Description
Every site manages risk. Quality risk management is the difference between managing it by habit and managing it by a method you can explain to an inspector, a Qualified Person or yourself in a year’s time.
What you will be able to do
- Apply the principles. Explain what QRM is and where EU GMP asks for it, use the words risk, harm and hazard correctly, and match effort to the level of risk.
- Assess a risk properly. Start with a risk question that can be answered, the right team and the facts, then identify, analyse and evaluate against criteria set in advance.
- Control, communicate and review. Reduce a risk to an acceptable level without creating a new one, accept what remains on purpose, tell the people who act on it, and reopen the assessment when events call for it.
- Choose the tool and the formality. Pick FMEA, fault tree analysis, HACCP, risk ranking or a basic method to fit the question, and set formality by uncertainty, importance and complexity, not by how busy the team is.
- Make it work in the quality system. Manage subjectivity, treat loss of supply as a quality risk, build QRM into deviations, changes and suppliers, and spot an assessment written to justify a decision already made.
Who it is for
People who take part in, lead or approve quality risk assessments on a manufacturing site: QA and QC staff, production supervisors and engineers, validation staff, people who raise deviations and change controls, and managers who sign off risk decisions. No earlier QRM training is assumed; every term is defined the first time it is used.
Basis
ICH Q9(R1); EudraLex Volume 4, Chapter 1, Principle, 1.4(xiv), 1.12, 1.13; Chapter 5, 5.27; Chapter 7, 7.4; Annex 11, 1; Annex 15, 1.7, 11.4, 11.7; ICH Q10, 1.6.2, 3.2.2, 3.2.3.
