Have you asked yourself the following question?  How do I, as the person in my organization who is accountable for effective implementation of the company’s “Compliance Plan,” hold my fellow leaders i.e. operational, quality assurance, maintenance, management, procurement as well as the folks working on floor, accountable for reliably executing their part of the Compliance Plan?

FSMA (FDA’s Food Safety Modernization Act), RMP (E.P.A ‘s Risk Management Plan) and PSM (OSHA’s Process Safety Management) are all designed to reduce the likelihood and or consequences of an incident associated with your respective manufacturing systems. Each was born out of several major accidents that led to the need for governmental oversite. Today there are many large and small consulting firms with vast regulatory knowledge and experience that can provide your food Manufacturing Plant(s) with a Compliance Plan. It is then your responsibility to implement the plan, with the largest challenge to implementation being the “Human Element.”

Are you fully prepared for the inevitable knock on your door and an inspector from the FDA, USDA, EPA or the Department of Labor arrives and states that his/her presence as a “routine follow-up” with “follow-up to what” being left to the imagination.  Let’s presume that after spending sometime reviewing your manufacturing facility, talking with supervisory staff and reading your written “Compliance Program”, they have a few questions. While you may be prepared to address any equipment, operational or document questions, are you ready to address questions identifying shortcomings in the “Human Element?”  After all, the delivery of “safety” is dependent primarily on the human element, whether advanced, automated processing systems are used or if all of the processing activities are carried out in a more manual manner.

Fast forward to the wrap up meeting and the inspector compliments you on the completeness of your plan but notes several items you are not doing per your written plan.  Common comments are, “The written “Compliance Plan” is not consistent with the way that your supervisors and production staff are conducting their day-to-day operations.  Why?” As the Plant Manager or Compliance Manager you are surprised and disappointed at the same time. You want to blame the Consultant that authored your Compliance Plan but can’t, due to the compliments on your plan from the Inspector. Now What?

The human element
We as humans, unlike electronic devices have free will. For example: We can choose how we are going to accomplish a task. In contrast: An automatic sampling device can only perform sampling as it is programmed to do so. FSMA, PSM and RMP Regulated Manufacturing Operations rely on Compliance Plans that reduce or eliminate the likelihood and or the consequences of a failure.  Your Compliance Plan includes many Administrative Controls as a means to meet your objective of Regulatory Compliance. These GMPs, CGMPs, BMPs, etc., were generated by your industry and incorporated in your plan. But, does it take into account the Human Element?  Did you test, verify and regularly evaluate and hold accountable the Human Elements as you do your equipment i.e. Process Control, Automatic Sampling, CIP, Calibrations, etc.?

A thought on how to solve this problem is to first separate your engineering/mechanical/electrical compliance items from your Human Element-dependent procedures. Then, with the people who are performing these tasks (a requirement for a Process Hazard Analysis) determine “the way” each task will be done.  document and train as required, then test “the way” to ensure it is doable by all and delivers repeatable compliance.  Remember “the way” is likely to need modifications as it is implemented by others, receives their input and interfaces with other standard operational procedures.

Four guiding principles
When developing Administrative Controls for Compliance, I recommend:

Principle one – Nothing is created and perfected at the same time. When a better “mouse trap” is available to your process, you invest in new equipment to perform tasks quicker, better or at a lower cost. Do you invest the same effort in the Human Element? Most business leaders would agree that the effort isn’t the same. Why not?

The second principle is:  Say what you do. Do what you say.  When I have been asked to help a plant resolve a Compliance outage, I first determine if the plan was “incomplete” or was the expectation of effective implementation unrealistic. Most times the Compliance Plan, from an Equipment Engineering perspective is very good, but not enough effort was spent on the Human Element and this has led to serious operational interruptions due to compliance issues. We then work together utilizing the principles from above and can solve those nagging compliance issues.

The third principle is a – Realistic Assessment of Your Human Talent – In order to have an effective “Compliance Plan”, the human part of the equation must be capable and on-board with their assigned responsibilities.   It is always a good idea to step back and look at how each person, top to bottom, in your Company or Plant executes (Human Element) the FSMA, PSM or RMP Plan as it was written (Do what you say). If not, why?

The fourth principle is – Accountability.  The calibration and maintenance of the “mouse trap” is essentially an accountability effort to ensure the “mouse trap” is effective on accomplishing what it was purchased to do.  How about the Human Element?  I have seen a number of companies put much effort into rewriting compliance procedures, exposing supervisors and production floor staff to them and then never following up with a check to identify if the new procedures have been in-grained into the routine operational fabric of the manufacturing plant.

As you improve and updat your company’s “Compliance Plan”, it is important to identify the tools available, both your company’s internal expertise, past successes and challenges, outcomes of recent government and third-party audits as well as your own internal audits to determine the effectiveness of the current “Compliance Plan” and to identify a path to updating and effectively implementing a new or enhanced “Compliance Plan”.  The best written “Compliance Plan” can become completely ineffective if the Human Element is not factored in.  Problems with the Human Element need immediate attention as any implementation short comings in the written Compliance Plan require either a rewrite of the Plan or a correction of the Human Element.

about the author: Robert P. Lavieri of EAS Consulting Group’s Independent Consulting Group is an expert in the development and delivery of governance programs for the development of sustainable compliance systems. His expertise includes design, development, and implementation of Standard Operating Procedures, Best Practices, Good Manufacturing Practices (CGMP’s) and technical expertise across a broad range of compliance areas.

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