ISO 9000 & AUDITS WORLD CONFERENCE ABSTRACT
Identify Dangers in CAPA 2015, and Build a Comprehensive Improvement System
The essence of an ISO 9001 based Quality Management System (QMS) is its requirement and ability to provide Continual Improvement to the organization. This has been true since it’s inception in 1987. Following the principles of Plan Do Check Act (PDCA), the system is built on planning the organization’s processes, checking for performance, and acting on any unacceptable performance by improving the processes that need to perform better. Over time, this yields system-wide Continual Improvement (CI) in quality, productivity, and therefore, profitability.
The core element of the system has been called Corrective & Preventive Actions or CAPA since the 1987 version. The 2015 version of ISO 9001 does not use the term Preventive Actions. This makes sense, since, the only difference between CA and PA was the trigger (problems that have happened or could happen- risk of happening). Hence the addition of Risk Based Thinking (RBT) throughout the Standard. However, there are several unintended dangers that must be recognized if you want to go beyond just minimal compliance:
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