Crossing Cultures in Audits and Inspections
Today the world, with its regulated industry, is strongly globalized. The cultural diversity of a company’s staff can be huge, reflecting different cultures from around the world. 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. Different cultures bring varying perspectives, which can influence how audits are perceived and conducted. 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. Understanding the nuances of each culture involved is essential for effective communication and successful outcomes.
True Multiculturalism and Cultural Limits
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.
The Impact of Culture on Audits and Inspections
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.
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Vita
- COO Experts Institut
- Senior Project Consultant
- Apotheker
- Langjährige internationale Projekttätigkeit in Europa, Nordamerika, Asien, Russland
- Sachkundige Person (D – AMG, AMWHV, CH – HMG, AMBV)
- Breite Compliance Expertise im Commercial (c)GMP- und Development GMP-Bereich (IMP-GMP)
- Langjähriger Third-Party GMP-Auditor (GMP- und Non-GMP)
- GMP/GDP-Trainer seit 2010
- Quality Culture Mediator
- Trained in cross-cultural aspects of communication, contextualization, and cultural anthropology as part of an MA.MIn and DIcs enrollment at Grace College&TS, US.
