Managing FSMA compliance without losing your mind

According to the FDA, the “Food Safety Modernization Act (FSMA) is the most sweeping reform of our food safety laws in more than 70 years…”

The overarching principle guiding the implementation of FSMA is FDA’s shift from detection and response to prevention. The basic steps for FSMA compliance are

1. carry out a hazard/risk assessment
2. create a written plan to deal with the identified hazards
3. document the implementation of and ongoing testing procedures outlined in this plan
4. plan for any corrective measures that may be necessary.

FMSA records are exhaustive

As you drill down into these four steps, the scope of FSMA compliance can seem overwhelming.  Your business is to produce good food, not to shuffle mountains of compliance paperwork

The Safe Quality Foods Institute created the ‘Basic SQF Manufacturing Audit Checklist’ has 192 things to do – plus sub-items!. They tried to create a condensed version but it’s still pretty hefty.

Here at Crystal Systems, we want to make your life easier. For a simpler approach, see our condensed FMSA checklist for busy operations managers

Why all this detail is needed

In brief, this preventive control system mandated by FDA’s FSMA Act is to be implemented by all food facilities in the U.S. that manufacture, process, pack, distribute, receive, hold, or import food, and for those firms exporting foodstuff to the US. The FDA is has superceded HACCP, or Hazard Analysis and Critical Control Points, which has been around for decades. Now you need HARPC, or Hazards Analysis and Risk-Based Preventive Controls. It’s helpful to understand the differences, but in most respects your day-to-day responsibilities are the same.

If you want to do some digging, there are lots of great in-depth resources out there. Check out

1. Government, for example the FDA regulation
2. Academic publications, like Learn how the FSMA Affects You
3. Industry associations, such as
4. Consultants, which you can find on Food Safety News

It’s impossible to compile all this information into a single checklist that fits all companies. And the audit checklists describe everything from the view of a huge, seldom-seen audit.  To be efficent and compliant, it’s best to focus on what’s needed to run the business day-to-day.

The Seven Steps of HARPC

1. Assess the hazards — This includes the normal product-specific hazards, along with a broad range of other hazards and facility-specific concerns such as food defense and emergency management issues.
2. Institute Preventive Controls — These include sanitation procedures for food contact points, staff hygiene training, environment monitoring, supplier verification, and more.
3. Monitor effectiveness of the controls — Not all controls are measurable by critical limit numbers, but these Preventive Controls can be evaluated on a routine basis.
4. Establish corrective action measures—Recall plans may not seem preventive, but the critical steps between knowing something is wrong with a product and keeping it away from consumers’ hands should involve identifying and correcting the weak spots within the controls. The objective is to prevent occurrences of unsafe and non-conforming food product.
5. Establish verification measures—The process of verification ensures that the facility is effectively meeting its food safety standards on a consistent basis.
6. Follow proper and required recordkeeping—As with any FDA ruling, nothing is properly done until it’s recorded.
7. Reanalyze the plan once every 3 years, or when needed—When changes in process or product happen, HARPC plans should be reevaluated.

A nice overview of the whole FSMA was done by the Global Food Safety Resource here:

The Food Safety Modernization Act (FSMA) – An Overview

What you need to do every day

We condensed most of the daily requirements in our condensed FMSA checklist for busy operations managers.

The Rule requires that records include information to identify the site; the date and the time of the activity documented; the signature or initials of the person performing the activity; and the identity of the product and the lot code.  So you need to keep track of:

o Process controls – Ensure the control of parameters during operations such as heat processing, acidifying, irradiating, and refrigerating foods.
o Food allergen controls – Ensure protection of the food from allergen cross-contact, including during storage, handling, and use.
o Sanitation controls – Ensure that the facility is maintained in a sanitary condition adequate to significantly minimize or prevent hazards such as environmental pathogens, biological hazards due to employee handling, and food allergen hazards.
o Supply-chain controls – Ensure that hazards associated with raw materials and ingredients received by a receiving facility have been managed prior to their receipt.

There are a few basic solutions to the record-keeping problem:

1. Lots of paper
2. Quality Management Systems
3. Manufacturing Execution Systems
4. Integrated ERP

Since Crystal Systems is a systems integrator focusing on small business, we have some thoughts about ERP:

Tier 1: you know who you are.  Oracle, SAP and Dynamics AX users have an entire ecosystem of modules and services to support FSMA compliance
Tier 2: Microsoft Business Central, Netsuite and other mid-level solutions have add-ons and integrations that work seamlessly within the system
Tier 3: Quickbooks, Sage One and other small-business ERP don’t usually go farther than lot traceability.

For small and cost-conscious mid-size business, we recommend the Acctivate extension for Quickbooks. It combines quality management records with receiving, manufacturing and warehouse operations.

If you want a convenient spreadsheet cross-referenced to the SQF Audit Checklist, please contact Crystal Systems.

Crystal Systems makes it easier for Quickbooks users to manage and audit SOP’s for food manufacturing.  We combine the user-friendly Acctivate ERP system with Sharepoint Document Mangement to collect all the necessary records.


Global Food Safety FSMA overview