Factory and Site Acceptance Testing Guide for Pharmaceutical Equipment

Check the availability of power, water supply, air, and service lines. The machine is moved out of packing then the machine will be inspected for any damage during transport handling as well as during loading and unloading. At this stage, the machine will be checked properly to check for any wear and tear during the transport service. Completion After the SAT is completed, a report is prepared that summarizes the test results and provides a final evaluation. Preparation Preparation includes the installation and configuration of the system or machine to be accepted. All results from SAT need to be monitored and recorded before being resourced with the appropriate personnel.

site acceptance testing

At Matrix Technologies we are committed to delivering exceptional engineering solutions. Providing the final acceptance from the client perspective does not indicate the end of the relationship. Additionally, it is critical to understand who has the authority from the client’s perspective to provide the final approval. Ultimately it is best to receive the approval from the individual leading the project for the client.

Factory Acceptance Testing – What Is FAT, and How Does It Work?

They stem across all borders of engineering, even into traffic signal equipment! By conducting an SAT all users are able to acknowledge a system is doing its job right. Performing a factory acceptance test is the responsibility of the equipment manufacturer. However, the requirement of FAT shall be specified in the scope document. Once the factory acceptance test is included in the project scope, there is no extra cost for the test.

site acceptance testing

Following the delivery and installation of your new LaZer Automation Solution, our experienced team of engineers will join you on site to assist with commissioning and provide site acceptance testing. A modified version of the previously executed FAT test plan will be utilized for SAT to guarantee that the solution still performs as expected and the system is ready to be put in service. Is a test of subsea equipment before installation, which is always performed on newly manufactured equipment, to check whether the equipment satisfy the performance and function requirements or not. Extended Factory Acceptance Test may be only applicable for several equipment or subsea structures, e.g., subsea trees with sub-assemblies.

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For a more complex system that endured an extensive FAT, performing those same steps for the SAT is presumably not an option. Every interlock, permissive, alarm, and/or function of the project was already tested at the FAT so is it really required to be tested again at the SAT? This again should be discussed with the client during the preparation phase.

site acceptance testing

Any changes to the equipment and processes used to produce a semi-solid dosage form may affect the physicochemical characteristics, bioavailability, and sensory qualities of the final product. Realize the value of connectivity, and, more specifically, https://globalcloudteam.com/ the value of information provided by checkweighing, metal detection, vision inspection, and X-ray inspection. Any standard tasks as part of your site acceptance test process can be made mandatory and it won’t be marked as complete until they’re done.

Operational Qualification (OQ)

Approach uncertain items and procedures with caution and, when in doubt, ask manufacturing technicians questions or pause testing to make sure the procedures are performed safely. Inspect your equipment with safe, reliable production or processing in mind. The test plan should check the functionality of all safety components site acceptance testing meaning and emergency switches and look for areas that may cause later problems or put a worker in a dangerous position. You should have an understanding of how the equipment will be utilized at your specific workplace. Have a testing plan in mind to expedite the testing process and ensure safety for all personnel.

site acceptance testing

User acceptance test criteria are usually created by business customers and expressed in a business domain language. These are high-level tests to verify the completeness of a user story or stories ‘played’ during any sprint/iteration. Operations1 is the ideal cloud software for employee-led production processes.

What are the Process in Factory Acceptance Testing?

Site acceptance testing provides a well-documented way to ensure that the scope of a project was met. Careful planning and execution of the site acceptance test ensures not only that the project deliverables were met, but it also provides a means of confidently bringing the system back into operation. More times than not, the client wants production to be back in service as quickly as possible, and rightfully so as the system is not generating revenue when it is not producing product.

  • The actual results are retained for comparison with the expected results.
  • Doing so makes it easier for all parties by eliminating second-guessing.
  • FAT testing is intended to provide you with a thorough understanding of how your new equipment operates.
  • FAT ensures that the equipment adheres to regulatory standards and safety requirements, ensuring a secure working environment for operators.
  • Before the FAT begins, the manufacturer should present the FAT procedure to the client for review and approval.

The solution provides intuitive worker guidance and connects the organization in manufacturing companies. The clipboard becomes a tablet, complexity becomes simplicity, blindspot becomes transparency. Site acceptance tests are of huge importance as they allow for a system to prove it is up to the job and can achieve its goals safely. FAT’s ensure the manufacturer is also safe, so the use of both acceptance tests is absolutely necessary.

Factory Acceptance Test Result

Warranty Period” as used herein, shall mean the twelve months following acceptance by the Department of the System after successful completion of all Site Acceptance Tests. The contractor shall rectify all deficiencies immediately, if found, in the performance of the system as per the requirement during the Site Acceptance Tests, at no cost to the High Court of Madhya Pradesh, Jabalpur. The contractor shall rectify all deficiencies immediately, if found, in the performance of the system as per the requirement during the Site Acceptance Tests, at no cost to High Court of Madhya Pradesh, Jabalpur.

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Matrix Technologies is one of the largest independent process design, industrial automation engineering, and manufacturing operations management companies in North America. To learn more about our manufacturing operations management capabilities and manufacturing process control solutions, contact Matt Fether, Department Manager. A third item that may need to be discussed is ownership of the process through the Site Acceptance Testing. Typically the project development team will have ownership at the beginning of the SAT with support by operations. But at what point is the system turned over to operations and what are the support requirements of the project development team at this point?

Site Acceptance Tests definition

List any anticipated shortcomings for the machine you are testing. These could include past issues experienced as well as expected outcomes for each phase of the process. Make a list of solutions for these potential problems to quickly and seamlessly work through issues during the testing process. Making changes to equipment during the FAT stage is much more cost-effective and efficient than making on-site modifications. The test results are compared against predetermined acceptance criteria to determine whether the equipment meets the client’s expectations. Any identified issues or discrepancies are addressed and resolved.

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