Process-based Versus Records-based Quality Systems – Which is the Key to EQMS Success?

Process-based Versus Records-based Quality Systems – Which is the Key to EQMS Success?

Joshua Centner, Industry Solutions Consultant, Pilgrim Quality Solutions

As an Industry Solutions Consultant, I interact with clients who are evaluating the features and functions of various Enterprise Quality Management Systems (EQMS). It seems there is one major factor which is overlooked time and time again. It pertains to the overall design of the EQMS, and will impact the long-term value of the solution to an organization. This critical element is whether the EQMS is a records-based system or a process-based system.

The two systems can appear very similar, which makes it difficult for clients to realize which type of system they are seeing. However, each one delivers significantly different results. Pay close attention to the differences between records-based and process-based systems, because I’ve see companies that mistakenly select and deploy a records-based system, only to scrap it 1-3 years down the road, and replace their EQMS with a process-based system.

What is a records-based EQMS?

A records-based system uses a “report” or a “document” to log all of the information about a particular quality event. It is the electronic equivalent of opening a Microsoft Word or PDF document, passing it from desk to desk, and getting input on the document in a sequential manner. It mirrors a paper-based process. However, by allowing the record to be passed to various users for input, it forces users to work with the full form or multiple forms even if they only need to enter pieces of information. The end result is a rigid process that doesn’t enable dynamic routing.

An example of a records-based CAPA process

Let’s use an example to illustrate the disadvantages of a records-based system. In this scenario there are two Corrective Action (CAPA) events or processes. One is a supplier CAPA and the other is an internal CAPA. In a records-based system there would potentially be two separate forms to maintain (one for supplier CAPAs and one for internal CAPAs). The user would choose which one they would need and initiate the document. This requires the company to create and maintain two separate forms which creates more work to configure, validate, and upgrade. Even if there was a single form created for both, it would be an extremely large form in order to incorporate all of the data for the different internal and supplier variables, and would include large gaps of empty space for recording the information, making it more complex for the user than it needs to be.

 

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How a process-based EQMS handles CAPA

Now, let’s look at how a process-based quality management system such as Pilgrim Quality Solutions’ SmartSolve® works in the same type of scenario. In a process-based system, all quality management processes are built on top of a platform and utilize intelligent workflow. A process-based system utilizes data intelligence to determine how and where to route each task. The platform also enables dynamic configuration, flexibility, and scalability for organizations within their processes.

In the scenario above, a process-based system would utilize one workflow for all CAPAs. When a user initiates a CAPA process, he or she uses a single click to indicate whether it’s a supplier, internal, or other type of CAPA. This selection would dynamically adjust the various forms and workflow steps. This allows fields to be exposed or hidden based on whether they are needed for that specific type of CAPA.

In addition, a supplier or internal CAPA team will be automatically assigned by the system, based on that initial one-click type selection. Each user assigned to a task will receive a form with the only the specific data that’s needed to sign off. There is no need to navigate multiple tabs or long forms. This makes the task simple and intuitive for that specific user and process.

The value of a process-based quality system

A process-based system enables organizations to take advantage of the true value of EQMS. Rather than mimic an inefficient, paper-based process, users can take advantage of built-in intelligence and best practices for more efficient task processing and decision making.

The value of a process-based system becomes multiplied when a company adds business units, product lines, or products. This enables the quality system to scale with your organization. Additional tasks and steps can be added with the click of the button. Based on certain conditions, the workflow, users, and teams can change automatically. When an individual receives a task, that person can open the record and only a specific set of information is displayed. Finally, upon signature, the document is automatically routed to the next user.

Process-based data drives reporting and compliance

There is another lens to use for comparing records-based versus process-based systems. When performing reporting, analytics, or trending, records-based systems tend to have fewer metadata tags so that searching, sorting, and reporting can be difficult. With a process-based system like SmartSolve, every field is tagged so that every single piece of quality system data can be sorted, filtered, and reported on. This ensures that a business can develop any report or analysis needed. This also aligns with the direction in which industry is headed — properly structured quality system data is increasingly becoming the key to compliance.

How to tell the difference?

Some quick questions during the evaluation process can unveil which type of system is being presented. Ask open-ended questions about the processes such as, “How does the system handle supplier-based CAPAs (SCARS) versus internal CAPAs?” If the answer is pointing toward multiple forms or requires the user to make decisions on how to proceed, then chances are it is a records-based system. If the response is based on the system making intelligent decisions and using a single process to manage all CAPAs, then chances are it is a process-based system.

It may also be useful to consider the reporting and analytics area of the solution. Below are a few good question to always ask, no matter the circumstances:

  • Can the solution analyze and incorporate data easily around every field in the system, including time spent in each task or phase?
  • If there are multiple CAPA actions, can the solution analyze the time spent on each action individually?
  • If you add fields to the forms, how are they incorporated into the reporting solution?

When an evaluation team is looking at a long-term EQMS, a process-based system provides more scalability, efficiency, and reporting benefits. These questions should help to draw a clear picture of the type of vendor you are evaluating so you can choose a system that aligns with your long-term quality system needs.

Do you have experiences with the difference between records-based and process-based quality systems? Please share them in the comments below.

Pilgrim Quality Solutions

Pilgrim pioneered quality management software more than 20 years ago for regulated enterprises that needed a better way to deliver, track and oversee quality-related activities.

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