Training in Writing Effective Deviation Investigation Reports
Working Words is best known in the pharmaceutical/biopharmaceutical industry for our successful trainings in root cause analysis and critical thinking/writing, which improve manufacturing and laboratory investigations.
Why Are Deviations So Significant?
Deviations come with huge costs in many directions. The average manufacturing deviation investigation requires hundreds of costly investigative man hours. In fact, costs of the average deviation are estimated to be $100,000 per deviation.
It has been estimated that lost batches cost companies $250,000 to $500,000 per batch. In some cases, batches that have to be scrapped cost over a million dollars or more each.
Atypical events and out-of-specification results can cost hundreds of thousands of dollars.
A pattern of repeated deviations and inadequate investigations reduces compliance, raises regulatory exposure, and requires comprehensive and costly remediation efforts. Productivity and efficiency are lessened, and cycle time is extended.
Delays in getting to market can costs millions per day, especially when the drug in question is a ‘blockbuster.’
When problems are allowed to recur repeatedly, they get worse, and the corrective and preventive actions require more time, effort, and money. Recalls can cost millions, and they affect the company’s reputation with consumers and regulators, as well as the company’s bottom line and its stock price. These are all costs that are significantly reduced by improving investigations and CAPA—which is where Working Words excels.
Through the application of our methods and processes, we have been able to deliver measurable returns on investment—helping companies reduce deviations by as much as 50%, as well as improve manufacturing efficiencies and save time and money.