How to Create and Implement an Effective Quality System Plan

The life sciences company with the best product deserves to be at the top of the market. But how do you systematize quality throughout your organization so that your company wins the top spot? You do that with a great quality management system (QMS).

There's a lot of information out there that explains how much better, easier, and compliant you'll be once you implement a QMS.

But — how do you get from the paper-based systems that you use now to a fully functioning QMS? What is the investment in time and manpower going to look like?

When you read the features lists on QMS software, it's like you've been handed the blueprints to a house, but you don't know the order of the steps to build it or how long it's going to take.

Do you start with the plumbing? Does the fireplace go up before the frame? Will you be done in a few weeks, or will it be months?

Fortunately, a map from paper-based to a fully functioning QMS exists. It's called a quality system plan.

We're going show you how to create and implement one so that your organization is in a great position to leverage quality as a competitive advantage while speeding up your time to market.

Executing an Effective Quality System Plan in 6 Steps

Building and executing a Quality System Plan isn't going to happen overnight. It's going to involve a lot of hard work from everyone on your team, but the results are going to be worth it.

In as little as four to six months, you can have your team trained and have your new quality-focused system fully implemented in your company.

So what are you waiting for? Let's get started.

1. Make Sure You Engage Everyone

Ownership from the beginning is important and will make it all more successful in the long run. You need every member on your team from the top of the food chain all the way down to be fully invested in executing your quality plan and in building a quality-centric culture.

Each team member will have their own contributions to your overall success. Take the time to help them understand their place and the importance they have in everyone's future.

Related Reading: The 9 Core Elements of a Quality Management System

2. Choose a Template that Fits

You're not the first company to build a quality system plan and implement it. Learn from others that have come before you and the templates that have been created by leading industry professionals.

If you have a good template and you understand the basics of quality systems, then you can typically write quality system procedures.

Your in-house quality manager should plan to allocate between four and eight hours to write each procedure using the template for guidance. This means that they would typically need to allocate at least one day per week to be done within six months.

3. Set a Timeline

You need to set a realistic timeline for implementation. We understand that you want to get to market quickly, and this may feel like you're delaying your launch, but trust us — neglecting quality in the beginning will only hurt you in the long run.

Implementing your plan will take at least four months, but it's more common to complete it in six to nine months.

Your team needs time to build the procedures and train on them. You will typically have around 30 procedures in your quality system, so if your team learned one procedure per week, it could take 30 weeks to get through your plan.

4. Organize Procedures Into Small Groups

Organizing the procedures into small groups of related procedures can help you speed up your implementation timeline.

By grouping related procedures together, your team can learn more procedures in a shorter time frame. For example, if you have multiple procedures that all relate to "Good Documentation Practices," you could train and implement on those at the same time vs. spreading them out over multiple days.

Related Reading: The 6 Common Document Control System Blunders That Hurt Life Sciences Companies the Most

5. Implement at a Steady Pace

You will be tempted to rush through the training and development of your procedures, but slow and steady wins the race.

Set a rhythm for development of procedures and training on them that is doable for your team without burning them out.

If you try to rush things too quickly, you'll end up with a team that doesn't fully understand the requirements and can make mistakes that will be costly later on.

6. Choose an eQMS that Meets Your Needs

An Enterprise Quality Management System (eQMS) will help you execute and track progress on your quality system plan.

• Create training tasks for your team, test proficiency, and track progress.
• Build your document workflows and approvals inside your system.
• Establish document revision best practices to ensure the latest versions are always accessible.
• and much more...

We designed Qualio with quality and compliance in mind for startup and scale-up life sciences companies. Schedule a demo today, and let's talk about how we can help you reach your quality goals and get you to market faster.