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May 26, 2020 Life Science Consulting

Overlooking Your QMS Could Cost You

James Meckstroth Principal Compliance Consultant

A Quality Management System (QMS) bridges an organization’s individual compliance practices with regulatory requirements.  It establishes the infrastructure and oversight requirements for manufacturing drugs under Good Manufacturing Practice (GMP), for conducting clinical trials in the form of Good Clinical Practice (GCP), and for performing clinical laboratory testing as Good Clinical Laboratory Practices (GCLP). A QMS also creates a platform for maintaining consistency across many changing regulated environments, including progression through the different phases of the clinical lifecycle, regulatory changes, or continual improvement initiatives. It is essential that your QMS can adapt with these dynamic environments.

In addition to the objectives of continual improvement, companies are now establishing new ways to operate as they navigate new requirements brought on by the COVID-19 pandemic. These new operating strategies must be supported or otherwise justified by your QMS.

Since the QMS embodies the structure that enables compliance across all your quality processes, a system that is current and harmonized with its contributing elemental components is critical for success.

Why focus on your QMS now?

An excellent question that can be easily answered by another.  Can you afford not to?

What is the cost of quality? 

The cost of “good” quality = resources + time spent on prevention and improvement.

The cost of “poor” quality = resources + time spent to manage, investigate, and correct defects, errors, and failures (which includes complaints, returns, recalls, scrap, and rework).

You can measure the cost of quality, good or bad, by reviewing historical metrics. How much time and effort is wasted on workarounds or corrections? By establishing a solid, phase-appropriate and risk-based QMS system to replace the ineffective non phase-appropriate system you may have in place, the potential ROI speaks for itself.

A “cost of quality” approach can help your management team visualize the impact that quality has on profit and how it may be utilized as a powerful metric for justifying organizational needs. With fewer errors or defects comes added capacity and faster profit returns, while reducing staff time spent on investigations or managing returns or recalls.  With added capacity comes the potential for new product development. You can invest a great deal of profit into new therapies by not dealing with quality issues.

A “good” Quality Management System translates to a good product.  A good product translates to customer and stakeholder satisfaction and organizational growth. To that end, lowering the cost of poor quality by decreasing production losses and expenses, improving timelines, and streamlining process also translates to profits.

Whether you are implementing, maintaining, or remediating a QMS, you are positioning yourself for success by investing in “good” quality.

Finding time to focus on your Quality Management System while targeting continuous quality improvements can be a challenge – this is where ProPharma Group can help. We can work with your team to improve:

  • control and compliance to reduce errors and rework
  • operational efficiencies through risk-based, phase appropriate, and scalable requirements
  • compliance and reduce downtime and approval time
  • time-to-market for new products

We have a team of subject matter experts and technical writers covering the whole spectrum of clinical and commercial QMS regulatory elements. Our SMEs have been working closely with regulated companies during the current pandemic to provide risk-based approaches for remote workers and social distancing requirements.

We can engage your organization remotely or in person to understand the uniqueness of your system, products, and needs. Once we understand your processes, we can assess the compliance of your existing system and identify any gaps with local or global regulatory and industry expectations.

With practical experience and observations of what drives industry and what impedes it, we provide tailored solutions to challenges or inefficiencies that you may be experiencing with your current systems to maintain compliance.

Contact us today for a complete evaluation of your current Quality Management System.

Stay tuned for Part 2 of this 3-part blog series to learn ways to use your QMS to mitigate regulatory risk.

 


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