SMB Validation

What does an IQ contain?

Installation Qualification Protocols include (but are not limited to) the following common sections:

Identification of Writer, Approvers, Executors and Revision History:
Provides documented evidence on the personnel involved in preparing and executing the protocol complete with samples of signatures, initials and date formats. A revision history is maintained to record any changes to the document and the date they occurred.

Objective, Testing Rationale, and Scope:
Defines the intent and limitations of the protocol and specifies the quality critical functions of the equipment.

Acceptance Criteria and Identification of Test Equipment Required:
Specifies the criteria for a successful implementation and provides the customer with a list of test equipment to supply.

Equipment/Process Description:
A detailed written description of the entire system is included so as to provide the less-informed reader with the level of information required to gain comprehensive understanding of how the system as a whole is designed to operate.

Equipment Identification:
Records the specific identification of the tested components of the system (Model number, serial number, customer equipment number, rated voltage/amperage, etc.

Purchase Order Verification:
A list of the purchase orders related to the project will be drawn up. A review of the installed system will be carried out for conformance to these documents.

Spare Parts Verification:
A review will be carried out to ensure that adequate documentation on spare parts is available to the facility.

Manufacturer’s Documentation Verification:
A review will be carried out to ensure that all appropriate vendor documentation has been collected and is available for reference.

Preventive Maintenance Program Verification:
A review will be carried out to ensure that proper documentation is available for the development of Preventive Maintenance procedures. Integration of the equipment in the facility’s PM Program will be verified.

Verification of Electrical Supply:
Adapted to the customer’s established methods, will verify the integrity, safety and proper installation of the machine’s electrical distribution network. This is usually done with personnel from the customer to give them first hand knowledge of the equipment.

Verification of Compressed Air Supply:
Adapted to the customer’s established methods, will ensure verification of adequate compressed air supply.

Identification of Vacuum/Dust Extraction System:
Identifies the source and location of all vacuum sources used with the system.

Control Equipment/Software Identification:
Will provide documented information on the control system or PLC used for control functions and will list the name and version of the software used. When requested by the customer, will ensure that a hard or disc copy of the program is available.

Control Printed Circuit Board Listing:
Identifies the major electronic boards (model and serial number) used in the logic circuit of the equipment. This will facilitate “same for same” replacement in case of failure of these electronic components.

PLC Testing - Input/Output Identification and Verification:
A loop check for PLC wiring will be carried out to verify programming. This is also normally carried out with personnel from the customer to provide them with detailed knowledge of the hardware.

Product Contact Surfaces Verification:
Verification that all product contact parts are composed of materials that are acceptable to the customer.

I.Q. Notes, Appendices, and Test Incidents:
These sections are provided to allow for proper documentation of any unforeseen occurrences during protocol execution.

Close Out and Sign Off:
Final approval of the executed document by authorized personnel is required in order to close out the document.