Whether it’s your first or fifth or five hundredth audit, you can never be too prepared. We recently hosted a webinar on exactly this topic, hosted by quality and systems expert Ed Morris. Morris walked through tips for preparation for and day of your audit.
Morris coaches clients to approach audits with confidence and organization, not with dread. He encourages businesses to focus on the spirit of the law vs. the letter of the law and advises clients, “Auditors are NOT expecting perfection. What they really want to see is if you have a Quality Culture in place and if you are working continuously to improve upon it.”
Below are some of the audit preparation tips Ed Morris shared during the webinar- and a link to the full presentation as well:
- Don’t be arrogant. It is not going to be beneficial if you enter into the audit with an attitude and bragging about your ‘clean bill of health’ to date. We’ve heard many businesses brag that they’ve been audited by the FDA in the past and never had a 483 nor an observation.
- Request a scope of the audit and an agenda in advance. The FDA will not likely provide much detail in advance but certainly those performing vendor qualification audits will be ready and willing to provide these- including a list of requested documents.
- Build a library of documents in advance of the audit. If you have an eQMS, you can easily set up a training program for the auditors and load it with the specific requested documents that they have requested.
- Designate the members of an audit team in advance. Assign specific roles and responsibilities-- experts recommend 1 technical person who can answer questions re: supply chain, systems, etc; 1-2 Quality specialists; 1 executive.
- Assign one person to serve as the “Speaker” during the audit. The speaker should be the only one answering questions. No one else should speak unless the speaker directs a question to them.
- Stick to the question. It’s important to answer their question and then STOP talking. Embellishing to provide additional clarity often results in revealing something that is somewhat detrimental.
- Relax! The auditors are people and they are professionals. Be friendly and establish a human connection of some kind with them upon arrival but don't go overboard.
- Prepare a good lunch and snacks for the auditors. You don’t want hungry/ cranky auditors. And if they end up in a bit of a food coma- that may be beneficial to your team.
- Spoon feed the auditors documents. Do not overwhelm them by doing a huge document dump.
- Ensure that your IT staff is trained in GxP and 21 CFR Part 11. Also, you will need to have a disaster recovery system in place- including RTO/ RPO metrics. And the disaster recovery plan should be tested annually at minimum.
Watch the full webinar on-demand now>>