Calculate your potential savings with our ROI Calculator
ROI CalculatorEmployee Competency Management can be defined as a system that helps in the identification, assessment, mapping, tracking, and auditing of the particular mix of technical, regulatory, behavioral, and operational competencies necessary for employees to perform their roles effectively.
Despite the sophistication of an enterprise’s automated systems, laboratory equipment, and enterprise architecture, there will always be a level of variation caused by human error. Within critical industries like pharmaceutical production, clinical diagnostics, commercial aviation, and petrochemical production, one capability deficit is capable of resulting in millions of dollars' worth of material waste, integrity breaches, or even industrial disaster. Employee Competency Management allows an enterprise to build a robust system of validation that uplifts the simple process of training verification to a formal compliance protocol.
A comprehensive system for competency management seeks to ensure that no direct-impact employee lacks documented, empirical evidence of their ability to perform their job duties. Such a measure defends the business from potential legal action, assures product consistency, and helps build an armored position with regard to regulatory compliance. Regulators scrutinize the ability of enterprises to track worker competency during surprise audits. Current Good Manufacturing Practice regulations, as mandated by FDA 21 CFR Part 211.25 and ISO 13485 medical device standards, consider untracked competency to be one of the largest governance flaws of any enterprise.
To construct a defensible and objective competency validation network, an organization must manage four core operational components:
Job Specific Competency Profile: The initial set of standards that outlines the specific competencies and skills requirements, required degrees, qualifications, and other factors related to each position within the company.
Multi-Dimensional Evaluation Systems: To remove any potential bias from the management decisions, competence needs to be verified using unbiased objective tools such as written tests, computer simulation exercises, anonymous sample analysis, and hands-on practice evaluations led by subject matter experts.
The Learning Management System (LMS) Matrix: A secure and reliable online platform that provides an up-to-date overview of qualifications obtained by all workers. The system automatically disables access to the batch records or machinery when an operator is no longer qualified or when their qualification expires.
Continuous Re-Qualification Intervals: Setting up a periodical requalification for certain high-risk processes, such as aseptic operations or non-destructive material testing, every 12-24 months in order to reduce the risk of skill deterioration and accommodate changes.
Deployment of data-driven competency management offers unparalleled agility for business operations. Using the skills matrix, production managers will be able to discover any bottlenecks within their workforce, for example, having only one qualified operator for a vital machine, and organizing cross-training programs aimed at redundancy.
Creating competency standards greatly decreases scrap, speeds up the onboarding process, facilitates international audits, and prevents errors from people. Thus, the extended workforce becomes a valuable asset for increasing brand value and manufacturing speed.
