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LEVERAGING TECHNOLOGY

TO AUTOMATE A FSMA-READY FOOD SAFETY PLAN

Copyright © 2018 SafetyChain Software

Leveraging Technology to Automate a FSMA-Ready Food Safety Plan

Introduction

As part of the FDA’s Food Safety Modernization Act (FSMA), food and beverage companies affected

by the ruling must discern which regulations apply to them. More importantly, they must also determine

which measures should be put in place to ensure compliance. To effectively navigate this process,

companies must start by identifying the gaps of current food safety plans relative to the program’s

requirements. Only then can new food safety plan procedures be successfully incorporated into overall

programs.

In updating their programs to comply with FSMA, companies throughout the food supply chain are

recognizing the value of leveraging technology and automation to handle the influx of complexities

and recordkeeping requirements. The technology available today can help them more effectively fulfill

requirements and ensure compliance.

Not only does technology aid in keeping track of and ensuring completion of Prerequisite Programs

(PRPs), Corrective/Preventive Actions (CAPAs), and FSMA’s in-depth documentation requirements, but

it can also help create bottom-line Return on Investment (ROI). Hard-dollar savings can be realized by

creating operational efficiencies that improve overall food safety and quality assurance (FSQA) program

management.

In this guide, we’ll explore how technology can help you automate an effective FSMA Food Safety Plan,

including:

The 6 core components of a FSMA Food Safety Plan

How automation helps manage food safety plan complexity

What to look for in a technology solution

How SafetyChain’s solutions can help

Let’s begin by looking at the factors needed in a FSMA Food Safety Plan.



The 6 Key Components of a FSMA Food Safety Plan

Each company should adopt its own unique food safety plan that supports its specific goals and

program requirements. With that said, there are six key components that every FSMA Food Safety Plan

should encompass, which are outlined below.

1 – Product and Facility Plan

Any food and beverage company under FSMA governance must have a written food safety plan in place

for each product or group of similar products; as well as the facility itself. This requirement could mean

that thousands, or even tens of thousands, of plan components would need to be written, incorporating

elements like PRPs, CCPs, specifications, and more.

More importantly, the plans cannot simply be written and set aside. There must also be demonstrable

proof that product and facility plans are being implemented and monitored on an ongoing basis. These

practices will be discussed in further detail in upcoming sections.

For now, however, consider the ways in which writing and putting these plans into action could

significantly impact your company’s resources. From keeping track of physical plans to actively ensuring

the plans are being followed, successfully implementing a FSMA Food Safety Plan can lead to potentially

overwhelming increases in people hours.

2 – Risk Assessment

A FSMA Food Safety Plan requires companies to identify potential hazards throughout the supply chain.

For your plan to be FSMA complaint, you must assess all risks that are reasonably likely to occur. From

that point, you must identify which are deemed significant. While the FDA does not provide a standard

definition of significance, FSMA does indicate that if someone knowledgeable in food safety would

see the risk as a hazard that they would want to control in order to protect the public, it should be

considered significant.

Potential hazards could include biological, chemical, and physical risks. You can identify risks based on

experience, the past history of your product, or that of similar products. Ultimately, however, for even the

most experienced companies and food safety managers, this process also tends to be labor-intensive,

requiring many hours of manual entry for analysis.

3 – Preventive Controls

Once risks are identified, you must then establish controls which will be put in place to mitigate them.

The Preventive Controls within your Food Safety Plan should be designed to do all that is possible to

prevent potential risks from occurring. It is important to note that the controls for a FSMA Food Safety

Plan can extend beyond hazard analysis critical control points (HACCP), and must also encompass

factors such as process controls, allergen controls, sanitation controls, training, and recall plans.



Managing Preventive Controls is among the most demanding aspect of food safety managers’ roles. With

the new regulations set forth by FSMA, it is likely the time and attention needed to effectively design and

maintain a plan with thorough Preventive Controls will only increase.

4 – Monitor, Verify, and Validate

The only way to ensure your FSMA Food Safety Plan works as it should is to actively monitor, verify, and

validate Preventive Controls. Continuous monitoring is required by the FDA, so not only will the plans

themselves need to be presented upon audits, but also proof of ongoing tracking. After all, the purpose

of FSMA is to prevent food safety outbreaks, versus responding to issues after they arise.

Ultimately, the ways in which your company oversees and tracks performance of the safety plan is up

to your discretion. With that said, tracking controls on an ongoing basis and documenting results are

two critical aspects of a successful plan. To ensure the plan is indeed working, you can measure specific

parameters such as belt speeds, temperatures, and so forth. You might also consider monitoring an

aspect of the environment, testing your product, or finding a similar means of tracking data. As you

might imagine, manually tracking such a significant amount of complex data over an ongoing basis can

become a substantial administrative burden for your food safety teams.

5 – CAPA and Reanalysis

According to FSMA, when Preventive Controls fail, CAPAs must be put in place. Plans and controls

must also be revisited periodically to ascertain whether any areas of improvement can be addressed. In

general, plans should be readdressed at least every three years, or if a food safety incident occurs and

was caused by a failure in Preventive Controls.



The objective of a FSMA Food Safety Plan is to identify CAPAs before they are needed. Thus, instead of

scrambling to come up with a solution after a safety or quality issue occurs, your company will already

have a plan in place so remedial action can be taken promptly and the impact can be minimized.

As with the other components of a Food Safety Plan described above, manually keeping and retrieving

CAPA records can be tedious and cumbersome. Moreover, it also leaves your records vulnerable to

human errors.

6 – Documentation

With FSMA, it is often said that “if it isn’t documented, you might as well not have done it.” Indeed,

every component of your plan must be documented: the programs in the Food Safety Plan, proof of

completion and validation, all test results and supplier documents, and CAPAs.

The objective is for your facility to be able to tell a narrative about your FSMA Food Safety Plan. When

you are able to show an FDA inspector that you not only understand your facility’s plan and its risks, but

that active management is also taking place, preparing for and undergoing audits will become much

simpler. In your documentation, you should be able to clearly demonstrate your challenges and how your

facility has managed them over time.

Without a single, unified system of records, the documentation process can go awry. A paper-based

approach can lead to inefficiencies, redundancies, incorrect data, and poor audit preparedness.

Additionally, when an audit approaches, efforts by your FSQA managers will be directed towards

organizing and pulling records, thereby potentially leaving your food safety programs at-risk in the

interim.



How Technology Automates FSMA Food Safety Plans

Based on the considerations outlined thus far, it’s clear that for many companies, successfully managing

complex FSMA requirements is arduous at best. With nearly 70% of companies polled in the 2017 Food

Safety & Quality Operations Survey by SafetyChain and the Acheson Group falling under FSMA, the evidence

proves that this latest FDA reform will continue to impact the majority of food and beverage companies

for the foreseeable future. The ability to stay competitive and perform well in audits therefore lies in

implementing solutions that can support the six components listed in the previous section of this eBrief.

Here’s how technology addresses each of the challenges outlined above:

Manage Multiple, Complex Plant & Facilities Plans

If you have very distinct products, each with their own set of risks, a separate plan must be in place for

each. Managing the multifarious steps for a number of unique plans can be complex, but FSMA software

can help through the following capabilities:

Define an unlimited number of specifications, Preventive Controls/PRPs, CCPs, Standard

Operating Procedures (SOP), Good Agricultural Practices, supplier requirements (including

documents associated with FSMA’s Foreign Supplier Verification Program), and more.

Electronically identify definitions by product/product groups and facility.

Set times/due dates for al PRPs, SOPs, CCPs, etc. through automated task scheduling. Further

define initial versus escalating alerts to further facilitate completion.

Maintain all of the elements above – regardless of number of facilities or locations – via one

centralized data repository with dashboard access for monitoring, trending, audits, and a real-

time, comprehensive look at your entire operations.

Not only does having all of your plans readily available via one convenient system aid in ensuring food

safety; it also provides you the tools and data needed to support continuous improvement, including

lowering operational costs and increasing your bottom-line results.

Pinpoint Risks More Precisely

Less than half of respondents (45%) in the previously-referenced survey stated that they have a viable

risk management strategy in place. Risks cannot be managed without first accurately identifying them.

While assessing risks requires in-depth analysis of a broad range of data, a comprehensive FSQA

software solution can help. Specifically, it will:

Ensure all FSQA test results, inbound COAs, CAPA information, and additional records are

accessible from a repository of complete, accurate, and up-to-the-moment data.

Provide actionable insights through analytics to help you identify trends and track KPI

performance so weaknesses can be readily pinpointed.



Enforce Preventive Controls

Managing Preventive Controls has been traditionally time-intensive, consuming a significant amount of

FSQA managers’ time and attention. With the help of a modern FSQA system, you can effectively manage

Preventive Controls with the ability to:

Establish schedules and notifications

for all Preventive Controls for complete

automation.

Analyze inbound COA information and

data from internal FSQA tests against

specifications in real time so non-

conformances can be addressed at the

earliest possible stage.

Receive real-time alerts when a control is

incomplete or FSQA test results deviate from specifications.

Achieve Live Operational Monitoring

Monitoring, verifying, and validating the components of your Food Safety Plan means your company

has not only stated what it’s going to do, but also that you’re making sure you’re doing it on an ongoing

basis and you’re ensuring that the plan achieves its objective: mitigating risks to produce safer food. A

comprehensive FSQA software solution supports these efforts in the following ways:

Define all PRPs, CCPs, etc. in the system so that each component of the plan is documented, and

ensure they are being completed when due through notifications from automated task scheduling

capabilities.

Electronically gather all related data and information for real-time assessment against

notifications. Data can include information and test results from suppliers, internal and third-

party labs, equipment, and even transportation. For example, tools like temperature probes can

communicate results in real-time to your FSQA software solution for instant visibility. You can also

monitor tolerance levels and quality metrics by item, line, location, shift, or attribute, including

target weight, dimensions, and other factors.

Capture data remotely on smart mobile devices to support teams in the fields, receiving docks, or

any other point within your supply chain.

Achieve validation through real-time analysis against specifications and Food Safety Plan

parameters, as well as real-time alerts on deviations, deficiencies, and omissions.



Establish & Reassess CAPAs

Without visibility into your operations, it becomes near-impossible to ensure CAPAs are being taken as

early as possible to minimize the impact of food safety issues. Limited visibility also makes it difficult to

perform a full assessment of plans and controls periodically to address problem areas. Technology solves

these issues with:

Real-time alerts to ensure CAPAs can be

taken at the earliest point upon detection of

deviations

Time- and date-stamped CAPA

documentation, including when required or

desired, before and after digital photos

Upstream, downstream, and internal visibility

for root cause analysis to pinpoint how and

when a safety deviation occurred

A comprehensive database of all PRPs,

CCPs, and FSQA data for reassessment and

continuous improvement

Comprehensive Documentation

Imagine trying to manually record, store, track, and retrieve all of the pieces of data described thus far.

Adopting a food safety software solution can free up your time and other critical resources with:

An easy-to-access, centralized repository of all plan elements, test results, proof of PRP/CCP/

SOP/GMP/GAP completion, and CAPAs to help you respond to audits and FDA/customer

inquiries on demand

Unalterable time- and date-stamps for the highest possible degree of FSQA efficacy

The ability to turn data into meaningful business intelligence through trending and benchmarking

for simple identification of areas needing improvement and actionable insights to help you

achieve bottom-line ROI

Intelligent supplier score carding on both a micro level such as supplier ingredient compliance, as

well as a macro level, including overall supplier performance

Adjustments to specifications for greater yield and product performance

The ability to prevent rework, withdrawals, and rejections

Reduction of errors and costs associated with manual data entry



What to Look for in a Solution

When seeking a technology solution to manage your FSMA Food Safety Plan, look for a system with the

ability to:

Say What You Do

Look for a system that can support a multitude of plans, allowing you to set up and define all of

your regulatory and non-regulatory requirements and programs.

Ensure the solution also allows you to set up all of the components of the Food Safety Plans and

data sources associated with your programs, including SOPs, PRPs, and GMPs. The system should

also be able to fully automate scheduling, including sanitation, renewal or revisions of program

components and forms; as well as data collection from equipment such as cooling or weight

machinery.

Do What You Say

Verify your solution has a workflow engine that ensures all tasks associated with your

requirements/programs – including food safety monitoring activities – are completed according

to documented schedules.

Confirm all tasks are associated with forms, such as, but not limited to, those for internal direct

observation inspections, quality attributes, internal/external lab data collection, and vendor forms.

Ensure It Works

Seek a system with a verification program that analyzes all program data collected, such as safety

assessments from mobile forms or test results from a lab, in real-time to the requirements and

specifications defined in the system.

Out-of-spec results should be automatically made aware to the appropriate parties via non-

conformance alerts. A CAPA should then be automatically generated and tracked to completion.

Document Efficiently

Make sure the solution time- and date-stamps every record collected, with eSignatures where

required, and makes them accessible from a central repository of data as part of your permanent

FSQA record.

Have the ability to access every document, test result, CAPA, and any other piece of program

data from any location, through a secure login from any laptop, smartphone, desktop, or tablet.



How SafetyChain Automates FSMA Food Safety Plans

With its comprehensive real-time data collection and automation tools, SafetyChain allows companies to

automate their FSMA Food Safety Plans in the following ways:

Achieve Ongoing Compliance

SafetyChain makes it

simple to preventive-based

programs and achieve 24/7

audit readiness so your teams

will have instant access to all

of the information needed

upon FDA inspections.

Do More With Less SafetyChain automatically

collects and manages data,

allowing you to effectively

administer Food Safety Plans

using fewer time and people

resources.

Improve Ongoing Visibility Analytical tools provide

instant and ongoing visibility

to help you monitor trends

to make informed decisions

that help you achieve FSQA

program goals and improve

bottom-line results.

Track Program Performance SafetyChain’s performance

tools and dashboards allow

managers to retrieve up-

to-the-moment insights on

performance of key metrics to

ensure Food Safety Plans are

working as they should.

Reduce Risks Most importantly,

SafetyChain provides

features such as real-time

program monitoring and non-

compliant alerts and analytics

to help you effectively

reduce risks and successfully

implement a FSMA-ready

Food Safety Plan.



Summary

At this point, the final FSMA rules are firmly in place, and enforcement is already underway. The deadline

for compliance has passed, so it is now the responsibility of each company affected by the ruling to

successfully implement a FSMA-ready Food Safety Plan. Understanding the gaps of your current food

safety plan relative to the FSMA rules that apply to your company can be challenging, but is critical to its

long-term success.

For the majority of companies, the next stage proves to be even more challenging: ensuring compliance

and audit preparedness through a robust and effective Food Safety Plan. To recap the key points in this

eBrief, here are the essential components of a FSMA-ready Food Safety Plan:

A plan for your facility and each unique product

Thorough assessment to identify significant risks

Preventive controls to effectively mitigate risks

Ongoing monitoring, verification, and validation

CAPA and reanalysis

Thorough documentation

Achieving these key objectives is precisely where technology can be leveraged to provide new

operational efficiencies that deliver bottom-line results. In delivering these results, a food safety software

solution can also ensure compliance and help you more effectively achieve the overarching goal of

delivering a safe, high-quality product.



About SafetyChainSafetyChain is a Quality Management System (QMS) that helps food and beverage companies improve

productivity, profitability, and compliance with a flexible, user-friendly software platform that captures,

manages, and analyzes real-time operations data.

Learn more at www.safetychain.com.

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