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An Adaptive Approach to Executing Projects in High-Risk Industries

Developing applications for high-risk industries like pharmaceutical, oil, gas, and nuclear power generation is an incredibly complex undertaking. These industries are heavily regulated — with good reason — and come with a large variety of standards and regulations to follow. It’s no wonder then that creating high-quality and safe end products efficiently and at scale becomes quite the challenge.

An Adaptive Approach to Executing Projects in High-Risk Industries

To explore best practices in this area, we spoke to Bence Toth, Process Automation Project Operation Manager at ABB, and Kalman Keresztesi CEO & Pharma Expert at Controsys. Read on to learn more about taking an adaptive approach to executing projects in high-risk industries and the main takeaways from our webinar.

The nature of high-risk industrial automation projects

Safety in high-risk industrial automation projects — as we discuss in our expert-led webinar, Adaptive Project Execution in High-Risk Industries — is paramount. This is true for the technology itself, the processes as a whole, and last but definitely not least, the humans involved. As a result, high-risk industries are very heavily regulated in order to ensure the safety of end-users and the products which go to market. But meeting regulations, standards, and guidelines gets a whole lot more complicated when you factor in the fact that the engineers, manufacturers, clients, and different industries and regions all have their own different regulations and requirements.

For context, engineering projects often comprise a large, multi-national team that includes but is not limited to end-users, suppliers, engineering companies, manufacturers, and external advisors and subject matter experts brought on as consultants. Each of these stakeholders will inevitably have their own way of working and their own toolkits for getting the job done. For example, customers have their own Quality Management System (QMS), digital or not, as do the manufacturers you’re going to work with.

On any given project, you’ll also be working with a variety of suppliers delivering equipment and parts, all of which will have their own QMS and other tools that you may need to take into account. All these tools need to be vetted and validated before they can be used for their specific purposes in the digital project management work that goes into developing products.

Where documentation comes in

The key to successful collaboration in projects like these is to harmonize the coexisting working systems and find a way to meet all the necessary regulations in the process. This is done through many aspects of project management, but most importantly, through a very high level of meticulous documentation. In a typical automation project, as our experts discuss in the webinar, more than 30% of the engineering hours often are allocated to Documentation Management, QA, Change Control, and Reviews. All that documentation helps prove that you’ve satisfied the requirements of GAMP® 5 guidelines or other relevant standards.

With such a big chunk of time spent on documentation and meeting regulations, getting it right can be the deciding factor in whether or not the project is considered a success or a struggle – and using the right tooling for it can make all the difference. Digital risk management solutions help control uncertainty, while tools that support digital documentation help the validation of computer systems used in production.

Challenges of paper-based documentation in high-risk industries

Change management

All projects have a lot of changes, and staying on top of them is particularly nightmarish if you’re still using paper-based documentation processes. Even the smallest modification can have a significant outcome in complex projects, and if there’s no visibility on all these moving parts, it can quickly get lost in the noise.

Complicated review workflow

When you are using a paper-based documentation system, or even legacy tools, it typically leads to complex and long reviews, which slows down the process of getting client approval and sign-off to move forward in the project.

Content versioning

Imagine endless versions of documents being circulated on company servers, by email, and being shared back and forth via cloud-based file-sharing tools. Not only is this typically not secure, but it makes it incredibly difficult to track everyone’s comments (especially with a global, distributed team) and to know which version is officially the final one.

Lower end-product quality

All of the above – a lack of transparency and visibility on changes, difficulty in getting customer feedback early on, and endless versions of documents – make collaboration and compliance difficult, which inevitably results in a lower quality product.

Related reading:
Legacy Toolchain Modernization: What You Need to Know

The advantage of going digital

Transitioning to digital documentation can bring a host of significant benefits to your organization’s project execution efforts. Here are a couple of the main ones you could expect to enjoy:

  • Getting feedback early

Collecting and responding to customer and stakeholder feedback sooner means that you can make changes as you go along, save time fixing bugs at the end of the development cycle, and make progress faster since customers can review and approve activities with electronic signatures.

  • Efficient project management

Having a birds-eye view of the team’s activities and what resources are needed for certain tasks allows you to better manage engineering schedules, resources, and cost estimates. With the right documentation management system, you can also develop templates that can simply be adapted to your next project instead of starting from scratch every time.

  • Transparency and traceability

This is vital for three key reasons: one, for smoother digital remote collaboration between cross-functional teams, two, for team leaders to check dashboards and reports to keep an eye on the progress of the project, and three, for compliance reasons in case you need to provide information for an audit.

  • Structured change management

You can work with different versions much more easily, control who has access to what, and adapt workflows as needed while keeping everyone up to date. This also means you can change scope on the fly if you work in an Agile environment.

In other words, using digital documentation instead of paper-based documentation gives you a competitive advantage by accelerating engineering activities and saving time, energy, and money by reducing the costs of poor quality in documentation and development. 

A more straightforward way to digitize documentation is to use an integrated Application Lifecycle Management platform which is specifically designed for advanced product and software development. Intland Software’ codebeamer, for example, extends ALM functionalities with product line configuration capabilities, is extremely configurable for complex processes, and comes with regulatory process templates with baked-in domain knowledge for specific industries.

Up next:
Legacy Toolchain Modernization: What You Need to Know

An adaptive approach to executing projects in high-risk industries

Ready to learn more about using integrated ALM software to turbocharge your efficiency and output quality when it comes to projects in high-risk industries?

Check out our webinar featuring experts from leading global technology company ABB and industrial automation company Controsys to learn more about integrated Application Lifecycle Management and how the right tooling will help you tackle project management challenges in the pharmaceutical, nuclear power plant, and oil and gas industries. 

Hear real-life use cases which showcase how codebeamer ALM helped ABB’s team to optimize performance on tight project schedules and achieve compliance with standards such as GAMP® 5, IEC 61508:2010 Part 3 Section 7.4.4, IEC 26262, and IEC 62138.



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