FAT Template Sample

FAT Template

The Process Flow

Validation Master Plan – Your company policy on Validation approach

User Requirements Specification – Specify your needs

Validation Plan – Document your Validation Method and specific plan here

FAT – Factory Acceptance Testing (Test all requirements at supplier site

Installation Qualification (IQ) Document your installation requirements

Operational Qualification (OQ) Document all Operational/Functionality Checks

Performance Qualification (PQ) Document Performance consistency

Summary Report Summarise all your validation findings

What is Validation?

Validation is to license equipment, a system or process to function against a predetermined outcome which has been established through prior studies of materials, product or the process itself. The Validation procedure begins as a project and then becomes a living state until the equipment, process or system is decommissioned or is no longer required.

Validation is a legal requirement under the European and US law governed by regulatory bodies – MHRA for the European market and the FDA for the US market.

Validations began heavily in the pharmaceutical industry and were later adopted by the Medical Device industry under legal requirements from the FDA and MHRA. It is now becoming a practise in the Automotive and Electronics industry.

Your Standard Operating Procedures – SOPs As part of your manufacturing procedure you must have Standard Operating Procedures to ensure that all stages of the process of manufacture is standardised under a controlled document that is easy to follow which can be assisted with aid of visual diagrams or photos.

The SOP must also be written in the language that is understood and be clear and unambiguous. The SOP must follow Good Documentation Practise.

Your Master Validation Schedule – controlling your programme Your Validations need to be outlined in a clear timeline with dates for completion with responsibilities. This must be a living document with dates for revalidation once the original validation has been completed. The revalidation frequency can be determined on risk and criticality of process. A frequency of yearly or every two years is common. At the intervals the equipment/process/system will typically be review for any change or any issues raised during the interval, and an assessment will be made if any revalidation activity needs to take place or if this can be justified with a rationale.

Your Validation approach – Validation Master Plan/Policy Your site wide document and take on validations should be clearly outlined in a high level document which is your Validation Master Plan or Policy which indicates your approach to validation from software systems to lab, cleaning, equipment etc. Responsibilities and your revalidation programme should also be listed here. A statistical programme must also be clearly outlined here.

What are you ordering/validating – writing a User Requirements Specification Very often people will purchase something and then consider validation. This is in fact contrary to a robust validation programme, since the Validation programme must begin prior to purchase. The User Requirement Specification outlines what is required, without this document the supplier may supply you equipment that has not been clearly understood. On some occasions an email detailing requirements with specifications or an uncontrolled document may be sent to the supplier, however without having this reviewed, approved and signed by all responsible parties causes confusion and disagreement at some point of installation and commissioning. To prevent mishaps and out of good practise it is advised to have a URS in place, which became more of a requirement in the pharmaceutical industry.

In the URS you should also document how you wish the delivery to take place of your supplied equipment.

Your supplier response – Functional Design Specification (FDS or similar) In response to the URS the supplier should detail a Functional Design Specification detailing how the equipment they will supply you will achieve your requested specifications. If this is not supplied you will also be at risk of accepting equipment that has not clearly been understood by the machine manufacturer/ supplier.

Testing what you have ordered before it is shipped – FAT Once the supplier has documented and described how they will achieve your specifications and you have agreed that the project can progress you must monitor the progress using a project plan. Regular visits should be agreed to monitor progress and ensure that all activities are correctly being pursued. Any complications must be understood, mitigated and dealt with as part of project planning. The FAT is a Factory Acceptance Test document.

Once the machine has been completed a test script must be provided to the supplier which is the FAT document. The tests will take place and witnessed by you and the supplier. The FAT is a controlled document detailing all the tests that took place, and signed off. The FAT document must be completed to satisfaction to provide you with confidence that the machine is ready for shipment to your site for installation and further qualification.

Installing your equipment – Installation Qualification Once the equipment has been despatched you must have all your plans for installation ready in order to accept the equipment, locate it and begin installation. The Installation Qualification (IQ) document is the start of the Qualification process, which is a controlled and approved document. Your IQ protocol must be approved with all the necessary checks with field entries for execution to check against the equipment at the time of installation. The protocol will be written using manuals and details of the equipment from the supplier. This is agreed and approved and executed with engineering knowledge.

Factory Acceptance Testing (FAT) Protocol for (Enter description here) Document Ref: (enter here)

Version: 1.0

Effective Date: (enter date here)

FAT PROTOCOL AUTHORISATION Name/Title Prepared by

Author

Reviewed by

Engineering

Reviewed by

QA

Reviewed by

Production

Reviewed by

Planning (if required)

Signature

Date

Signature

Date

FAT PROTOCOL REPORT AUTHORISATION Name/Title Completed by

Author

Reviewed by

Engineering

Reviewed by

QA

Reviewed by

Production

Reviewed by

Planning (if required)

Brief Description:

Enter Description Here of equipment for installation and place of installation

Objective:

To ensure the (enter equipment here) fully complies with the requirements of the purchase specification (enter details here) dated (enter date here), and that the machine is accepted for delivery to (enter your details here).

TEST AND INSPECTION SHEETS

The test process is a series of visual examinations, safety checks and test running of the (enter equipment here) . The following tests are to be conducted and supervised by (Your Company Here) with the aid of (Supplier Name Here).

MACHINE SAFETY AND FUNCTIONALITY INSPECTION CHECKLIST

SAFETY CHECKS

Test No

Test Description

Acceptance Criteria

24

The equipment is free from damage.

No scratches, visual damage

25

The equipment is clean and free of debris and swarf.

26

Guarding complies with URS specification.

27

Equipment operates safely with trap points protected.

28

Guards allow adequate visibility and access to machine.

Guards must be non obstructive and transparent

29

Sharp edges and corners have been removed.

Edges and corners should be easy to touch

Should be clean

Check against URS

Trap points should be protected

Pass/Fail

Initial/Date