Advanced Quality Control Charts and Reports
Description, Purpose and Objective
NOTE
The Advanced Charts and Reports suite is the analytical intelligence and management auditing console of the Quattrol platform. Its purpose is to provide higher level mathematical and data mining tools (Six Sigma metrics, quartile scatter plots, technical performance indices and compilation of executive compliance reports).
The objective of this module is to provide management and quality assurance personnel with consolidated indicators of the capacity of the analytical process, allowing the design of preventive control schemes and the evaluation of inter-site variability and inaccuracy in a robust manner before issuing official reports.
Context of Use
This advanced panel is operated by:
- Laboratory Directors and Quality Managers: To carry out quality control planning based on Sigma, evaluate the consistency of the reagent catalog (lots) and justify methodological decisions before accreditation auditors.
- Auditors and Laboratory Network Administrators: To compare the dispersion between multiple locations and export the unified executive report of analytical performance.
1. Decision Chart (Westgard / Six Sigma)
Purpose
Evaluation of analytical quality metrics based on the Six Sigma scale ($\sigma$). It serves as an objective criterion for the selection and optimization of the Westgard control rules required for each assay, reducing false rejections and optimizing analytical costs.
Tabs and Modalities
- CC Test: Plots the Sigma status of an individual assay.
- Group CC: Plot and position multiple group trials on the same decision diagram.
- Custom: Simulation environment where the user enters hypothetical values of Total Allowable Error (ET%), Bias, and Coefficient of Variation (CV%) to model the resulting Sigma without altering the actual data.
Input Parameters
- Date range: Time window selector being evaluated.
- CC Test / CC Group😗* Autocomplete fields to choose the essay or group template.
Actions
- Calculate: Processes the data and draws the points on the Sigma zones (World Class, Excellent, Good, Marginal, Unacceptable).
- Clear: Resets the variables and initializes the simulation quadrant.
- Print: Compiles the decision graph along with the imprecision/bias table into a downloadable file.
2. Analytical Performance Indices
Purpose
Automated calculation and consolidation of key operational capacity metrics of the method. It measures the methodological robustness by correlating the Coefficient of Variation (CV%), the Bias%, the Global Quality of the trial and the Analytical Performance Index (ADI).
Tabs and Modalities
- CC Test: Unitary focused calculation for a test.
- CC Group: Consolidated matrix of indices for the entire analytical profile.
Input Parameters
- Date range: Time range for statistical calculation.
- CC Test / CC Group😗* Selection of the entity under analysis.
Actions
- Print: Download the detailed report with analytical performance tables.
3. Whisker Plot (Box Plot)
Purpose
Graphic representation that describes the dispersion and symmetry of the results through the use of the median, the limits of the first and third quartiles (scatter box), and the whiskers that indicate the upper and lower limits, automatically identifying outliers (outliers).
Tabs and Modalities
- Analyte: Graphically compares the dispersion of the same measurement across multiple locations in the laboratory.
- Reagent lot: Evaluates the consistency of the results by contrasting the variability of different reagent lots from the same assay.
Input Parameters
- Headquarters: Multiple selection of physical locations or branches to compare.
- Measurands: Specification of the analyte under analysis.
- Date range: Collection period of the represented data.
Actions
- Calculate: Runs the queries against the database and renders the boxplot.
- Clear: Resets the general filter boxes.
- Print: Download the case variability and comparison report.
4. Performance Report
Purpose
Unified and consolidated report that synthesizes the laboratory's analytical quality audit, compiling the Sigma status, compliance with error goals and rule violations reported by analyzer in a single report ready for printing or institutional filing.
Input Parameters
- Laboratory:* Selector of the headquarters or entity connected in session.
- Instrument:* Filter to limit the report to a specific analyzer at the headquarters.
- Level:* Degree of depth of the statistical contrast (e.g. Level 3: Measuring - Batch - Method - Instrument).
- Area and Lots: Specific filters for classification of the analytical catalog.
- Date range: Audited time frame.
Actions
- Generate: Compiles and processes the historical information to render the report on the screen.
- Print: Processes the physical print or PDF export version of the unified document.
Viewing and Downloading
To get any of the advanced analytics:
- Enter the required filtering parameters.
- Click the Calculate or Generate buttons as appropriate. The platform will process the historical data from Firestore and display a real-time visual draft at the bottom of the screen.
- Once the interactive draft is verified, press the Print button to export the final file in high resolution.
Roles and Permissions Required
Access to the advanced statistical analysis and management report generation functions is governed by the following roles and permissions:
Due to its strategic impact, this panel is limited to the profiles of Laboratory Director, Quality Coordinator and System Auditors.
- Sigma Decision Graphs:
sigma_graphics_read: Allows you to enter the view, graph the Six Sigma scale and use the interactive simulator.sigma_graphics_create: Allows you to attach monthly notes and comments to the decision report.
- Analytical Performance Indices:
report_statistical_read: Enables querying and rendering of method capacity tables.
- Whisker Plot (Box Plot):
boxplot_graphic_read: Allows access to the Box Plot route and comparisons by Sites and Reactive Batch.
- Executive Performance Report:
performance_report_read: Grants authorization to interact with the filters and enable the global executive report generation button.
- General Printing Actions:
performance_report_read/report_statistical_read: Mandatory to execute the export actions and Print the reports.