Ryan Systems, Inc.

Validating Your Food Safety Preventive Control Plan with Teams and SPC


The newly finalized FDA FSMA Preventive Controls require that all registered food supply entities establish what the feds call “valid” preventive control plans and organizational systems.  According to the rules, your plan must be validated by a Preventive Controls Qualified Individual before you begin production.  These requirements are not sufficiently covered in FSPCA PCQI certification training and most PCQI certified personnel do not understand validation requirements or have the knowledge base required to protect themselves and the company from prosecution in the event of an outbreak.

Four critical process validation areas must be covered: 

  1. Process Design (Scaling-up the process from design to full volume)
  2. Process Qualification (Process must be capable of reproducible commercial manufacturing)
  3. Assurances that the process is in and can remain in a state of control.

Validation means that you must:

  • Understand the sources of hazardous variation
  • Detect the presence and degree of variation
  • Understand the impact of variation on the process and ultimately on product attributes
  • Control the variation in a manner commensurate with the risk it represents to the process and product
  • Reduce and eliminate the hazards
  • Provide documented proof

Validation of the plan means that your company will have to prove that it can control biological, chemical and physical hazards and is working to eliminate those hazards. This means you must establish systems to implement environmental sampling and be able to use the data from the samples to gain control over potential hazards. The data that is returned to you from the samples will provide you with baseline and ongoing monitoring information regarding how preventive your processes currently really are.

The data must be statistically analyzed, causes identified and procedural and process changes implemented to continually improve your internal operations. This is a giant leap in requirements from what we all have known as last year’s “food safety audit”. Quantitative evidence and objective analysis are replacing older strategies that were basically reviews of your ability to document activities as part of your verification requirements.

If you are afraid of “statistics”, this easy session by expert speaker Dr. John M. Ryan will make enough simple sense for you to begin developing a sophisticated strategy to attack chemical, bacterial and physical hazards and their causes. 

Why You Should Attend

If you plan to take or have recently taken the FSPCA Preventive Controls Qualified Individual (PCQI) training and do not understand the implications of the validation rules, you must attend this training.  As a PCQI, you are responsible and liable for your company’s ability to prevent human illness and death resulting from your company’s products.

As you learned, the validation plan must be approved prior to production under the approval of a PCQI.  Most companies require outside help to establish competent validation plans but you must begin today since the deadline for many company’s compliance passed on September 17, 2016.

FDA FSMA preventive controls require validation of food safety plans.  Validation is a specialized and demanding part of the rules on the preventive controls of human and animal foods that requires oversight by a PCQI qualified individual competent in research design, statistics, sampling, monitoring, SPC and other quantitative approaches that must be used to quantitatively demonstrate that processes from design to final product are valid.  Attendees must begin to understand what they must do to work with a PCQI validation specialist as part of rule compliance. 

This session is designed to help move employees to the validation competency levels required.

Areas Covered

  • Building a strong team support base
  • Know the difference between common and assignable causes
  • Understand the difference between control and specification limits
  • Calculate and establish baseline process capabilities and set improvement goals
  • Causal analysis
  • How teams bring processes under control with the Solution Tracking Sheet (STS)
  • Keep processes under control using SPC
  • Quickly and easily learn the SPC language
  • Establish an SPC monitoring system
  • Sample and collect valid monitoring data
  • Quantitative calculations and SPC made simple (add, subtract, multiply and divide)
  • Quickly develop process averages, range and p-charts
  • Interpret SPC Trends just by looking at them
  • Know when to make changes and when to leave things alone
  • Understand control limits and the place they play in decision making
    • Control limits
    • Statistics to make decisions
    • The meaning of six-sigma
    • Record keeping made easy

Who Should Attend

  • Preventive Control Qualified Individuals (PCQI)
  • Personnel working on preventive control plans
  • Compliance personnel
  • Food manufacturing, handling and storage upper management personnel
  • Food quality team member specialists
  • Food safety team member specialists
  • Mid-level personnel from all registered food operations
  • Trainers
  • Supervisors and some line personnel in food operations
  • Process maintenance personnel
  • Process design and line support engineers
  • Sanitation specialists


  1. Interpreting the Validation Rules
  2. Building a Team Support System
  3. Bringing Processes Under Control
  4. Keeping Processes Under Control (Statistical Process Control)

Who will benefit from this presentation:

PCQI certified persons who do not understand validation

Food safety and quality team members who might be afraid of “statistics”

All companies registered food operations and food importers in the United States

Presenter--Dr. John Ryan

Dr. John Ryan is a certified Preventive Controls Qualified Individual (PQCI) specializing in food safety process control and food safety plan validation.  He holds a Ph.D. in research and statistical methods and has extensive international manufacturing quality and operations experience in large and small manufacturing operations.  He is a retired Hawaii State Department of Agriculture Quality Assurance Division administrator.  He currently operates two business divisions focused on preventive control validation and food safety during transportation operations.  He has previously published books on food safety during transportation processes, food fraud, teams and teamwork and has recently completed a new book on validating preventive controls in food operations.