{"id":4541,"date":"2017-08-25T16:35:00","date_gmt":"2017-08-25T16:35:00","guid":{"rendered":"https:\/\/www.waters.com\/blog\/data-integrity-matters-the-human-factors\/"},"modified":"2022-07-28T03:07:59","modified_gmt":"2022-07-28T03:07:59","slug":"data-integrity-matters-the-human-factors","status":"publish","type":"post","link":"https:\/\/www.waters.com\/blog\/data-integrity-matters-the-human-factors\/","title":{"rendered":"Data Integrity Matters | The Human Factors"},"content":{"rendered":"

3 signs that you need to create a culture of compliance<\/h2>\n

As mentioned in my first post on data integrity<\/a>, people trust that companies create safe, quality products and rely on data to support that belief. But most product data, especially laboratory testing, should be designed to catch studies, batches, or test samples that fail to meet specifications. A test is no use if it cannot raise an alarm when something is not right.<\/p>\n

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Of course any company is driven to create good quality products \u2013 but the purpose of testing is to ensure a consistent level of quality, not simply to create data that \u201cproves quality.\u201d Data that shows perfect answers all the time can also raise concern of trust: \u201cAre you sure? It passes all the time? Can I believe it?\u201d<\/p>\n

Quality departments are often seen as a necessary cost to a business, something that has to be done to meet requirements. Their true value to the business\u2019s reputation and brand in preventing costly or dangerous errors is often missed. Similarly, test results that could indicate poor product or product performance should be celebrated, but in order to meet company expectations\u00a0\u2013 they\u2019re often denigrated.<\/p>\n

Does your laboratory show these early warning signs of Quality problems?<\/p>\n

\u26a0 Common reactions to an individual creating results that fail:<\/strong>
\n\u2022 \u201cWhat did you do wrong?\u201d
\n\u2022 \u201cGo back and try again.\u201d<\/p><\/blockquote>\n

An individual analyst may feel pressure to avoid presenting \u201cfailed tests\u201d and be tempted to try again to get the right result. But when the behavior becomes the modus operandi<\/em> of a Quality Control department or a clinical study director, public safety is seriously put at risk.<\/p>\n

In many regulatory observations, the analyst staff may not even be aware that \u201cfudging the result into specification\u201d is a serious quality issue. Oftentimes a responding comment is that this practice \u201cis normal.\u201d If everyone who trained the analyst and who works around them thinks it is expected, then it becomes the norm.<\/p>\n

\u26a0 Performance measurements can indicate a problem:<\/strong>
\n\u2022 Increasing the number of batches passed by the laboratory
\n\u2022 Reducing the number of OOS results
\n\u2022 A 100% pass rate
\n\u2022 Reducing the turnaround time of tests<\/p><\/blockquote>\n

On the other hand, analysts may also be pressured to follow pointless rules.<\/p>\n

\u26a0 Arbitrary laboratory rules should also raise warning flags:<\/strong>
\n\u2022 \u201cNo manual integration\u201d
\n\u2022 \u201cNo single-test injections permitted before you start an HPLC sequence\u201d
\n\u2022 \u201cYou must get QA approval to reintegrate a chromatogram\u201d
\n\u2022 \u201cIf you need to repeat a run, you must complete this 40-page report first\u201d
\n\u2022 \u201cYou must print out every method, every chromatogram, every integration and all the audit trails to submit to QA\u201d<\/p><\/blockquote>\n

Raising these kinds of barriers to productivity simply drives analysts to find creative way to obscure their own errors from view.<\/p>\n

And finally, we should acknowledge the individual pressures that management and supervisors may put on their teams to pretend those results never happened. In the major Ranbaxy fraud case<\/a> (2013), senior directors who were aware and uncomfortable with \u201cless than ideal study data\u201d resigned from the company rather than stand up to the executives who were financially motivated to ensure new products were approved.<\/p>\n

Much has been written about the need for a Culture of Quality<\/strong> but equally important is nurturing a Culture of Courage<\/strong>, where staff can confidently raise concerns about how common laboratory testing practices can be improved or may be being misused, with immunity and without fear of retribution.<\/p>\n

Educating employees about the \u201cWhy?\u201d of data integrity as well as simply enforcing it should encourage those who are deep in the details of a process \u2013 whether laboratory testing or manufacturing\u00a0\u2013 to be involved in continually improving the quality and integrity of the data they produce.<\/p>\n

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Read more articles in Heather Longden\u2019s blog series, Data Integrity Matters<\/a>.<\/em><\/p>\n

More resources:<\/strong><\/h4>\n