The IQC Journey: PHASE 1
You should already have the 9-step Internal Control system and its necessary tools at hand to achieve greater stability in the analytical system and security in delivering results (with 85% less time in the daily control routine)
Therefore, check out the guide to help you understand the practical process of the first phase of the IQC Journey: Building the Base and Internal Quality Control Routine.
The guide presents simple planning for IQC, based on the requirements of the new RDC 978/2025 ANVISA. Very valuable for laboratories that face challenges in applying Control and validating quantitative tests on a daily basis, carrying out the correct critical analysis to guarantee the safety of the results delivered.
The Journey of Internal Quality Control
"Get from point A to point B"
Follow the steps to implement Internal Quality Control in the clinical laboratory and achieve good stability of the analytical system.
The IQC Journey is a simple-to-follow system, delivering the ideal IQC method for quality managers and laboratory professionals who need to:
- apply the rules for all analytes daily,
- know the errors and make the critical analysis quickly,
- has a stable analytical system, achieving security in releasing results to patients.
In this material we will present a simple guide focused on planning for the Construction of the IQC Base and Routine:
Base Construction and Routine
- Planning
- Personal
- Control Material Preparation
Error Identification and Critical Analysis
- Levey-Jennings Plot
- Westgard Rules
- Review
Corrective Actions and System Stability
- Action and Documentation
- Measurement Uncertainties
- Maintaining Stability
My Lab Got It…
- Analytical system stability
- Error recurrence control
- Employee engagement
- Daily validation of controls
- Security in releasing results
- Correct interpretation of data
- Complete IQC management
- Plotting graphs quickly and dynamically
- Application of multiple rules for all analytes
- Knowing the calibration time
- Compliance with standards and inspection
My Lab Needs…
- Validate control daily
- Maintain analytical system stability
- Control the recurrence of errors
- Empower people and control turnover
- Graphing speed
- Ensure safe release of results
- Perform critical analysis correctly
- Simplified management of the entire process
- Comply with ANVISA and accreditation requirements
- Know how to apply multiple rules
Base Construction
and IQC Routine
Lay the foundation of IQC
GCQ must be documented, including:
I – list of all tests carried out;
II – form of control and frequency of use;
III – limits and acceptability criteria for control results;
IV – evaluation and recording of control results;
V – CEQ performance report of all tests carried out, issued by the Proficiency Test Provider with a minimum annual frequency.
List of analytes, equipment, parts and materials used
Organize materials:
- Identify the supplier of the control material and have the set of analytes (tests or tests) in your line.
- Estimate your consumption and plan volume acquisition for at least 6 months of the same batch.
Get the materials:
- Contract with your supplier the control materials for the tests planned at 2 levels of control.
The Service that performs EAC must record the receipt of products for in vitro diagnostic use, reagents and supplies. The records must present data such as the batch number, compliance with transport conditions, date of receipt and other information necessary to guarantee traceability and quality.
Set control type
(Base on sample control format offered by manufacturers)
Identify the control level indicated for that batch in the manufacturer's recommendations. Ex:
- Level 1 for values in the reference range
- Level 2 for pathological values
Art. 102 – The use of reagents, supplies and products for in vitro diagnosis and their preservation and storage conditions must comply with the manufacturer's recommendations for use, with their revalidation not being permitted after the expiration date.
Art. 103 – The Service that performs EAC is permitted to carry out analytical tests in order to guarantee the quality of inputs and products used in the operational processes of the service itself.
Carry out the runs
Perform tests on control samples in the same way as you do for patients. Collect the results for analysis.
Choose an IQC Validated Method
The use of the Internal Quality Control system (QualiChart) guarantees compliance with regulatory requirements and the safety of results:
- Monitoring of routine data from all monitored equipment and units in one place.
- Automatic test of Westgard's Multiple Rules, calculation of Mean, Standard Deviation and Coefficient of Variation.
- Automatic Levey-Jennings Plot.
- Standardization of control processes, individualizing each analyte.
- Displays nonconformity alerts and classifies error types.
- Assistance in finding the root cause of nonconformity and identifying a solution.
- Record of correction actions to control recurrence. Compilation into history and report.
- Complete history of each analyte and non-conforming occurrences, violated rules and corrective measures, for guidance in case of error recurrence.
- Registration and control of interventions on each equipment, according to the requirements of RDC 978/2025 ANVISA – Arts. 92 and 93.
- Compliance with all requirements of ANVISA's RDC 978/2025.
Start Phase in preparation
Define the analyte and enter run data for each level.
It must be ensured that analyzes are carried out in accordance with established standards, using a validated and reliable method. The adoption of procedures based on reliable sources guarantees the quality and precision of the results obtained.