Setting a Successful Quality Strategy From Day One

“Retrofitting quality into a biotech firm is the worst thing you can do … Thinking you can do quality later is the biggest lie people tell themselves.”

— A Chief Science Officer

Quality has a less than positive reputation in some corners. People see quality as something that can stifle progress. In fact, part of quality is about understanding and following guidelines and regulations (notice, I didn’t say rules), so that patients stay safe, and companies stay clear of regulator ire. That is part of its essence.

Building a Voluntary Quality Assurance (VQA®) Culture from day one involves acting as a partner that helps instead of hinders. The goal is to be a partner that adds value. That involves making sure people see quality as supporting and sharing similar values, attributes, and characteristics of the organization.

A company culture can simply result from the accumulation of decisions made over time. But it can be cultivated, and with a strong company culture, people can understand expected outcomes and behaviors and act accordingly.

Just because we are in a highly regulated field doesn’t mean that there must be more work and less innovation. In fact, having the proper culture in place can create more innovation, more efficiency, and more productivity. As a result, people feel part of a community and a company that values them and their work. A VQA Culture® ensures that:

  • The proper systems are in place, and personnel are trained on those systems.
  • People understand their roles and responsibilities within those systems and take ownership.
  • Company leaders and personnel are all dedicated to larger goals of compliance and not wasting time with checkbox exercises.

There are 4 Pillars that are vital to build the right culture.

  1. Collaboration Rather Than Confrontation
    Fostering openness and information sharing can raise levels of confidence and trust. That trust creates a “safe environment” for a continued free exchange of ideas and concerns. When this happens, quality operates as a team coach — supporting and educating and training — rather than as a police officer “enforcing the law.” People become more accepting, open to learning and remaining in compliance.

  2. Proper Education & Training
    Education is where we put the “why” back into quality. It is one of the critical tools in building a VQA® Culture. Education engages and sensitizes personnel to how their actions impact quality. Training is where we reinforce what we explained during the education step. It makes them efficient and builds confidence, thereby improving performance. An investment in your team’s education and training is an investment in your company’s success.

  3. Setting Proper Expectations
    Everyone works better when they know what is expected of them. This is why setting expectations and effectively communicating them through education and training results in greater productivity, and ultimately, more committed, engaged, and accountable personnel.
  1. Accountability
    When people have accountability, they have ownership and want to succeed. They know and feel that what they do matters and has value. Accountability also empowers personnel to speak up and identify issues or concerns. This approach focuses on creating a safe environment for the free flow of ideas and concerns that bring people together, provides them with tools to be successful and empowers them to do the right thing.

These Pillars all work together and in concert. The work doesn’t end with one pillar and then start with another. They interlock and influence each other. Much of this approach involves treating people as they would like to be treated — with respect and dignity afforded to human beings.

Through such an approach, quality can:

  • Break down the “us-vs.-them” mentality.
  • Become incorporated into the fabric, or muscle memory, of the organization.
  • Set an important foundation for building all downstream systems.

This approach allows a company to operate more comfortably and efficiently from a position of knowledge and strength, as well as being mindful of the people who are doing the work.

Want to learn how to implement the Pillars of a VQA® Culture at your organization? Contact us here.

 

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