About SECA

We bring behavioural and cognitive science to investigate the real cause behind human errors!

The sequence of events

Who We Are

With systematic workflow and advanced business analytics, users can use SECA to strengthen their quality culture and influence company-wide performance while reducing human error.

SECA automates error investigations throughout the product lifecycle to help organizations navigate standards and demonstrate regulatory compliance. It leads to continuous improvement and significant cost savings in pharmaceutical manufacturing operations.

SECA is the industry’s first Error control software that uses artificial intelligence, predictive analytics and business intelligence to improve quality decision-making and enable the transition from reactive quality to proactive quality.

SECA is based on the below concepts of to effectively prevent, control and reduce human errors

It consists of below major components that helps get to the cause of failures

ESI (Error Source Identification)

The ESI step in Human Error Investigation helps analyze the information during investigations and provides a systematic method to classify the errors with respect to their source. The ESI can be used to aid in appropriate root cause identification and generate relevant actions to reduce errors.

The ESI broadly comprises of categories in the ESI framework which is further inclusive of multiple performance influencing factors/ causes to help the investigator effectively break down a Human error into rational reasons for the error. The single generalized term – ‘Human Error’ – is split into non-singular possible root causes for more specific details of the error type. Each root cause is then represented by a collective characterization of the various layers of causative factors

This tool can be exploited by the quality or manufacturing investigators using the set rules for categorization, helping them leverage the systematic mode of error investigation.

ESI

PIFs (Performance Influencing Factors)

Performance Influencing Factors, or PIFs, are factors that combine with basic human error tendencies to create error-likely situations. In general terms PIFs can be described as those factors which determine the likelihood of error or effective human performance.  It should be noted that PIFs are not automatically associated with human error.

Performance Influencing Factors (PIFs) are the characteristics of the job, the individual and the organisation that influence human performance. Optimising PIFs reduces the likelihood of all types of human failure.

CIF (Cognition Influencing Factors) Check

The CIF check helps in evaluation of the conditions that affect human cognition at work. It specifically identifies error precursors in the defined area/ task and determines conditions under which the reliability of cognition may be reduced.

In CIF Check step of the Human Error investigation, the focus is on the mental processes which underlie observable behaviour, e.g., decision making and problem solving. It uses a cognitive approach to Cause Analysis.

The CIF check framework mostly focuses on stimuli that affects cognition (specifically cognitive overwork). It uses a set of Cognition Influencing Factors (CIFs) to describe the context in the scenario/ task under analysis.

Also, it is a Semiquantitative Tool – It uses an ordinal scale as a measurement scale that allocates values to variables based on their relative ranking with respect to one another in each data set i.e., CIFs.

The Sequence of Events When you Investigate an Error

1
Human Error or Other Failure
2
Error Source Identification
3
Identify Internal / External Factors
4
Complete CIF Check
5
Check CAPA requirement
6
Take Actions as Recommended
7
Complete Error Investigation Report
8
Trend Errors

For Quality and Manufacturing Errors in Pharmaceuticals

We bring behavioural and cognitive science to investigate the real cause behind human errors!