Many manufacturers, especially in non-regulated industries, do not have experience with a formalized approach to managing and controlling their manufacturing systems. These businesses may be unfamiliar with the purpose and benefits of a structured documentation system for defining specifications and test protocols.
Most of these documents are interrelated. These documents contain technical and operational information about the company's manufacturing systems and provide the foundation for effective operational and quality control as well as successful regulatory inspections.
User Requirements - Technical and operational requirements that the manufacturing system must achieve. The initial version of this document provides the background information for soliciting vendor bids. Subsequent versions of the document are refined to conform with the capabilities of the selected vendor and fine details that may not have been fully developed upon initial bid request.
System Specifications - Detailed technical and operational document providing a complete description of the as-built system. The initial version of this document is based upon the User Requirements and actual design details. Subsequent versions of the document are refined to conform to changes to the manufacturing system as a result of testing during FAT/SAT and commissioning testing.
Factory/Site Acceptance Testing (FAT/SAT) - Outlines basic testing procedures to be performed at the factory prior to shipment and during startup at the manufacturing site. Primarily focused on engineering subsystems such as:
- Component identification.
- Electrical power system inspection.
- Pneumatic and hydraulic fluid system inspection.
- Basic functional operation.
- Vendor documentation.
This testing verifies that the as-built system has been adequately designed in accordance with the User Requirements and all required materials have been provided by the vendor.
Commissioning Testing - Much more detailed testing procedures than executed during FAT/SAT. Commissioning provides a high management comfort level that the manufacturing system is ready for validation qualifications and acceptance criteria parameters have been determined and evaluated for suitability. Commissioning testing verifies that the information detailed in the System Specifications completely describes the installed, as-built system.
Installation Qualification (IQ) - Provides documented verification of the installation parameters detailed in the System Specifications. The IQ generally provides documented verification of items such as:
- Instrumentation calibration.
- Electrical protection (overloads, fuses, circuit breakers).
- Safety interlocks.
- Security systems.
- Proper component installation.
- Alarm features.
- Functional operation.
Operational Qualification (OQ) - Provides documented verification of the operational parameters detailed in the System Specifications. The OQ generally provides documented verification of the operational capabilities and limitations of the manufacturing system.
Performance Qualification (PQ) - Provides documented verification of the performance parameters detailed in the System Specifications. The PQ provides documented verification of the ability of the manufacturing system to consistently and reliably perform the processes for which it is intended. A successful PQ provides high confidence that manufacturing processes are repeatable and maintain control within required tolerances.