5 Quality Control Procedures for Life Sciences Startups
In recent years, there has been an increased focus on merging product innovation with product safety and quality. Without an intimate understanding of major quality control procedures, your growing startup or scale-up will likely face serious challenges related to both product innovation and quality.
As a result, you may experience significant delays to market. And as a growing startup or scale-up, you probably don’t have the resources or funds to withstand these kinds of obstructions.
All of this begs the question: Which quality control procedures does your life sciences startup need to follow to streamline product development and activate massive growth?
As an industry-leading quality management system (QMS) provider, we’ve worked hand-in-hand with the world’s top life sciences companies, and we know what it takes to institute results-driven quality control procedures.
In this article, we’ve highlighted some of the top quality control procedures and tips to create products that appeal to consumers and align with evolving laws and regulations.
The Top 5 Quality Control Procedures for Life Sciences Startups
Unfortunately, there are some common misconceptions about quality control procedures. Typically, life sciences startups confuse quality controls with quality assurance and vice versa.
What is the difference between quality assurance and quality control? To get a better idea, let’s get our definitions straight:
- Quality assurance focuses on designing and building quality into the product life cycle.
- Quality controls focuses on the test procedures to verify that a product is safe and effective for consumer use.
In short, quality assurance is proactive, and quality controls are reactive.
The importance of effective quality control procedures cannot be overstated. In fact, effective controls ensure that you’re meeting your quality objectives. Without them, product quality will almost certainly suffer, and regulatory compliance infractions will ensue.
As your startup looks to solidify its quality control plan, start by incorporating the following procedures into your approach.
1. Identify quality objectives
Start by identifying quality objectives. The most common quality objectives include:
- Reducing the total percentage of products with serious defects
- Increasing total output or performance of products
- Improving operational efficiency and performance
- Maintaining increased levels of customer satisfaction
However, focusing on strategic quality objectives is easier said than done. In most instances, startups and scale-ups lack the resources needed to break free from crisis response and move toward proactive quality management.
As such, an investment in a results-driven QMS platform can help to instill increased awareness of quality and compliance. Moreover, an industry-leading QMS can help you resolve quality issues without major manual inputs. As a result, you can focus more of your resources and efforts on meeting quality objectives and spend less time putting out fires.
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2. Promote a culture of quality
It goes without saying that quality must be a company-wide focus.
Unfortunately, it only takes one simple quality misstep to ruin your company’s reputation.
For this reason, building and promoting a culture of quality is essential. Of course, quality is a broad term that influences a number of focus areas, including regulatory compliance, training, change control management, and more.
An integrated QMS combines all of these elements into one system. The right QMS will even break down organizational silos to unite teams and quality processes.
3. Resolve consumer complaints rapidly
Unfortunately, inadequate complaint handling is one of the most common quality management issues. For compliance purposes, complaint handling must be orchestrated in conjunction with FDA CFR Part 820.198.
Your QMS should solve complaint handling for you by letting you assign specific risks to complaints. In turn, you can identify high-risk complaints that need immediate attention.
4. Automate change management
Change management is a streamlined approach for ensuring that product changes are thoroughly reviewed and implemented effectively. Automating change management helps you maintain a high-quality product even as your business evolves.
The ideal QMS is essential for defining, planning, and executing your change management strategy. Without the centralized automation a QMS provides, you risk introducing waste quality control issues into your process.
5. Collaborate across teams
Finally, employee communications are the driving force behind quality controls. ISO 9001 underlines the importance of communication and collaboration as a major responsibility of senior leadership and executive teams.
According to ISO 9001 Auditing Practices Group Guidance on Internal Communication, effective communications “contributes to the success of any organization’s quality management system.” On the flipside, “many problems that occur with an organization’s quality management system can be traced back to poor communication.”
In most cases, the QMS will help you to streamline communication and collaboration across teams. As a result, your organization will experience increased efficiency in day-to-day operations, which can reduce time to market.
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