Overview
Ongoing Quality Control (QC) monitoring is a regulatory requirement for those laboratories performing routine analytical measurements. QC monitoring helps laboratories ensure the accuracy, precision, and reliability of their analytical procedures and results. Laboratories typically run Internal (IQC), External (EQC), or Analytical Quality Control (AQC) samples alongside unknown samples during their routine analysis (batch runs or sequences). Each QC sample will have one or more pre-determined target (mean) results, for a given analytical test method. The analysis results of these QCs can then be used to monitor whether the method is in ‘control’. Variance from these target value(s) will typically vary statistically (normally distributed around the target) within the tolerance of the method, the equipment used, and the sample’s matrix. The role of QC samples is to identify any significant changes in performance from their predetermined reference control values.
Aside from routine quality control checks, QC monitoring also plays a crucial role in helping laboratories save costs through the following:
- Early detection of errors in analytical processes and instruments. Error prevention avoids the release of inaccurate results that could lead to costly reanalysis or investigations into discrepancies.
- Reduced waste and optimal resource utilisation. High-quality QC results ensure the optimal usage of reagents and consumables without the need to repeat the analysis.
- Preventative maintenance. Continuous QC monitoring enables labs to identify trends in equipment malfunctions or deteriorating performance. Timely preventative maintenance or re-calibration helps to avoid expensive equipment breakdowns.
- Ongoing compliance and improved efficiency. Rigorous QC monitoring ensures regulatory compliance and prevents non-compliances with associated costs, or reputational damage. This leads to improved efficiency and translates into quicker turnaround times, and increased throughput without compromising the accuracy of results.
QCs compliance is the key performance indicator for most laboratories, and while there is a natural failure rate, the aim is to keep unplanned QC failures as low as possible (e.g. well below 5%, depending on the sector).
Dedicated QC monitoring software offers tools tailored for laboratory needs, providing advanced analysis, efficiency, compliance support, and integration capabilities with existing solutions (such as laboratory information management system, LIMS or LIS, and instrument control software). It streamlines quality control processes, enhances accuracy, and enables continuous improvement, making it a valuable asset for maintaining high-quality analytical standards.
CSols offers its well-established AqcTools software package dedicated for QC monitoring in laboratories. AqcTools provides statistical tools to analyse and to monitor the performance of analytical methods and instruments. AqcTools has a client – server architecture, where a Windows PC compatible client application supports all routine use (i.e. chart review, exception management, limit review, and reporting) All data is stored in a database managed by the Microsoft SQL Server or Oracle database manager.
In summary, AqcTools handles all aspects of QC monitoring including the following :
- Data analysis. AqcTools allows laboratories to insert and analyse the QC data to identify trends, calculate control limits, and assess the ongoing performance of their analytical methods.
- Quality control charts. AqcTools generates control charts (such as Shewharts or Levey-Jennings charts) using time-based plotting of measurements to visualise QC data and detect any deviations or trends.
- Trend analysis. AqcTools helps in trend analysis by spotting shifts or drifts in data by applying Westgard rules, which could indicate issues with instruments, reagents, or processes.
- Statistical calculations. AqcTools performs statistical calculations to determine the accuracy, precision, and overall performance of analytical methods based on QC data.
- Flagging and alerting. AqcTools includes functionalities to flag out-of-control data points or instances that fall beyond predetermined thresholds, alerting lab personnel to investigate potential issues.
- Reporting. AqcTools reporting includes and is not limited to data comparison reports, limit suitability reports, trend summary reports, and normality reports.
- Uncertainty of measurement. AqcTools Uncertainty of Measurement (UoM) module includes comprehensive UoM evaluation according to ISO 11352:2012 and Nordtest standards and allows the evaluation of performance testing scheme data.
This FAQ document provides feedback on AqcTools performance and functionality. As a guide, AqcTools is particularly suited to situations where the laboratory has the following requirements:
- Regulatory compliance and accreditation – the laboratory needs to meet the ISO15189 or ISO17025 requirements for IQC, EQC, or AQC processing, and data storage.
- Routine testing – the laboratory is performing routine testing and must ensure the ongoing accuracy and reliability of tests.
- Implementation of new assays/tests – QC monitoring for new assays/tests helps to validate their performance.
- Instruments, reagents and consumables performance monitoring – the laboratory needs to ongoingly ensure the performance of analytical equipment, reagents and consumables, and identify any poor performance prior to breakdowns or assay failures.
- Process optimisation and continual improvement – the laboratory is required to optimise workflows, enhance performance through throughput, turnaround times, and overall efficiency.
General
Data entry
- Would AqcTools allow manual data input?
AqcTools provides two methods of manual entry of QC results to cover results that are generated from non-instrument/analysers or low throughput assays. These are the ‘Enter Results’ and ‘Enter Results by Template’ modules.
Enter Results is designed for entering one or more results for a single QC. Once the user has selected a specific QC from the menu they can quickly enter single or multiple results for that QC by direct keyboard entry or by pasting data from another source.
The ‘Enter Results by Template’ is a more popular choice among users. It provides flexibility and ease of use by allowing the entry of multiple QCs/results through a predefined Excel template. This means the format of the template can have different styles and layouts to suit the assay, analyser, or user.
- Is it possible to transfer results electronically to the AqcTools database?
Yes, there are several options for the electronic import of results into the AqcTools database to provide automation of this process. These make use of the AqcTools background import service. The different options are:
LIMS or middleware – here the import service reads QC sample results into the AqcTools database which are being stored in a LIMS database or are captured via a middleware server. Useful where the LIMS or middleware system already captures QC results but doesn’t provide a full range of QC capabilities.
Links for LIMS – here the import service can read data extracts generated by the Links for LIMS software directly integrated with instrument(s). Can be used with or without LIMS connectability and provides immediate feedback on QC limits.
Instrument – where an instrument produces data in a data file containing annotated QC results, the import service can read the data files directly.
- Can I change QC results in AqcTools?
It is possible to change QC results in AqcTools, in the event of an error. However, changes like this can only be made by an authorised user and must be accompanied by a reason. All of these changes will be logged in the audit trail.
Data processing and statistics
- Does AqcTools calculate bias?
Yes, rolling bias (and RSD) are calculated for individual results as they are added to AqcTools. The calculations are performed on a definable number of valid previous results. Until the configured number of results is available, the rolling RSD and bias calculations will not be performed. Additionally, bias calculations for the dataset are displayed and compared with the released limits.
- Does AqcTools calculate measurement uncertainty?
Yes, AqcTools has a comprehensive measurement uncertainty (UoM) module which requires a separate license and can be added to the AqcTools client. UoM is assessed according to ISO 11352:2012 and Nordtest standards and allows the evaluation of performance testing scheme data.
- Can I assess if my QC data is normally distributed?
Yes, a Frequency Histogram and Normal Probability Plot for the current QC dataset can be used to assess the normal distribution of the QC data.
- Does AqcTools use Westgard rules for QC trend monitoring?
Westgard rules have been implemented into the software to allow limit and trend monitoring of the entered results. In addition, the rules are configured into one or more rule sets allowing flexibility in the implementation of different rule sets for the data from different QC types and/or analytical methods.
- Does AqcTools have the ability to select the data and calculate the mean and standard deviations?
AqcTools calculates the ‘mean’ in a mean chart from the most recent user-defined number of points or date range. This approach allows any changes in QC lots to be taken into account when selecting data to calculate and review the new limits.
- When the QC data changes over time, would AqcTools allow us to review the limits?
Yes, AqcTools allows the review and assignment of new limits for the QC data, including testing the significance of the limit change.
- Does AqcTools have the ability to incorporate the lab’s external QA (EQA) data?
Yes, AqcTools allows EQA data to be imported and in the Uncertainty of Measurement (UoM) module the support for proficiency testing (PT) schemes is available with bespoke chart design for EQA results.
- Would it be possible to report different datasets together and compare these in AqcTools?
Yes, it is possible to use a standard AqcTools report to provide a comparison report between the data from two or more QCs. The following options are available on AqcTools for reporting and comparison of data:
Data Comparison Report – This compares data from selected QC’s over the same time period.
Limit Suitability Report – Provides further statistical checks.
Trend Summary Report – provides details of Trends over the selected time period.
Normality Report – To aid investigations into any issues.
SQL / Custom Reports – The extraction of raw data points from the connected QCs, for example by analytical batch, is possible through an SQL / Custom Report created by CSols, to present the related data together.
Charting – Display
- In what form are the charts displayed?
AqcTools displays the data on Shewhart/Levey-Jennings charts or one-sided charts. In addition to individual points, batch and day mean results can be displayed on the chart.
Usually, a single component per chart is displayed. However, AqcTools allows to combine data from more than one QC to a single chart. This can be advantageous where data for similar methods use the same QC solution on the same instrument under identical conditions.
- Are charts limits shown on the charts?
Yes, once limits are set and released, AqcTools displays the 2sd and 3sd limits, target-, and calculated means on a chart. Displaying 1sd limits is an optional feature that can be added to the chart.
- Are annotations displayed?
Yes, QC failures (exceptions) are colour-coded and displayed on a chart, alongside day tend failures (e.g. 5 successive days above mean), comments made about the data, and limit releases. Full information about the data points can be seen by clicking on the specific data point.
- Can a user navigate between QC charts?
Yes, our users can view one chart at a time and move quickly forward and backward from chart to chart with simple arrow keys. Alternatively, it is possible to open multiple charts simultaneously for comparison. Users can also use exception management functions to only visit those charts that need reviewing.
- Would AqcTools recognise the QC values which are out of range?
Yes, AqcTools uses a rule set (based on Westgard and Western Electric Zone rules) to detect any QC limit and trend failures (exceptions) when importing new results. Individual results and daily mean results are checked. A rule set includes the following rules:
- An Action failure when QC result is > +/-3sd from the mean but < +/- 4sd (Westgard 13s rule).
- A Warning failure when QC result is > +/-2sd from the mean but < +/- 3sd (Westgard 12s rule).
- An Action failure when two QC results > +/-2sd from the mean (double warning or Westgard 22s and R4s rule).
- An Action failure on rising or falling trends (Westgard 7T, 8T etc. rules).
- An Action failure on rising and falling trends (Westgard 6x, 7x etc. rules).
- An Action failure on 4 control measurements in the group > +/-1sd from the mean (Westgard 41s rule).
- An Action failure on warning after action fail.
- An Action failure on 2 out of 3 warnings.
All failures (exceptions) are directly annotated to each chart to allow follow-up user interaction.
- Would AqcTools allow us to use one-sided charts?
Yes, AqcTools allows the usage of one-sided charts when Shewhart/Levey-Jennings charts are not suitable for presenting the data.
Failure (Exception) Management
- Can I conduct an investigation of QC failures and record it on AqcTools?
Yes, AqcTools allows a full investigation of the QC failures, with associated remedial and corrective actions and escalation to different user levels (from Analyst to the laboratory Manager).
- If multiple QC results have failed due to the same reason, can I assign the same investigation to all of these?
Yes, AqcTools allows Shared Investigation functionality whereby multiple data points can be associated with the same investigation.
- Our laboratory runs hundreds of QCs per day, generating large amounts of QC data. Can I check QC failures without opening charts one by one?
Yes, QC failures (Exceptions) that have not been completed can be tracked, accessed, and updated via the Incomplete Exceptions Report. The report has hyperlinks to the QC chart in case the user would like to view the chart.
Limit Review
- How do I set the initial limits of my charts?
AqcTools allows manual entry of limits (based on expected and validation data) and calculation of limits from existing QC data set.
- Can I set a limit review period?
Yes, a limit review period and limit expiry (as a date in the future or after a certain number of batches/results) can be set for the QC data.
- How do I review my chart limits
AqcTools calculates and compares the released limits with newly collected data by conducting the following checks:
The mean and standard deviation for the newly collected data are calculated and compared to the previous dataset, to see if they are significantly different (using F- and t-test). This allows checking whether the method is performing the same as at the time of the last Limit Review.
The standard deviation and bias of the newly collected data are calculated and compared to the values obtained during validation and to the industry regulatory values (using F- and t-test). This is to ensure that the method is not slowly drifting away, in small insignificant steps, from its original performance and prove that it is not exceeding the Regulatory requirements.
- We have 100’s of charts, can we review them together?
AqcTools allows the review of QC data through incomplete exceptions reports for all QC results entered over a specified time-period. This functionality allows the user to focus on the QC failures and save time from opening up charts one by one.
Data security, version control, backup and recovery
- Is the access to AqcTools client controlled by individual logins?
Once security is activated, users are required to log in to AqcTools using individual login details and passwords. Individual’s passwords can be reset by users with sufficient privileges.
- Is there an audit trail for changes made in AqcTools by users?
AqcTools maintains an audit trail of key actions and changes performed by users.
- Can anyone in the laboratory access the full functionality and make changes to the QC data in AqcTools?
AqcTools user accounts can be tailored to specific roles and controlled by the software’s security. User privileges can be set in a way that restricts manipulations with QC results for certain users (e.g. Analyst or Lab Technician level) and allows more control for others (Shift Leaders, Managers). The restrictions are set to be in line with the laboratory’s needs.
- Where is the QC data kept?
AqcTools uses a Microsoft SQL Server or Oracle database management software to hold all of the QC data and ancillary records to support the AqcTools application.
- Will our IT department have access to AqcTools application?
IT department staff would not usually require access to the AqcTools client application directly. As the application is usually managed by the laboratory’s Quality administrator. However, CSols would normally recommend that there is an IT admin account for backing up the database.
- Is AqcTools version controlled?
AqcTools is version-controlled. The version of your system can be found in the Help > About menu.
- How will the data backups be managed for AqcTools?
It is recommended that the database is backed up on at least a daily basis, using the usual database tools and IT procedures applied locally. The frequency of the backups can be defined by the laboratory, taking into account the workload. If the database resides on an instrument PC in a laboratory and is not part of a corporate network then CSols can provide an automatic backup service.
- Will it be possible to restore the earlier version of the database from backups?
Yes, the restore of the AqcTools database is possible from backup.
Installation & Connectivity
- Where is the software installed
The AqcTools database can be installed ‘on premise’ on a local laboratory server or a PC workstation providing the server or workstation is networked. For improved security the database can also be installed onto a server in the organization’s server farm. An increasing number of customers are also installing the AqcTools database in the ‘cloud’. CSols recommend that the Microsoft Azure database is used.
The AqcTools Client can be installed on laboratory PC desktops, or deployed using Citrix or other shared desktop solutions.
- What are the requirements for the PC to run the AqcTools client?
Any modern Windows-based workstation or laptop with typically >2GHz CPU and >4BG main memory and Windows 10 or 11 Operating system (Windows 7 is supported). Microsoft .Net 4 and higher is required.
- What are the requirements for network connection for the AqcTools client?
The workstation must have a suitable Ethernet or Wi-Fi network card if it is being used in a networked configuration.
- What are the requirements for the database?
Either a Microsoft SQL Server or Oracle relational database is supported.
Oracle 12g or newer is supported.
Microsoft SQL Server 2018 or later is supported although AqcTools works on earlier versions. The free-to-download ‘Express’ version of SQL Server is sufficient for most laboratories.
Users will need read/write access to the AqcTools database, how this is handled will depend on the client’s configuration and needs.
- What would be the size of the database?
The volume of stored QC data varies depending on the size of the laboratory, the number of assays, and the QC samples used. It ranges from 250,000 to 1,000,000 QC results (by far the largest table) per Gigabyte (GB) of database storage.
Regulatory compliance
- Would AqcTools be fit for purpose for use in regulated/accredited laboratories?
Yes, AqcTools functions are designed to provide a laboratory with the ability to support the accreditation requirements of the ISO17025 or ISO15189 standards.
Cost Saving
- Will AqcTools improve my productivity?
Yes, AqcTools can significantly improve a laboratory’s productivity through the optimisation of workflows, reduction in manual efforts, improvements in data accuracy, and enabling proactive decision-making—all of which contribute to a more productive laboratory environment.
Quantification of the productivity improvements due to the use of AqcTools can vary significantly based on several factors, including the size and complexity of the laboratory, and the existing workflow inefficiencies.
- Does AqcTools improve laboratory quality?
Yes, the comprehensive and systematic approach provided by AqcTools ensures that laboratories maintain high-quality standards, uphold the accuracy of results, adhere to regulations, and continually strive for improvement—all crucial aspects of ensuring laboratory quality.
IT Support and training
- We don’t have a captive programmer/IT person in the lab nor the expertise, can your software do the job, and then can you support us afterwards?
Yes, we have a dedicated support desk.
- Would CSols provide user training for AqcTools?
Yes, CSols offers the following packages: basic user (analyst), administrator (manager), and Uncertainty of Measurement module training. This provides a comprehensive overview of AqcTools functionality.