Installation Qualification

This page is under construction. When finished, this page shall provide guidance on installation qualification protocols.

The following are test cases for IQ documentation, a sample IQ is located here

Stage 1: System Documentation
	System Instrumentation	Manufacturer
		Equipment Type
		Model/ID
		Serial number
		Asset number
		Required Calibration
		Classification (Internal) This section is not always utilized by companies. Classification, however, allows the definitions of requirements within the validation SOPs. Listed are samples of what might be used to classify	I	Simple, no electronic parts, no moving parts
			Ib	critical part, no electronic or moving parts
			II	moving parts, no electronic parts
			IIb	critical part, moving, no electronics
			III	simple electronic parts
			IIIb	critical part, simple electronics
			IV	firmware
			IVb	Critical part, firmware
			V	software
	Manual Verification	Operational Manual(s) list	The user manuals that are provided with the equipment and are documented and located in the correct department. The location marked in the qualification should be the permanent location of the manual when needed for reference. This may be physical, electronic, or both.
	Technical Document Verification	Technical Document List	Components of the system may include technical documents or certifications, such as factory/site acceptance testings, purchase orders, design documentation, factory calibration, concentration verifications for solutions, or other qualifications. The location marked in the qualification should be the permanent location of the documentation when needed for reference. This may be physical, electronic, or both.
	Drawings Verification	Drawings/Blueprints List	Drawings of the equipment, the electrical system, or other figures are located and a location is documented with the permanent site for future reference. This may be physical, electronic, or both.
	Computer System Documentation	Computer Systems List	A list of any included firmware or software associated with system.
		Software Operating Parameters List	A list of actionable, selectable, or adjustable options provided by computer system. Examples include timers, speed, temperature, or other variable adjustments in addition to reading and archiving options.
	Component Verification	Component List	This list identifies the separate parts of a system or equipment. For example, a manual buffing station would include a foot pedal, motor, buffing wheel. A mixing tank would include input and output locations, a mixing paddle, a motor, and a user interface. A more complicated system such as a packaging line may include a number of components: packaging material infeed, filling material infeed, thermoformer, filling station, conveyor belts, weigh station, coolant pumps, sealers, labeling, cutting station, multiple user interfaces, shrink wrapper, heat tunnel, and more. Some of these parts may require calibration or preventative maintenance specific to the component.
		Physical Operating Parameters List	A list of settings available on system, either static or adjustable. This may include speed, size, location of components, amount of air/gas provided, or other considerations.
	Auxiliary Equipment Verification	Auxiliary equipment list	This list identifies auxiliary equipment that may be used on or by the system, but are not controlled by the system. Such equipment may include cleaning components, coolant pumps, balances, calibration weights, among others.
	Associated Materials/Resources	Associated Materials List	A list of all materials or resources needed associated with the system. This list includes any material that is required to be supplied to the system to ensure proper usage and that the materials are approved for use. This section may be bypassed if included in URS
			This may include compressed air, water, gasses, sanitizing chemicals for CIP, lubricants, standards, or other
	Safety Requirements	Safety Requirement List	A list of all associated safety regulations or company policies associated with system or materials. This may include such requirements as chemical storing procedures, moving parts coverage, emergency stops. This section may be bypassed if listed on URS
	Spare Parts List Verification	Spare Parts List(s)	A location is documented with the permanent site of a spare parts list for future reference. This may be physical, electronic, or both. This list location may be the operational manual or technical documents.
Stage 2: Physical Verification
	Nameplate Verification	Nameplate	The nameplate of the equipment is located and the data is verified to match the documentation.
	Physical Installation Verification	Physical State	The physical state of the system is assessed, any damage should be noted in addition to verifying all components listed in the documentation are present. This assessment may also include system level, integration into processes or auxiliary equipment, or other installation requirements.
		Component Verification	Components on the component list are present and are set up in accordance to any blueprints or drawings.
		System Integration	The system’s integration into processes or with auxiliary equipment is assessed. This includes connections to utilities, CIP, and may also include connecting areas to systems involved in product’s previous or future steps.
		Materials Verification	All materials documented in the associated materials list are present
		Safety Verification	All safety requirements and procedures listed in the safety requirement list are present
		Placement Verification	All parts and materials associated with system have a defined placement or storage area
		Materials of system construction	Product touching surfaces or work area enclosures may be validated for safety in many cases. Example: type of stainless steel required for centrifugal pump, type of safety glass in viewing window
			Materials can be validated through documentation or testing.
	Utilities Verification	Water	The correct class of water is available. Source, sterility, plumbing, and testing is validated as needed.
		Electrical	The correct source of electrical is available. Source, wiring, breakers validated as needed.
		Gas(ses)	The correct source(s) of gas(ses) are available. Delivery and storage systems validated as needed
		Pressurized Air	The correct source(s) of pressurized air are available. Delivery and storage systems validated as needed
	Environmental Requirements Verification	Temperature	A system to ensure the correct temperature range is validated. Temperature is in range when testing
		Humidity	A system to ensure the correct humidty range is validated. Humidity is tested to verify in range.
		Ventilation	A system for ventilation of toxic/harmful/contaminated air is available and validated if needed.
		HEPA/Airflow	A system for supplying airflow is validated and tested as needed. For Aseptic processing, this validation my include ACH, first air validation, smoke testing, unidirectional/laminar flow or more.
	Computer System Verification	Operating System Verification	Verify the operating system is installed as documented
		Backup Verification	Verify the system back up or archive ability and location if applicable
	Test Instrument Calibration	Calibration Verification	Verify the calibration of any test instruments used in the previous test cases.