Key Performance Indicator (KPI) is a measurable value that shows the progress in meeting a specific goal. Quality KPIs specifically measure the performance and effectiveness of processes, products, or services.
Quality KPIs are crucial in the pharmaceutical industry, where products and services directly impact human health and well-being. By tracking quality KPIs, companies can measure their performance and make informed decisions on their products, services, and processes’ effectiveness and compliance.
This article defines quality KPIs in the pharmaceutical manufacturing industry. It also explains their importance, and relevant requirements, exemplifies metrics to track, and the role of eQMS software in monitoring these KPIs.
Pharmaceutical companies are increasingly recognizing the importance of quality assurance and turning to QMS software solutions to streamline processes and improve the accuracy of quality KPI tracking.
SimplerQMS offers fully validated (GAMP 5) eQMS software designed specifically for Life Science companies that also includes quality KPI tracking capabilities. You can book a free demo to see SimplerQMS in action and better understand the capabilities of our solution.
This article covers the following topics:
- What Are Quality KPIs in the Pharmaceutical Industry?
- Why Are Quality KPIs and Metrics Important in the Pharmaceutical Industry?
- Which Requirements Mention Quality KPI Measurement?
- What Are the Key Quality KPIs and Metrics That Pharmaceutical Companies Should Track?
- What Is the Role of Pharmaceutical Quality KPI Monitoring Software?
What Are Quality KPIs in the Pharmaceutical Industry?
Like in many other industries, quality KPIs (Key Performance Indicators) in the pharmaceutical industry are quantifiable metrics that track and assess the performance of a company’s processes, services, or products.
The KPIs should be specific, measurable, achievable, relevant, and time-bound. They should also be aligned with the company’s overall quality strategy and objectives.
Both quality metrics and KPIs are measurements that track performance, but they serve different functions.
The difference between quality metrics and quality KPIs in Life Science is that metrics are detailed measurements for monitoring processes used internally for operational improvements, such as defect rates. However, quality KPIs are a strategic subset of metrics influencing broader business decisions and communicating performance to stakeholders, such as customer satisfaction.
Why Are Quality KPIs and Metrics Important in the Pharmaceutical Industry?
Quality KPIs and metrics are essential in the pharmaceutical industry, given their direct impact on human health and well-being.
Pharmaceutical companies have been tracking and monitoring quality KPIs and metrics for a long time, helping ensure the quality of their products, driving continuous improvement efforts, and helping ensure compliance with regulatory requirements.
Tracking quality KPIs and metrics, such as process performance, audit findings, customer complaints, and others, helps companies to ensure the effectiveness of the quality management system.
Which Requirements Mention Quality KPI Measurement?
Several requirements applicable to pharmaceutical companies, such as ISO 9001:2015, ICH Q10, and the FDA Quality Metrics Reporting program, among others, mention quality KPI measurement.
Below are a few examples of requirements that specify quality KPI.
The international standard for quality, ISO 9001:2015, is a standard that provides a set of requirements for companies to implement a quality management system (QMS).
ISO 9001:2015 mentions in Section 4.4.1 that companies must monitor the processes for the quality management system using KPIs that help ensure the effective operation and control of these processes.
The ICH Q10 is a guideline for the pharmaceutical quality system.
Section 4.1 specifies management should have a formal process for reviewing the pharmaceutical quality system periodically.
The review should include the assessment of KPIs to monitor the effectiveness of processes within the pharmaceutical quality system, such as:
- Change management processes
- Risk assessment
- Regulatory inspections
The ICH Q10 provides a comprehensive model for an effective pharmaceutical quality system. If you want to know more about this requirement, please read our dedicated article on ICH Q10 pharmaceutical quality system guidelines.
FDA Quality Metrics Reporting Program
The FDA Quality Metrics Reporting program is a voluntary data-sharing program for companies to help the FDA identify and mitigate product quality risks.
The FDA proposes developing and implementing a Quality Metrics Reporting Program to support its quality surveillance activities. This program would require companies to submit quality metrics data to the FDA.
The KPI reporting program is intended to help the FDA identify and address potential quality problems before they impact the safety and efficacy of pharmaceutical products.
What Are the Key Quality KPIs and Metrics That Pharmaceutical Companies Should Track?
The key quality KPIs and metrics that pharmaceutical companies can track vary depending on the product, processes involved, and quality goals.
The FDA Quality Metrics Reporting Program is working toward establishing a public docket where they propose some KPIs pharmaceutical companies should track.
Below are examples of KPIs for different pharmaceutical practice areas according to the FDA Quality Metrics Reporting Program.
Manufacturing Process Performance
Manufacturing process performance refers to the evaluation of how effectively and efficiently a manufacturing process operates.
The following are examples of manufacturing process performance KPIs and manufacturing metrics that can measure the effectiveness and efficiency of drug manufacturing operations.
Process Capability/Performance Indices (CPK/PPK)
Process capability and performance indices are measures of how well a process is performing relative to its specification limits.
Process capability and performance indices are calculated using statistical methods to determine how well a manufacturing process is meeting its requirements.
Lot Acceptance Rate (LAR)
The lot acceptance rate is the proportion of lots that were accepted in a given period.
It is calculated by dividing the number of lots that were accepted by the total number of lots that were produced.
Some examples of inputs that can be used to calculate LAR include:
- Lots completed
- Lots dispositioned
- Lots attempted
- Lots rejected
- Lots released
- Lots approved
- Abandoned lots
- Parallel/backup lots
Right-First-Time Rate (RFT)
The right-first-time rate is a measure of the proportion of lots manufactured without the occurrence of a deviation or nonconformance.
The RFT is calculated by dividing the number of products or processes that are completed correctly on the first attempt by the total number of products or processes completed.
Examples of inputs that can be used to calculate a right-first-time rate include:
- Number of deviations
- Lots dispositioned
- Lots attempted
- Number of nonconformances
- Lots approved in the first pass
Lot Release Cycle Time
Lot release cycle time is a measure of the amount of time it takes for the lot disposition process.
It is calculated by measuring the time from the completion of the manufacturing process to the release of the lot for shipment. For instance, it can be calculated in hours, days, or weeks.
Pharmaceutical Quality System Effectiveness
Pharmaceutical quality system effectiveness is the degree to which a pharmaceutical company’s QMS can achieve its intended objectives.
It is a measure of how well the pharmaceutical quality system helps ensure products are safe, effective, and of high and uniform quality.
The following are examples of KPIs and metrics that can be used to assess the effectiveness of a pharmaceutical company’s quality management system in consistently producing and controlling the quality of pharmaceutical products while meeting applicable requirements.
CAPA effectiveness is the measurement of CAPA plans that have been implemented and deemed successful.
CAPA effectiveness is calculated by monitoring the CAPA plans that have been closed as effective in relation to the total number of CAPA plans that have been initiated.
Repeat Deviation Rate
The repeat deviation rate is a metric of the deviations that occur multiple times. In other words, it tells you how often a specific deviation occurs. A high repeat deviation rate KPI indicates that a particular deviation is occurring frequently and that corrective action needs to be taken.
Change Control Effectiveness
Change control effectiveness is the measure of how well a company manages changes to its GMP facilities, systems, equipment, or processes in a timely and effective manner.
Examples of inputs that can be used to calculate this metric include:
- On-time closure of the change
- Total number of late effectiveness checks
- Total number of changes initiated
- Number of changes that are initiated reactively versus proactively
- Total number of changes deemed effective
Overall Equipment Effectiveness
Overall, manufacturing equipment effectiveness is the measure of how well a machine or production line is performing relative to its full potential.
It is calculated taking into account three factors: availability, performance, and quality.
Unplanned maintenance is the tracking of maintenance that is not planned or scheduled in advance. It is often caused by unexpected equipment failures.
Some inputs that can be used to calculate this metric include total maintenance hours and planned maintenance hours.
Laboratory performance is the ability of a laboratory to produce accurate and reliable test results.
The examples below are laboratory performance KPIs and metrics that can be used to measure the efficiency and accuracy of a pharmaceutical company’s laboratory.
Adherence To Lead Time
The adherence to lead time is the proportion of laboratory tests that are completed on time, according to schedule requirements.
This metric can be calculated by tracking the number of days between the test start date and completion date for quality control.
Right-first-time is the measurement of the proportion of laboratory tests that are conducted without the occurrence of a deviation.
The right-first-time rate can be calculated by tracking the number of invalid assays due to human errors or cGMP documentation errors during a review.
Invalidated/Overturned Out-Of-Specification Rate (IOOSR)
The invalidated or overturned out-of-specification rate is the measure of the laboratory’s ability to perform tests accurately.
Some inputs that can be used to calculate this metric are the total number of tests conducted and the out-of-specification results.
Calibration timeliness is the measurement of the laboratory’s adherence to inspecting, calibrating, and testing equipment for its intended purposes. This metric can be measured by tracking calibration criteria and schedules.
Supply Chain Robustness
Supply chain robustness is the ability of a supply chain to withstand changes and continue to operate effectively. It is a measure of the supply chain’s resilience and adaptability.
The following are examples of KPIs and metrics that can be used to assess the supply chain’s ability to meet the company’s needs for raw materials, components, and finished products on time and in full.
On-Time In-Full (OTIF)
On-time in full is a supply chain metric that measures the percentage of orders that are delivered to the customer containing the correct quantity and according to the schedule.
Examples of inputs that can be used to calculate this quality KPI include:
- Number of orders shipped
- Number of past-due orders
- Number of orders shipped within tolerance
The fill rate is the quantification of how many orders were sent out compared to the total amount of orders during a specific time.
Examples of inputs that can be used to calculate the fill rate include:
- Total number of orders shipped
- Number of orders placed
- Number of orders received
Disposition on time is a measure of how well a company can release batches of products on time.
Examples of inputs that can be used to calculate this metric include the total number of lots dispositioned and the total number of lots dispositioned on time.
Days of Inventory On-Hand
Days of inventory on hand is the measure of how long it takes a company to sell its inventory. It is the number of days that inventory remains in stock.
What Is the Role of Pharmaceutical Quality KPI Monitoring Software?
Pharmaceutical quality KPI monitoring software assists pharmaceutical companies in automating the tracking and reporting of quality metrics in real-time, as well as providing a centralized platform for gathering data on various quality metrics and pharmaceutical KPIs.
Modern QMS software solutions offer quality KPI monitoring capabilities.
SimplerQMS is a fully validated (GAMP 5) eQMS software solution for Life Sciences. It also simplifies access to quality KPI data, allowing for timely decision-making and proactive quality management.
SimplerQMS provides periodic KPI reports that could be tailored according to the company’s needs.
SimplerQMS supports compliance with several Life Science requirements, including ISO 9001:2015, ISO 13485:2016, FDA 21 CFR Part 11, 211, and 820, EU GMP Annex 11, EU GMP, and more. SimplerQMS solution provides comprehensive support for QMS processes, helping Life Science companies to achieve and maintain compliance.
QMS processes supported include document management, change management, employee training management, CAPA management, customer complaint management, audit management, supplier management, and more.
To assess the benefits of implementing an eQMS for your company, download our eQMS Business Case template.
The template will help you calculate the potential efficiency gains, cost savings, and compliance improvements. By presenting this information to management clearly and concisely, you can build a strong case for implementing an eQMS.
Quality KPIs are specific metrics that measure the performance of a company’s process, service, or product. KPIs are used to track progress toward quality goals, thus helping companies to identify areas for improvement and ensure compliance with regulatory requirements.
Nowadays, many eQMS solutions also offer quality KPI monitoring capabilities. The software automates the tracking of quality metrics and provides a centralized platform for gathering data on various quality parameters.
SimplerQMS is a fully validated (GAMP 5) eQMS software solution for Life Sciences. Our system includes dashboards that display users’ tasks and assignments as soon as they log in and include graphics for easy data visualization. Furthermore, we provide periodic KPI reports that can be tailored according to the company’s needs.
Discover how SimplerQMS can help you improve your quality KPI monitoring. To learn more about how our software can streamline your QMS management, schedule a demo with our quality experts.