Failure analysis reports are usually created when companies suffer from a manufacturing or product failure and do not know what the cause of the problem or how to fix it.
Pharmaceutical failure analysis testing usually results from a products shelf life suddenly declining, finding foreign particles or contaminates, or complaints of unforeseen reactions in customers.
Manufacturing failure analysis testing usually involves identifying unwanted residues or contaminants on or in a product or determining the cause of corrosion or other chemical reactions happening to a product. This list goes on through many industries that work with a range of materials including metals, rubbers, plastic, polymers, etc. From identifying foreign odors to determining what an unknown substance is failure analysis reports can be useful to solve a wide variety of problems.
Failure analysis reports are not always a bad thing. While many companies decide to gamble on a PR nightmare that hopefully never comes to light, more prepared companies use failure analysis testing as a pre-emptive step to identify and battle future problems before they have a chance to arise.
For pharmaceutical failure analysis testing a company may run multiple shelf life tests over time to ensure that their product is still lasting as long as advertised for. This can be a critical problem with pharmaceuticals as once they start to breakdown their effects when taken can significantly change from what was intended. Many pharmaceutical companies preform occasional batch-to-batch testing at a chemical level over time to identify any unwanted changes that are occurring within their product over time.
Manufacturing failure analysis testing is often used when a raw ingredient supplier is changed to show if the new supplier's ingredients reach the standards that the manufacture is used to working with. Without this testing a manufacturer may not realize the problem until after several batches of the product are produced and shipped. If the manufacture learns of the product problem caused from lower quality raw materials being used in product from their customers through complaints it could cause a large PR problem. By using a failure analysis laboratory proper testing can be done to insure a final products quality and let a manufacture know what to expect from their products.
What is a failure analysis laboratory? Certain testing laboratories can assist companies with solving answers and by compiling a detailed failure analysis report. Using these reports companies can either use the information to fix current product failure problems and learn how to put proper quality control testing in place that can prevent problems that would have otherwise happened at some point down the road.
Companies that are already suffering from a product failure problem can use rush testing services from independent contract laboratories to quickly identify the cause of their problem and determine both a solution on how to quickly fix the issue as well as develop new procedures to put in place to prevent similar problems from happening in the future.
Dr. Shri Thanedar, Ph.D, is the CEO and Chief Chemist at Avomeen Analytical Services. He has over 20 years of experience serving as chief scientist or expert witness on over 20 litigation support projects involving chemical analysis, product failure analysis, reverse engineering, and polymer and rubber analysis.
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