Design Qualification and the Enhanced Design Review
SysComm will support our Clients in executing either Design Qualification (DQ) or Enhanced Design Reviews (EDR). For more information on the typical differences, and motivations behind these reviews, please read on below.
SysComm will provide support in the following key ways :
- Provision of systematic & methodical approach to DQ/EDR, including training.
- Augmentation of standard DQ/EDR to incorporate equally critical Commissioning Enabling Reviews&Start up Reviews.
- Acting as independent facilitator/chair at the DQ/EDR process.
- Support of Client Quality Unit team where requested, with QA personnel competent and experienced in projects & operations.
- Provision of report, with closeout actions, timelines, and owners to Client team for action.
The DQ / EDR approach, in conjunction with SysComm’s augmented support services will serve the client by confirming the design :
- Is Appropriate
- Meets User, Regulatory, and Safety Requirements
- Facilitates systematic construction, for both area handover and localized commissioning.
- Supports testing for Requirements (which can exceed normal operations data, sampling etc.)
SysComm also supports this process through facilitating User Requirements Definition, and where required by the Client System Level and Component Level Criticality Assessments. Please click on the links to see more information.
Whereas the intent of Design Qualification (DQ) is clear to most within our industry, a very broad spectrum of understanding has existed for a number of years surrounding the actual methods to be employed in achieving these goals.
At a very basic level, a DQ serves to demonstrate that the design (typically at BOD stage) is capable of delivering upon the initial requirements set out, usually in a User Requirements Specification (URS). Historically, however, many companies believed that this could be achieved through a near literary review of Specification documents against requirements and the execution of Peer Reviews, GMP Reviews and HAZOP’s among other activities. Other companies set out codes of practice that they believed delivered upon the same intent, without a specific DQ activity.
Client attendance at these activities is typically limited to Operations, Engineering, and as deemed appropriate Validation. The Quality Unit is usually not directly represented.
Enhanced Design Review
Either in response to the general lack of a standard approach to DQ execution or as an inevitable evolution of the idea, the concept of an Enhanced Design Review has been mooted since the beginning of the century as a structured, methodical approach to delivering upon the goals of the DQ step.
ASTM 2500E Standard – Full EDR is a requirement.
Outside of the structured approach, the fundamental difference between a DQ and an EDR is that the latter is a more forward looking activity, working to clarify not only that the design is met, but which Critical Aspects of the design are key to the successful delivery of the job.
This approach sets out to establish what the key requirements are for the project, rather than simply inherit them from earlier documents. Critically, this is in terms of not only User Requirements but also the Regulatory Requirements that may be associated with them. It either confirms and amends previously stated critical requirements, or establishes them itself through a set of Risk-Assessments and/or Criticality Assessments. It then verifies where in the design these key deliverables are handled, and also by extension how they might be tested.
The attendance of strong, experienced Validation and Quality unit representatives at this activity is of critical importance to the value it delivers to the Client, in particular if Enhanced Commissioning is to be employed, followed up by a leveraging or verification step.
In order to execute a project in compliance with the ASTM2500E standard, the Client must execute a comprehensive project review step where the design at that point is checked against :
- User Requirements
- Design measures to address Critical Aspects (and/or Critical Parameters/Components)
- Regulatory Requirements associated with Critical Aspects, and User Requirements.
As part of this activity, a clear testing strategy must also be agreed whereby each of the Requirements and Critical Aspects are demonstrated and recorded in a manner which will support the verification step inherent to the ASTM approach.
The attendance of experienced, empowered Validation and Quality unit personnel at this review is critical to the successful outcome of the project, in particular with regards to the verification of testing from the Enhanced Commissioning phase.
A key and topical output from this approach is that once the Validation & Quality Unit have signed off on the EDR Report, Critical Aspects, and associated agreed testing and documentation methods, then there is scope for a significant reduction if not elimination of their oversight of the Enhanced Commissioning phase, with oversight limited exclusively to the Critical Aspects.
For an abstract discussion on the ASTM2500E Standard, and how it in conjunction with an Enhanced Design Review can facilitate greater cost efficiency in executing Enhanced Commissioning, and a leveraged Qualification/Verification model, please click here, or visit our page.