Training Doyens

OVERVIEW In order to solve problems every organization must know how to conduct an investigation in the workplace, identify root causes, and implement workable corrective action in a timely manner. An effective CAPA management requires training internal investigators, who can also coach others in the organization, to employ critical thinking. The process must provide a common model and language within the organization, which allows investigators to master the process quickly and easily.  WHY SHOULD YOU ATTEND This webinar will include discussions on proper CAPA system maintenance, CAPAcompliance checklist, the new CAPA law, root cause analysis , documentation of the Corrective and Preventative Actions and developing a robust CAPA plan. It will give tips on how to develop CAPAs pertaining to longer term projects and ensure they stay on track.   AREAS COVERED • Definition of a CAPA o When a CAPA is needed o Development of the essential pieces of a robust CA...

OVERVIEW While preventive action is now covered by ISO 9001:2015 clause6.1, 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 "nonconformances" 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 8D is not required if the process ow...