Qualification is expensive when it is done backwards. Equipment is bought against a purchase order rather than a specification, installed to suit the site, and only then does somebody ask for documented evidence that it does what the process needs. The requirements are then inferred from the equipment, protocols are written to fit what was built, and the gaps are closed with retrofits and repeated testing. Sequenced properly at the front of the project, the same work costs a fraction of that.

The alternative is to write the requirements down first and let them drive everything downstream. A User Requirements Specification states what the system must do in measurable terms. A Functional Design Specification states how it will do it. Design Qualification confirms the proposed design satisfies both before money is committed, and the later stages test against those same requirements once the equipment exists. Each stage checks the one before it, and the traceability an auditor asks for becomes a by-product rather than a separate exercise.

What the work involves

URS development starts with your people. We run workshops with operations, engineering, quality, maintenance and procurement to gather what the system genuinely has to achieve, then turn that into requirement statements that are clear, testable and free of assumption. Functions, capacities, outputs and control features are defined, and performance parameters such as throughput, accuracy, reliability and environmental limits are captured with numbers attached. Interfaces with existing systems are specified, along with maintenance, safety, access and training needs, and any regulatory requirements, whether GMP, ATEX, DSEAR or PUWER.

The FDS takes it further, particularly for automated and control systems. It sets out start-up, normal operation, shutdown and fault handling, control philosophies covering sequences, interlocks, alarms and operator actions, inputs and outputs, setpoints and control loops, integration with SCADA, PLC and HMI, and access levels and logging. Agreeing that before code is written is cheaper than finding at commissioning that the sequence does not match how the plant is run.

Design validation is the checkpoint before commitment. Drawings, specifications and calculations are reviewed against the URS, FDS and project scope, findings are documented and closed, and a report confirms the design is fit to proceed. Qualification then follows the familiar route: DQ against the requirements, IQ to document correct delivery and installation, OQ to test controls, alarms and interlocks under defined conditions, and PQ to confirm consistent performance under real process conditions. We draft and execute the protocols and manage testing and non-conformance tracking alongside your QA teams and vendors. Our work is delivered under a quality management system certified to ISO 9001:2015.

What you get

  • A structured, approvable URS built from input across your business
  • Measurable performance and capacity figures rather than aspirations
  • An FDS covering operating modes, interlocks, alarms and I/O
  • Independent design validation against the URS, FDS and scope
  • DQ, IQ, OQ and PQ protocols, drafted and executed
  • Managed test execution, deviation handling and non-conformance closure
  • A qualification documentation package for inspection
  • Traceability from requirement through design and testing to sign-off

When clients typically call us

  • A capital purchase is going out to tender with no written requirements
  • Vendor quotations cannot be compared because each has scoped something different
  • An installed asset needs qualifying and the requirements were never recorded
  • An audit has flagged missing validation documentation
  • A new automated line is being specified and operations and quality disagree
  • Delivered equipment does not do what the site expected and nothing settles it

Frequently asked questions

Is a URS necessary for a straightforward equipment purchase?

It should be proportionate to the risk, but even a short one pays for itself. Without a written requirement, vendors price different scopes and you have nothing to test against on delivery. It does not need to be long, it needs to be specific.

Can you qualify equipment we already have?

Yes. It takes more effort than doing it in sequence, because the requirements must be reconstructed and agreed retrospectively, but it is achievable. We establish the intended use, write the requirements, assess the gap and produce the protocols to close it.

What is the difference between validation and qualification?

In practice, qualification is documented evidence that a specific item of equipment is suitable, correctly installed and performing. Design validation checks that the design as a whole meets the requirement before it is built. One assures the asset, the other the decision.

Do you work with our existing quality system?

Yes. Protocols and templates are written to fit your document structure, numbering and approval routes, not ours. The output has to sit comfortably in your system after we leave, or it will not be maintained.

Related: Part of our engineering consultancy services. See also commissioning support and FEED studies.

If you are specifying equipment or facing a qualification you would rather not reconstruct, the earliest conversation is the cheapest. Talk to us about your project. Request a call