QAQCprogrammas

QAQCprogrammas, typically written as QA/QC programs, are structured sets of policies, procedures, and activities designed to ensure quality throughout a product’s lifecycle. They integrate quality assurance and quality control functions to both prevent defects and verify conformity to requirements.

Quality assurance (QA) is process-oriented and focuses on preventing defects by planning, designing processes, documenting standards, training staff, and conducting audits. Quality control (QC) is product-oriented and concentrates on detecting defects through inspections, testing, sampling, and reviewing results to confirm that outputs meet specifications.

A typical QAQC program includes a quality policy and objectives, a quality management system, standard operating procedures, change and configuration management, supplier quality management, training and competency tracking, document control, and data collection for performance monitoring. It also covers inspection and test plans, acceptance criteria, nonconformance reporting, corrective and preventive actions (CAPA), and internal or external audits.

Implementation follows a lifecycle: define requirements, establish processes and controls, develop QA and QC plans and test/inspection plans, execute, collect data, and analyze trends. When issues are found, CAPA processes are used to address root causes. The program emphasizes continuous improvement through methods such as PDCA, Six Sigma, or Lean.

QAQCprogrammas are used across industries, including manufacturing, construction, software, and healthcare. They are supported by standards such as ISO 9001, ISO 13485, and GMP in regulated environments. The goals are to reduce defects, ensure regulatory compliance, improve traceability, manage risk, and increase customer satisfaction while lowering lifecycle costs.