How do you talk to a GMP auditor?

Based on my experience I can add tips and best practices -Before going to audit room, take few minutes to understand the question and refer existing practices related to query. -maintain better eye contact -Listen to auditor, if not clear on question ask again -Quick replies will give confidence but it is not correct all the times -Ask time to provide necessary evidences -If required call SME to explain -Some times we may fail to convey auditor during audit, no worries we can address that with good response.

GMP auditors are also humans and diverse in their personalities, behaviours, attitudes and professionalism. Before and when talking to auditors, it is quite important to know the expectations, requirements and knowledge/expertise of each auditor, the auditees will face during audits. Also, it is worth paying attention to the fact that how auditors treat and talk to their auditees and presenters. There are many different types and experiences.

Prior to the audit, time permitting, perform a gap assessment using the audit agenda. Though there may not be time to address the gaps identified, there is time to document findings and formulate a plan and best path forward. Set up a command center and coach identified individual who may be of interest during the audit on proper "audit etiquette". Provide guidance on being comfortable with silence and answering only the questions asked. Be positive and honest during audits. Most importantly, debrief all team participants and document everything.

Keep calm. The auditor is a human being doing a job, the same as you. Answer what you are asked about. No more, no less. Do not open disagree or oppose to the auditor. Choose your words and bring the auditor gently to your position.

In the preparation of the necessary documents and evidence, accuracy and honesty are key characteristics that should not be overlooked. Facing and responding to an auditor is not a death sentence as auditing leads to the improvement of the GMP process.

In my experience, the relationship with auditors has been very friendly, i do not believe in stereotypes, he is just another professional like you, probably with the same experience like you, obviously there must be areas in where he is more knowledgeable than you and viceversa. The auditor is trying to follow a protocol of questions that you probably have anticipated. Just be clear, honest, transparent with them and this will reflect the type of professional tab you are. I do normally have great memories of my audits because you can know other experiences and Challenges thta this person have endured, AND LEARN of them.

Not only is it important to know the purpose and scope of an audit, it is important to know the purpose and motivation of your auditor. This goes a long way in determining how to show respect and courtesy. Some auditors approach an audit mainly seeking evidence of control / compliance to specified requirements. Others may be seeking evidence of noncompliance leading to findings. It is important to highlight to this second group how your organization complies and if not, how your QMS adequately addresses quality issues.

Of course be polite and respectful. But also remember that an auditor is not necessarily familiar with all the ways that a system could be compliant, especially in computer system validation. If you are working at the leading edge of system design, then you may need to educate the auditor!

Maintaining a respectful and professional demeanor is important not only for the audit to go well but to ensure the audit is not stopped early by the auditor. Even if nonconformances are found, it's important to remember that these audits are for the sole purpose of continuous improvement and ensuring the company's QMS is being maintained correctly and effectively. Getting defensive or rude will just make the audit worse for everyone involved and will do more harm than good.

Audits can often be a stressful situation. Remember to stay calm, be respectful and realize that the auditor is there to do their job and not to take questions personally. If people change their mindset for an inspection to be an opportunity to share the high level of compliance within the site, it can be a very pleasant experience. If you do not know the answer to a question, do not lie or guess. You should respectfully refer a colleague with greater knowledge in that area to answer the question.

One thing I have found helpful is listening auditor carefully, try to understand from the question about the risks auditor foresee. While answering questions, try to include existing controls to eliminate those risks and be ready with examples to present if asked by auditor.

I have seen some SME's get rattled or give too much information when answering an auditor's question. We always prep any SMEs that will be talking with the auditor by explaining that it is okay to think through the response before answering. We also try to encourage employees that are interviewed to refer back to the procedure, physically pull up the procedure, and walk the auditor through the process. One of the hardest skills to learn when working with an auditor is to answer only the question that is asked and to be comfortable sitting in silence while the auditor digests the answer.

Always answer the question that is asked, don't be afraid to ask the auditor to repeat the question so that you fully understand. Provide clear and concise answers and do not waffle or go off topic. Present data (Policies, Procedures or Studies) to back up your statements.

Beating around the bush can show the auditor that you are hiding something, so one should answer what has been asked. Don't talk about things you weren't asked and don't give more information if not requested, though it can contribute to building a good rapport if some extra knowledge is shown. But this should be done with extreme caution, not causing damage to the company.

Be prepared to admit if you don't know something. Best to admit it and say that you will find out. Never guess! Express willingness to change or modify an approach if necessary.

Always be honest during an audit. Present the data requested and stick to the facts, not your feelings. An audit is not personal. If information is requested and there is a known gap, say so, but also state where you are as an organization with addressing the gap.

I agree with honesty and transparency but would add that it is really important to understand the information prior to presenting it to an auditor. In the circumstance where an auditor has requested something that is problematic in some way, it is important to balance transparency and holding information until it is understood. If not, this may add confusion and misinformation. It is acceptable and advised to tell an auditor that the information is being collected but there is a concern that is being reviewed rather than to rush forward with partial information that could be misconstrued.

An audit should be an opportunity to show how compliant the site is and there should be no issues sharing information. If you do not have the answer at hand, feel free to request time to gather the supporting documents and go back to the auditor soon after. This follow up should not be left too long as they might suspect that you are struggling to find the data.

Be quick wirh your response. Good and controlled systems will provide feedback (response) fairly quickly. This is the sign to the auditor that the things are kept under control. Having the separate, special room close to the auditing room, for the team to prepare and with the most critical documentation will speed up the process. Make sure you correct/fix/rectify as many findings during the audit as you can and that they have been recorded and properly run through the system. This may reduce the number of obserbations or help during the classificaiton of those.

Over my career, I had numerous of interactions with GxP auditors with different regulatory agencies around the world including with the agency's national experts in Data Integrity. Be confident and positive is the key success factor. However, it is based on the strength of the quality system you have built and the organizational discipline to adhere to it. For those of us in Information Technology (IT) quality, it means that we must be well articulated in four key areas: regulatory requirements (and expectations), internal business processes, internal quality system, internal IT practices, and digital technology. We need to understand how technologies are used in the business processes and where they impact data integrity.

Auditors are generally happy to provide input to open topics so long as it is relevant to your manufacturing process. The site tour is a great opportunity to show case the high levels of GMP compliance on your site. Be proud of what you and the site team have done.

Two things to always remember! The first is that there is no such thing as perfect. There will always be at least 1 finding during an audit. We are afterall in the business of continuous improvement. Graciously accept the finding(s) as they are meant...with positive intent. They are a road map for improvement. The second is that you (your organization) and the regulatory auditor/inspector have the same ultimate goal...to ensure SAFE and EFFECTIVE products are available for consumers. They are partners with a different perspective and a different lense through which your organization and processes are viewed. Utilize their insight to drive systemic improvements.

Here are some essential audit Do's and Don'ts: Do's: When presenting remotely, use your camera, ensure a quiet environment, and share the relevant screen. Wait for the auditor's questions; avoid assuming or prompting. Keep your mobile on silent and set TEAMs status to "do not disturb." Acknowledge your limits; if you can't answer, provide the right contact. Embrace pauses; auditors need time to review. Guide the auditor through your process; don't just read procedures. Listen carefully and wait for the auditor to finish before responding. Don'ts: Never discuss topics you're not trained on. Avoid leaving the audit room without necessity. Refrain from casual conversations. Don't question the auditor unless you need clarification.

I would add a section on audit organization and logistics. One key to achieving some of the considerations; clear and respectful, honest and transparent, proactive and responsive, confident and positive, -is to have well established and well organized logistics for audit support. Understanding what has been requested, what has been provided, what is still outstanding, as well as all of the questions asked by an auditor, are crucial to success. Developing a strong system for tracking requests, processing requests, and delivering the requests is important as is the team managing these requests.

Don't lie! If your company is found to be deficient, then tell the auditor that you will rectify the matter and ask the auditor for any suggestions for how best to rectify the matter.

Always remember that you and auditor(s) are not enemies, since if they feel there's some animosity, that could jeopardize the audit big time. Always remember and openly show that you consider audits as opportunities to learn and improve. Don't be arogant and speak about your organization as extremely good, that there are no flaws, gaps etc. This looks like challenging the auditor to show you the opposite, which you certainly won't like since, with almost 100% certainty, they will succeed to do so.