Data integrity might appear to be a “buzz” word for regulators and management, but as the Volkswagen scandal involving 90,000 cars and the Qantas “tailstrike” incident indicate, it is of paramount importance in all industries.
In the pharmaceutical and medical device industries we constantly see similar failings which could have devastating consequences on patients. David Churchward, GMDP Inspector from the MHRA, recently cited data integrity as a continuing critical inspection deficiency.
The VW scandal
For those unfamiliar with VW’s emissions scandal the story goes like this: Volkswagen, in trying to increase their sales of diesel cars in the USA, introduced software that could detect when a car’s emissions were being tested and would then turn the pollution controls on. At all other times the controls were turned off, resulting in up to 30 times the claimed pollution levels.
Whether this fraudulent action was widely known and condoned or the result of a small group of rogue engineers is irrelevant. It sounds ominously like the data integrity issues that lead to the world’s largest product recall by Pan Pharmaceuticals in Australia back in 2003 and the reportedly rouge analyst in that instance. Ultimately, the incident highlights the importance of organisational leadership and a culture focused on Quality in all aspects. Technical and procedural controls are only effective in the right company culture.
The Qantas tailstrike
Investigation reports reveal that on 1 August 2014, a Qantas aircraft’s tail contacted the ground during take-off. Such “tailstrikes” are potentially dangerous so how did this happen? Apparently two mishaps occurred “independently and inadvertently.” First, when working out the plane’s takeoff weight on a notepad, the captain forgot to carry the “1,” resulting in an erroneous weight of 66,400 kg rather than 76,400 kg. Second, the co-pilot made a “transposition error” when carrying out the same calculation on the Qantas on-board performance tool (OPT)—an iPad app for calculating takeoff speed, amongst other things. “Transposition error” is an investigatory euphemism for “he accidentally hit 6 on the keyboard rather than 7.”
This incident was the result of two independent data entry errors which together negated the error check controls designed to catch a data input error. The first error was made by the captain in a manual calculation on a notepad to determine the take-off weight. The second occurred when inputs were incorrectly entered into an iPad app to calculate take-off speed, yes, hard to imagine a validated iPad app in our industry. This shows that data integrity and data quality are equally important for manual (paper) and electronic data.
Data integrity in pharma and medical device manufacturing
We – the pharmaceutical and medical device industries – can learn from these incidents by ensuring data integrity is considered at all staged of the manufacturing process.
My thoughts are we should proactively strive to have “success by design”. How to do this? Firstly, and most importantly, we must have strong leadership on the criticality of data. We must include well designed paper and IT systems, trained, vigilant staff and we should conduct regular self inspections or at least regular Gemba walks by management and the Quality team, who should proactively seek out errors that may be a result of fat fingers, falsification and/or fraud. Refer to a recent PDA presentation I presented in Melbourne.
On the 4th December, PharmOut will be hosting a free breakfast in Melbourne where we will be learning from Boeing how to balance Lean Manufacturing in a high risk environment. Please contact me if you are interested in learning more.