Strike the Right Balance between Compliance and Quality

Sparta Systems

A focus on compliance is necessary for Life Sciences companies. Complying with regulations is a core part of their ‘right to operate’, making it possible for them to manufacture and sell their products. But manufacturers that focus exclusively on compliance at the expense of other core quality objectives put themselves at significant risk.  

A compliance-only focus risks failure in other quality areas such as product quality, safety, efficacy and continuity of supply. They may also lose sight of the goal, which is delivering safe, effective, high-quality products to the market quickly and consistently.  

Manufacturers that balance compliance with a broader set of quality objectives, contributing the necessary resources to each area, are much more likely to achieve all key objectives at the same time. 

Here’s how you can do the same.  

Identify the Right Key Performance Indicators (KPIs)  

When it comes to measuring performance, companies often strive for a “balanced scorecard”—where the internal functions of a business are achieving the desired external results. However, in quality operations, if a manufacturer’s scorecard is focused solely on compliance, then it is inherently out of balance. The measures do not sufficiently address core quality objectives: 

• Product quality 
• Product safety 
• Efficacy  
• Continuity of supply 

• Compliance 
   

In other cases, a manufacturer may develop KPIs that measure the efficiency rather than effectiveness of its operations. Measuring how fast a task is completed is far easier than measuring whether an action had an impact on product quality and safety. To strike a balance between quality and compliance, Life Sciences manufacturers must establish KPIs that go beyond checking a compliance box.  
 

These KPIs must get down to the root cause of quality issues and measure how effectively the company addressed them. Given the increasingly outsourced Life Sciences supply chain, companies must also have KPIs focused on supplier quality performance.   

Manufacturers with KPIs that balance compliance with quality have the insights necessary to address all five quality objectives. Furthermore, quality teams can show executive leadership that their role goes well beyond compliance scorekeeper, and they can impact organization-wide performance. 

Foster a Culture of Quality  

In order to balance compliance and quality, a manufacturer must build a culture of quality within its organization. This is more than the culture of the quality group itself—it is the culture of the entire organization, including third parties. It means that every group and individual that plays a role in the product lifecycle understands the importance of quality and is committed to advancing it.  

It is not enough for the C-suite to say, “We must focus on quality,” or for the company to invest in advanced technologies for quality management without first investing in its policies, people, processes and data. Life Sciences manufacturers must build a framework that infuses quality into each aspect of their operations.  

Establish a Framework for Quality and Compliance  

Manufacturers must have a comprehensive framework in place that establishes and maintains a culture of quality throughout their organizations and extends out to external business partners. A critical component of this framework is a balanced scorecard with KPIs that measure quality improvements, rather than compliance checklists.  

Download the white paper to learn key elements of a framework Life Sciences manufacturers can use to mitigate risk, drive the development of safe, effective products and satisfy regulatory requirements.