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Showing posts with the label CAPA and Root Cause Analysis

CAPA: Corrective and Preventive Actions and Non-Conformance

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OVERVIEW If you only fix the symptoms   – what you see on the surface – the problem will almost certainly happen again, which will lead you to fix it, again, and again, and again. If, instead, you look deeper to figure out why the non-conformance is occurring, you can fix the underlying systems and processes that caused it. WHY SHOULD YOU ATTEND When you have a non-conformance in the laboratory, how do you approach it? Do you jump in and start treating the symptoms? Do you stop to consider whether there's actually a deeper problem that needs your attention? Learn the root cause analysis steps to determine the origin of a problem. You will learn about a specific set of steps, along with root cause analysis tools and techniques, to find the primary cause of the problem, so that you can: Determine what happened Determine why it happened Figure out what to do to reduce the likelihood that it will happen again AREAS COVERED Defining the prob...

Root Cause Analysis and CAPA using 8-D Problem Solving Method

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OVERVIEW While preventive action is now covered by  ISO 9001:2015  clause 6.1, Actions to address risks and opportunities, no change to existing  CAPA  processes is necessary to fulfill this requirement. These processes can also be extended to address opportunities by treating gaps between the current and desired states as "non-conformances" that the  CAPA  process can easily address. The CAPA process also supports numerous ISO 9001:2015 clauses that range from performance evaluation (9) to organizational knowledge (7.1.6), the latter in the form of a lessons learned data base. The hiyari hatto ("experience of almost accident situation") or error cause removal (ECR) process is meanwhile an employee-initiated CAPA process. It begins when a worker, or indeed any relevant interested party, identifies a potential safety or quality risk, but the context can be easily expanded to improvement opportunities. A formal CAPA process such as  8 Disciplin...