What Exactly Is Meant by FDA’s Qualified Individual?
By Jose Sabal
It is known in all industries that the biggest difficulty in achieving product consistency is the capability of employees of performing validated activities exactly as they are documented. Otherwise, the activity will not be valid, and a hazard may be present. Personnel management is not an easy task to implement, even with well-defined policies, procedures and experienced and capable human resources managers.
By nature, people differ. We all have different backgrounds and experiences. Some are capable of accepting criticism and can change their behavior accordingly. Some have characteristics that allow them to stand up after falling and keep going. Others are always looking for better ways to do things and not relying on “…we have been doing this exactly the same way for over 15 years…”
As of today, we know that the implementation of the Food Safety Modernization Act (FSMA) rules will rely on a “qualified individual.” The current definition describes this person as such:
“A qualified individual would be required to prepare the food safety plan, develop the hazard analysis, validate the preventive controls, review records and conduct a reanalysis of the food safety plan (or oversee these activities). To be qualified, an individual would be required to successfully complete training in accordance with a standardized curriculum or be otherwise qualified through job experience to develop and apply a food safety system.” Source: FSMA Proposed rule for “Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food.”
Therefore, a qualified individual will be required to:
• Prepare the food safety plan
• Develop the hazard analysis
• Validate the preventive controls
• Review records
• Conduct a reanalysis of the food safety plan
All the activities mentioned above imply that the qualified individual must be “capable.” Is a qualified individual capable of performing the activities above just by successfully completing training in accordance with a standardized curriculum or by being otherwise qualified through job experience to develop and apply a food safety system?
It is known that, to consider a person capable of performing an activity effectively, the person must have the necessary knowledge, skills to effectively apply the knowledge and, most importantly, the right attitude. Each of these components is independent of the others.
We all can attend a class or course and understand the content of the training; this makes up the knowledge component. People can demonstrate knowledge by taking a test and passing it. Does this mean that a person is capable? In my opinion, the answer is no. Many people obtain degrees in college. When they start working, they are not found to be able to deliver the results expected. On the other hand, many people don’t have a degree in college and they excel in their jobs. My point is, taking a class and passing an exam or test does not necessarily qualify a person to perform an activity.
In regards to the experience, based on the definition of a qualified individual, this person must be able to prepare a food safety plan. This means, among other activities, that this person must be able to do the following:
• Understand what the requirements of the law are and how to implement them
• Search for all the regulations that are applicable for his/her industry
• Read and understand the requirements
• Develop documentation and procedures that can be validated
• Effectively train employees using those validated procedures
• Verify they are capable of performing the activities according to such procedures
Employees must also monitor those procedures to maintain evidence that they were performed as approved and, if there is a deviation, they must identify, isolate, assess and decide the final disposition of product that might be affected by a deviation and develop an action to prevent reoccurrence. All of the aforementioned activities require knowledge and experience about food safety hazards, how to evaluate their risks and how to develop procedures or controls that will effectively control them.
The final section of this article includes attitudes that people exert. No one can change the attitude of another person but can influence it. Attitude is what makes someone motivated to keep trying even after failing.
While watching a presentation delivered by Victor Küppers about attitude, he said to calculate the value of a person, you need to add the knowledge and the experience (skills). Then, multiply by the attitude. Having the right attitude multiplies the knowledge as well as the skills.
Going beyond the qualified individual, the food safety culture in any food processing or manufacturing company heavily depends on the attitude of the individuals that make up the company.
It is up to senior management to understand that they alone have the power to influence a positive change towards the creation and maintenance of this culture by selecting a qualified individual that has the knowledge to successfully complete training in accordance with a standardized curriculum and be qualified through job experience to develop and apply a food safety system. In this way, the qualified individual would have the right attitude towards the responsibilities assigned to him or her.
Jose Sabal is a food safety consultant, trainer and auditor at Sabal Food Safety Consulting. He can be reached at 786.210.3635.