- Test Plan Preparation: The equipment manufacturer prepares a detailed test plan outlining the specific tests to be performed during the FAT process. This plan serves as a roadmap for conducting comprehensive evaluations.
- Test Execution: The tests are conducted under simulated operating conditions in the factory premises. The equipment is thoroughly inspected, and various functional tests are performed to ensure its compliance with design specifications.
- Performance Evaluation: The equipment's performance is evaluated based on predetermined acceptance criteria. This includes verifying its functionality, reliability, safety features, and adherence to industry standards. Any deviations or issues are documented for further rectification.
- Documentation: A comprehensive report is generated, summarizing the test results, deviations (if any), and recommendations for improvement. This document serves as an essential reference for the client during the acceptance process.
- Quality Assurance: FAT ensures that the equipment is thoroughly tested before delivery, minimizing the risk of malfunctions or deficiencies at the client's site.
- Cost and Time Savings: Identifying and resolving issues during the FAT stage reduces potential delays and costly modifications during the installation and commissioning phases.
- Compliance and Safety: FAT ensures that the equipment adheres to regulatory standards and safety requirements, ensuring a secure working environment for operators.
- Test Plan Customization: A customized test plan is developed based on the client's requirements, taking into account the specific conditions and operational parameters of the site.
- Installation and Integration: The equipment is installed, integrated with the existing infrastructure, and configured to meet the site-specific requirements. Any necessary calibrations and adjustments are made during this phase.
- Operational Testing: The equipment undergoes a series of tests to evaluate its performance, functionality, and interaction with other systems. This includes load testing, stress testing, and verification of specific features relevant to the client's operations.
- Acceptance Criteria Assessment: 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.
- Final Documentation: A comprehensive report is generated, summarizing the SAT results, including the test outcomes, compliance with acceptance criteria, and recommendations for further optimization.
- Customization and Adaptation: SAT allows for the customization and fine-tuning of equipment to ensure optimal performance within the client's unique operational environment.
- Verification of Specifications: SAT verifies that the equipment fulfills the specifications outlined in the contract, meeting the client's specific needs and requirements.
- Seamless Integration: SAT ensures that the equipment integrates smoothly with existing systems, minimizing disruptions and potential compatibility issues.
3.5 Prior to installation, equipment should be confirmed to comply with the URS/ functional specification at the vendor site, if applicable.
- small, standard equipment
- equipment that cannot be readily installed at the vendor’s site (e.g. HVAC-Systems
- for complex equipment
- equipment with new technology
- If transportation is important, e.g. from Europe to Asia!
- when installation on site is complicated and equipment has to go back to the vendor when it fails
- transport and installation did not have a negative impact
- tests are performed and documented in a GMP-compliant manner
- supervision by the qualification team
- Completeness of installation
- Dimensions and correct design
- Materials and surfaces
- Functional tests, performance tests and safety functions
- Completeness of documentation
- Testing according to approved test protocols.
- Test protocols approved by all involved parties (user, manufacturer, engineering partner - if applicable)
- SAT may include tests from FAT under „real“ conditions. Not all conditions can be simulated in manufacturers workshop!
- Reporting of results and deficiencies
- Target of FAT: Approval for shipping to installation site
- Targets of SAT: Final acceptance, proof of process guarantees, hand-over from manufacturer to user.
- Introduction incl. short process description
- Scope of the test plan
- Deficiency handling
- Responsibilities
- Identification of reference instruments and test personnel
- Test description and test result summary sheet
- Attachments (forms for test raw data, SOPs, etc. )
- Time schedule for the tests
- What has to be tested and what are the acceptance criteria?
- How shall the tests be executed? Test conditions?
- According to which guidelines and standards?
- Who is responsible for test preparations, delivery of test material and test execution?
- What has to be done when a test fails?
- How are the test results to be reported?
- The equipment is generally operated by supplier’s personnel
- Functional tests are witnessed / supervised by personnel of the user
- Other tests/checks are executed by either manufacturer or user
- Qualification staff of user shall be involved in testing to avoid double testing in subsequent IQ / OQ / PQ
- Tests may have also the purpose of training for the users personnel (participation of operators, technical and maintenance staff is recommended).
- All results form the tests have to be reported in the test protocol
- When tests could not be carried out as planned: describe why and how it has been done instead.
- If acceptance criteria are not met: write down in a deficiency form
- Deficiency forms must have clear indication of deviation, actions to solve the deviation, time lines and responsibilities
- Requirements for re-testing and final approval have to be stated in the deficiency form.
Object: Date: | ||
Deficiency number: | ||
Description of deviation
Name / Signature .......................................... Date……………………………. | ||
Consequence of deficiency | ||
Proposed solution (vendor) | ||
Representative (vendor) |
| |
Name / Signature……..................................... Date .................................. | ||
Solution accepted ❏ Solution not accepted ❏ | ||
Comments | ||
Representative (purchaser)
Name / Signature .......................................... Date .................................. | ||
Implemented solution (vendor)
Name / Signature ............................................ Date…………………………… | ||
Result accepted ❏ Result not accepted ❏ | ||
Comments | ||
Approval (Purchaser Representative) |
| |
Name / Signature .......................................... Date .................................. | ||
Deficiency closed (Vendor Representative)
Name / Signature ........................................... Date.................................. | ||
- Sufficient information flow between manufacturer and user during the engineering and manufacturing phase.
- Clearly documented test conditions and acceptance criteria (Test plans).
- Frequent inspections during manufacturing.
- Well prepared equipment (readiness for tests!) and availability of necessary installations (e.g. media supply) and test material.
- Clearly defined responsibilities and experienced personnel on all sides.
Problem | Solution |
Equipment has not been completed by the vendor. Necessary Pre-checks are not completed | Define proper time schedule, supervise progress + ensure sufficient communication |
Testing material (ampoules, plastic films, granulate, etc ..) is not available for FAT | Specify quality, amount and delivery time as early as possible |
Required utilities (steam, cooling water, air, etc..) are not available | Specify quality and number of necessary utilities and provide them for test |
Equipment does not fit the spec, (misunderstandings? unqualified vendor?) | Thorough check of specifications à DQ Selection of adequately experienced vendor Audit the vendor and qualify him |
Specified tests cannot be executed due to “protocol error” | Sufficient checking and approval of test plan (by technical and validation dep.) |
Test plans are too “complicated / awkward”, not practical | Ensure easy understandable test plan by cross check for suitability |
The plant is not ready (building, rooms, utilities), no real product, missing approvals | Time scheduling and progress supervision in all areas. If necessary, delay delivery |
Staff (operators, maintenance) not sufficiently trained or not enough personnel available to support trials | Early recruiting and planning in of resources |
Test fails because site specific conditions were not considered in planning | Thorough check of URS with regard of site-specific conditions (e.g., media press.) |
Equipment does not arrive on time due to failed FAT, rework or other reasons | Consider possible delays in planning. Prepare alternative activities |
Equipment has been damaged during transport or parts are missing | Choose reliable freight forwarder, correct packing + protection Check transport ways before start of delivery |
Equipment has been installed incorrectly | Choose qualified installation company. Preferably involve vendor of equipment |
