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Case Study - Pfizer Inc. agreed to pay a $975,000(!) civil penalty(!!) |
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Pfizer Inc. agreed to pay a $975,000(!) civil penalty (!!) to resolve alleged violations of the Clean Air Act (!!!) at its former manufacturing plant.
The alleged violations, which occurred between October 2002 and December 2005, resulted from a failure of Pfizer’s leak detection and repair (LDAR) program at its former manufacturing plant. Violations included a failure to properly conduct pressure tests to identify leaks, repair leaks before start-up, to equip open-ended lines with a cap or other seal and to document leak tests to establish full compliance with the LDAR requirements.
What that has to do with documents control? The LDAR program sets forth various equipment, testing and record-keeping requirements to ensure that any leaks of air pollutants from equipment - it's not enough to perform the tests you must also document the results according to the requirements - validate and verify. Sounds familiar?
And still?!? O.K. let's assume that Pfizer's top management had nothing to do with the decision not to perform the tests and actually the employees are to blame for not performing the tests. Just assume. In organization where documents control is imposed and enforced, a disaster like this (both environmentally and financially) would be prevented. A periodically quality inspection of the manufacturer would reveal quickly that the test weren’t taken and alert the concerned parties. The concerned parties than would act, the inspectors would have not detect a pollution, and a lot of money could have been saved.
What about you? Are your organization is operating under any kind of legal requirements? If do, do yourself a favor and see that the requirements are fulfilled and documented. Don’t let the inspectors find it out. You would probably have to pay a lot of money. More about this here... |