Mickey Garcia, MasterControl
MEDdesign

QMS Doesn’t Have to Be So Difficult

By Mickey Garcia
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Mickey Garcia, MasterControl

A guide to how and why QMS software helps medical technology companies.

Suppose you’re explaining to your mother how to find a program using her new Netflix subscription. You might tell her to first press the Power button on the TV, then to press the Power button on her new streaming device. Next you might tell her to hit the Search button and use the on-screen keyboard to type in the name of her favorite show.

Now imagine having to give these instructions in writing only. With careful and specific written instructions, she might access her show the first time without incident. Or there may be an unexpected hiccup in the process: Maybe the broadband connection times out, or the router is accidentally turned off, or Netflix has stopped streaming that show. Eventually, her ability to execute the process you defined for her will fail. Then what? Chances are your mom will call you and ask what to do next.

This simple anecdote demonstrates some common quality management challenges.

In a professional work environment, we often don’t know who wrote the procedures we follow. Even if we do, verbal instructions to deviate from a procedure are by trial and error. And even when they do work, verbal instructions don’t help all the other employees who rely on the same procedure. Sooner or later, it becomes clear that it’s not always easy to “say what you do and do what you say,” as directed by ISO 9001.

Two Basic Tasks of Quality Management

You can think of quality management as having two primary objectives:

  • Define a Design Specification or Procedure. The design specification might be for a product or a piece of equipment, or the procedure might be for a business process or manufacturing process. Either way, there are several things you must do to successfully develop your specification or procedure: Understand its intended purpose and the needs of its users; test and validate it to qualify that it suits the purpose for which it was originally designed; and document it with sufficient detail that it can be executed reliably. In other words, “say what you do.”
  • Execute the Design Specification or Procedure. Once the specification or procedure has been defined and qualified, it can be executed repeatedly as needed. The inputs to the process (e.g., material components), the conditions surrounding its execution, and its final outcome should all be recorded. Its critical-to-quality characteristics should also be checked for conformance to the original specification or procedure. In other words, “do what you say.”

These two basic quality management tasks are applied repeatedly across many different contexts. In product development, product designs are created and validated, as are the manufacturing processes and equipment to produce the product. In manufacturing, those specifications and procedures are executed to produce the product. In regulatory affairs, submissions are created based on procedures defined in accordance with the needs of the target regulatory agencies. In facilities, the physical plant is maintained to meet the specifications of its original designers.

Quality Management Challenges

In practice, these two quality management tasks tend to be much more difficult than they sound. Each task can present its own unique challenges.

For example, when defining a business process, the author must make certain assumptions about the context in which the process will be executed. Often the author won’t even be aware of many of the assumptions he or she is making.

In the Netflix example, the described procedure made several such assumptions, among them that your mom’s broadband would be working and that Netflix offers the show in question. If the assumed context is invalid, the procedure may not achieve its intended objective. Dealing with the many potential variations that may be encountered during a process is the source of much of the complexity in defining a process.

Another challenge is the inherent imprecision of human language. For instance, the Netflix procedure may say to “click the Search button.” But your mom may not associate the word “click” with pressing a button on her remote, or she may not recognize the magnifying glass icon as a “button.”

While there are several challenges in defining a design specification or procedure, there are at least as many challenges in repeatedly executing a well-defined specification or procedure. Just ask manufacturers how many of their production runs yield 100 % conformance to specification. Variability of all types plagues the execution of every process and must be taken into account.

There are always exceptions and anomalies. These exceptions may be found during pre-established inspections, or they may be identified by the final user. Sometimes exceptions are anticipated, in which case you may already know how to deal with them, and sometimes exceptions are unexpected and must be assessed to determine their impact and severity, their root causes and their remediation.

The Quality Management System

Because the jobs of defining and executing specifications and procedures are so much harder than they seem, these two quality management tasks must be supported by a Quality Management System (QMS) that will make the whole venture more reliable.

The QMS serves as the medium in which the aforementioned tasks occur. The system mandates the management leadership and oversight to enable these tasks to be completed properly. Equally as important, the QMS also provides tools for managing documentation and records, for disseminating training, for dealing with changes, and for tracking approvals. It also provides a means to resolve the inevitable exceptions and deviations.

Many of these QMS tasks can be done without electronic tools. However, when each person in an organization is performing dozens of these tasks each day, it quickly gets beyond the capabilities of a manual system to handle effectively. Electronic QMS software can help facilitate all of these processes to make an organization’s quality management activities more efficient and effective.

First, QMS software will streamline the process of documenting and collaborating on your specifications or procedures. Once these specifications or procedures have been documented, they are routed to the right set of experts for review and approval. Upon approval, the electronic QMS helps to roll out the new specifications or procedures by facilitating training along with any other activities leading up to the effective date. Once made effective, the electronic QMS will provide the most up-to-date specifications or procedures to the employees who will be executing them.

Many times, the electronic QMS will even serve as the repository of the documented evidence for the execution of the specification or procedure. Moreover, when things go wrong, the electronic QMS provides a place to capture anomalies and deviations. It guides you through the process of finding the root causes for these issues, and it allows you to close the loop by enabling any updates needed in the original specification or procedure.

Simplifying QMS to Improve Quality Management

Historically, adopting an electronic QMS has been a complex, complicated effort for medtech companies. QMS software providers have traditionally supplied a set of basic capabilities but forced companies to wrestle with custom-tailoring those capabilities to suit their specific needs. At times, this has caused companies to feel like they have simply traded in one set of headaches for another.

Today, things are turning around. QMS software is becoming more capable and configurable without the need for expensive and time-consuming setup and customization.

Zarbee’s Naturals, a provider of health and wellness products, is among a new breed of companies embarking on QMS by putting an emphasis on quick and easy QMS adoption. The Utah-based manufacturer uses a new generation of cloud-based QMS solution that offloads much of the setup and maintenance to the QMS vendor. The product, called Spark, is designed to be ready-to-use by companies without any special IT expertise. The vendor provides the servers, maintenance and upgrades as well as pre-built configuration and validation scripts that can be used as the basis for the company’s production system.

Tom Gosse, who serves in operations and quality support for Zarbee’s, says the ready-to-use cloud product is ideal for small, growing companies. Zarbee’s currently employs approximately two-dozen people. “For a company our size, without the technical expertise to manage servers in terms of back-ups, security and firewalls, having [a vendor] handle all that for us saves us money in terms of hiring someone to manage that and the hardware to run it,” says Gosse.

It is hard enough to establish design specifications and procedures that can be executed reliably time and time again. Lacking the proper QMS tools, organizations are making it harder to achieve their quality management objectives. And as QMS software becomes easier to adopt, the reasons for not having a robust QMS solution are evaporating quickly.

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Mickey Garcia, MasterControl

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