Whitepaper: Transforming Deviation Management


Suggested by /u/ghattoy in a previous thread.

Reading this would be like staring directly at the sun for some QA people. Deviations where I work are tracked by initiator, and QA is debating whether to make this tracking public as a way to increase pressure on mfg to increase compliance.

Some people worry that it makes people afraid to surrender bad news quickly. As a compromise, I want to suggest to QA that they display their tracking of only minor deviations and entry errors (spelling, write overs, etc). People in manufacturing only see this tracking as if its an HR type thing to document poor performance. In reality, initiating a deviation is much better than the alternative: deviating but trying to hide or minimize it. Some deviations are inevitable, for example ones that result form a poorly written batch record or SOP. If we are worrying about what HR will think of a deviation, we risk losing sight of what really matters, which is what a patient/ clinician (and after that, regulator/ client) would think of the deviation.

submitted by /u/DasIstMeinPfand

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Whitepaper: Transforming Deviation Management

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