Sample size during Product Validation

After successful DV testing, the product moves into the PV phase. PV testing is conducted on units that are manufactured using the final production process, materials, and equipment. The purpose of PV is to validate that the production process can consistently produce units that meet the design specifications.

The sample size for PV is typically smaller than for DV, as indicated by the user input of around 10 samples. This is because the focus of PV is on the consistency and capability of the production process rather than the design itself.

These tests are crucial for products that incorporate complex mechanical, electrical, and chemical components, as they must perform reliably under a wide range of operating conditions and comply with stringent safety and environmental regulations.

Mechanical and Electrical Testing (5 Samples)

For Mechanical and Electrical Testing, the allocated 5 samples will undergo a series of tests designed to validate the mechanical robustness and electrical integrity of the product:

1. Pressure and Flow Testing for Hydraulic Components: These tests are critical for ensuring that hydraulic pumps and valves meet their performance specifications.
2. Leakage Testing: Conducted to verify the integrity of hydraulic systems, ensuring that there are no leaks under pressure.
3. Load and Fatigue Testing: These tests assess the ability of electromechanical components to withstand operational stresses and repeated cycles of stress.
4. Electrical Testing for ECUs and Electromechanical Devices: This includes verifying insulation resistance, dielectric strength, and EMC to ensure proper operation in their electromagnetic environment.

Given the nature of these tests, some can be combined or performed in sequence to reduce the number of samples needed. For instance, the same sample that undergoes pressure and flow testing can subsequently be used for leakage testing. Similarly, load testing can be followed by fatigue testing on the same sample, as both tests relate to the mechanical durability of the product.

Environmental and Durability Testing (5 Samples)

For Environmental and Durability Testing, another set of 5 samples will be subjected to tests that simulate the environmental challenges the product may face during its lifecycle:

1. Thermal Shock and Temperature Cycling: These tests evaluate the product’s ability to withstand extreme temperature variations and operate reliably across different temperature ranges.
2. Vibration and Shock Testing: To simulate transportation and operational stresses, these tests are crucial for verifying the product’s resistance to mechanical shocks and vibrations.
3. Humidity and Corrosion Testing: These tests ensure the product’s long-term reliability by assessing its resistance to humid and corrosive environments.

As with Mechanical and Electrical Testing, there is potential to perform some of these tests sequentially on the same samples. For example, after a sample has been subjected to thermal shock, it can often be used for humidity and corrosion testing. This approach maximizes the data obtained from each sample while minimizing the total number of samples required.

In summary, by allocating 5 samples to each category and strategically planning the sequence of tests, it is possible to conduct a thorough validation of the product’s mechanical, electrical, environmental, and durability characteristics with a reduced number of samples. This efficient testing strategy helps to conserve resources while still ensuring that the product meets all necessary specifications and standards for its intended application.