Building Systems with Efficiency and Profitability in Mind.
One of the foundations of current Good Manufacturing Practices (cGMPs) is often defined as a place for everything and everything in its place. An approach to this is having us create a robust 5S system for your company. The five (5) stages are:
Set in Order
Allergens are one of the most demanding areas of food safety and must be successfully integrated to protect both consumers and the brand name. There are eight (8) allergens within the United States that cause 90% of allergic reactions. These eight (8) allergens are:
It would be easy enough to omit these allergens from all products, but this would not be practical, as consumers appreciate allergens for texture, taste and processing results that they expect. The key to food safety when implementing allergens is the ability to develop, and maintain, a robust Allergen Control Plan (ACP). To create this program, a systematic approach is used to determine the allergen(s) in the plant, validation of said allergens and the plant's ability to control those allergens. The University of Nebraska has completed a ton of allergen research and state that "the allergen is not the issue, but it is the undeclared allergen that is dangerous." We can implement our ACP solution to ensure that your facility, and brand, is fully protected and your consumers are safe.
Our team can assess, evaluate accuracy and recommend changes for your inventory management of raw materials, packaging and finished goods to increase efficiency and profitability.
One of the new requirements arriving from FSMA is the requirement of a bio-security policy. This requirement is outlined by laws passed and points to the Public Health Security and Bio-terrorism Preparedness and Response Act of 2002. The solution that we offer consists of an in-depth analysis of the plant and leads to identifying security risks and developing better procedures. Our program meets all regulatory and third party audit requirements. We can help you by building a robust Bio-security Policy, which serves to protect your ingredients, packaging and products.
After a food safety or quality event, it is easy to forget to determine, and implement changes for, a problem. We use ThinkReliability's Cause Mapping program and training to conduct a thorough root cause analysis, establish corrective actions and ensure that the issue is not repeated. This program can also be used to correct issues, such as microbiological, that have shown to be tough to resolve. We have experience trending results and drilling down to root causes for product oxidation, microbiological issues, pathogen issues, foreign material and many other issues.
One of the easiest ways to obtain food safety is to create and implement a changeover matrix. This matrix is an easy-to-use visual guide for employees when changing from one product to another. The changeover takes account for allergens, protected status products (Non-GMO, Organic, etc.) and also coloring and additives. We can develop a changeover for both the processing and packaging areas of your plant.
Both CIP and COP systems ensure that your product remains safe and maintains the quality aspects and shelf life that you expect from your products. When these systems go down, you can expect to see a significant decrease in quality and an increase in microbiological activity. With this solution, we troubleshoot these systems, including the hot set, and repair them.
One of the free services that we offer when visiting a plant is a cost analysis reduction. We use our experience to evaluate your system, propose changes based upon return on investment (ROI) and help implement those changes. This evaluation of your plant, and the subsequent savings, can help recover a part or the whole cost of the services that you purchase from us. If needed, we can develop a Pareto chart and implement conference calls to help keep initiatives moving forward and track savings.
One of the systems required for food safety is a validated Crisis Management Plan. This plan is developed as a proactive approach to dealing with food safety, food quality, personnel safety and many other issues that may occur. We develop these plans according to the needs of your plant and operation.
It is said that if it isn't documented, it didn't happen. We develop, and implement, a robust documentation control system to meet any food manufacturing need, Regulatory and GFSI requirement.
We have developed a system to rid the clutter in manufacturing plants and make audits less stressful. Our system incorporates the use of a streamlined electronic filing system. This allows for quick access to production records for audits, mock recall exercises, customer complaints and many other reasons. We have tested various methods and found the perfect and easiest way to do this. We have brought this system to numerous plants with huge success.
Training is not only a required aspect of a GFSI system, such as BRC or SQF, but it is also the ethical thing to do when producing food. We offer training solutions for not only food safety and food quality, but also for general employee safety. We can develop a training system to meet your needs and requirements. From new employee food safety and quality orientation training to monthly refreshers, we can offer a solution for you.
We have enlisted the help of several engineers to help bring solutions to the food manufacturing industry. We are extremely confident in saying that whatever issue may arise, we have more than likely seen it before, something similar to it or know someone who can help. We have a full machine shop to fabricate custom engineering solutions for your facility.
We offer general and sanitary piping and tubing, general help with enrobing and tempering machines, repairs and installation of chillers and troubleshooting, repair and replacement of HVAC systems. We can also troubleshoot most pneumatic systems and manufacturing equipment.
Our team can help to evaluate your plant and design a sustainable and resilient environmental monitoring program. With this solution, we develop an environment map of your facility, establish zones, assign site numbers, identify the indicator organism and solidify the sampling schedule with trending results.
Our ERP and MRP solutions can be used to streamline and increase the profits for your facility. We offer expert implementation, upgrading and consulting solutions for Power 6, Oracle, Caelus, MAS, ROSS and PLEX enterprise resource planning systems. Our experts help companies implement these systems from new projects to general consulting. General consulting consists of data migration, training, designing process flows and utilizing all components of an ERP and MRP system.
Many fillers come with the added benefit of a programmable CIP system. This addition to a machine can be a huge advantage in reducing microbiological contamination. Unfortunately, it is sometimes hard to program these units to function correctly. If you are having microbiological problems with a filler, and it has a self-contained CIP system, it is more than likely an issue with the system itself. We have experience with these systems and can even install a self-contained system on a filler that doesn't already have one.
A Food Safety / HACCP Plan is one of the most vital assessments that can be completed for your company and the products that you produce. Unfortunately, writing these plans can be a daunting task. A HACCP plan is required for:
Meat and Poultry (USDA; 9 CFR part 417)
Juice (FDA; 21 CFR part 120)
Seafood (FDA; 21 CFR part 123)
All other food food manufacturers are required to have a Food Safety Plan (FDA; 21 CFR part 117)
We will visit your facility and write your Food Safety / HACCP Plan(s) while you focus on the other intricacies of your company. The Food Safety / HACCP Plans that we build are looked highly upon by both regulatory agencies and GFSI certifying bodies.
We have brought many plants into compliance with the Food Safety Modernization Act (FSMA). This encompasses food destined for animal feed, developing Food Safety Plans, environmental monitoring and other requirements. If you are a new manufacturer or just haven't had time, or the knowledge, to update your process to FSMA standards, we are here to help.
This solution works with the supplier in the country of origin, along with the importer, to navigate through the regulations established by FSMA in bringing foreign ingredients or finished product into the United States.
We have worked for years with the FOSS FT-120. We have experienced numerous issues with this equipment and would enjoy walking you through troubleshooting the machine. We can also help setup preventive maintenance and calibration programs for the machine. Give us a call first to try and resolve issues.
Our company offers full plant auditing and gap analysis auditing to numerous standards. We offer this service for general plant auditing, GFSI preparation and for your supply chain. If you would like to rely on something other than a third party audit certificate to validate the safety of your supply chain, we can complete an on-site audit and evaluation. By having us complete a gap analysis of your plant, we can help prepare you for upcoming GFSI, regulatory and customer audits.
Most large retailers and customers require Global Food Safety Initiative (GFSI) audits from a facility before purchasing products from them. This can be a daunting task for a supplier, but we can streamline this process and use our knowledge and experience to develop your programs and successfully lead you through the auditing process. This can be as hands-on or hands-off as you would like. We can implement the programs required for most current versions of GFSI standards and can also be onsite, or on call, during your facilities audit. Furthermore, we can offer support for writing corrective action plans for debits incurred during these audits.
The production of safe and ethical foods require current Good Manufacturing Practices (cGMPs) to be in place for the facility. Not only are these policies good ideas, but cGMPs are also required in the Code of Federal Regulation (CFR). We offer this solution to help build and document these programs. The cGMP programs that we can write for your facility include, but is not limited to:
Plant and Grounds
Sanitary Facilities and Controls
Equipment and Utensils
Processes and Controls
Warehousing and Distribution
The implementation of FSMA has had a major regulatory impact on the importation of food ingredients and finished products. To be allowed within the United States, the supplying country is required to have a comparable food safety standard to that of the United States. As of 2020, only New Zealand and Canada are identified as comparable. If the product or ingredient is coming from another country, without a comparable food safety standard, the importer is required to ensure that the product is safe for entry into the United States. This system is known as the Foreign Supplier Verification Program (FSVP). We take this hassle and stress from the importer and ensure that the supplier is approved and the ingredient or finished product is received.
We understand what it means and how it feels to lose personnel and have an open position. Food safety initiatives and programs are often left behind and unattended during a vacancy. This makes it hard for the next individual taking the job. It also makes it hard for audits and answering questions for regulatory inspections. We developed this program to help in these circumstances. This solution offers our assistance in keeping the company on the right track and maintaining the food safety programs within the facility during a vacancy. With our experience, we have the ability to be an interim Quality Assurance Manager for your site. Using this program, we will ensure that all food safety programs, including environmental monitoring, auditing, HACCP, calibrations, etc., remain intact during the transitional period.
We have the experience to not only develop a testing program for your products, but also introduce you to ISO certified laboratories. These laboratories will issue validated COAs for all food testing issues that may arise. Some of the examples of testing includes: Microbiological, Added Sugar, Caffeine, Gas Chromatography, Allergens and Shelf Life.
Keeping a facility clean is one thing, but being able to brainstorm what requires cleaning, and the interval of that cleaning, can be more of a challenge. Some of the most often overlooked items include refrigeration cooling coils, ventilation ductworks and air blow cleaning and sanitizing. We can complete an evaluation of your plant and provide you with a Master Sanitation System (MSS) that is easy to manage and works towards continuous improvement.
One of the most overlooked aspects of food safety is properly commissioning equipment. This process includes the Food Safety / HACCP Plan analysis, passivation, examination for niches, CIP validation, post construction cleaning plans, product sampling plans, Standard Operating Procedures and numerous other items. Using our solution to commission new equipment can ultimately save you time and money, as we have the experience to ask the questions that others may not think of.
Building a new manufacturing site can be a fun, but stressful, period for a company. It can also be challenging to know exactly what needs to get done. Things can get overlooked, which can lead to negative financial impacts. Using all the members of our team, we can deal with regulatory plan approval, GFSI audit scheduling, Kosher certification, equipment placement for efficiencies, new plant requirements, warehouse racking options and design, new building approvals and many other issues. We also offer full equipment commissioning plans for the new facility.
With our experience, we can build and implement a Non-GE program. This program is easier, and less costly, for milk or milk containing products. With this program, you do not have to use organic milk, whereas with Non-GMO Project Verified you are locked into that. We will be with you through every step of this process, including the final Non-GE certifying body audit.
We can work on packaging solutions that contain Non-GMO declarations without having to go through the arduous process of becoming Non-GMO Project Verified. We can lead you through the process of adding this symbol to your packaging to reach health conscious consumers and ultimately increase sales.
If you are interested in going through the Non-GMO Project Verified process, we are here to help. The Project Verified certification is the gold standard of Non-GMO programs. We can develop your system and achieve the ability for your product to use this coveted butterfly symbol. This symbol is used to drive sales and reach health conscious consumers.
Passivation is the most important process that you can do to a stainless steel piece of equipment, tank or line. This process should be completed after welding, grinding or when the surface of the metal has been scratched, gouged or marred. Without this process, stainless steel impurities will corrode and show as rust. Using a passivation technique, we are able to expose certain elements in the metal and build a corrosion resistant barrier. With this solution, we can order the chemicals, complete the work and get the equipment, tank or line ready to use.
The writing and implementation of food safety, food quality and general policies is the first step in solidifying a robust program within a plant. Following the policy with an assessment ensures that personnel understand and acknowledge the policy and standards set forth. With this solution, we are able to write standard policies, and assessments, to bring your facility to the next level in food safety, food quality and general practices.
Preventive Controls (PCs) are the required backbone of a Food Safety Plan. All facilities that fall under FSMA regulations must have PCs under the Code of Federal Regulations. Required Preventive Controls under 21 CFR 117.135 include:
Food Allergen Controls
Other Controls (hygiene training and cGMPs)
We can help develop and implement these controls. It is best to utilize us to build your whole Food Safety / HACCP Plan as a complete project, which will include Preventive Controls or Prerequisite Programs.
Cleaning and sanitation is the first line of defense against cross-contamination and shelf life issues. We have experience in developing sanitation controls for many different types of facilities. These process controls develop a cleaning strategy, and verification, for each line and/or equipment in your facility. The pre-operational controls contain all necessary items to satisfy audits and includes ATP swabbing sites and protocols.
With our well-seasoned process improvement and warehousing experts, we can use the principles of Kaizen Lean Manufacturing and Six Sigma to build a robust, and sustainable, processing and/or warehousing system. These improvement strategies keep both food safety regulatory practices and profitability as the main focus.
New product, line extension, cost reduction or reversed engineered product? We have done all of these on tight budgets and timelines.
We have experience in rebuilding and repairing product and dosing pumps. This includes vitamin pumps, LMI pumps and numerous other styles of pumps. Depending on the issue, we can usually get your pump back to you within a few days. For vitamin pump repairs, we can help with manual addition calculations while your pump is getting repaired.
Not only are we able to develop formulas, but we also develop the Principle Information Panel (nutritional data, ingredient declaration, etc.) to be used with these formulas. The panel that we develop follows the 2020 NLEA conventions and ensures that your product is fully protected from mislabeling, potential consumer risks and possible recalls. Beginning in 2020, product packaging for bio-engineered foods will need to be declared. Please use the USDA website for more information on this mandate. We have also put help in our Guidance Documents section of this website. Or, give us a call and we can help develop packaging that meets these, and all other, requirements.
Product quality issues can negatively impact shelf life, consumer expectations, production efficiencies, the reputation of the company and possibly the safety of the product. Fortunately, most issues are easy to solve and straightforward. For the more complicated situations, we offer our experience and solutions. We use our knowledge of microbiological growth and vectors to evaluate the situation, propose a corrective action plan and implement solutions to resolve the issue. We can also propose solutions for oxidation, foreign material and many other quality hurdles.
Our firm can evaluate your products and develop a product testing frequency and protocol. With our experience, we can establish an in-house analytical testing program or solidify a third party testing regimen. We can help guide your facility with industry testing standards and practices, which includes shelf-life stability testing protocols.
Using our specialized processes, we are able to build efficient production planning strategies which serve to drive down costs, increase efficiencies and help identify hurdles in your manufacturing process. This solution can help establish material and packaging planning and also order scheduling. This solution can be extremely useful for new or rapidly expanding companies.
A Quality Manual is a set of instructions and procedures that is written for your company to guide you through everyday processes and/or abnormal issues. This manual is a step-by-step guide on how to legally resolve obstacles that occur within the process, or to be used as a resource for questions. Our Quality Manual covers everything from cGMP requirements to Recall Efficiency Questionnaires. This manual, specifically built for your company, is a valuable solution that can help you through audits, troubleshooting and helping to implement quality solutions.
Our Quality Programs & Time Schedule solution helps keep track of many programs within the plant. One of the hardest things to do is to keep track of the timing of calibrations and other required programs. With all of the weekly, monthly, quarterly and annual requirements, our solution keeps track of them all. It also allows for a more streamlined process when auditors ask when a particular task or item was competed.
Being able to trace and recall products is the most important thing that a company can do. When things go bad, the longer that a deleterious product sits on store shelves the greater the chance that consumers, or company reputations, will get hurt. Having the ability to trace product, packaging and raw materials is not only legally required, but it is the ethical thing to do. With our Recall Preparation & Planning solution, we develop and implement a Recall Team, schedule team meetings and lead the company through mock recalls. With the results of these mock recalls, we will develop an action plan to improve the percentage found or the time taken to trace the products. A standard efficiency, which we will help you achieve, is 100% +/- 1% within four (4) hours. We highly recommend that you use our Quality Manual Writing & Implementation solution when developing a recall plan.
With the implementation of more strict regulatory standards, it is only a matter of time before a regulatory agency visits your facility. The FDA has increased sampling programs across the board, and we project that certain processes, such as fruit and vegetable and supplements, will become more regulated. Although we cannot relieve the anxiety that accompany these visits, we can offer solutions that help prepare for, and respond to, regulatory agencies. QCS offers consulting that advises you of your rights in regards to food manufacturing and what regulatory personnel can view and what is considered proprietary, and therefore private, documents. The Quality Manual deals directly with these issues.
We can develop and write SOPs and SSOPs for many processes in your facility. We use our industry experience to establish best practices for completing tasks within the plant. We use our SSOPs for sanitation tasks within the plant, while SOPs give employees procedural guides for all other areas. These documents are written in such a way as to give an employee explicit instructions on how to complete a job both safely and thoroughly. An option is to also include an assessment for the training. Along with writing the SOPs and/or SSOPs, we can also perform the training with the employees.
A Statistical Process Control (SPC) system not only meets expectations set by GFSI schemes, but it also helps the bottom line for a company. Common SPC systems for a plant include weight control and labeling vision systems. When looking at a weight SPC, it can be seen that huge profits can be saved in product shrink. We can implement SPC solutions that fit your needs and serve to save the company money.
Steam pumps are mechanical systems used to return condensate back to a boiler. We ran a cost savings initiative for a plant, rebuilt the steam pumps, installed steam traps and were able to both make steam equipment function better and save the plant around $30,000 annually. This savings was seen after spending around $6,000 for parts and labor to install the parts. We can supply the parts and repair your system to return it to a functioning state.
We have dealt with numerous temperature monitoring solutions and can develop not only an in-house calibration program, but also recommend a solution that fits your requirements and aligns with regulatory demands. We can offer data logging systems, manual temperature tracking programs, in-process temperature monitoring, automated COP and CIP temperature monitoring and logistics temperature logging and tracking. A single instance of temperature abused product that is rejected by a customer will more than likely cost more than the implementation of this program.
Our team offers calibration services for your facility's temperature monitoring devices using NIST thermometers. We also specialize in developing easy to follow calibration schedules for your plant. These schedules exceed expectations set by both GFSI and regulatory agencies.
Some customers require the use of the USDA's trademarked Organic status symbol. This robust program can be difficult to navigate, implement and be successful with. Raw ingredient sourcing can be challenging for this project. We make it extremely easy for you by building the system and also sourcing the raw ingredients. If not a customer requirement, this status may give you the edge to a competitive Consumer Packaged Goods (CPG) market.
A lack of time is usually the reason for not rebuilding valves and/or valve clusters. Unfortunately, this can cause product issues. Due to contamination that can occur in valves, staying on top of maintenance can save you financially. If you are having problems finding time to rebuild valves or full clusters, we can help. We work on both product and CIP valves. With our rebuild program, we replace the consumable parts and rebuild the actuator. We can work to procure and replace springs, valve stems and other items on valves and actuators, so there is no need to purchase a new one. You can send us a valve or actuator to repair and we should be able to have it back to you within a few days. Whatever your need is with valves or actuators, we have the solution.
Our company can be utilized to identify warehousing, process flow and efficiency issues. We work to resolve FIFO and inventory management problems to lower costs associated with raw material and packaging obsolescence due to expiration or packaging conversions. We also specialize in building, organizing and implementing warehousing solutions that focus on resource allocation and profitability using configuration management and other databases. Using just-in-time (JIT) standards, we have the solution to determine optimal inventory levels and reduce waste.