CAPA
Skill packages tagged with “CAPA”
CAPA Report
Corrective and Preventive Action reports for audit non-conformities. Enforces 5 Whys root cause analysis and a future Effectiveness Check date (ISO 9001 / ISO 13485).
ISO 17025 Complaints & Nonconforming Work
Establish complaint handling and nonconforming work procedures per ISO/IEC 17025:2017 Clauses 7.9 and 7.10. Covers the full complaint lifecycle (receipt, investigation, root cause analysis, resolution, trend analysis) and nonconforming work management (identification, impact evaluation, halt/hold/recall actions, customer notification, work resumption authority, CAPA linkage). Validates both processes for completeness and regulatory alignment.
ISO 17025 Risk, Opportunity & Corrective Action Management
Identify and manage laboratory risks and opportunities per ISO/IEC 17025:2017 Clauses 8.5–8.7. Produces a scored risk register, corrective action procedure with root cause analysis, and CAPA tracking log. Risk register validator checks entry completeness and scoring; corrective action tracker validates procedure elements from trigger through effectiveness verification.
ISO 20000 Monitoring and Measurement (Clause 4.5.4.1)
Define monitoring, measurement, and review framework for the SMS per ISO/IEC 20000-1:2011. Establish KPIs for all SMS process areas (Clauses 4-9), define measurement methods and targets, create CAPA tracking, and set up effectiveness reviews.
ISO 27001 Monitoring, Measurement & Evaluation
Draft and validate the Clause 9.1 report (PDCA 'Check') and Clause 6.2 objectives register: six validation tools covering KPI effectiveness, CAPA linkage for every failed control, CAPA field completeness (root cause, corrective action, owner, date, effectiveness review), cross-document audit NC reconciliation, and objectives completeness (including Clause 6.2(c) risk register linkage and Clause 6.2(h) resources).
MDevSPICE Software Problem Resolution Process
Document and evidence the software problem resolution process per IEC 62304 and MDevSPICE: problem reporting, analysis, root cause, corrective action, and link to maintenance and CAPA.