BEGIN:VCALENDAR X-WR-TIMEZONE:US/Eastern DTSTART:20190115T130000 DTEND:20190115T140000 VERSION:2.0 LOCATION:OnlinePRODID:-//Training Doyens //EN METHOD:REQUEST BEGIN:VEVENT DTSTAMP:20190115T000000 DTSTART;TZID="US/Eastern":20190115T130000 DTEND;TZID="US/Eastern":20190115T140000 SUMMARY:Root Cause Analysis and CAPA using 8-D Problem Solving Method DESCRIPTION: 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 Disciplines (8D) method is not required if the process owner can implement a simple solution on the shop floor, although the problem and solution should still be documented in a lessons learned data base. As stated by Henry Ford, "The benefit of our experience cannot be thrown away," and Ford also credited his hourly workers for most of his productivity and efficiency improvements. PRIORITY:3END:VEVENT END:VCALENDAR