TraceGains has proudly partnered with Nancy Scharlach, President and Chief Technical Director for FSMA International for over five years. Nancy is a Lead Instructor for FSMA Rule Foreign Supplier Verification Programs (FSVP) and FSPCA Preventive Controls for Human Food and International HACCP Alliance. As a registered SQF Consultant in High Risk Processing and HACCP Alliance Trainer, she's seen it all. Below, Nancy shares her expertise, noting what auditors will look for, and what they will ask.
Before any food safety audit, it's essential to set proper expectations within your facility to ensure everyone involved in the audit process understands what auditors may examine.
Expectations should include:
- Using a Food Safety Management System (FSMS)
- Keeping a HACCP and/or HARPC program
- Maintaining accurate records and robust recordkeeping
- Preparing your employees for auditor interactions
- Having a facility, equipment, and cultural compliance regarding food safety
1. Food Safety Management System (FSMS)
Using a comprehensive FSMS is critical to the success of your business. The best systems go beyond the basics of food regulation and acceptable workplace practice. Nancy outlines that an audit-passing FSMS should include:
- Quality and food safety manuals
- Management commitment and company policies
- Standard Operating Procedures (SOPs) and Prerequisite Programs (PRPs)
- Work instructions
- Organizational charts, job descriptions, crisis teams, etc.
- Food safety preventative controls (HACCP/HARPC)
2. HACCP and HARPC
Most people in the industry are familiar with HACCP, but there are quite a few people in food safety who might not fully understand HARPC and the differences between them. A few common questions Nancy hears are:
- What is HARPC?
- Do I need HARPC?
- How does this apply to me?
- If I have HACCP, am I compliant with HARPC?
While the FDA mandates HACCP, its mandatory application is limited to juice, seafood, retail, and foodservice. With that said, HACCP's principles span across all food production segments and integrated into all GFSI and audit scheme requirements. These principles are primarily concerned with raw materials, products, and processes, and large brands often mandate them for suppliers.
Alternately, HARPC applies to almost all food processing facilities. HARPC requires that companies have written plans that identify hazards, list the steps needed to minimize or prevent those hazards, identify monitoring procedures, record the results, and specify what actions must arise. The FDA evaluates these plans and checks for proper implementation and adherence during an audit. Additionally, HARPC requires planning for potential terrorist acts, intentional adulteration, and food fraud.
3. Records and Recordkeeping
Detailed records and adequate recordkeeping are essential to pass audits and comply with regulatory requirements - that much is obvious. Nancy suggests companies perform internal reviews, ensuring that consistent documentation is kept top of mind for all departments.
According to Nancy, SOPs, manuals and records, CCPs, supplier management/performance, training, CAPAs, team meetings, internal audits, etc. make up 60% of any given audit.
Additionally, if an auditor notes a non-conformance within records or incomplete corrective action records, they begin to look for trends, which can lead to a systematic breakdown and a more difficult audit overall.
A few key weaknesses that tend to surface with recordkeeping include:
- Lack of ongoing employee training: Having temporary workers or a high turnover rate creates challenges and requires more consistent education.
- Lack of sufficient tools: Companies do not always have the right tools to capture and act on important information.
- Incorrect information: For example, incorrectly captured critical control points.
- Lack of sign-offs and verification protocols: Absence of verification is a common error and is a reoccurring weakness seen in audits.
4. Preparing Employees
Audits can be intimidating and stressful for employees. Adequately preparing employees for audits will make them more comfortable and will help the auditor. Train the team on common questions they may be asked and what to expect:
Who will auditors interview? Anyone and everyone is fair game. Auditors expect all employees in the facility to know critical food safety and audit code details. No one is exempt from these interviews, and it's up to the auditor's discretion (and sometimes mood). Prepare everyone.
What to expect from an auditor interview: Auditors are trained to be professional, ethical, and courteous when conducting audits and interviews. Interviews will focus on ensuring:
- Employees receive regular training.
- Management is committed to food safety and allocates appropriate resources to Food Safety and Quality Assurance.
- Key positions have completed additional training topics related to their job skills or requirements.
Common interview questions:
- Where is the food safety manual stored?
- What do you do if you see a mouse?
- What allergens are in your facility?
- What are three examples of personal hygiene?
- When do you wash your hands?
- How long do you wash your hands?
- How often should you change your company shirt or smock?
- Why is nail polish not allowed?
- Why should you not wear perfume or cologne?
- What are your company's Critical Care Points?
- What does SQF stand for?
The only way to prepare employees is to train them. Include real-life examples and stories. Training should be ongoing, well-documented, and fresh. Your employees are your greatest asset; continued training will give them the tools to succeed.
5. Facility, Equipment, and Cultural Compliance
When it comes to food safety, the most important factor is the processing environment; it is also where contamination and risk are most prevalent.
The facility, equipment, and company culture drive the visual evidence of how an auditor assesses the dedication and commitment to food safety (if the auditor sees chaos, they can assume chaos within the facility).
Auditors will generally try and do a facility walk-through within the first 90 minutes of arriving to assess the condition of the facility and hygiene practices (unannounced is a 60-minute window).
The adage is true - first impressions are lasting impressions.
Examples of "The Good"
Excellent facilities operate with high standards, stick to best practices and GMPs, and instill a culture of "World Class Food Safety Practices."
Consistent education and compliance maintenance can prevent common minor non-conformities. Senior management must lead by example and create a company culture dedicated to safety and quality.
And "The Ugly"
Facilities that had critical non-conformances resulting in automatic failures often display no real commitment to true food safety, and direct product adulteration was evident.
Want to be ready for any audit at any time? For more tips and best practices, download our eBook, "Are You Ready for an Audit" here.