Corrective Action Workshop CAPA Based on 8D Methodology Angelo G. Scangas President, Quality Support Group Inc. 978-430-

1. Corrective Action WorkshopCAPABased on 8D MethodologyAngelo G. ScangasPresident, Quality Support Group Inc.978-430-7611

2. Objectives – Training expectations • At the conclusion of this module, you should: • Have an understanding of the basic tools and the knowledge needed to collect and analyze data to solve problems that affect the quality of your products and services. • Be better able to implement solutions and containment actions. • Have a full understanding of the key elements of the problem solving process (Root Cause Analysis). • Develop a verification process to prevent re-occurrence • Share a uniform basis and approach in the methodology of problem solving.

3. Order of topics in training module. • Trigger points for problem solving activity • Case Study • The Problem Solving Approach • Problem Statement • Interim Action / Containment. • Problem Definition and Analysis of Root Cause. • Define Root Cause and Escape Point. • Choose and Verify Corrective action. • Implement and Validate Corrective Action. • Prevent Recurrence. • Congratulate the Team

4. The Eight Disciplines D0 Recognize Symptoms D1 Establish a Team D2 State and Describe the Problem D3 Contain the Symptoms D4 Find and Verify Root Cause D5 Select and Verify Corrective Action D6 Implement and Verify Permanent Corrective Action D7 Prevent Recurrence and Correct System Flaws D8 Recognize the Team

5. Problem-Solving Process Identify Potential Causes Select Probable Causes Is Probable Cause a Root Cause? Find Root Cause Become Aware of Problem Establish Team Describe Problem Contain Systems Select & Verify Corrective Actions Prevent Recurrence Implement and Validate Corrective Actions Recognize Team

6. Trigger points for problem solving activity. What trigger points have you experienced? • Customer Complaints • Non-Conformances • Process Control Indicators • Cost Reduction Effort • Continuous Improvement Effort • Suggestion

7. The Problem Solving Approach 1. Problem Statement. 2. Interim Action / Containment. 3. Problem Definition and Analysis of Root Cause. 4. Define Root Cause and Escape Point. 5. Choose and Verify Corrective action. 6. Implement and Validate Corrective Action. 7. Prevent Recurrence.

8. What’s The Problem?“A problem well-defined is a problem half-solved.” Problem Statement • The problem statement is a statement that clearly and concisely identifies the object of a problem, and the unsatisfactory condition for which the cause is not known. What is the problem? Why is it a problem? Based on what evidence? Problem statement

9. The Problem Solving Approach 1. Problem Statement. 2. Interim Action / Containment. 3. Problem Definition and Analysis of Root Cause. 4. Define Root Cause and Escape Point. 5. Choose and Verify Corrective action. 6. Implement and Validate Corrective Action. 7. Prevent Recurrence.

10. Remember... Containment does not eliminate the root cause of the problem. Inform Customer of problem and actions taken to contain it. Customer Loyalty is an organization’s greatest asset!

11. The Problem Solving Approach 1. Problem Statement. 2. Interim Action / Containment. 3. Problem Definition and Analysis of Root Cause. 4. Define Root Cause and Escape Point. 5. Choose and Verify Corrective action. 6. Implement and Validate Corrective Action. 7. Prevent Recurrence.

12. What is the Problem Definition? The Problem Definition is a detaileddescription of the relevant facts of the problem, assembled from information readily available, as well as additional fact finding and data collection. “Fact List” Problem definition and analysis

13. What does the Problem Definition do? It defines the boundaries of the problem in terms of what it IS, and what it could be but IS NOT. It looks at all the possibilities, and eliminates the ones that are not part of the problem. It limits the search by excluding logical impossibilities. It clarifies and pins down the facts. Problem definition and analysis

14. Is/Is Not

15. What is a “Root Cause”? A root cause is the reason for a condition or an action at its origin or source. In the context of problem solving, a root cause is one considered to be far enough into the sequence of causes and effects, that removing it will eliminate the effect completely and permanently. Problem definition and analysis

16. Problem Definition and Analysis process How to do it…. 1. Develop a list of facts to record all relevant information that is known with certainty. This list serves as a database for an accurate description of the problem. Information must be factual, not inferred. Problem definition and analysis

17. Data collection techniques Methods used to conduct or facilitate collection of data • Check-sheets • Observations • Interviews • Statistical Process Control charts • Process Capability Studies • Design of Experiments • Test reports • Scrap reports Problem definition and analysis

18. Separate the vital few from the trivial many Analysis Tools Pareto Diagram 100 100% 90 90% 80 80% 70 70% 60 60% 50 50% 40 40% 30 30% 20 20% 10 10% 0 0% Defect Type Problem definition and analysis

19. Analysis Tools Cause-and-Effect Diagram Used to structure data collection and analysis to find the root cause of a problem. Machines Methods People Problem Materials Environment Problem definition and analysis

20. 1st why? Analysis Tools Cause-and-Effect Analysis Cause (Machine) Use for grouping ideas. Any grouping that make sense can be used. The most common are: Methods, Machines, Materials, People and Environment 2nd why? 4th why? 3rd why? 5th why? Effect The Problem Cause (Method) Problem definition and analysis

21. Analysis techniques • Brainstorming • Repeated Whys Why it happened, why it wasn’t detected Other analysis techniques • 3W1H What, Where, When, How big • 5W2H What, Why, When, Where, Who, How, How many • Timeline of changes to people, material, machines, suppliers, measurements, methods, environment, specifications. • Comparative analysis: IS versus IS NOT • Comparative analysis: Should Vs. Actual • Reproduction of the problem • Review of Failure Mode and Effects Analysis . S Problem definition and analysis

22. Output from the Problem Definition and Analysis process. The output from the Problem Definition and Analysis process is a list of potential root causes each of which could explain the occurrence of the problem. Problem definition and analysis

23. The Problem Solving Approach 1. Problem Statement. 2. Interim Action / Containment. 3. Problem Definition and Analysis of Root Cause. 4. Define Root Cause and Escape Point. 5. Choose and Verify Corrective action. 6. Implement and Validate Corrective Action. 7. Prevent Recurrence.

24. Define root cause and escape point Which is the Root Cause? • The root cause is the one identified that satisfies the requirement of completely explaining the effect. It is the single verified reason that accounts for the problem. • The root cause is supported by the facts without contradiction. • The root cause is the one whose removal should make the effect stop permanently. Define root cause and escape point

25. Define root cause and escape point (continued) Inability to detect the problem at a control point is NOT a root cause. (Conversely, the ability to detect the problem does not remove the root cause.) Which is (NOT) the Root Cause? S Define root cause and escape point

26. The Problem Solving Approach 1. Problem Statement. 2. Interim Action / Containment. 3. Problem Definition and Analysis of Root Cause. 4. Define Root Cause and Escape Point. 5. Choose and Verify Corrective action. 6. Implement and Validate Corrective Action. 7. Prevent Recurrence.

27. Criteria for a Permanent Corrective Action What does a good corrective action do? • Fixes the problem at the root cause level • Generates no additional problems • Has been verified to work It’s best if the corrective action can be designed so it does not require detection. (Mistake proof) Choose and verify corrective action

28. The Problem Solving Approach 1. Problem Statement. 2. Interim Action / Containment. 3. Problem Definition and Analysis of Root Cause. 4. Define Root Cause and Escape Point. 5. Choose and Verify Corrective action. 6. Implement and Validate Corrective Action. 7. Prevent Recurrence.

29. Corrective Action implementation plan • Develop a detailed implementation plan. Be sure to include What, Where, When, Who, and How (4W and 1H). • Involve those who will be affected. • Inform those who need advance notification. • Secure approvals when necessary. • Track timing of implementation. • Control any product affected by a change. Implement and validate corrective action

30. 4W’s and 1 H What How Where When Who ( will be done) (will it be done) (will it be done) (will do it) (will it be done) Implement and validate corrective action

31. The Problem Solving Approach 1. Problem Statement. 2. Interim Action / Containment. 3. Problem Definition and Analysis of Root Cause. 4. Define Root Cause and Escape Point. 5. Choose and Verify Corrective action. 6. Implement and Validate Corrective Action. 7. Prevent Recurrence.

32. Prevent Recurrence • The way to prevent recurrence of the problem is to standardize the corrective action and the lessons learned into the operating system for the process. Prevent Recurrence

33. That’s a wrap!Thank you! • Any further questions? • +’s and ∆’s