If your food safety and quality assurance (FSQA) staff is like most, you may be struggling to determine how to comply with the Food and Drug Administraton’s proposed Food Safety Modernization Act rules in a way that will keep you within your operational key performance indicators (KPIs) — and remain competitive in an industry that already has low profit margins.

For a growing number of produce companies, large and small, the answer to this challenge is automation.

Automation can be a way to more effectively manage FSQA, comply with FSMA and lower costs with bottom-line return on investment.

A Food Safety Chain Management System (FSCMS) is an emerging automation technology designed to help ensure FSQA compliance and documentation at all points along a company’s value or supply chain.

I once asked my colleague, Dan Bernkopf, a 35-year “FSQA guy,” to sum up in a one sentence what FSQA is all about. He responded, “It’s about saying what you do, doing what you say, making sure it works and making sure it’s documented” — and that’s what an FSCMS does.

Let’s see how it works.


1. Say what you do

With an FSCMS, your regulatory, non-regulatory and program requirements are set up and pre-defined in the system — pre-loaded Global Food Safety Initiative codes, for example.

All components of your food safety plans — and the data sources necessary to support requirements — are also defined. This includes data from labs/equipment, forms and all standard operating procedures, prerequisite programs (PRPs), good agricultural practices and task schedules — agricultural water testing specifications and schedules, for example.

2. Do what you say

An FSCMS has a workflow engine that ensures all tasks are completed according to schedule; auto-notifications are sent when tasks are due — such as an alert to a field supervisor when an animal intrusion inspection is due. These systems also typically have mobile device capabilities to enable “at the source” form data capture — pre-harvest assessments, for example.

3. Ensure it works

An FSCMS has a verification engine that analyzes data in realtime against specifications. If results are out of spec, an alert is issued. The FSCMS can then automatically generate a timely corrective and preventive actions (CAPA) and track it to completion.

4. Make sure it’s documented

With an FSCMS, every component is time- and date-stamped — and accessed from a central repository of data as part of a company’s permanent FSQA record — for trending, continuous improvement and of course to comply with FSMA recordkeeping and audit requirements.

How does an FSCMS help compliance with FSMA’s proposed preventive controls and produce rules?

A FSMA-ready food safety plan under the Preventive Controls for Human Food rule requires six major components.

Let’s first look at each of these along with how FSCMS automation can help.


Requirement 1 —

Product and facility plan: FSMA requires companies to have a written food safety plan for every product/product group and facility. This could mean literally hundreds of PRPs, critical control points (CCPs), specifications and more — along with a potentially overwhelming increase in people hours to ensure plans are followed. Because an FSCMS allows you to define and schedule — with due/overdue alerts — an unlimited number of preventive controls/PRPs, CCPs, SOPs, GAPs, supplier requirements and more — compliance is facilitated in a way that ensures plans are followed and documented without the need to add more staff.


Requirement 2 —

Risk assessment: The Preventive Controls rule proposes that you must assess risks reasonably likely to occur — traditionally a daunting task because the information required is typically in different formats and locations — requiring many, many hours of manual entry for analysis. With an FSCMS, all FSQA test results, inbound certificates of analysis (COAs), CAPA data and more are accessible from a central repository of complete, time/date-stamped data — promoting in-depth analysis and trending for risk assessment.


Requirement 3 —

Preventive controls: Once risks are assessed, preventive controls must be put in place. FSCMS automation helps you manage preventive controls with the ability to set up automated schedules, task due date and time notifications and escalated alerts when tasks or tests are incomplete.


Requirement 4 —

Monitor, verify and validate: The rule calls for continuous monitoring, verification and validation of preventive controls to prevent food safety outbreaks vs. responding to them after the fact. With FSCMS automation, all data and information associated with safety plans — from all internal and external sources — is electronically gathered and analyzed against specs. The system then issues real-time alerts on deviations, deficiencies and omissions — allowing you to ensure tasks and tests are completed and preventing non-compliant products from going to the next point in your chain. I spoke recently to the quality manager from a produce packer who received a cellphone alert that a cold-storage unit was about to reach its high temperature limit. She was able to send someone immediately to assess and fix the problem before it was too late. Before deploying an FSCMS, she said she may not have received the alert in time and would likely have had to destroy product.


Requirement 5 —

CAPA and reassessment: The rule requires that when preventive controls fail, corrective and preventive actions be put in place and reassessed. FSCMS automation helps you comply not only with the realtime alerts to ensure timely CAPAs — but also with root cause analysis via upstream and downstream and internal visibility into all tasks and tests. The centralized repository of data promotes the ability to frequently reassess for continuous improvement — determining if hygiene retraining is required, as one of thousands of examples.


Requirement 6 —

Document: As we’ve heard said many times, “With FSMA, if it isn’t documented you might as well not have done it.” An FSCMS’ centralized repository of safety plan elements, test results, proof of CAPAs and more, supports this requirement with the ability to respond to audits and FDA and customer inquiries on demand.


Produce rule requirements

Just as with the preventive controls rule, FSCMS automation applies the same “Say what you do, do what you say…” principles to the proposed Produce Rule. Requirements are defined and scheduled. Data is analyzed to specs in real time for timely CAPA. Everything is centrally documented. So SOPs can be defined for training requirements: specs for agricultural water testing can be analyzed in real time; mobile devices can be used to send before/after pictures of biological soil inspections; notifications can go out for scheduled sanitation maintenance; the list is virtually limitless.


The ROI of FSMA automation

Sounds good, right? But while most organizations recognize the benefits, the reality is that it can be hard to get buy-in for technology investments given pressures to remain competitive and profitable.

An FSCMS, however, provides measurable ROI — making it easier to build a business case. FSCMS ROI falls into the following categories:


Don’t hesitate to automateTime and labor reduction: If your workload is growing but your staff is not, an FSCMS allows you to “do more with less” — spending time working on a CAPA for two certificates of analysis that were out of spec, for example, vs. having to spend hours pouring through hundreds of COAs to find exceptions. There’s a return on “people investments” too — having your quality manager spending time analyzing, vs. entering, data.

Audit Readiness: An FSCMS allows you to eliminate a large percentage of hours associated with FDA, GFSI and customer audits. You can also realize reductions in fines and deductions from lack of documentation, non-current forms and the like.

Materials and yield: Because test results are analyzed in real time, with alerts when deviations are detected, timely CAPAs are facilitated — preventing re-work and the chance of non-compliant raw materials, ingredients and packaging from entering production.

Risk mitigation: Real-time analysis and alerts also allow you to prevent many internal and customer withdrawals, rejections and recalls.

Continuous improvement: In-depth analysis from a centralized repository of data promotes continuous improvement — fine-tuning weight specs, for example — to help you make improvements that affect the bottom line.

Additionally, because FSCMS are cloud-based — without hardware or software to install — the cost of ownership is much lower than with traditional systems.

What do you think? Let’s start the conversation on Twitter at @thepacker and @LevinFoodSafety.