You are going about your regular day when you suddenly receive a call from security: “The FDA is here.” Having worked in food-industry back rooms, board rooms, and rooms in between for 40 years, I’ve heard numerous comments—some typical and others quite shocking. In chronological order from 1973 to 2015, following are just a few of these, along with lessons learned and a few tips.
“The FDA might come.” Yep, the FDA arrived to investigate the foodborne illness incident that affected a child. Lesson learned: Control Salmonella by not contaminating sterilized product. Separate uncooked material from cooked material by building in sanitary design with walls, traffic patterns, and air flow to clearly segregate uncooked from cooked products and ingredients.
“That’s not my job.” Lesson learned: Ensure you have job descriptions, responsibilities, requirements, measurable standards, accountability, performance reviews, and standard operating procedures for all positions.
“Do you know how much that will cost?” QA response: “Although it is difficult to capture QA savings when all is going well, it is easy to detail the cost of a serious food safety failure.” Lesson learned: Capture costs of non-quality to justify ROI for food safety improvements.
“You can’t stop production.” QA response: “I can hold the product.” Lesson learned: Make production accountable for quality. One cannot inspect quality into a product; and there is a difference between quality control and quality assurance.
“Why can’t I ship that product?” Substandard product was a surprise as lab information was completed after product was in the bag, too late for process adjustments. Lesson learned: Establish and measure in-process attributes predicting finished product compliance.
“My boss has more authority than your boss.” Lesson learned: Overriding QA decisions is a risky venture. Don’t have QA report to manufacturing. Having QA on the same level as accounting, engineering, maintenance, and manufacturing provides a balance of authority.
“We can’t do it that way.” Ignorance is bliss was an attitude of years past. Lesson learned: Educate and train your employees and contractors. A continuous-improvement culture and understanding of changes need to be clearly communicated.
“Take me back to the airport.” ... Following an undesirable plant tour as part of an interview process. Lesson learned: Don’t judge a book by its cover. Anything is possible with the right vision, mission, and management style and appropriate resources committed to quality.
“You have the authority of this high office, go do right with it.” Lesson learned: Use delegated authority appropriately. If one wants to recover from a crisis in an effective manner, lead teams to their goals by cutting red tape and providing the necessary resources in a timely manner.
“You don’t want to call the FDA.” QA response: “Customers are concerned and I don’t want so many inspections.” The FDA was called to provide a high-authority inspection and results were shared with all customers. Lesson learned: The FDA can help and be cooperative; no joke.
“Go take care of the issue, and don’t come back until it is fixed.” Lesson learned: A spending opportunity exists in assuring an issue does not repeat. During stressful times with short-term pressure, think long term to assure fixes will be sustainable.
“How much would a kid’s life cost us if we let that bad product out through the supply chain and into the public?” When a statement like this is heard in a board room, it means some executive does not see the big picture. Lesson learned: Provide the board with facts; educate and offer solutions. Refer to the company’s ethics in difficult decision making.
“The FDA will come.” In response to undesirable incidents in the food industry during 2007-2009 (i.e., pet food, infant formula, peanut butter)the FDA has unprecedented authority; quality assurance and food safety professionals have an unprecedented challenge. Lesson learned: TBD
Although it is difficult to draw conclusions regarding foodborne illness trends over the last 40 years, it is probable that foodborne disease is underreported and food safety has not improved. Some surveys indicate only 20% of Americans think food producers take food safety into account. Now is a good time to ask ourselves what we stand for. Too many consumers have lost trust with the food industry. Misleading customers or hesitating to do what is right in quality assurance and food safety will affect the reputation of the entire industry. Are you are in a “hide it” mode, reflecting a past attitude? Now might be a good time for an industry culture change by working with the FDA.