[Ask The Experts] How to Prepare for an Audit

Preparing for an audit is like studying for a final. Cramming the night before just doesn’t work, particularly when the "professor" (auditor) could appear with a "pop quiz" (unannounced audit) at any time.

Instead, just as students should attend class, review notes, and test themselves throughout the course of the class, food plants should apply audit-focused practices on a day-to-day basis, review existing systems for applicability and employee understanding, and test themselves for improvement. However, just as the final evening of study can help a student be more confident and do better on the finer details of an exam, so too can some final preparations make a plant audit go a bit more smoothly and show your facility in its best light. The following eight steps for preparation are a compilation of advice from industry experts Cathy Brandhorst, founder of Commercial Environmental Services, Inc. in Saint Augustine, Fla.; Tim DonLevy, president of DonLevy Laboratories in Crown Point, Ind.; Ronald Kauffman, president of Food Industry Sanitation Auditors (FISA) in Olathe, Kan.; and a Food Safety Summit presentation by Kendle/AAC Consulting Group Inc. President Ed Steele and Senior Consultant Carl Reynolds.

1. Review systems and documentation. Systems, practices and documentation are critical to any plant program, and they become particularly significant during an audit. Your documentation shows not only that you have systems in place but that you are following program practices on a regular basis, tracking the results and making changes for improvement. If you have not been keeping records all along, you won’t be able to create documentation for the audit; but at least a few days before an audit, you can and should:

 check all reports to ensure that the documentation is conducted at the correct frequency and that they are up to date. Although you can’t change previous inaccuracies before an audit, you can make current corrections and/or updates.

 review all documentation for any other disparities or variances for which inspectors may request explanation.

 organize reports in an easy-to-review format.

 compile all documentation in a single, easily accessible location, such as a conference room or extra office which has been allocated for the auditor’s use.

2. Review your food-safety plan, systems and Standard Operating Practices (SOPs). "Simply – You have to have your ducks in a row," DonLevy says. Programs need to be in place, run according to design, and signed off with documentation. "Whatever you say is there, you need to do." Review each program to determine:

 Is it serving the function for which it is intended?

 Are your managers setting examples of compliance and requiring complete adherence to all plans, systems and SOPs?

 Do employees follow the systems and understand their particular roles?

 Is documentation applicable and accurate for each system and program?

If you have defined, documented programs being applied on a regular basis, you will normally not have any problems in an audit, Kauffman says. "It’s the people who don’t follow their own programs that do [have problems]."

3. Conduct a self audit; make corrections. Once you’ve verified that your systems are in place, conduct a "mock" or internal audit. Use actual auditing forms and run through everything you’re supposed to be doing, Brandhorst says.

 If you come across anything that is not being done, "implement it immediately."

 If you find that you have more in-depth service deficiencies, it is often worth the investment to hire a consultant who can work with you on the area – particularly if the area is a critical component of a vendor or regulatory audit.

A self audit conducted in advance of the third-party audit gives you the time to adjust and improve systems rather than trying to apply a bandage with an overnight fix. "If you rush to do things at the end, a good auditor will know," Kauffman says.

4. Involve employees; hold employee meetings. "To be truthful, you ought to be ready for an audit at any time," Kauffman says, but it is helpful to hold employee meetings, review practices, and reiterate consequences of audit failures.

Employees need to know why audits are important to your business, Brandhorst affirmed, and what they can do to build success. Regular employee awareness meetings can help management relay the financial consequences of doing well on an audit; ensure that employees understand food-safety programs, why these are important and the reasons behind their specific duties; and reiterate standard GMPs, even those as basic as removing watches and jewelry, stowing personal items, and not chewing gum. Such GMPs should be automatic for all employees, but are actually often the cause of audit point deductions. "Even if the meetings are only five minutes a week, it makes it a priority to employees," Brandhorst says.

Ongoing meetings are of greatest benefit, but additional meetings just before an audit also can be helpful. While unannounced audits are standard for regulatory agencies and are becoming more and more common with third-party and vendor inspections, you generally know within a two- to three-month window when these will be occurring and can make some preparation for them.

Involving employees can also simplify program application and documentation, particularly in small plants, DonLevy says. Too often the plant manager and/or quality assurance manager are responsible for the entire system, resulting in the small plants having trouble maintaining all the necessary documentation and record-keeping.

5. Strive to impress. "Spring clean" your plant – get into the nooks and crannies, search for hidden spiderwebs, clean beneath pallets, paint walls to create a good first and lasting impression. Don’t worry that the inspectors will think you are trying to impress them, Brandhorst says, "Of course you are! You want to do everything the best you can." And of the inspectors, she adds, "They want to know that you want to impress them."

6. Expect – and plan for – the unexpected. Murphy’s Law says that if something can go wrong, it will; and you can expect this will apply in at least one area under audit. The most important thing to do when you encounter an issue is to handle it in a professional and thorough manner and take action. For example, if a condenser starts to leak over a rack the morning of your inspection, move the product and call for repair. "You’ll lose fewer points if you document corrective action, than if you say, ‘Yeah, it broke. We have to fix it,’’’ Brandhorst says.

If something happens during the audit, she advises, be proactive. Ask the auditor to stop the inspection temporarily while you take care of the problem. If at all possible, have the problem fixed before the inspector leaves.

7. Plan for improvement. Planning for improvement in food safety and security can be very important to inspectors, who want to know that you have continuous improvement plans in place. Let the auditor know what your strategies are for improvement over the next year, and ask for his or her recommendations or suggestions on other improvements to your operations.

"Be open to different opinions," DonLevy says. The purpose of an audit is to evaluate the systems, and if a plant is not open to change, the audit results will become one more piece of filed paper.

8. Know current regulatory priorities. In addition to all the previous, you can take a few extra steps to prepare for regulatory audits by doing your homework, Steele says. "Find out what FDA is looking at and prioritizing for the coming year." While this will not, by any means, prepare you for a full audit, it may flag some areas for extra consideration, such as allergens or food defense. Realize, too, he adds, that many of the regulatory inspections have been contracted out to the states and, thereby, hold the same authority as the FDA. "They are the same thing as if FDA came in, they are just done by state inspectors."

CONCLUSION. Of all the advice from the experts on getting your plant prepared for an audit, that which was most often repeated, virtually verbatim was: Do what you say you’re doing. Apply the programs you’ve set for your plant; ensure employees understand and follow the food-safety practices; document it all. Otherwise, as Kauffman states, it’s like having a Bible on the coffee table coated in a layer of dust. It’s there, but it’s obvious that it’s not being used. QA