On a medical project, difficulties do not always begin at the commissioning stage. They often appear much earlier, in a plan that failed to anticipate an operational constraint, a requirement that was translated too quickly, or a technical choice that seemed coherent on paper but proves problematic when confronted with real-world conditions. Identifying a difficulty at this stage generally makes it possible to address it before it affects project execution. This is precisely the role of **Design Qualification (DQ)**: reviewing what has been planned before it becomes difficult to modify. Q2ESB Ingénierie carried out this approach for DM Pharma, in a project that illustrates concretely what a design review involves in the medical sector and why it provides an essential foundation for the rest of the project.
Design Qualification takes place before implementation
Design Qualification, commonly referred to as **DQ**, consists of verifying that a project — including installations, equipment and technical layouts — meets the applicable requirements from the design stage. It takes place before implementation and therefore before Operational Qualification, which will later test the actual operation of the installations once they have been put in place.
In practical terms, this means comparing what is shown in the plans and specifications with what the project is actually expected to achieve: required functions, regulatory requirements, industry good practices and future operating conditions. This work is not limited to checking documentary consistency. It involves verifying that the selected design choices remain appropriate when considered in their actual intended use, and documenting this verification so that it can be traced, justified and referred to at a later stage.
This step has a simple but decisive purpose: it gives the project owner visibility into the robustness of the design before committing the resources required for implementation. Documenting this verification is not merely an administrative formality — it can later help justify the selected design choices if they are questioned by an auditor or regulatory body, or simply provide a reference for the team taking over the subsequent qualification stages.
In the medical sector, this traceability requirement is particularly important. A project intended for medical installations and equipment generally operates within a demanding regulatory and standards framework, where compliance is not limited to proper operation: it often also requires documented evidence that the applicable requirements were identified and taken into account from the design stage. This dimension gives Design Qualification its structuring role, far beyond a simple plan review.
Why review the design before moving forward?
The question deserves to be addressed directly: what happens if this verification is not performed, or is carried out too late? In medical project engineering, a problem identified after implementation will almost always require more time and resources to resolve than one identified during the design phase.
Several types of difficulties can arise when the design has not been sufficiently reviewed in advance:
- A drawing has to be revised after construction has started, resulting in delays and additional costs that could have been avoided.
- A technical incompatibility between two systems is only identified when they are integrated on site.
- A regulatory or functional requirement has been incorrectly translated, or simply omitted, from the initial specifications.
- Once commissioned, an installation proves difficult to operate or maintain under the intended conditions.
- A late modification has to be made to an installation that is already in place, with all the constraints this entails.
- The documentation produced during the design phase is incomplete, making the subsequent qualification process more difficult.
These situations are not specific to any one project. They are general challenges inherent in technical design processes carried out in demanding environments. Design Qualification does not claim to eliminate all risks — no method can — but it can significantly reduce the likelihood of such issues emerging late, when they become more difficult to address.
The Design Qualification mission carried out for DM Pharma
It was within this framework that Q2ESB Ingénierie supported DM Pharma. The mission aimed to verify and document the compliance of the design of the project’s installations and equipment with the applicable functional, technical and regulatory requirements, as well as with good practices in the medical sector.
Q2ESB’s intervention was not limited to reviewing drawings. It covered a range of interconnected activities: design analysis and review, verification of functional and technical requirements, review of plans and specifications, analysis of technical installations, assessment of compliance with applicable requirements, identification and analysis of critical points, preparation of the Design Qualification documentation, and preparation of the documentary basis required for subsequent qualification stages.
This multi-faceted approach is significant. It reflects how a design review needs to be conducted to be genuinely useful: it is not enough to verify documents individually; they must also be cross-checked against the installations themselves and the requirements applicable to them, in order to obtain a consistent overall view rather than a series of disconnected checks.
What did Q2ESB review during this mission?
Functional and technical requirements
Everything starts with the need. Before reviewing a plan, it is first necessary to clarify what the installation must actually achieve: which functions it must perform, under what conditions and with what margins. This chain — from need to requirement, from requirement to design choice, and from design choice to verification — structures the entire process.
As part of the DM Pharma mission, this stage involved ensuring that the project’s functional and technical requirements had been properly incorporated into the selected design choices. A poorly formulated requirement, or one insufficiently linked to a specific technical solution, represents a point of vulnerability that can affect all subsequent project stages — which is why this verification is carried out first.
Plans and specifications
Document review plays a central role in Design Qualification, but it should not be reduced to a formal verification exercise. The objective is to ensure that the plans and specifications correctly translate the identified needs, that the technical choices they contain are consistent with one another, and that the information required for operation is properly documented.
This cross-review also makes it possible to identify inconsistencies or points requiring clarification before they become fixed. A drawing may appear technically correct while containing an ambiguity that, if not resolved at this stage, becomes an open issue during implementation — when addressing it is invariably more costly.
Technical installations
During a design review, an installation should be examined within its environment and in relation to its interfaces with the other elements of the project. Depending on the nature of the project, this analysis may include networks, technical interfaces and installation constraints.
This systemic approach distinguishes a rigorous design review from a simple point-by-point compliance check. A technical solution may be perfectly suitable when considered independently and yet create an unforeseen constraint when integrated with the rest of the installation. The analysis of the technical installations carried out as part of this mission specifically addressed this overall consistency.
Critical design points
Not all observations identified during a design review have the same significance. Part of Q2ESB’s work consisted of identifying and analysing the project’s critical points — elements that could affect compliance, operation, safety, performance or a subsequent stage of the project.
The objective is not to produce an exhaustive list of minor observations. It is to prioritise the issues requiring particular attention, so that the project team knows where to focus its efforts before proceeding. This prioritisation is what makes Design Qualification genuinely operational: it transforms a technical review into a decision-support tool.
A critical point is not necessarily a design error. It may be an area of uncertainty that needs clarification before being finalised, an interface between two systems requiring additional verification, or a requirement whose interpretation should be confirmed with the project owner. Distinguishing between these different levels of criticality helps avoid two opposite pitfalls: underestimating an issue that should have been escalated, or overwhelming the project team with observations that do not require immediate action.
From technical review to the Design Qualification dossier
A design review that is not documented loses much of its value. For this reason, the mission carried out for DM Pharma concluded with the preparation of a **Design Qualification dossier**, whose purpose is to document the entire process: the elements reviewed, the requirements taken into account, the conclusions reached and, where applicable, the deviations or observations identified.
This documentary traceability serves two purposes. First, it provides a means of subsequently justifying the selected design choices, which may prove useful when dealing with a regulatory body or during an audit. Second, it provides a reference for the teams involved in subsequent project stages, without requiring them to reconstruct the initial reasoning. A well-structured qualification dossier remains useful long after it has been prepared.
Preparing the subsequent qualification stages
One aspect of the mission deserves particular attention because it changes the way Design Qualification should be viewed: it is not an isolated stage. The mission entrusted to Q2ESB explicitly included preparing the documentary basis required for subsequent qualification activities.
In practical terms, this means that the work carried out during the design phase does not end there. It forms the foundation for the subsequent qualification of installations and equipment — first Installation Qualification and then Operational Qualification — which will verify, once the installations have been implemented, that what was planned actually operates as expected. A well-executed Design Qualification facilitates this subsequent work: it avoids having to start from scratch to reconstruct the requirements and design choices underlying the project. Conversely, insufficiently documented DQ can complicate later stages by requiring the project logic to be reconstructed when it should have been documented from the outset.
What the DM Pharma experience demonstrates about Design Qualification
Beyond the specific mission, Q2ESB’s support for DM Pharma illustrates three principles that extend beyond this particular project and apply more broadly to Design Qualification processes in the medical sector.
Verify before implementation. A design decision is always easier to correct on a document than once the installation is in place. In projects subject to schedule constraints, carrying out this verification early preserves dedicated time for analysis before design choices are finalised. Design Qualification provides a framework for maintaining this review phase without compromising the robustness of the project.
Put requirements at the centre of the design. The quality of a design is not measured solely by its technical feasibility. A solution may be technically achievable while still failing to fully meet the functional, regulatory or operational requirements applicable to the project. Systematically refocusing the analysis on requirements, rather than feasibility alone, is what distinguishes a rigorous design review from a simple technical check.
Prepare documentary continuity. Documentation produced upstream is not merely an additional administrative burden: it directly facilitates the organisation of subsequent project stages. A well-structured Design Qualification dossier can then be used by the teams involved in later stages, including those who were not part of the initial design process.
Frequently asked questions about Design Qualification
What is the difference between Design Qualification and Operational Qualification?
DQ focuses on documents — plans, specifications and requirements — before implementation. Installation Qualification then verifies that what has been built corresponds to what was designed, followed by Operational Qualification, which tests the actual operation of the installations. These stages are interconnected, and an incomplete DQ dossier can have an impact on subsequent stages.
When should Design Qualification be launched?
As soon as the plans and specifications have reached a sufficient level of detail to be assessed against the project requirements, and before any significant commitment to the implementation phase.
What does a Design Qualification dossier contain?
It brings together the elements reviewed, the requirements taken into account, the conclusions reached and, where applicable, the deviations or observations identified — providing a traceable record of the entire process and a reference for subsequent stages.
Who should be involved in the process?
Depending on the project, technical, quality and sometimes regulatory teams may be involved, so that the requirements reviewed reflect all applicable constraints rather than only the technical perspective.
Q2ESB Ingénierie supports controlled-environment projects
The mission carried out for DM Pharma reflects the way Q2ESB Ingénierie approaches the qualification of installations and equipment: starting from the project’s requirements rather than applying a standardised method without distinction. This approach applies both to Design Qualification assignments and to broader controlled-environment projects, where installation design must meet technical and regulatory requirements specific to the medical sector.
For project owners looking to secure a design phase before moving into implementation, or preparing the subsequent qualification stages of an ongoing project, the Q2ESB team remains available to discuss the specific requirements of each installation.
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