QBit QA Consulting
Broomfield, CO
763-567-8783

Risk Management & Risk Assessment

QBit QA Risk Management & Risk Assessment consulting is a strategic advisory service that assists organizations in understanding, evaluating, and controlling risks by leveraging industry expertise, data analytics, and best practices to develop risk mitigation strategies that align with a company’s goals and regulatory requirements.

Unmanaged risks can lead to financial losses, compliance violations and reputational damage. Proactive risk management enhances decision-making, increases operational resilience, and ensures business continuity, giving companies a competitive advantage.

Risk Management is the systematic application of quality management policies, procedures and practices to the tasks of assessing, controlling, communicating and reviewing risk.

Risk Assessment is the systematic process of organizing information to support a risk decision to be made within a risk management process. It consists of the identification of hazards and the analysis and evaluation of risks associate with exposure to those hazards.

ISO 3100 – Relationship between the risk management principles, framework and process.

LINKS

Pharmaceutical Risk Management
FDA

The FDA implemented ICH Q9 Quality Risk Management guidance on 04MAY2023.

ICH
Medical Device Risk Management
FDA

The FDA has issued a Final Ruling to amend the cGMP requirements of Part 820 by incorporating by reference ISO 13485. The revision will be referred to as the Quality Management System Regulation (QMSR) and will become effective 02 FEB 2026.

ISO