Successful Communication in Audits
Necessity of audits in the GMP and GDP environment
Audits play an important role in the GMP and GDP environment. Many companies are subject to regulatory monitoring and are regularly inspected by the competent authority. Internationally active companies must expect that authorities from other countries will announce their intention to carry out an inspection. Audits are also an issue for all companies seeking or renewing ISO certification.
Audits are also indispensable for other reasons, though. Partner qualification is a core element for implementing GMP and GDP requirements. The EU GMP and GDP guidelines emphasize the need for an effective quality management system and appropriate monitoring for all partners and service providers in the manufacturing and distribution chain. In addition, self-inspections should be performed to internally monitor the implementation of and compliance with GMP and GDP principles.
Since the beginning of the Corona pandemic with the associated travel restrictions, both authorities and companies have, of necessity, increasingly carried out distant assessments or remote audits.
Even conducting purely paper-based audits without video or audio communication was possible in certain cases before the pandemic. Ultimately, however, remote assessments do not offer the same level of security as on-site audits. Thus, it is to be expected that on-site audits will continue to be carried out in the future - at least for initial audits and on special occasions.
The audit situation as a challenge
When conducting an audit, technical knowledge is of great importance. However, one should also be aware of the psychological factors associated with audit work. Audits also require a high degree of interaction if they are to be successful.
Both auditors and the audited company are interested in a positive outcome of the audit and will make corresponding efforts to respond to the other side. What is specifically understood by a positive outcome will be judged quite differently by both sides.
Auditors have an interest in getting to know the audited company and understanding the general procedures and processes. Ultimately, however, the auditors are also interested in obtaining all the necessary information to be able to assess compliance with the requirements. In addition, all information must simply be available to be able to write the audit report properly.
The audited company is first of all interested in obtaining the corresponding certificate or in obtaining or maintaining the status as a qualified supplier. On the one hand, the view from outside and suggestions for improvement formulated in the audit report are seen as an opportunity to improve the company's own system and are thus received positively. On the other hand, hardly any company will be interested in seeing a large number of deficiencies documented in the audit report or in having weaknesses that it has already identified itself brought to the centre. It is also possible that, for reasons of confidentiality, not all of the auditors' questions can be answered in the desired detail.
Under certain circumstances, this quite contrary view can lead to tensions. In international audits, there may also be language barriers, for example if the audit takes place in English but neither the auditor nor the employees of the audited company speak English as their native language.
Recommendation
5/6 February 2025
Handling of Foreign Particles in APIs and Excipients - Live Online Training
Especially when conflict situations come up, but also generally during the entire audit process, dialogue skills and communication play a decisive role.
The transmission of information
According to the so-called sender-receiver model, communication is described in its simplest form as a linear process, namely the transmission of a message from a sender to a receiver. Several steps are necessary for this.
One communication partner (sender) must first encode his thoughts. This is necessary because the sender cannot transfer his thoughts or intentions one-to-one from his head to the head of the receiver. In communication, coding therefore means the translation of thoughts into speech, gestures or facial expressions. The other communication partner (receiver) receives the message. Now, however, he must decode the received message, i.e. interpret the received signals. He then shows a reaction, which in turn can be picked up by the communication partner. The individual communication is not complete until the response has been decoded by the sender and checked for correctness against the original idea.
The entire process is accompanied by sources of interference, which in information theory is referred to as "noise". Noise therefore means something that interferes with the sending or understanding of the message. In relation to an audit, this can be language barriers or cultural differences, for example.
Why do people show a certain behaviour
It is always helpful to be aware that people have different personalities and act differently in concrete situations. There is a whole range of models that have been used to try to describe or measure human behaviour in general and human communication in particular.
A very illustrative, but at the same time quite simple model is the so-called Iceberg Model. Here, communication is symbolized by an iceberg, which has both visible (on the surface) and invisible (below the surface) parts. According to the model, similar to an iceberg, only a small part of the message, namely 20%, is more or less obviously recognizable or directly perceptible. This factual level includes, for example, numbers, data and facts. The remaining 80% of the information is transmitted in a hidden way via the relationship level. This includes emotions, tone of voice, facial expressions and gestures. This information supplements the factual level and at the same time influences the message.
Another model, known as the Left Brain/Right Brain Theory, assumes that the brain is divided into two halves or hemispheres. Within each half, specific regions control specific functions. This model, which is considered outdated in its rather sweeping assessment, however, assumes that either the right or left side of the brain is dominant in a person. People who have a "left-brain dominance" think or act mainly logically, analytically and objectively, but lack creativity and emotion. Conversely, people with "right-brain dominance" are considered intuitive, creative, subjective, emotional and artistic, but lack analytical thinking.
Finally, the Herrmann model developed by Ned Herrmann (four-quadrant model of the brain; whole-brain model) should be mentioned. This is a system for measuring and describing thinking preferences. According to the model, a person's thinking style can be mapped into four quadrants - A (blue, "the rational self"), B (green, "the safekeeping self"), C (red, "the feeling self"), and D (yellow, "the experimental self"). The associated analysis instrument is called the HBDI (Herrmann Brain Dominance Instrument). The format of the instrument is a 120-question questionnaire, the evaluation of which provides a profile for the person in question, from which the thinking preferences and the expression within the four quadrants can be vividly extracted. Among other things, the evaluation can help to understand why it is easier to communicate with some people than with others.
Whichever model is used, all models for communication in an audit lead to the realization that everybody involved may well be different and react differently in certain situations. Since you cannot choose your counterpart in an audit, it is important to prevent conflicts through appropriate communication.
Appropriate communication as a challenge in an audit
For an audit to be successful for both sides, it should be characterized by an atmosphere of trust and respect, although this by no means has to mean that there is agreement on every point. Discussions should be relaxed, yet factual, and characterized by openness and honesty. Especially when it comes to formulating the identified deficiencies or deviations, good and at the same time appreciative communication is essential.
The keys to successful verbal communication are an open-minded attitude, acceptance of other opinions and respectful interaction. Value judgments and personal comments should be avoided.
Questioning techniques
The success of an audit depends on the auditor asking the right question at the right time and, at the same time, formulating the questions in such a way as to obtain the desired answer. It is usually advisable to start with rather general questions in order to first gain a basic understanding. Only then more specific questions should follow. If the auditor starts the conversation immediately with very detailed questions, there is a risk that more important information will be lost.
Questions can be formulated in very different ways. By choosing the appropriate question technique in each case, the auditor can significantly improve the result. A distinction is made between the following types of question, among others:
- Open questions: They start with words such as "Why", "When", "What", "Where". Phrases such as "Describe..." or "How does your company ensure that ...?" are also conceivable. Open-ended questions are a good way to start a conversation and get an overview of a process and learn more details. They allow the other person to speak freely and give them the opportunity to elaborate on the content. In an audit, it is advisable to work with open questions as often as possible, because this is how the most information can be obtained. However, the auditor should make sure that the answers are not too detailed.
- Closed questions: A closed question can be answered with either a single word or a short sentence. Often, a closed question will result in a yes/no answer. In an audit, such questions are useful for reviewing general regulatory requirements or working through audit checklists. An example is, "Do you have an SOP on OOS results?"
The two question types can be divided into further subgroups:
- Alternative questions: They allow the counterpart to choose between two or more possible answer options.
- Control questions: A control question can be used to check whether what was previously said was correctly understood ("Did I understand you correctly that...?"). In complex issues, control questions can be helpful to ensure that the issue is later correctly included in the audit report.
- Suggestive questions: This is a form of question that already suggests a certain answer and can thus quickly have a manipulative effect. In an audit, this question should be used sparingly, and if possible only when the questioner is sure that the answer will be positive. An example could be: "You certainly have an organizational chart that you can briefly explain to me?"
- Counter questions: Counter-questions such as "Why do you want to know that?" can quickly have a provocative effect and therefore offer potential for conflict.
- Chain questions: Chain questions are two or more questions attached to each other, e.g. "Who is responsible for the sampling and how is the training required for this documented?" Such questions should rather not be used in an audit. The disadvantage is that the questioner receives an answer to either the first or the second part of the question and it may be unclear exactly what the answer refers to.
Nonverbal communication
"You cannot not communicate." This is one of the most famous quotes by communication scientist Paul Watzlawick. What is meant is that communication takes place all the time. In addition to verbal communication, non-verbal communication, i.e. all aspects that are not directly related to the spoken message, is of great importance. Particularly worth mentioning here are facial expressions and gestures as well as body posture and tone of voice.
As a rule, nonverbal communication runs completely automatically alongside verbal communication. It therefore takes place unconsciously and spontaneously and cannot be controlled in most cases.
Recommendation
10-12 February 2025
European GMPs and the Role of the Qualified Person (QP) (Day 1 and 2) + Clinical Trial Supplies (Day 3) – Live Online Training
In an audit, however, you can also use nonverbal communication quite consciously to create trust, radiate self-confidence or strengthen the effect of your own words. It is advisable to pay attention to eye contact and to check your own sitting posture or standing position.
Tips for the audit practice
In conclusion, the following aspects can be mentioned which have proven helpful in audit practice for a successful outcome: From the auditor's perspective:
- Prepare for the audit in the best possible way.
- Respect cultural differences.
- Arrive on time. Arriving significantly too early can lead to stress right at the beginning of the audit, because the employees of the audited company may not yet be ready. Conversely, being late will result in not being able to follow the agenda that was agreed upon in advance.
- Choose your questioning techniques wisely.
- Avoid unnecessary interruptions.
- Remain calm and serene, even if you don't like the answers you receive or they seem incomplete.
- Give your counterparts enough time to answer and let them finish. Conversely, make sure that you do not receive answers that are too excessive and miss the point of the question. Formulate short summaries yourself and ask specific questions if necessary.
- If you do not want to receive provocative answers, do not ask provocative questions.
- Always remain factual and avoid accusations, blame, and generalizations.
- Avoid irony and sarcasm.
From the auditee's perspective:
- Answer thoughtfully. Take time for your answer.
- Maintain eye contact and make sure your posture is open and facing the other person. Pay attention to your body language. Adapt your facial expressions and gestures to the content.
- Never take criticism from the auditor personally.
- Never use killer phrases such as "We've always done it that way."
- Avoid getting caught up in justifications.
Author:
Dr Markus Funk
... joined CONCEPT HEIDELBERG in 2019 and organises and conducts courses and conferences on behalf of the ECA Academy in the areas GDP and Analytics.
