This series on inspection success has stressed the importance of making a good first impression,  preparing your inspection management team, using inspection management software, who to have available during an inspection, and how to fulfill the inspector’s requests.  We conclude the series with a discussion about what to do at the end of each day of an inspection.

You want to do a wrap-up meeting at the end of each inspection day.  The inspector usually covers what they examined today, presents what they found, and briefly describes the most critical findings found today.  The inspector or investigator will usually NOT cover all findings.  You will need to check the complete audit report.

If this is a multi-day audit, the inspector may give you a list of documents, specific items, or areas that they want to see when they return the following day.

Inspection

When the audit is over, you will have a final wrap-up meeting.  If the inspection is an FDA inspection, the inspector will present a Form 483 listing their findings listed in order from most to least important.  If it is not an FDA audit, the inspector will usually do the same thing, minus the Form 483.  Listen to the inspector.  Ask questions to clarify anything you are unsure of.  Do not argue. Be polite.  Say thank you.  The inspector may give you their preliminary conclusion if you do or do not operate in a “State of Control”. Do not argue. The inspector will tell you how the final audit report will come to you, when you can expect to receive it, and how to respond to the audit report.

Thank the inspector. Walk the inspector out and bid them a pleasant evening. Always be polite to your inspector.

When it is all over and the inspector is gone, go through the 483 or the audit report.  Your audit response will respond to absolutely everything.  Quote each finding, write down your response, and attach evidence for everything.  Cover every single point. If the inspector wants evidence for green, blue, and yellow valves, provide one attachment for each color valve. They want evidence to prove that you did what you say you did.

PSC® can help you achieve success on every audit.  Consult with our experts. We have over 25 years of experience with audits, audit preparation, mock audits, and compliance gap analysis.  Consider using PSC’s AuditUtopia® and ACE Inspection™ audit management software to automate and simplify your audit process.  PSC® is your one-stop solution for audit and inspection success.

Related Articles

Quality 101 for Cannabis Products

Quality 101 for Cannabis Products

Quality is the driving factor that keeps our food system safe. In the United States, there is an unspoken trust put into our food system to keep it safe. How does this safety happen? There are systems and procedures that maintain the integrity of the products consumed...

Equipment Calibration – Keeping Your Equipment in Top Working Order

Equipment Calibration – Keeping Your Equipment in Top Working Order

When thinking about the heart of the company, the equipment that produces your product must come to mind. Without good working equipment, your products may become compromised and hurt the company’s reputation for producing good quality products. Let’s say that during...

Applying Quality Risk Management (QRM) to C&Q Planning

Applying Quality Risk Management (QRM) to C&Q Planning

Since the publication of ICH Q9 “Quality Risk Management,” applying the principles of Quality Risk Management (QRM) as part of Pharmaceutical Quality Systems is an expectation of global regulatory agencies. The effective application of QRM requires a significant...

See Also

PSC Software Solutions

ACE

Hire Consultants

PSC Biotech Services provide fast, budget-friendly, high-level expertise.

Follow Us

Share, Engage, Stay Current

Stay In the Loop - Join Our Newsletter