The essential reasons for performing manufacturing process qualification are to lower costs related to manufacturing and to adhere to requirements. When products that do not meet the requirements are ridden of before production, it helps to significantly lower operation cost and time. It is often necessary to meet requirements in order to qualify for a number of regulations, such as those implemented by the FDA or product specifications promised to consumers.
The best manufacturing process qualifications are achievable by having a well-rounded understanding of the various processes involved in manufacturing and the requirements of the product or service. A good tool to help one understand how to do so is to use process mapping. It is easier to understand all the various elements of a process by using this tool and encourages new ideas such as testing and further innovation studies.
As mentioned before, it is vital for manufacturing process qualifications to clearly understand the requirements that are related to the product. It is common for different industries to have different sets of standards and it is essential to follow these standards specifically.
There are four key features to developing a document that specifies the standards of manufacturing process qualifications, which include: design, installation, operational and performance qualifications. Each of these features needs to have a pre-consented procedure as well as data to back up the results.
There are many other reasons that manufacturing process qualification is an important procedure. It is not practical to begin the use of equipment or tools without knowing whether or not they can produce the required product. Often times, tools and equipment are expensive, high-tech and may even require a specific person to operate/control it; all these factors involve various costs that could otherwise be put to better use.
In order for an organization to reach success, it is necessary to spend time and money wisely. Therefore, understanding whether or not resources are effective and efficient, is vital. There are too many costs associated with unhappy customers, defected products, recalls and so on, all clubbed under a broad heading called ‘Cost of poor quality”.
Manufacturing process qualification is required to ensure product quality, lower overall costs, adhere to regulations, improve productivity & consumer satisfaction all resulting in accelerated business development and growth.
About the Author: Shruti Bhat PhD, MBA
Dr. Shruti Bhat is an award-winning Business Excellence Leader, Global Continuous Improvement Mastermind, Best-selling Author and Speaker. She is Continuous Improvement Advisor to several start-ups, mid-size and growing firms in Canada, USA, India, Africa and Emerging markets. She has authored eight business books and is an invited speaker at several national and international conferences, symposia and workshops.
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