Corrective Action & Preventive Action (CAPA) + PDCA

Corrective and preventive action (CAPA, also called corrective action/preventive action or simply corrective action) consists of improvements to an organization's processes taken to eliminate causes of non-conformities or other undesirable situations.

Corrective vs. Preventive Action. Professionals frequently express confusion as to the difference between corrective and preventive action.

A corrective action deals with a nonconformity that has occurred, and

a preventive action addresses the potential for a nonconformity to occur.

What Is CAPA?

1. Corrective Action: Elimination of the cause or causes of an existing nonconformity or undesirable situation in order to prevent recurrence.

2. Preventive Action: Identification and elimination of the cause(s) of potential nonconformities in order to prevent occurrence.

What is the purpose of a CAPA?

The purpose of the corrective and preventive action subsystem is to collect information, analyze information, identify and investigate product and quality problems, and take appropriate and effective corrective and/or preventive action to prevent their recurrence.

Defining Correction, Corrective Action and Preventive Action

• Correction: Action to eliminate a detected nonconformity
• Corrective action: Action to eliminate the cause of a nonconformity and to prevent recurrence
• Preventive action: Action to eliminate the cause of a potential nonconformity or other potential undesirable situation

In short, preventive action prevents occurrence and corrective action prevents recurrence, while correction basically refers to containment. If these terms still seem fuzzy, consider the difference between putting out a fire versus eliminating the hazards likely to cause one.

What is the Eight disciplines (8d) CAPA process?

Eight disciplines (8Ds) problem solving is a method developed at Ford Motor Company used to approach and to resolve problems, typically employed by engineers or other professionals. Focused on product and process improvement, its purpose is to identify, correct, and eliminate recurring problems.

8D follows the logic of the PDCA cycle. The disciplines are: 

D0: Preparation and Emergency Response Actions: Plan for solving the problem and determine the prerequisites. Provide Emergency Response Actions

D1: Use a Team: Establish a team of people with product/process knowledge.

D2: Describe the Problem: Specify the problem by identifying in quantifiable terms the who, what, where, when, why, how, and how many (5W2H) for the problem.

D3: Develop Interim Containment Plan: Define and implement containment actions to isolate the problem from any customer.

D4: Determine and Verify Root Causes and Escape Points: Identify all applicable causes that could explain why the problem has occurred. Also identify why the problem was not noticed at the time it occurred. All causes shall be verified or proved. One can use five whys or Ishikawa diagrams to map causes against the effect or problem identified.

5 Whys is an iterative interrogative technique used to explore the cause-and-effect relationships underlying a particular problem. The primary goal of the technique is to determine the root cause of a defect or problem by repeating the question "Why?". Each answer forms the basis of the next question.

Ishikawa diagrams

Ishikawa diagrams (also called fishbone diagrams, herringbone diagrams, cause-and-effect diagrams, or Fishikawa) are causal diagrams created by Kaoru Ishikawa that show the causes of a specific event.

D5: Verify Permanent Corrections (PCs) for Problem will resolve problem for the customer: Using pre-production programs, quantitatively confirm that the selected correction will resolve the problem. (Verify that the correction will actually solve the problem.)

D6: Define and Implement Corrective Actions: Define and Implement the best corrective actions.

D7: Prevent Recurrence / System Problems: Modify the management systems, operation systems, practices, and procedures to prevent recurrence of this and similar problems.

D8: Congratulate the Main Contributors to your Team: Recognize the collective efforts of the team. The team needs to be formally thanked by the organization.

Example : 

Employee Performance

An employee who receives a poor performance review may be given the chance to improve by establishing a corrective action plan that sets expectations for what is required to get back to satisfactory performance.

The actions in an employee corrective action plan are similar to regular performance objectives in that they are typically designed to be specific, measurable, achievable, relevant and time-bound.

Overview: Corrective Action Plan
Type	Problem Management Performance Management Corrective Action
Definition	A set of actions designed to correct an issue, problem, non-compliance or underperformance.
Related Concepts	Problem Management » Action Plan » Reduce Risk » Corrective Action » Incident Management » Root Cause Analysis »

The PDCA Cycle

PDCA (plan-do-check-act, sometimes seen as plan-do-check-adjust) is a repetitive four-stage model for continuous improvement (CI) in business process management. The PDCA model is also known as the Deming circle/cycle/wheel, Shewhart cycle, control circle/cycle, or plan–do–study–act (PDSA).

Plan

Establish objectives and processes required to deliver the desired results.

Do

The do phase allows the plan from the previous step to be enacted. Small changes are usually tested, and data is gathered to see how effective the change is.

Check

During the check phase, the data and results gathered from the do phase are evaluated. Data is compared to the expected outcomes to see any similarities and differences. The testing process is also evaluated to see if there were any changes from the original test created during the planning phase. If the data is placed in a chart it can make it easier to see any trends if the PDCA cycle is conducted multiple times. This helps to see what changes work better than others, and if said changes can be improved as well.
Example: Gap analysis, or Appraisals.

Act

Also called "Adjust", this act phase is where a process is improved. Records from the "do" and "check" phases help identify issues with the process. These issues may include problems, non-conformities, opportunities for improvement, inefficiencies and other issues that result in outcomes that are evidently less-than-optimal. Root causes of such issues are investigated, found and eliminated by modifying the process. Risk is re-evaluated. At the end of the actions in this phase, the process has better instructions, standards or goals. Planning for the next cycle can proceed with a better base-line. Work in the next do phase should not create recurrence of the identified issues; if it does, then the action was not effective.

 Concept : Begin with the End in Mind

Begin with the End in Mind means to begin each day, task, or project with a clear vision of your desired direction and destination, and then continue by flexing your proactive muscles to make things happen.