The majority of existing Hazard Analysis Critical Control Point (HACCP) programs were implemented a decade ago. These programs were generally designed as paper-based data collection and record-management systems. In the intervening years, the limitations of paper based systems have become painfully clear:
• Labor-intensive operations
• Transcription errors
• Difficult and time-consuming record retrieval and reporting
• Cost and space requirements for record storage
We have been researching the requirements to create a viable electronic HACCP (eHACCP) system that successfully manages the operational aspects of HACCP from collecting data to validating and reporting results (Figure 1). An effective eHACCP system must contain the following components:
Electronic data collection – The goal is to eliminate the manual clip board to reduce labor costs and improve data quality. The food safety technician interface should be configured to match the operation and Standard Operating Procedures (SOPs). The interface should enforce SOPs by data collection workflow control and govern workforce access through dependable sign-on identification procedures.
eHACCP should also support the data collection and handling associated with assignable cause and corrective action logging. This will not only be used to document the response to process failures but is also important for continuous process improvement (CPI) efforts.
Database – The system should be based on a secure, compliant database that can provide immediate data access and analytics to support CPI.
Alarming – The system should provide alarms when a critical value is violated. It is useful to incorporate statistical process control (SPC) calculations that can trigger advisory alarms on run or rule violations that indicate the process is destabilizing and in danger of violating CCP values. You can drill down to the analytics and charts, evaluate the process and take appropriate and effective action to guarantee food safety.
Analytics – The system should provide real-time operational understanding of the underlying process through SPC and related process analytics. Useful systems will also provide role-appropriate reporting to staff throughout the enterprise.
Reporting – The system should provide HACCP reports that meet regulatory, customer and internal audit requirements. This includes multiple level review and secure digital signature capabilities. These reports should be storable in the database and available for immediate retrieval when needed.
Security – The eHACCP system must include appropriate electronic security and comply with the electronic regulatory record-keeping requirements of either the FDA (21CFR11) and/or Food Safety and Inspection Service (FSIS).
The electronic system that meets these requirements has a number of critical advantages. First, there is an improvement in the accuracy of the data. Next, data are entered in a format that permits easy analysis. Often, HACCP data collected on paper forms are entered into a computer for further analysis. This frequently leads to input errors. In addition, the HACCP data might be used in a limited manner such as the verification prior to release of product. Usually, paper data are not analyzed to determine whether negative trends are present that may lead to future food safety incidents. Finally, the use of electronic systems reduces operational costs. Clerks do not have to re-enter data into the computer. There is no need to verify the accuracy of the data-entry process. Most importantly, the cost to store electronic records is less than the cost to store paper records.
Success in moving from paper to electronic systems is achieved by managing the transition as a project. The project includes the following key components: