June 20, 2017

Automated process management systems are the workhorses of every modern company. These systems guide operations and improve quality and efficiency. Hidden away in the core of each automated process management system lies the unsung yet essential electronic form. Avoid QMS form design mistakes by following some proven guidelines.

Forms are the arteries that pump information to the heart of your quality management system through:

  • Workflow: Completed form responses and trigger actions and workflows, including approval processes.
  • Tasks: Forms create automated tasks for responsible parties while managing user permissions.
  • Capture: Forms capture required substantiation including documents, photos, signatures, and time stamps.

Form design automates the processes of your quality management system. Mistakes can require extensive re-working and render a system ineffective.  Let’s look at five key mistakes often made when designing electronic forms and how things can be done better.

QMS Form Design Mistake 1: Mirroring Paper Forms

The first mistake to avoid when designing electronic forms is to copy legacy forms.  While paper forms are (hopefully) long gone in most modern businesses, existing semi-automated forms are most likely derivatives of paper forms and flowchart artifacts. Ensure that electronic forms are evaluated to identify and exclude unnecessary, process-stalling attributes carried over from legacy systems.

Companies with established, effective automated quality management systems have achieved success though evolution. They document legacy processes to glean what still works and where gaps and holdups exist.  They don’t design forms based on “the way we’ve always done it,” but based on the most efficient processes for today’s GMP environment. Typically, this is done in collaboration with a QMS provider that brings extensive expertise in form design and process management.

QMS Form Design Mistake 2: Overuse of Approvals and Signatures

The second mistake to avoid when designing electronic forms is overusing approvals and signatures. Nearly all automated processes incorporate multiple approval and/or signature steps. Eliminate the ‘need to know’ in the approval process and evolve to the streamlined efficiency mindset.

Too many approvers create bottlenecks within any process. Approval steps should ensure that the right people—essential employees—are involved at the right time. For example, if a corrective action requires a design change, an engineering manager may be required to evaluate the proposed change before it can be implemented. The entire design team doesn’t need to approve it (you can inform them via email or notification).

QMS Form Design Mistake 3: Collecting the Wrong Information at the Wrong Time

The main job of an electronic form is to collect information. So, what’s the wrong information? It’s either too much information, not enough information, irrelevant information, or even requesting information at the wrong time.

Users get frustrated when they are asked to enter unnecessary data.  Electronic forms should be sensibly designed to route documents using intelligent workflow that can automatically show or hide fields to specific users and groups.

In summary, create fields that collect the right information at the right time. Focus on efficiently automating quality processes; not information overload and duplication.

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QMS Form Design Mistake 4: Creating Form Silos

No form is an island. Forms are one part of an integrated system of processes that are interconnected in a quality management system.   Complaint handling may be connected to corrective action systems. Document management systems get connected to change management systems.

Therefore, connect information gathered from previous steps to subsequent steps. Here again, we emphasize the importance of systematic design of your automation strategy. For example, if a corrective action form is launched from a problem tracking form, all previously collected data should be pre-filled on the problem tracking form (see Mistake 3). Linking processes and pre-populating form fields saves time, eliminates errors and increases productivity.

Here’s another tip – ensure all form fields have the same naming conventions across processes. Remember, each form is a part of a larger system.

QMS Form Design Mistake 5: Failure to Adapt

Automated quality management is not static.  You can’t set it and forget it. Businesses with effective quality management systems adapt to a constantly changing business environments. As business evolves, so to must its processes automation needs and by extension, its electronic forms. Just because a form is designed and released doesn’t mean it cannot or should not be improved.

As a best practice, seek feedback from users. Their suggestions are often the best data source for guiding form improvements.  In addition, solicit feedback from managers who are using the data to make decisions. For example, if supplier qualification is based on delivered product quality, it is important to ensure that problem tracking forms allow you to trace product problems back to the correct supplier.  Better yet, include employees and managers as part of your implementation team.


Good forms ensure good processes.  Forms are the foundation of an effective electronic quality management system.  They are where automated business processes meet people. Therefore, to ensure that business processes are optimized, forms must be designed with an evolutionary mindset.  Forms should streamline approvals and data collection and be configurable to adapt to changing and increasing quality processes.  Finally, remember to monitor feedback from users and managers to keep forms up to date and relevant.

A flexible QMS platform–like AssurX–allows the deployment and modification of forms as needed, with the power to integrate all workflows, data and documentation into a single system.