Basic Introduction of Equipment Development & Qualification (Part 2)
From last section –Basic Introduction of Equipment Development & Qualification, we have a general structure about equipment development process which is a step-by-step process.
In this article, the equipment development process is twisted and the linkage between design development and integration, validation phase is made. Please find Figure 1 below.
Requirement
When we develop an equipment from zero to one, the first thing we are focus on is to make sure the equipment functionality is right. However, the explanation of equipment functionality and acceptance criteria could be difference between different perspective. To provide a comprehensive requirement on every aspect (e.g. technical, risk, quality assurance, business…etc.) for developing equipment, it is important to have cross-function together and find balance/ alignment internally.
Designing
After Design Review meeting, the backbone of equipment design shall be fixed. Supplier starts to design the equipment and the main design documents are Functional Specification, Hardware Design Specification and Software Design Specification which are based on the output of Design Review meeting. These documents may be adjusted during implementation phase due to technical issues or updated requirements. And it shall be fixed as part of Design Qualification evidence before validation phase while considering the objective of validation.
Commissioning & Qualification, and Validation (DQ, IQ, and OQ)
After implementation phase, the Commissioning & Qualification, and Validation (DQ, IQ, and OQ) can be conducted to verify the equipment functionality and is suitable used in production area. The test items in this phase could be lots of differences between equipment due to the risk evaluation of equipment which could be impacted by the requirement, maturity, intended use, product quality, data integrity, safety and so on. The double arrow here means the test items could be leveraged between different activities with appropriate justification.
Validation (PQ)
After completing the Validation (DQ, IQ, and OQ), Validation (PQ) is conducted. Here is focus on the process which is aim at providing high degree assurance about the commercial manufacturing. To confirm the process is capable of consistent/ reproducible production, the sampling and statistical results may be stricter in PQ than normal production to justify the confidence of the process.
In summary:
To make an equipment or process come true, it’s a balance between requirement, design, quality and business. From validation point of view, risk for product quality, data integrity and safety shall be controlled/ mitigated is the key point. All designed test items and collected results are back to the objective of validation.
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