欧美偏差验证培训资料CAPAs, Validation, and Deviation Training.pptVIP

Definition of a Deviation “Improper handling of investigations and lack of a thorough root cause analysis is a major sources of problems and inspectional/audit findings” 1. CAPAs 2. Responsibilities Operational Department(s) / QA Define CAPAs Implement actions QA / Operational Department(s) Follow-up Close out deviation 3. Definitions  Corrective Action An action to eliminate the cause of an existing deviation / non-conformity / defect in order to prevent re-occurrence. Preventive Action An action taken to detect and eliminate the causes of a potential deviation / non-conformity / defect in order to prevent occurrence. Preventive actions are actions to reduce the probability that a potential problem will occur. 4.1 CAPA Plan CAPA Plan 4.2 Impact on the CAPA Plan What is impacting the CAPAs and their timelines ? Correct and comprehensive description of the deviation Correct and comprehensive description of the root cause Seriousness of the problem Actual risk Potential risk Resources Expected outcome / objective ? challenge of CAPAs (1:n) Fantasy 4.3 a Defining the right CAPAs CAPA Plan 4.3 a Defining the right CAPAs CAPA Plan 4.3 b Defining the right CAPAs CAPA Plan 4.3 b Defining the right CAPAs CAPA Plan 4.3 c Defining the right CAPAs CAPA Plan 4.4 CAPA Follow up / status evaluation Ask yourself: Have all objectives of this CAPA Plan been met ? Have all changes been completed and verified ? Has the root cause effectively been addressed ? Has appropriate communication and training been implemented ? Could the CAPA plan have an adverse effect on other processes ? 4.5 Effectiveness of CAPAs Question: How can you check the effectiveness of CAPAs to prevent errors from happening again ? Trending deviation rate w/ temporary increase of on-line/off-line checks outcomes of self inspections / audits / inspections complaint rate / pattern Awareness increase through improved root cause analysis Establ. multi-functional w