Work experience & education

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. CAPA - DMAIC

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. 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. 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. Cause & Effect ( Fish Bone )

13. 5 M ’ s – Root Causes

14. Hypothesis Testing Sample 1 & 2

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. ANOVA (continue) Step 4: Construct ANOVA table Stat>ANOVA>One way Input: Response=Response, Factor=material, √ = store residuals & store fits

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. ANOVA (continue)

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 ]

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.

31. Improvement – Process Map Process Map of Sensor Isolator Burn In

33. Improvement – Value Stream Maps CT = Cycle Time PT = Process Time CO =

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. 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. 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

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. 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. 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. 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. 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. 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

46. Elements of FMEA

48. FMEA – 1 st Why

49. FMEA – 2 nd Why

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.

55. 5S 3 Key Elements

60. 5S Sort (Imp. Template)

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 .

65. Before 5S Set In Order (Sample)

66. 5S Set In Order (Sample)

70. 5S Create a Standard for common areas.

71. 5S Audit Forms Sort Set in Order Shine Standardized Sustain

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.

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.

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.

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.

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.

87. Process Validation

88. Risk Management

89. SolidWorks - Sample

92. Decision Rules

94. Kaizen Example Layouts, Screw to long, Screw loose, Process redundant, creating to many failures, paint, cosmetic