Pharma Risk Register

A Failure Mode and Effects Analysis (FMEA)-based risk register with 18 risks covering data quality, traceability, documentation, programming, and compliance categories. Includes probability, impact, and detectability scores on a 1-5 scale. Structured according to ICH (International Council for Harmonisation) Q9 quality risk management principles.

Usage

risk_register_pharma

Format

A tibble with 18 rows and 9 columns:

risk_id

Character. Unique risk identifier (RISK-001 to RISK-018).

description

Character. Risk description.

category

Character. Risk category.

probability

Integer. Probability of occurrence (1-5).

impact

Integer. Impact severity (1-5).

detectability

Integer. Detectability rating (1-5).

owner

Character. Risk owner name.

mitigation

Character. Mitigation action (or NA).

status

Character. Status: open, mitigated, closed, accepted.

Source

Synthetic risk register based on ICH (International Council for Harmonisation) Q9 quality risk management principles.

Examples

data(risk_register_pharma)
table(risk_register_pharma$category)
#> 
#>    compliance  data_quality documentation   programming  traceability 
#>             4             6             4             2             2