Corrective Action Preventative ActionPreventative …

1 Corrective ActionCorrective ActionPreventative ActionPreventative ActionPreventative ActionPreventative ActionDefining Alternatives toDefining Alternatives to TrainingAs a Root CausePresentation SponsorsPresentation Sponsors Corporate Quality Director at MME Group Inc ISO 9001:2008 & ISO 13485-:2003 Certified Customer Base includes a who s who in Medical, Safety and Government and Government industries. Chief Operating Officer at Twin Cities Medical Valley Health & Medical company providing networking, advertising, support, news and data to the Health and Medical Medical community. Communications Chair at MN ASQ 1203 BA in Business from Baker College (Flint, MI) Significant Training in Lean, Six Sigma, Employee Development, Strategic Planning and Auditingand Auditing Over 20 years in Quality Roles in Inspection Engineering and ManagementRoles in Inspection, Engineering and Management.

2 Microelectronics for Medical and Health industry Contract Manufacturing Plastic and Metal components and assemblies. MN ASQ Website Twin Cities Medical Valley Websitejsykes@mmegroup Linkedin TCMV QEN MNASQMNASQ Jay Sykes Successful implementation of CAPA is highly dependent upon understanding performance indicators and effectively using them to identify performance deficienciesidentify performance deficiencies. When training is used as a default response in Corrective actions, Preventative actions andin Corrective actions, Preventative actions and system audit responses, the opportunity to leverage CAPA for continuous improvement and strategic advantage is lost.

3 We will review the many forms of Corrective and Preventative actions. We will then turn our attention to Root Cause Analysis with a focus on understanding the 6 Analysis with a focus on understanding the 6 phases of Performance Taking away recognition that training is only Taking away recognition that training is only one seventh of the performance indicator elements. Corrective & Preventative Action Review Defining Performance Indicators Organizational Culture Impact Philosophy to Application The New Economics -Dr. Edward Deming Let s Talk Quality -Phillip Crosby Quality Planning and Analysis , Quality Control Handbook-6thAddition -Juran Implementing Six Sigma2ndAddition Forrest Implementing Six Sigma-2ndAddition Forrest Breyfogle The Oz Principle , Journey to the Emerald City -Craig Hickman, Tom Smith, Roger Connors Crosby Stills & Nash Crosby, Juran, Harrington, of methodologiesReview of methodologies Improvement to an organization's processes taken to eliminate causes of non-conformities or other undesirable situations.

4 ReactiveCorrective Reactive Corrective Preemptive - Preventative 4 Step- PDCA-Deming-Shewart 5 Step- DMAIC- 6 Step- Six Step Several Versions. 8 Step- 8D Eight Disciplines4 StepProcess4 Step Process Establish the objectives and processes necessary to deliver results in accordance with the expected output (the target or goals)goals). By establishing output expectations, the completeness and accuracy of thecompleteness and accuracy of the specification is also a part of the targeted improvement. When possible start on a small ffscale to test possible effects. Implement the plan, execute the process, make the product. Collect data for charting and analysis in the following "CHECK" and "ACT"stepsACT steps.

5 Study the actual results (measured and collected in "DO" above) and compare against the expected results (targets or goals from the"PLAN") to ascertain any differencesthe PLAN ) to ascertain any differences. Charting data can make this much easier to see trends over several PDCA cycles and insee trends over several PDCA cycles and in order to convert the collected data into information. Information is what you need for the next step "ACT". Request Corrective actions on significant differences between actual and planned resultsdifferences between actual and planned results. Analyze the differences to determine their root causes. Determine where to apply changes that ill i l d if hwill include improvement of the process or product.

6 When a pass through these four steps does not pgpresult in the need to improve, the scope to which PDCA is applied may be refined to plan and improve with more detail in the next iteration ofimprove with more detail in the next iteration of the cycle, or attention needs to be placed in a different stage of the process. 5 StepProcess5 Step Process Define the problem, the voice of the customer, and the project goals, specifically. Measure the key aspects of the ypcurrent process and collect relevant datarelevant data. Analyze the data to investigate and gverify cause-and-effect relationships. Determine what the relationships are, and attempt to ensure that all factors have been considered.

7 Seek out root cause of the defect under investigation. Improve or optimize the current process based upon data analysis using techniques such as design of experiments, poka yoke or mistake proofing, and standard work to create a new, future state process. Set up pilot runs to establish process capability. Control the future state process to ensure that any deviations from target are corrected before they result in defects. Implement control systems such as statistical process control, production boards , visual workplaces, and continuously monitor the process. 6 StepProcess6 Step Process Define the problem, non-conformance or potential issue.

8 Define and implement temporary countermeasures to contain the problem. Conduct analysis to determine the root cause of the problem. Define and implement permanent countermeasure that will prevent re-occurrence. Analyze data to determine the effectiveness of the actions implemented. Determine and update all procedures/processes and documentation to the improved Step Root Cause CountermeasuresIl tC Effectiveness of Counter Measure8 Implement New New Control 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 (5W2H) for the problemand how many (5W2H) for the problem.

9 Of the team. The team needs to be formally thanked by the organizationthanked by the organization D3: Developing Interim Containment Plan Implement and verify Interim Actions: Define and implement containment actions to isolate the problem from any customerthe problem from any customer. D4: Determine and Identify and Verify Root Causes and escape points: Identify all applicable causes that could explain why the problem has occurred Also identify why theproblem has 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. One can use 5 Whys or IhikDiti tIshikawa Diagram to map causes against effect/Problem identified.

10 D5: Choose and verify Permanent Corrections (PCs) for Problem/Non Conformity: Through pre-production programs quantitatively confirm that the selected correction willconfirm that the selected correction will resolve the problem for the customer. D6: Implement and validate PCAs: Define and Implement the best Corrective actions. D7: Prevent recurrence/ Corrective Actions: Modify the management systems, operation systems, practices, and procedures to prevent recurrence of this and all similar problemsrecurrence 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 organizationCorrective And Preventative ActionCorrective And Preventative Action Planning Stage Teams, Problem Definition, Containment Activities Root Cause StageArguably the single most important element of the Arguably the single most important element of the problem solving process.