Making the Most of Audits

The unexpected arrival of an FDA inspector can be stressful. One rarely knows where the area of focus will be. Even routine inspections can dive deeper if the investigator notes something of interest during the audit. But there are other types of audits that may be more concerning.

A targeted audit occurs when FDA is reacting to specific risks in the industry such an outbreak or food safety trends. If an inspection has significant findings, a compliance follow-up inspection will verify corrective actions following a previous audit. For-cause inspections are often expedited as the agency is responding to a specific issue such as an illness outbreak in which the company’s products may be involved.

Routine Audits

Routine audits, such as internal or third-party, help keep the operation on track so that FDA’s visit has limited findings. Internal audits gage the state of the operation at regular intervals. The internal audit program should define the frequency, the scope, recordkeeping and the party responsible. Different types of internal audits can be conducted at various times throughout the year.

For example, a facility audit could encompass areas in the warehouse or manufacturing environment and scrutinize cleanliness and the condition of structural components, lighting, and equipment. An assessment of GMPs might be included in this audit to evaluate employee compliance with company policies such as not wearing jewelry or fingernail polish. Employee practices such as improperly storing sanitation equipment might be noted.

A document review of records, SOPs, and policies might comprise another type of internal audit. An annual review of the entire food safety system could cover customer complaints, supplier issues, processes, corrective actions, employee training, available resources, the food defense plan, and if warranted, the allergen plan.

Finally, a critical look at the food safety or HACCP plan and associated records will establish the validity of the food safety plan by determining whether  preventative control measures have been operating as intended and effectively controlling the identified hazards.

“Internal audit reviews can identify gaps in the system,” said Julius Patkai, Julius Patkai & Associates. “Conducting internal food safety audits can provide a great deal of benefits to organizations, such as improving your food safety culture and awareness, enhancing your food safety performance and compliance, and strengthening customer trust and satisfaction."

Third-Party Audits

The third-party audit takes it to another level by having a fresh set of eyes look at the entire operation. Although a variety of schemes are available, customers often dictate the type of audit required: GFSI, BRC, SQF, ISO, or another.

Like an FDA audit, the third-party audit provides an unbiased view. During the physical inspection, the auditor might see details that may go unnoticed by in-house staff such as a slit of light beneath a dock door or a plastic strip curtain that’s touching the floor.

An analysis of policies and SOPs along with an accompanying examination of records verifies that written programs and company practices align. While third-party audits don’t dictate the way a company writes its programs, they must meet the scheme’s expectations. Environmental monitoring programs, for instance, should be based on the company and its products’ risks. This will be reflected in the zones that are swabbed and the types of pathogens that are tested for. Thresholds and corrective action measures should be reasonable to the industry.

A strong advantage of the third-party audit is the focus on areas that are easily overlooked by the organization. Pest control records are a prime example. Because most businesses hire an outside company to provide services, they often assume that unless they see any evidence, the job is being done correctly. It’s not unusual for an auditor to examine the paperwork and find that reports aren’t accurate. There might be discrepancies between the number of bar-code scanned traps and the number of traps depicted on the map. Technician licenses might not be current. The scope may be misleading. Worse, during the physical inspection the auditor might discover an issue with bait stations or traps.

Audit results, corrective actions, and root cause analysis provide the means for the organization to continually improve the effectiveness of the food management system. Importantly, these steps help companies stay current.

Food safety schemes and regulatory requirements are continually changing. Third-party audits can help companies stay prepared. Patkai concluded, “Third-party audits evaluate food safety performance, identify gaps in an operation, maintain customer quality/food safety expectations, mitigate food safety incidents such as product recalls and traceability, and ensure compliance with FDA/FSMA regulatory requirements.”

Following a schedule of audits, both internal and third-party, is important to building a strong food safety culture. While compliance with customer and regulatory requirements is critical, maintaining a pro-active atmosphere among managers and employees has far-reaching benefits, not the least of which are preventing costly recalls and protecting the company’s reputation.