English is common for most who work in a GxP-regulated industry. Though most would consider themselves firm English speakers, the truth of the matter is: most will never go beyond some standard vocabulary, and most have only little understanding of English grammar and writing style. After the Brexit, in Europe very few are English native speakers. One could likely make a case for that even English EU GxP Guidance and Drug Regulation documents suffer from this issue.
No, English is in fact not easy – good English is just not!
In company GxP documents and reports the English text often suffers from features of other languages which are unknowingly imposed on it because authors and reviewers are not native speakers.
Consequences of Poor Language Quality
Clarity and quality suffer, content is misrepresented, reports are harder to read later on, procedures are misinterpreted due to undetected ambiguity, even wrong conclusions can be the consequence of using substandard “EUnglish” instead of actual English.
And when a native English speaking authority comes in for inspection (USFDA, TGA, MHRA) all of a sudden QA wonders why the authorities have such trouble seeing through the local QMS and GxP-system and find what they read rather irksome (if You need to look up “irksome” then I totally got You!).
“And here we thought all is fine…”.
Tailored Training by Experts Institute
Experts Institut offers a customized and Taylor-made applicational training on “Technical Editing of GxP Documents: The Relevance of Quality and Style”. This training is relevant for really all levels of GMP-/GxP-regulated organizations. The training provides theoretical elements of English language features and how they can interfere with other languages in GxP documents and reports. Important elements in English writing style are presented as well. Application of the theoretical part is then trained in inductive workshop sections to gain immediate hands-on understanding of how all this plays out in real GxP life.
Basic quality systems can make good use of this, just as well established ones can.
It is a great contribution to the foundation of Pharmaceutical Quality Management Maturity.
This training is one of many reasons why Experts Institut is so unique in its work portfolio: We go beyond GMP/GxP-only – We see the big picture – We see the whole.
For your benefit.
Feel free to contact us and make an appointment to talk about how we can customize this expertise to Your need. Get ahead and in touch with us – info@expertsinstitut.de
Today the world, with its regulated industry, is strongly globalized. The cultural diversity of a company’s staff can be huge. This is one reason why many would assume that the entire world can be talked to, related to and understood quite readily. It is part of everyday work for many after all—or so we think.
In the area of audits and inspections, crossing cultures happens all the time. Where supply chains are globalized, trans-national and trans-continental audits and inspections are mandatory and pretty much normal in many company and regulatory settings.
This poses a problem though: we learn to communicate, read, and perceive in our birth culture. And even if a society is highly diverse, we are still product of a cultural framework that is discrete—in other words, that has boundaries. It is simply impossible for one person to really become multicultural—our lifespan is just not large enough. You may be the child of a double or third culture set of parents, but true multiculturalism in a single individual is virtually impossible.
So as we are controlled by our birth culture, we do not learn how to properly navigate in foreign cultural contexts (and globalization does not do away with this at all). We may think we know what is going on around us when we engage people from other host cultures, but we really do not. Even in a seasoned friendship with someone from another country, there will still be a vast degree of ignorance in understanding the other person. We believe we know and understand. But we miss most of it in reality. We continue to filter everything we experience, see, hear and judge through what we believe is normal, and our frame of reference is our birth culture. And we cannot stop doing it because we are not even aware of it.
And now it gets interesting: This problem includes audit and inspection situations!
Good auditing is more than knowing compliance requirements, audit methodology, and a work experience of 100+ or even 1000+ audits.
Culture is so powerful that it controls everything we think, say and do. And what we expect of others. In an audit situation (also in GMP inspections), this routinely produces misunderstandings. And many of them are never corrected, simply because neither the auditor nor the auditee is aware of them.
From document reviews, an auditor may conclude that a company is falsifying records, when the truth is though that what the auditor saw has nothing to do with cheating at all.
An auditor may think the auditee is trying to avoid saying the truth about a given audit question or subject, but there is no intent of this in the conversation at all. But the auditor is blind to this.
As a result of examples like these, auditors will put their impressions into the report, in a coded form of course, but it will color all parts of the report and the perception of GMP deficiencies—even the judgment on severeness.
If an auditor is not aware of what is missed and where the personal perception of things is going astray, then such an auditor must improve. The objectiveness of the report will suffer, and the picture that is brought home is greatly inaccurate. We do a disservice to the auditee and to our own sending unit. And frankly, to ourselves…
This plays out even more drastically in audits of suppliers or service providers where no GMP or GxP quality system is available. Such cultural ignorance can make or break the business relationship altogether.
How can You improve?
– Stop thinking that cultural differences are easy to figure out. You cannot guess them. You need extra training for this.
– Understand that cultural differences have little to do with differing food preferences or how a business card must be presented.
– Respect that standards—even GMP—can be lived effectively in different ways.
– Open to the truth that You do not know everything best.
Want to know more? Ask for cross-cultural factor training for auditors and inspectors @ExpertsInstitut.
We can help You. And after this You will never be the same. You will be a better auditor. You may—in fact—be a better You. Yes – really.
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