Before I made the transition to working in Quality Assurance, I was enrolled part-time as a Ph.D. student at Loyola University in Chicago. I started with the intention of specializing in 19th-century literature but pretty quickly became enamored of applied linguistics. I might have spent years happily using politeness theory to analyze proposals and anti-proposals in Jane Austen’s novels had my husband and I not decided to relocate to Boston, where universities took a dimmer view of accepting a part-time Ph.D. student.
The interest in linguistics persists, though, and it comes up frequently in my role as an inspection readiness coach. The interaction between auditor and auditee fits linguist Erving Goffman’s definition of a face-threatening act (or FTA; linguists, like clinical researchers, are fond of acronyms).
Face is a person’s desire for respect (“positive face”) coupled with their desire for freedom to make their own decisions (“negative face”). A face-threatening act is disrespect or constraint. Criticism, disapproval, and disagreement are threats to positive face; orders, recommendations, and suggestions are threats to negative face. Audits positively brim with these acts. Auditors communicate findings, ask critical questions, demand documents, and insist on CAPAs. (No wonder everyone loves us.)
It doesn’t take an Ivy League linguist to explain how auditees react to face-threatening acts. At best, audit requests are disruptive and irritating; at worst, the auditee presented with a finding can become embarrassed, agitated, defensive, or angry. Strong reactions are unpleasant for both the auditor and auditee. Thus, auditors instinctively or deliberately employ face-saving politeness strategies to avoid unpleasantness and help auditees remain receptive to their audit findings.
According to Goffman, positive politeness strategies are statements that build consensus between auditor and auditee: “I’ve also been on the receiving end of audits.” “I know how disruptive an audit can be.” “We’re happy for the opportunity to partner with you in this audit.” Compliments (“These SOPs are really well-written and comprehensive”) and self-deprecating statements (“This is a really difficult study design, it has taken me a while to grasp it”) are other positive politeness strategies.
Negative politeness strategies during an audit may involve using neutral language and factual statements to describe audit findings (“The monitoring plan specifies visits every four weeks. The team visited every eight weeks”). Distancing and hedging language are other examples (“Would it be possible to see the audit trail for this subject?” “I know this is going to be a huge effort, but could you please pull the previous seven versions of this protocol?”).
Some auditors eschew politeness altogether, which is known as a bald on-record strategy: (“Show me the audit trail” or “You didn’t adhere to the monitoring plan.”) They may feel that politeness strategies give tacit permission to auditees to hide information, or that requests couched in polite language are not clear. Stories abound of auditors and inspectors that use bald on-record strategies to try to fluster or trip up auditees. In my experience, though, most auditors don’t work this way; it’s simply not an effective means of getting information from interviewees. Typically, if an auditor is terse or critical, it’s because the auditor is flustered.
Auditors are human, like everyone, and auditees don’t always appreciate the fact that the auditor has to absorb a huge amount of information about a clinical study in a short amount of time to do their job. Just as the auditee is nervous about answering questions, the auditor may be nervous about asking them. Looking like a fool by asking irrelevant questions or not grasping the answers is a self-face-threatening act, leading the auditor to be less polite.
Auditees can also commit face-threatening acts to the auditor. If an auditor points out a finding, and the auditee becomes angry or teary, this threatens the auditor’s positive face (“I’m not a good auditor if my auditee is upset”). If the auditee refuses to accept the finding, this threatens the auditor’s negative face (“This is going to take a lot of time to resolve and could put me off schedule”).
As we prepare for an audit or inspection, we can’t control the auditor’s or inspector’s demeanor, but we can use our knowledge of politeness strategies and face-threatening acts to reduce contentious exchanges during the audit. In the next blog post in this series, we’ll discuss how to do that.