Equipment Qualification

It is the tests performed to “Establish confidence that process equipment & ancillary systems are capable of consistently operating within established limits & tolerances”

The Design Qualification (DQ) :
It is part of the Qualification/verification activity. This document ensures that the designed process solution/equipment meets all the specified requirements; i.e. functional operational and safety requirements of the process & end user. It ensures that the design would be in line with the required standards / guidelines.
It is pre-defined, agreed & approved specifications required for equipment to be manufactured.
The Design Qualification shall prove that the equipment is in accordance with the approved Technical Offer and the URS
The DQ shall be executed and completed before the process solution / equipment is taken for manufacturing activity. It should be performed & approved prior to purchase of components/RM.
DQ is the detailed descriptive document for the components, process sequences which the system is capable of executing for respective process.
Should approved by Customer/user.

BAPS has in house capability of designing the Process logics / control philosophies for every process solutions designed. In-house strength in converting the logic to smart programming, this testing is performed during the development of the software / automation programs, the screen formats, password matrix, interlocks & all critical alarms that will be loaded onto the process solutions.
The objective is to qualify/verify that the performance of the control system software meets the approved functional specification and end user requirements.

Once the system is ready as per Approved DQ, at BAPS it is tested for all mechanical, functional, process performance as per the requirements of user , process and regulatory guidance. If any deviation or noncompliance is observed, it will get documented. The system is again checked after taking corrective actions. We believe that the process solution is ready to get commissioned for intended application before it gets introduced to client for FAT.
An approved pre-FAT protocols covering extensive tests are being used for pre-FAT execution. The set of documents are ready for inspection *if required, by client. A through Pre FAT gives lots of confidence to face any authority or client. It is the proactive step taken as a part of our QMS.
BAPS has a dedicated team for pre-FAT & FAT under the function Quality.

It becomes an imperative to check, verify the system designed as per requirements of user, process & regulations before it gets dispatched. It is not always practically possible to do all the testing at site; hence FAT becomes a MUST.

Knowing the expectations from client , BPAS has designed a fully equipped dedicated facility for FAT. To provide WET FAT, BAPS has created a state of art FAT center with treated RO & pathogen free, low conductivity water system, complete back up of filtered steam, cooling water, uninterrupted dry oil free air supply with redundancy. All the master calibrated instruments required for the different tests are available with their respective documentation. The FAT facility is designed like any clean room with docking stations, where multiple systems can be tested independently at a time.
FAT is performed at BAPS FAT center, NASHIK. It is performed in presence of end user/client. Its objective is to demonstration to the user that the equipment / system complies with his URS & approved DQ.

We understand the requirements of client & their QA quality function, in line with the same, a detailed FAT protocol is designed at BAPS. It is shared with the client minimum 2 weeks prior to actual scheduled FAT. Any specific test, process requirements can be incorporated in FAT protocol before actual FAT. An approved FAT protocol is used for execution of FAT.
Client have the flexibility to select representative tests & rest can be verified from the approved pre-FAT documents. However, the user is free to ask complete FAT tests.

After a successful FAT, the systems are paked & dispatched to the site. BAPS team of project management does the Installation & commissioning as per their respective SOPs/ protocols. SAT is performed by team BAPS, with our testing instruments, at the user’s site. A pre-approved SAT protocol is used for execution of the SAT. The objective is to verify that the system still complies to URS & DQ , even after transit & change in quality of utilities from FAT to site.
Not all the tests from pre FAT/FAT, but few critical tests like CIP/SIP, pressure hold test, control loop testing etc. are performed after approval from client.

Installation qualification:
The Installation qualification (IQ) is part of the qualification/verification activity which ensures that every single component on the system is as per required specifications of types, MOC etc. It is the protocol to install the respective system to meet its intended application. It guides how to connect/hook up the system with respective utilities, it guides how to assemble the system. Basically, it is the guideline/protocol to make the system ready for operation.

Operational Qualification (OQ) :
Operational qualification (OQ) is part of the qualification/verification activity which ensures the installed system operates accurately to meet the requirements and expectations of the user/process.
It is performed after approved Installation, it is the protocol to check functionality of the system, it ensures that the said system for its intended application is operating within the said limits/tolerance of the parameters. It ensures that the system is meeting URS & DQ.
Every functional operation is tested in execution of this protocol. OQ ensures & approves that the system is ready for actual intended use.