In the framework of QbD, how is quality defined?
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pharmamanufacturing Manufacturing Community Member 151 Posts
Re: Defining quality20 September 2016 at 11:32am Last edited: 20 September 2016 at 11:33amBefore you can design for quality, you must first understand it. Every product, no matter what it is, possesses characteristics that are critical to its quality. It could be a dimension, a material or chemical composition, a function, etc. For each of these critical characteristics, you must determine the ideal target, a criterion which should always be driven by the customer. Upper and lower allowable limits are created based on what is acceptable to and safe for the customer, and for the product to be reliable. These limits become your product specifications.
The traditional view of quality defines it as compliance with specifications (i.e., keeping all critical characteristics within the upper and lower allowable limits). But the reality is, anytime a critical characteristic misses its target, even if just by the smallest of margins, the product’s performance begins to degrade and it starts to incur a cost for things like extra processing or special handling. This cost increases exponentially the farther the critical characteristic is from its target, as does the risk to the customer. Therefore, a better operational definition of quality is on target with minimal variation. The most successful companies, regardless of industry, work under this definition.
Craig Gygi, Leading Quality and Continuous Improvement Expert and MasterControl Strategic Partner
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