Joe Stout: Audit prep is no small task

by Joe Stout
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As an auditor, plant quality manager and sanitation manager over the years, my quest was to be always audit-ready and have a facility and equipment considered “food safe” at all times. Let’s define what this means. In the scope of a typical third-party or internal corporate audit scheme, it defines how well a facility conforms to applicable sets of quality and food safety standards, every minute, every hour and ­every day — yes 24/7 — regardless of shift. This refers to having the correct documentation and records and having flawless execution consistent with them.

Audits, whether internal, external, government or part of a Global Food Safety Initiative (GSFI), all induce a level of anxiety prior to and during the audit, at an exit meeting and finally when the report arrives. The anxiety is well-founded as these can be facility-changing events. If the plant is not acceptable, a company could lose business, receive regulatory warning letters or even become perceived as unfixable to a parent company, which could mean closure over time.

On the positive side, a good audit can be beneficial for a bakery, increasing volume, gaining a good reputation within the company or with regulatory agencies, and establishing a path forward for capital investment and growth. From a career perspective, it can either be positive as a promotional opportunity, or if it does not go well, a negative for the plant staff and the manager. At times, a failed audit can even be what’s commonly known as a CLM, or “career-limiting move.” 

Audits can be equally risky for the auditor, as well. What if something important is missed during the audit and the visit is followed by a recall due to an issue that should have been identified? What if the audit is followed by a regulatory visit, which finds unsanitary or otherwise violative conditions? We have seen a few of these in the past several years. As an auditor, I experienced this and fortunately documented items, only a week later were identified by a regulatory agent, who subsequently created a generous list of violations noted on a Form FDA 483. This could be a CLM for an auditor. 

Such potential ramifications reveal why audits are so important. The challenge is how to manage audits to optimize the score and the food safety systems while ensuring the systems and fundamental food safety practices are sustained following the audit. Unfortunately, in some situations, audit preparation can take months to ensure proper documentation and execution yielding a good audit score. However, if there is not continued diligence on the paperwork and the execution, the only benefit of the audit preparation is a good score based on a few days of observations. This postpones the CLM concern, but without continued diligence and commitment to remaining audit-ready, failure is imminent.

To be successful, an auditor must be knowledgeable about the process, regulation and standards and be inquisitive and focused on food safety programs and their execution. Oftentimes, depending on the standard, the time needed to review the programs and documentation is overwhelming, which leaves little time to spend on the plant floor examining execution. Unfortunately, this is a missed opportunity, as many floor issues tend to go unnoticed. Many auditors spend 75% of the audit reviewing documentation (to satisfy the expectations of the standard and reporting requirements) and 25% on the floor observing program execution.

When I audited, I had the freedom to spend 75% of the time on execution and then 25% evaluating programs. This allowed me to observe operational execution, where programs are truly tested. The goal was to encourage modification of the weak execution on the floor and the programs that governed them.

Preparing correctly for an audit is vital to scoring well and making sure the work is sustainable, so you can be audit-ready in the future. The adage of “do what you say, say what you do, and prove it” is a good start. However, what you do must meet the criteria of acceptability of existing standards. As a simple example, you cannot use a cat in your facility to control mice. This would be effective to control rodent populations but would be an unacceptable ­control method.

The standards and codes must be articulated in your policies, procedures and work instructions to meet expectations of the standards you are working with. If your goal is GFSI certification, you must choose an audit scheme you feel comfortable with, select your product categories and meet those standards and expectations.

Keep in mind, the score should not be the end goal. It should be an opportunity for continuous improvement based on a thorough investigation targeted to identify potential food safety risks and their corrections. It is about continuous improvement and understanding new opportunity areas. To a large degree, GFSI audit schemes are focused more on the documentation process and less on the execution. Nonetheless, these schemes have driven improvement in the food industry’s programs and associated execution; they should be managed and visible to company executives.

These points are important to consider, but they are strictly a reflection of the plant’s condition at the time of the audit. The term “audit ready” takes us to another place, which is to be always consumer ready. That’s right — someone will eat this food; therefore, we should focus on executing perfectly ­every time while maintaining perfect documentation.

With the recent FDA hearings on the Food Safety Modernization Act, consumers who lost loved ones or who were seriously sickened testified on their specific situations. These true stories were heart-wrenching to hear. They triggered in me a memory I have had for years, which has been a great reminder of how important quality, sanitation and food-safety functions are in the food industry. In 1998, following a large retail meat recall, Helen Bodnar lost her life due to listeriosis. At the time, 20/20 ran a segment on the recall and focused on Helen and her husband, John. He recalled the pain Helen experienced and her struggles with the disease as it took her life. This segment made a lasting impression on me. John and Helen reminded me of my own parents.

It was a tragic story and has been a constant reminder of the responsibilities of those working in food safety. An audit score is important; however, being audit-ready and food-safe mean everything to consumers of the products we make.

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