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Surviving a Third Party Audit –
the Good, the Bad and the Ugly!
NAFFS Staff Report
Attendees of the 100th Annual NAFFS Convention were treated to an in-depth presentation on surviving a third party audit by panelists Dolf DeRovira, president, Flavor Dynamics; Ramesh Shah, chief quality officer, FONA International, and Donna Schaffner, associate director, QA& Training, Rutgers Food Innovation Center, with Bob Weeks of Weeks Communications serving as moderator.
Schaffner focused on preparing for a third-party audit. She stressed the importance of good recordkeeping, noting these are legal documents that will be scrutinized by auditors. Included in those documents should be training records for all employees on personal hygiene, adverse health and any other food safety training required by the individual’s job description.
Schaffner said companies should prepare an in-house document that outlines who will be involved in the audit preparations, in-person during the audit as well as at the exit interview. Schaffner urged the audience to ensure ALL personnel understand that they are there to LISTEN, not to interrupt the auditor’s report or to argue with the audit findings. Any “mistakes” in the report should be immediately addressed by the senior “responsible individual” present, at the conclusion of the exit meeting. She stressed the importance of setting a timeline and a plan for executing any corrective actions at the conclusion of the audit.
The audit, she said, is centered around a hazard analysis that’s conducted to determine if any hazards exist that must be addressed by you, your supplier and/or someone further back in the supply chain. If any supply chain preventive controls are needed, there are stringent requirements for documentation to demonstrate those controls are in place, being monitored and have proven to be effective.
Shah spoke about the unique challenges of working with multi-national companies. “The local culture and business etiquette are quite different from ours,” he said. Challenges such as a language barrier and the need for reliable translation can be obstacles. He urged tolerance and said it’s important to listen when you are working in a foreign country. “Do not interrupt long speeches,” he said. “Other cultures don’t like to be embarrassed. ‘Loss of face’ is a serious matter.”
If you have bad news, be sure to deliver it privately, he warned. Patience is also critical when working with multi-national companies. Discussion takes place at a much slower pace than what Americans are used to. Be respectful of seniority and authority; everything must be OK’d by the boss. Nodding/shaking does not mean that they agree or disagree with you.
When traveling, it’s important to plan your trip well in advance and to expect the unexpected, Shah said. One trip to India he needed to use a plane, a train, a local cab and a rickshaw to reach his destination. A one-day audit can take three days to complete when you consider transportation, traffic jams and weather issues, he said.
On one GMP audit, he added, operators actually rode donkeys to work. “You can imagine the dirty, dusty conditions upon arrival. And there were no shower facilities other than hand and face washing. So showers had to be constructed and lockers and uniforms provided.”
Get to know the culture before visiting a country, Shah said. Don’t order beef in India or pork in a Muslim country. In China, he noted, it’s considered rude not to sample food from every dish offered. “So be sure to politely let them know if you are a vegetarian before going out to dinner,” he said. “And be very careful of political discussions – don’t even go there!”
When it comes to regulatory challenges, Shah said standards are very different and not updated in China, India and Southeast Asia. There is not a good understanding of Kosher, Organic or GMO. Third-party certification costs, he warned, will be higher in those countries.
DeRovira provided an outline of creating a food safety plan. “You need a qualified individual who will be required to prepare the food safety plan, develop the hazard analysis, validate the preventive controls, review records and conduct a reanalysis of the food safety plan,” he said.
When developing a HAACP plan, there are seven steps: You need to:
- Conduct a hazard analysis
- Identify critical control points
- Establish critical limits
- Establish monitoring procedures
- Establish corrective actions
- Establish verification procedures
- Have a record keeping procedure
This must be focused on the specific facility, he said. “For example, are there microbial or allergen potential hazards? Once you know that, you can establish critical limits.”
He said there’s some confusion as to the difference between validation and verification. “Validation equals – does it make sense that what you are doing works? And verification means to verify and prove that it is working.”
When it comes to corrective actions, DeRovira said one needs to know the root cause. “You need to find out why it happened so that you can prevent it from reoccurring. Once that is established, you need to monitor it to make sure you solved the problem.”
Recordkeeping has been cited by many as one of the biggest hurdles to successful audits. “If it wasn’t recorded, it was never done,” said DeRovira. Keeping thorough records is of utmost importance, he stressed.
DeRovira said since there are different types of audits, it’s important to get details about the audit in order to properly prepare. He also mentioned some common problems. “If you have allergens, how are you storing the allergens? If you have compound allergens or unlike allergens, you can’t store them above one another. For example, don’t store soy and dairy together. Train your staff (and document it). Stress to them if they see an ingredient, to be sure it is labeled properly,” he said. Take steps to effectively monitor compliance. “For example, you can do a quick swab occasionally but be sure to do a quantitative analysis at least once a year to make sure your cleaning program is safe and effective,” he said.
For those who’ve never been involved in an audit, DeRovira suggested a pre-audit. “Pay someone to come in and give you an idea of what you are looking at. It will be worth it in the long run.”