In a proprietary study issued by Sparta Systems in 2019, 66 percent of life sciences professionals said compliance was their top quality objective for the year – but compliant products aren’t always quality products.
Compliance simply means a minimum standard was achieved. Quality has further-reaching implications – and more dire outcomes if companies miss the mark. Patient safety, trust and reputation are all at risk when quality falls short.
Poor quality has financial penalties too.

In a 2017 study, McKinsey & Company estimated that two-thirds (or more) of a company’s quality costs are spent remediating the effects of poor quality.
In contrast, good quality can have positive impacts on profitability and create key competitive advantages. McKinsey & Company’s report said exceptional quality can even create barriers to entry for some competitors, lower risk, and drive innovation.
Similar but different
Compliance and quality are related, but have distinctly different processes and outcomes. Compliance is a key element of quality, but it shouldn’t supersede other aspects, like product quality, safety, efficacy, or supply continuity.
Compliance describe tasks that are completed, typically in isolation, and then checked off a list.

Quality, on the other hand, permeates an organization, affecting everything from hiring and R&D to vendor selection and internal change management.

A quality focus affects how teams view their work and connects staff to a greater purpose, like saving lives.
Who’s responsible?
A lapse in quality occurring anywhere in the company can result in serious consequences. As such, quality is everybody’s responsibility.
Despite its extensive reach, too many organizations treat quality as “someone else’s job.” In a survey by LNS Research, 50 percent of life sciences executives said their organization viewed quality as a single department rather than an organizational responsibility.[1]
To achieve consistent, growth-enabling performance, life sciences companies must infuse quality into every aspect of their operations.

Every group and individual that affects the product lifecycle must understand the importance of quality and commit to advancing it.
More Than Just a Pretty Slogan
In a Forbes Insights report on the Culture of Quality, 75 percent of senior executives said their corporate culture promoted quality, but less than half of employees with quality job titles believed the same.
Posters and slogans aren’t enough. Life sciences companies need a framework to establish an unshakeable, organization-wide commitment to quality.
Incorporating quality into six organizational components can build a quality-driven culture: 

  1. Policies and decision making: Policies, governance and risk management that affect quality must be enterprise-wide, not just departmental. Quality teams should also have influence on decisions that affect quality, covering both internal and external parties.
  2. People: Employees should understand how they are responsible for delivering safe and effective products, from design through development, to the point of care and beyond. Training, reporting structures and incentives can encourage team members to put quality first.
  3. Process optimization: Quality and efficiency go hand-in-hand. Make sure quality professionals are in the right locations globally and have the right skills and resources to affect performance.
  4. Integration: All elements of quality, including compliance, should be addressed together rather than through siloed approaches. Integrate quality systems and processes, such as complaint management, change control and training. It will be easier to see how quality lapses in one area of the business can cascade – and to proactively resolve issues.
  5. Data: A single source of master quality-related data can be leveraged to impact performance globally. Data should be accessible and standardized across markets in order to support confident and accurate decision-making.
  6. Business Insights: Establish key performance indicators (KPIs) that lead toward achieving your overall corporate goals. Balance compliance metrics with measures of all five quality objectives: product quality, safety, efficacy, continuity of supply and compliance. KPIs should measure suppliers’ and external parties’ performance as well as your own.

Life sciences companies don’t operate to comply; they exist to help patients and save lives. To keep patients healthy and safe, life sciences companies need to make quality a key focus of everything they do. Companies that incorporate quality into broader objectives are more likely to achieve all of their goals.  
Where does your company stand in the compliance-quality spectrum? Download the whitepaper Balancing Compliance and Quality to find out.