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 The FDA is has superceded HACCP, or Hazard Analysis and Critical Control Points, which has been around for decades.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 FoodProtection.org
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.

References

SQFI
GMA
FDA
HAACP vs HARPC
Global Food Safety FSMA overview

The condensed FMSA checklist for busy operations managers

No need to stress out when auditors or executives tell you it’s time for an FSMA audit.  It’s probable that your operation is already clean and safe, so why not break this down into managable pieces?

Chances are that your Quality Assurance experts already have a FSMA audit checklist.  If not, take a look at our post about how to manage an FSMA audit without losing your mind.

We built this around the requiremetns of the Safe Quality Food Institute (SQF), and other auditors will be similar.  You can download the SQF documents here.  At first glance, the SQF checklist is overwhelming.   The ‘Basic Manufacturing Checklist’ from SQF has 90 pages, with up to five items on a page!  Fear not, our condensed checklist will get you out of this unscathed.   There are steps that you can take to manage the situation:

Identify the things that are done as part of normal operations.  Our checklists in this article should give you a good handle on these.  They break down into three sections:

  • Routine operations which should be recorded in Receiving documents, Batch Production Records and other normal transactions.
  • Scheduled tasks, such as equipment maintenence.
  • As-needed procedures, such as safety training for visitors

All of the day-to-day records should be in one of the ‘operations’ sections.  A quality audit will also have sections to inspect ‘structural’ things which are done when the company makes a major change such as construction or new processes.  These include

  1. These are things like the construction of the facility and certification of external laboratories. The company is going to need to show evidence for these, so you need to decide how the information will be collected.
  2. Things that are require controlled documents about your operations.  These are things like the food safety manual and planning for compliance with relevant legislation.

Now you can focus on confirming that your ‘operations’ documents support your FSMA safety plan.  These are the different ways FSMA documentation is handled:

  • Paper checklists.  We hope you can minimize these, but it’s hard to get rid of all of them.
  • Files of paper documents.  These can be a management headache, so we recommend computer systems to replace them.
  • Accounting software.  We generally call this the ERP (Enterprise Resource Planning) system.  Many of your records are created or collected in the ERP, and you can satisfy the auditors with reports from the system.
  • Document Management software.  Permanent records like SOP’s and vendor certifications are often stored in a Document Management system like SharePoint.
  • Process Management software.  Anything that can assign tasks and keep track of completion is going to help you run a compliant, efficient system.  You need to make sure the records will be acceptable in an audit, though.
  • Quality Assurance software.  QA systems combine Document Mangement and Process Management in a single system that is focused on quality.

The easiest and most efficient solution is to minimize paper and rely on an ERP system that combines accounting records, document control, process management and quality control events.

So finally we come to the checklists of things that you need to keep track of.  These may not fit your situation exactly, but they are a lot simpler than the giant audit list that you started with.

Production records

These document how you handle day-to-day operations in compliance with the food safety plan

After cleaning and sanitation operations, pre-operational inspection is done of food processing areas, product contact surfaces, equipment, staff amenities and sanitary facilities and other essential areas.
Track usage of disposable gloves and aprons, and the cleaning, sanitization and storage of non-disposable gloves and aprons
Store raw materials (i.e. frozen, chilled, and ambient), ingredients, packaging materials, equipment, and chemicals in safe and hygenic locations
Lot expiration records will show that all ingredients, materials, work-in-progress, rework, and finished product are utilized within their designated shelf-life.
Keep records of temperatures in freezing, chilling and cold storage rooms
Receive and store pest control bait, hazardous chemicals and toxic substances so as not to present a hazard to staff, product, packaging, product handling equipment or areas in which the product is handled, stored or transported.
Loading, transport and unloading records showing compliance with temperature control, product integrity and prevention of cross contamination.
Vehicles (e.g. trucks/vans/containers) used for transporting food are be inspected prior to loading to ensure they are clean, in good repair, suitable for the purpose and free from odors or other conditions that may impact negatively on the product.
Keep records of temperatures in refrigerated units before loading (and repeatedly during loading if appropriate.)
Log the temperature in refrigerated units before unloading, the time required for unloading, and interval measurements if appropriate.
Dry ingredients and packaging are received and stored separately from frozen and chilled raw materials to ensure there is no cross contamination.  Unprocessed raw materials are received and segregated to ensure there is no cross contamination.
Thawing of food is done safely in equipment and rooms appropriate for the purpose.
Keep records showing that high risk food is protected/segregated from other processes, raw materials or staff  when a “kill” step, a “food safety intervention” or post process handling is required.
Production records show the use and cleaning of screens, sieves and filters used to remove or detect foreign matter
Keep records of foreign object detection materials removed by them, including corrective actions resulting from the inspections.
Batches affected by foreign matter contamination are reworked or disposed of
Production records show that when allergenic material is present, cleaning and sanitation of product contact surfaces between line changeovers is effective, appropriate to the risk and legal requirements, and sufficient to remove all potential target allergens from product contact surfaces,
Labels are reviewed at receipt to confirm accuracy and to apply change-over procedures
Product is reviewed at completion of manufacturing to confirm correct labelling

As-needed records

These document your handling of exceptions to the daily process

After cleaning and sanitation operations, pre-operational inspection is done of food processing areas, product contact surfaces, equipment, staff amenities and sanitary facilities and other essential areas.
Track usage of disposable gloves and aprons, and the cleaning, sanitization and storage of non-disposable gloves and aprons
Store raw materials (i.e. frozen, chilled, and ambient), ingredients, packaging materials, equipment, and chemicals in safe and hygenic locations
Lot expiration records will show that all ingredients, materials, work-in-progress, rework, and finished product are utilized within their designated shelf-life.
Keep records of temperatures in freezing, chilling and cold storage rooms
Receive and store pest control bait, hazardous chemicals and toxic substances so as not to present a hazard to staff, product, packaging, product handling equipment or areas in which the product is handled, stored or transported.
Loading, transport and unloading records showing compliance with temperature control, product integrity and prevention of cross contamination.
Vehicles (e.g. trucks/vans/containers) used for transporting food are be inspected prior to loading to ensure they are clean, in good repair, suitable for the purpose and free from odors or other conditions that may impact negatively on the product.
Keep records of temperatures in refrigerated units before loading (and repeatedly during loading if appropriate.)
Log the temperature in refrigerated units before unloading, the time required for unloading, and interval measurements if appropriate.
Dry ingredients and packaging are received and stored separately from frozen and chilled raw materials to ensure there is no cross contamination.  Unprocessed raw materials are received and segregated to ensure there is no cross contamination.
Thawing of food is done safely in equipment and rooms appropriate for the purpose.
Keep records showing that high risk food is protected/segregated from other processes, raw materials or staff  when a “kill” step, a “food safety intervention” or post process handling is required.
Production records show the use and cleaning of screens, sieves and filters used to remove or detect foreign matter
Keep records of foreign object detection materials removed by them, including corrective actions resulting from the inspections.
Batches affected by foreign matter contamination are reworked or disposed of
Production records show that when allergenic material is present, cleaning and sanitation of product contact surfaces between line changeovers is effective, appropriate to the risk and legal requirements, and sufficient to remove all potential target allergens from product contact surfaces,
Labels are reviewed at receipt to confirm accuracy and to apply change-over procedures
Product is reviewed at completion of manufacturing to confirm correct labelling

Scheduled procedures

These records show that you have done maintenance, training and other routinely scheduled operations the right way:

Maintain records of routine maintenance of plant and equipment in any food processing, handling or storage area, to show compliance with a maintenance-control schedule and procedures to minimize contamination of the product.
Lubricate equipment located over product or product conveyors with food grade lubricants which are controlled to minimize the contamination of the product.
Calibrate measuring, test and inspection equipment.
Inspections for pest activity are done on a regular basis by trained personnel, and the appropriate actions taken if pests are present.
Manintenance and monitoring records are kept for compressed air systems, and other gasses used in the manufacturing process.
Check that vehicle and container loading minimizes unnecessary exposure of the product to conditions detrimental to product and package integrity.
Inspect the plant and equipment to be sure they remains in good condition, equipment has not become detached or deteriorated and is free from potential contaminants.
Log the routine inspections of food handling/contact zones to ensure they are free of glass or other like material.
Inspect the condition of wooden pallets and other wooden utensils used in food handling/contact
Screens, sieves and filters used to remove or detect foreign matter are maintained and calibrated on schedule
The product trace system is tested to ensure:
i. Finished product is traceable to the customer (one up) and provides traceability through the process to the manufacturing supplier and date of receipt of raw materials, food contact packaging and materials and other inputs (one back);
ii. Traceability is maintained where product is reworked;
iii. Records show raw and packaging material and finished product dispatch and destination.
Test the ability to notifiy customers and other essential bodies when product must be withdrawn or recalled from distribution.
A periodic review of product and manufacturing records is done to ensure that the company is using methods to control allergens and to prevent sources of allergens from contaminating product during production and storage
Based on risk assessment, validate the effectiveness of procedures for the effectiveness of the cleaning and sanitation of areas and equipment.
Implement a refresher training program that includes temporary, seasonal and full time employees/contractors.

 

All of these operational checklist items need routine record-keeping, and they usually appear on Standard Operating Procedures.

If you want a spreadsheet with these checklist items, cross-referenced to the SQF Element ID’s, please contact us.

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.