Making Quality Accessible through the 4 Cores of a Voluntary QA Culture.
Improve understanding, acceptance and accountability through an innovative approach to creating a Voluntary QA Culture.
“Quality” is the most overused term and the least understood.
CQS’s 4-core approach to creating a “Voluntary QA Culture” is what sets us apart. CQS works with pharmaceutical companies to build a proactive collaborative approach to Quality through risk-based, scientific solutions for your specific needs. All based on the 4 Cores.
With 20+ years of experience in the pharmaceutical and biotechnology industries, CQS partners with GMP/GLP/GCP leaders to develop custom strategies and programs so that everyone—not just QA departments—understands their role in maintaining a proactive and collective approach to Quality.
Quality is everything—all of the processes and procedures and human interaction, decisions, choices, and assessments—that create and deliver new therapies to market. When dealing with Active Pharmaceutical Ingredients (APIs) or Drug Products (DPs), Quality has a direct impact on identity, purity, strength, uniformity, availability, stability, monitoring, and traceability.
The job must be a collaborative effort within an organization for everyone to be successful. It is larger than any one person or one department, and everyone has a part to play.
The Four Cores:
1. Proper Education and Training
“If you think training is expensive, try ignorance.”
Training makes employees more engaged and sensitized to Quality so they can have impact and feel valued.
It also can make them efficient and more likely to be aware of issues that must be raised. Training workers gives them new skills that help improve production, improve standards, reduce mistakes, build workforce confidence and create a better environment.
An investment in your employees’ skill sets is an investment in your company. Everyone gets better and feels more part of the process.
2. Setting Quality Expectations
Setting expectations that are specific and measurable allows people to know what is expected of them. Being clear about expectations makes the goals, objectives and critical success factors clear so everyone one knows what they are, resulting in greater efficiencies and greater productivity.
Engaging with employees to set realistic expectations makes them more committed, engaged and accountable.
Nothing can be more empowering than when employees feel responsible for their own work and their own actions.
Accountability is essential for ensuring proper performance within an organization. It also provides employees the freedom to speak up and to identify issues before they become a crisis.
When people are accountable, they have ownership and want to succeed.
4. Collaboration not Confrontation
Collaboration is a key factor to ensure value. Quality departments must foster an environment of openness and information sharing to raise their profile and levels of confidence and trust among employees.
When Quality operates more as a team coach than a police officer “enforcing the law,” people better understand and accept the role and responsibility they play in maintaining Quality.
Collaboration can help improve compliance performance, which can reduce delays, waste and redundancy. It can also help open up an organization to innovative practices.