IFQHC Framework (Competency Management)

The IFQHC module manages competency frameworks and personnel assessments for regulated environments. It supports predefined framework presets (EU GMP, US FDA) and custom configurations, tracks competency levels from trainee to expert, and manages assessment evidence and expiration dates — all critical for GxP data integrity compliance.

IFQHC stands for the competency and qualification standards that underpin quality management systems in pharma and healthcare.

Overview

In regulated industries, personnel must be demonstrably competent in their roles. Auditors expect documented evidence that operators, analysts, and managers have been assessed against defined competency criteria, that assessments are current (not expired), and that gaps are being addressed. The IFQHC module provides the digital infrastructure for this.

Getting Started

1. Navigate to the IFQHC section from the main menu.
2. Click New Framework to create a competency framework.
3. Select a preset (EU GMP, US FDA, Simple, or Custom) and configure the framework parameters.
4. Define competency domains and criteria within the framework's config JSONB.
5. Record assessments against the framework for individual users.
6. Set competency levels and expiration dates.
7. Track assessment history and flag upcoming expirations.

How It Works

Competency Frameworks

A framework defines the competency model for a specific regulatory context:

Field	Description
Name	Framework title (e.g., "EU GMP Annex 11 Competency Model")
Preset	Template: eu_gmp, us_fda, simple, or custom
Config	JSONB configuration for competency domains, criteria, and scoring rules
Created By	The user who established the framework

Presets provide a starting point with industry-standard competency domains. The custom preset allows organizations to define their own structure entirely.

Competency Assessments

An assessment records a point-in-time evaluation of a person's competency:

Field	Description
Framework	Which competency framework was used
User	The person being assessed
Assessor	The person conducting the assessment
Role	The role being assessed (e.g., "QC Analyst", "Production Operator")
Level	Competency level achieved
Evidence	JSONB field for supporting documentation
Notes	Free-text assessment notes
Expires At	When this assessment expires and requires reassessment

Competency Levels

Assessments use a four-tier competency model:

Level	Description
Trainee	Currently in training, not yet competent to work independently
Competent	Meets minimum requirements, can perform the role with supervision
Proficient	Fully capable, works independently and can handle exceptions
Expert	Deep expertise, can train others and define best practices

Assessment History

The getFrameworkById procedure returns the framework along with its 50 most recent assessments (including user and assessor details). The listAssessments procedure provides filtered, paginated access to the full history with filtering by framework, user, and competency level.

Expiration Management

Assessments can carry an expiresAt date. When an assessment expires, the individual must be reassessed before they can be considered competent. This is critical for GxP environments where competency must be current and documented.

Configuration

Frameworks and assessments are scoped to the organization. Frameworks are listed with optional filtering by preset and name search. Assessments are listed with optional filtering by framework, user, and level. Both support pagination (default 20, max 100).

Permissions

Action	Required Role
Create/edit frameworks	Quality manager or admin
Record assessments	Authorized assessor or admin
View frameworks and assessments	Any organization member
Delete frameworks	Admin only
Delete assessments	Admin only

All mutations are logged to the audit trail with framework and assessment metadata.

Tips & Best Practices

Start with a preset

Use the EU GMP or US FDA preset as a starting point, then customize the config to match your organization's specific competency requirements. This ensures regulatory alignment from the beginning.

Set expiration dates proactively

Define standard validity periods for each competency level (e.g., competent assessments valid for 12 months, expert for 24 months). Set expiration dates at assessment time, not retrospectively.

Attach evidence to every assessment

Regulatory auditors expect documented evidence of competency. Attach training records, exam results, observed performance evaluations, and sign-off forms to each assessment.

Track assessor qualifications

Assessors themselves must be qualified to assess others. Ensure assessors have at least "proficient" level in the domains they evaluate and document this in the framework configuration.

Related Features

• Compliance Radar — competency requirements are often part of regulatory compliance
• Inspections — inspection readiness depends on personnel competency
• KPI Boards — track competency coverage rates as People KPIs
• Tech Transfer — technology transfers require verified personnel competency at the receiving site