Operating Excellence is built on Corrective & Preventive Actions
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This document provides an overview of Corrective Action Preventive Action (CAPA) and how to implement an effective CAPA process. It defines CAPA and explains the difference between corrective and preventative actions. It outlines the benefits of a mature CAPA system, including increased quality, reduced costs from problems, and improved customer satisfaction. The document then discusses various tools that can be used in the CAPA process, including root cause analysis techniques like 5 Whys, fishbone diagrams, and Pareto charts to identify causes and prioritize actions. Examples are provided for how to apply these tools to analyze specific business processes.
Operating Excellence is built on Corrective & Preventive Actions
- 1. Thank You Corrective Action Preventive Action A Framework
- 2. Agenda CAPA Problem Solving Process Root Cause Analysis RCA Techniques Solution Effectiveness CAPA Template & Examples
- 3. What is CAPA? Correction Action taken to eliminate the detected non-conformity Corrective Action Action taken to eliminate the root cause and symptom of an existing deviation or nonconformity to prevent recurrence The horse has already escaped the barn This is a REACTIVE action that eliminates proble ms identified in products, services, or processes and takes care of the immediate problem Preventive Action Action taken to eliminate the potential causes of a nonconformity, defect, or other undesirable situation in order to prevent occurrence Non-Conformity (NC) Unexpected, unwanted events affecting Standard, rules and laws This is a PROACTIVE action which avoids deviation through planned activities. It also eliminates or reduces the recurrence of the problem.
- 4. A mature CAPA system can serve as a useful tool for analyzing past events, correcting existing non conformities and preventing future events. A mature CAPA system goes beyond regulatory compliance to positively impact our customers by increasing the value of our products and services. Proposal CAPA Process - structured, formalized way to investigate NC and determine appropriate corrections, corrective actions and preventative actions and measure their effectiveness. (With records) Mature CAPA Process
- 5. What are the benefits of using CAPA? If used properly, the CAPA system will provide a means to prevent the deviation from recurring. How…? It provides a structured platform to conduct a systematic investigation of the deviation. The investigation provides the means to develop a permanent corrective action It provides a framework for documentation that the corrective actions are indeed effective. Additionally, a CAPA system is the cornerstone of the organization’s Quality Management System (QMS).
- 6. Why CAPA? DescriptionObjective Quality problems can have a significant financial impact on a company. Good Business Practice Discipline among employees about importance of qualityEmployee Involvement Customer Satisfaction The ability to correct existing problems or implement controls to prevent potential problems is essential for continued customer satisfaction.
- 7. When to use CAPA ? • External Customer (ie., Vendor, Symantec) Escalations / Complaints on calls / phone / emails • Internal Customer (ie., downstream processes, peers) Escalations / Complaints on calls / phone / emails • QC errors / Spot check errors • Any red / yellow in any performance metrics • Negative / development feedback in NPS action responses Any negative metric or comment (“real or perceived”) reported , logged or escalated should be part of the CAPA to analyze and address the business issue and manage customer perception effectively
- 8. Steps to be followed Step No Description of the Steps to be followed Aspect 1 Register the complaint Correction 2 Make correction on immediate basis on the issue 3 Analyze as to why the mistake happened to find the “Root Cause” of the issue Corrective Action4 Identify the best possible Corrective Action on the root cause to prevent the error from recurring 5 Implement the same on the shop floor 6 Check if the same issues can occur in other areas/process/department Preventive Action 7 If yes check the feasibility to implement the same corrective action as a preventive action in the other areas/process/departments
- 9. Problem- Solving Process Become Aware of Problem Establish Team Describe Problem Contain Systems Select & Verify Corrective Actions Implement and Validate Corrective Actions Prevent Recurrence Recognize Team Find Root Cause Identify Potential Causes Select Probable Causes Is Probable Cause a Root Cause?
- 11. What is the Problem Definition? The Problem Definition is a detailed description of the relevant facts of the problem, assembled from information readily available, as well as additional fact finding and data collection. The Problem Solving Approach 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. Information must be factual, not inferred.
- 12. 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? 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. Which is the Root Cause?
- 13. A thorough investigation will provide the needed information to establish the root cause. The following questions are useful in gathering data during a Root Cause Analysis (RCA). – Who was involved in the deviation? – What was the deviation? – Where did the deviation occur? – When did the deviation occur? – How did it happen? – How frequently does it happen? The questions serve to capture the maximum amount of detail regarding the deviation or occurrence. They help provide data to understand why the deviation occurred RCA Questions
- 14. The Root Cause Analysis is also aided by asking questions that relate to controls to deviation. Describe any physical, organizational, or process controls in place to detect deviations. Were the controls in place? What was their level of effectiveness? Describe any barrier failures. Are there environmental problems? – Are the work conditions suitable? – Are there process flow problems? – Are there facilities problems? Are instructions for use clear? Are there problems with staff communication or staff training? – Is there adequate supervision? Are there problems with the methods, SOPs, forms, or task analysis? – Do the steps performed match the operating procedures? – Has a process recently changed? More RCA Questions
- 15. Analysis Tools - Pick a Systematic Technique The Problem Solving Approach Pareto Diagram Separate Vital few from Trival Many Cause-and-Effect Diagram Used to structure data collection and analysis to find the root cause of a problem RootCause W hy -1 W hy -2 W hy -3 W hy -4 W hy -5 5 Whys? Analysis techniques Brainstorming Repeated Whys Why it happened, why it wasn’t detected etc.,
- 16. 5 Why analysis 1 • Formalize the problem on which the team will focus (a simple opportunity statement). • Involve everyone with relevant experience 2 • Ask Why the problem occurs and write the answer down below the problem (visible to the team such as on a white board). 3 • Continue to ask why until it seems improbable that the team can reasonably drill down further. • Note that 5 is a standard and iterations may take more or less than 5 whys to get to the root cause of the problem. Most effective when day to day business process problems involve human interactions or factors. When to use it? Steps Outcome Used to determine the root cause of a problem by drilling down through several repetitions of “Why” a problem exists. Purpose A question-asking technique used to explore underlying cause and effect relationships to problems. Definition The final why will quickly lead the team to a root cause upon which action can be taken while dissuading the participants from getting stuck in logic traps. This root cause should be changed to improve and controlled to sustain the improvement.
- 17. Business Process Example- 5 Why analysis Observation: Major part of the billing errors are contributed by 4 locations Why? Observation: Users citing the ERP system as challenging Why? Observation: Pricing capture process for ERP too complicated Why? Observation: Users not sure about the price to be input into ERP Why? Observation: Multiple price list provided to user, mainly from Sales, Corporate and Distributions Investigation: When was the last refresher training conducted. Are SOPs followed for the Pricing capture process? Result: Refresher Training was conducted approx. 2yrs back. Conclusion: To reduce the billing errors, SOPs has to be reinforced with robust refresher training plans Billing Errors ERP Challenges Complicated Process Users unsure about Process Reinforce SOPs & Refresher trainings
- 18. RootCause Why-1 Why-2 Why-3 Why-4 Why-5 RCA 1 - 5 Why Analysis Example Problem Statement: Wrong Attachment was sent to the customer. (Instead of invoice Copy a Purchase order Copy was sent). Why 1- Why was wrong attachment sent to the customer? Because Processor inserted the wrong file into the mail. Why 2- Why did the processor insert the wrong file? Processor was not able to distinguish between a Invoice Copy and a Purchase order Copy Why 3- Why processor is not able to distinguish between these two? Because the title of the file saved is almost similar Why 4- Why is the file name almost similar? Because there is no specific prefixes identified to save these copies 5 Why Analysis: Example
- 19. Repeat Errors – Detect multiple causes There can be N number of reasons for an error. A B C… source of errors (Can be any of the 5 Ms from Cause and effect). A1, A2, A3… exact cause in that particular source of error. Consequences of acting on one source of errors root cause will help us to identify the exact particular source of a error, but there can also be other potential sources through which the same error can occur C B D A A2 C2 D2 B2 RCA 2 - Fish bone
- 20. Fishbone Analysis 1 • Define the problem/effect which the team understands and agrees. 2 • Brainstorm all possible causes, bring in as many relevant causes to the problem, do not try to critically evaluate them for the moment. 3 • Start catagorizing the issues into logical subgroups. • 4 Ps, 6 Ms 4 • Do a 5 Why analysis to understand the root cause of each of the problems that the group comes up with. 5 • Map the root causes in sub-nodes or sub catagories. List down all potential causes. Gain insights from a larger group of people. To drive discussion among many team members. As eliminate possibilities of leaving an unknown cause. To get better understanding of a metric or required outcome When to use it? Steps Outcome To analyse a problem in details with the help of brainstorming among end users, SMEs, stakeholders. It helps in finding all the relevent issues affecting a business outcome. Purpose A structured problem solving approach to identify possible problems/effects. Also called a Cause and Effect Analysis and Ishikawa diagram. It looks like a de-skinned fishbone. Definition A skeleton of a fish like structure where the head of fish starts the problem and each bone attached to the rib is a major category of problems. These major categories have various issues which in turn has root cause coming out of 5 Why analysis
- 21. Reasons for MSS inaccuracy for billing Lack of training material Policies Ownership People (Ownership/ Rigor) Not 1st time right record creation Procedures Universal access Algorithm to calculate billing number Technology Allows mistakes No formal training intervention for HR (as doers or as mentors) Access: COE level No system validation Policies No Penalty HR/FLM/SPOC overlap No changes post exit login Approval hierarchies No SOP on billing related fields No hints available while making changes No formal training intervention for Ops Pre-populated default values Excel sheet corrections allowed No dashboards Bulk hiring (growth)- billing details not known Back fill- incorrect alignment Non usage of Employee database for billing (alternate process for billing allowed Business Process Example
- 22. Pareto Analysis Chart 1 •Create a data table of factors and its frequency sorted in ascending order 2 •Calculate the cumulative percentage for each factor 3 •Create a bar chart from the data table with cumulative % 4 •Change the chart style of cumulative % series to line chart and select it as secondary axis 5 •Major factors will be represented as the highest bars at the left hand side of the chart To choose which causes to eliminate first. When there are many problems or causes and you want to focus on the most significant When analyzing data about the frequency of problems or causes in a process When you are weighing options to prioritize which one would yield maximum result When to use it? Steps Outcome Pareto chart helps to visually identify the important factors which contributes to large portion of the outcomes by highlighting the most frequent occurring ,among a set of factors. It is based upon the principle that roughly 80% of the effects comes from 20% of the causes. Purpose A technique used for decision making based on the Pareto Principle, known as the 80/20 rule. Pareto analysis is based on the idea that 80% of a project's benefit can be achieved by doing 20% of the work or conversely 80% of problems are traced to 20% of the causes. Definition Couple of bars will be significantly higher than the rest which will enable to select the vital few items for further actions
- 23. Business process example To reduce the DSO from 84 days we have identified a project on improving the Billing accuracy. We need to know where to start or what is the focus area? Use Pareto Analysis ( 80/20 rule) to depict the below graph Seven steps to identifying the important causes using Pareto Analysis: ¹ Form a table listing the causes and their frequency as a percentage. Arrange the rows in the decreasing order of importance of the causes, i.e. the most important cause first. Add a cumulative percentage column to the table. Plot with causes on x-axis and cumulative percentage on y-axis. Join the above points to form a curve. Plot (on the same graph) a bar graph with causes on x-axis and percent frequency on y-axis. Draw a line at 80% on y-axis parallel to x-axis. Then drop the line at the point of intersection with the curve on x-axis. This point on the x-axis separates the important causes on the left and less important causes on the right. SL Operations Site Billing Accuracy Billing Errors cum 1 Indianapolis 12% 176 20% 2 New York 17% 167 40% 3 Phoenix 22% 156 58% 4 San Jose 27% 147 75% 5 Philadelphia 82% 37 79% 6 Dallas 83% 34 83% 7 Jacksonville 85% 31 86% 8 Houston 85% 31 90% 9 Los Angeles 86% 29 93% 10 San Antonio 85% 30 97% 11 Chicago 92% 16 99% 12 San Diego 94% 12 100%
- 24. What about you and your team? Rollout CAPA & Enjoy below benefits Your precious time Efficient & Effective process performance Gain Customer satisfaction, trust & loyalty Do you have repeat issues that you need to resolve?
- 25. Thank You