Back in July last year two laboratory test technicians were sent to jail in Hong Kong for falsifying compression test results on concrete cubes at the contract test lab Jacobs. At the time of discovering the issue 19 lab techs were arrested. See more...
And now a NASA investigation has sighted “Altered test results” behind the failure of a clamshell structure that encapsulates satellites as they travel through the atmosphere as being responsible for the failure of its Taurus XL Orbiting Carbon Observatory (OCO) and Glory missions in 2009 and 2011, respectively. See more ...
The issue of stakeholders falsifying results or editing reports in the materials or device manufacture and test verification supply chain is not new, way back in 2000’s the medical industry was hit by the problem initially identified in India’s drug and medical device industry, then found in Germany’s and on and on, this contributed to the USA FDA’s work in 2000’s and finally the issue of 21 CFR Part 11 the Code of Federal Regulations that establishes the United States Food and Drug Administration regulations on electronic records and electronic signatures (ERES). Part 11, as it is commonly called, defines the criteria under which electronic records and electronic signatures are considered trustworthy, reliable and equivalent to paper records.
Our Tinius Olsen materials testing platform “Horizon” under which materials tests are controlled, results calculated, reported and saved is CFR21 Part 11 capable. But more and more I believe this capability and the functionality which enables compliance is of use beyond the medical industry, in fact in any industry where the testing of materials, components and devices is of significance. The key to Horizon’s capability is not just indelible digital record keeping but the functions and ever-present cloak of compliance it maintains as a deterrent. If an operator changes a test parameter, performs an edit or a delete Horizon can be configured to place an alert on screen, transmit notifications and require digital 3rd party sign off before the operator can proceed. This level of monitoring in no way effects a user’s productivity, I would go as far as to say it improves productivity because of the implicit move away from paper recording and or operators tapping data into the system for batches and tests. At Tinius Olsen we are pleased to have partnered with compliance specialists Xybion to offer a total solution enabling users to underpin their test results and product compliance status.
And better still the capability can be added to existing Tinius systems, be they testing metals, composites, concrete, packaging systems, toys, baby soothers, in fact any raw material or device or component strength and performance testing system.
Five ways to prepare for your first day
If I may add my own personal Tip No. 6 it goes something like this: From time to time a more senior member of staff will start explaining something...