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