CAPA QUALITY ASSURANCE HOW TO
CAPA QUALITY ASSURANCE ISO

A good term for the process of enjoying an opportunity could be Opportunity Capture. The work-flow are all the same- because you are always focused on the process that needs to be changed to effectuate the risk or the opportunity. Mathematically speaking, the difference is only in the – or + sign. In the second case the problems are forecast to occur.Īnother point to remember but usually considered are “ Opportunities”, as the opposite of “Risk”. Although they both prevent future problems, in the first case, the problems have already occurred. There is difference, however, between Corrective Actions and Preventive Actions. In other words, you work on the product to dispose of the NC, and you must work on the process to perform CAPA.Īlso, you should note that CA generally PA is focused on negative triggers, such as nonconformances, findings, etc-aka Problems. It is easy to understand that for doing CAPA, you must change the process that produced the NC. Just remembering this axiom, it is easy to understand the magnitude of the difference between Corrections and CAPA. It’s self-evident and does not need any proof. Just like a commonly known axiom: “A straight line is the shortest distance between two points”. To understand this special terminology- CAPA, we need to consider an axiom: “Product is the Result of a Process”. These, of course, are Dispositions as described above. The normal English usage of the term does not assume any time boundaries, and therefore some people mistakenly think that they have taken CAPA when they have performed actions such as rework, scrap, return to vendor, etc. The terms “Corrective Action” and “Preventive Actions” ( CAPA) are special terms in Quality Assurance Technology to define actions that are taken to prevent Nonconformances in the future. The reason is that over time Nonconformances ( NCs) provide valuable understanding of the manufacturing process.

It is Best Practice to record all incidents of nonconformance, no matter how easy or simple or fast it is to dispose of the nonconforming product. These are called Records of Nonconformance. It is a requirement to document incidents of nonconformance.

Often Rework and repair requires additional process steps to remove the defect, and Best Practice is to document these steps for help in future incidents, and in calculating the Cost of Poor Quality. Common methods for dispositioning are Scrap, Rework, Repair, Return to Vendor, use as is (with special approval from product specialists or customers). The point is that the manufacturer is focused only on the number of defective products on hand. The steps are detection (of a defective product- nonconformance) and disposition of the defective or non-conforming product.

Corrections are actions you take to make a defective product good enough to be able to sell to a customer.

It is common for people to mix Corrections with Corrective Actions.

CAPA QUALITY ASSURANCE HOW TO

This paper will therefore help you understand how to avoid harmful misunderstandings, and how to get the most business benefits from the CAPA process. The intent of this paper is to help people understand it as a tool, so that it is used to the fullest, and benefit from the business aspect of having a Quality Management System.

CAPA QUALITY ASSURANCE ISO

Corrective and Preventive Action (aka Capa corrective and preventive action) is the most widely misunderstood part of ISO 9001, and it’s the most powerful tool available to companies and industries of all types.

Capa quality assurance