Aimee Penko is an engineering execution manager for Arcadis.

Aimee Penko

Isometric View of a Pharmaceutical Factory - Industrial Design for Prints, Cards, Posters, and Digital Graphics | Image Credit: © Anna– Stock.Adobe.com

The successful build or retrofit of a pharmaceutical facility or lab area depends on competent design deliverables. The design team is challenged with designing a facility that meets client business and regulatory requirements but also incorporates all applicable codes and standards while understanding and mitigating site constraints. Speed to market for a product is often a critical project charter that emphasizes design schedule compression, adding another challenge for the design team. All of these challenges can lead to poor quality of design deliverables if a robust quality plan is not in place.

As the industry faces increased scrutiny to bring drugs to market quicker, and at the same time reduce costs, understanding the nuances of design quality becomes paramount. This commentary is intended to be a primer for companies that are just setting off down their own design path or working with outside consultants to build or retrofit their pharmaceutical facility.

Regardless of one’s level of expertise, however, it pays to be more fully versed on the ins and outs of design quality, and the implications of paying insufficient attention to this aspect throughout the project design phase life cycle.

It’s important to understand the difference between design quality and manufacturing quality. When people in the industry hear the word “quality,” they typically think of “manufacturing quality”—the process of ensuring the product meets validated quality acceptance criteria and is thus safe to release to the public.

Design quality refers to the process of producing technically correct design deliverables that will be used to build or modify an existing pharmaceutical facility. Technical correctness is more than just individual disciplines working on their scope. Accuracy of deliverables takes into account that all scope is shown correctly, follows appropriate codes and standards, meets client requirements, and is coordinated with other disciplines to provide a design that can be constructed and validated.

Drawings should be coordinated with specifications so there is no conflict or ambiguity. Deliverables between disciplines should look uniform by following well-defined project standards. If an engineering or architectural drawing is 100% technically correct but contains multiple spelling and graphical errors, the customer (owner/client, permitting Authority Having Jurisdiction [AHJ], or constructor) may question the accuracy of the deliverable because spelling, format, title block, and revision information errors reflect poor attention to detail.

The backbone of effective design quality is a robust quality management system (QMS). A QMS provides the framework by establishing standardized processes and procedures that the design team will follow. It encompasses the procedures for the entire firm, covering all aspects of design delivery, down to seemingly mundane elements like how drawings are set up and numbered. Adherence to the QMS aligns the team on policies and procedures to streamline operations, but also enhance traceability and accountability.In addition, the QMS establishes a means for continuous improvement of deliverables and procedures through lessons learned feedback.

The QMS framework should be developed in compliance with ISO 9001, which defines the requirements for a quality management system (1). ISO 9001 is the most recognized QMS standard and the only standard within the ISO 9000 series that organizations can be certified to. The International Council for Harmonisation (ICH) Q9 Quality Risk Management guideline is another valuable reference (2). It provides guidance on managing quality risk by providing tools and principles for controlling and communicating the risk.

It’s crucial to understand that while the QMS provides a strong quality framework and documents the processes required for project review stage gates, it’s not enough. Checking a box on a checklist does not always ensure technical quality is achieved.

Technical quality is achieved by orchestrating many different types of design reviews, facilitated by experienced peers, before deliverables are issued on a project. A second set of qualified eyes helps to identify items that might have been missed by someone who has been looking at the same documents for months. This collaborative effort also fosters accountability for design outcomes, for an overall better result that directly addresses facility requirements.

Sustaining design quality throughout the project with a rigorous design review process is paramount. The reviews should happen at a frequency defined in the project execution plan, and certainly before deliverables are issued to the customer. There are multiple different types of design reviews that can be performed on a project.

 All deliverables should undergo an intra-discipline technical check.This check should be performed by a peer from that discipline that is technically competent to review the deliverables. The discipline check should involve reviewing both drawings and specifications for intra-discipline coordination between documents and technical correctness. The checker should also verify quality attributes like format, spelling, revision information, notes, etc. to ensure they are presentable to the customer.

 The squad check is an inter-disciplinary review by all disciplines on a project. It provides the opportunity to review other discipline’s deliverables to ensure scope is coordinated between the team.

For example, a mechanical engineer should review electrical drawings to ensure all mechanical equipment is powered as-specified and safely. A reflected ceiling plan (RCP) should be checked by multiple disciplines such as electrical, mechanical, fire protection, and architecture to ensure there are no clashes between lights, diffusers, sprinkler heads, and ceiling system. The squad check also provides another opportunity to ensure spelling, format, and revision information is correct on the documents. If desired, the squad check exercise participants may include external team members such as the client, construction manager, and/or sub-contractors

 Clash detection is similar in many ways to a squad check, but it’s conducted in the project three-dimensional (3D) model. Coordination software looks for clashes between (new and existing) design elements such as equipment, piping, duct, lighting, walls, and building columns just to name a few. Clashes are not always evident on two-dimensional (2D) drawings, so using 3D visualization makes them easier to identify. The clashes are published to the design team for resolution.

A Building Information Modeling (BIM) coordinator will facilitate this exercise by running the clash detection software, logging the occurrences, and expediting clash resolution between disciplines. Although no design will ever be 100% clash free, the majority of clashes should be resolved before issue, and those that aren’t reconciled shall be documented for the field team to review and mitigate before constructing in the field.

 It’s important to review and mitigate risk throughout the project. Risk assessments can take on many different forms. Initially, the project should be reviewed by leadership to make sure it’s set up for success. The review should focus on scope, project risk, budget, schedule, and execution strategy.

A risk register is another useful tool to help mitigate risk. The risk register is used to document risks identified by the team along with the resolution after discussion with the client. Late project changes are another source of possible risk and can have a cascading effect on multiple disciplines on a project.

For example, if a process change requires ethanol, the project team needs to reevaluate codes and standards to confirm if design changes are warranted. A room may require fire rated walls and a specialized fire protection system where they may not have been required (or budgeted for) previously. This type of risk could be mitigated by conducting a proper third-party peer review to provide contingency guidance to the design team. It’s vital to evaluate and mitigate risk throughout the design development to set the project up for success.

It practically goes without saying, but neglecting design quality can result in dire consequences. The most alarming outcomes include heightened construction and operational safety risk, or even outright project suspension or cancellation impacting availability of the medicines that patients are depending on.

Beyond human impact, however, the financial repercussions of poor design quality can be severe. For design firms, insufficient attention to design quality upfront may affect the bottom-line profit—or worse yet, no profit at all if substantial corrections or changes need to be made to the design after construction begins.

Poor design quality can even expose companies to regulatory actions and lawsuits. This concern cannot be overstated. If a design leads to some type of catastrophe event such as a fire, loss of life, or product recall, the company could be subject to large fines or even lose their license to practice in a particular state.

In this regard, design quality just makes good business sense for companies providing architectural and engineering services to the pharmaceutical industry. A tarnished business reputation affects client trust and loyalty, which obviously makes it difficult to attract repeat clients. In an industry where a trustworthy and honest reputation is essential, the fallout from poor design quality can be catastrophic.

So, for companies that may be embarking on a design project for the first time, what are some fundamental takeaways?

As said at the outset, design quality is inherently different from manufacturing quality. Design quality focuses on ensuring the design team provides quality deliverables that are technically correct, follow all applicable codes and standards, are well coordinated between disciplines, and can be constructed and validated.

Quality must start at the project kick-off by establishing a well-defined quality plan.The QMS provides the framework that defines the processes and procedures for achieving the design objectives and helping to shape the project quality plan. Relying on procedures and checklists alone will not guarantee quality deliverables. The design reviews must be executed by technically competent peers (or subject matter experts) to ensure the accuracy of the design.

When starting a project, one must fully understand the user (customer) requirements and project design charter. The scope of the project must be articulated to design and construction partners to ensure the project team ultimately delivers an optimal facility.

When retrofitting an operating facility, all existing drawings, current manufacturing conditions, and new facility requirements should be shared with the design team very early in the project to plan for minimal production capacity interruption. An early and comprehensive foundation of scope understanding enables an efficient and meticulously detailed project with an accelerated delivery.

Design quality is not merely a regulatory checkbox; it is a foundational element of successful pharmaceutical manufacturing design. By prioritizing a rigorous approach to design quality, companies can mitigate risks, enhance employee safety, and foster a culture of accountability and excellence.

The stakes are high, and the importance of design quality cannot be overstated. As regulatory frameworks become more stringent and the industry evolves, a commitment to design quality will not only protect lives but also safeguard the future of pharmaceutical companies.

ISO. 9001:2015 - Quality Management Systems (ISO, 2021).

ICH. ICH Q9(R1) Quality Risk Management (ICH, 2023).

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Vol. 49, No. 2
March 2023
Pages: 28-30

When referring to this article, please cite it as Penko, A. Design Quality in Pharmaceutical Design: A Primer for Facility Executives. 

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Being fully versed on the ins and outs of design quality can improve the project design phase life cycle.  