Compliance vs. Efficiency: Is Your Organization FDA Compliant but Falling Behind on Being Efficient?

January 11, 2019

By Randy Gasa, Director, Quality & Compliance

Do you feel that your organization supports efficiency?  When dealing with the FDA regulated industry, many manufacturers focus on being minimally compliant but often fail to look for efficiencies within their compliant processes.

To understand how to be efficient, we must first understand the current state of compliance in the industry.  Compliance in itself is a challenge to manufacturers as shown by FDA data.  In 2015, the overall number of Quality System (QS) surveillance inspections decreased slightly from CY2014 to CY2015. However, the number of Warning Letters stayed the same.  There were over 900 FDA Form 483’s* and over 3,500 FDA Form 483 observations citing Quality System Regulation (21 CFR 820) issues in 2015.  The most affected areas were Production and Process Controls (P&PC) and Corrective and Preventive Actions (CAPA). Since these areas are fundamental parts of the Quality System, this can be alarming.  However, implementing efficiencies into existing processes can also increase your level of compliance.

Let’s take a look at three ways to improve efficiency in your quality processes:

  1. First, use a risk-based approach. The industry has ramped up its focus on risk in the last few years with the 2012 revision to ISO 14971 and the 2016 revision to ISO 13485.  If you don’t document your decisions based on risk, how can you justify these decisions?  Utilizing a risk-based approach in business is essentially “showing your work.”  Walking through a thought process within a Risk Management framework can be the difference between getting observations or not during an FDA audit.
  1. Next, eliminate duplicative processes and collect the “right” data. Are you documenting critical parts of your process in an efficient manner?  Are there areas that you are over-documenting or under-documenting?  Over-documenting can lead to inefficient manufacturing via useless data or process steps.  Under-documenting may result in non-compliance through lack of process control and inability to determine a true root cause when investigating failures.  Are you re-documenting investigations for post-market complaints or CAPAs that have the same failure mode?  Look to leverage other approved CAPAs or complaints and reference them properly.  Are you testing the entire functionality of your equipment?  Look at testing only to the intended use of your equipment or process.  This method of testing is a simple way to be both compliant and efficient.
  1. Lastly, focus on continuous improvement. Continuous improvement is an essential element in a quality system aiming to improve efficiency by optimizing a process and eliminating wasted efforts in production.  CAPA is a great tool for continuous improvement if used correctly.  It not only addresses systemic issues or failures, but it also includes CAPA principles that address proactive improvement efforts (including corrective actions and the ensuing preventive actions).   These efforts are primarily directed towards reducing variability in process and product quality characteristics. Continuous improvement can only occur when a product is already in compliance. Otherwise, the improvement may cause errors to occur.

Onebridge can help you with your compliance or efficiency needs.  We are experienced in FDA remediation projects and provide consulting services focused on Quality, Regulatory, and Engineering. Reach out to me at 317.643.4857 to discuss your compliance and efficiency strategies.

*Specific form number FDA uses to document observations

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