Job Aid 2 IA Process Model 4 75

Job Aid 2: IA Process Model 4 -75 WHO participates in this process? § § Quality manager (schedules audits and reviews results) Trained and competent internal auditors Auditees Management review team (review audit results) OUTPUTS: PROCESS: Internal Audit PROCESS OWNER: Internal audit program coordinator (i. e. quality manager) What INFORMATION is needed to perform the process? (procedures, methods, forms, information, etc. ) § § § § Approved audit schedule Internal Audit SOP Audit plan Communication memos Applicable standards Laboratory’s documentation Process models (tools, reagents, equipment, hardware, software, infrastructure, safety, etc. ) § § Internal auditing tracking software Corrective/Preventive tracking software RECORDS: § § § Audit reports Completed Checklists Associated corrective action / preventive action reports What METRICS are maintained to determine process effectiveness? § With WHAT? Continual improvement resulting from the corrective and preventive actions taken § § § % of corrective and preventive action reports completed and verified on or before the estimated completion date Satisfaction scores from auditees and auditors after the report has been issued % of audits started on time Number of complaints regarding auditor performance % of audit reports completed on time Turnover of the audit staff