Programs

Course Content:

• Official requirements

Documentation of the qualification

Design Qualification (DQ)

Installation Qualification (IQ)

Operational Qualification (OQ)

Performance Qualification (PQ)

Qualification of established facilities

Requalification

• Preparation of the qualification

Commissioning

Sequence

Qualification team

Responsibilities

• Qualification documentation

Qualification master plan

Qualification plan

Qualification report

Labeling of the qualification status

SOP - “Qualification of facilities and equipment”

• Design qualification (DQ)

User requirements (user specifications)

• Installation qualification (IQ)

Examples of IQ plans

Materials and lubricants

Supply of (energy and media) utilities

Measuring and controlling technology points and initial calibration

Calibration records

P & I diagrams Pipes

Technical documentation

IQ report

Example: Fluid bed equipment

• Operational qualification(OQ)

Examples of OQ plan

Safety devises

OQ report

Example: Fluid bed dryer

• Performance qualification (PQ)

Retrospective qualification