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Your Next Quality System: the Determination of Failure or Success in Regulated Environments
In today’s world of regulatory compliance and arduous product competition, a well-planned quality system is highly recommended. For life science and high-tech companies an efficient quality system is even more essential. In fact, a quality system for these industries is a ‘fight-or-fly’ ‘do-or-die’ affair. In other words, a quality system for life science and high-tech professionals can be one of the largest factors in determining positive end results, financial success and the customer satisfaction that companies concerned with high-standard quality production and regulated by the FDA, ISO, EMEA, and/or SOX desire.
So what’s the problem?
If life science and high-tech professionals know that a streamlined quality system is of the utmost importance, why do many companies lag in quality while failing to meet compliance standards?
The answer is that many life science and high-tech companies are holding on for dear life to quality systems that don’t work. Whether the quality system is paper-based, a hybrid or a Web-based system it still won’t function without specific goals, a flexible control plan and technology that provides both speed and support. To learn more about quality control goals and realistic “tempering” strategies that can be implemented via technology options read the following 5 steps to quality control success:
Step #1: Know Your Company’s Goals for a Better Quality System
The phrase “quality control” implies two types of goals that must be met and properly balanced within a regulated environment. The word “quality” for instance can imply the type of goals that will lead to product success and the genuine satisfaction of customers. The word “control” implies the tempering agents that won’t allow quality goals to “cross the line” of various realistic factors. These agents may include financial limitations, document management, compliance standards, the ability of employees to perform, dynamics between company departments, etc. Both quality goals and control tempering agents are important. Quality goals usually occur in the minds of managerial professionals and the tempering agents occur via technological solutions and via company employees.
Record your quality centered goals first and then let the tempering process occur in steps #2-5.
Step #2: Adapting Goals to Financial Factors for a Better Quality System
Once you have recorded your goals it’s time to temper them to reality, and what are more realistic than finances?
Obviously you want to have the highest amount of quality control that you can afford so look for a quality system that will (at the very least) provide Web-based document control (see step #3) and some sort of audit control. Also, look for a system that can grow over time (i.e. expand into additional quality processes with NonConformance, CAPA or Change Control solutions).
Step #3: Assessing Document Management for a Better Quality System
Since documentation control is required for almost every quality control or compliance procedure, it makes sense to make document management a priority for every quality process.
Whether a quality process is based on audits, CAPAs or change control procedures, look for a document control application that can streamline your quality processes and meet all regulatory compliance standards.
Step #4: Assessing Compliance Management for a Better Quality Control System
Meeting compliance regulations is on every life science company’s to-do list. Compliance regulations can greatly temper your original quality goals. For this reason, it is essential to invest in quality system technology that will change as regulations change, and provide the necessary updates for your quality system solution. Validation support is also a plus. Some companies offer validation scripts so that you can complete validation in-house.
Step #5: Assessing the Ability of Employees to Perform for a Better Quality System
The ability of your employees to understand quality and compliance standards and to act on those standards is of vital importance. How can you estimate your employees’ ability in order to best understand how your initial quality goals might be affected by their behavior? Consider investing in a software training solution that integrates with your document control solution. The solution should include the automated tracking of training related documents, should be Web-based, should include the automated assignment of tasks and tests as well as connections (if finances permit) to change control or audit results. The solution should also include automated test grading and escalation capabilities in case some employees aren’t quite rising to the occasion.
Conclusion for a Quality System Article
No matter what your quality goals are, it does matter how you choose to temper those goals with the right technology and the right people. Stop and consider the many ways in which your quality system could be better.
About the Author
Marci Crane is a copywriter for MasterControl in Salt Lake City, Utah. For more information in regards to quality system software solutions and services, please feel free to contact a MasterControl representative.