A recall is hard enough, without the process dragging on for several cycles and several months. The years long Takata airbag and recent General Mills flour recalls that go through cycle after cycle are some recent examples of long painful recalls that never seem to go away. We just got our Honda recall notice a couple weeks ago for airbags years after the first announcement. Taking the steps to get traceability done right the first time will greatly reduce this exposure.

If you are doing your job right in the Food Safety area, it is very likely that your recall will be based on an issue with a purchased ingredient. SMB food manufacturers just do not have the resources to test every lot coming in the door. This means that if you are a typical food processor, you are going to find that ingredient in more than one product and more than one batch. This is where the one up and one down can catch you with your pants down.

Pull up the diagram to the right, and you can see how a likely complaint will filter through your production cycle and customer base when an ingredient is involved. You will see from this one example on one lot that an ingredient used in only 4 products can generate recall chains affecting many customers not in the original product issue. In your typical FDA trace of a lot, you might only identify the ingredient as the source of contamination but not trace forward again to other production. This would still leave you with tracing every other batch and product the ingredient was used in.

This is where a new generation of simple inventory and production software can greatly reduce your risk and increase the traceability of your product. This example is only showing 4 recipes and 3 clients for each product. Many of my clients have dozens of ingredients, 10 or more products and hundreds of clients. The permutations for this complexity would overwhelm most hand or excel based record systems.

Even very small producers and Brand Holders with contract manufacturing should consider an online inventory system to track the distribution of lots. We provide hand systems when helping clients start down the road to food safety, but the ability to track even a moderate amount of production and distribution with records that have to be updated offline as paper or Excel sheets quickly results in insufficient use of the system. Choosing a system that is both easy to use, and has integrations with many of the business support tools such as CRM and accounting will increase your production control and traceability, while reducing the actual time you spend offline entering data.

Over 1/5 of the food production in the United States is grown by small family farms. These operations are often only family members as workers or a couple helpers at most. You can find the same thing happening now in the craft food movement. Can you really assure safe and quality food at this level of production with the same tools used on an operation with 20, 200 or 2,000 management and field staff?

Although a process based on analysis, documentation and monitoring may seem pretty simple to understand, at an implementation level, the concepts often do not translate. The goals of any quality control system can be lost in the effort to maintain the system. Why build a bridge that will carry an elephant to a place it does not need to go? It could be a lot smaller to just get me there.

A neighbor of mine does quality control for the space industry. They work with small engineering and machining companies building highly critical parts of which very few are needed. While doing audits of ISO certified firms, it was discovered that all the compliance costs had gone into the documentation to comply and there was no understanding of how to apply it to the process of building parts. They have since switched to process audits that look to see, no matter how simply documented, if the controls are implemented in the process.

The space industry faced the same issues small farms face in doing critical tasks whether rocket parts or safe food. A GFSI farm audit is going to have 300 questions whether you have 2 employees or 2000 employees. Do you really need to have an SOP template so Ma can tell Pa to wash his hands before heading out to the packing shed?

Rather than the scale determining when FSMA implementation should take place, it should determine how it is implemented. This would also mean having a scale approach to GFSI or Harmonized level audits in the checklists. I have yet to meet an operator that understood the HACCP Plan or Risk Assessment left with them by a previous consultant. Since 95% of the risk issues are common in either food production or food processing, this endless cash mill of custom plans seems a further barrier to implementation.

The industry AgNet is part of is on a constant steeplechase to help clients meet the increasing audit standards often at the cost of well-implemented practices. Perhaps it is time to stop and look at the models we are building for documented compliance and develop a model focused on effective implementation at any scale. #PAPERTRAILOFTEARS

Suppliers and their certification agencies are sometimes their own worst enemies. There is a paranoia around certificates and products which slows down the approval process for new operations and products. Much of this is based on bad interpretation and choosing paper over data for a false sense of security.

Fraudulent Certificates

Suppliers are constantly telling me they do not send out certificates due to fraud. The USDA has only 18 fraudulent certificates listed on their website in the last 18 months. That is only one per month out of the over 30,000 certified operations worldwide. In only one case was the operator in the US. Most falsified certificates are from imported product.

Post your certificate on your website or customer portal and keep it updated. If a client or certification agency wants to check the validity, they can go to the USDA Organic Integrity Website or your certification agency website if they have listings. We had a client change suppliers just this week due to the difficulty in getting the certificate from the old supplier. Do not accept “Letters of Good Standing” from your certification agency. Other certification agencies no not like them and they have little standing. If you have paid and updated your information, the certification agency should not keep you from marketing properly by withholding an updated certificate. It is their duty to inspect and issue conditions. They should not hold up renewed certificates because they do not have time to inspect.

Attached Lists and Product Updates

Most organic certificates consist of a certificate face and an attached list. You need both on file from your supplier. Certification agencies are always chasing down this second page from client suppliers. The rub is, most certification agencies which issue the Certificate and Attached List as separate documents, never explain to the clients the importance of the attached list. Simple fix- issue them as one document.

The reason the Attached List(Product Listing, Product Profile) is such an issue, is the mother hen approach certification has taken. Every single product variation, package, formulation and brand representation is supposed to be approved before marketing according to the certification agency. In reality, the regulation, shown below, says only the categories need to be listed. This was verified by me with a USDA regional manager for the organic program. It is overly picky certification agencies and buyers that have driven this nanny state issue. Is it really that important if you roast organic Sumatra coffee or organic Kenya coffee?

§205.404(b) The certifying agent must issue a certificate of organic operation which specifies the:
(1) Name and address of the certified operation;
(2) Effective date of certification;
(3) Categories of organic operation, including crops, wild crops, livestock, or processed products produced by the certified operation; and
(4) Name, address, and telephone number of the certifying agent.

Operators are supposed to be “certified” to produce organic product. The basic definition of certified usually meaning being capable of doing the entire process correctly. Agreed, a lot of people never get it, but that is what the annual inspections are designed to catch. I would much prefer tougher sanctions and less reporting. My goal is to always train clients to do it correctly, not just do it for them.

It is clear this is half vent and half advice. Organic certification is already a intensely confusing process due to the vagueness of the term in general and the regulation specifically. Making it more difficult by overcompensating based on anecdotal evidence about fraud and onerous interpretations of regulation costs everyone. Suppliers and Certification Agencies should work together to make this system work for them.

FSMA, the FDA’s Federal Food Safety Modernization Act, is here. We are now in the year, or two, of compliance for most companies. This is the headline driving many of you to pursue food safety certification. In many cases, your buyers have already asked for it.

In order to take the first step on this journey, it would be helpful to understand the food safety universe a little and some of the acronyms.

HACCP- Hazard Analysis Critical Control Point, a NASA inspired process to analyze and document hazards to a process. http://www.fda.gov/Food/GuidanceRegulation/HACCP/ucm2006801.htm

GFSI- Global Food Safety Initiative, a collaborative standard to which many high level food safety standards certify to. www.mygfsi.com

Food Safety Standard- These can be private or accredited(many companies do them) standards against which the audit is done.

Certifier-CB- Certification Body- The actual company that manages the certification and arranges the auditor visit.

All of this food safety world existed before FSMA legislation. The regulation does require third party certification. This is just the measuring stick many buyers and companies will use to validate the plan put in place. The FSMA legislation just requires you have a compliant plan in place.

The deadline for business less than one million in sales to have a plan in place is August 30, 2018. For operations with more than one million in sales, but fewer than 500 employees, the deadline is August 30, 2017. If you are larger than this, you better have one in place already, but if not, you have until August 30, 2016.

Since your buyers or your boss are likely to require a 3^rd party certification, you might as well use that as your guidepost for setting up a Quality Assurance plan. A good QA plan makes sure the facility produces a quality product with consistency. Food Safety is just an inherent part of this process.

There are three options to choose from before you start. The first is to just put a simple pl
an in place without certification. If you have a buyer like Whole Foods that requires some type of certification no matter how small your operation, you can contract with a private standard. When trying to land the larger distribution deal or client, you may have to go the GFSI route with an accredited standard.

For very small operators without the need or resources for a third party audit, you can find simple plans and record keeping systems on the internet. You will want some basic controls and records for product handling, cleaning and staff hygiene with the records to back it up. The one major requirement that many organizations will miss is the traceability. Keep logs of every roast batch with incoming green lots, and note the roasted lots going out to customers on the sales records. These lot codes can be as simple as the roast date.

You may have a buyer or internal request for an audit or certification without specification. There are private standards out there like UL and NSF for small operations. Call and get pricing along with a copy of the audit from either your buyers recommended company, or a couple private standards. You will use the audit to verify you have all the policies, procedures and records systems in place required to pass that audit.

If you are going for distribution deal or large client, chances are you will need to step up to a GFSI level audit. Most of these audits are extensive and resource heavy. They can require special staff certifications and several days. There is an exception now.

The PrimusGFS audit was designed as a Fresh Produce audit, but includes agricultural handling up to and including cooking and cutting(or roasting and grinding.) Maranatha Import Export, Inc was the first US based roaster pass this audit done by Food Safety Certifiers.

Preparation for a GFSI level audit can be much more substantial than an internal plan or private standard requires. These audits tend to be several hundred questions and all require a HACCP based plan with analysis of production. At minimum, you will either need someone to take an online or local HACCP course, or hire a HACCP consultant to do this part.

The HACCP plan and the standard chosen will determine the policies, procedures and records systems needed for the operation. Luckily for coffee roasters, the HACCP plans will all be very similar and have similar control points requiring monitoring such as de-stoner and magnets. There are even some sample HACCP plans for coffee available.

If you have a consultant working on the HACCP with you, be sure they have the standard you are working off. You should end up with one comprehensive plan. It may be a couple manuals such as a Quality Assurance Manual and a Good Manufacturing Process(GMP) manual, but they all work together. If you are an organic operation, include those operating guidelines.

Far too often we see operations ending up with 3 or 4 manuals and multiple records systems because HACCP was by one person, the food safety manual by another and the organic by somebody else. There should be one manual to run one business one way. Once you have the manual with policies and procedures along with a records system, it is time to check yourself.

Every GFSI audit requires a self-audit annually. You basically use the same standard the auditor is going to use. The first step is to review the HACCP plan and make sure the process flows and control points are still correct and being monitored. You then do the entire Food Safety audit on yourself.

The result of this annual review should bring up all the items that need correction. These are cleverly referred to as “Corrective Actions”. Once you have done the internal audit and the corrective actions, you can schedule the 3^rd party audit with a certification body. This outside audit will lead to another set of Corrective Actions that need to be responded to before final certification.

Some big take-aways fom this should be that FSMA and your buyers will require action. There is a process that is not impossible to do. There are options that are right for your size. With the availability now of PrimusGFS for roasters, even a GFSI level certification can be achieved by medium sized roasters.

Resources

AIB HACCP- http://www.aibonline.org/aibOnline_/secure.aibonline.org/php/ecomm-catalog.aspx?catalogNbr=11-3140A

FSMA- http://www.fda.gov/Food/GuidanceRegulation/FSMA/

Food Safety Certifiers- http://www.foodsafetycertifiers.com/

PrimusGFS- http://www.primusgfs.com/certificationBodies.aspx

NSF- http://www.nsf.org/services/by-industry/food-safety-quality/processing/processing-audits

UL-Everclean- http://www.evercleanservices.com/Services/Audits/Food-Safety-Audits

There is a term used in the organic certification world “Organic by Neglect” to indicate farmers seeking organic certification because they do nothing to the field. It is a myth that organic production is the absence of chemicals. Organic production is the mindful replacement of artificial environmental control through chemicals with directed management of natural processes. Farm neglect is not organic production and can be detrimental to the farm and surrounding producers.

There is nothing natural about a grove of lined up trees of one fruit crop or rows of a single planted green. These environments create conditions that can attract crop specific pests or deplete and erode soils without proper monitoring and maintenance. This is the basis of the requirements of the Organic System Plan. You must show what you are going to do, not what you are not going to do. 

We are certainly no fans of paperwork at AgNet, but the age-old success adage of Make the Plan and Follow the Plan certainly applies to organic farming. Because we are not relying on preventive sprays of toxic chemicals to kill pests and disease or premixed chemical nutrients to feed the plants, the environment needs to be more closely monitored to assure the plants are not under attack and have access to nutrients in the soil. Failure to monitor properly can lead to infestations that can lead to damage to the farm or soil depletion and erosion that can lead to long term soil degradation.

As part of our assistance to local farmers seeking certification, we are designing simple planning and record-keeping tools to raise their awareness of monitoring. This also allows them to keep records of their monitoring which is an essential part of organic certification. We seek out farm consultants and PCAs to provide regular monitoring and feedback as part of their organic plan. Our mission in certification assistance is not to just complete the paperwork, but convey the process being documented so they can understand how to properly maintain organic production.

The next time you are at the Farmers Market, do not ask your local farmer the “No Spray” question, ask them what they are doing to avoid soil depletion (good flavor and nutritional value), inhibit pest buildup (prevent those nasty State Emergency Sprays) and  improve the environment (habitat for bees, wildlife and clean water).