Part 3: Systems and Documentation

In the absence of proper food safety systems, the ability to consistently produce safe foods is not assured.  Leaders of food and beverage processing companies should expect their teams to have systems in place that are robust, documented, reviewed and audited.


A food safety system includes the processes, procedures, and responsibilities for achieving food safety policies and objectives. With implementation of the Food Safety Modernization Act (FSMA) for FDA-regulated facilities, Food Safety Plans along with Good Manufacturing Practices and other prerequisite programs have become key components of food safety systems.  Food Safety Plans include the hazard analysis which in turn is used to determine the risk based preventive controls needed for processes, sanitation, allergens and the supply chain.


Documentation includes training, specifications, formulas, hazard analyses, validation data for process controls, sanitation records, supplier management documents, ingredient certificates of analysis, processing logs, temperature monitoring, lot information, lab testing records and more.  Basic forms of documentation are paper based.  Paper records are commonly used, but expedient access to those records for trending and traceability is a challenge.  There are many information technology (IT) solutions available that can simplify the process of documenting systems and provide excellent tracking and trending capabilities.  Some examples of IT systems that support food safety systems and documentation:

  • Document management systems to manage important food safety system documents and records.
  • Corrective Action/Preventive Action (CAPA) programs to manage non-conformities in the food safety system.
  • Statistical Process Control (SPC) systems which can be used to manage critical-to-food safety and critical-to-regulatory processing and packaging controls.
  • Supplier Management Systems to manage important supplier and co-manufacturer information, including audits.

Many companies are implementing Product Lifecycle Management (PLM) IT systems as part of product innovation and brand protection risk management strategies.  Kalypso is a global innovation consulting firm that provides information on PLM implementation and use of this broad IT system approach to support food safety systems and FSMA compliance.

How does a food company leader know if food safety systems are in place and adequate?  A key component of a food safety system is an audit program (self-audits and third party audits) to verify the systems are in place and executed.

Next in this series we will discuss the facilities and equipment infrastructure needed to achieve food safety by design.