Having a strong food safety system in place is a law and a must- have for all major food retailers.
When I work with my customers on updating food safety and quality control system, I always refer to FDA FSMA (Food Safety Modernization Act) templates and guidance.
Below find my recommended steps to get underway on developing or reviewing your food safety system:
- Download FDA’s FSMA HACCP and HARPC plan template- there is a handy tool called Food Safety Plan Builder and make sure that your hazard analysis and accompanying risk assessments meet FSMA standards.
- Assemble or review who is on your food safety/quality assurance team- this is a very important step. Strong QA programs can only be implemented when there is a full management commitment to this process. A hallmark of a well-run food manufacturing operation is a member of senior management (for smaller companies this may be even a CEO or a COO) who is involved, active and open to feedback when it comes to ensuring food safety. As an auditor, I always know that my audit will be productive if a CEO or a founder are present at the opening meeting. Make sure that your quality assurance team includes people from all functions: operations, management, shipping/receiving and maintenance and R&D.
- PCQI (Preventive Controls Qualified Individual) Training- while having a PCQI it is cost-effective way to get your QA manager up to speed on how to develop, implement and monitor process controls and GMP programs in your operation. PCQI courses are offered in person in virtually every county in CA (approx. $450-$750 for a 2.5-3 day classroom style course)- a great investment considering that you will now have an in-house resource for safety and quality.
- Evaluate and describe your products- what product category they belong to? What risk category? This is where a qualified experienced consultant can provide your team with a head start on how to build your system in a way that suits your product profile. Remember, there is no “one size fits all” HACCP or a HARPC plan. For example, if your facility processes protein powder and a nutrition bar you must have two difference HARPC or a HACCP plans for each product. This is because the processes and the ingredients are very different and therefore hazards are different as well.
- Develop a process flowchart- this is a map of your operations. Typically flowcharts outline ingredient journey through your facility and how they are combined as part of processing them into a product. You do not need to include QA programs, such as compliance testing for your products or ingredients. Those will be covered under your preventive controls.
- Hazard analysis for ingredients: the objective of this step is to understand what types of biological, chemical, physical and radiological hazards might be present in the ingredients you use. A QA manager who attended a PCQI course can do this independently. Hazard analysis must be done for each ingredient as well as the processing aid (if present) used in your products. I use a handy FDA guidance called Hazard Analysis and Risk Based Preventive Controls for Human Food- Draft for the Industry, appendix 1, potential hazards for foods and processes.
- Process Hazard analysis- this is done for your processing steps and must follow your flowchart. Depending on the complexity of your operations, you may need a help of a qualified consultant at this point to help your QA manager to apply principles that they learned in the PCQI class.
- Determine whether hazards in your facility will be controlled via critical control points (CCP), preventive controls (PC) or a combination of the two. As an example, for most confectionary manufacturers, there is at least 1 CCP (metal detection) and several PC’s such as sanitation, supplier assurance, allergen control etc.
- Start outlining what are the PC and CCP’s in
your operations and writing policies that detail how the hazards are to be
controlled. Below are some examples of what this means.
- Example 1: you have identified that Salmonella spp (i.e. species) (a biological hazard) may be present in dark chocolate that is used in your filled dark chocolate truffles. The programs that need to be implemented in your operation then would include Supplier Assurance program (which will require certificate of analysis for Salmonella spp. to be present for every lot that enters your operation) and Shipping/Receiving procedures which will guide the staff to check for the appropriate documentation at receiving.
- Example 2- you manufacture some products that are allergen free on the same equipment where products with allergens are manufactured. Allergens are considered to be chemical hazards. Therefore preventive controls in place are: Allergen control program, Sanitation program, Supplier Assurance Program and GMP. All of those programs together will be able to provide basic controls for ensuring that undeclared allergens in your product present risk to the allergen sensitive consumer.
- GOOD NEWS- your risk analysis is now complete. Now you are ready to start working on your programs and processes! That is because you have done your homework and understand WHAT you need to control in your operations. It’s time to work on HOW you are going to control it.
Developing product quality plan appears to be simple but requires quite a bit of work but is very much worth it. It is because it’s very easy to see the benefits of a well thought out and implemented product quality system:
- Demonstrating compliance with customer requirements
- Consistent quality and efficacy of the products you manufacture;
- Compliant facilities and operations that are inspection ready ;
- Higher customer satisfaction and strong brand loyalty;
- Higher staff satisfaction.
Lastly it’s also important to recognize that the food safety system is a living, breathing document because your food manufacturing operation is very complex. Your food safety program must be updated at least annually or as needed based on your changing circumstances. Here are some examples of when food safety system must be evaluated:
- Introduction/installation of new manufacturing line
- New product introductions
- Repeated CCP deviations (which may indicate that your controls are ineffective)
- Manufacturing facility upgrades or facility relocations.
So get started soon and remember- help is available whenever
you need it.
 Not applicable for all ingredients, only for certain ones like spices, tea etc.
 D. A Powell, C.J. Jacob, B.J Chapman, Enhancing food safety culture to reduce rates of foodborne illness, Food Control, Volume 22, Issue 6, June 2011, pp 817-822.