Evaluating Equipment Options

Considering investing in production equipment? There are several issues to address before moving forward with such a purchase. While price is certainly one consideration, there are several other factors to review to ensure a wise investment that will pay dividends over time. Validation of quality control, for example, cannot be overlooked, nor can qualification of vendors.

Design qualification is one of the first steps. It is essential to consider desired product characteristics, required capacity, space needs, and additional services and components. It is common at this stage to prepare a user requirement specification (URS) document to detail the company’s needs, which allows suppliers to target their proposals accordingly. During qualification, compare the URS against the proposed designs to ensure a good fit.

The next step is to bring the factory into the loop, to make sure the equipment can be installed and operate as it was designed. This step is called the factory acceptance test (FAT), whereby the supplier’s factory submits a document verifying how the equipment works in real time, even running performance tests using appropriate materials. The FAT test must use the right conditions (i.e., air, water, steam services) to ensure a machine will meet the initial URS.

Upon delivery of the equipment, IQ qualification takes place. An IQ protocol should be used to document the specific attributes of a facility or item of equipment, to prove installation of the unit was correctly performed and that installation specifics of the supplier have been met. During the IQ process, it should be verified that the item matches the purchase spec and all drawings, manuals, spare parts list, vendor address and contract numbers, and other important documentation are available.

If the customer is sure the equipment is well installed, they can proceed to operation qualification (OQ). OQ protocol documents specific (dynamic) attributes of a facility or item of equipment to prove it operates as expected throughout an operating range. This will also help ensure the equipment functions as expected with real ingredients, under real operating conditions.

Finally, the customer reaches performance qualification. This protocol describes the procedure to be followed for demonstrating a system or equipment can consistently perform and meet required specifications under routine operation (or worst case conditions).

While performance qualification is the final initial step, in real life, equipment does require adjustments over time to ensure the investment lasts. Establishing timing for a re-qualification period (periodic or after-change), verify the equipment is examined thoroughly on an on-going basis, and after changes such as equipment adaptation, maintenance, movement and repairs.

By following these protocols, companies can be confident their investments in equipment will offer the performance over time they are seeking. Then work with the supplier in a partnership to maximize personnel training and realize optimal customer service. Suppliers should also offer quality assurance documentation, technical support, URS documents and much more to ensure the highest quality business transaction. 

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