생명과학 eQMS 14개 항목
Quality Risk Management Checklist (ICH Q9)
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Confirms that quality risk management activities follow a structured, science-based process for risk assessment, control, communication, and review with appropriate rigor and subjectivity control. Use to establish or audit the QRM program.
ICH Q9(R1)21 CFR 211EU GMP Chapter 1
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QRM Process and Governance
- Is a documented QRM process established covering initiation, assessment, control, communication, and review? *
- Is the level of formality of QRM defined based on uncertainty, importance, and complexity? *
- Are measures in place to manage subjectivity and bias in risk evaluation? *
- Are appropriate tools (FMEA, HACCP, FTA, risk ranking) selected for the situation? *
Risk Assessment
- Is the risk question and scope clearly defined at initiation? *
- Are risks identified against defined harms, with probability, severity, and detectability assessed? *
- Is a cross-functional team with relevant expertise involved in the assessment? *
- Record the risk assessment tool used.
Risk Control
- Are risk reduction and acceptance decisions documented with rationale? *
- Are controls verified to reduce risk to an acceptable level without introducing new risks? *
- Is residual risk evaluated and formally accepted by an appropriate decision maker? *
Communication and Review
- Are QRM outputs communicated to relevant stakeholders and decision makers? *
- Are risk assessments reviewed periodically or when new knowledge or events arise? *
- Is QRM linked to the pharmaceutical quality system and product/process lifecycle? *
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