1 User Requirement Specification

This document should contain what are the machine requirements before purchase.

2 Design Qualification
This document details how the machine technical specification meets the User Requirement
specification

3 Installation qualification (IQ)

IQ means is it installed correctly. Important IQ considerations are (whatever applicable),
i. Equipment design features (i.e. materials of construction clean ability, etc.)
ii. Installation conditions (wiring, utilities, functionality, etc.)
iii. Calibration, preventative maintenance, cleaning schedules
iv. Safety features
v. Supplier documentation, prints, drawings and manuals
vi. Software documentation
vii. Spare parts list
viii. Environmental conditions (such as clean room requirements, temperature, humidity)
ix. Documented operator training;
x. Operating manual or procedure.
Alarms, warning systems, or machine stops shall be challenged in the event that critical process
parameters exceed predetermined limits (Wherever applicable).
Critical process instruments, sensors, displays, controllers, etc. shall be certified as calibrated
and have written calibration schedules.
There shall be written preventive maintenance and cleaning schedules.
The application of software systems, such as programmable logic controller, data collection,
and inspection systems, shall be validated to ensure that they function as intended. Functional
tests shall be performed to verify the correct functioning of the software and hardware, and
especially the interfaces. The system shall be checked (e.g. by entering correct and incorrect
data, by simulating a loss of electrical power) to detect the availability, reliability, identity,
accuracy and traceability of data or records.
4 Operational qualification - (OQ)
The process parameters should be challenged to assure that they will result in a product that
meets all defined requirements under all anticipated conditions, i.e., worst case testing.
OQ considerations include (whatever applicable):
i. Process control limits
ii. Raw material specifications
iii. Process operating procedures
iv. Material handling requirements
v. Process change control
vi. Training
vii. Short term stability and capability of the process,
viii. Potential failure modes, action levels and worst-case conditions
ix. The use of statistically valid techniques such as screening experiments to establish key
process parameters and statistically designed experiments to optimize the process
can be used during this phase.

5 Performance Qualification
Justify all your product requirements are met by running few actual product on the machine.