How To Avoid a Failed QMS Implementation

April 16, 2023

How To Avoid a Failed QMS Implementation

No one implements a new QMS just for fun.

If you’ve compared quality management software options, made a purchase, and are now staring down the barrel of implementing that QMS, there was a good reason for all that work. 

Usually, it’s because you simply reached the limits of your paper QMS or the generic software solutions you’ve cobbled together. You know you need to make this change now to stay audit-ready and make life easier for your entire team. 

Only one thing stands in your way: implementation. 

At Greenlight Guru, our onboarding and implementation team has helped more than 1,000 customers implement our QMS software. And along the way, we’ve learned a thing or two about what makes (or breaks) a QMS implementation. 

Here’s what I’d tell anyone implementing a new QMS who wants the process to go as quickly and painlessly as possible:

BONUS CONTENT: Use this QMS Implementation Checklist to build your task force and keep track of all key dates and critical events during the project!

Create a dedicated QMS implementation task force

The first step in your QMS journey is establishing an implementation task force. Some companies will designate a single person to implement their QMS, but frankly, a team of one is not enough to get the job done. 

For a project of this size and scope—one that involves multiple departments—you need a truly cross-functional task force. 

In practice, the task force should probably include:

  • Quality folks

  • Product development folks

  • Clinical folks (if applicable)

  • An executive sponsor

  • A QMS owner

When I say “QMS Owner”, I’m talking about the project manager for your QMS implementation. Each process or, in Greenlight Guru terms, “workspace” (CAPA, training, risk, etc.) should have its own designated owner, but the QMS owner runs point for the entire project. Their job is to coordinate everyone, unblock people who are having issues, communicate with the QMS vendor, and ultimately own the success of the project. 

I’ve also included the executive sponsor on this list because executive buy-in and participation is critical. An executive sponsor can not only help get you the resources you need, but they’re also there because an eQMS is a big purchase, and the executive team needs to see it’s a successful use of the budget. 

Be transparent about your QMS implementation from the very beginning

Over the years, I’ve noticed that Quality departments often hoard information about the new QMS until it’s ready for everyone to start using. I get it—I’m a perfectionist, too. And the best way to get something done is to just do it yourself, right? Not quite. 

The Quality team’s perfection paralysis comes from a good place—they don’t want to bother anyone with something that isn’t perfect yet—but it’s not a good way to operate. Gatekeeping information about the new QMS platform is one of the quickest ways to derail implementation. You need everyone on board with this, and you can’t get that buy-in if people don’t know what’s going on. 

Instead, bring up the new QMS early and often. Educate everyone about what’s happening, why it’s happening, and what success with this new platform will look like. 

One of the most interesting things we’ve seen at Greenlight Guru is that the success rate of QMS implementation skyrockets when both Quality and Product Development are involved from the very beginning (rather than just Quality).

It makes sense, though. Think about all the software tools you’ve used at work. How likely were you to quickly start using something that was given to you without any warning or preparation?

So don’t be a red light to your team on the road to implementation. Be a green light (I know, I know—can’t help it!). Keep the information flowing and share as much as you can about the project, including the timing of the roll-out, to the broader team.

Then focus on getting to your first value as quickly as possible

“First value” is a term we like to use in customer success, and it’s exactly what it sounds like. Your first value is that “aha moment”—the moment when you start seeing value from your new software. 

At Greenlight Guru, we ask all our new customers about their first value because we know from experience that the faster we can get them to it, the easier the rest of the implementation and onboarding will be. 

For most MedTech companies, that first value is publishing documents in the platform. But you can go deeper than that. What kind of documents? Your supplier SOPs and forms? Your quality manual? What would you love to have in this platform as soon as possible?

Because if we can do that together—if you can show your team the value of this tool ASAP—it’s going to give them confidence and build trust early on, when it’s needed most. Plus, achieving your first value gives us something to celebrate with you!

Keep the ball rolling by focusing on hitting your milestones

Once you put a QMS implementation on the backburner, it’s hard to get it back on track. And the best way to keep your momentum is by creating some key milestones that you need to hit over the course of the implementation project. 

And don’t keep them to yourself, either! Share them with your team and build some excitement about what you’ll accomplish over the next few months. Share them with your QMS software provider so you both know what you’re working toward. True, you eat an elephant one bite at a time, but it’s a good idea for everyone to know which bite they’re taking next. 

I love when a new Greenlight Guru customer tells me they’ve got an audit coming up in X number of months and they want to use our platform for the audit. Now, that kind of critical event lights a fire under everyone. 

Once you have critical events identified (like audits or submissions) and milestones established (like getting a workspace up and running or releasing training to the team), you have a roadmap to success. 

The most successful companies we see at Greenlight Guru are those that follow their roadmap and continue to meet with their Guru regularly (generally every week or two). And don’t worry about developing milestones yourself! Our Gurus have proven plans and execution documents we can adjust to your team’s needs.

Like I said, no one implements a QMS for fun. There’s a reason you went out and bought this platform. And you will see the results; just don’t take your foot off the gas. 

BONUS CONTENT: Use this QMS Implementation Checklist to build your task force and keep track of all key dates and critical events during the project!

Greenlight Guru gives you the customized onboarding path you need for a successful QMS implementation

At Greenlight Guru, our dedicated onboarding and implementation team is made up of seasoned medical device professionals—just like you. We know the pitfalls and the paths around them because we’ve been in your shoes.

Whether you’re bringing decades of documents to our QMS platform or starting from scratch, we’ll work with you to understand your first value and get you there fast. Every MedTech company is different, which is why we customize your onboarding path to your unique needs. We also have 80+ templates to help get you started and the #1 MedTech education destination: Greenlight Guru Academy.

Implementing a new QMS platform doesn’t have to be overwhelming. If you’re ready for an implementation experience that’s built just for you, then get your free demo of Greenlight Guru today!

Taylor Brown is a Medical Device Guru, certified Lead Auditor for ISO 13485, and a card-carrying Quality Nerd. She got her start in the industry as a technical writer and quickly became an audit readiness and support specialist, traveling around the United States to establish ISO 13485 compliant quality systems. She...

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