Christy Mazzarisi

Christy Mazzarisi

Senior Consultant

A former colleague once told me the concept of quality must be owned by the entire organization, not just the quality department. That sentiment still resonates today.

Establishing a successful quality culture in a pharmaceutical, biotech or medical device company must start from the top down—from the CEO to every department. The culture of quality needs to be engrained in every process and decision that leaders and employees make within the business. 

How do you know if you have a strong quality culture within your organization?

Assess the maturity of your quality culture by evaluating these areas in your Quality Management System (QMS):

  • Key Performance Indicators (KPIs) – In a culture of quality, your KPIs will tell you a lot about how your company is doing regarding performance. The better your KPI data, the more you can see that quality is built into your processes and culture. KPIs can show that you are tracking leading indicators rather than lagging them. This in turn shows regulators you are a proactive organization.
  • Quality Management Review Boards – Having regular quality review board meetings are another indicator of a strong quality culture. These meetings typically contain all the leaders within an organization, not just the quality leader; and this shows accountability is built into the entire enterprise around KPIs and quality metrics. The accountability is not just on the quality department.
  • Risk-based Thinking – Having a strong risk-based management process shows that the organization is trying to maintain control over their systems and is focused on the areas of the most risk.  Documenting your risk assessments and risk management meetings is a great way to show regulators that you take your business seriously and truly embed quality where it counts. 

Here are four practical steps for embedding a robust quality culture in your organization today:

  1. Understand quality’s position

It is important for the business to understand the “why” of regulations and the reasons quality functions as it does. Stakeholder interviews and “lunch and learn” sessions can help educate areas of the business on the importance of “why.” People need to recognize the great benefits a culture of quality can provide, such as a good reputation, successful commercialized products, process efficiencies (which means cost reduction and faster time to market), accelerated time to market, and good standing with regulatory bodies.

  1. Follow the leader

Start with the CEO. If he or she does not see the quality and compliance department as an asset, this can pose a challenge in moving the business to change its mindset. Quality functions are not just necessary to avoid scrutiny by the regulatory bodies; they must be seen as a value to the business. Quality should be in the CEO’s operating model as a center of excellence for the rest of the organization to follow. Partnered with top executives, quality can lead by example. 

  1. Build quality into your processes

Be proactive in establishing or reviewing processes to ensure quality is “built in” from the first step. This can be part of your standard operating procedure review process. During each process review, continuous improvement activities can ensure all steps are evaluated for quality using a risk-based decision-making approach. This is a great time to add value to your processes and really engrain that quality culture feel into your procedures. Be sure to include your relevant process stakeholders in the review process.

  1. Empower your employees

Support your employees in making value-based decisions in their everyday tasks. Have confidence in your seasoned staff to make valid and legitimate decisions to support the quality of their job and/or product. The seasoned employee will be able to reduce risk in their relevant areas of business from their practical experience and hands-on knowledge.

Embed quality values into training, company settings, meetings, and so on, and the staff will live and breathe them. This goes back to the point that most people will follow the actions of their leaders. Also keep in mind that having the right processes in place (where a seasoned employee helped create the process) will help adoption of a quality culture.

Empowering employees means providing robust hands-on training to enable a strong understanding of their role in the company and supports buy-in to a culture of quality. By allowing seasoned employees to make their own decisions more often, morale will increase significantly, leading to less risk, mistakes and less turnover.

On the other hand, having little or no quality culture can pose many serious business issues, resulting in costs to the bottom line, such as:

  • Fines/debarment/breach of compliance, which can stop or delay time to market and cause huge financial impacts
  • Damage to company reputation, whether in the news or media passed along to your customers and also on behalf of the regulatory bodies during inspections
  • Lack of leadership commitment, which is felt and seen by the organization as a negative impact of “leading by example”
  • Poor work ethics, which can reduce the quality of product and outputs of daily tasks, potentially creating major compliance risks for the organization

The benefits of a strong quality culture lead to numerous organizational benefits, not the least of which is having staff that feel empowered in knowing they are making a difference in the lives of patients and providing safe and effective, quality therapies into the marketplace. A quality culture also enables leaders to build trust in staff, patients and professionals alike, by supporting a clean reputation in the industry. At its core, an organization with a quality mindset has patient safety at the forefront and sees the quality department as an asset to their top dollar.

Learn more about CGI’s Quality, Compliance and Manufacturing practice.

About this author

Christy Mazzarisi

Christy Mazzarisi

Senior Consultant

Christy Mazzarisi is a Senior Consultant and Quality & Manufacturing subject matter expert in Life Sciences at CGI. Christy is an innovative and accomplished Quality Systems Professional with a broad background in Pharmaceutical and Laboratory sciences (specializing in business development) with R&D and commercial manufacturing ...