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How to Be Audit Ready All the Time – Q&A with Experts

Posted by Tara Guthrie

Jul 7 2016
Jul 7 2016

The food industry’s dense regulatory landscape has evolved significantly in the era of FSMA, the “new” FDA investigator, GFSI, and increased liability exposure. With new regulations launched this year, increased inspection mandates, and looming deadlines for compliance, how can you set a “new normal” of being audit ready all the time? Take this advice from food policy experts.


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Will you be ready when FDA inspectors arrive? 

There’s increasingly more emphasis on food safety culture. How do you go about establishing a culture of food safety? 

Melanie Neumann: This question is more important than ever. In years past many in the industry may have talked about food safety culture, but few put actual practices in place to create. Mainly because safety culture is difficult to describe and even more difficult to quantify. However, in the last few years significant research has been done to understand what food safety culture looks and feels like in a food company. Even better yet, companies are beginning to understand how to measure food safety culture and set performance indicators against it. All this excellent research reveals several different yet effective definitions for food safety culture.

 

What is the first step supervisors should take? 

MN: Food safety leaders should meet with their food safety teams and start by defining what “food safety culture" means to their organization and team.

 

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How can leadership teams keep safety training information top of mind for employees without overwhelming them with too many different topics?

Laura Nelson: Concern for overwhelming employees is very valid. The National Center for Biotechnology Information published research showing the average attention span is now 8.3 seconds – less than a goldfish! Leading food companies recognize that classroom training is just one facet of learning. Building and delivering effective awareness programs through the use of posters, huddle guides, digital signage, company newsletter, etc. helps to reinforce critical fundamentals that sustain safety culture. 

There is tremendous value in joining forces with your colleagues in food safety, workplace safety, HR, and operations to establish a unified training strategy on critical competencies. These should be implemented for all job functions. Establishing consensus on those topics allows for a plan to be established on the time needed for employee training.  Finally, empowering front line supervisors to validate those key employee behaviors are being applied on the plant floor helps to reinforce training.

 

FDA Audit Ready All The Time

 

What do you predict for the future of regulations and liability in the food industry – do you think the risks will continue to rise? 

MN: Unfortunately yes, I do think the risks will continue to rise. That is one of the many reasons why I do what I do for a living--to help the food industry understand, prepare for, and reduce these increasing legal, regulatory, and brand risks that we see hitting manufacturers harder than ever. 

FDA is waging a war on pathogens--when companies have a foodborne illness outbreak causing a human illness the agency will be investigating, and the Department of Justice (DOJ) will not be far behind, The DOJ will likely conduct its own investigation into potential civil or criminal liability as well. 

 

Oftentimes, frontline employees are hesitant to speak up about issues in the plant, how do we encourage employees to speak up?

LN: When frontline employees are given positive reinforcement and/or recognition for identifying issues in the plant, employees will embrace this responsibility. Unfortunately, some companies fall short of establishing a culture that facilitates two-way communication with employees. For example, if an employee points out a broken machine guard and is subsequently blamed for it, then all employees learn not to communicate these type of issues out of fear. Instead, employees that recognize food safety or workplace safety risks should be celebrated so that a culture of shared responsibility is created. 

This approach to two-way communication may take some additional training and coaching up front, but the results can yield a tremendous ROI on the time and resources spent. When this shared responsibility is done well, companies have grown their internal audit program to every facet of their plant at any given moment of operation.

 

Why do you think more than 60% of employees who have been trained are not following their food safety program on the plant floor?

LN: Many companies are working with lean now more than ever. Yet, operations have more to manage, more complex equipment, more demanding customer specifications, more diverse workforce, more regulations – and the list goes on.  Because of these competing responsibilities, training requirements. These sometimes fall to the bottom of management’s to-do list. 

Because of competing time and resources, training events – especially onboarding – may be provided in large chunks of time like one day covering all company policies, food safety, and workplace safety training. Remember the average attention span? Large information dumps like this are simply too much for employees to retain. 

Additionally, our workforce changes significantly over the years but our training materials often fail to keep up with the times. For many, courses may not be updated for years, and out of date training will no longer engage employees that have already completed them. Mind of the Food Worker research indicates that employees often consider training content too complex, and often targeted to an inappropriate education level.

 

How do we bridge the gap between training and practice on the frontline?

LN: Simplify the training. Bridge cultures and languages. Use images as opposed to excessive words, and continually update the content. Incorporate elements that encourage employee engagement. Most importantly, offer the training in small chunks. As a rule of thumb take about 15 – 20 minutes or less per topic and employees will retain more. 

Employee knowledge is just one aspect of converting training to skills and habits. Validating worker behaviors, and understanding how they apply their knowledge on the front-line is essential to any safety culture. Companies that empower their frontline supervisors to coach their employees and have their employees conduct peer to peer observations not only drive compliance, but also keep their employees committed to upholding a culture of safety.

 

Documentation continues to be a challenge for many facilities, do you have any tips on best practices for record keeping and documentation?

MN: I am often quoted for the following "If it’s not documented it didn't happen." But it's true. Agencies have no way to verify a manufacturer is monitoring and verifying its process preventive controls, or has validated its pasteurizer if it doesn't have the appropriate records to substantiate it. Simply "saying" you do what you are supposed to be is far from sufficient enough to satisfy a regulator, or a customer (or a lawyer).

Also, find a way to access your records quickly and easily. Leverage technology when possible to produce records in a timely manner. The FDA now has a 24 maximum records production requirement. There are several records required--including your training records! 


ABOUT THE EXPERTS 

Melanie Neumann, J.D., M.S.

Melanie Neumann, J.D., M.S. is the President and Global Food Safety Attorney of Neumann Risk Services, LLC, (NRS), a food law firm that helps companies manage various risks where law, food safety, food science, and the brand intersect. Melanie has over 18 years of experience advising food and beverage companies. She leverages her years as a food lawyer and her master’s degree in food safety to help industry clients understand legal, regulatory and business risks relating to food laws and regulations as well as food safety risks.

Laura Dunn Nelson
Laura Dunn Nelson is Alchemy's Vice President of Business Development. She brings over 30 years of experience implementing food safety and quality control programs for processing, packaging, food service, and retail operations. Laura has worked with global retailers and manufacturers in the implementation of their food and workplace safety programs. She has assisted food companies in the successful implementation of good manufacturing practices (GMP), quality assurance, and HACCP programs. 

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