Quality vs. Compliance: These 5 Questions Will Determine Your Focus

    What is Quality v Compliance? Have you ever recommended a restaurant based on their lack of health violations?

    Listen to the audio version of this article read by a real person here (Sound on!):

    "You should try Famous Fred's because they have a really good score with the health department!"

    It doesn't happen.

    It's similar to the difference between quality and compliance in product development. If Famous Fred simply tries to run a restaurant whose goal is not to get citations from the inspectors, he won't be in business long. He has to serve up delicious, quality food to his customers.

    In the same way, life science companies must focus on producing high-quality products. If you aim for the high bar of quality, you'll get compliance. If you aim for the low bar of compliance, you probably won't get high quality.

    Without a culture of quality in place, your employees may lose sight of how the devices they're building help the consumer. Meanwhile, your management team may focus too much on the budget and potential profitability. As a result, no one is focusing on quality.

    Quality vs. Compliance: 5 Critical Questions You Must Ask

    Quality vs. compliance. They're both necessary components to product development, but as an organization, it's critical to understand the differences.

    Quality is the condition and functionality of your product and will determine how well your target market receives your devices. Meanwhile, compliance is a set of rules and regulations that the FDA requires you to follow.

    So how can you tell that your company is focused on quality, rather than only following regulations to meet compliance? There are a few questions we always ask to reveal gaps in your systems and processes that can help transform your company into a quality-centric organization. We'll outline and discuss them below.

    1. How Can We Make Our Product Easier to Use?

    The FDA does not evaluate ease-of-use, but for the consumer, it's a key factor. Even if you create a compliant product from the standards of the FDA, if it’s not of high-quality or it’s difficult to use, customers may not find enough value in it. As a result, there won’t be repeat orders, and customers won’t be satisfied.

    That’s why when you’re in the early planning stages of product development, it’s critical to assess ease-of-use alongside of any compliance processes.

    2. Who Are the Best Suppliers?

    When you’re choosing partners for your product development, you must adequately assess suppliers and contractors. You will need to document these assessments and create contracts with any suppliers you establish a partnership with. These contracts must clearly outline any expectations and regulations that each partner will follow.

    Otherwise, you expose yourself to low-quality products and even challenges with creating compliant products.

    3. How Can We Convert Unhappy Customers Into Evangelists?

    The FDA requires that you process complaints in a uniform and timely manner, as well as documentation of oral complaints upon receipt. The FDA does not require you to win back dissatisfied customers. However, if you treat customer satisfaction with the same respect as regulation guidelines, you can effectively convert every complainer into an evangelist.

    If you can learn to adapt your complaint handling processes to win over any unsatisfied customers, you can turn around any failed investments, improve your operations, and even gain a competitive advantage. For instance, you can offer any disgruntled customers a discount on their next order or a partial refund.

    4. How Can We Make Sure Everyone in the Company Stays Motivated?

    The FDA requires that companies train their employees in internal quality management procedures and CFR requirements. However, to create a culture of quality, rather than compliance, you need to go beyond FDA mandatory training. You need to ensure that employees feel supported, financially motivated and understood.

    When your employees are happy, they will feel motivated and encouraged, leading to higher productivity and stronger loyalty to work. If you want to achieve peak operational efficiency, investing in your team is the very first step.

    5. How Can We Build a Company for the Long Haul?

    Often, companies focus so much on ensuring compliance for current projects, they don't think about quality in the long-term. When you operate this way, you're not thriving, because you don't have systems in place to help support your team. You're more prone to mistakes and you can't learn from your errors.

    If you decide to implement a quality management software, it can drive drastic quality improvements and track your processes. Once you start identifying your gaps, you can establish the right processes to amend them and create a stronger foundation.

    When the entire team is more productive, and processes run smoothly, you’ll naturally trim costs regarding efficiency and experience over time.

    Get Your Quality Score

    Creating a company culture that focuses on quality isn’t an overnight thing. It requires the right training, mindset, processes, technology, and forward thinking. The entire team needs to be on the same page.

    Until you assess where you are, it will be difficult to move forward. In addition to asking yourself the five questions in this post, you can use our Quality Score to evaluate your company's focus and current state. Our short, insightful quality score can help you determine the areas that need the most improvement.