Common Documentation Roadblocks in Engineering Management

Author: John Campbell | March 22, 2021

Documentation is critical to ensuring compliance with required industry regulations in the safe production of equipment and parts. However, despite its importance, many manufacturers struggle to get a handle on the documentation process and the nuances of each moving part.

In engineering management, documentation is often thought of as a necessary evil, and it can be overwhelming—but it doesn’t have to be the headache that it so often becomes. By making some simple adjustments to your documentation process, you can save yourself significant time, money and aggravation.

Let’s start by exploring some of the most common traps that project teams fall into. Do any of them sound familiar?

An inefficient approval process: Your review and approval process rarely occurs in a vacuum; you’re likely required to engage various stakeholders across multiple teams, buildings or even the globe. Maybe you’ve got contractors or subcontractors involved in your project, which can add additional complexity.

Given the stakeholders involved, what is your process for review, approval and sign-off? If you’re dealing with a paper-based system, all bets are off. All it takes is for one person to sign in the wrong spot or format the date incorrectly and you’ve just bought yourself additional delays. Barring a physical meeting of the minds, where everyone gathers under the same roof to complete the sign-off process (an expensive, if not impractical, option), there’s really no efficient way to ensure all required signatures are received by the required date in the required format.

Inadequate notification system: What is your notification process for alerting stakeholders to a document that needs review, approval or signature? In our experience, this task is commonly handled via email. And because people are bombarded with dozens (sometimes hundreds) of emails in a single day, the odds of your email notification being read and addressed in a timely manner aren’t great. Think about your own inbox; the sheer volume of messages coming at you on an ongoing basis makes it easy to overlook even the most important emails.

Invalidated e-signature system: It’s possible, even likely, that you have some sort of e-signature system in place, but is it validated? This is an important step that many project teams overlook. Without validating your e-signature process, you have no way of ensuring the authenticity of the signature. You also need to consider compliance requirements. For example, FDA-regulated businesses, such as medical device manufacturers, need an e-signature system that adheres to the 21 CFR Part 11 compliance requirements, which dictates how a company can use electronic records and digital signatures in place of paper-based documentation. There’s more to an e-signature than a digital signature in an electronic file. Failing to ensure that the necessary validation and compliance protocols are in place could have significant consequences.

Version control and status tracking: How do you ensure that the appropriate people are signing the latest document? How often are you releasing your documents, and are they locked for editing? Then there are status-tracking considerations. If your approval process is managed over email, you’ve likely found yourself caught in the time-sucking trap of sifting through your inbox, trying to figure out where the document stands in the review process.

These challenges can lead to user frustration, bottlenecks and project delays. The good news is, using a browser-based software program like Polarian, you can easily track and manage your documentation throughout the lifecycle of the project.

Below are some useful strategies to help you streamline your documentation process:

Define a workflow: Start by defining a documentation workflow up-front—one that works for you and your company. In Polarian, you can create a workflow with fields that let you mark the status of each state, as shown in the example below.

Provide real-time status: In a software application like Polarian, users can gain visibility into the status of each project state. For example, reviewers can see where the project stands, who’s reviewed which documents, where bottlenecks might be forming and more—which also serves to create an environment of accountability.

You might also consider creating custom reports that show what’s in each person’s queue, while giving the entire team access to view the project’s progression in real-time, rather than waiting for one person to deliver a status update.

Use a validated e-signature program: A tool like Polarian offers functionality that ensures e-signature compliance with industry regulations, with the ability to display who has and hasn’t signed the document.

The documentation process can prove laborious (if not maddening) when not managed properly. But with the right tools and processes in place, many of your headache-inducing barriers will be removed, in favor of a documentation process that facilitates a smoother project flow, greater accuracy and shorter review cycles for a project that’s delivered on time and on budget.

If you are interested in learning more about Polarion, or would like to take part in a demo, contact our team today.

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Dan Sterling Photo of Dan Sterling President
250 Moonachie Rd., Suite 400 Moonachie, NJ 07074
201-227-7569 dan@sterlingmedicaldevices.com
John Campbell Photo of John Campbell VP of Operations
250 Moonachie Rd., Suite 400 Moonachie, NJ 07074
201-227-7569 jc@sterlingplm.com
John Fargo Photo of DanJohn Fargo PLM Manager
250 Moonachie Rd., Suite 400 Moonachie, NJ 07074
201-227-7569 jf@sterlingplm.com