Corrective Action and Preventive Action is a system to collect and analyze information regarding non-conformances in process. Identifying and investigating problems before putting in to place a corrective plan for the current problems, and a preventive plan for future or repeat problems. The goal of CAPA is continuous improvement, ensuring that all processes are designed and operate to a set standard across the organization.
The basic responsibilities of CAPA is to identify the non-conforming items within a process – usually in the production of a product, remove them from their current position within a process, analyze them and then take remedial action. A brilliant system for those working towards, or under the ISO 9001 standard.
It is the responsibilities of the CAPA team members to identify how an item goes against conformity, and then determine the root cause, usually using CA Plus. Finding the root cause can assist in reducing repeated actions that could cause the non-conformity again in the future. The root cause is not always an obvious thing so will need investigating using a combination of the CA Plus tools taught in our workshops. These include the Fishbone Diagram, Pareto analysis, fault tree analysis, and Failure Modes and Effects Analysis (FMEA).
When using FMEA, failures that rank high are examined first and it is the responsibility of the organization to then address these potential failures using corrective action. Assigning team members who can complete specific inspections or quality procedures, redesign the product/process, or provide operator retraining where user error is at fault. Deadlines need to be put in place for the actions, making responsibility clear cut and tracking of improvements easier.
Prevent Action responsibilities are to look at precursor data and analyze potential risks, their likelihood of happening and the consequences (like the ranking in FMEA). Preventive Action helps determine an organization’s tolerance to risk, and what resources it has in place to lower unacceptable risks. Using the ATM method of accepting the risk and letting it go, transferring the risk to a specialist where the organization cannot accept it, and using change in management to mitigate the re-occurrence.
As CAPA is a continuous improvement system, the items which CAPA have been taken against the need to be re-assessed to determine their new ranking and to ensure improvement has been made.
Throughout this, all communication and procedures need to be clear-cut and trackable. With non-conformities documented, their root causes and investigations documented as well as outcomes and trends reported to management level for review. Staff and management need to be agreeable on the procedures in place and the processes involved in continuously improving the quality of systems and process.
When areas of CAPA are not strongly upheld and people are not held accountable for their part in the process, the non-conformities will continue to arise, and improvements will not be made. CAPA can lower the cost of quality, improve the number of compliant products for both national and international requirements.
To learn how to use CAPA in your business get booked on one of our workshops in the coming year. To find out more visit our Workshop Page.