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The recently updated BRCGS Global Standard Food Safety includes for the first time a requirement for the so-called commissioning of new equipment. This is new in the food industry, but has been around in the pharmaceutical industry for much longer.
The commissioning now required aims to ensure the product safety and product quality of new machines that are going into production for the first time. The validation model used in the pharmaceutical sector teaches us that in addition to commissioning, there are other steps to prevent errors at the earliest possible stage. The figure below illustrates this using the so-called V-model.
The V-model teaches us that, prior to commissioning, the requirements for the new machine must be identified and the design reviewed. A URS (User Requirement Specification) is ideally suited for this purpose. This document lists the requirements from both the consumer's and user's point of view of the device.
The starting point for such a URS is the critical product quality attributes - abbreviated from CQA (Critical Quality Attributes) - that may be affected by the purchase of the new machine. These may be chemical and microbiological product criteria, but may also affect the readability of the ingredient declaration or the proper sealing of the packaging. The trick is to translate these CQAs into critical process parameters, such as residence time and temperature requirements for a pasteurizer to meet microbiological standards. The document will also include all operational requirements, such as product to be processed, desired speed and capacity. Finally, the functional and design criteria complete the list of all possible hardware requirements. The last category includes not only all restrictions imposed by legislation, hygiene guidelines and the location in the building, but also the wishes of the users, such as operators. Optionally, the URS can be supplemented with the requirements for the associated software.
The next validation step is Design Qualification (DQ): evaluating on paper the design of the new machine. Based on information from the supplier, such as a drawing, it is assessed for compliance with the URS, then documented, possibly followed by a check at the machine supplier's production site to assess as many criteria as possible on site prior to shipping. This is the so-called FAT, Factory Approval Test. After the new equipment is installed, the qualification phase starts; a documented evaluation through inspections and tests. The number of steps depends on the complexity of the equipment, the extent to which it is customized and the product risk. At a minimum, Installation Qualification (IQ) should take place: the check of functional and design requirements, for example, with the physical on-the-floor detailed comparison of drawing and reality, a check of utilities, document verification and a check of calibration of measuring equipment. In addition, verification of the required changes to the existing quality management system is already started in this phase.
Once functional and design requirements are demonstrated, operational qualification (OQ) can begin. These tests demonstrate that the machine meets the range of critical process parameters established in URS. This is often done during test runs with a simulant, such as water. Commissioning consists of an IQ and the on/off tests from the OQ. For more complex or high-risk equipment, the PQ (Performance Qualification) can demonstrate that the equipment is capable of meeting the critical product quality characteristics as we have identified in the URS. Crucial in this phase is to test during a production run under the most difficult conditions imaginable. At this stage, the monitoring plan should also be prepared for the purpose of monitoring regular production. Once the qualification report is approved by all stakeholders, including a representative of the production department, commercial production can be started.
Working according to the V-model requires the use of a multidisciplinary team. It requires knowledge of both consumer, laws and regulations, product and process. Hence, a validation team includes not only QA staff but also operators, process technologists, product developers and technical service staff. This team will also jointly perform the tests, with reporting and documentation often handled by the quality department. The working method described can be summarized with two proverbs: 'think before you begin' and 'trust is good, but control is better'. When mandatory commissioning is carried out in this way, not only is the new equipment inspected, but the chances of a successful first production run are high.
In the new equipment commissioning training, you will learn a methodology to ensure that these requirements are met during purchase, installation and commissioning of new equipment. Want to know more? Check out the training page or contact us at info@precongroup.com.
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