How can a Quality Management System (QMS) be fit for purpose and efficient?

Lee Debenham, Director of Scientific Affairs

What is your perception of a Quality Management System? What comes to mind when you hear the words “Quality Assurance”? Do you groan when another SOP training assignment hits your inbox? If you have worked in the pharmaceutical industry long enough you’ve probably encountered a negative view of Quality held by other departments. In one of my first jobs in the industry I was employed in Quality Assurance and during my induction to the company I met with the Commercial Director. As I introduced myself and shook his hand he looked at me wearily and said “So you’re the new member of the sales prevention team are you?” Sales prevention. That’s how Quality was perceived.

In my 25 years in the industry I’ve worked at a variety of companies in a range of Quality and Compliance roles and a similar thread has run throughout. So where does that negative view come from and why can the QMS be viewed as a hindrance to business? Below are some of the reasons:

Time and Cost Implications: Implementing robust quality assurance processes requires time, resources, and investment. QA activities can add extra steps and time to business processes.
Compliance Burden: Meeting stringent regulatory requirements can be complex and demanding. Companies may perceive the need to navigate a maze of regulations and guidelines as a burden, as it requires extensive documentation, adherence to strict procedures, and frequent review to demonstrate compliance.
Perceived Conflict with Speed and Innovation: In highly competitive markets, businesses often face pressure to bring products to market quickly and stay ahead of competitors.
Resistance to Change: Implementing quality practices may require changes to existing processes, procedures, and organisational culture.
Perception of Limited Return on Investment (ROI): Quality activities are often seen as cost centres rather than profit generators.
Misalignment with Business Goals: In certain cases, there may be a misalignment between the objectives of quality assurance and broader business goals.

At this point I’m going to ask you to bear with me, as I’m going to use an analogy that I hope resonates. If you imagine a pharmaceutical company as a Formula 1 team:

The CEO is the driver, steering the car around the track, navigating the circuit and controlling the car to the best of their ability.
Manufacturing are the engine, producing the power that drives the vehicle.
Sales and Marketing are the fuel. Sales provide the energy that is required by the engine.
Supply Chain are the gearbox, effectively providing the power from the engine to the wheels in order to get the car to where it need to be.
Business Development are the designers, looking for improvements and ways to make the car better.
Human Resources are the pit crew, ensuring that all team members are clear on their role and able to perform efficiently.

So, in this comparison exercise which part of the F1 car would the Quality Management System be? Be honest – how many of you answered, “The brakes”? The part of the car that slows it down. The part that’s used to reduce forward momentum. There is no doubt that the brakes play a vital role in the car – they prevent crashes and save lives – but is that all the QMS should do?

A poor Quality Management System that is not fit for purpose will unnecessarily slow the business down and can have significant negative impact to the company. Here are some of the key consequences:

Compromised Product Quality: A weak QMS can result in compromised product quality, leading to substandard or unsafe pharmaceutical products reaching the market. This can have serious implications for patient safety and health.
Increased Compliance Risks: A deficient QMS exposes the company to increased compliance risks. Non-compliance with GxP regulatory requirements can lead to regulatory penalties, fines, or suspension of operations.
Inefficient Resource Allocation: Without an effective QMS, resources are often misallocated, leading to inefficiencies and increased costs.
Customer Dissatisfaction: Poor quality management can result in dissatisfied customers and loss of trust. Negative experiences can damage the company’s reputation and result in the loss of customers to competitors.
Lack of Continual Improvement: An ineffective QMS often lacks a culture of continual improvement. Without proper monitoring, analysis, corrective actions / preventative actions, and Key Performance Indicators (KPIs), recurring issues may go unresolved, leading to persistent quality problems.
Over-burdensome: A poor QMS can negatively affect employee morale and engagement. Inconsistent quality standards, lack of clear procedures or even too many SOPs can create confusion, frustration, and demotivation among employees. This can result in decreased productivity, increased employee turnover, and difficulties attracting and retaining skilled professionals.

Back to the question – “Which part of the F1 car would the Quality Management System be?” My team and I strive for the CNX Therapeutics QMS to be the Traction Control. In simple terms, traction control helps to identify any slip or loss of grip between the tyres and the road surface to help the driver avoid wheelspin and maintain control over the car. An effective QMS acts like the traction control as it helps the car get around corners faster and safer. When the business faces a bend, an efficient QMS keeps it on track without losing momentum.

What are the benefits of an efficient QMS?

Consistent Product Quality: Ensures consistent adherence to quality standards throughout the organisation’s operations. By implementing robust processes, procedures, and controls, companies can consistently produce products that meet or exceed customer expectations.
Regulatory Compliance: The QMS helps organisations navigate complex regulatory landscapes and ensures compliance with relevant industry standards, guidelines, and regulations. This instils confidence in stakeholders and facilitates market access and expansion.
Reduced Burden: By continually reviewing and improving our SOPs and processes CNX ensures our QMS is lean and fit for purpose. We are able to quickly adapt to changes whilst maintaining GxP compliance.
Cost Reduction: An efficient QMS optimizes processes, reduces waste, and minimizes errors and defects. By identifying and addressing root causes of quality issues, organisations can improve efficiency, reduce production costs, and enhance overall profitability.
Continuous Improvement: Promotes a culture of continuous improvement and learning within the organisation. Continual improvement initiatives result in increased efficiency, productivity, and competitiveness.
Enhanced Risk Management: An effective QMS incorporates risk management principles into its processes. By identifying and assessing risks, organisations can implement proactive measures to mitigate or eliminate potential threats to quality and safety.
Supplier Relationship Management: A robust QMS includes strong supplier quality management processes. This reduces the risk of supply chain disruptions, improves product quality, and fosters mutually beneficial supplier relationships.
Employee Engagement and Empowerment: A mature QMS emphasizes the importance of employee involvement and empowerment. This promotes a sense of ownership, pride, and accountability, leading to higher job satisfaction, increased productivity, and reduced employee turnover.
Improved Decision-Making: An efficient QMS provides organisations with reliable data and metrics for informed decision-making. This fosters a culture of evidence-based decision-making and reduces reliance on intuition or guesswork.

In conclusion, an effective, efficient and mature Quality Management System offers a wide range of benefits to organisations. CNX Therapeutics is dedicated to our robust QMS that not only ensures customer satisfaction and regulatory compliance but also drives overall operational excellence, financial success, and long-term sustainability.