection points, PPM, Cycle time per setup </li></ul><ul><li>Identifies steps needing measurements system analysis. </li></ul><ul><li>Identify KPOV’s for capability studies </li></ul><ul><li>Identify holes in control plan </li></ul><ul><li>Opportunities for eliminating steps. </li></ul><ul><li>Benefits Value Gain Focuses on customer Reduces the hidden factory Raises Visibility Removes hidden waste Spotlights value & waste Eliminate tribal knowledge Promotes Awareness Shifts the culture from Who to what Capture knowledge allowed the error Communication Awareness </li></ul>
  30. 30. Identify Waste <ul><li>Layout ( Transportation ) </li></ul><ul><li>Waiting </li></ul><ul><li>Incapable process </li></ul><ul><li>Poor maintenance </li></ul><ul><li>Poor work Methods </li></ul><ul><li>Inadequate training </li></ul><ul><li>Poor Product Design </li></ul><ul><li>Overproduction </li></ul><ul><li>Equipment Design & Selection </li></ul><ul><li>Poor work place organization </li></ul><ul><li>Supplier Quality/Reliability </li></ul><ul><li>Tool down time </li></ul><ul><li>Inappropriate Processing </li></ul><ul><li>Unnecessary / Excess Motion </li></ul><ul><li>Unnecessary Inventory </li></ul><ul><li>Defects </li></ul><ul><li>Underutilization of Employees </li></ul>
  31. 31. Improvement – Process Map Process Map of Sensor Isolator Burn In
  32. 32. Value Stream Maps Value Stream Mapping is a tool used to identify and prioritize based on problems & opportunities and their effects on the system. Provides linkage for improvement activities. Video Provides process and time observations used to calculate total Lead time, Value-added time, Value-added ratio. Display material and information flow from the customer through the supply base. Establish project priority and identify opportunities. Identify and set goals for improvement metrics. Identifying and quantifying waste (in time and costs) <ul><li>Steps to make VSM: </li></ul><ul><li>Determine what individual product, service, or family you will map. </li></ul><ul><li>Draw Process Flow 5. Collect process data & connect it to the boxes </li></ul><ul><li>Add Material Flow 6. Add Process & lead time data to the chart </li></ul><ul><li>Add Information Flow 7. Verify Map </li></ul>
  33. 33. Improvement – Value Stream Maps CT = Cycle Time PT = Process Time CO =
  34. 34. Total Lead Time Lead time - (also called cycle time, process cycle time, process lead time) The time from when a work item enters a process until it exits, i.e.: machine time to process part, time to order & receive material, operator time (set machine up, retrieve & load material, unload & move material, inspection, packing, shipping). Cycle Time =Total Lead Time = Number of Things in Process Average Completion Rate This shows how lead time is related to the number of things in process (WIP) and the completion (exit) rate of the process. To improve Total Lead Time, and in turn PCE, either increase capacity (average completion rate) and / or reduce WIP. Workstation Turnover Time (WTT) for a given process step to workstation is the amount of time needed to set up and complete one cycle of work an all the different “ things ” (work items, SKUs) at that step. WTT is important step (time trap) to work on first.
  35. 35. Process Cycle Efficiency (PCE) PCE – indicates how efficiently the process is converting work-in-process into exist/completions. It measures the overall health of the process by taking the value-add time (work needed to be done as desired by customer) divided by the total lead time. Any process with low PCE will have large non-value-add costs and opportunities for cost reduction . The only way to improve PCE is to get rid of non-value-add work and costs. PCE's of less than .1 (or .1 x 100 = 10%) are common pre-improvement values. The goal is 1 . PCE = value add time (customer is willing to pay) / cycle time. Cycle time - (also called lead time, process cycle time, process lead time) The time from when a work item enters a process until it exits, i.e.: machine time to process part, time to order & receive material, operator time (set machine up, retrieve & load material, unload & move material, inspection, packing, shipping). Value stream process mapping is a graphical tool used to identify value added and non value add steps and time. Takt time = customer demand rate - value add chart = available time (480 min) / # products to be shipped that day. Ex.: 480 min / 5 parts day = 88 minutes to ship a part to meet customer demand.
  36. 36. Reasons for using SPC are to 1) Establish a measurement baseline, 2) Detect special cause variation, 3) Ensure process stability & enabling predictability, 4) Monitor process over time, 5) confirming the impact of process improvement activities. Before plotting SPC one must determine if the data is Attribute or Variable: Variable Data - is a measurable defect ( continuous data ) . Length, width, height, (Cycle time, response time, continuous data). Always provides more info. & require lower sample size and is a requirement to be Normal distribution . Stat>Basic>Normality test P value must be > 0.05 When the data is not normal apply the Central Limit Theorem to normalize data. Which states the distribution of averages ( )approaches normal if u take large enough of samples. SPC For Continuous Data
  37. 37. <ul><li>2 grouped of charts (I, mR - few data points & , R - Subgroups ) are generally shown: </li></ul><ul><li>I ( individual ) chart is used to monitor Mean when it ’ s impossible to group into subgroups & therefore subgroup size is 1. Such as 1 data point per day, week, or month. Occurs when measurement are expensive. The R charts (below) must be in control before we can use the I chart. </li></ul><ul><li>Moving Range Chart (mR or R) is used when data is collected as individual observations & to monitor the moving Mean when it ’ s impossible to group into subgroups. Stat>Control Charts> * Individuals > ImR </li></ul><ul><li>Control limits are </li></ul><ul><li>UCL= + 3 Ϭ & LCL= - 3 Ϭ </li></ul><ul><li>= ave. or mean = ∑ data / # points </li></ul><ul><li>In this case the I chart is out of </li></ul><ul><li>Control at point 13,14,26,27. </li></ul><ul><li>In this case the R chart is out </li></ul><ul><li>Of Control at point 28. </li></ul>= ave. of moving ranges MR SPC Charts for Continuous Data
  38. 38. , R chart (Xbar & R, Average + Range) Stat>Control Charts> * Subgroup > R Plots averages of subgroups (Xbar) on one chart & the ranges (R) within the subgroups on the other chart. This chart is used with a sampling plan to monitor repetitive process. <ul><li>Subgroup sizes typically range from 3 to 9 items </li></ul><ul><li>Xbar chart will highlight changes to the average (between subgroups or process accuracy) </li></ul><ul><li>All of the Tests for Special Causes (next page) can be applied with these charts </li></ul><ul><li>The R chart will detect changes to within subgroup dispersion (spread, process precision) </li></ul>The 2 graphs below represent 2 Suppliers making the same product. Using Xbar, R chart with a sample of 5 you can see Supplier 1 is in while Supplier 2 is out of control. The R chart in #2 does not indicate that the process is out of control. However, you notice that the center line is at 3.890, which is almost 3x larger than Supplier 1's R of 1.341 SPC Charts for Continuous Data
  39. 39. The tests below relate to “ zones ” which mark off the standard deviation from the mean. Zone “ C ” is + 1 std. dev.; Zone “ B ” is between 1 & 2 std. Dev.; and Zone “ A ” is between 2 & 3 std. dev. When creating SPC charts with subgroups apply the 8 tests displayed in options. 4 are shown below. stat>control charts>with subgroups>Xbar, R Xbar option - test Interpreting Control Charts
  40. 40. Process Capability – Cpk, Cp Process Capability answers: ● How well are we doing? ● Are the process improvements making a difference? ● How well could we be doing? ● What can we expect tomorrow, next week? ● Which supplier, machine, process, factory, etc. is giving us the best quality?
  41. 41. Process is consider Capable when it’s output variability is able to stay within customer specifications. Process must be in control before performing Cpk. Supplier 1 is in control while Supplier 2 is out (see pg 3). Cpk - Process capability index evaluates the productivity of an in-control process to the requirement limits. It can only be applied when the response displays a normal distribution (p >.05). Used when is not easily adjusted. Cpk = ( - LSL)/3 Ϭ or (USL- )/3 Ϭ Which ever is the smaller of the two . Cp - Process Capability indices (Cp) is used to measure how closely the process can reach the optimum level of satisfaction of customers. Used when the is constantly monitor and can be easily adjusted. It takes in all the possible elements needed for assuring improved quality products and services. Cp = (USL – LSL) / 6 Ϭ μ = Population mean =sample Mean Ϭ - Standard Deviation USL & LSL - Upper and Lower Specification Limits and is derived & set by the Customer Process Capability – Cpk, Cp
  42. 42. Below is an example of two suppliers supplying part that meet specifications 600mm + 2mm. Using the stat>quality>tool>capability 6 pack>normal on camshaft. mtw . Subgroup=5, Lower spec.=598, Upper spec.=602, Options>target 600, Tests>all 8. For Supp. 1 the process mean falls short of the target and the process distribution mean lies to the left of the target. The left tail of the distribution falls outside the lower specification limit. We would like to see a Cpk much larger than 1, because the larger the index, the more capable the process. The Cpk index = 0.90, indicating they need to improve by reducing variability and by centering the process around the target. Sup. 2 fails Test 1 at points 8,& Test 6 at points 12 & 13. Several points are outside the LSL & USL. Cpk & Cp are below 1. The Xbar chart & tests clearly indicate Suppler 2 is out of control even though P>.05. Supplier 1 is definitely the better of the two but can still use some improvement. Process Capability – Cpk, Cp
  43. 43. In my last job my manager asked me to determine the process capability for our department to see if we are reaching a goal of closing a Non-conformities within one calendar week (USL = 7 days). A primary performance index is the time taken to close a customer complaint. I reviewed the last 400 complaints & collected data on how much time it took to close a complaint. File name Process Capability .mtw column C4. Using the Stat>basic statistics>graphical summary you can see data is skewed toward the left & therefore not normal. This justifies the use of the Weibull Distribution for data that is skewed. Using the Stat>quality tools>capability analysis>non-normal & selecting column C4 and USL = 7. Process Capability – Cpk, Cp
  44. 44. 6 sigma Process Capability (see previous page) To find the process capability and refer to a 6 sigma process. Do the following: 6 sigma process refers to a Z ST score = 6 and is usually calculated from long term data. Z L T = 3 Ppk (for normal distribution) This is now consider normal due to obtaining DPPM using non-normal calculation in the previous page. using Minitab calc>probability distribution> normal Click inverse, mean=0, standard deviation=1, input constant =.90601 (number good). Then Z L T = 1.317 & Z ST = Z LT + 1.5 = 2.82 Therefore the current process is reported as a 2.82 sigma process which is consider not capable. See table . On the previous page you have a DPPM (parts per million) of 93993.97 & a Ppk of .34 To find the % of good and bad do the following: 93993.97 / 1,000,000 = .09399 which is 9.39% bad or 100% - 9.399% = 90.6% good. Or 1000000 by (1M – 93993.97)/1M = .906007
  45. 45. FMEA - Failure Mode Effects & Analysis <ul><li>FEMA – is a Potential Problem Analysis (PPA) process for uncovering & dealing with potential problems that are likely to occur with the process, product, or service. In other words estimate & prioritize the risks associated with probable failures (Risk Prioritization Num. - RPN ). </li></ul><ul><li>3 Types: </li></ul><ul><ul><li>Design – exposes problems before rollout to expose problems that may occur after release. Ex. Malfunctions, safety, hazards </li></ul></ul><ul><ul><li>Process – used to improve existing process & transactions that may result in defects, efficiency, safety hazards, etc. </li></ul></ul><ul><ul><li>System – Analyzes systems in early stages of concept & design </li></ul></ul><ul><li>Preventative – remove the likely cause of a potential problem </li></ul><ul><li>Contingent – reduce the impact of a problem that cannot be prevented. </li></ul><ul><li>Good idea to have vendors implement FEMA ’ s. </li></ul>
  46. 46. Elements of FMEA
  47. 47. <ul><li>SEVERITY of the effect: </li></ul><ul><ul><li>As it applies to the effects on the local system, next level, and end user. Scale of 1 (least severe) to 10 (most severe). </li></ul></ul><ul><li>OCCURRENCE frequency of the cause: </li></ul><ul><ul><li>Likelihood that a specific cause will occur and result in a specific failure mode. Scale of 1 (least often) to 10 (most often). </li></ul></ul><ul><li>DETECTION system for spotting the failure: </li></ul><ul><ul><li>Ability of the current I proposed control mechanism to detect and identify the failure mode. Scale of 10 (no detection) to 10 (good detection). </li></ul></ul><ul><ul><li>RPN = O x S x D </li></ul></ul><ul><ul><li>Occurrence x Severity x Detection </li></ul></ul>Risk Priority Number
  48. 48. FMEA – 1 st Why
  49. 49. FMEA – 2 nd Why
  50. 50. Determining Sample Size <ul><li>α is the risk of finding a difference when there really isn’t one (usually set at 5%) </li></ul><ul><li>β is the risk of not finding a difference when there really is one. (Power value = (1- β )= .9) </li></ul><ul><li>σ If the standard deviation is known the critical difference δ can both be input accurately </li></ul><ul><li>Choosing an appropriate Sample size: </li></ul><ul><li>1. Select the risk level of α error or level - Usually 5% </li></ul><ul><li>2. Select the β level – between 5 - 20% </li></ul><ul><li>3. Select the critical difference δ or Delta you would like to detect in your experiment. </li></ul><ul><li>4. Establish or estimate current process sigma σ </li></ul><ul><li>5. Use software Minitab or the sample size selection table to determine n (number of samples required per experimental factor level. </li></ul><ul><li>6. Develop the sample plan </li></ul><ul><li>Test and make proper conclusion. </li></ul><ul><li>Example: 1 Mean </li></ul><ul><li>A industry standard average response time to get back to a customer is 18 minutes. Historically, the standard deviation of the process is 5.2 minutes ( + 5.2 minutes). The team wanted to implement improvements to get an average of 13 minutes response time. Given σ = 5% and β = 10% (power = 90). What sample size is needed. </li></ul><ul><li>Solution: </li></ul><ul><li>Currently Ho: Average 18 minutes [5% ( α ) chance of saying Ave. = 13 if Ave = 18 min. </li></ul><ul><li>Trying to achieve Ha: Average 13 minutes [10% ( β ) chance of saying Ave. = 18 if Ave = 13 min. </li></ul><ul><li>Stat>power & sample size>1-sample t </li></ul><ul><li>Input: Difference (13 – 18)=-5, Power value (1- β ) =.9, Sigma 5.2, in options = select less than, & significant level α =.05 </li></ul><ul><li>Answer: Sample size = 11 </li></ul>
  51. 51. Design of Experiments (DOE) DOE is a systematic approach to investigation of a system or process. A series of structured tests are designed in which planned changes are made to the input variables of a process or system. The effects of these changes on a pre-defined output are then assessed.
  52. 52. Lean Manufacturing ( Video ) <ul><li>The goal of Lean Manufacturing is to: </li></ul><ul><li>To optimize the manufacturing process as much as possible by reducing non-value added processes. </li></ul><ul><li>Eliminate anything that doesn't help achieve customer specifications. </li></ul><ul><li>Minimize or eliminate anything the customer would be unwilling to pay for. </li></ul>
  53. 53. Project – Apply Lean Concepts & 5S to Refurbishing Pumps. <ul><li>Identify and eliminate Waste </li></ul><ul><ul><li>5S (Sort, Set in order, Shine, Standardize, Sustain) </li></ul></ul><ul><ul><li>Value Stream Maps </li></ul></ul><ul><ul><li>One Piece Flow </li></ul></ul><ul><li>Operational Improvement </li></ul><ul><ul><li>Process Flow & Lay out </li></ul></ul><ul><ul><li>Process Cycle Efficiency (PCE) </li></ul></ul><ul><ul><li>Process Balancing </li></ul></ul><ul><li>System Synchronization (Kaizen) </li></ul><ul><ul><li>Production Planning – capacity planning </li></ul></ul><ul><ul><li>Supply Chain – vendor participation </li></ul></ul><ul><ul><li>Distribution – customer pull, VOC, </li></ul></ul>
  54. 54. <ul><li>W hy are we in business – to satisfy a demand & make a profit </li></ul><ul><li>W hy would we make more profit using the 5s – time & space is consider value ($ # / # sq. ft) </li></ul><ul><li>W hy is time so critical – wasted time and space reduces profits </li></ul><ul><li>W hy & how is time & space related to 5s – using 5s helps identify & eliminate unnecessary time & space in producing product. </li></ul><ul><li>W hat is consider wasted time & space – Ex. misplaced tools, things in production that are not needed and take up space. </li></ul>5S – Seeing the benefits using 5W
  55. 55. 5S 3 Key Elements
  56. 56. 5S Sort (Def. & Implementation) <ul><li>Definition: </li></ul><ul><li>Sort refers to the practice of going through all the tools, materials, etc., in the work area and keeping only essential items. The goal is to remove all nonessential items from the work place. Everything else is either stored offsite or discarded. This leads to fewer hazards and less clutter. </li></ul><ul><li>Steps Taken for Implementing Sort: </li></ul><ul><li>Select Team members: </li></ul><ul><ul><li>Dario Guerrio, Juan Sandoal, Abel Cadena, Jane Nguyen, Kim Li, and Shannon McGowan. </li></ul></ul>
  57. 57. <ul><li>Area selected is Pumps Refurbish & Tear Down </li></ul><ul><li>Questions to ask to prevent confusion & wasted effort: </li></ul><ul><ul><ul><li>What is this? </li></ul></ul></ul><ul><ul><ul><li>When did you last use it? </li></ul></ul></ul><ul><ul><ul><li>Is it critical or unique for the department / operation? </li></ul></ul></ul><ul><ul><ul><li>If its inventory, is this the minimal amount needed to keep up with the production schedule? </li></ul></ul></ul>5S Sort (questions to ask)
  58. 58. <ul><li>Upon identifying items not belonging to the area fill out a Red Tag & place on item. </li></ul><ul><li>5 day Local holding “ Red Tag ” area is located in the east corner of Mfg. Area of building D7. </li></ul>5S Sort
  59. 59. <ul><li>Take before and after pictures of application areas. Ex. Disassembly, Cleaning, Discard Area, Bin Stacking, Assembly, Testing, Break-in, etc.. </li></ul><ul><li>After 5 days record and move items to the Central Red Tag area where everyone can sift through the items to see if there is something needed – records are used so company can track assets. </li></ul><ul><li>7. After 1 month items in the central area were either dispose of, recycled, trashed, donated or resold. </li></ul>5S Sort (Steps)
  60. 60. 5S Sort (Imp. Template)
  61. 61. 5S Set In Order (Def.) “ Set In Order” is a means to arrange needed items in the area and to identify or label them so that anyone can find them or put them away. Slogan: A place for everything and everything in it’s place so it should be easy to find. Goal: To arrange all needed work items in line with the physical workflow, and make them easy to locate .
  62. 62. <ul><li>Steps Taken for Implementing Sort: </li></ul><ul><li>Select team members: </li></ul><ul><ul><li>John Salvetierra, Jeff Kerner, Chuong Nugyen, Jamie Sipes, Bill Orais and Shannon McGowan. </li></ul></ul><ul><li>Selected areas are Refurbish Pumps & Tear Down at Entegris & Box Build at Jabil, PCB Test at KLA Tencor. </li></ul>5S Set In Order (Implementation)
  63. 63. <ul><li>Take before and after process time. </li></ul><ul><li>Look for ways to make the work place more visually instructive. </li></ul><ul><li>Label floor space, carts, tools, area, etc.. </li></ul><ul><li>Post acceptable & unacceptable work output. </li></ul><ul><li>Display charts on quality performance trends. </li></ul>5S Set In Order (Imp. Template)
  64. 64. <ul><li>Video sample of Set In Order </li></ul>Before After 5S Set In Order (Sample)
  65. 65. Before 5S Set In Order (Sample)
  66. 66. 5S Set In Order (Sample)
  67. 67. 5S Shine (Def.) <ul><li>To have a work place “ Shine ” one must remove dirt & debris, inspect & clean equipment, and eliminate sources of contamination. </li></ul><ul><li>Goal: </li></ul><ul><ul><li>Keep area and equipment clean so as to recognize anything out of place: </li></ul></ul><ul><ul><ul><li>Oil Leak from equipment, excessive heat, damage or worn tools or equipment. </li></ul></ul></ul><ul><ul><li>Improve quality by getting rid of contamination. </li></ul></ul>
  68. 68. <ul><li>Steps Taken for Implementing Shine: </li></ul><ul><li>Select team members: </li></ul><ul><ul><li>Mark Renolet, Jeff Kerner, Sam Vales, Jamie Sipes, Bill Orais and Shannon McGowan. </li></ul></ul><ul><li>Selected work areas are Assembly areas at Abbott Diagnostic, Refurbish Pumps & Tear Down at Entegris & Box Build at Jabil, PCB Test at KLA Tencor. </li></ul>Shine
  69. 70. 5S Create a Standard for common areas.
  70. 71. 5S Audit Forms Sort Set in Order Shine Standardized Sustain
  71. 72. 5S Seeing The Benefits <ul><li>One of the surest ways to identify these benefits is to establish and track specific metrics. Some examples are listed below. </li></ul><ul><li>Measure the time required to locate items in the workplace before 5S and then measure the time required after the workspace has been improved. </li></ul><ul><li>It is easier and faster to train employees in a work area that is orderly and well marked. </li></ul><ul><li>Take pictures in the work place before and after implementing 5S. Pictures are very effective at visually </li></ul><ul><li>Concrete measurements are a complement to the pictures, fueling the momentum needed to sustain 5S. </li></ul>
  72. 73. 6 Sigma <ul><li>Is broken into 3 major topics: </li></ul><ul><ul><li>A Statistical term & business metric (Process Capability) </li></ul></ul><ul><ul><li>A business strategy & initiative (Reduce Variation) </li></ul></ul><ul><ul><li>A problem solving / prevention system & methodology (DMAIC). </li></ul></ul>The objective of Six Sigma Quality is to reduce process output variation so that on a long term basis, which is the customer's aggregate experience with our process over time, this will result in no more than 3.4 defect Parts Per Million (PPM) opportunities (or 3.4 Defects Per Million Opportunities – DPMO
  73. 74. Design For Manufacturability (DFM) DFM – is the process and practice of designing products so it can be produced efficiently at the highest level of quality while considering manufacturing requirements. <ul><li>Guidelines: </li></ul><ul><li>Minimize Total Number of Parts </li></ul><ul><li>Develop a Modular Design </li></ul><ul><li>Minimize Part Variation </li></ul><ul><li>Design Parts to be Multifunctional </li></ul><ul><li>Design Parts to be Multiuse </li></ul><ul><li>Avoid separate fastener </li></ul><ul><li>Design Parts for Ease of Fabrication </li></ul><ul><li>Minimize Asm. Dir. </li></ul><ul><li>Maximize Compliance </li></ul><ul><li>Minimize Handling </li></ul><ul><li>Simplify Adjustments </li></ul><ul><li>Avoid Flexible parts </li></ul><ul><li>Implement Pull vs Push </li></ul>
  74. 75. Design For Manufacturability (DFM) <ul><li>Factory Design Considerations: </li></ul><ul><li>Cycle & Takt Time </li></ul><ul><li>Quality (SPC, 6 sigma, Lean Manufacturing, Tracking (barcode)) </li></ul><ul><li>Process Capability (Cp, Cpk, Process Maps) </li></ul><ul><li>Ease of Manufacturing (VOC, Value Analysis) </li></ul><ul><li>Ease of Assembly (Environment, Facility) </li></ul><ul><li>Ease of Testing </li></ul><ul><li>Service & Repair </li></ul><ul><li>Inventory (suppliers, availability, lead times) </li></ul><ul><li>Shipping (packaging, equipment, material) </li></ul>
  75. 76. Design Controls For Med. Devices <ul><li>What is Design Controls FDA 21 CFR PART 820.3: </li></ul><ul><li>Design & Development – Planning </li></ul><ul><li>Design Inputs – Origin of Requirements </li></ul><ul><li>Design Outputs – Documents to be build </li></ul><ul><li>Design Review – On Track </li></ul><ul><li>Design Verification – Output same as Input </li></ul><ul><li>Design Validation – Design same as customer requirements </li></ul><ul><li>Design Transfer – To manufacturing </li></ul><ul><li>Design Changes – Correct and upgrade the design </li></ul><ul><li>Design History File – Document Design, & Design process </li></ul>
  76. 77. 21 CFR Part 820 cGMP cGMP are set forth in the QMS regulations. The requirements used to govern the methods used the facilities, design, manufacturing, packaging, labeling, storage, installation, and servicing of all devices intended for human use.
  77. 78. 21 CFR Part 820 820.5 Quality System – maintain a quality system appropriate for medical device mfg.. 820.20 Mgmt. Resp. – shall establish its policy & objectives for commitment to quality. 820.22 Quality Audit – are conducted to assure that the quality system is in compliance with the establish quality system requirement and to determine the effectiveness of the quality system. 820.25 Personnel – shall have sufficient personnel with the necessary education, background, training, & experience to assure that all activities required are correctly done. 820.30 Design Controls – Class I, II, III shall establish and maintain procedures to control the device in order to ensure that specified design requirements are met. 820.40 Document Control – shall establish & maintain procedures to control all documents. 820.50 Purchasing Control - shall establish & maintain procedures to ensure that purchased or otherwise received product and services confirmed to specified requirements. 820.60 Identification - shall establish & maintain procedures for identifying product during all stages. 820.65 – Traceability – each mfg. of a device that is intended for surgical implant into the body can be identified with control number of each unit, lot, or batch #. 820.70 – Production & Process controls - shall develop & monitor production process to ensure device conforms to its specification.
  78. 79. 21 CFR Part 820 820.72 – Inspection, measuring, & test equip. – each mfg. Shall ensure all equip. is suitable for its intended purpose & is capable of producing valid results. 820.75 – Process Validation is where a process can be fully verified by inspection & test, validated & approved. Each mfg. shall ensure validated process are performed by qualified individual, continual monitoring of control methods of data is documented & dated. If process changes or deviates, mfg. Shall re-evaluate & perform revalidation where appropriate. 820.80 – Receiving, in-process, & finished device acceptance – each mfg. Shall establish & maintain procedures for accepting incoming product & outgoing product. Finish devices shall not be released for distribution till required activities have been completed. 820.86 – Acceptance Status – Each mfg. Shall be able to identify status of acceptance of each product 820.90 – Nonconforming Product – Each mfg. Shall maintain procedures to control nonconforming product that include identification, doc., evaluation, segregation, & disposition. The evaluation will include a decision whether or not a need of an investigation is required and the people associated. 820.100 – CAPA – Each mfg. Shall maintain procedures for implementing CAPA that include analyzing, investigating, identifying, verifying, implementing, relaying info related to problem to those directly responsible for assuring quality of product. 820.120 – Device Labeling – Each mfg. shall establish & maintain procedure to control labeling activities. 820.130 – Device Packaging – Each mfg. shall ensure the packaging containers are design to protect the device from alteration or damage during handling, shipping, & storage.
  79. 80. 21 CFR Part 820 820.140 - Handling – Each mfg. shall establish & maintain procedures to ensure that mix-ups, damages, deteriorations, contamination, or other adverse effects to product do not occur during handling. 820.150 – Storage – Each mfg. shall establish & maintain procedures for control of storage areas and stock rooms for prevent mix-ups, damage, contamination, etc. 820.160 – Distribution – Each mfg. shall establish & maintain procedures for control & distribution of finished devices that include name & address of the initial consignee, ID & quantity, date, and control number. 820.170 – Installation - Each mfg. of a device requiring installation shall establish & maintain installation instructions. 820.180 – Records Requirements – shall be maintain at the mfg. establishment that is accessible to responsible officials of the mfg & employees of FDA. 820.181 – Device Master Records - Each mfg. shall maintain DMR. 820.184 – Device History Records - Each mfg. shall maintain DHR. 820.186 – Quality System Records - Each mfg. shall maintain QSR. 820.198 – Complaint Files - Each mfg. shall maintain complaint files.
  80. 81. 21 CFR Part 820 820.200 – Servicing – Where servicing is required Each mfg. shall establish & maintain instructions & procedures for performing and verifying servicing meets the specified requirements. 820.250 - Statistical Techniques – Where appropriate Each mfg. shall establish & maintain procedures for identifying valid statistical techniques required for establishing, controlling, and verifying the acceptability of process capability and product characteristics.
  81. 82. ISO 13485 - 5 Principal Elements <ul><li>Quality Management System : </li></ul><ul><li>Documentation requirements </li></ul><ul><li>Quality Manual </li></ul><ul><li>Control of Documents </li></ul><ul><li>Control of Records </li></ul><ul><li>Management Responsibility </li></ul><ul><li>Management Commitment </li></ul><ul><li>Customer Focus </li></ul><ul><li>Quality Policy </li></ul><ul><li>Planning </li></ul><ul><li>Responsibility, authority & communication </li></ul><ul><li>Resource Management : </li></ul><ul><li>Human Resources </li></ul><ul><li>Competence, awareness, training. </li></ul><ul><li>Infrastructure </li></ul><ul><li>Work Environment </li></ul><ul><li>Production Realization: </li></ul><ul><li>Planning </li></ul><ul><li>Customer-related Process </li></ul><ul><li>Design & Development inputs, outputs, review, verification, validation, changes </li></ul><ul><li>Purchasing </li></ul><ul><li>Control of Monitoring & Measuring Dev. </li></ul>
  82. 83. ISO 13485 - 5 Principal Elements <ul><li>Measurement, Analysis, & Improvements : </li></ul><ul><li>Monitoring & Measuring </li></ul><ul><li>Internal Audit </li></ul><ul><li>Monitoring & Measuring Processes </li></ul><ul><li>Monitoring & Measuring of Product </li></ul><ul><li>Control of Nonconforming Product </li></ul><ul><li>Analysis of Data </li></ul><ul><li>Improvement with continual improvement, CAPA </li></ul>
  83. 84. Verification & Validation for Medical Devices <ul><li>Regulations & Standards for V & V: </li></ul><ul><li>FDA Design Controls – 21 CFR 820.30 </li></ul><ul><ul><li>Design Verification shall confirm that the design output meets the design input requirements. The results of the design verification, including ID of the design, methods, the date and the individuals performing the verification, shall be documented in the DHF. </li></ul></ul><ul><ul><li>Design Validation shall be performed under defined operating conditions on initial production units, lots, or batches, or their equivalents. Design validation shall ensure that devices conform to defined user needs and intended uses and shall include testing of production units under actual or simulated use conditions. </li></ul></ul><ul><li>ISO 13485: 2003 – Quality Management System for MD Manufacturing. </li></ul><ul><ul><li>7.3.5 Design Verification & 7.3.6 Design Validation </li></ul></ul><ul><li>ISO 14971: 2007 – Application of Risk Mgmt. To Medical Devices </li></ul><ul><ul><li>6.3 Implementation of risk control measures. </li></ul></ul>
  84. 85. Verification & Validation for Medical Devices <ul><li>Key Tasks in V & V </li></ul><ul><li>Establish product requirements and perform risk analysis (what exactly are we building and how can it hurt someone?) </li></ul><ul><li>Determine the applicable standards (what do regulators say we have to test?) </li></ul><ul><li>Develop a test plan </li></ul><ul><li>Develop test methods, as necessary </li></ul><ul><li>Write test protocols (draft) and perform informal testing </li></ul><ul><li>Validate test tools </li></ul><ul><li>Build devices to test </li></ul><ul><li>Release test protocols </li></ul><ul><li>Execute test protocols </li></ul><ul><li>Evaluate results and write test reports. </li></ul>
  85. 86. Verification & Validation for Medical Devices <ul><li>Key Concepts for V & V: </li></ul><ul><li>Well-written requirements & risk analysis are crucial to V& V(make sure requirements are verifiable!) </li></ul><ul><li>Some tests are more important that others (risks) </li></ul><ul><li>Much of the testing that needs to be done is already defined in applicable standards. </li></ul><ul><li>Formal V & V testing should be performed </li></ul><ul><ul><ul><li>Using calibrated and controlled test equipment </li></ul></ul></ul><ul><ul><ul><li>According to written protocols that include pre-defined conditions for testing and acceptance criteria. </li></ul></ul></ul><ul><ul><ul><li>Using test protocols which were approved prior to use </li></ul></ul></ul><ul><li>Test protocols and test reports should become part of the Design History File </li></ul><ul><li>If you do not control the configuration of the device under test then the test results are meaningless. </li></ul><ul><li>Start testing early in development; develop test methods as product develops. </li></ul>
  86. 87. Process Validation
  87. 88. Risk Management
  88. 89. SolidWorks - Sample
  89. 90. Gage R & R <ul><li>Define: Involves evaluating the Reliability & Repeatability of a measurement system. </li></ul><ul><li>Repeatability refers to the inherent variability of the measurement system. It is the variation that occurs when successive measurements are made under the same conditions. </li></ul><ul><ul><li>Same person Same part </li></ul></ul><ul><ul><li>Same characteristic Same instrument </li></ul></ul><ul><ul><li>Same set-up Same environment </li></ul></ul><ul><li>Reproducibility has the same bullet points above except the variation in the average of the measurements made by different operators using the same measurement instrument and technique when measuring the identical characteristic on the same part or process. </li></ul>
  90. 92. Decision Rules
  91. 93. Kaizen <ul><li>Define: Is used for intensive project where emp. Are pulled off their regular job. </li></ul><ul><li>Team works 3 to 5 days full time (spreading project work over 3 to 6 months. </li></ul><ul><li>Team spends 100% of their time on the project during the event </li></ul><ul><li>Project is well define going in (boundaries must be well defined ahead of time) </li></ul><ul><li>Basic Data already gathered. </li></ul><ul><li>Basis for action (will act when 70 to 80% confident vs. 95% in typical DMAIC </li></ul><ul><li>Implementation is completed as much as possible during the event </li></ul><ul><li>Items that cannot be finished during the event are to be completed within 20 days </li></ul><ul><li>When to use Kaizen: </li></ul><ul><li>When obvious waste sources have been identified </li></ul><ul><li>When the scope & boundaries of a problem are clearly defined & understood. </li></ul><ul><li>When implementation risk is minimal. </li></ul><ul><li>When results are needed immediately. </li></ul><ul><li>In the early stages of deployment to gain momentum & build credibility of the DMAIC. </li></ul><ul><li>When opportunities to eliminate obvious sources of instability & waste have been identified through process mapping, work area tour, data collection, etc. </li></ul>
  92. 94. Kaizen Example Layouts, Screw to long, Screw loose, Process redundant, creating to many failures, paint, cosmetic

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