Reviewed and Approved by Kaci Foote, Accreditation Manager, FSNS Certification & Audit
1-Minute Summary
- Many food and beverage manufacturers pursue GMP certification to grow their business or satisfy customer requirements.
- First, make sure your facility is registered with the appropriate regulatory agency – FDA, USDA, or both – before the audit. Unregistered facilities automatically fail.
- Confirm that a GMP audit meets your needs. Some customers may want you to meet additional requirements best provided by a GFSI audit (like SQF or BRCGS).
- Use a GMP checklist to perform a self-assessment and close any compliance gaps prior to your official GMP audit.
- Once ready, schedule your audit and prepare to receive your final report.
Why GMP Audits Matter
Generally, two different types of customers contact our Certification & Audit team about a GMP audit:
- Those that have been making food products for years without a hitch, but suddenly a potential new customer asks them for Good Manufacturing Practices (GMP) certification.
- New companies that want to achieve GMP certification right away to build trust with future clients.
Either way, GMP certification is a key milestone for many facilities since it provides third-party proof that your facility meets industry standards for food safety, helping you access new markets.
But before scheduling your audit, follow these steps to help ensure you’re ready to pass.
1. Register with the Right Regulatory Authority
Step one is to make sure your facility is legally registered with the appropriate regulatory agency.
- FDA oversees most food facilities.
- USDA covers meat, poultry, and egg products.
- Dual jurisdiction facilities need to register with both.
If you’re not registered, your GMP audit will result in an automatic failure. This is one of the first questions our team will ask new audit prospects. The last thing we want is for you to go through the process only to fail due to an easily addressed oversight.
2. Confirm That a GMP Audit Meets Your Needs
Once we’ve confirmed proper registration, we’ll ask another important question:
Are you confident that GMP certification will meet your needs?
While a cost-effective entry point into the work of food safety certification, GMP certification is not always sufficient. Some large retailers or distributors require certification to a more robust GFSI-recognized standard, such as…
Before you commit time and money to preparing for a GMP audit, ask your customer what certification they require. Don’t waste time preparing for the wrong one.
We help walk you through which GFSI certification may be right for your business here.
3. Use a Checklist and Perform a Gap Assessment
With those two requirements handled, it’s time to assess your audit readiness. Start by requesting the right checklist:
- Use a standard GMP audit checklist, or
- Request a customer-specific checklist if you’re preparing for an audit tied to a buyer like Whole Foods or Costco.
FSNS Certification & Audit offers a complimentary GMP Audit Checklist for this purpose.
Use the checklist to conduct a self-assessment to identify areas that need improvement. Working with facilities that are new to this process, we often find common red flags around the facility, such as…
- Worn or uncleanable surfaces: Rusted equipment, wooden cutting boards and utensils, and harborage sites violate GMP standards.
- Poor facility flow or traffic control: For example, going from a processing area to a retail counter without changing gloves or aprons creates cross-contamination risk.
- No traceability system: Run a mock recall to test your ability to trace ingredients and finished products.
- Inadequate cleaning or pest control programs: These are foundational to a safe facility, meaning you must develop Standard Operating Procedures (SOPs) if you don’t have them.
Your goal in this step is to find the gaps, develop SOPs and corrective actions, and implement them before the audit.
4. Train Your Team on GMP Basics
If your team has been doing things the same way for years, this step can be the most challenging. It’s difficult to instill new habits, but your staff must understand GMPs and be trained to follow them before you can pass an audit. It’s common for the auditor to talk to workers during a GMP audit to gauge their understanding of food safety and their specific role.
Review the GMPs outlined in the regulations that apply to your facility:
- FDA-regulated food facilities must follow GMPs outlined in 21 CFR Part 117, Subpart B.
- USDA-regulated establishments must comply with sanitation regulations under 9 CFR Part 416.
A few common non-compliances we see, especially at facilities that are new to food safety certification, include…
- Jewelry worn in processing areas, which can fall into and contaminate food.
- Failure to wear PPE, such as gloves, aprons, and hairnets.
- Failure to change gloves or aprons when moving between zones (e.g., from back-of-house to retail counter).
Doing things differently is frequently a challenge, but it’s critical for food safety and passing an audit.
5. Conduct a Final Self-Audit
Before you bring in an auditor, conduct a rigorous walk-through of your facility. Be brutally honest:
- Are your written programs being followed?
- Do your SOPs match what’s happening on the floor?
- Are corrective actions being documented and resolved?
Some facilities use AI or boilerplate templates to write their food safety plans. While a good start, those documents are often too general and fail to capture the unique practices of your facility. Your plan must describe operations at your facility, and your team’s activities must be reflected in your plan. As the saying goes…
“Do what you say, say what you do.”
6. Schedule Your Audit
Once you’ve confirmed your readiness, schedule your GMP audit. The auditing body will give you details about:
- Required documentation
- Expected duration
- Scope of the audit
Allow enough lead time to make final adjustments and communicate with your team about the big day.
7. After the Audit: The Final Report
After the audit, you’ll receive a detailed report outlining your facility’s performance. This may include:
- Conformities: What you did well
- Non-conformities: What needs correction
Once you’ve addressed any issues and closed corrective actions, your certification process is complete. You can provide your final report to the customer to demonstrate your GMP certification!
Preparing for a GMP audit can feel like a burden, especially if you’ve been in business for years without GMP certification. But passing your audit confirms your adherence to GMPs and helps build trust with your customers.
If you need help preparing or are ready to schedule a GMP audit, our team is happy to help.
