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What Makes a Quality Management System Effective?

July 11th, 2014 by Henry Macartney

Quality Management SystemModern quality management systems are often called upon to help their users meet varied regulatory standards and guidelines. For instance, your company may employ a single gap-analysis scheme to prepare your production lines for FDA and ISO audits and alike and simply plug in the appropriate standards as necessary. With the existence of such comprehensive systems comes the need for heightened efficiency and improved organization.

Defining Quality Management Efficacy

Business metrics vary widely. One thing most frameworks can agree on, however, is the fact that performing the same task repeatedly wastes time and other irrecoverable resources. For instance, if in the process of qualifying a specific piece of manufacturing hardware prior to ISO and FDA inspections, you have to generate two separate items of operating history documentation for each change you implement, you'll end up wasting a lot of time. If, however, you can create a quality management system that allows you to create more accessible, uniform documentation and simply flag relevant data on a per-standard basis, you'll cut down on unnecessary paperwork and retain the ability to pull information as needed. In short, even something as simple as the way you use record-keeping software could be playing a critical role in how good you are at compliance.

Correcting Past Mistakes

The other major measure of how efficiently a quality system functions is how well it responds to problems. Say you note deviations in the appearance of one of your pharmaceutical product lines, or the FDA introduces new regulations pertaining to supply chain integrity. In both situations, you'll need to make changes rapidly enough to avoid regulatory consequences and document the improvements you made for subsequent proof. If you're not using metric tracking for self evaluation now, you need to get started. It's critical to evaluate your quality systems with the same level of intense scrutiny you apply to your production lines and suppliers. This is the only way quantify performance data so that you can improve your CAPA strategies and deal with regulatory action without as much waste.

Tailoring Your Quality Management System

Take a look at the way you implement quality management strategies. Is there room for improvement? It's highly likely that there are things you could be doing better, even if you're not sure how to begin. The big problem for many firms is that they're so specialized they don't have as many ready benchmarks as they'd like. For instance, your shippers might be able to draw on a vast amount of pre-existing industry data to learn how to improve the efficiency of their freight management efforts. The fact that you're using a novel process or that your industry peers guard their secrets more closely, however, may prevent you from using similar resources. Furthermore, there's no guarantee that adopting some other firm's generic quality management process will deliver the high levels of efficiency you require. Studied, third-party perspectives become valuable assets for firms that want to implement efficient quality management schemes. GxP-CC consultants have spent years analyzing existing quality systems and making critical changes that ultimately led to drastic improvements and helped their users do more with their business performance data. Learn how to fortify your compliance systems and eliminate inefficiencies by contacting GxP-CC today.

Posted in FDA Audits, FDA Compliance, FDA & European Regulations, GxP CC, ISO audits, Quality Management Systems

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Henry Macartney

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