In our previous blogs on GDP auditing, we have focused on why supply chain oversight (and first-hand knowledge of suppliers) is critical, and the importance of planning your audit. In this article, I look at how to manage the day of the audit and address a few of the worries that I have personally experienced over 50+ audits. I’ve split this into a number of different areas:
Communication
Most auditees find audits inherently stressful and so it’s important to remember some communication guidelines; stay professional and clear in your communications, maintain positive body language, both at the opening meeting and throughout the audit, and remember that in the vast majority of cases (including when the audit is not going well), that people want to do a good job and have patient safety as their priority.
Arrival
Arriving late is never a good start – I always try to be on site 15 minutes before I want the opening meeting to start to allow for setting up, connecting to Wi-Fi, getting a coffee etc. Use the arrival as an opportunity to learn about the company – was your access restricted (hope so!), did you have to sign a visitors’ book, or acknowledge any site rules? What’s the dress code? Are doors open? Is the site secure? All these factors (and more) are indicators of a company’s culture and approach to compliance.
Opening meeting
The opening meeting is your opportunity to confirm how you want the day to go and to answer any questions that the auditees may have. Reiterate the audit objectives and scope. Highlight that you’re looking for compliance (not non-compliance). Ask if there are any concerns about the agenda and availability of personnel. Introduce the audit team and provide an opportunity for auditees to ask questions.
Keep your eye on the time in this meeting (if these auditees are presenting a 100 slide PowerPoint, you’ll need to move it along!) Ensure you understand the high-level company detail and get a feel for the company culture and management oversight and direction especially relating to quality related objectives (having senior management in the opening and closing meeting is generally a good indicator of a positive culture).
Multi-tasking during the audit
Once of the most challenging parts of an audit is listening to the auditee, making the appropriate level of notes (that are legible enough to read later!), asking open questions, and keeping an eye on the agenda and the clock – all at the same time. The best advice I can offer here is to stay calm and remember you are looking at a sample not every document and record. Move on in line with your agenda unless you identify a risk that needs to be further explored (and hopefully you can catch that time up later).
I type my notes as I go along where possible, but I appreciate this is not everyone’s preference (and make sure you save them frequently!!). Record the references of the documents that you have reviewed as you go along (and include versions/approval dates, and titles) – I do this on 3 separate Microsoft word documents for audit notes, documents reviewed and any observations (good and bad). Colour coding can also work. Don’t be worried about having a few minutes to get your head in order and collate your thoughts. If you have a co-auditee or an audit team, check in with each other regularly to ensure you stay on track – you could also switch review items between yourselves.
Facility tour
Don’t rush the facility tour; this is your opportunity to speak to the people doing the work, observe routine operations and look into the facilities and equipment. I work through the process of goods-in through to goods-out whilst taking in the details about environmental control, monitoring probe locations, pest control, security, access control, cleaning etc as we go around. Don’t forget to see all segregated areas, in both cold chain and controlled ambient, and depending on the facility and its location you may be interested in the neighbouring units and external influences.
Raising good feedback
Always note areas where you feel that the company is doing well, shows good practices and/or exceeds the standards you are auditing against. Raise these as you identify them, and in the closing meeting.
Raising concerns
Ensure you listen to the auditee after you have asked them a question and then review / document the evidence. Always ask for clarification if something isn’t clear. If you have any observations, raise these to the auditee as you go so they can respond – you might find they can produce a positive response and evidence to address your concern.
Private auditors meeting
Even if you are auditing alone, before the closing meeting ensure that you have some time to gather your thoughts. If you do have an audit team, use the time to discuss what was seen during the audit and align findings/nonconformities.
Remember that non-conformities should be factual, accurate, incontestable, and retrievable.
Ensure you have a list of the things you want to raise in the closing meeting (this is where my 3 separate Microsoft word documents come in very useful).
Closing meeting
This is high level summary of what has happened in the day.
• Thank the auditees for their time, cooperation and hospitality.
• Reconfirm the reason and scope of audit.
• Present your findings, good and bad – and ensure findings are understood and acknowledged. I don’t categorise any findings in the closing meeting and I explain that this will be included in the final report.
• Provide an opportunity for the auditee to respond/ask questions.
• Record any divergence in opinion (and ensure you document this in your final report).
• Provide the expected timelines on when the auditee will receive the findings and the report (as the two may differ if the findings need to be given sooner).
• Inform them what they should do when they get the report (e.g. identify root cause, propose CAPA including timelines, and provide a written response in a defined timeline).
I’d be keen to hear your audit tips, and if you need any support on audit any part of your supply chain, please get it touch.
