Guide Rules, graphs and statistics

Methods for Internal Quality Control

QualiChart editorial team

Analysis of methods for IQC

Analysis of the problems surrounding the traditional methods used for IQC: manufacturer-assigned range, Spreadsheets, LIS/ Equipment, with a comparison of the modern solution System for IQC.

This guide, presented below, will help you understand, criticize what you use and choose the one with efficient resources to improve the quality of analysis processes, facilitate decision-making and increase confidence in the results you deliver to patients.

It contains the way to overcome restrictions of traditional methods and better evaluate the analytical performance of the Clinical Analysis Laboratory.

The new regulation RDC 978/2025 ANVISA makes the use of traditional methods for Internal Quality Control unfeasible, requiring an appropriate tool to meet the most rigorous control criteria. QualiChart is an ideal system as a modern method for IQC, fully meeting DRC requirements, reducing the time spent on the daily control routine by 85% and ensuring efficiency, compliance and reliability in laboratory results.

Manufacturer's Stated Range
Spreadsheets
LIS / Equipment
System for IQC

Data Stream

Manufacturer's Stated Range

  • Presents values as a reference for starting the control
  • References are only for initial analyzes

Spreadsheets

  • Manual data collection and entry
  • More time taken to execute

LIS / Equipment

  • Data provided by equipment
  • Information presented separately

System for IQC

  • Data from all equipment in one place

Analytical calculations

Manufacturer's Stated Range

  • Does not apply multiple rules
  • Does not calculate Mean, Standard Deviation and Coefficient of Variation

Spreadsheets

  • Enables control chart plotting
  • There is no possibility of handling more than one control level

LIS / Equipment

  • Automatically plots the graph
  • Some do not apply Multiple Rules

System for IQC

  • Multiple Rules Automatic Test
  • Calculation of Mean, Standard Deviation and Coefficient of Variation
  • Automatic Levey-Jennings Plot

Time and processes

Manufacturer's Stated Range

  • Many processes involved
  • More time taken to execute

Spreadsheets

  • Speeds up time spent on execution
  • Large amount of data to process
  • Typos

LIS / Equipment

  • Information presented more objectively
  • Little standardization of the analytical environment

System for IQC

  • Process standardization
  • Fast and automatic execution

Data interpretation

Manufacturer's Stated Range

  • Does not find trends and other changes
  • Does not allow analysis of the Levey-Jennings graph

Spreadsheets

  • Requires understanding from technicians at the bench to interpret data

LIS / Equipment

  • Manual joining of data from each device
  • Requires understanding from technicians at the bench to interpret data

System for IQC

  • Launches error alerts
  • Classifies the type of error
  • Searches for the root cause to identify a solution

Review

Manufacturer's Stated Range

  • You must know the steps for a more assertive critical analysis
  • Too much information to deal with manually

Spreadsheets

  • Depends on technical knowledge for evaluation
  • Does not allow a complete view of the control for evaluation

LIS / Equipment

  • Does not perform a comparative analysis of the laboratory impression, measured by the Coefficient of Variation

System for IQC

  • Automatically performs critical analysis
  • Launches alerts
  • Classifies the type of error
  • Searches for the root cause to identify a solution

Error handling

Manufacturer's Stated Range

  • Takes a long time to evaluate the type of error
  • Definition of corrective action made difficult

Spreadsheets

  • Bench experience required to identify root causes and define corrective actions

LIS / Equipment

  • Does not display alerts for nonconformities
  • Makes it difficult to evaluate errors and make decisions

System for IQC

  • Indicates nonconformity
  • Presents possible causes of variation in results
  • Defines remediation actions for recurrence control

Control Management

Manufacturer's Stated Range

  • Lack of personnel to carry out the process
  • Difficulty passing daily control for all analytes

Spreadsheets

  • Does not allow complete control analysis
  • Incomplete and delayed evaluation

LIS / Equipment

  • Limited view of the analytical environment
  • Difficulty maintaining control stability

System for IQC

  • Monitoring in one place of routine data from all monitored equipment and units

Information Record

Manufacturer's Stated Range

  • Lack of effective registration
  • Makes it difficult to consult significant information about occurrences in the control

Spreadsheets

  • Very complex to handle the numerous quantitative tests, with records and reports

LIS / Equipment

  • Demands daily logging actions for numerous analytes, analysis logging and reports

System for IQC

  • Complete history of each analyte and non-conforming occurrences, rules violated and corrective measures, for guidance in case of error recurrences

Evaluate your current method

Your current method performs internal control in full form?

Answer with YES or NO to assess whether the method you use today meets IQC requirements:

  • Does your current method automatically centralize control data from all equipment into a single system?
  • Does your current method apply Westgard Multiple Rules automatically and alert you to control errors?
  • Does your current method automatically identify the type of error and present possible causes and corrective actions?
  • Can you complete the IQC routine for all lab analytes in less than 30 minutes per day?
  • Does your current method record the complete history of occurrences and generate IQC reports ready for Health Surveillance?

0 NOT answered

If you answered NO to three or more of these questions, your current method is not fully performing internal quality control.

The next step

Get to know QualiChart — the system dedicated to IQC

Discover how more than 1,400 laboratories have reduced routine time by 85% and eliminated internal control errors.

Request free demo →

Continue studying IQC

See all articles

Share this content on WhatsApp

Your next step in quality control

Put QualiChart to the test. Free for 30 days.

Create your account and evaluate QualiChart in your laboratory. Do you prefer a guided introduction? Request a demo with our team.