Last week, TraceGains had the opportunity to host a webinar, Inside the Mind of a Food Safety Auditor, with Nancy Scharlach, President and Chief Technical Director at Soterian Systems, LLC, and Registered SQF Consultant in High Risk Processing. During her webinar presentation, Nancy took us behind the scenes as she explored the topic of audits and helped to give listeners an idea of what auditors will be looking for and asking.
Prior to any food safety audit, it’s important to set proper expectations within your facility in order to ensure everyone involved in the audit process understands what might be and will be examined.
Expectations in order to successfully pass an audit include:
- Having a Food Safety Management Systems (FSMS) in place
- Having a HACCP and/or HARPC program
- Ensuring accurate records and good recordkeeping
- Preparing your employees for auditor interactions
- Having a facility, equipment, and cultural compliance regarding food safety
All of these topics paint a picture for auditors, for regulatory, and even customers regarding how well the company approaches food safety practices.
Let’s dig in a little deeper to understand what it is these expectations mean.
1. Food Safety Management Systems
Whether you are in food production, storage, packaging, or preparation, having a comprehensive food safety management system (FSMS) is critical to the success of your business. It needs to go beyond the basics of food regulation and acceptable workplace practice. So then, what should be included in an audit-passing FSMS?
According to Nancy, it should include the following:
- Quality and Food Safety Manuals
- Management Commitment and Company Policies
- Standard Operating Procedures (SOPs) and Prerequisite Programs (PRPs)
- Work Instructions – The day-to-day activities in the plant along with descriptions on how you do them
- Org. Charts, Job Descriptions, Crisis Teams, etc.
- Food Safety Preventative Controls (HACCP/HARPC)
2. HACCP and HARPC Comparison
Most folks are familiar with HACCP, but there are quite a few people in food safety that might not fully understand HARPC and the differences between the two. A few common questions Nancy hears include:
- 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 also mandates HACCP, its mandatory application is for juice, seafood, retail, and foodservice (USDA/FSIS has its own HACCP rules, too). Still, HACCP’s principles are prevalent across all segments of food production and have been integrated into all GFSI and audit scheme requirements. These principles are primarily concerned with raw materials, products, and processes, and often are mandated by large brands to their suppliers, and suppliers’ suppliers.
HARPC, on the other hand, applies to almost all food processing facilities and requires that companies have written plans that identify hazards, list the steps needed to minimize or prevent those hazards, identify monitoring procedures and record the results, and specify what actions will be taken to correct should problems arise. These plans will be evaluated by FDA, and checked for proper implementation and adherence.
Additionally, HARPC requires planning for potential terrorist acts, intentional adulteration, and food fraud. So there are some minor differences between a HACCP plan and a HARPC plan.
3. Records and Recordkeeping
Everyone who has worked in a processing facility knows that records and adequate recordkeeping is essential to pass audits and comply with regulatory requirements. To keep good records going, it’s in the best interest of your company to perform internal audits and ensure that recordkeeping is top of mind for all departments, not just quality. Why? When it comes to auditing, all departments require recordkeeping.
According to Nancy, approximately 60% of audits are spent on SOPs/manuals and records (day-to-day), CCPs, supplier management/performance, training, CAPAs, team meetings, internal audits, etc. This is why it’s simply a good idea to keep internal audits going.
Additionally, if an auditor notes a non-conformance within records, or if corrective action records are not completed, it’s at this point an auditor with begin to look for trends, which can ultimately lead to a systematic breakdown and a more difficult audit overall. This is why it’s so crucial to make sure all records are in good shape.
A few key weaknesses that tend to surface with recordkeeping include:
- Lack of Ongoing Employee Training: Having temporary workers and a high turnover rate create huge challenges and require a lot more training on your end.
- Lack of Available Tools: Management teams don’t always give processors the right tools to capture important information.
- Incorrect Information: An example could be an incorrectly captured critical control point.
- Lack of Sign Offs and Verification Protocols: Verification is common error and is a reoccurring weakness seen with audits.
There are a good number of areas where recordkeeping is required, and not just of the day-to-day items, but also the more complex exercises. A few areas include:
4. Preparing Employees
So once you know your recordkeeping is good to go, how do you ensure your number one asset—your employees—are well prepared for what might happen? It can be really intimidating/stressful for employees to see a bunch of people walking through the plant with white coats on and with an auditor.
The only way to really help employees feel more comfortable is to prep them for possible interviews by providing them with common interview questions, which can definitely aid in relaxing them.
So…who do auditors interview?
Anyone! Yes, anyone within the company is capable of being interviewed, including key office positions.
Auditors expect all employees in the facility to know key information regarding food safety and your audit code. No one is exempt from these interviews, and it basically comes down to what the auditor feels like doing that day, so make sure everyone is prepared.
What should you expect from an auditor interview?
Some of the hardest parts to preparing for an audit are integrating a positive culture in regards to food safety. This does include employee behavior. To help prepare them for what they can expect, let employees know auditors are trained to be professional, ethical and courteous when conducting audits and interviews.
Additionally, they are also required to interview employees to ensure:
- Proper employee training has been implemented
- Management commitment is evident and proper resources are allocated to support the food safety program
- Adequate information has been trained to all employees in the facility
- Key positions have completed additional training topics related to their job skills or requirements
Common interview questions:
How do you prepare employees?
Training. There is no substitute for a comprehensive, documented employee training program. Auditors will look at what your training topics were, whether or not you do training with all employees, and examples of how you handle training for temps.
But training doesn’t have to be boring. Nancy shared an example of one of her clients using a GMP Jeopardy format for training, allowing everyone to participate and even win prizes. Try to switch up the format if you can, and remember to include images for real life situations to help emphasis key points.
Again, Nancy emphasized that training is most important and it must be ongoing and well-documented to ensure evidence is available for auditors. Auditors will know how well training is done by the interview results.
5. Facility, Equipment, and Cultural Compliance
When it comes to food safety, the most important factor is the processing environment. This is where food safety and practices come into play, and this is where contamination and the real risks are relevant.
According to Nancy,
- The facility, equipment and employee/company cultural drive the visual evidence of how an auditor views or ‘sizes up’ 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 60 minute window). This is not a code, but more of a general rule.
- Suppliers that operate under hygienic conditions; high grade equipment, building construction and employee practices, will earn more ‘initial respect’ from the auditor.
Ultimately, the auditor’s first impression is relevant.
Examples of the Good, Bad and Ugly
As the saying goes, a picture is worth a thousand words, but in some instances, no words can be found to describe some of "the ugly" Nancy has seen during her audits.
Facilities that operate with high standards, best practices and GMP’s, and instill a culture of “World Class Food Safety Practices."”
Examples of common, minor non-conformities, which can be avoided if ongoing training and compliance transcends from senior management through all departments and employees.
Examples of facilities that had critical non-conformances where automatic failures occurred and the evidence indicates no real commitment to true food safety and direct product adulteration was evident.
At the end of the day, if management is committed to the right food safety practices, and will provide adequate resources, food safety will be top of mind and the company culture will shift in a positive direction.
Watch our on-demand webinar, Inside the Mind of a Food Safety Auditor, with Nancy Scharlach to hear more about some of the good, the bad, and the ugly things she's seen in her career.
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