An Enhanced RPN Model Incorporating Maintainability Complexity for Risk-Based Maintenance Planning in the Pharmaceutical Industry
Bibliographic record
Abstract
In pharmaceutical manufacturing, the reliability of machines and utility assets is critical to ensuring product quality, regulatory compliance, and uninterrupted operations. Traditional Risk-Based Maintenance (RBM) models quantify asset criticality using the Risk Priority Number (RPN), calculated from the probability and impact of failure alongside detectability. However, these models often neglect the practical challenges involved in diagnosing and resolving equipment issues, particularly in GMP-regulated environments. This study proposes an enhanced RPN framework that replaces the conventional detectability component with Maintainability Complexity (MC), quantified through two practical indicators: Ease of Diagnosis (ED) and Ease of Resolution (ER). Thirteen Key Performance Indicators (KPIs) were developed to assess Probability, Impact, and MC across 185 pharmaceutical utility assets. To enable objective risk stratification, Jenks Natural Breaks Optimization was applied to group assets into Low, Medium, and High risk tiers. Both multiplicative and normalized averaging methods were tested for score aggregation, allowing comparative analysis of their impact on prioritization outcomes. The enhanced model produced stronger alignment with operational realities, enabling more accurate asset classification and maintenance scheduling. A 3D risk matrix was introduced to translate scores into proactive strategies, offering traceability and digital compatibility with Computerized Maintenance Management Systems (CMMS). This framework provides a practical, auditable, and scalable approach to maintenance planning, supporting Industry 4.0 readiness in pharmaceutical operations.
Fetched live from OpenAlex and de-inverted. Abstracts are not stored in this database: the inverted indexes are 8.6 GB of the frame’s 9.3 GB of text, and the host has 13 GB free.
How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.002 | 0.003 |
| Meta-epidemiology (narrow) | 0.001 | 0.001 |
| Meta-epidemiology (broad) | 0.001 | 0.001 |
| Bibliometrics | 0.001 | 0.001 |
| Science and technology studies | 0.000 | 0.001 |
| Scholarly communication | 0.002 | 0.001 |
| Open science | 0.001 | 0.001 |
| Research integrity | 0.001 | 0.001 |
| Insufficient payload (model declined to judge) | 0.003 | 0.000 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".