Related Experiment Video
Updated: May 16, 2026
05:47
Simulation of a Scaled Assembly Process with Collaboration of a Robotic Arm and Monitoring through a Vision System for Quality Control
Published on: August 29, 2025
The reliability-quality relationship for quality systems and quality risk management
H Gregg Claycamp1, Faiad Rahaman, Jason M Urban
1Office of New Animal Drug Evaluation, Center for Veterinary Medicine (CVM), U.S. Food and Drug Administration (FDA).
PDA Journal of Pharmaceutical Science and Technology
|November 28, 2012
Summary
Engineering reliability, the probability of a system functioning correctly over time, is crucial for pharmaceutical quality. This concept, distinct from statistical reliability, integrates predictive quality assurance into manufacturing processes.
Area of Science:
- Pharmaceutical Manufacturing
- Quality Management Systems
- Engineering Reliability Theory
Background:
- Pharmaceutical quality assurance is shifting from post-manufacturing assessment to integrated design.
- Current quality risk management tools like FMEA and RCA are reactive, not predictive.
- Existing pharmaceutical guidelines lack focus on engineering quality and predictive reliability.
Purpose of the Study:
- To define engineering reliability within the context of pharmaceutical quality.
- To explore the linkage between engineering reliability, quality systems, and quality risk management.
- To differentiate engineering reliability from statistical (assay) reliability.
Main Methods:
- Literature review and conceptual analysis.
- Discussion of current good manufacturing practice (cGMP) tools.
- Exploration of established reliability engineering principles.
Main Results:
- Engineering reliability is a predictive measure of system and component function over time.
- Reliability is integral to proactive quality assurance and risk management in pharmaceuticals.
- A clear distinction exists between engineering reliability and static, assay-based reliability.
Conclusions:
- Integrating engineering reliability principles can enhance pharmaceutical quality and predictive capabilities.
- Pharmaceutical quality management systems should incorporate engineering reliability for lifecycle quality assurance.
- Further exploration of engineering reliability's application in pharmaceutical manufacturing is warranted.
Related Concept Videos
01:05Quality Control
Quality control is one of the three cyclical quality assurance activities that help keep a system under statistical control. Typical quality control activities include creating quality control charts, conducting proficiency testing, and documenting and archiving results.
Quality control helps track data, visualize trends, and identify variations, making it easier to detect deviations that may affect the accuracy of an analysis. One way to do this is by generating a quality control chart, which...
Quality control helps track data, visualize trends, and identify variations, making it easier to detect deviations that may affect the accuracy of an analysis. One way to do this is by generating a quality control chart, which...
01:19Quality Assurance
Quality assurance is the overarching term used to describe the activities employed to ensure the proper performance of a system. These activities can be classified into three categories: quality control, quality assessment, and internal corrective measures. Typically, these activities work cyclically: quality control is performed before and during the analysis, while quality assessment occurs during and after the investigation. Internal corrective measures are implemented based on the findings...
01:02The R Chart
In statistical process control, control charts, particularly R charts, are instrumental in monitoring process variations and identifying non-random patterns that run charts might miss. R charts track the variability within process subgroups, which is crucial when standard deviation use is impractical or unknown process variations exist.
R charts are pivotal for pinpointing shifts in process variability. Stability is indicated when all data points remain within the defined upper and lower...
R charts are pivotal for pinpointing shifts in process variability. Stability is indicated when all data points remain within the defined upper and lower...
01:23Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches
Biopharmaceutical studies constitute a vital field aiming to enhance drug delivery methods and refine therapeutic approaches, drawing upon diverse interdisciplinary knowledge. In research methodologies, the choice between controlled and non-controlled studies significantly influences the study's reliability and accuracy.
Non-controlled studies, commonly employed for initial exploration, lack a control group, rendering them susceptible to biases and external influences. In contrast, controlled...
Non-controlled studies, commonly employed for initial exploration, lack a control group, rendering them susceptible to biases and external influences. In contrast, controlled...
01:30Health Information Technology and Healthcare Information System
Health Information Technology (HIT)
Health Information Technology, commonly called HIT, integrates advanced information systems and technology in healthcare settings. Its primary functions include:
Health Information Technology, commonly called HIT, integrates advanced information systems and technology in healthcare settings. Its primary functions include:
01:12Relative Risk
Relative risk (RR) is a statistical measure commonly used in epidemiology to compare the likelihood of a particular event occurring between two groups. This metric is important for evaluating the relationship between exposure to a specific risk factor and the probability of a particular outcome. It plays a crucial role in medical research, public health studies, and risk assessment. Relative risk quantifies how much more (or less) likely an event is to occur in an exposed group compared to an...